CN111556728B - Controlling a surgical instrument based on sensed closure parameters - Google Patents

Abstract

A surgical instrument includes an end effector, a motor for opening and closing jaws, a sensor configured to detect a tissue compression parameter associated with tissue between the jaws, and a control circuit. The control circuit is configured to determine a value of the tissue compression parameter via the sensor when the jaws transition from the open configuration to the closed configuration, cause the motor to increase a time to transition the jaws to the closed configuration based on whether the value of the tissue compression parameter is above a first threshold, and provide feedback based on whether the value of the tissue compression parameter is below a second threshold.

Description

Control surgical instruments based on sensed closure parameters

Cross-references to related applications

This patent application is filed under Title 35 United States Code Section 119(e) of U.S. Provisional Patent Application Serial No. 62/691,227 titled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSUREPARAMETERS" filed on June 28, 2018. Priority rights, the entire disclosure of this provisional patent application is incorporated herein by reference.

This application is filed in accordance with the provisions of Title 35, United States Code, Section 119(e), U.S. Provisional Patent Application Serial No. 62/650,887, March 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES", filed on March 30, 2018. The U.S. provisional patent application serial number 62/650,877 titled "SURGICAL SMOKE EVACUATION SENSINGAND CONTROLS" filed on March 30, 2018, and the U.S. provisional patent application titled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM" filed on March 30, 2018 No. 62/650,882 and priority interest in U.S. Provisional Patent Application Serial No. 62/650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATHPAD WITH SEPARABLE ARRAY ELEMENTS", the disclosures of each of these provisional patent applications The contents are incorporated herein by reference in their entirety.

This patent application, pursuant to 35 U.S.C. § 119(e), also claims U.S. Provisional Patent Application Serial No. 62/640,417, filed on March 8, 2018, titled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR" and priority interest in Provisional Patent Application Serial No. 62/640,415 titled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR" filed on March 8, 2018. The full disclosure content of each of these provisional patent applications is at Incorporated herein by reference.

This patent application also claims U.S. Provisional Patent Application Serial No. 62/611,341, filed on December 28, 2017, titled INTERACTIVE SURGICAL PLATFORM, in accordance with Title 35, United States Code, Section 119(e). U.S. Provisional Patent Application Serial No. 62/611,340, titled CLOUD-BASED MEDICALANALYTICS, filed on December 28, 2017, and Robot-Assisted Surgical Platform (ROBOT ASSISTED) filed on December 28, 2017. SURGICAL PLATFORM), the disclosures of each of which are incorporated herein by reference in their entirety.

Background technique

The present disclosure relates to various surgical systems.

Contents of the invention

In one aspect, a surgical instrument includes: an end effector including a jaw convertible between an open configuration and a closed configuration; a motor operably coupled to the jaw, the motor being Constructed to enable the jaws to transition between an open configuration and a closed configuration;

a sensor configured to transmit at least one signal indicative of a tissue compression parameter associated with tissue between the jaws; and a control circuit coupled to the sensor and the motor. The control circuit is configured to: receive the at least one signal; when the jaw transitions from the open configuration to the closed configuration, determine a value of the tissue compression parameter based on the at least one signal; cause the motor to determine whether the value of the tissue compression parameter is higher than a first threshold to increase the time for transitioning the jaws to a closed configuration; and feedback is provided based on whether the value of the tissue compression parameter is below a second threshold.

In another aspect, a surgical instrument includes: an end effector having a jaw convertible between an open configuration and a closed configuration; and one or more sensors along the The tissue contacting surface of each of the jaws is provided with one or more sensors configured to detect contact with tissue. The surgical instrument also includes a motor operably coupled to the jaws, the motor configured to convert the jaws between an open configuration and a closed configuration; and control circuitry coupled to the one or more sensors. and that motor. The control circuit is configured to: determine an initial point of contact between tissue and the tissue contact surface of the jaws; determine the spacing between the jaws at the initial point of contact; determine the degree of contact between the tissue contact surface and the tissue; cause the motor to causing the jaws to transition to the closed configuration at a rate corresponding to the spacing between the jaws and the degree of contact between the tissue contact surface and the tissue at the initial point of contact; and causing the motor to transition the jaws to the closed configuration in response to the force exerted by the motor. The rate at which the jaws transition to a closed configuration is regulated by whether the force exceeds a threshold, where the threshold corresponds to the spacing between the jaws at the initial point of contact and the degree of contact between the tissue contact surface and the tissue.

In one aspect, a surgical instrument includes: an end effector having a jaw configured to transition between an open configuration and a closed configuration to grasp tissue; and a contact sensor assembly, the contact sensor assembly being configured to sense tissue against the contact sensor assembly. The surgical instrument also includes: a position sensor configured to sense a configuration of the jaws; a motor coupled to the jaws, the motor configured to move the jaws between an open configuration and a closed configuration. transition; and a control circuit coupled to the contact sensor assembly, the position sensor, and the motor. The control circuit is configured to: determine an initial contact point with tissue contacting the jaw; determine a configuration of the jaw at the initial contact point via a position sensor; determine a configuration of the jaw at the initial contact point via the contact sensor assembly The amount of tissue contact; the closing rate at which the motor transitions the jaws to the closed configuration is set based on the configuration of the jaws and the amount of tissue contact at the initial contact point; the closing rate at which the motor transitions the jaws to the closed configuration is based on the configuration of the jaws and the amount of tissue contact at the initial contact point to set a closing threshold; and to control the motor based on the force exerted by the motor to cause the jaws to transition to a closed configuration relative to the threshold.

Description of the drawings

Various aspects are characterized with particularity in the appended claims. However, the various aspects (regarding surgical organization and methods) and further objects and advantages may be best understood by reference to the following description taken in conjunction with the accompanying drawings.

Figure 1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

Figure 2 is a surgical system for performing a surgical procedure in an operating room in accordance with at least one aspect of the present disclosure.

Figure 3 is a surgical hub paired with a visualization system, a robotic system, and smart instruments in accordance with at least one aspect of the present disclosure.

4 is a partial perspective view of a surgical hub housing and a combination generator module slidably received in a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure.

Figure 5 is a perspective view of a combination generator module with bipolar, ultrasonic and unipolar contacts and smoke exhaust components in accordance with at least one aspect of the present disclosure.

6 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular enclosure configured to slidably receive a plurality of modules in accordance with at least one aspect of the present disclosure.

7 illustrates a vertical modular housing configured to slidably receive a plurality of modules in accordance with at least one aspect of the present disclosure.

8 illustrates a surgical data network including a modular communications hub configured to enable modular or dedicated devices located in one or more operating rooms of a medical facility in accordance with at least one aspect of the present disclosure. Connect any room in a medical facility for surgical operations to the cloud.

Figure 9 is a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

Figure 10 illustrates a surgical hub including a plurality of modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure.

11 illustrates one aspect of a Universal Serial Bus (USB) network hub device in accordance with at least one aspect of the present disclosure.

12 illustrates a logic diagram of a control system for a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

13 illustrates a control circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Figure 14 illustrates a combinational logic circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Figure 15 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

16 illustrates a surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure.

Figure 17 is a schematic illustration of a robotic surgical instrument configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure.

18 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure.

Figure 19 is a schematic diagram of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure.

20 is a stroke length graph illustrating an example of a control system that modifies the stroke length of a clamping assembly based on articulation angle.

21 is a closed tube assembly positioning graph illustrating an example of a control system for modifying the longitudinal position of a closed tube assembly based on an angle of articulation;

Figure 22 is a comparison of a suturing method that utilizes controlled tissue compression versus a suturing method that does not utilize controlled tissue compression.

Figure 23 is a force graph shown in part A and an associated displacement graph shown in part B, where the force graph and the displacement graph have an x-axis defining time and a y-axis of the displacement graph defining firing. The travel displacement of the link, and the y-axis of the force curve defines the torque sensed on the motor configured to advance the firing link.

Figure 24 is a schematic diagram of a tissue contact circuit showing the completion of the circuit when a pair of spaced contact plates are in contact with tissue.

25 is a perspective view of a surgical instrument having an interchangeable shaft assembly operatively coupled thereto in accordance with at least one aspect of the present disclosure.

Figure 26 is an exploded assembly view of a portion of the surgical instrument of Figure 25 in accordance with at least one aspect of the present disclosure.

Figure 27 is an exploded assembly view of a portion of an interchangeable shaft assembly in accordance with at least one aspect of the present disclosure.

Figure 28 is an exploded view of the end effector of the surgical instrument of Figure 25 in accordance with at least one aspect of the present disclosure.

29A is a block diagram of the control circuitry of the surgical instrument of FIG. 25 spanning two figures in accordance with at least one aspect of the present disclosure.

29B is a block diagram of the control circuitry of the surgical instrument of FIG. 25 spanning two figures in accordance with at least one aspect of the present disclosure.

30 is a block diagram of the control circuitry of the surgical instrument of FIG. 25 illustrating interfaces between the handle assembly and the power assembly, and between the handle assembly and the interchangeable shaft assembly, in accordance with at least one aspect of the present disclosure.

Figure 31 depicts an exemplary medical device that may include one or more aspects of the present disclosure.

Figure 32 depicts an exemplary end effector of a tissue-encircling medical device in accordance with one or more aspects of the present disclosure.

33 depicts an exemplary end effector of a medical device that compresses tissue in accordance with one or more aspects of the present disclosure.

34 depicts exemplary forces exerted by an end effector of a medical device compressing tissue in accordance with one or more aspects of the present disclosure.

Figure 35 also depicts exemplary forces exerted by an end effector of a medical device compressing tissue in accordance with one or more aspects of the present disclosure.

Figure 36 depicts an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure.

Figure 37 also depicts an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure.

Figure 38 also depicts an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure.

Figure 39 is also an exemplary circuit diagram in accordance with one or more aspects of the present disclosure.

Figure 40 is also an exemplary circuit diagram in accordance with one or more aspects of the present disclosure.

Figure 41 is a graph depicting example frequency modulation in accordance with one or more aspects of the present disclosure.

Figure 42 is a graph depicting a composite RF signal in accordance with one or more aspects of the present disclosure.

Figure 43 is a graph depicting a filtered RF signal in accordance with one or more aspects of the present disclosure.

Figure 44 is a perspective view of a surgical instrument having interchangeable shafts capable of articulation.

Figure 45 is a side view of the distal end of a surgical instrument.

Figures 46 to 50 plot the gap size as a function of time (Fig. 46), the firing current as a function of time (Fig. 47), the tissue compression as a function of time (Fig. 48), and the anvil strain as a function of time (Fig. 49 ) and a graph of triggering force over time (Figure 50).

Figure 51 is a graph plotting tissue compression changes with tissue displacement for normal tissue.

Figure 52 is a graph plotting tissue compression as a function of tissue displacement to differentiate between normal tissue and diseased tissue.

Figure 53 illustrates one embodiment of an end effector including a first sensor and a second sensor.

54 is a logic diagram illustrating one embodiment of a process for adjusting measurements of a first sensor based on input from a second sensor of the end effector shown in FIG. 53 .

Figure 55 is a logic diagram illustrating one embodiment of a process for determining a lookup table for a first sensor based on input from a second sensor.

Figure 56 is a logic diagram illustrating one embodiment of a process for calibrating a first sensor in response to input from a second sensor.

Figure 57 is a logic diagram illustrating one embodiment of a process for determining and displaying the thickness of a tissue segment clamped between the anvil and staple cartridge of an end effector.

Figure 58 is a logic diagram illustrating one embodiment of a process for determining and displaying the thickness of a tissue segment clamped between the anvil and staple cartridge of an end effector.

Figure 59 is a graph showing adjusted Hall effect thickness measurements compared to unmodified Hall effect thickness measurements.

Figure 60 shows one embodiment of an end effector including a first sensor and a second sensor.

Figure 61 illustrates one embodiment of an end effector including a first sensor and a plurality of second sensors.

62 is a logic diagram illustrating one embodiment of a process for adjusting measurements of a first sensor in response to a plurality of second sensors.

Figure 63 illustrates one embodiment of a circuit configured to convert signals from a first sensor and a plurality of second sensors into digital signals that can be received by a processor.

Figure 64 illustrates one embodiment of an end effector including multiple sensors.

Figure 65 is a logic diagram illustrating one embodiment of a process for determining one or more tissue properties based on multiple sensors.

Figure 66 illustrates one embodiment of an end effector including a plurality of sensors coupled to a second jaw member.

Figure 67 illustrates one embodiment of a staple cartridge including a plurality of sensors integrally formed therein.

Figure 68 is a logic diagram illustrating one embodiment of a process for determining one or more parameters of a tissue segment clamped within an end effector.

Figure 69 illustrates one embodiment of an end effector including multiple redundant sensors.

Figure 70 is a logic diagram illustrating one embodiment of a process for selecting the most reliable output from multiple redundant sensors.

Figure 71 illustrates one embodiment of an end effector including a sensor that includes a specific sampling rate to limit or eliminate spurious signals.

72 is a logic diagram illustrating one embodiment of a process for generating thickness measurements of a tissue segment positioned between an anvil and a staple cartridge of an end effector.

Figures 73 and 74 illustrate one embodiment of an end effector including sensors for identifying different types of staple cartridges.

75 illustrates one aspect of a segmented flex circuit configured to be fixedly attachable to a jaw member of an end effector in accordance with at least one aspect of the present disclosure.

76 illustrates one aspect of a segmented flex circuit configured to be mountable to a jaw member of an end effector in accordance with at least one aspect of the present disclosure.

Figure 77 illustrates one aspect of an end effector configured to measure tissue gap GT in accordance with at least one aspect of the present disclosure.

Figure 78 illustrates one aspect of an end effector including a segmented flex circuit in accordance with at least one aspect of the present disclosure.

Figure 79 illustrates the end effector shown in Figure 78 with the jaw member clamping tissue between the jaw member and the staple cartridge in accordance with at least one aspect of the present disclosure.

80 is a diagram of an absolute positioning system for a surgical instrument in accordance with at least one aspect of the present disclosure, wherein the absolute positioning system includes a controlled motor drive circuit arrangement including a sensor arrangement.

Figure 81 is a diagram of a position sensor including a magnetic rotational absolute positioning system in accordance with at least one aspect of the present disclosure.

82 is a cross-sectional view of an end effector of a surgical instrument showing firing member travel relative to tissue grasped within the end effector in accordance with at least one aspect of the present disclosure.

Figure 83 is a first graph of two Closure Force (FTC) curves depicting the force applied to the closure member during the closure phase to close on thick and thin tissue, and two Firing Force (FTF) curves. The second graph depicts the force applied to the firing member to fire through thick and thin tissue during the firing phase.

84 is a diagram of a control system configured to provide progressive closure of a closure member during a firing stroke as the firing member is distally advanced and coupled to a clamping arm, in accordance with at least one aspect of the present disclosure. The desired rate reduces the closing force load on the closing member and reduces the firing force load on the firing member.

Figure 85 illustrates a proportional integral derivative (PID) controller feedback control system in accordance with at least one aspect of the present disclosure.

86 is a logic flow diagram depicting a process of a control program or logic configuration for determining a speed of a closure member in accordance with at least one aspect of the present disclosure.

Figure 87 is a timeline depicting situational awareness of a surgical hub in accordance with at least one aspect of the present disclosure.

88 illustrates a block diagram of a surgical system configured to control surgical functions in accordance with at least one aspect of the present disclosure.

89 illustrates a block diagram of a surgical system configured to enable situational awareness to control surgical functions in accordance with at least one aspect of the present disclosure.

Figure 90 is a logic flow diagram depicting a situational awareness-based algorithm for controlling surgical functions in accordance with at least one aspect of the present disclosure.

Figure 91 is a logic flow diagram depicting an algorithm for controlling surgical functions in accordance with at least one aspect of the present disclosure.

Figure 92 illustrates a portion of a patient's tissue including a tumor and a surgical margin defined relative to the tumor, in accordance with at least one aspect of the present disclosure.

93 is a logic flow diagram depicting a process of a control program or logic configuration for solving a device selection problem in accordance with at least one aspect of the present disclosure.

94 illustrates a block diagram of a surgical system configured to determine the appropriateness of a surgical instrument based on device parameters and sensed parameters in accordance with at least one aspect of the present disclosure.

Figure 95 shows a block diagram of a surgical instrument in accordance with at least one aspect of the present disclosure.

96 illustrates a logic flow diagram of a process for controlling a surgical instrument based on the integrity of clamped tissue in accordance with at least one aspect of the present disclosure.

97 illustrates a first graph depicting force over time for closure of an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

98 illustrates a second graph depicting force for closure over time for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

99 illustrates a logic flow diagram of a process for controlling a surgical instrument based on the physiological type of tissue being clamped, in accordance with at least one aspect of the present disclosure.

Figure 100A illustrates a side elevation view of an end effector grasping a substance in accordance with at least one aspect of the present disclosure, with the end effector in an initial contact position with the substance.

Figure 100B illustrates a side elevational view of an end effector grasping substance with the end effector in a closed condition in accordance with at least one aspect of the present disclosure.

101A illustrates a side elevational view of an end effector grasping a vessel in an initial contact position with the vessel in accordance with at least one aspect of the present disclosure.

101B illustrates a side elevational view of an end effector grasping a vessel with the end effector in a closed state in accordance with at least one aspect of the present disclosure.

102 illustrates first and second graphs, respectively, depicting force for closure and closure speed over time for an exemplary fired end effector of a surgical instrument grasping a substance, in accordance with at least one aspect of the present disclosure. Graph.

103 illustrates third and third graphs, respectively, depicting force for closure and closure speed over time for an exemplary fired end effector of a surgical instrument grasping a vessel in accordance with at least one aspect of the present disclosure. Four curve graph.

104 illustrates a fifth graph depicting force for closure and closure speed over time for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

105 illustrates a fifth graph depicting force for closure and closure speed over time for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

106 illustrates a fifth graph depicting force for closure and closure speed over time for an exemplary fired end effector of a surgical instrument in accordance with at least one aspect of the present disclosure.

Figure 107 shows a graph depicting impedance over time to determine when the jaws of a surgical instrument contact tissue and/or staples in accordance with at least one aspect of the present disclosure.

Figure 108 shows a first graph depicting various tissue closure thresholds for controlling end effector closure in accordance with at least one aspect of the present disclosure.

Figure 109 shows a second graph depicting various tissue closure thresholds for controlling end effector closure in accordance with at least one aspect of the present disclosure.

110 is a logic flow diagram depicting a process for adjusting a control program or logic configuration of a closure rate algorithm in accordance with at least one aspect of the present disclosure.

Detailed ways

The applicant for this patent application owns the following U.S. patent applications filed on June 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

·The U.S. patent application serial number __________ titled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAYELEMENTS", attorney docket number END8542USNP/170755;

·The U.S. patent application serial number __________ titled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSEDCLOSURE PARAMETERS", attorney docket number END8543USNP/170760;

·The U.S. patent application serial number __________ titled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ONPERIOPERATIVE INFORMATION" and the attorney docket number is END8543USNP1/170760-1;

·The U.S. patent application serial number __________ titled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", attorney docket number END8543USNP2/170760-2;

·The U.S. patent application serial number __________ titled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", attorney docket number END8543USNP3/170760-3;

·The U.S. patent application serial number __________ titled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUEDISTRIBUTION IRREGULARITIES", attorney docket number END8543USNP4/170760-4;

·The U.S. patent application serial number __________ titled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TOCANCEROUS TISSUE" and the attorney docket number is END8543USNP5/170760-5;

·The U.S. patent application serial number __________ titled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES", attorney docket number END8543USNP6/170760-6;

·The U.S. patent application serial number __________ titled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", attorney docket number END8543USNP7/170760-7;

·The U.S. patent application serial number __________ titled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", attorney docket number END8544USNP/170761;

·The U.S. patent application serial number __________ titled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT", attorney docket number END8544USNP1/170761-1;

·The U.S. patent application serial number __________ titled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY", attorney docket number END8544USNP2/170761-2;

·The U.S. patent application serial number __________ titled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSIONCAPABILITIES", attorney docket number END8544USNP3/170761-3;

·The U.S. patent application serial number __________ titled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL", attorney docket number END8545USNP/170762;

·The U.S. patent application serial number __________ titled "SURGICAL EVACUATION SENSOR ARRANGEMENTS", attorney docket number END8545USNP1/170762-1;

·The U.S. patent application serial number __________ titled "SURGICAL EVACUATION FLOW PATHS", attorney docket number END8545USNP2/170762-2;

·The U.S. patent application serial number __________ titled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL", attorney docket number END8545USNP3/170762-3;

·The U.S. patent application serial number __________ titled "SURGICAL EVACUATION SENSING AND DISPLAY", attorney docket number END8545USNP4/170762-4;

·The U.S. patent application serial number __________ titled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUBOR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM", and the attorney docket number is END8546USNP/170763;

·The U.S. patent application serial number __________ titled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROLCIRCUIT FOR INTERACTIVE SURGICAL PLATFORM", attorney docket number END8546USNP1/170763-1;

· U.S. Patent Application Serial No. __________, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FORCOMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE", Attorney Docket No. END8547USNP/170764; and

·The U.S. patent application serial number __________ titled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS", attorney docket number ND8548USNP/170765.

The applicant for this patent application owns the following U.S. provisional patent applications filed on June 28, 2018, and the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

U.S. Provisional Patent Application Serial No. 62/691,228, entitled A Method of using reinforced flex circuits with multiple sensors with electrosurgical devices;

·U.S. Provisional Patent Application Serial No. 62/691,230, titled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;

·U.S. Provisional Patent Application Serial No. 62/691,219, titled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;

U.S. Provisional Patent Application Serial No. 62/691,257, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEMPARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVESURGICAL PLATFORM);

U.S. Provisional Patent Application Serial No. 62/691,262, entitled SURGICAL EVACUATION SYSTEM WITH ACOMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKEEVACUATION DEVICE); and

·U.S. provisional patent application serial number 62/691,251, titled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS;

The applicant for this patent application owns the following U.S. patent applications filed on March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

· U.S. patent application serial number 15/940,641, titled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

· U.S. patent application serial number 15/940,648, titled INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICESAND DATA CAPABILITIES;

· U.S. patent application serial number 15/940,656, titled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES;

· U.S. patent application serial number 15/940,666, titled SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;

U.S. Patent Application Serial No. 15/940,670, titled COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS;

· U.S. Patent Application Serial No. 15/940,677, entitled Surgical Hub Control Arrangement;

U.S. patent application serial number 15/940,632, titled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD;

U.S. Patent Application Serial No. 15/940,640, entitled COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHAREDWITH CLOUD BASED ANALYTICS SYSTEMS);

· U.S. patent application serial number 15/940,645, titled SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;

· U.S. Patent Application Serial No. 15/940,649, titled DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH ANOUTCOME;

·U.S. patent application serial number 15/940,654, titled SURGICALHUB SITUATIONAL AWARENESS;

·U.S. patent application serial number 15/940,663, titled SURGICALSYSTEM DISTRIBUTED PROCESSING;

· U.S. Patent Application Serial No. 15/940,668, titled AGGREGATION AND REPORTING OF SURGICAL HUB DATA;

U.S. Patent Application Serial No. 15/940,671, titled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATINGTHEATER;

· U.S. patent application serial number 15/940,686, titled DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;

·U.S. patent application serial number 15/940,700, titled STERILEFIELD INTERACTIVE CONTROL DISPLAYS;

· U.S. patent application serial number 15/940,629, titled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

· U.S. patent application serial number 15/940,704, titled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;

· U.S. Patent Application Serial No. 15/940,722, entitled CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY; and

·U.S. Patent Application Serial No. 15/940,742, titled Dual Complementary Metal Oxide Semiconductor (CMOS) Array Imaging (DUAL CMOS ARRAY IMAGING);

The applicant for this patent application owns the following U.S. patent applications filed on March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

· U.S. patent application serial number 15/940,636, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;

· U.S. patent application serial number 15/940,653, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;

· U.S. patent application serial number 15/940,660, titled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONSTO A USER;

U.S. Patent Application Serial No. 15/940,679, entitled CLOUD-BASED MEDICAL ANALYTICS FORLINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OFLARGER DATA SET);

U.S. patent application serial number 15/940,694, titled CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITYSEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION;

U.S. Patent Application Serial No. 15/940,634, entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTICATION TRENDS AND REACTIVE MEASURES;

U.S. Patent Application Serial No. 15/940,706, entitled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and

· U.S. patent application serial number 15/940,675, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;

The applicant for this patent application owns the following U.S. patent applications filed on March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

· U.S. patent application serial number 15/940,627, titled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

· U.S. patent application serial number 15/940,637, titled COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

· U.S. patent application serial number 15/940,642, titled CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

· U.S. patent application serial number 15/940,676, titled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

· U.S. patent application serial number 15/940,680, titled CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

· U.S. patent application serial number 15/940,683, titled COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Patent Application Serial No. 15/940,690, entitled DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

· U.S. patent application serial number 15/940,711, titled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

The applicant for this patent application owns the following U.S. provisional patent applications filed on March 28, 2018, and the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

· U.S. Provisional Patent Application Serial No. 62/649,302, titled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATIONCAPABILITIES;

· U.S. Provisional Patent Application Serial No. 62/649,294, titled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD;

·U.S. provisional patent application serial number 62/649,300, titled SURGICAL HUB SITUATIONAL AWARENESS;

· U.S. Provisional Patent Application Serial No. 62/649,309, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER for determining devices in the operating room;

·U.S. Provisional Patent Application Serial No. 62/649,310, titled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

· U.S. Provisional Patent Application Serial No. 62/649291, titled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;

·U.S. Provisional Patent Application Serial No. 62/649,296, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;

· U.S. Provisional Patent Application Serial No. 62/649,333, titled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION ANDRECOMMENDATIONS TO A USER;

U.S. Provisional Patent Application Serial No. 62/649,327, entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTICATION TRENDS AND REACTIVE MEASURES;

· U.S. Provisional Patent Application Serial No. 62/649,315, titled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;

· U.S. Provisional Patent Application Serial No. 62/649,313, titled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;

· U.S. Provisional Patent Application Serial No. 62/649,320, titled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

· U.S. Provisional Patent Application Serial No. 62/649,307, entitled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

· U.S. Provisional Patent Application Serial No. 62/649,323, titled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

The applicant of this patent application owns the following U.S. provisional patent application filed on April 19, 2018, the full disclosure contents of which are incorporated herein by reference:

·U.S. provisional patent application serial number 62/659,900, titled METHOD OFHUB COMMUNICATION;

The applicant for this patent application owns the following U.S. provisional patent applications filed on March 30, 2018, and the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

·U.S. Provisional Patent Application Serial No. 62/650,887, titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;

· U.S. Provisional Patent Application Serial No. 62/650,877 titled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS";

·U.S. Provisional Patent Application Serial No. 62/650,882 titled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";

as well as

· U.S. Provisional Patent Application Serial No. 62/650,898 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAYELEMENTS".

The applicant for this patent application owns the following U.S. provisional patent applications filed on March 8, 2018, and the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

· U.S. Provisional Patent Application Serial No. 62/640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR; and

· U.S. Provisional Patent Application Serial No. 62/640,415 titled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM THEREFOR".

The applicant for this patent application owns the following U.S. provisional patent applications filed on December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety:

·U.S. Provisional Patent Application Serial No. 62/611,341, titled "INTERACTIVE SURGICAL PLATFORM";

· U.S. Provisional Patent Application Serial No. 62/611,340, entitled CLOUD-BASED MEDICAL ANALYTICS; and

·U.S. provisional patent application serial number 62/611,339, titled ROBOTASSISTED SURGICAL PLATFORM;

Before describing various aspects of surgical devices and generators in detail, it should be noted that the application or use of the illustrative examples is not limited to the details of the configuration and arrangement of components illustrated in the drawings and detailed description. Illustrative examples may be implemented alone or combined with other aspects, variations and modifications, and may be practiced or performed in a variety of ways. Furthermore, unless otherwise indicated, the terms and expressions used herein have been selected for convenience of the reader in describing the exemplary embodiments and not for purpose of limitation. Furthermore, it should be understood that one or more of the aspects, expressions of aspects and/or examples described below may be combined with any one or more of the other aspects, expressions of aspects and/or examples described below.

Before describing various aspects of surgical devices and generators in detail, it should be noted that the application or use of the illustrative examples is not limited to the details of the configuration and arrangement of components illustrated in the drawings and detailed description. Illustrative examples may be implemented alone or combined with other aspects, variations and modifications, and may be practiced or performed in a variety of ways. Furthermore, unless otherwise indicated, the terms and expressions used herein have been selected for convenience of the reader in describing the exemplary embodiments and not for purpose of limitation. Furthermore, it should be understood that one or more of the aspects, expressions of aspects and/or examples described below may be combined with any one or more of the other aspects, expressions of aspects and/or examples described below.

Certain exemplary aspects will now be described in order to provide a thorough understanding of the principles of the structure, function, manufacture, and use of the presently disclosed apparatus and methods. One or more examples of these aspects are illustrated in the accompanying drawings. Those of ordinary skill in the art will appreciate that the apparatus and methods specifically described herein and illustrated in the drawings are non-limiting exemplary aspects, and that the scope of the aspects is limited only by the claims. Features shown or described in connection with one exemplary aspect may be combined with features of other aspects. Such modifications and variations are intended to be included within the scope of the claims.

Referring to Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (eg, a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with a cloud 104 that may include a remote server 113 . In one example, as shown in FIG. 1 , surgical system 102 includes visualization system 108 , robotic system 110 , and handheld smart surgical instrument 112 configured to communicate with each other and/or with hub 106 . In some aspects, surgical system 102 may include M number of hubs 106 , N number of visualization systems 108 , O number of robotic systems 110 , and P number of handheld intelligent surgical instruments 112 , where M, N, O, and P are greater than or An integer equal to one.

FIG. 3 illustrates an example of a surgical system 102 for performing a surgical procedure on a patient lying supine on an operating table 114 in a surgical operating room 116 . Robotic system 110 is used as part of surgical system 102 during surgical procedures. Robotic system 110 includes a surgeon's console 118 , a patient-side cart 120 (surgical robot), and a surgical robot hub 122 . The patient side cart 120 may maneuver at least one removably coupled surgical tool 117 through a minimally invasive incision in the patient while the surgeon views the surgical site through the surgeon's console 118 . Images of the surgical site may be obtained by the medical imaging device 124 , which may be maneuvered by the patient side cart 120 to orient the imaging device 124 . The robotic hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118 .

Other types of robotic systems may be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use in the present disclosure are described in U.S. Provisional Patent Application Serial No. 62/611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017 , the entire disclosure of this patent is incorporated herein by reference.

Various examples of cloud-based analytics performed by the cloud 104 and suitable for use in the present disclosure are described in the U.S. Provisional Patent Application Series entitled "CLOUD-BASED MEDICAL ANALYTICS" filed on December 28, 2017 No. 62/611,340, the entire disclosure of which is incorporated herein by reference.

In various aspects, imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.

The optical components of imaging device 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.

One or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum (sometimes called the optical spectrum or luminescent spectrum) is that part of the electromagnetic spectrum that is visible to (ie, detectable by) the human eye, and may be referred to as visible light or simply light. A typical human eye will respond to wavelengths in air from about 380nm to about 750nm.

The invisible spectrum (ie, the non-luminescent spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (ie, wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma-ray electromagnetic radiation.

In various aspects, imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopy, angioscopy, bronchoscopy, choledochoscopy, colonoscopy, cytoscope, duodenoscope, enteroscope, esophago-duodenoscope (gastroscope) ), endoscopy, laryngoscopy, nasopharyngeal-renal endoscopy, sigmoidoscopy, thoracoscopy and hysteroscopy.

In one aspect, the imaging device uses multispectral monitoring to discern topography and underlying structure. Multispectral images are images that capture image data across specific wavelength ranges of the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and UV. Spectral imaging may allow the extraction of additional information that the human eye fails to capture with its red, green, and blue receptors. The use of multispectral imaging is covered under the heading "Advanced Imaging Acquisition Module" in U.S. Provisional Patent Application Serial No. 62/611,341, filed on December 28, 2017, titled "INTERACTIVE SURGICALPLATFORM" Described in greater detail, the disclosure of this patent is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool for relocating the surgical field after completing a surgical mission to perform one or more of the previously described tests on the treated tissue.

It is self-evident that strict disinfection of the operating room and surgical equipment is required during any surgery. The strict hygiene and sterilization conditions required in the "surgical suite" (i.e., operating room or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process requires sterilizing any material that contacts the patient or penetrates the sterile field, including the imaging device 124 and its attachments and components. It will be appreciated that a sterile field may be considered a designated area that is considered free of microorganisms, such as within a tray or a sterile towel, or the sterile field may be considered an area surrounding a patient that is prepared for a surgical procedure. The sterile field may include scrubbed team members who are appropriately dressed, as well as all furniture and fixtures in the area.

In various aspects, visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays strategically positioned relative to a sterile field, as shown in FIG. shown in 2. In one aspect, visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are disclosed in U.S. Provisional Patent Application Serial No. 62/611,341, filed on December 28, 2017, titled "INTERACTIVE SURGICALPLATFORM" and titled "Advanced Imaging Acquisition Module" ” is described below, the entire disclosure of which patent application is incorporated herein by reference.

As shown in FIG. 2 , the primary display 119 is positioned in the sterile field to be visible to the operator at the operating table 114 . Furthermore, the visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. The visualization system 108 directed by the hub 106 is configured to utilize displays 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, hub 106 may enable imaging system 108 to display snapshots of the surgical site recorded by imaging device 124 on non-sterile display 107 or 109 while maintaining a real-time feed of the surgical site on primary display 119 . Snapshots on a non-sterile display 107 or 109 may allow a non-sterile operator to perform diagnostic steps related to a surgical procedure, for example.

In one aspect, the hub 106 is also configured to be able to route diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to the main display 119 within the sterile field, where it can be viewed by the sterile operator at the operating station. . In one example, the input may be a modified form of a snapshot displayed on non-sterile display 107 or 109 , which may be routed through hub 106 to primary display 119 .

Referring to Figure 2, surgical instrument 112 is used during a surgical procedure as part of surgical system 102. Hub 106 is also configured to coordinate the flow of information to the display of surgical instrument 112 . For example, U.S. Provisional Patent Application Serial No. 62/611,341 titled "INTERACTIVE SURGICAL PLATFORM" was filed on December 28, 2017, the entire disclosure of which is incorporated herein by reference. Diagnostic input or feedback entered by a non-sterile operator at visualization tower 111 may be routed by hub 106 to surgical instrument display 115 within the sterile field, where the input or feedback may be viewed by the operator of surgical instrument 112 . Exemplary surgical instruments suitable for use in surgical system 102 are described in U.S. Provisional Patent Application Serial No. 62/611,341 titled "INTERACTIVE SURGICAL PLATFORM" filed on December 28, 2017, titled "Surgical Instrument Hardware" Surgical Instrument Hardware", the disclosure of that patent is incorporated herein by reference in its entirety.

Referring now to FIG. 3 , hub 106 is depicted in communication with visualization system 108 , robotic system 110 and handheld smart surgical instrument 112 . Hub 106 includes hub display 135 , imaging module 138 , generator module 140 , communications module 130 , processor module 132 and storage array 134 . In certain aspects, as shown in FIG. 3 , the hub 106 also includes a smoke exhaust module 126 and/or an extraction/flush module 128 .

During surgical procedures, the application of energy to tissue for sealing and/or cutting is often associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of the tissue. Fluid lines, power lines, and/or data lines from different sources often become tangled during surgical procedures. Valuable time can be lost during the surgical procedure to resolve this issue. Disconnecting a pipeline may require disconnecting the pipeline from its corresponding module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of tangling between such lines.

Aspects of the present disclosure provide a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably received in a docking base of the hub housing. The docking base includes data contacts and power contacts. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component and a unipolar RF energy generator component housed in a single unit. In one aspect, the combination generator module further includes a smoke exhaust component for at least one energy delivery cable connecting the combination generator module to the surgical instrument, configured to exhaust smoke generated by applying therapeutic energy to the tissue, At least one smoke evacuation component for fluids and/or particles, and a fluid line extending from the remote surgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to the aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.

Certain surgical procedures may require the application of more than one energy type to tissue. One energy type may be more beneficial for cutting tissue, while a different energy type may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasonic generator can be used to cut sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the hub modular housing 136 is the ability to quickly remove and/or replace various modules.

Aspects of the present disclosure provide modular surgical housings for use in surgical procedures involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking base including a first docking station. a port, the first docking port including first data and power contacts, wherein a first energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the first energy generator module is slidably movable out electrically engages the first power and data contacts.

Further to the above, the modular surgical housing further includes a second energy generator module configured to generate a second energy different from the first energy for application to the tissue, and a second docking base including a second docking port including second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts , and wherein the second energy generator module is slidably movable out of electrical engagement with the second power and data contacts.

Additionally, the modular surgical housing includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

Referring to FIGS. 3-7 , aspects of the present disclosure are presented as a hub modular housing 136 that allows modular integration of the generator module 140 , the smoke exhaust module 126 , and the extraction/flush module 128 . The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. As shown in Figure 5, the generator module 140 may be a generator module having integrated monopolar components, bipolar components, and ultrasonic components supported on a single unit slidably inserted into the hub modular housing 136. in housing unit 139. As shown in FIG. 5 , the generator module 140 may be configured to be connectable to a monopolar device 146 , a bipolar device 147 , and an ultrasound device 148 . Alternatively, generator module 140 may include a series of unipolar generator modules, bipolar generator modules, and/or ultrasonic generator modules that interact through hub modular housing 136 . The hub modular housing 136 may be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular housing 136 such that the generators will act as a single generator.

In one aspect, the hub modular housing 136 includes a modular power and communications backplane 149 with external and wireless communications connections to enable removable attachment of the modules 140, 126, 128 and interactive communications therebetween.

In one aspect, the hub modular housing 136 includes a docking base or drawer 151 (also referred to herein as a drawer) configured to slidably receive the modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and the combination generator module 145 slidably received in the docking base 151 of the surgical hub housing 136 . The docking port 152 having power and data contacts on the back of the combination generator module 145 is configured to enable the corresponding docking port 152 to be connected when the combination generator module 145 is slid into place within the corresponding docking base 151 of the hub module housing 136 . The docking port 150 engages the power and data contacts of the corresponding docking base 151 of the hub modular housing 136 . In one aspect, the combined generator module 145 includes bipolar, ultrasonic and monopolar modules and a smoke exhaust module integrated together into a single housing unit 139, as shown in Figure 5.

In various aspects, the smoke evacuation module 126 includes a fluid line 154 that communicates trapped/collected smoke and/or fluid from the surgical site to, for example, the smoke evacuation module 126 . Vacuum extraction from the smoke extraction module 126 may draw smoke into the openings of the utility duct at the surgical site. The common conduit coupled to the fluid line may be in the form of a flexible pipe that terminates at the smoke exhaust module 126 . The common conduits and fluid lines define a fluid path extending toward the smoke exhaust module 126 slidably received in the hub housing 136 .

In various aspects, the aspiration/irrigation module 128 is coupled to a surgical tool including an aspiration fluid line and an aspiration fluid line. In one example, the aspiration and aspiration fluid lines are in the form of flexible tubes extending from the surgical site toward the aspiration/irrigation module 128 . One or more drive systems may be configured to flush fluid to and aspirate fluid from the surgical site.

In one aspect, a surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, an aspiration tube, and an irrigation tube. The suction tube may have an inlet at its distal end and extend through the shaft. Similarly, the suction tube may extend through the shaft and may have an inlet adjacent the energy delivery tool. The energy delivery tool is configured to deliver ultrasound energy and/or RF energy to the surgical site and is coupled to the generator module 140 via a cable that initially extends through the shaft.

The flush tube can be in fluid communication with the fluid source, and the suction tube can be in fluid communication with the vacuum source. A fluid source and/or vacuum source may be located in the aspiration/flush module 128 . In one example, the fluid source and/or vacuum source may be seated in the hub housing 136 independently of the aspiration/flush module 128 . In such examples, the fluid interface can connect the aspiration/flush module 128 to a fluid source and/or vacuum source.

In one aspect, the modules 140, 126, 128 and/or their corresponding docking bases on the hub modular housing 136 may include alignment features configured to enable the module's docking ports to be aligned with their corresponding docking ports on the hub. Corresponding ports in the docking base of modular housing 136 engage. For example, as shown in FIG. 4 , the combination generator module 145 includes side brackets 155 configured to slidably engage corresponding brackets 156 of corresponding docking bases 151 of the hub modular housing 136 . The bracket cooperates to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub modular housing 136 .

In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the modules are sized to be received in the drawers 151 . For example, side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. Among other things, the drawers 151 vary in size and are each designed to accommodate specific modules.

Additionally, the contacts of a specific module can be keyed to engage the contacts of a specific drawer to avoid inserting a module into a drawer with mismatched contacts.

As shown in FIG. 4 , the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate interaction between modules housed in the hub modular housing 136 communication. Alternatively or additionally, the docking port 150 of the hub modular housing 136 may facilitate wireless interactive communication between modules housed in the hub modular housing 136 . Any suitable wireless communication may be employed, such as, for example, Air Titan-Bluetooth.

6 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular housing 160 configured to slidably receive multiple modules of a surgical hub 206. Laterally modular housing 160 is configured to laterally slidably receive and interconnect modules 161 . Modules 161 are slidably inserted into docking bases 162 of a transverse modular housing 160 that includes a base plate for interconnecting modules 161 . As shown in Figure 6, the modules 161 are arranged transversely in a transverse modular housing 160. Alternatively, the modules 161 may be arranged vertically in a transverse modular housing.

7 illustrates a vertical modular housing 164 configured to slidably receive a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into a docking base or drawer 167 of a vertical modular housing 164 that includes a base plate for interconnecting the modules 165 . Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in some cases the vertical modular housing 164 may include laterally arranged drawers. Additionally, the modules 165 may interact with each other through the docking ports of the vertical modular housing 164 . In the example of Figure 7, a display 177 is provided for displaying data related to the operation of module 165. Additionally, the vertical modular housing 164 includes a main module 178 that houses a plurality of sub-modules slidably received therein.

In various aspects, imaging module 138 includes an integrated video processor and a modular light source, and is suitable for use with a variety of imaging devices. In one aspect, the imaging device consists of a modular housing that can be assembled with a light source module and a camera module. The housing can be a disposable housing. In at least one example, the disposable housing is removably coupled to the reusable controller, light source module, and camera module. The light source module and/or camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. On the other hand, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanning beam imaging. Likewise, the light source module may be configured to deliver white light or different lights, depending on the surgical protocol.

During a surgical procedure, it can be inefficient to remove a surgical device from the surgical site and replace the surgical device with another surgical device that includes a different camera or a different light source. Temporary loss of view of the surgical field can lead to undesirable consequences. The modular imaging device of the present disclosure is configured to allow for mid-stream replacement of a light source module or camera module during a surgical procedure without having to remove the imaging device from the surgical site.

In one aspect, an imaging device includes a tubular housing including a plurality of channels. The first channel is configured to slidably receive a camera module that is configured for snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module that is configured for snap-fit engagement with the second channel. In another example, the camera module and/or light source module can be rotated to a final position within its respective channel. A threaded engagement may be used instead of a snap-fit engagement.

In various examples, multiple imaging devices are placed at different locations in the surgical field to provide multiple views. Imaging module 138 may be configured to be able to switch between imaging devices to provide an optimal view. In various aspects, imaging module 138 may be configured to be able to integrate images from different imaging devices.

Various image processors and imaging devices suitable for use in the present disclosure are described in U.S. Patent 7,995,045 entitled COBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, issued on August 9, 2011, which patent is incorporated by reference. The entire text is incorporated into this article. In addition, U.S. Patent 7,982,776 titled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, published on July 19, 2011, describes various systems for removing motion artifacts from image data. This patent is incorporated by reference in its entirety. Such systems may be integrated with imaging module 138. In addition, U.S. Patent Application Publication No. 2011/0306840 titled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS" published on December 15, 2011 and "SYSTEM FOR PERFORMING AMINIMALLY INVASIVE SURGICAL PROCEDURE" published on August 28, 2014 ” U.S. Patent Application Publication No. 2014/0243597, the disclosures of each of these patent applications are incorporated herein by reference in their entirety.

8 illustrates a surgical data network 201 including a modular communications hub 203 configured to enable modular devices located in one or more operating rooms of a medical facility or specifically equipped for surgical operations. Any room in a medical facility is connected to a cloud-based system (eg, cloud 204 may include remote server 213 coupled to storage device 205). In one aspect, modular communications hub 203 includes network hub 207 and/or network switch 209 in communication with a network router. Modular communications hub 203 may also be coupled to local computer system 210 to provide local computer processing and data manipulation. Surgical data network 201 may be configured as passive, intelligent, or switched. The passive surgical data network acts as a conduit for data, allowing it to be moved from one device (or segment) to another and to cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic across the surgical data network and configuring each port in the network hub 207 or network switch 209 . Smart surgical data networks may be referred to as manageable hubs or switches. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

Modular devices 1a-1n located in the operating room may be coupled to modular communications hub 203. Network hub 207 and/or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred via routers to cloud-based computers for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 may be coupled to network hub 207 and/or network router 211 to connect devices 2a-2m to cloud 204. Data associated with devices 2a-2n may be transmitted to cloud 204 via network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to local computer system 210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 can be expanded by interconnecting multiple network hubs 207 and/or multiple network switches 209 with multiple network routers 211 . The modular communications hub 203 may be included in a modular control tower configured to slidably receive a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be included in the modular control tower. The modular communication hub 203 is connected to the display 212 to display images acquired by some of the devices 1a-1n/2a-2m, for example during a surgical procedure. In various aspects, devices 1a-1n/2a-2m may include, for example, various modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, Aspirate/irrigation module 128 , communication module 130 , processor module 132 , storage array 134 , a surgical device connected to a display, and/or other modular devices connectable to modular communication hub 203 of surgical data network 201 . Contact sensor module.

In one aspect, surgical data network 201 may include network hub(s), network switch(s), and network router(s) connecting devices 1a-1n/2a-2m to the cloud. combination. Any or all of the devices 1a-1n/2a-2m connected to a network hub or network switch can collect data in real time and transmit the data to a cloud computer for data processing and manipulation. It should be understood that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "the Internet," although the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to a "type of Internet-based computing" in which disparate services (such as servers, storage, and applications) are delivered to a computer located in a surgical suite (e.g., fixed, mobile, temporary, or on-site). Modular communication hub 203 and/or computer system 210 in an operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 via the Internet. Cloud infrastructure can be maintained by a cloud service provider. In this case, the cloud service provider may be the entity that coordinates the use and control of the devices 1a-1n/2a-2m located in one or more operating rooms. Cloud computing services can perform extensive calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to be connected to a computer that communicates with cloud computing resources and storage.

Applying cloud computing data processing techniques to data collected by devices 1a-1n/2a-2m, the surgical data network provides improved surgical outcomes, reduced costs and improved patient satisfaction. At least some of devices 1a-1n/2a-2m may be employed to observe tissue status to assess leakage or perfusion of sealed tissue following tissue sealing and cutting procedures. At least some of the devices 1a-1n/2a-2m may be employed to identify pathology, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes tissue and phenotype localization and edge confirmation. At least some of devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques, such as overlaying images captured by multiple imaging devices. Data collected by devices 1a-1n/2a-2m, including image data, may be transferred to cloud 204 or local computer system 210 or both for data processing and manipulation, including image processing and manipulation. Data can be analyzed to improve surgical procedure outcomes by determining whether further treatments such as endoscopic intervention, emerging technologies, targeted radiation, targeted intervention, and the application of precision robotics to tissue-specific sites and conditions can be pursued. This Class data analysis can be further processed with outcome analysis, and the use of standardized methods can provide helpful feedback to confirm surgical treatment and surgeon behavior, or recommend modifications to surgical treatment and surgeon behavior.

In one implementation, operating room devices 1a-1n may be connected to modular communications hub 203 via wired channels or wireless channels, depending on the configuration of devices 1a-1n to the network hub. In one aspect, network hub 207 may be implemented as a local network broadcaster operating on the physical layer of the Open Systems Interconnection (OSI) model. The network hub provides connectivity to devices 1a-1n located in the same operating room network. The network hub 207 collects data in the form of packets and sends them to the router in half-duplex mode. The hub 207 does not store any Media Access Control/Internet Protocol (MAC/IP) used to transmit device data. Only one of the devices 1a-1n can send data through the network hub 207 at a time. The network hub 207 has no routing tables or intelligence as to where to send information and broadcasts all network data on each connection and through the cloud 204 to the remote server 213 (FIG. 9). Network hub 207 can detect basic network errors such as conflicts, but broadcasting all information to multiple ports can pose security risks and cause bottlenecks.

In another implementation, operating room devices 2a-2m may be connected to network switch 209 via wired channels or wireless channels. Network switch 209 operates in the data link layer of the OSI model. Network switch 209 is a multicast device used to connect devices 2a-2m located in the same operating room to the network. The network switch 209 sends data to the network router 211 in the form of frames and operates in full-duplex mode. Multiple devices 2a-2m can send data simultaneously through network switch 209. Network switch 209 stores and uses the MAC addresses of devices 2a-2m to transmit data.

Network hub 207 and/or network switch 209 are coupled to network router 211 to connect to cloud 204 . Network router 211 works in the network layer of the OSI model. Network router 211 creates routes for transmitting data packets received from network hub 207 and/or network switch 211 to cloud-based computer resources for further processing and manipulation by any of devices 1a-1n/2a-2m or all data collected. Network router 211 may be employed to connect two or more different networks located at different locations, such as, for example, different operating rooms at the same medical facility or different networks located at different operating rooms at different medical facilities. The network router 211 sends data to the cloud 204 in the form of packets and operates in full-duplex mode. Multiple devices can send data simultaneously. Network router 211 uses IP addresses to transmit data.

In one example, network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host. USB hubs can expand a single USB port to multiple levels so that more ports are available for connecting devices to the host system computer. Network hub 207 may include wired or wireless capabilities for receiving information over wired or wireless channels. In one aspect, the Wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in the operating room.

In other examples, operating room devices 1a-1n/2a-2m may communicate with modular communications hub 203 via the Bluetooth wireless technology standard for use over short distances (using short wavelength UHF radios from 2.4 to 2.485 GHz in the ISM band). Wave) exchange data from fixed and mobile devices and build Personal Area Networks (PAN). In other aspects, the operating room devices 1a-1n/2a-2m can communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE) and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, and designated as 3G, 4G, 5G and Any other wireless and wired protocols above. The computing module may include multiple communication modules. For example, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO et al.

The modular communications hub 203 may serve as the central connection for one or all of the operating room devices 1a-1n/2a-2m, and handles a data type known as frames. Frames carry data generated by devices 1a-1n/2a-2m. When the frame is received by the modular communications hub 203, it is amplified and transmitted to the network router 211, which transmits the data to the cloud computing resources using multiple wireless or wired communications standards or protocols as described herein.

Modular communications hub 203 can be used as a stand-alone device or connected to compatible network hubs and network switches to form larger networks. Modular communications hub 203 is generally easy to install, configure, and maintain, making it a good option for networking operating room units 1a-1n/2a-2m.

Figure 9 illustrates a computer-implemented interactive surgical system 200. Computer-implemented interactive surgical system 200 is similar to computer-implemented interactive surgical system 100 in many aspects. For example, computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to surgical system 102 . Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204 that may include a remote server 213 . In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room devices, such as, for example, smart surgical instruments, robots, and other computerized devices located in the operating room. . As shown in FIG. 10 , modular control tower 236 includes modular communications hub 203 coupled to computer system 210 . As shown in the example of FIG. 9 , modular control tower 236 is coupled to imaging module 238 coupled to endoscope 239 , generator module 240 coupled to energy device 241 , smoke evacuator module 226 , aspiration/irrigation module 228 , communication module 230, processor module 232, storage array 234, smart device/instrument 235 optionally coupled to display 237, and non-contact sensor module 242. The operating room equipment is connected to cloud computing resources and data storage via modular control tower 236 . Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices/instruments 235, visualization system 208, etc. may be coupled to modular control tower 236 via wired or wireless communication standards or protocols, as described herein. Modular control tower 236 may be coupled to hub display 215 (eg, monitor, screen) to display and overlay images received from imaging modules, device/instrument displays, and/or other visualization systems 208 . The hub display can also combine images and overlays to display data received from devices connected to the modular control tower.

FIG. 10 shows a surgical hub 206 that includes multiple modules coupled to a modular control tower 236 . Modular control tower 236 includes a modular communications hub 203 (eg, network connectivity device) and computer system 210 to provide, for example, local processing, visualization, and imaging. As shown in FIG. 10 , modular communications hub 203 can configure connections in layers to expand the number of modules (eg, devices) that can be connected to modular communications hub 203 and transmit data associated with the modules to computer system 210 , cloud computing resources, or both. As shown in Figure 10, each of the network hubs/switches in modular communications hub 203 includes three downstream ports and one upstream port. An upstream network hub/switch is connected to the processor to provide communication connections to cloud computing resources and local display 217 . Communication with cloud 204 may occur through wired or wireless communication channels.

The surgical hub 206 employs a non-contact sensor module 242 to measure the dimensions of the operating room and generates a map of the surgical room using an ultrasonic or laser type non-contact measurement device. The ultrasound-based non-contact sensor module scans the operating room by emitting a burst of ultrasound waves and receiving the echoes as they bounce off the operating room walls, as described in a December 28, 2017 submission titled "INTERACTIVE SURGICAL PLATFORM), which is incorporated herein by reference in its entirety, wherein the sensor The module is configured to determine the size of the operating room and adjust Bluetooth pairing distance limits. The laser-based non-contact sensor module scans the operating room by emitting laser pulses, receiving laser pulses that bounce off the walls of the operating room, and comparing the phase of the emitted pulse to the received pulse to determine the size and adjust the operating room Bluetooth pairing distance limit.

Computer system 210 includes a processor 244 and a network interface 245. Processor 244 is coupled to communication module 247, storage device 248, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus. The system bus may be any of several types of bus structures, including a memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any of the various available bus architectures, including but not limited to 9-bit bus, Industry Standard Architecture (ISA), Micro Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other peripheral bus.

Processor 244 may be any single-core or multi-core processor, such as those offered by Texas Instruments under the tradename ARM Cortex. In one aspect, the processor may be, for example, a Texas Instruments LM4F230H5QR ARM Cortex-M4F processor core that includes 256KB of single cycle flash or other non-volatile memory (up to 40MHZ) On-chip memory, prefetch buffer for improved performance above 40MHz, 32KB single-cycle sequential random access memory (SRAM), loaded with Software's internal read-only memory (ROM), 2KB electrically erasable programmable read-only memory (EEPROM), and/or one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI )Analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which can be found in the product data sheet.

In one aspect, the processor 244 may include a safety controller, including two series of controller-based controllers such as the TMS570 and RM4x, known under the trade names also manufactured by Texas Instruments for Hercules ARM Cortex R4. Safety controllers can be configured to be used specifically for IEC 61508 and ISO26262 safety-critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity and memory options.

System memory includes volatile memory and non-volatile memory. A basic input/output system (BIOS), which contains basic routines for transferring information between elements within a computer system, such as during startup, is stored in non-volatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. Furthermore, RAM is available in various forms such as SRAM, Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDRSDRAM) Enhanced SDRAM (ESDRAM), Synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM ).

Computer system 210 also includes removable/non-removable, volatile/non-volatile computer storage media, such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as disk drives, floppy drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. Additionally, disk storage may include storage media, alone or in combination with other storage media, including but not limited to optical disk drives such as compact disk ROM devices (CD-ROM), compact disk recordable drives (CD-R drives), optical disk rewritable drives (CD-RW drive) or Digital Versatile Disk ROM drive (DVD-ROM). To facilitate connection of the disk storage device to the system bus, removable or non-removable interfaces may be used.

It will be appreciated that computer system 210 includes software that acts as an intermediary between the user and the underlying computer resources described in a suitable operating environment. Such software includes operating systems. An operating system, which may be stored on a disk storage device, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored in system memory or disk storage. It should be understood that the various components described herein may be implemented with various operating systems or combinations of operating systems.

A user enters commands or information into computer system 210 through input device(s) coupled to I/O interface 251 . Input devices include, but are not limited to, pointing devices such as mice, touch balls, stylus pens, touch pads, keyboards, microphones, joysticks, game pads, satellite dishes, scanners, TV tuner cards, digital cameras, digital camcorders, Material camera, etc. These and other input devices are connected to the processor via the system bus via interface port(s). The interface port(s) include, for example, serial port, parallel port, game port, and USB. The output device(s) use the same type of port as the input device(s). Thus, for example, a USB port can be used to provide input to a computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (such as monitors, displays, speakers, and printers, among other output devices) that require special adapters. Output adapters include, by way of example, but are not limited to, providing a connection between an output device and a system bus. Video and sound cards of the device. It should be noted that other devices or systems such as remote computer(s) provide both input and output capabilities.

Computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as cloud computer(s) or local computers. The remote cloud computer(s) may be a personal computer, server, router, network PC, workstation, microprocessor-based appliance, peer-to-peer device, or other public network node, etc., and generally includes the many or all of the components. For simplicity, only the memory storage device with the remote computer(s) is shown. The remote computer(s) are logically connected to the computer system through a network interface, and then physically connected via a communications connection. Network interfaces cover communication networks such as local area networks (LAN) and wide area networks (WAN). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5, etc. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Network (ISDN) and its variants, packet-switched networks, and digital subscriber lines (DSL).

In various aspects, computer system 210, imaging module 238 and/or visualization system 208 of Figure 10, and/or processor module 232 of Figures 9-10 may include an image processor, image processing engine, media processor, or Any dedicated digital signal processor (DSP) used to process digital images. Image processors can employ parallel computing with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) technology to increase speed and efficiency. Digital image processing engines perform a range of tasks. The image processor may be a system-on-chip with a multi-core processor architecture.

The communication connection(s) refers to the hardware/software used to connect the network interface to the bus. Although the communication connection is shown for example clarification within the computer system, it may also be located external to the computer system 210. The hardware/software necessary to connect to the network interface includes, for illustrative purposes only, internal and external technologies such as modems, including conventional telephone-grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

11 illustrates a functional block diagram of one aspect of a USB network hub 300 device in accordance with at least one aspect of the present disclosure. In an illustrative aspect, USB hub device 300 employs Texas Instruments' TUSB2036 integrated circuit hub. USB hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 in accordance with the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP0) input paired with a differential data positive (DM0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, each of which includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.

The USB hub 300 device is implemented with a digital state machine rather than a microcontroller, and does not require firmware programming. A fully compliant USB transceiver is integrated into the circuitry for the upstream USB transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full-speed devices and low-speed devices by automatically setting the slew rate based on the speed of the device attached to the port. The USB network hub 300 device may be configured to be capable of being in a bus-powered mode or a self-powered mode, and includes hub power logic 312 for managing power.

The USB hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. SIE 310 typically includes up to transaction level signaling. Functions handled may include: packet identification, transaction sequencing, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, non-return to zero inversion (NRZI) data encoding/decoding and bit stuffing, CRC generation and Verification (token and data), Packet ID (PID) generation and verification/decoding, and/or serial-to-parallel/parallel-to-serial conversion. 310 receives clock input 314 and is coupled to pause/resume logic and frame timer 316 circuitry and hub repeater circuitry 318 to control upstream USB transceiver port 302 and downstream USB transceiver port 304 through port logic circuits 320, 322, 324 ,306,308 communication. SIE 310 is coupled via interface logic to command decoder 326 to control commands from the serial EEPROM via serial EEPROM interface 330 .

In various aspects, USB hub 300 can connect 127 functions configured in up to six logical layers (tiers) to a single computer. Additionally, the USB hub 300 can be connected to all external devices using standardized four-wire cables that provide both communications and power distribution. The power configuration is bus-powered mode and self-powered mode. USB network hub 300 can be configured to support four power management modes: a bus-powered hub with individual port power management or grouped port power management, and a self-powered hub with individual port power management or grouped port power management. In one aspect, USB network hub 300, upstream USB transceiver port 302 is plugged into a USB host controller using a USB cable, and downstream USB transceiver ports 304, 306, 308 are exposed for connection of USB compatible devices and the like.

surgical instrument hardware

12 illustrates a logic diagram of a control system 470 for a surgical instrument or tool in accordance with one or more aspects of the present disclosure. System 470 includes control circuitry. The control circuit includes a microcontroller 461 including a processor 462 and a memory 468 . For example, one or more of sensors 472, 474, 476 provide real-time feedback to processor 462. A motor 482 driven by a motor driver 492 is operatively coupled to the longitudinally movable displacement member to drive the I-beam cutter element. Tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to a processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member as well as the position of the firing member, firing rod, and I-beam knife element. Additional motors can be provided at the tool driver interface to control I-beam firing, closed tube travel, shaft rotation and articulation. Display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on display 473 may be overlaid with images acquired via the endoscopic imaging module.

In one aspect, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the main microcontroller 461 may be a LM4F230H5QR ARM Cortex-M4F processor core, available from, for example, Texas Instruments, which includes 256KB of single-cycle flash or other non-volatile memory (up to to 40MHz), prefetch buffer to improve performance above 40MHz, 32KB single-cycle SRAM, loaded with Software's internal ROM, 2KB of EEPROM, one or more PWM modules, one or more QEI analogs, and/or one or more 12-bit ADCs with 12 analog input channels, details of which can be found in the product data sheet.

In one aspect, the microcontroller 461 may include a safety controller including two families of controllers such as the TMS570 and RM4x, known commercially, also manufactured by Texas Instruments It's called Hercules ARM Cortex R4. Safety controllers can be configured to be used specifically for IEC 61508 and ISO26262 safety-critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity and memory options.

The microcontroller 461 can be programmed to perform various functions such as precise control of the speed and position of the knife and articulation system. In one aspect, microcontroller 461 includes processor 462 and memory 468. Electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical link to the articulation or knife system. In one aspect, motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drives may be readily substituted for use in tracking system 480 including an absolute positioning system. The absolute positioning system is described in detail in U.S. patent application publication 2017/0296213 titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, published on October 19, 2017. As described, the entirety of this patent application is incorporated herein by reference.

The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement members and articulation systems. Microcontroller 461 may be configured to be able to calculate the response in the software of microcontroller 461 . The calculated response is compared to the measured response of the actual system to obtain the "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that equalizes the smooth continuous nature of the simulated response with the measured response, which allows the detection of external influences on the system.

In one aspect, motor 482 may be controlled by motor driver 492 and may be employed by a firing system of a surgical instrument or tool. In various forms, motor 482 may be a brushed DC drive motor with a maximum rotational speed of approximately 25,000 RPM. In other arrangements, motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. Motor driver 492 may include, for example, an H-bridge driver including field effect transistors (FETs). The motor 482 may be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly may include a battery, which may include a plurality of battery cells connected in series that may be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and/or rechargeable. In at least one example, the battery cell may be a lithium-ion battery, which may be coupled to and detachable from the power component.

Motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller designed for use with external N-channel power metal-oxide-semiconductor field-effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Driver 492 includes a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows the A3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor can be used to provide the above battery supply voltage required by the N-channel MOSFET. The high-side driver's internal charge pump allows DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation can occur through either the high-side or low-side FET. Power FETs are protected against breakdown by resistor-adjustable dead time. Integrated diagnostics provide indication of undervoltage, overtemperature, and power bridge faults, and can be configured to protect the power MOSFETs under most short-circuit conditions. Other motor drives may be readily substituted for use in tracking system 480 including an absolute positioning system.

Tracking system 480 includes a controlled motor drive circuit arrangement including position sensor 472 in accordance with at least one aspect of the present disclosure. Position sensor 472 for an absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing rod or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Therefore, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool such as a drive member, firing member, firing rod, I-beam, or any element that is capable of displacement. In one aspect, a longitudinally movable drive member is coupled to the firing member, firing rod, and I-beam. Therefore, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, a longitudinally movable drive member, firing member, firing rod, or I-beam, or combination thereof, may be coupled to any suitable linear displacement sensor. Linear displacement sensors may include contact displacement sensors or non-contact displacement sensors. Linear displacement sensors may include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRT), sliding potentiometers, magnetic sensing systems including movable magnets and a series of linearly arranged Hall effect sensors, A magnetic sensing system including a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical sensing system including a movable light source and a series of linearly arranged photodiodes or photodetectors, a fixed light source and a series of Optical sensing system of movable linear arrangement of photodiodes or photodetectors, or any combination thereof.

The electric motor 482 may include a rotatable shaft operatively interfaced with a gear assembly mounted on the displacement member in meshing engagement with a set of drive teeth or a rack. The sensor element may be operably coupled to the gear assembly such that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor arrangement may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system, and the output indicator displays the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member including a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member means a longitudinally movable firing member, a firing rod, an I-beam, or a combination thereof.

A single rotation of the sensor element associated with position sensor 472 is equivalent to a longitudinal linear displacement d1 of the displacement member, where d1 is the movement of the displacement member from point "a" to point " b” longitudinal linear distance. The sensor arrangement may be coupled via a gear reduction that causes the position sensor 472 to complete only one or more revolutions for the full travel of the displacement member. The position sensor 472 can complete multiple rotations for the full stroke of the displacement member.

A series of switches (where n is an integer greater than one) may be employed alone or in conjunction with gear reduction to provide unique position signals for more than one rotation of position sensor 472 . The status of the switch is fed back to the microcontroller 461 which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+...dn of the displacement member. The output of position sensor 472 is provided to microcontroller 461. The position sensor 472 of this sensor arrangement may include a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

Position sensor 472 may include any number of magnetic sensing elements, such as magnetic sensors classified, for example, according to whether they measure the total magnetic field or the vector component of a magnetic field. The techniques used to produce both types of magnetic sensors cover many aspects of physics and electronics. Technologies used for magnetic field sensing include probe coils, flux gates, optical pumps, nuclear spins, superconducting quantum interferometers (SQUID), Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnets Impedance, magnetostrictive/piezoelectric composite materials, magneto-diodes, magneto-transistors, optical fibers, magneto-optics, and magnetic sensors based on micro-electromechanical systems, etc.

In one aspect, position sensor 472 for tracking system 480 that includes an absolute positioning system includes a magnetic rotational absolute positioning system. Position sensor 472 may be implemented as an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. Position sensor 472 interfaces with microcontroller 461 to provide an absolute positioning system. Position sensor 472 is a low voltage and low power component and includes four Hall effect elements located in the area of position sensor 472 on the magnet. A high-resolution ADC and intelligent power management controller are also provided on the chip. A Coordinate Rotation Digital Computer (CORDIC) processor (also known as bitwise and Volder's algorithm) is provided to perform simple and efficient algorithms for computing hyperbolic and trigonometric functions that require only addition, subtraction, bit shifting, and table lookups operate. Angular position, alarm bits, and magnetic field information are transmitted to microcontroller 461 via a standard serial communication interface, such as a serial peripheral interface (SPI) interface. Position sensor 472 provides 12 or 14 bit resolution. Position sensor 472 may be an AS5055 chip available in a small QFN 16-pin 4x4x0.85mm package.

Tracking system 480 including an absolute positioning system may include and/or may be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. The power source converts the signal from the feedback controller into a physical input to the system: in this case, a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, the other sensor(s) may include sensor arrangements such as those described in the patent entitled STAPLE CARTRIDGE TISSUETHICKNESS issued on May 24, 2016. U.S. Patent 9,345,481, the full text of which is incorporated herein by reference; U.S. patent application publication 2014/0263552 titled Staple Cartridge Tissue Thickness Sensor System (STAPLE CARTRIDGE TISSUE THICKNESS) published on September 18, 2014, the full text of which is incorporated herein by reference incorporated herein; and a U.S. patent titled TECHNIQUES FOR ADAPTIVECONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT filed on June 20, 2017 Application Serial No. 15/628,175, the entirety of which is incorporated herein by reference. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system will have limited resolution and sampling frequency. Absolute positioning systems may include comparison and combining circuitry to combine the calculated response with the measured response using algorithms such as weighted averaging and theoretical control loops that drive the calculated response towards the measured response. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system from known inputs.

Therefore, an absolute positioning system provides an absolute position of the displacement member when the instrument is powered on, and does not retract or advance the displacement member to a reset (clear or home) position as may be required with conventional rotary encoders, which are only active for the motor. The number of steps forward or backward taken by 482 is counted to deduce the position of the device actuator, drive rod, knife, etc.

Sensors 474 (such as, for example, strain gauges or microstrain gauges) are configured to measure one or more parameters of the end effector, such as, for example, the amplitude of strain exerted on the anvil during the clamping operation, which amplitude may indicate The closing force applied to the anvil. The measured strain is converted into a digital signal and provided to processor 462. Alternatively or in addition to sensor 474, sensor 476 (such as a load sensor) may measure the closing force applied to the anvil by the closing drive system. A sensor 476 such as a load sensor may measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge slide configured to cam the staple driver upward to push the staple into deforming contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to sever tissue when the I-beam is advanced distally by the firing rod. Alternatively, current sensor 478 may be employed to measure the current drawn by motor 482. The force required to advance the firing member may correspond to the electrical current drawn by motor 482, for example. The measured force is converted into a digital signal and provided to processor 462 .

In one form, strain gauge sensor 474 may be used to measure the force applied to tissue by the end effector. Strain gauges can be coupled to the end effector to measure forces on the tissue being treated by the end effector. A system for measuring force applied to tissue grasped by an end effector includes a strain gauge sensor 474, such as, for example, a microstrain gauge configured to measure, for example, one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain applied to the jaw member of the end effector during the clamping operation, which can be indicative of tissue compression. The measured strain is converted into a digital signal and provided to the processor 462 of the microcontroller 461 . Load sensor 476 may measure the force used to operate the blade element, such as to cut tissue trapped between the anvil and staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. Measurements from the magnetic field sensor may also be converted into digital signals and provided to processor 462 .

Microcontroller 461 may use measurements of tissue compression, tissue thickness, and/or force required to close the end effector as measured by sensors 474, 476, respectively, to characterize the selected position of the firing member and/or the velocity of the firing member. corresponding value. In one example, memory 468 may store techniques, formulas, and/or lookup tables that may be employed by microcontroller 461 in evaluation.

The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with the modular communication hub, as shown in Figures 8-11.

Figure 13 illustrates a control circuit 500 configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. Control circuit 500 may be configured to enable the various processes described herein. Circuit 500 may include a microcontroller including one or more processors 502 (eg, microprocessor, microcontroller) coupled to at least one memory circuit 504 . Memory circuitry 504 stores machine-executable instructions that, when executed by processor 502, cause processor 502 to execute machine instructions to implement the various processes described herein. Processor 502 may be any of a variety of single-core or multi-core processors known in the art. Memory circuit 504 may include volatile storage media and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

14 illustrates a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. Combinational logic circuit 510 may be configured to enable the various processes described herein. Combinational logic circuit 510 may include a finite state machine including combinational logic 512 configured to receive data associated with a surgical instrument or tool at input 514 , process the data through combinational logic 512 and provide Output 516.

15 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. Sequential logic circuitry 520 or combinational logic 522 may be configured to enable the various processes described herein. Sequential logic circuit 520 may include a finite state machine. Sequential logic circuit 520 may include, for example, combinational logic 522, at least one memory circuit 524, and clock 529. At least one memory circuit 524 may store the current state of the finite state machine. In some cases, sequential logic circuit 520 may be synchronous or asynchronous. Combinational logic 522 is configured to receive data associated with a surgical instrument or tool from input 526 , process the data through combinational logic 522 and provide output 528 . In other aspects, circuitry may include a combination of a processor (eg, processor 502, Figure 13) and a finite state machine to implement the various processes herein. In other implementations, the finite state machine may include a combination of combinational logic circuits (eg, combinational logic circuit 510, FIG. 14) and sequential logic circuits 520.

Figure 16 illustrates a surgical instrument or tool that includes multiple motors that can be activated to perform various functions. In some cases, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, and a third motor can be activated to perform a third function. In some cases, multiple motors of robotic surgical instrument 600 may be individually activated to cause firing motion, closing motion, and/or articulation motion in the end effector. Firing motion, closing motion, and/or articulation motion may be transmitted to the end effector, for example, through the shaft assembly.

In some cases, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 is operably coupled to a firing motor drive assembly 604, which can be configured to transmit firing motion generated by the motor 602 to an end effector, specifically for displacing the I-beam element. In some cases, the firing motion generated by motor 602 may cause, for example, staples to be deployed from the staple cartridge into tissue captured by the end effector and/or cause the cutting edge of the I-beam element to be advanced to cut the captured tissue. organize. The I-beam elements can be retracted by reversing the direction of motor 602.

In some cases, a surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605 configured to transmit the closure movement generated by the motor 603 to an end effector, specifically for displacing the closure tube to close the anvil. seat and compresses the tissue between the anvil and cartridge. The closing movement may transition the end effector, for example, from an open configuration to an approximated configuration to capture tissue. The end effector can be shifted to the open position by reversing the direction of motor 603.

In some cases, a surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operatively coupled to respective articulation motor drive assemblies 608a, 608b, which may be configured to transmit articulation generated by the motors 606a, 606b to the end effector. In some cases, articulation allows the end effector to articulate relative to the axis, e.g.

As discussed above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be individually or independently activated to perform one or more functions while other motors remain inactive. For example, articulation motors 606a, 606b may be activated to articulate the end effector, while firing motor 602 remains inactive. Alternatively, firing motor 602 may be activated to fire multiple staples and/or advance the cutting edge, while articulation motor 606 remains inactive. Additionally, closure motor 603 may be activated simultaneously with firing motor 602 to advance the closure tube and I-beam elements distally, as described in greater detail below.

In some cases, a surgical instrument or tool may include a common control module 610 that may be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 may regulate multiple motors one at a time. For example, the common control module 610 may be individually coupled to and detachable from multiple motors of the surgical instrument. In some cases, multiple motors of a surgical instrument or tool may share one or more common control modules such as common control module 610. In some cases, multiple motors of a surgical instrument or tool may independently and selectively engage the common control module 610. In some cases, the common control module 610 may switch from interfacing with one of the plurality of motors of the surgical instrument or tool to interfacing with another of the plurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can selectively switch between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or closing motor 603. In at least one example, as shown in Figure 16, switch 614 can move or transition between multiple positions and/or states. In a first position 616, the switch 614 can electrically couple the common control module 610 to the firing motor 602; in a second position 617, the switch 614 can electrically couple the common control module 610 to the closing motor 603; in a third position 618a , the switch 614 can electrically couple the common control module 610 to the first articulation motor 606a; and in the fourth position 618b, the switch 614 can electrically couple the common control module 610 to, for example, the second articulation motor 606b. In some cases, a separate common control module 610 may be electrically coupled to the firing motor 602, closing motor 603, and articulation motors 606a, 606b simultaneously. In some cases, switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the motor's shaft. The force on the end effector may be sensed in any conventional manner, such as through a force sensor on the outside of the jaws or through a torque sensor for the motor that actuates the jaws.

In various cases, as shown in Figure 16, the common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may regulate power emitted from power source 628 to the motor coupled to common control module 610, for example based on input from microcontroller 620 ("controller"). In some cases, when the motor is coupled to the common control module 610, a microcontroller 620 may be employed, for example, to determine the current drawn by the motor, as described above.

In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform various functions and/or computations described herein. In some cases, one or more of memory units 624 may be coupled to processor 622, for example.

In some cases, power source 628 may be used to power microcontroller 620, for example. In some cases, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some cases, the battery pack may be configured to be releasably mountable to the handle for powering surgical instrument 600 . Multiple series-connected battery cells may be used as power source 628 . In some cases, power source 628 may be, for example, replaceable and/or rechargeable.

In various cases, processor 622 may control motor driver 626 to control the position, direction of rotation, and/or speed of the motor coupled to common controller 610 . In some cases, processor 622 may signal motor driver 626 to stop and/or deactivate motors coupled to common controller 610 . It should be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other device that combines the functionality of a computer's central processing unit (CPU) on one integrated circuit or at most several integrated circuits. Basic computing device. A processor is a general-purpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and provides a result as output. Because a processor has internal memory, it is an example of sequential digital logic. The processor operates on numbers and symbols represented in the binary number system.

In one example, processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In some cases, microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core, which includes: 256KB of single-cycle flash or other non-volatile memory (up to 40MHZ) on-chip memory, pre-programmed memory to improve performance above 40MHz Fetch buffer, 32KB single cycle SRAM, loaded with Software's internal ROM, 2KB of EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Other microcontrollers can be easily swapped for use with module 4410. Therefore, the present disclosure should not be limited to this context.

In some cases, memory 624 may include program instructions for controlling each of the motors of surgical instrument 600 that may be coupled to common controller 610 . For example, memory 624 may include program instructions for controlling firing motor 602, closing motor 603, and articulation motors 606a, 606b. Such program instructions may cause the processor 622 to control firing, closure, and articulation functions based on input from algorithms or control programs of the surgical instrument or tool.

In some cases, one or more mechanisms and/or sensors (such as sensor 630) may be used to alert processor 622 of program instructions that should be used in a particular setting. For example, sensor 630 may alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In some cases, sensor 630 may include, for example, a position sensor that may be used to sense the position of switch 614 . Accordingly, processor 622 may use program instructions associated with firing the I-beam of the end effector when, for example, sensor 630 detects that switch 614 is in first position 616; 614 is in the second position 617 using program instructions associated with closing the anvil; and the processor 622 may be used to cause the end effector when the switch 614 is detected in the third position 618a or the fourth position 618b, such as by sensor 630 Program instructions related to joint movement.

Figure 17 is a schematic illustration of a robotic surgical instrument 700 configured to operate the surgical tools described herein, in accordance with at least one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of the displacement member, distal/proximal displacement of the closure tube, axis rotation, and articulation of single or multiple articulation drive links. In one aspect, surgical instrument 700 may be programmed or configured to individually control the firing member, closure member, shaft member, and/or one or more articulation members. Surgical instrument 700 includes control circuitry 710 configured to control a motor-driven firing member, a closure member, a shaft member, and/or one or more articulation members.

In one aspect, robotic surgical instrument 700 includes control circuitry 710 configured to control anvil 716 and I-beam 714 (including sharp cutting edge) portions of end effector 702 via a plurality of motors 704a-704e , the staple cartridge 718, the shaft 740, and one or more articulation members 742a, 742b can be removed. Position sensor 734 may be configured to provide position feedback of I-beam 714 to control circuit 710 . Other sensors 738 may be configured to provide feedback to the control circuit 710 . Timer/counter 731 provides timing and counting information to control circuit 710. Energy source 712 may be provided to operate motors 704a-704e, and current sensor 736 provides motor current feedback to control circuit 710. Motors 704a-704e may be individually operated in open loop or closed loop feedback control via control circuit 710.

In one aspect, control circuitry 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause one or more processors to perform one or more tasks. In one aspect, the timer/counter 731 provides an output signal, such as an elapsed time or a digital count, to the control circuit 710 to correlate the position of the I-beam 714 as determined by the position sensor 734 to the output of the timer/counter 731 are coupled such that the control circuit 710 can determine the position of the I-beam 714 relative to the home position at a specific time (t) or the time (t) when the I-beam 714 is in a specific position relative to the home position. Timer/counter 731 may be configured to be able to measure elapsed time, count external events, or time external events.

In one aspect, control circuitry 710 may be programmed to control the functionality of end effector 702 based on one or more tissue conditions. Control circuit 710 may be programmed to directly or indirectly sense tissue conditions, such as thickness, as described herein. Control circuit 710 may be programmed to select a firing control program or a closure control program based on tissue conditions. The firing control program may describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower speed and/or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher speed and/or at a higher power. The closure control program may control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of shaft 740 and articulation members 742a, 742b.

In one aspect, control circuit 710 may generate a motor setpoint signal. Motor setpoint signals may be provided to various motor controllers 708a-708e. Motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to motors 704a-704e to drive the motors 704a-704e, as described herein. In some examples, motors 704a-704e may be brushed DC electric motors. For example, the speed of motors 704a-704e may be proportional to the corresponding motor drive signal. In some examples, the motors 704a-704e may be brushless DC electric motors, and the corresponding motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Furthermore, in some examples, motor controllers 708a-708e may be omitted and control circuit 710 may directly generate the motor drive signals.

In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program in a closed-loop configuration. The response of the instrument may include the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to one of the motors 704a-704e during the open loop portion, the pulse width of the motor drive signal and so on. Following the open loop portion, the control circuit 710 may implement the selected firing control sequence for the second portion of the displacement member's stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e to cause the displacement member to translate at a constant speed based on translation data describing the position of the displacement member in a closed-loop fashion.

In one aspect, motors 704a-704e may receive power from energy source 712. Energy source 712 may be a DC power source driven by a main AC power source, a battery, a supercapacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to individual moveable mechanical elements, such as I-beam 714, anvil 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706e. Transmissions 706a-706e may include one or more gears or other linkage components to couple the motors 704a-704e to the movable mechanical element. Position sensor 734 may sense the position of I-beam 714 . Position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 714 . In some examples, position sensor 734 may include an encoder configured to provide a series of pulses to control circuit 710 as I-beam 714 is translated distally and proximally. Control circuit 710 may track the pulses to determine the position of I-beam 714 . Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of movement of I-beam 714 . Also, in some examples, position sensor 734 may be omitted. In the case where any of the motors 704a-704e are stepper motors, the control circuit 710 can track the position of the I-beam 714 by aggregating the number and direction of steps that the motor 704 has been commanded to perform. Position sensor 734 may be located in end effector 702 or at any other part of the instrument. The output of each motor 704a-704e includes a torque sensor 744a-744e for sensing force, and has an encoder for sensing rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firing member such as the I-beam 714 portion of the end effector 702 . Control circuit 710 provides a motor set point to motor control 708a, which provides a drive signal to motor 704a. The output shaft of motor 704a is coupled to torque sensor 744a. Torque sensor 744a is coupled to transmission 706a coupled with I-beam 714 . Transmission 706a includes movable mechanical elements such as rotational elements and firing members to control movement of I-beam 714 distally and proximally along the longitudinal axis of end effector 702 . In one aspect, the motor 704a may be coupled to a cutter gear assembly that includes a cutter gear reduction set that includes a first cutter drive gear and a second cutter drive gear. Torque sensor 744a provides a firing force feedback signal to control circuit 710. The firing force signal represents the force required to fire or displace the I-beam 714. The position sensor 734 may be configured to provide the position of the I-beam 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710 . End effector 702 may include additional sensors 738 configured to provide feedback signals to control circuit 710 . When ready for use, control circuit 710 may provide a firing signal to motor control 708a. In response to the firing signal, motor 704a may drive the firing member distally along the longitudinal axis of end effector 702 from a proximal start of stroke position to an end of stroke position distal to the start of stroke position. As the firing member is translated distally, the I-shaped beam 714 with the cutting element positioned at the distal end is advanced distally to cut tissue located between the staple cartridge 718 and the anvil 716 .

In one aspect, the control circuit 710 is configured to drive a closure member, such as the anvil 716 portion of the end effector 702 . Control circuit 710 provides a motor set point to motor control 708b, which provides a drive signal to motor 704b. The output shaft of motor 704b is coupled to torque sensor 744b. Torque sensor 744b is coupled to transmission 706b coupled to anvil 716 . Transmission 706b includes movable mechanical elements such as rotational elements and closing members to control movement of anvil 716 from the open and closed positions. In one aspect, the motor 704b is coupled to a closed gear assembly including a closed reduction gear set supported in meshing engagement with a closed spur gear. Torque sensor 744b provides a closing force feedback signal to control circuit 710. The closing force feedback signal represents the closing force applied to the anvil 716 . Position sensor 734 may be configured to provide the position of the closure member as a feedback signal to control circuit 710 . Additional sensors 738 in end effector 702 may provide a closing force feedback signal to control circuit 710 . Pivotable anvil 716 is positioned opposite staple cartridge 718 . When ready for use, control circuit 710 may provide a closing signal to motor control 708b. In response to the closing signal, motor 704b advances the closing member to grasp tissue between anvil 716 and staple cartridge 718 .

In one aspect, control circuit 710 is configured to cause rotation of a shaft member such as shaft 740 to cause end effector 702 to rotate. Control circuit 710 provides a motor set point to motor control 708c, which provides a drive signal to motor 704c. The output shaft of motor 704c is coupled to torque sensor 744c. Torque sensor 744c is coupled to transmission 706c, which is coupled to shaft 740. The transmission 706c includes a movable mechanical element such as a rotary element to control the rotation of the shaft 740 over 360° clockwise or counterclockwise. In one aspect, the motor 704c is coupled to a rotary transmission assembly that includes a tube gear section formed on (or attached to) a proximal end of the proximal closure tube for operable A rotating gear assembly is operatively supported on the tool mounting plate. Torque sensor 744c provides a rotational force feedback signal to control circuit 710. The rotational force feedback signal represents the rotational force applied to shaft 740 . Position sensor 734 may be configured to provide the position of the closure member as a feedback signal to control circuit 710 . Additional sensors 738 such as a shaft encoder may provide the rotational position of shaft 740 to control circuit 710 .

In one aspect, control circuit 710 is configured to enable articulation of end effector 702 . Control circuit 710 provides a motor set point to motor control 708d, which provides a drive signal to motor 704d. The output shaft of motor 704d is coupled to torque sensor 744d. Torque sensor 744d is coupled to transmission 706d, which is coupled to articulation member 742a. The transmission 706d includes movable mechanical elements such as articulation elements to control the ±65° articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut that is rotatably journalled on a proximal end portion of the distal spine and is rotatably driven thereon by an articulation gear assembly. Torque sensor 744d provides an articulation force feedback signal to control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702 . Sensor 738 , such as an articulation encoder, may provide the articulation position of end effector 702 to control circuit 710 .

In another aspect, the articulation functionality of robotic surgical system 700 may include two articulation members or links 742a, 742b. These articulation members 742a, 742b are driven by separate disks on the robot interface (rack) driven by two motors 708d, 708e. When separate firing motors 704a are provided, each of the articulation links 742a, 742b may be driven antagonistically relative to the other link to provide resistance to the head to maintain motion and load when the head is not moving, and when the head is not moving, Provides joint movement when the head articulates. Articulation members 742a, 742b are attached to the head at a fixed radius as the head rotates. Therefore, when the head rotates, the mechanical advantage of the push-pull link changes. This change in mechanical advantage may be more pronounced for other articulation linkage drive systems.

In one aspect, one or more of the motors 704a-704e may include a brushed DC motor with a gearbox and a mechanical link to the firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External effects are the unmeasured, unpredictable effects that things such as tissue, surrounding bodies, and friction have on a physical system. Such external influences may be referred to as drag forces, which act on one of the electric motors 704a-704e. External influences such as drag can cause the operation of the physical system to deviate from the desired operation of the physical system.

In one aspect, position sensor 734 may be implemented as an absolute positioning system. In one aspect, position sensor 734 may include a magnetic rotary absolute positioning system implemented as an AS5055 EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. Position sensor 734 may interface with control circuitry 710 to provide an absolute positioning system. The location may include a plurality of Hall effect elements located above the magnet and coupled to a CORDIC processor, also known as the bitwise method and the Volder algorithm, which CORDIC processor is provided to implement the calculation of the hyperbolic function and Simple and effective algorithms for trigonometric functions, hyperbolic functions and trigonometric functions only require addition operations, subtraction operations, digital shift operations and table lookup operations.

In one aspect, control circuitry 710 may communicate with one or more sensors 738 . Sensor 738 may be positioned on end effector 702 and adapted to operate with robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Sensors 738 may include magnetic sensors, field sensors, strain gauges, load sensors, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or for measuring tip Any other suitable sensor for one or more parameters of actuator 702. Sensors 738 may include one or more sensors. Sensor 738 may be located on the staple cartridge 718 platform to determine tissue position using segmented electrodes. Torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and/or articulation forces. Thus, the control circuit 710 may sense (1) the closing load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the portion of the staple cartridge 718 that has tissue thereon , and (4) the loads and positions on the two joint motion rods.

In one aspect, one or more sensors 738 may include strain gauges such as microstrain gauges configured to measure the magnitude of strain in anvil 716 during clamping conditions. Strain gauges provide an electrical signal whose amplitude changes with the amount of strain. Sensor 738 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 716 and staple cartridge 718 . Sensor 738 may be configured to detect the impedance of the tissue segment between anvil 716 and staple cartridge 718, the impedance being indicative of the thickness and/or integrity of the tissue therebetween.

In one aspect, sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magnetoresistance (MR) devices, giant magnetoresistance (GMR) devices, magnetometers, or the like. In other implementations, sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, or the like. Likewise, the switch may be a solid-state device, such as a transistor (eg, FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, sensors 738 may include electroless conductor switches, ultrasonic switches, accelerometers, inertial sensors, and the like.

In one aspect, sensor 738 may be configured to measure the force exerted on anvil 716 by the closure drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the anvil 716 to detect the closing force applied to the anvil 716 by the closure tube. The force exerted on the anvil 716 may represent the tissue compression experienced by the tissue segment trapped between the anvil 716 and the staple cartridge 718 . One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closing force applied to the anvil 716 by the closure drive system. One or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. Control circuitry 710 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 716 in real-time.

In one aspect, current sensor 736 may be used to measure the current drawn by each of motors 704a-704e. The force required to propel any of the movable mechanical elements, such as the I-beam 714, corresponds to the current drawn by one of the motors 704a-704e. This force is converted into a digital signal and provided to processing circuit 710. The control circuit 710 may be configured to simulate the response of the actual system of the instrument in the controller's software. The displacement member may be actuated to move the I-beam 714 in the end effector 702 at or near a target speed. Robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers, including but not limited to, for example, PID, state feedback, linear squared (LQR), and/or adaptive controllers. Robotic surgical instrument 700 may include a power source to, for example, convert signals from a feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force. Additional details are disclosed in U.S. Patent Application Serial No. 15/636,829 titled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, filed on June 29, 2017. The full text of the patent begins with Incorporated herein by reference.

18 illustrates a block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure. In one aspect, surgical instrument 750 is programmed to control distal translation of a displacement member such as I-beam 764 . Surgical instrument 750 includes an end effector 752 , which may include an anvil 766 , an I-beam 764 (including a sharp cutting edge), and a removable staple cartridge 768 .

The position, movement, displacement and/or translation of a linear displacement member such as I-beam 764 may be measured by an absolute positioning system, sensor arrangement and position sensor 784. Because I-beam 764 is coupled to the longitudinally movable drive member, the position of I-beam 764 may be determined by measuring the position of the longitudinally movable drive member using position sensor 784 . Accordingly, in the following description, the position, displacement, and/or translation of I-beam 764 may be accomplished by position sensor 784 as described herein. Control circuit 760 may be programmed to control translation of a displacement member such as I-beam 764 . In some examples, control circuitry 760 may include one or more microcontrollers, microprocessors, or processors for executing instructions that cause one or more processors to control a displacement member (eg, I-beam 764) in the manner described. Other suitable processor. In one aspect, the timer/counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the I-beam 764 as determined by the position sensor 784 to the output of the timer/counter 781 , so that the control circuit 760 can determine the position of the I-beam 764 relative to the starting position at a specific time (t). Timer/counter 781 may be configured to be able to measure elapsed time, count external events, or time external events.

Control circuit 760 may generate motor setpoint signal 772 . Motor setpoint signal 772 may be provided to motor controller 758 . Motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to motor 754 to drive motor 754, as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774 . In some examples, motor 754 may be a brushless DC electric motor, and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754 . Furthermore, in some examples, motor controller 758 may be omitted and control circuit 760 may generate motor drive signal 774 directly.

Motor 754 may receive power from energy source 762 . Energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. Motor 754 may be mechanically coupled to I-beam 764 via transmission 756 . Transmission 756 may include one or more gears or other link components for coupling motor 754 to I-beam 764 . Position sensor 784 may sense the position of I-beam 764 . Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 764 . In some examples, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as I-beam 764 is translated distally and proximally. Control circuit 760 may track the pulses to determine the position of I-beam 764 . Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of movement of I-beam 764 . Also, in some examples, position sensor 784 may be omitted. In the case where motor 754 is a stepper motor, control circuit 760 may track the position of I-beam 764 by aggregating the number and direction of steps that motor 754 has been instructed to perform. Position sensor 784 may be located in end effector 752 or at any other part of the instrument.

Control circuitry 760 may communicate with one or more sensors 788 . Sensor 788 may be positioned on end effector 752 and adapted to operate with surgical instrument 750 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or for measuring end effector 752 any other suitable sensor for one or more parameters. Sensors 788 may include one or more sensors.

One or more sensors 788 may include strain gauges such as microstrain gauges configured to measure the magnitude of strain in anvil 766 during clamping conditions. Strain gauges provide an electrical signal whose amplitude changes with the amount of strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 766 and staple cartridge 768 . Sensor 788 may be configured to detect the impedance of the tissue segment between anvil 766 and staple cartridge 768, the impedance being indicative of the thickness and/or integrity of the tissue therebetween.

Sensor 788 may be configured to measure the force exerted on anvil 766 by the closure drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closure tube. The force exerted on the anvil 766 may represent the tissue compression experienced by the tissue segment trapped between the anvil 766 and the staple cartridge 768 . One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. One or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during the clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.

Current sensor 786 may be employed to measure the current drawn by motor 754. The force required to propel I-beam 764 corresponds to the current drawn by motor 754 . This force is converted into a digital signal and provided to control circuit 760.

The control circuit 760 may be configured to simulate the response of the actual system of the instrument in the controller's software. The displacement member may be actuated to move the I-beam 764 in the end effector 752 at or near a target speed. Surgical instrument 750 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, PID, state feedback, LQR, and/or adaptive controllers, for example. Surgical instrument 750 may include a power source to, for example, convert signals from a feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force.

The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or I-beam 764 via a brushed DC motor having a gearbox and mechanical connection to the articulation and/or knife system. Another example is an electric motor 754 that operates a displacement member and articulation driver such as an interchangeable shaft assembly. External effects are the unmeasured, unpredictable effects that things such as tissue, surrounding bodies, and friction have on a physical system. This external influence may be referred to as the drag force acting on the electric motor 754 . External influences such as drag can cause the operation of the physical system to deviate from the desired operation of the physical system.

Various exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical stapling and cutting tool. For example, motor 754 may drive the displacement member distally and proximally along the longitudinal axis of end effector 752. The end effector 752 may include a pivotable anvil 766 and a staple cartridge 768 positioned opposite the anvil 766 when configured for use. The clinician can grasp tissue between anvil 766 and staple cartridge 768 as described herein. When instrument 750 is ready for use, the clinician may provide a firing signal, such as by pressing a trigger of instrument 750 . In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal start of stroke position to an end of stroke position distal to the start of stroke position. I-beam 764 with cutting elements positioned at the distal end may cut tissue between staple cartridge 768 and anvil 766 as the displacement member is translated distally.

In various examples, surgical instrument 750 may include control circuitry 760 programmed to control distal translation of a displacement member, such as I-beam 764, based on one or more tissue conditions. Control circuit 760 may be programmed to directly or indirectly sense tissue conditions, such as thickness, as described herein. Control circuit 760 may be programmed to select a firing control program based on tissue conditions. The firing control program may describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower speed and/or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and/or at a higher power.

In some examples, control circuit 760 may initially operate motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control program. The response of the instrument may include the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, the sum of the pulse widths of the motor drive signals, etc. Following the open loop portion, the control circuit 760 may implement the selected firing control sequence for the second portion of the displacement member's travel. For example, during the closed-loop portion of the stroke, the control circuit 760 may adjust the motor 754 in a closed-loop manner based on translational data describing the position of the displacement member so that the displacement member translates at a constant speed. Additional details are disclosed in U.S. Patent Application Serial No. 15/720,852, entitled SYSTEM AND METHODS FOR CONTROLLINGA DISPLAY OF A SURGICAL INSTRUMENT, filed on September 29, 2017. The entire application is incorporated herein by reference.

Figure 19 is a schematic diagram of a surgical instrument 790 configured to control various functions in accordance with at least one aspect of the present disclosure. In one aspect, surgical instrument 790 is programmed to control distal translation of a displacement member such as I-beam 764 . Surgical instrument 790 includes an end effector 792, which may include an anvil 766, an I-beam 764, and a removable staple cartridge 768, which may be coupled to an RF cartridge 796 (shown in dashed lines) exchange.

In one aspect, sensor 788 may be implemented as a limit switch, electromechanical device, solid state switch, Hall effect device, MR device, GMR device, magnetometer, or the like. In other implementations, sensor 638 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, a UV sensor, or the like. Likewise, the switch may be a solid-state device, such as a transistor (eg, FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, sensors 788 may include electroless conductor switches, ultrasonic switches, accelerometers, inertial sensors, and the like.

In one aspect, position sensor 784 may be implemented as an absolute positioning system, including a magnetic rotational absolute positioning system implemented as an AS5055EQFT monolithic magnetic rotational position sensor, available from Austria Microsystems, AG ). Position sensor 784 interfaces with control circuitry 760 to provide an absolute positioning system. The location may include a plurality of Hall effect elements located above the magnet and coupled to a CORDIC processor, also known as the bitwise method and the Volder algorithm, which CORDIC processor is provided to implement the calculation of the hyperbolic function and Simple and effective algorithms for trigonometric functions, hyperbolic functions and trigonometric functions only require addition operations, subtraction operations, digital shift operations and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife member that includes a knife body that operatively supports the tissue cutting blade thereon, and the I-beam may further include an anvil engagement tab or feature. and channel engaging features or feet. In one aspect, staple cartridge 768 may be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, RF bin 796 may be implemented as an RF bin. These and other sensor arrangements are described in commonly owned U.S. Patent Application Serial No. 15/628,175 entitled "TECHNIQUESFOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT" filed on June 20, 2017, which is incorporated by reference in its entirety. incorporated into this article.

The position, movement, displacement and/or translation of a linear displacement member such as I-beam 764 may be measured by an absolute positioning system, a sensor arrangement, and a position sensor designated as position sensor 784 . Because I-beam 764 is coupled to the longitudinally movable drive member, the position of I-beam 764 may be determined by measuring the position of the longitudinally movable drive member using position sensor 784 . Accordingly, in the following description, the position, displacement, and/or translation of I-beam 764 may be accomplished by position sensor 784 as described herein. Control circuit 760 may be programmed to control translation of a displacement member such as I-beam 764 as described herein. In some examples, control circuitry 760 may include one or more microcontrollers, microprocessors, or processors for executing instructions that cause one or more processors to control a displacement member (eg, I-beam 764) in the manner described. Other suitable processor. In one aspect, the timer/counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the I-beam 764 as determined by the position sensor 784 to the output of the timer/counter 781 , so that the control circuit 760 can determine the position of the I-beam 764 relative to the starting position at a specific time (t). Timer/counter 781 may be configured to be able to measure elapsed time, count external events, or time external events.

Control circuit 760 may generate motor setpoint signal 772 . Motor setpoint signal 772 may be provided to motor controller 758 . Motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to motor 754 to drive motor 754, as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774 . In some examples, motor 754 may be a brushless DC electric motor, and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754 . Furthermore, in some examples, motor controller 758 may be omitted and control circuit 760 may generate motor drive signal 774 directly.

Motor 754 may receive power from energy source 762 . Energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. Motor 754 may be mechanically coupled to I-beam 764 via transmission 756 . Transmission 756 may include one or more gears or other link components for coupling motor 754 to I-beam 764 . Position sensor 784 may sense the position of I-beam 764 . Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 764 . In some examples, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as I-beam 764 is translated distally and proximally. Control circuit 760 may track the pulses to determine the position of I-beam 764 . Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of movement of I-beam 764 . Also, in some examples, position sensor 784 may be omitted. In the case where the motor 754 is a stepper motor, the control circuit 760 may track the position of the I-beam 764 by aggregating the number and direction of steps that the motor has been instructed to perform. Position sensor 784 may be located in end effector 792 or at any other part of the instrument.

Control circuitry 760 may communicate with one or more sensors 788 . Sensor 788 may be positioned on end effector 792 and adapted to operate with surgical instrument 790 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or for measuring end effector 792 any other suitable sensor for one or more parameters. Sensors 788 may include one or more sensors.

One or more sensors 788 may include strain gauges such as microstrain gauges configured to measure the magnitude of strain in anvil 766 during clamping conditions. Strain gauges provide an electrical signal whose amplitude changes with the amount of strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 766 and staple cartridge 768 . Sensor 788 may be configured to detect the impedance of the tissue segment between anvil 766 and staple cartridge 768, the impedance being indicative of the thickness and/or integrity of the tissue therebetween.

Sensor 788 may be configured to measure the force exerted on anvil 766 by the closure drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closure tube. The force exerted on the anvil 766 may represent the tissue compression experienced by the tissue segment trapped between the anvil 766 and the staple cartridge 768 . One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. One or more sensors 788 may be sampled in real time by the processor portion of the control circuit 760 during the clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.

Current sensor 786 may be employed to measure the current drawn by motor 754. The force required to propel I-beam 764 corresponds to the current drawn by motor 754 . This force is converted into a digital signal and provided to control circuit 760.

When RF cartridge 796 is loaded in end effector 792 in place of staple cartridge 768 , RF energy source 794 is coupled to end effector 792 and applied to RF cartridge 796 . Control circuitry 760 controls the delivery of RF energy to RF bin 796 .

Additional details are disclosed in U.S. Patent Application Serial No. 15/636,096, filed on June 28, 2017, entitled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME), the entire text of which is incorporated herein by reference.

Figure 20 shows a stroke length graph 20740 that illustrates how the control system may modify the stroke length of the closed tube assembly based on the articulation angle θ. Such modification of the stroke length includes shortening the stroke length to a compensated stroke length (eg, defined along the y-axis) as the joint angle θ increases (eg, defined along the x-axis). The compensated stroke length defines the length of travel of the closure tube assembly in the distal direction to close the jaws of the end effector. The compensated stroke length is dependent on the articulation angle θ and prevents excessive travel of the closure tube assembly on the surgical device. cause damage.

For example, as shown in stroke length graph 20740, when the end effector is not articulating, the stroke length of the closure jaw of the closure tube assembly is approximately 0.250 inches, and when the articulation angle θ is approximately 60 degrees, the compensated stroke Length is approximately 0.242 inches. Such measurements are provided by way of example only and may include any of various angles and corresponding stroke lengths as well as compensated stroke lengths without departing from the scope of the present disclosure. In addition, the relationship between the joint motion angle θ and the compensation stroke length is nonlinear, and the shortening rate of the compensation stroke length increases as the joint motion angle increases. For example, the decrease in the compensation stroke length between 45 degrees and 60 degrees of joint motion is greater than the decrease in the compensation stroke length between 0 degrees and 15 degrees of joint motion. Although with this approach, the control system adjusts the stroke length based on the joint motion angle θ to prevent damage to the surgical device (e.g., jamming the distal end of the closure tube assembly in the distal position), it still allows the distal closure tube to move around the joint. Advancement during movement makes it possible to at least partially close the jaws.

Figure 21 shows a closed tube assembly positioning graph 20750 illustrating one aspect of the control system modifying the longitudinal position of the closed tube assembly based on the articulation angle θ. Such modification of the longitudinal position of the closure tube assembly includes retracting the closure tube assembly proximally a compensating distance (e.g., along the y axis) when the end effector articulates and based on the articulation angle θ (e.g., defined along the x-axis) axis limit). The compensating distance of proximal retraction of the closure tube assembly prevents distal advancement of the distal closure tube, thereby maintaining the jaws in the open position during articulation. By retracting the closure tube assembly proximally a compensating distance during articulation, the closure tube assembly can travel a stroke length from a proximally retracted position to close the jaws when the closure assembly is activated.

For example, as shown in closed tube assembly positioning graph 20750, the compensation distance when the end effector is not articulating is zero, and the compensation distance when the articulation angle θ is approximately 60 degrees is approximately 0.008 inches. In this example, the closed tube assembly retracts a compensation distance of 0.008 inches during articulation. Therefore, in order to close the jaws, the closing tube assembly can be advanced the length of stroke from this retracted position. Such measurements are provided for example purposes only and may include any of a variety of angles and corresponding compensation distances without departing from the scope of the present disclosure. As shown in Figure 21, the relationship between the joint motion angle θ and the compensation distance is nonlinear, and the rate of compensation distance extension increases with the increase of the joint motion angle θ. For example, the increase in the compensation distance between 45 degrees and 60 degrees is greater than the increase in the compensation distance between 0 degrees and 15 degrees.

When clamping patient tissue, the forces exerted by the clamping device (eg, linear stapler) and tissue can reach unacceptably high levels. For example, when a constant closure rate is employed, the force can become high enough to cause excessive trauma to the clamped tissue and can cause deformation in the clamping device such that acceptable tissue clearance is not maintained throughout the suture path. . Figure 22 is a graph illustrating the power applied to tissue at a constant anvil closure rate during compression (i.e., without using controlled tissue compression (CTC)) versus the power applied to tissue at a variable anvil closure rate during compression (i.e., using CTC). ) graph of power applied to tissue. The closure rate can be adjusted to control tissue compression so that the power applied to the tissue remains constant over a portion of the compression. When utilizing a variable anvil closure rate, the peak power applied into the tissue according to Figure 22 is much lower. Based on the power applied, the force (or a parameter related or proportional to the force) exerted by the surgical device may be calculated. In this regard, power can be limited so that the force exerted through the surgical device (eg, through the jaws of a linear stapler) does not exceed the yield force or pressure that causes the jaws to open such that when in the fully closed position, the tissue The gap is not within the acceptable range along the entire length of the stitching. For example, the jaws should be parallel or sufficiently close to parallel such that tissue clearance remains within acceptable or target ranges for all staple locations along the entire length of the jaws. Furthermore, the limitation of applied power avoids or at least minimizes trauma or damage to tissue.

In Figure 22, the total energy applied in the method without using CTC is the same as the total energy applied in the method using CTC, that is, the area under the power curve of Figure 22 is the same or substantially the same. However, the difference in the exploited power distribution is large, as the peak power is much lower in the examples with CTC compared to the examples without CTC.

In the example using a CTC, power limitation is achieved by slowing down the closing rate, as shown at line 20760. It should be noted that the compression time B' is longer than the closing time B. As shown in Figure 22, the device and method that provides a constant rate of closure (i.e., without using CTC) achieves the same 50 lb compression force at the same 1 mm tissue gap as the device and method that provides a variable rate of closure (i.e., with CTC) . While devices and methods that provide a constant rate of closure may achieve compressive force at the desired tissue gap over a shorter period of time than devices and methods that use a variable rate of closure, this produces peaks in power applied to the tissue, such as As shown in Figure 22. In contrast, the exemplary aspects shown using CTC begin to slow the rate of closure to limit the amount of power applied to the tissue below a certain level. By limiting the power applied to the tissue, tissue trauma can be minimized relative to systems and methods that do not use CTCs.

Figure 22 and additional examples are further described in U.S. Patent No. 8,499,992 entitled "DEVICE AND METHOD FORCONTROLLING COMPRESSION OF TISSUE" filed on June 1, 2012 and published on August 6, 2013, which is disclosed in its entirety. The contents are incorporated herein by reference.

In some aspects, the control system may include a plurality of predefined force thresholds that assist the control system in determining the position of the electron beam and/or the angle of articulation of the firing axis and appropriately controlling based on such determinations. At least one motor. For example, the force threshold may vary based on the length of travel of a firing rod configured to translate the firing shaft, and such force threshold may be compared to measured torque of one or more motors in communication with the control system. Comparison of the measured torque to the force threshold may provide the control system with a reliable means of determining the position of the electron beam and/or the articulation motion of the end effector. This may allow the control system to appropriately control one or more motors (e.g., reduce or stop torsional loads) to ensure proper firing of the firing assembly and articulation of the end effector, as well as to prevent damage to the system, as will be discussed below Describe in more detail.

Figure 23 shows a force and displacement graph 20800 that includes measured force in Part A relative to measured displacement in Part B. Both Part A and Part B have an x-axis that defines time (for example, seconds). The y-axis of part B defines the travel displacement of the firing link (eg, in millimeters), and the y-axis of part A defines the force applied to the firing rod, thereby advancing the firing axis. As shown in Part A, travel of the firing rod within a first range of articulation 20902 (eg, the first approximately 12 mm of travel) causes the end effector to articulate. For example, at the 12mm displacement position, the end effector articulates fully to the right and is mechanically unable to articulate further. As a result of being in full joint motion, the torque on the motor will increase and the control system may sense that the joint motion force peak 20802 exceeds the predefined joint motion threshold 20804 as shown in Part A. The control system may include more than one predefined joint motion threshold 20804 for sensing more than one direction of maximum joint motion (eg, left joint motion and right joint motion). After the control system detects an articulation force peak 20802 that exceeds a predetermined articulation threshold 20804, the control system may reduce or stop actuation of the motor, thereby protecting at least the motor from damage.

After the firing rod is advanced beyond the joint range of motion 20902, a displacement mechanism within the surgical stapler can cause further distal advancement of the firing rod to cause distal advancement of the firing shaft. For example, as shown in Part B, traveling between approximately 12 mm and 70 mm of travel displacement may cause the electron beam to advance along the firing stroke 20904 and cut tissue trapped between the jaws, however, other travel lengths are also contemplated by the present disclosure. within the range. In this example, the electron beam's maximum firing travel position 20906 occurs at 70 mm of travel. At this point, the electron beam or knife abuts the distal end of the magazine or jaw, thereby increasing the torque on the motor and causing the control system to sense a spike in knife travel force 20806 as shown in Part A. As shown in Part A, the control system may include a motor threshold 20808 and an end of a knife travel threshold 20810 that branches from the motor threshold 20808 and decreases (e.g., non-linearly) as the electron beam approaches the maximum firing stroke position 20906 ).

The control system may be configured to monitor sensed motor torque during at least the last portion of the distal stroke 20907 of the electron beam (eg, the last 10% of the firing stroke 904) before the electron beam reaches the maximum firing stroke position 20906. When monitored along such a final portion of the distal stroke 20907, the control system can cause the motor to reduce torque, thereby reducing the load on the electron beam. This may protect the surgical stapler, including the electron beam, from damage by reducing the load on the electron beam as the electron beam approaches the maximum firing stroke position 20906, thereby reducing electron beam impact on the distal end of the cartridge or jaw. As mentioned above, such an impact can produce a knife travel force peak 20806 that can exceed the knife travel threshold 20810 but not exceed the motor threshold 20808, thereby not damaging the motor. Therefore, the control system may stop actuation of the motor after the knife travel force peak 20806 exceeds the knife travel threshold 20810 and before the knife travel force peak 20806 exceeds the motor threshold 20808, thereby protecting the motor from damage. Additionally, the tapering of the knife travel threshold 20810 prevents the control system from initially believing that the electron beam has reached the maximum firing stroke position 20906.

After the control system detects that the knife travel force peak 20806 exceeds the knife travel threshold 20810, the control system may confirm the position of the electron beam (e.g., at 70 mm displacement and/or at the end of the firing stroke 20904) and may based on such known The displacement position retracts the firing rod to reset the electron beam at the most proximal position 20908 (e.g., 0 mm displacement). At the most proximal position 20908, the control system may sense a peak knife retraction force 20812 that exceeds a predefined knife retraction threshold 20814, as shown in Part A. At this point, if desired, the control system can be recalibrated and correlate the position of the electron beam to be in the original position where subsequent advancement of the firing link in the distal direction (e.g., approximately 12 mm long) will cause displacement The positioner disengages the electron beam from the firing rod. Once disengaged, travel of the firing rod within the range of articulation 20902 will again cause articulation of the end effector.

Accordingly, the control system may sense torque on the motor that controls the travel of the firing rod and compare such sensed torque to a plurality of thresholds to determine the position of the electron beam or the angle of articulation of the end effector, thereby Properly controls the motor to prevent damage to the motor, and confirms the positioning of the firing lever and/or electron beam.

As discussed above, the tissue contact or pressure sensor determines when the jaw member initially comes into contact with the tissue "T". This enables the surgeon to determine the initial thickness of tissue "T" and/or the thickness of tissue "T" prior to clamping. In any of the above surgical instrument aspects, as shown in Figure 24, contact of the jaw member with tissue "T" is closed by establishing contact with a pair of opposing plates "P1, P2" disposed on the jaw member Originally disconnected sensing circuit "SC". The contact sensor may also include a force-sensitive transducer that determines the amount of force applied to the sensor, which may be assumed to be the same as the amount of force applied to tissue "T." Such forces applied to the tissue can then be converted into an amount of tissue compression. The force sensor measures the amount of compression the tissue is experiencing and provides the surgeon with information about the force "T" applied to the tissue. Excessive tissue compression can negatively impact the "T" of tissue being operated on. For example, excessive compression of the tissue "T" can lead to tissue necrosis and, in some procedures, staple line failure. Information about the pressure applied to tissue "T" allows the surgeon to better determine that undue pressure is not being applied to tissue "T".

Any of the contact sensors disclosed herein may include, but are not limited to, electrical contacts placed on the interior surface of the jaw, which upon contact with tissue closes an otherwise open sensing circuit. The contact sensor may also include a force-sensitive transducer that detects when the clamped tissue first resists compression. Force transducers may include, but are not limited to, piezoelectric elements, piezoresistive elements, metal film or semiconductor strain gauges, inductive pressure sensors, capacitive pressure sensors, and the use of spring tubes, capsules, or bellows to drive arcs on resistive elements. Potentiometric pressure transducer for brush arm.

In one aspect, any of the aforementioned surgical instruments may include one or more piezoelectric elements to detect pressure changes occurring on the jaw member. Piezoelectric elements are bidirectional transducers that convert stress into electrical potential. Elements may consist of metallized quartz or ceramic. In operation, when stress is applied to a crystal, the material's charge distribution changes, causing a voltage to be generated across the material. Piezoelectric elements can be used to indicate when either or both jaw members are in contact with tissue "T" and the amount of pressure exerted on tissue "T" after contact is established.

In one aspect, any of the aforementioned surgical instruments may include or be provided with one or more metal strain gauges positioned within or on a portion of the body of the surgical instrument. Metal strain gauges work on the principle that the resistance of the material depends on the length, width and thickness. Therefore, when the material of a metal strain gauge undergoes strain, the resistance of the material changes. Therefore, a resistor made of this material incorporated into a circuit will convert strain into changes in electrical signals. Advantageously, the strain gauge may be placed on the surgical instrument such that pressure applied to the tissue affects the strain gauge.

Alternatively, on the other hand, one or more semiconductor strain gauges may be used in a similar manner to the metal strain gauges described above, but with a different transduction mode. In operation, when the lattice structure of a semiconductor strain gauge deforms due to applied stress, the resistance of the material changes. This phenomenon is called the piezoresistive effect.

In another aspect, any of the aforementioned surgical instruments may include or be provided with one or more inductive pressure sensors to convert pressure or force into movement of the inductive elements relative to each other. This movement of the sensing elements relative to each other changes the overall inductance or inductive coupling. Capacitive pressure transducers similarly convert pressure or force into movement of capacitive elements relative to each other, thereby changing the overall capacitance.

In yet another aspect, any of the aforementioned surgical instruments may include or be provided with one or more capacitive pressure transducers to convert pressure or force into movement of the capacitive elements relative to each other, thereby changing the overall capacitance.

In one aspect, any of the aforementioned surgical instruments may include or be provided with one or more mechanical pressure transducers to convert pressure or force into motion. In use, the movement of a mechanical element is used to deflect a pointer or dial on a gauge. This movement of the needle or dial can represent the pressure or force exerted on the tissue "T". Examples of mechanical elements include, but are not limited to, spring tubes, capsules, or bellows. By way of example, mechanical elements may be coupled with other measuring and/or sensing elements such as potentiometer pressure transducers. In this example, the mechanical element is coupled to an arc brush on a variable resistor. In use, pressure or force can be converted into mechanical movement that deflects a brush on the potentiometer, thereby changing the resistance to reflect the applied pressure or force.

The combination of the above aspects, particularly the combination of gap and tissue contact sensors, provides the surgeon with feedback and/or real-time information regarding the condition of the surgical site and/or target tissue "T". For example, information about the initial thickness of tissue "T" can guide the surgeon in selecting an appropriate staple size, and information about the clamping thickness of tissue "T" can let the surgeon know whether the selected staple will form appropriately with the tissue. Information related to the initial thickness of "T" and the clamping thickness can be used to determine the amount of compression or strain on tissue "T", and information related to the strain on tissue "T" can be used to avoid compressing the tissue to Excessive strain values and/or avoid suturing tissue that has experienced excessive strain.

Additionally, force sensors can be used to provide the surgeon with the amount of pressure applied to the tissue. The surgeon can use this information to avoid placing undue pressure on the tissue "T" or to avoid suturing a tissue "T" that has experienced excessive strain.

Figure 24 and additional examples are further described in U.S. Patent No. 8,181,839 entitled "SURGICAL INSTRUMENTEMPLOYING SENSORS" filed June 27, 2011 and published on May 5, 2012, the entire disclosure of which is incorporated by reference. Incorporated herein.

Certain aspects are shown and described to provide an understanding of the structure, function, manufacture, and use of the disclosed apparatus and methods. Features shown or described in one example may be combined with features of other examples, and modifications and variations are within the scope of the disclosure.

The terms "proximal" and "distal" refer to a clinician manipulating the handle of a surgical instrument, where "proximal" refers to the portion closer to the clinician and "distal" refers to the portion further away from the clinician . The spatial terms "vertical," "horizontal," "upward," and "downward" are used with respect to the figures for convenience and are not intended to be limiting and/or absolute, as surgical instruments may be used in many orientations and positions. .

Exemplary devices and methods for performing laparoscopic and minimally invasive surgical procedures are provided. However, such devices and methods may be used in other surgical procedures and applications, including, for example, open surgical procedures. Surgical instruments may be inserted through natural orifices or through incisions or punctures formed in tissue. The working or end effector portion of the instrument can be inserted directly into the body or through an access device having a working channel through which the end effector and elongated shaft of the surgical instrument can be advanced.

Figures 25-28 depict a motor-driven surgical instrument 150010 for cutting and fastening, which may or may not be reusable. In the illustrated example, surgical instrument 150010 includes a housing 150012 that includes a handle assembly 150014 configured to be grasped, manipulated, and actuated by a clinician. Housing 150012 is configured for operative attachment to an interchangeable shaft assembly 150200 having an end effector 150300 operably coupled thereto configured to perform One or more surgical tasks or surgical procedures. In accordance with the present disclosure, various forms of interchangeable shaft assemblies may be effectively employed in conjunction with robotically controlled surgical systems. The term "housing" may encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system configured to generate and apply a force that may be used to actuate an interchangeable shaft assembly. At least one control movement. The term "frame" may refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robotically controlled surgical instrument and/or a portion of a robotic system operable to operatively control a surgical instrument. The interchangeable shaft assembly may be used with various robotic systems, instruments, components, and methods disclosed in U.S. Patent No. 9,072,535 entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," which is incorporated herein by reference in its entirety.

Figure 25 is a perspective view of a surgical instrument 150010 with an interchangeable shaft assembly 150200 operatively coupled thereto in accordance with at least one aspect of the present disclosure. Housing 150012 includes an end effector 150300 that includes a surgical cutting and fastening device configured to operably support a surgical staple cartridge 150304 therein. Housing 150012 may be configured for use with an interchangeable shaft assembly including an end effector adapted to support different sizes and types of staple cartridges, with different shaft lengths, Size and type. Housing 150012 may be used with a variety of interchangeable shaft assemblies, including assemblies configured to apply other motion and forms of energy, such as radio frequency (RF) energy, ultrasonic energy, and/or motion, to the end effector arrangement. , this end effector arrangement is suitable for use with a variety of surgical applications and procedures. The end effector, shaft assembly, handle, surgical instrument, and/or surgical instrument system may utilize any suitable fastener or fasteners to secure tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and/or attached to an end effector of a shaft assembly.

The handle assembly 150014 may include a pair of interconnectable handle housing segments 150016, 150018 interconnected by screws, snap features, adhesives, or the like. The handle housing segments 150016, 150018 cooperate to form a pistol grip portion 150019 that can be grasped and manipulated by a clinician. The handle assembly 150014 operatively supports a plurality of drive systems configured to generate and apply control motion to corresponding portions of the interchangeable shaft assembly operably attached thereto. A display may be provided below cover 150045.

Figure 26 is an exploded component view of a portion of surgical instrument 150010 of Figure 25 in accordance with at least one aspect of the present disclosure. The handle assembly 150014 may include a frame 150020 operatively supporting a plurality of drive systems. Frame 150020 operatively supports a "first" or closure drive system 150030 that imparts closing and opening motion to interchangeable shaft assembly 150200. Closure drive system 150030 may include an actuator, such as closure trigger 150032 pivotally supported by frame 150020 . Closure trigger 150032 is pivotally coupled to handle assembly 150014 via pivot pin 150033 such that closure trigger 150032 can be manipulated by a clinician. When the clinician grasps the pistol grip portion 150019 of the handle assembly 150014, the closure trigger 150032 can pivot from an activated or "unactuated" position to an "actuated" position and more specifically to fully compressed or Fully actuated position.

The handle assembly 150014 and the frame 150020 operably support a firing drive system 150080 configured to impart firing motion to a corresponding portion of the interchangeable shaft assembly attached thereto. The firing drive system 150080 may utilize an electric motor 150082 located in the pistol grip portion 150019 of the handle assembly 150014. Electric motor 150082 may be a DC brush motor with a maximum rotational speed of, for example, about 25,000 RPM. In other constructions, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. Electric motor 150082 may be powered by power source 150090 , which may include removable power pack 150092 . Removable power pack 150092 may include a proximal housing portion 150094 configured to be attachable to a distal housing portion 150096. The proximal housing portion 150094 and the distal housing portion 150096 are configured to operatively support a plurality of batteries 150098 therein. Batteries 150098 may each include, for example, a lithium-ion (LI) or other suitable battery. Distal housing portion 150096 is configured for removably operative attachment to control circuit board 150100 operably coupled to electric motor 150082 . Several batteries 150098 connected in series can power the surgical instrument 150010. Power source 150090 may be replaceable and/or rechargeable. Display 150043 located under cover 150045 is electrically coupled to control circuit board 150100. Cover 150045 can be removed to expose display 150043.

The electric motor 150082 may include a rotatable shaft (not shown) operably interfaced with a gear reducer assembly 150084 mounted to engage with a set or set of teeth 150122 on the longitudinally movable drive member 150120 The strips are engaged. The longitudinally movable drive member 150120 has a rack of drive teeth 150122 formed thereon for meshing engagement with a corresponding drive gear 150086 of the gear reducer assembly 150084 .

In use, the polarity of the voltage provided by the power source 150090 can operate the electric motor 150082 in a clockwise direction, wherein the polarity of the voltage applied to the electric motor by the battery can be reversed to operate the electric motor 150082 in a counterclockwise direction. When the electric motor 150082 rotates in one direction, the longitudinally movable drive member 150120 will be driven axially in the distal direction "DD". When the electric motor 150082 is driven in the opposite rotational direction, the longitudinally movable drive member 150120 will be driven axially in the proximal direction "PD". Handle assembly 150014 may include a switch that may be configured to enable reversal of polarity applied to electric motor 150082 by power source 150090 . The handle assembly 150014 may include a sensor configured to detect the position of the longitudinally movable drive member 150120 and/or the direction in which the longitudinally movable drive member 150120 is moving.

Actuation of the electric motor 150082 may be controlled by a firing trigger 150130 that is pivotally supported on the handle assembly 150014. The firing trigger 150130 is pivotable between an unactuated position and an actuated position.

Returning to Figure 25, the interchangeable shaft assembly 150200 includes an end effector 150300 that includes an elongated channel 150302 configured to operatively support a surgical staple cartridge 150304 therein. End effector 150300 may include an anvil 150306 that is pivotally supported relative to elongated channel 150302. Interchangeable shaft assembly 150200 may include articulation joint 150270. The construction and operation of end effector 150300 and articulation joint 150270 are set forth in U.S. Patent Application Publication No. 2014/0263541 entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," which is incorporated herein by reference in its entirety. . Interchangeable shaft assembly 150200 may include a proximal housing or nozzle 150201 formed from nozzle portions 150202, 150203. The interchangeable shaft assembly 150200 may include a closure tube 150260 extending along the shaft axis SA that may be utilized to close and/or open the anvil 150306 of the end effector 150300.

Returning to FIG. 25 , closure tube 150260 is translated distally (direction "DD") to close, for example, in response to actuation of closure trigger 150032 in the manner described in the previously referenced U.S. Patent Application Publication No. 2014/0263541 Anvil 150306. The anvil 150306 is opened by translating the closure tube 150260 proximally. In the anvil open position, closure tube 150260 moves to the proximal position.

Figure 27 is another exploded assembly view of a portion of interchangeable shaft assembly 150200 in accordance with at least one aspect of the present disclosure. Interchangeable shaft assembly 150200 may include a firing member 150220 supported for axial travel within spine 150210 . Firing member 150220 includes an intermediate firing shaft 150222 configured to be attachable to a distal cutting portion or blade bar 150280. Firing member 150220 may be referred to as a "second shaft" and/or a "second shaft assembly." The intermediate firing shaft 150222 may include a longitudinal slot 150223 in the distal end configured to receive the tab 150284 on the proximal end 150282 of the blade bar 150280. The longitudinal slot 150223 and the proximal end 150282 may be configured to permit relative movement therebetween and may include a sliding joint 150286. The sliding joint 150286 may allow the intermediate firing shaft 150222 of the firing member 150220 to articulate the end effector 150300 about the articulation joint 150270 without moving, or at least substantially moving, the cutter bar 150280 . Once the end effector 150300 has been properly oriented, the intermediate firing shaft 150222 can be advanced distally until the proximal sidewall of the longitudinal slot 150223 contacts the insert 150284 to advance the blade 150280 and fire the staple positioned within the channel 150302 Until the warehouse. The spine 150210 has an elongated opening or window 150213 therein to facilitate assembly and insertion of the intermediate firing shaft 150222 into the spine 150210. Once the intermediate firing shaft 150222 has been inserted into the spine, the top frame segment 150215 can be engaged with the shaft frame 150212 to enclose the intermediate firing shaft 150222 and knife bar 150280 therein. The operation of firing member 150220 can be found in US Patent Application Publication No. 2014/0263541. Ridge 150210 may be configured to slidably support firing member 150220 and closure tube 150260 extending about ridge 150210. Spine 150210 may slidably support articulation driver 150230.

The interchangeable shaft assembly 150200 may include a clutch assembly 150400 configured to selectively and releasably couple the articulation driver 150230 to the firing member 150220. Clutch assembly 150400 includes a locking bushing or locking sleeve 150402 positioned about firing member 150220 , wherein locking sleeve 150402 is rotatable between an engaged position and a disengaged position in which locking sleeve 150402 articulates actuator 150230 Coupled to the firing member 150220, the articulation driver 150230 is not operably coupled to the firing member 150220 in the disengaged position. When the locking sleeve 150402 is in the engaged position, distal movement of the firing member 150220 may move the articulation driver 150230 distally; and correspondingly, proximal movement of the firing member 150220 may move the articulation driver 150230 proximally. When locking sleeve 150402 is in the disengaged position, movement of firing member 150220 is not transmitted to articulation driver 150230; and therefore, firing member 150220 may move independently of articulation driver 150230. Nozzle 150201 may be used to operatively engage and disengage the articulation drive system from the firing drive system in various manners described in US Patent Application Publication No. 2014/0263541.

The interchangeable shaft assembly 150200 may include a slip ring assembly 150600 that may be configured to conduct power to and/or from the end effector 150300 and/or to communicate signals, for example. Communicates signals to and/or from the end effector 150300. The slip ring assembly 150600 may include a proximal connector flange 150604 and a distal connector flange 150601 positioned within slots defined in the nozzle portions 150202, 150203. The proximal connector flange 150604 can include a first face, and the distal connector flange 150601 can include a second face positioned adjacent the first face and moveable relative to the first face. Distal connector flange 150601 is rotatable relative to proximal connector flange 150604 about shaft axis SA-SA (Fig. 25). The proximal connector flange 150604 may include a plurality of concentric or at least substantially concentric conductors 150602 defined in a first face thereof. Connector 150607 may be mounted on the proximal side of distal connector flange 150601 and may have a plurality of contacts, where each contact corresponds to and is in electrical contact with one of conductors 150602. This arrangement allows relative rotation between the proximal connector flange 150604 and the distal connector flange 150601 while maintaining electrical contact between the two flanges. The proximal connector flange 150604 may include an electrical connector 150606 that may, for example, place the conductor 150602 in signal communication with the shaft circuit board. In at least one example, a wire harness including a plurality of conductors may extend between electrical connector 150606 and the shaft circuit board. The electrical connector 150606 may extend proximally through a connector opening defined in the chassis mounting flange. The entire text of U.S. Patent Application Publication No. 2014/0263551 entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" is incorporated herein by reference. The entire text of U.S. Patent Application Publication No. 2014/0263552 entitled "STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM" is incorporated herein by reference. More details about slip ring assembly 150600 can be found in U.S. Patent Application Publication No. 2014/0263541.

Interchangeable shaft assembly 150200 may include a proximal portion fixedly mountable to handle assembly 150014, and a distal portion rotatable about a longitudinal axis. The rotatable distal shaft portion is rotatable about the slip ring assembly 150600 relative to the proximal portion. The distal connector flange 150601 of the slip ring assembly 150600 can be positioned within the rotatable distal shaft portion.

Figure 28 is an exploded view of an aspect of the end effector 150300 of the surgical instrument 150010 of Figure 25 in accordance with at least one aspect of the present disclosure. End effector 150300 may include an anvil 150306 and a surgical staple cartridge 150304. Anvil 150306 can be coupled to elongated channel 150302. A hole 150199 may be defined in the elongated channel 150302 to receive a pin 150152 extending from the anvil 150306 to allow the anvil 150306 to pivot relative to the elongated channel 150302 and the surgical staple cartridge 150304 from an open position to a closed position. Firing rod 150172 is configured to translate longitudinally into end effector 150300. The firing rod 150172 may be constructed from one solid portion or may include a laminate material including a stack of steel plates. The firing rod 150172 includes an I-shaped beam 150178 and a cutting edge 150182 at its distal end. The distal protruding end of the firing rod 150172 may be attached to the I-beam 150178 to help space the anvil 150306 from the surgical staple cartridge 150304 positioned in the elongated channel 150302 when the anvil 150306 is in the closed position. The I-beam 150178 may include a sharp cutting edge 150182 that severes tissue when the I-beam 150178 is advanced distally by the firing rod 150172. In operation, I-beam 150178 may fire surgical staple cartridge 150304. Surgical staple cartridge 150304 may include a molded cartridge body 150194 that retains a plurality of staples 150191 disposed on staple drivers 150192 located in corresponding upwardly opening staple cavities 150195. The wedge slide 150190 is driven distally by the I-beam 150178 to slide on the cartridge tray 150196 of the surgical staple cartridge 150304. The wedge slider 150190 cams the staple driver 150192 upward to extrude the staple 150191 into deformed contact with the anvil 150306 while the cutting edge 150182 of the I-shaped beam 150178 cuts off the clamped tissue.

I-beam 150178 may include an upper pin 150180 that engages anvil 150306 during firing. The I-beam 150178 may include an intermediate pin 150184 and a bottom base 150186 that engage portions of the bin body 150194, bin tray 150196, and elongated channel 150302. When the surgical staple cartridge 150304 is positioned within the elongated channel 150302, the slot 150193 defined in the cartridge body 150194 can be aligned with the longitudinal slot 150197 defined in the cartridge tray 150196 and the slot 150189 defined in the elongated channel 150302 . In use, I-beam 150178 may slide through aligned longitudinal slots 150193, 150197, and 150189, wherein, as shown in FIG. 28, bottom base 150186 of I-beam 150178 may extend along the length of slots 150189 and along the Intermediate pin 150184 can engage the top surface of bin tray 150196 along the length of longitudinal slot 150197 and upper pin 150180 can engage anvil 150306 . The I-beam 150178 may separate or restrain the anvil 150306 and the surgical staple cartridge 150304 as the firing rod 150172 is advanced distally to fire staples from the surgical staple cartridge 150304 and/or cut into tissue trapped between the anvil 150306 and the surgical staple cartridge 150304. Relative movement between surgical staple cartridges 150304. The firing rod 150172 and I-beam 150178 can be retracted proximally, allowing the anvil 150306 to be opened to release the two sutured and severed tissue portions.

29A and 29B are block diagrams of the control circuitry 150700 of the surgical instrument 150010 of FIG. 25 spanning two figures in accordance with at least one aspect of the present disclosure. Referring primarily to Figures 29A and 29B, handle assembly 150702 can include a motor 150714, which can be controlled by motor driver 150715 and used by a firing system of surgical instrument 150010. In various forms, motor 150714 may be a DC brush drive motor with a maximum rotational speed of approximately 25,000 RPM. In other arrangements, motor 150714 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. Motor driver 150715 may include, for example, an H-bridge driver including field effect transistor (FET) 150719 . Motor 150714 may be powered by power assembly 150706 releasably mounted to handle assembly 150200 for supplying control power to surgical instrument 150010. Power assembly 150706 may include a battery, which may include a plurality of battery cells connected in series that may be used as a power source to power surgical instrument 150010. In some cases, the battery cells of power assembly 150706 may be replaceable and/or rechargeable. In at least one example, the battery cell may be a lithium-ion battery detachably coupled to power assembly 150706.

Shaft assembly 150704 may include a shaft assembly controller 150722 that may communicate with the safety controller and power management controller 150716 via an interface when shaft assembly 150704 and power assembly 150706 are coupled to handle assembly 150702. For example, the interface may include a first interface portion 150725 , wherein the first interface portion may include one or more electrical connectors for coupling engagement with a corresponding shaft assembly electrical connector, and a second interface portion 150727 . One or more electrical connectors may be included for coupling engagement with corresponding power assembly electrical connectors, thereby allowing the shaft assembly controller 150722 to communicate with power management when the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702 Controllers 150716 communicate electrically with each other. One or more communication signals may be transmitted through the interface to communicate one or more power requirements of the attached interchangeable shaft assembly 150704 to the power management controller 150716. In response, the power management controller may adjust the power output of the battery of power assembly 150706 based on the power requirements of attached shaft assembly 150704, as described in greater detail below. The connector may include switches that may be activated after the handle assembly 150702 is mechanically coupled to the shaft assembly 150704 and/or the power assembly 150706 to allow electrical communication between the shaft assembly controller 150722 and the power management controller 150716 .

For example, the interface routes one or more communication signals through the main controller 150717 located in the handle assembly 150702, thereby facilitating the transfer of such communication signals between the power management controller 150716 and the shaft assembly controller 150722. In other cases, when the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702, the interface may facilitate a direct communication line between the power management controller 150716 and the shaft assembly controller 150722 through the handle assembly 150702.

The main controller 150717 may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the main controller 150717 may be, for example, the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, which includes: 256KB of single-cycle flash or other non-volatile memory (up to to 40MHz), prefetch buffer for improved performance over 40MHz, 32KB single-cycle serial random access memory (SRAM), loaded with Software internal read-only memory (ROM), 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations , one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which can be found in the product data sheet.

The safety controller may be a safety controller platform including two controller-based families such as the TMS570 and RM4x, known also by Texas Instruments under the tradename Hercules ARM Cortex R4. Safety controllers can be configured to be used specifically for IEC 61508 and ISO 26262 safety-critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity and memory options.

Power component 150706 may include power management circuitry, which may include power management controller 150716, power modulator 150738, and current sensing circuitry 150736. When the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702, the power management circuit can be configured to regulate the power output of the battery based on the power requirements of the shaft assembly 150704. The power management controller 150716 may be programmed to control the power modulator 150738 to regulate the power output of the power component 150706 and the current sensing circuit 150736 may be used to monitor the power output of the power component 150706 to provide power to the battery for the power management controller 150716 Feedback about the output allows the power management controller 150716 to adjust the power output of the power component 150706 to maintain the desired output. Power management controller 150716 and/or axis assembly controller 150722 may each include one or more processors and/or memory units that may store multiple software modules.

Surgical instrument 150010 (Figs. 25-28) may include an output device 150742, which may include a device for providing sensory feedback to the user. Such devices may include, for example, visual feedback devices (eg, LCD displays, LED indicators), audio feedback devices (eg, speakers, buzzers), or tactile feedback devices (eg, haptic actuators). In some cases, the output device 150742 may include a display 150743, which may be included in the handle assembly 150702. Shaft assembly controller 150722 and/or power management controller 150716 may provide feedback to a user of surgical instrument 150010 via output device 150742 . The interface may be configured to enable coupling the shaft assembly controller 150722 and/or the power management controller 150716 to the output device 150742. Alternatively, output device 150742 may be integrated with power assembly 150706. In such cases, communication between the output device 150742 and the shaft assembly controller 150722 may be accomplished through the interface when the shaft assembly 150704 is coupled to the handle assembly 150702.

Control circuit 150700 includes circuit segments configured to control operation of electrical surgical instrument 150010 . The safety controller segment (segment 1) includes the safety controller and the main controller 150717 segment (segment 2). The safety controller and/or master controller 150717 is configured to be able to interact with one or more additional circuit segments, such as an acceleration segment, a display segment, a shaft segment, an encoder segment, a motor segment, and a power segment. Each of the circuit segments may be coupled to a safety controller and/or a master controller 150717. The main controller 150717 is also coupled to the flash memory. The main controller 150717 also includes a serial communication interface. The main controller 150717 includes multiple inputs coupled to, for example, one or more circuit segments, batteries, and/or multiple switches. The segmented circuitry may be implemented by any suitable circuitry, such as a printed circuit board assembly (PCBA) within the powered surgical instrument 150010. It will be understood that the term "processor" as used herein includes any microprocessor, processor, microcontroller, controller, or combination of the functions of a computer's central processing unit (CPU) into one integrated circuit or up to several Other basic computing devices on integrated circuits. The main controller 150717 is a multi-purpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and provides the results as output. Because a processor has internal memory, it is an example of sequential digital logic. Control circuit 150700 may be configured to enable one or more processes described herein.

The acceleration segment (segment 3) includes the accelerometer. The accelerometer is configured to detect movement or acceleration of the powered surgical instrument 150010 . Input from the accelerometer may be used, for example, to transition to and from sleep mode to other modes, identify the orientation of the powered surgical instrument, and/or identify when the surgical instrument has been lowered. In some examples, the acceleration segment is coupled to the safety controller and/or the main controller 150717.

The display segment (Segment 4) includes a display connector coupled to the main controller 150717. The display connector couples the host controller 150717 to the display through the display's one or more integrated circuit drivers. The integrated circuit driver of the display may be integrated with the display and/or may be located separately from the display. The display may include any suitable display, such as an organic light emitting diode (OLED) display, a liquid crystal display (LCD), and/or any other suitable display. In some examples, the display segments are coupled to the safety controller.

Shaft segment (Segment 5) includes controls for coupling to the interchangeable shaft assembly 150200 (Figs. 25 and 27) of the surgical instrument 150010 (Figs. 25-28), and/or for coupling to the interchangeable shaft assembly One or more controls of end effector 150300 of 150200. The shaft segment includes a shaft connector configured to couple the main controller 150717 to the shaft PCBA. The axis PCBA includes a low-power microcontroller with ferroelectric random access memory (FRAM), articulation switches, axis release Hall effect switches, and axis PCBA EEPROM. The axis PCBA EEPROM includes one or more parameters, routines and/or programs specific to the interchangeable axis assembly 150200 and/or the axis PCBA. The shaft PCBA can be coupled to the interchangeable shaft assembly 150200 and/or integrated with the surgical instrument 150010. In some examples, the axis segment includes a second axis EEPROM. The second axis EEPROM includes a plurality of algorithms, routines, parameters and/or other data corresponding to one or more axis assemblies 150200 and/or end effector 150300 that may interface with the powered surgical instrument 150010 .

The position encoder section (section 6) includes one or more magnetic angular rotary position encoders. One or more magnetic angular rotational position encoders configured to identify the motor 150714 of the surgical instrument 150010 (Figs. 25-28), the interchangeable shaft assembly 150200 (Figs. 25 and 27), and/or the end effector 150300 rotation position. In some examples, a magnetic angular rotary position encoder may be coupled to the safety controller and/or main controller 150717.

The motor circuit segment (Segment 7) includes a motor 150714 configured to control movement of the powered surgical instrument 150010 (Figs. 25-28). The motor 150714 is coupled to the main microcontroller processor 150717 through an H-bridge driver and motor controller including one or more H-bridge field effect transistors (FETs). The H-bridge driver is also connected to the safety controller. The motor current sensor is connected in series with the motor and is used to measure the current consumption of the motor. The motor current sensor communicates signals with the main controller 150717 and/or the safety controller. In some examples, motor 150714 is coupled to a motor electromagnetic interference (EMI) filter.

The motor controller controls the first motor flag and the second motor flag to indicate the status and position of the motor 150714 to the main controller 150717. The main controller 150717 provides the pulse width modulation (PWM) high signal, PWM low signal, direction signal, synchronization signal and motor reset signal to the motor controller through the buffer. The power segment is configured to provide a segment voltage to each of the circuit segments.

The power section (section 8) includes the battery coupled to the safety controller, main controller 150717 and additional circuit sections. The batteries are coupled to the segmented circuit through battery connectors and current sensors. The current sensor is configured to measure the total current consumption of the segmented circuit. In some examples, one or more voltage converters are configured to provide predetermined voltage values to one or more circuit segments. For example, in some examples, the segmented circuit may include a 3.3V voltage converter and/or a 5V voltage converter. The boost converter is configured to provide a boost voltage up to a predetermined amount, such as up to 13V. Boost converters are configured to provide additional voltage and/or current during power-dense operation and are capable of protecting against voltage drop conditions or low power conditions.

Multiple switches are connected to the safety controller and/or main controller 150717. These switches may be configured to control operation of the surgical instrument 150010 (Figs. 25-28), operation of the segmented circuit, and/or indicate the status of the surgical instrument 150010. Emergency door switches and Hall effect switches for emergency use are configured to indicate the status of the emergency door. Multiple articulation switches (such as left-to-left articulation switch, left-to-right articulation switch, left-to-center articulation switch, right-to-left articulation switch, right-to-right articulation switch, and right Centering articulation switch) is configured to control articulation of the interchangeable shaft assembly 150200 (Figs. 25 and 27) and/or the end effector 150300 (Figs. 25 and 28). The left reversing switch and the right reversing switch are connected to the main controller 150717. The left switch (including the left-to-left articulation switch, the left-to-right articulation switch, the left-to-center articulation switch and the left reversing switch) is connected to the main controller 150717 through a left flexible connector. The right side switch (including the right side to left articulation switch, the right side to right articulation switch, the right side to center articulation switch and the right reversing switch) is connected to the main controller 150717 through a right flexible connector. The firing switch, clamp release switch and shaft engagement switch are connected to the main controller 150717.

Any suitable mechanical, electromechanical, or solid state switches may be used in any combination to implement multiple switches. For example, the switch may be a limit switch that operates using movement of components associated with surgical instrument 150010 (Figures 25-28) or the presence of an object. Such switches may be used to control various functions associated with surgical instrument 150010. A limit switch is an electromechanical device consisting of an actuator mechanically connected to a set of contacts. When an object comes into contact with the actuator, the device operates the contacts to make or break an electrical connection. Limit switches are durable, easy to install and reliable in operation, making them suitable for a variety of applications and environments. Limit switches determine the presence or absence, passage, positioning, and end of an object's travel. In other implementations, the switch may be a solid-state switch that operates under the influence of a magnetic field, such as a Hall effect device, a magnetoresistive (MR) device, a giant magnetoresistive (GMR) device, a magnetometer, or the like. In other implementations, the switch may be a solid state switch that operates under the influence of light, such as an optical sensor, an infrared sensor, an ultraviolet sensor, and others. Likewise, the switch may be a solid-state device, such as a transistor (eg, FET, junction FET, metal oxide semiconductor FET (MOSFET), bipolar transistor, etc.). Other switches may include wireless switches, ultrasonic switches, accelerometers, inertial sensors, and others.

30 is another block diagram of the control circuit 150700 of the surgical instrument of FIG. 25 illustrating the connection between the handle assembly 150702 and the power assembly 150706, and the handle assembly 150702 and the interchangeable shaft, in accordance with at least one aspect of the present disclosure. Interfaces between components 150704. The handle assembly 150702 may include a main control 150717, a shaft assembly connector 150726, and a power assembly connector 150730. Power component 150706 may include power component connector 150732, power management circuitry 150734, which may include power management controller 150716, power modulator 150738, and current sensing circuitry 150736. Shaft assembly connectors 150730, 150732 form interface 150727. The power management circuit 150734 may be configured to regulate the power output of the battery 150707 based on the power requirements of the interchangeable shaft assembly 150704 when the interchangeable shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702. The power management controller 150716 can be programmed to control the power modulator 150738 to regulate the power output of the power component 150706 , and the current sensing circuit 150736 can be used to monitor the power output of the power component 150706 to provide the power management controller 150716 with the battery 150707 The feedback related to the power output allows the power management controller 150716 to adjust the power output of the power component 150706 to maintain the desired output. The shaft assembly 150704 includes a shaft processor 150720 coupled to a non-volatile memory 150721 and a shaft assembly connector 150728 to electrically couple the shaft assembly 150704 to the handle assembly 150702. Shaft assembly connectors 150726, 150728 form interface 150725. The main controller 150717, the axis processor 150720, and/or the power management controller 150716 may be configured to enable one or more of the processes described herein.

Surgical instrument 150010 (Figures 25-28) may include an output device 150742 for providing sensory feedback to the user. Such devices may include visual feedback devices (eg, LCD displays, LED indicators), auditory feedback devices (eg, speakers, buzzers), or tactile feedback devices (eg, haptic actuators). In some cases, the output device 150742 may include a display 150743, which may be included in the handle assembly 150702. Shaft assembly controller 150722 and/or power management controller 150716 may provide feedback to a user of surgical instrument 150010 via output device 150742 . Interface 150727 may be configured to enable coupling shaft assembly controller 150722 and/or power management controller 150716 to output device 150742 . Output device 150742 may be integrated with power component 150706. When the interchangeable shaft assembly 150704 is coupled to the handle assembly 150702, communication between the output device 150742 and the shaft assembly controller 150722 may be accomplished through the interface 150725. Having described the control circuit 150700 (Figs. 29A, 29B, and Fig. 6) for controlling the operation of the surgical instrument 150010 (Figs. 25-28), the present disclosure now turns to the surgical instrument 150010 (Figs. 25-28) and the control circuit. Various configurations of 150700.

Referring to Figure 31, surgical stapler 151000 may include a handle component 151002, a shaft component 151004, and an end effector component 151006. Surgical stapler 151000 is similarly constructed and equipped as motor-driven surgical cutting and fastening instrument 150010 described in conjunction with FIG. 25 . Therefore, details of operation and construction will not be repeated here for convenience and clarity. End effector 151006 can be used to compress, cut, or suture tissue. Referring now to Figure 32, the physician may position end effector 151030 around tissue 151032 before performing compression, cutting, or suturing. As shown in Figure 32, no compression can be applied to the tissue in preparation for use of the end effector. Referring now to Figure 33, a physician may use end effector 151030 to compress tissue 151032 by engaging a handle of a surgical stapler (eg, handle 151002). In one aspect, tissue 151032 may be compressed to its maximum threshold, as shown in Figure 33.

Referring to Figure 34, various forces can be applied to tissue 151032 by end effector 151030. For example, when tissue 151032 is compressed between anvil 151034 and channel frame 151036 of end effector 151030, vertical forces F1 and F2 may be applied through the anvil and channel frame. Referring now to Figure 35, as tissue 151032 is compressed by end effector 151030, various diagonal and/or lateral forces may also be applied to the tissue. For example, force F3 may be applied. In order to operate a medical device such as the surgical stapler 151000, it may be desirable to sense or calculate various forms of compression applied to tissue by the end effector. For example, it is known that vertical or lateral compression may allow the end effector to perform a staple operation more precisely or accurately or may inform the operator of the surgical stapler, enabling more correct or safe use of the surgical stapler.

Compression through tissue 151032 can be determined from the impedance of tissue 151032. At various levels of compression, the impedance Z of tissue 151032 may increase or decrease. By applying voltage V and current I to tissue 151032, the impedance Z of tissue 151032 can be determined at various levels of compression. For example, the impedance Z can be calculated by dividing the applied voltage V by the current I.

Referring now to Figure 36, in one aspect, the RF electrode 151038 can be positioned on the end effector 151030 (eg, on the cartridge, knife, or channel frame of the end effector 151030). Additionally, electrical contacts 151040 may be positioned on anvil 151034 of end effector 151030. In one aspect, the electrical contacts can be positioned on the channel frame of the end effector. When tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, the impedance Z of tissue 151032 changes. The vertical tissue compression 151042 caused by the end effector 151030 can be measured as a function of the impedance Z of the tissue 151032.

Referring now to Figure 37, in one aspect, when RF electrode 151038 is positioned, electrical contacts 151044 can be positioned on opposite ends of anvil 151034 of end effector 151030. When tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, the impedance Z of tissue 151032 changes. The lateral tissue compression 151046 caused by the end effector 151030 can be measured as a function of the impedance Z of the tissue 151032.

Referring now to FIG. 38 , in one aspect, electrical contact 151050 can be positioned on anvil 151034 and electrical contact 151052 can be positioned on an opposite end of end effector 151030 at channel frame 151036 . RF electrode 151048 may be positioned transversely to the center of end effector 151030. When tissue 151032 is compressed between anvil 151034 of end effector 151030 and, for example, channel frame 151036, the impedance Z of tissue 151032 changes. Lateral compression 151054 or angular compression 151056 on either side of the RF electrode 151048 can be caused by the end effector 151030 and can be measured as a function of different impedances Z of the tissue 151032 based on the relative positioning of the RF electrode 151048 and electrical contacts 151050 and 151052 .

Referring now to Figure 39, frequency generator 151222 can receive power or current from power source 151221 and can supply one or more RF signals to one or more RF electrodes 151224. As mentioned above, one or more RF electrodes may be positioned at various locations or components on the end effector or surgical stapler, such as the staple cartridge or channel frame. One or more electrical contacts, such as electrical contacts 151226 or 151228, may be positioned on the channel frame or anvil of the end effector. Additionally, one or more filters, such as filter 151230 or 151232, may be communicatively coupled to electrical contacts 151226 or 151228. Filters 151230 and 151232 may filter one or more RF signals provided by frequency generator 151222 before engaging a single return path 151234. The voltage V and current I associated with one or more RF signals may be used to calculate the impedance Z associated with tissue that may be compressed and/or between one or more RF electrodes 151224 and electrical contacts 151226 or 151228 or communicatively connected.

Still referring to Figure 39, various components of the tissue compression sensor system described herein may be located in the handle 151236 of the surgical stapler. For example, as shown in circuit diagram 151220a, frequency generator 151222 may be located in handle 151236 and receive power from power source 151221. Additionally, current I1 and current I2 can be measured on the return path corresponding to electrical contacts 151228 and 151226. The impedances Z1 and Z2 can be calculated using the voltage V applied between the supply path and the return path. Z1 may correspond to the impedance of tissue that is compressed and/or communicatively coupled between the RF electrode 151224 and one or more of the electrical contacts 151228 . Additionally, Z2 may correspond to the impedance of tissue that is compressed and/or communicatively coupled between the RF electrode 151224 and one or more of the electrical contacts 151226. The impedances Z1 and Z2 corresponding to different compression levels of tissue compressed by the end effector can be calculated using the formulas Z1 = V/I1 and Z2 = V/I2.

Referring now to Figure 40, one or more aspects of the present disclosure are depicted in circuit diagram 151250. In one implementation, a power source at the handle 151252 of the surgical stapler may provide power to the frequency generator 151254. Frequency generator 151254 may generate one or more RF signals. One or more RF signals may be multiplexed or summed at a multiplexer 151256, which may be in the shaft 151258 of the surgical stapler. In this way, two or more RF signals can be superimposed (or, for example, nested or modulated together) and transmitted to the end effector. The one or more RF signals may power one or more RF electrodes 151260 at the end effector 151262 of the surgical stapler (eg, positioned in the staple cartridge). Tissue (not shown) may be compressed and/or communicatively coupled between one or more of the RF electrodes 151260 and one or more electrical contacts. For example, tissue may be compressed between one or more RF electrodes 151260 and electrical contacts 151264 positioned in the channel frame of end effector 151262 or electrical contacts 151266 positioned in the anvil of end effector 151262 and/or communicatively connected. Filter 151268 can be communicatively coupled to electrical contact 151264, and filter 151270 can be communicatively coupled to electrical contact 151266.

The voltage V and current I associated with the one or more RF signals may be used to calculate the impedance Z associated with the tissue that may be present in the nail cartridge (and communicatively coupled to one or more RF electrodes 151260) and the channel frame or anvil (and communicatively coupled to one or more of electrical contacts 151264 or 151266) is compressed.

In one aspect, various components of the tissue compression sensor system described herein may be located in the shaft 151258 of a surgical stapler. For example, as shown in circuit diagram 151250 (and in addition to frequency generator 151254), impedance calculator 151272, controller 151274, non-volatile memory 151276, and communication channel 151278 may be located in shaft 151258. In one example, frequency generator 151254, impedance calculator 151272, controller 151274, non-volatile memory 151276, and communication channel 151278 may be located on a circuit board in shaft 151258.

Two or more RF signals can return on a common path via electrical contacts. Additionally, two or more RF signals can be filtered before joining the RF signals on a common path to distinguish the individual tissue impedances represented by the two or more RF signals. Current I1 and current I2 can be measured on the return path corresponding to electrical contacts 151264 and 151266. The impedances Z1 and Z2 can be calculated using the voltage V applied between the supply path and the return path. Z1 may correspond to the impedance of tissue that is compressed and/or communicatively coupled between the RF electrode 151260 and one or more of the electrical contacts 151264. Additionally, Z2 may correspond to the impedance of tissue that is compressed and/or communicatively coupled between the RF electrode 151260 and one or more of the electrical contacts 151266. Impedances Z1 and Z2 corresponding to different compressions of tissue compressed by end effector 151262 can be calculated using the equations Z1 = V/I1 and Z2 = V/I2. In the example, impedances Z1 and Z2 can be calculated by impedance calculator 151272. Impedances Z1 and Z2 can be used to calculate various compression levels of tissue.

Referring now to Figure 41, a frequency plot 151290 is shown. Frequency plot 151290 shows the frequency modulation of two RF signals nested. As mentioned above, the two RF signals can be nested before reaching the RF electrode at the end effector. For example, an RF signal with frequency 1 and an RF signal with frequency 2 can be nested together. Referring now to Figure 42, the resulting nested RF signal is shown in frequency plot 151300. The composite signal shown in frequency plot 151300 includes the two RF signals of composite frequency plot 151290. Referring now to Figure 43, a frequency plot 151400 is shown. Frequency graph 151400 shows an RF signal having frequency 1 and frequency 2 after being filtered (eg, by filters 151268 and 151270). The resulting RF signal can be used to perform separate impedance calculations or measurements on the return path, as described above.

In one aspect, filters 151268 and 151270 may be high-Q filters such that the filter range may be narrow (eg, Q=10). Q can be defined by center frequency (Wo)/bandwidth (BW), where Q=Wo/BW. In one example, frequency 1 may be 150kHz and frequency 2 may be 300kHz. The feasible impedance measurement range can be 100kHz-20MHz. In various examples, other sophisticated techniques such as correlation, quadrature detection, etc. may be used to separate the RF signals.

Using one or more of the techniques and features described herein, a single energized electrode on the staple cartridge or the isolation knife of the end effector can be used to make multiple tissue compression measurements simultaneously. If two or more RF signals are superimposed or multiplexed (or nested or modulated), they can be transmitted down the single power side of the end effector and can be transmitted between the channel frame or the end effector return on the anvil. If the filter is built into the anvil and channel contacts before they engage the common return path, the tissue impedance represented by the two paths can be distinguished. This provides a measure of vertical versus lateral tissue compression. This approach also provides proximal and distal tissue compression depending on the placement of the filter and the location of the metal circuit. The frequency generator and signal processor may be located on one or more chips on a circuit board or daughter board (which may already be present in the surgical stapler).

In one aspect, the present disclosure provides an instrument 150010 configured with various sensing systems (described in conjunction with Figures 25-30). Therefore, details of operation and construction will not be repeated here for convenience and clarity. In one aspect, the sensing system includes a viscoelasticity/rate of change sensing system to monitor blade acceleration, rate of impedance change, and rate of tissue contact change. In one example, the rate of change of knife acceleration can be used as a measure of tissue type. In another example, the rate of change of impedance can be measured with a pulse sensor and can be used as a measure of compressibility. Finally, knife firing rate-based sensors can be utilized to measure the rate of tissue contact change to measure tissue flow.

The rate of change of a sensed parameter, or otherwise stated, how long it takes for a tissue parameter to reach an asymptotic steady-state value, is a separate measurement in itself and may be more valuable than the sensed parameter from which it is derived. To enhance the measurement of a tissue parameter, such as waiting a predetermined amount of time before taking a measurement, the present disclosure provides a novel technique for employing such measurement derivation, such as the rate of change of the tissue parameter.

Derivative techniques or rate of change measurements become most useful, it being understood that no single measurement can be taken alone to significantly improve nail formation. The combination of multiple measurements makes a measurement valid. In the case of tissue gaps, it is helpful to know how much of the jaw is covered by tissue to make gap measurements relevant. Measurements of the rate of change in impedance can be combined with measurements of strain in the anvil to correlate the forces and pressures applied to tissue gripped between the jaw members of the end effector, such as the anvil and staple cartridge. Endoscopic surgical devices can employ rate-of-change measurements to determine tissue type rather than just tissue compression. Although gastric and lung tissue sometimes have similar thicknesses, and even similar compression properties when lung tissue is calcified, instruments can be modified by using measurements such as gap, compression, applied force, tissue contact area, rate of change in compression, or rate of gap change. combinations to differentiate between these organizational types. If any of these measurements are used alone, endoscopic surgical devices may have difficulty distinguishing one tissue type from another. The rate of change in compression may also help the device determine whether the tissue is "normal" or if there is some abnormality present. Not only measuring how much time has elapsed, but measuring the change in the sensor signal and determining the derivation of the signal will provide another measurement to enable the endoscopic surgical device to measure the signal. Rate-of-change information can also be employed to determine when steady state is reached to signal the next step in the process. For example, after grasping tissue between the jaw members of an end effector (such as an anvil and a staple cartridge), when tissue compression reaches a steady state (e.g., approximately 15 seconds), an indicator to initiate firing of the device or Triggers can be enabled.

This article also provides methods, apparatus, and systems for time-dependent evaluation of sensor data to determine stability, creep, and viscoelastic characteristics of tissue during operation of a surgical instrument. Surgical instruments, such as the stapler shown in Figure 25, may include instruments for measuring operating parameters such as jaw gap size or distance, firing current, tissue compression, amount of jaw covered by tissue, anvil strain, and triggering force. etc.) various sensors. Measurements of these senses are important for automatic control of surgical instruments and providing feedback to clinicians.

Various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time, can be measured using the examples shown in conjunction with Figures 30-49. A current sensor connected in series with battery 2308 can be used to monitor the motor current.

Turning now to Figure 44, a reusable or non-reusable motor-driven surgical cutting and fastening instrument 151310 is depicted. The motor-driven surgical cutting and fastening instrument 151310 is similarly constructed and equipped as the motor-driven surgical cutting and fastening instrument 150010 described in connection with FIGS. 25-30 . In the example shown in Figure 44, instrument 151310 includes a housing 151312 that includes a handle assembly 151314 configured to be grasped, manipulated, and actuated by a clinician. Housing 151312 is configured for operative attachment to an interchangeable shaft assembly 151500 having a surgical end effector 151600 operably coupled thereto, the surgical end effector 151600 configured to Perform one or more surgical tasks or surgical procedures. Because the motor-driven surgical cutting and fastening instrument 151310 is similarly constructed and equipped as the motor-driven surgical cutting and fastening instrument 150010 described in connection with FIGS. 25-30 , the operations and operations will not be repeated herein for convenience and clarity. Construction details.

Figure 44 depicts a housing 151312 shown in conjunction with an interchangeable shaft assembly 151500 that includes an end effector 151600 that includes a surgical staple cartridge 151304 configured to operably support therein. Surgical cutting and fastening devices. Housing 151312 may be configured for use with an interchangeable shaft assembly that includes an end effector adapted to support different sizes and types of staple cartridges, with different shaft lengths, Size and type etc. Additionally, housing 151312 may also be effectively used with a variety of other interchangeable shaft assemblies, including those configured to apply other motion and forms of energy (such as radio frequency (RF) energy, ultrasonic energy, and/or motion) to suitable Those components of end effector arrangements used in conjunction with various surgical applications and procedures. Additionally, the end effector, shaft assembly, handle, surgical instrument, and/or surgical instrument system may utilize any suitable fastener to secure tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and/or attached to an end effector of a shaft assembly.

Figure 44 shows surgical instrument 151310 with interchangeable shaft assembly 151500 operably coupled to it. In the arrangement shown, the handle housing forms a pistol grip portion 151319 that can be grasped and manipulated by a clinician. Handle assembly 151314 operatively supports therein a plurality of drive systems configured to generate and impart various control motions to interchangeable shaft assemblies operably attached thereto corresponding part. A trigger 151332 is operably associated with the pistol grip for controlling various of these control movements.

Continuing with FIG. 44 , the interchangeable shaft assembly 151500 includes a surgical end effector 151600 including an elongated channel 151302 configured to operatively support a staple cartridge 151304 therein. End effector 151600 may also include an anvil 151306 that is pivotally supported relative to elongated channel 151302.

The inventors have discovered that for controlling a surgical instrument, such as the instrument shown in Figure 44, the derived parameters may even be more useful than the one or more sensed parameters on which the derived parameters are based. Non-limiting examples of derived parameters include the rate of change of the sensed parameter (eg, jaw gap distance) and the length of time that elapses before the tissue parameter reaches an asymptotic steady-state value (eg, 15 seconds). Derived parameters such as rate of change are particularly useful as they significantly improve measurement accuracy and also provide information directly from the sensed parameters. For example, the rate of change in impedance (i.e., tissue compression) can be combined with strain in the anvil to correlate compression and force, which allows the microcontroller to determine tissue type rather than just the amount of tissue compression. This example is exemplary only, and any derived parameters can be combined with one or more sensed parameters to provide more information regarding tissue type (eg, stomach vs. lung), tissue health (calcified vs. normal), and surgical device operating status. Accurate information (e.g. clamping completed). Different tissues have unique viscoelastic properties and unique rates of change, making these and other parameters discussed in this article useful markers for monitoring and automatically regulating surgical protocols.

46 is an exemplary graph illustrating gap distance as a function of time, where gap is the space between jaws occupied by clamped tissue. The vertical (y) axis is distance, and the horizontal (x) axis is time. Specifically, referring to Figures 44 and 45, gap distance 151340 is the distance between the anvil 151306 of the end effector and the elongated channel 151302. In the open jaw position, at time zero, the gap 151340 between the anvil 151306 and the elongate member is at its maximum distance. The width of gap 151340 decreases as anvil 151306 is closed, such as during tissue clamping. The rate of change of gap distance can vary because tissue has non-uniform elasticity. For example, some tissue types may initially show rapid compression, resulting in a faster rate of change. However, as the tissue is continuously compressed, the viscoelasticity of the tissue can cause the rate of change to decrease until the tissue cannot be compressed further, at which point the gap distance will remain essentially constant. As tissue is squeezed between the anvil 151306 of the end effector 151340 and the staple cartridge 151304, the gap decreases over time. One or more sensors described in conjunction with Figures 31 to 43, such as magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or Any other suitable sensor may be adapted and configured to be able to measure the gap distance "d" between the anvil 151306 and the staple cartridge 151304 as a function of time "t", as graphically represented in Figure 46. The rate of change of gap distance "d" over time "t" is the slope of the curve shown in Figure 46, where slope = Δd/Δt.

Figure 47 is an exemplary graph showing firing current of an end effector jaw. The vertical (y) axis is current, and the horizontal (x) axis is time. As described herein, and as shown and described in conjunction with Figure 25, a surgical instrument and/or its microcontroller may include a current sensor that detects changes during various operations, such as clamping, cutting, and/or suturing tissue. Utilized current. For example, when tissue resistance increases, the instrument's electric motor may require more current to clamp, cut, and/or suture the tissue. Similarly, if the resistance is lower, the electric motor may require less current to clamp, cut, and/or suture tissue. Therefore, firing current can be used as an approximation of tissue resistance. The sensed current can be used alone or more preferably in conjunction with other measurements to provide feedback about the target tissue. Still referring to Figure 47, during some operations, such as suturing, the firing current is initially high at time zero but decreases over time. During operation of other devices, current may increase over time if the motor draws more current to overcome increasing mechanical loads. Additionally, the rate of change of firing current can be used as an indicator of tissue transition from one state to another. Therefore, the firing current, and particularly the rate of change of the firing current, can be used to monitor device operation. As the knife cuts through tissue, the firing current decreases over time. The rate of change of firing current may vary if the tissue being cut provides more or less resistance due to tissue characteristics or the sharpness of knife 151305 (Figure 45). When cutting conditions change, the work done by the motor changes and therefore the firing current will change over time. When the knife 151305 is firing, a current sensor can be used to measure the firing current as a function of time, as graphically represented in Figure 47. For example, current sensors can be used to monitor motor current. The current sensor may be adapted and configured to be able to measure the motor firing current "i" as a function of time "t", as graphically represented in Figure 47. The rate of change of firing current "i" over time "t" is the slope of the curve shown in Figure 47, where slope = Δi/Δt.

Figure 48 is an exemplary graph of impedance versus time. The vertical (y) axis is impedance, and the horizontal (x) axis is time. Impedance is low at time zero, but increases over time as tissue pressure increases under manipulation (eg, clamping and suturing). The rate of change varies over time as tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304 is severed by the knife or using an electrode between the anvil 151306 of the end effector 151340 and the staple cartridge 151304 RF energy sealing. For example, as tissue is cut, the electrical impedance increases, and when the tissue is completely severed by the knife, the electrical impedance reaches infinity. Additionally, if the end effector 151340 includes electrodes coupled to a source of RF energy, the electrical impedance of the tissue increases as energy is delivered through the tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. The electrical impedance increases as energy passing through the tissue dries the tissue by evaporating the water in the tissue. Ultimately, when the appropriate amount of energy is delivered to the tissue, the impedance increases to very high values or infinity when the tissue is severed. Additionally, as shown in Figure 48, different tissues may have unique compression characteristics, such as compression rates, that differentiate the tissues. Tissue impedance can be measured by driving sub-therapeutic radiofrequency current through tissue grasped between first jaw member 9014 and second jaw member 9016 . One or more electrodes may be positioned on either or both anvil 151306 and staple cartridge 151304. The time-varying tissue compression/impedance of the tissue between the anvil 151306 and the staple cartridge 151304 can be measured, as graphically represented in Figure 48. Sensors described in conjunction with Figures 31 to 43, such as magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors and/or any other suitable The sensor can be adapted and configured to be able to measure tissue compression/impedance. The sensor may be adapted and configured to be able to measure tissue impedance "Z" as a function of time "t", as graphically represented in Figure 48.

Figure 49 is an exemplary plot of strain versus time for anvil 151306 (Figures 44, 45). The vertical (y) axis is strain, and the horizontal (x) axis is time. During suturing, for example, the anvil 151306 strain is initially high but decreases as the tissue reaches a steady state and less pressure is exerted on the anvil 151306. The rate of change of strain in the anvil 151306 can be measured by a pressure sensor or strain gauge positioned on either or both the anvil 151306 and the staple cartridge 151304 (Figs. 44, 45) to measure the force exerted on the anvil 151306. The pressure or strain on the tissue between 151306 and staple cartridge 151304. Anvil 151306 strain can be measured as a function of time, as graphically represented in Figure 49. The rate of change of strain "S" with time "t" is the slope of the curve shown in Figure 49, where slope = ΔS/Δt.

Figure 50 is an exemplary graph of triggering force versus time. The vertical (y) axis is triggering force, and the horizontal (x) axis is time. In some examples, the triggering force is graduated to provide tactile feedback to the clinician. Thus, at time zero, trigger 151320 (Fig. 44) pressure may be at its lowest point, and trigger pressure may increase until the operation (eg, clamping, cutting, or suturing) is completed. The rate of change of the triggering force can be measured by a pressure sensor or strain gauge positioned on the trigger 151302 of the handle 151319 of the instrument 151310 (Fig. 44) to measure the actuation of the knife 151305 (Fig. 45) by gripping the anvil 151306 and the staple The force required for tissue between bins 151304. The time-varying force of trigger 151332 can be measured, as represented graphically in Figure 50. The rate of change of strain triggering force "F" with time "t" is the slope of the curve shown in Figure 50, where slope = ΔF/Δt.

For example, stomach and lung tissue can be differentiated even though these tissues may have similar thicknesses, and if lung tissue is calcified, these tissues may have similar compression properties. Stomach and lung tissue can be differentiated by analyzing jaw gap distance, tissue compression, applied force, tissue contact area, compression change rate, and jaw gap change rate. For example, Figure 51 shows a graph of tissue pressure "P" as a function of tissue displacement for various tissues. The vertical (y) axis is tissue pressure, and the horizontal (x) axis is tissue displacement. When tissue pressure reaches a predetermined threshold, such as 50 pounds per square inch to 100 pounds per square inch (psi), the amount of tissue displacement and the rate of tissue displacement before reaching the threshold can be used to differentiate the tissue. For example, vascular tissue reaches a predetermined pressure threshold with less tissue displacement and a faster rate of change than colon, lung, or stomach tissue. Furthermore, the rate of change (tissue pressure divided by displacement) of vascular tissue is nearly asymptotic at a threshold of 50 psi to 100 psi, whereas the rate of change of the colon, lung, and stomach is not asymptotic at a threshold of 50 psi to 100 psi. It should be understood that any pressure threshold may be used, such as between 1 psi and 1000 psi, more preferably between 10 psi and 500 psi, and still more preferably between 50 psi and 100 psi. Additionally, multiple thresholds or graduated thresholds can be used to provide further resolution of tissue types with similar viscoelastic properties.

The rate of change in compression also enables the microcontroller to determine whether the tissue is "normal" or if there is some abnormality, such as calcification. For example, see Figure 52, compression of calcified lung tissue follows a different curve than compression of normal lung tissue. Therefore, tissue displacement and the rate of change of tissue displacement can be used to diagnose and/or differentiate calcified lung tissue from normal lung tissue.

Additionally, certain sensed measurements may benefit from additional sensory input. For example, in the case of jaw gap, knowing how much of the jaw is covered by tissue can make gap measurements more useful and accurate. If a small portion of the jaw is covered in tissue, tissue compression may appear less than if the entire jaw is covered in tissue. Therefore, the amount of jaw coverage can be taken into account by the microcontroller when analyzing tissue compression and other sensed parameters.

In some cases, elapsed time can also be an important parameter. Measuring how much time has elapsed, along with the sensed parameters and derivative parameters (e.g., rate of change), provides more useful information. For example, if the jaw gap change rate remains constant after a set period of time (e.g., 5 seconds), the parameter may have reached its asymptotic value.

Rate of change information is also useful for determining when steady state is reached to signal the next step in the process. For example, during clamping, when tissue compression reaches a steady state (e.g., no significant rate of change occurs after a set period of time), the microcontroller can send a signal to the display, thereby alerting the clinician to begin the next step in the procedure. A step such as nail firing. Alternatively, the microcontroller can be programmed to automatically start the next surgical phase (eg, staple firing) once steady state is reached.

Similarly, the rate of impedance change can be combined with strain in the anvil to relate force and compression. The rate of change will allow the device to determine tissue type rather than just measuring compression values. For example, if the lungs are calcified, the stomach and lungs sometimes have similar thicknesses and even have similar compression properties.

The combination of one or more sensed parameters with derived parameters provides a more reliable and accurate assessment of tissue type and tissue health, and allows for better device monitoring, control and clinician feedback.

Figure 53 illustrates one embodiment of an end effector 152000 including a first sensor 152008a and a second sensor 152008b. End effector 152000 is similar to end effector 150300 described above. End effector 152000 includes a first jaw member or anvil 152002 pivotally coupled to a second jaw member 152004. The second jaw member 152004 is configured to receive the staple cartridge 152006 therein. Staple cartridge 152006 includes a plurality of staples (not shown). The plurality of staples may be deployed from staple cartridge 152006 during a surgical procedure. End effector 152000 includes first sensor 152008a. The first sensor 152008a is configured to measure one or more parameters of the end effector 152000. For example, in one embodiment, first sensor 152008a is configured to measure gap 152010 between anvil 152002 and second jaw member 152004. The first sensor 152008a may include, for example, a Hall effect sensor configured to detect the magnetic field generated by the magnet 152012 embedded in the second jaw member 152004 and/or the staple cartridge 152006. As another example, in one embodiment, first sensor 152008a is configured to measure the force exerted on anvil 152002 by second jaw member 152004 and/or tissue clamped between anvil 152002 and second jaw member 152004 one or more forces on.

End effector 152000 includes second sensor 152008b. Second sensor 152008b is configured to measure one or more parameters of end effector 152000. For example, in various embodiments, the second sensor 152008b may include a strain gauge configured to measure the amount of strain in the anvil 152002 during the clamping state. Strain gauges provide an electrical signal whose amplitude changes with the amount of strain. In various embodiments, the first sensor 152008a and/or the second sensor 152008b may include, for example, a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistor sensor, capacitive sensor, optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 152000. The first sensor 152008a and the second sensor 152008b may be arranged in a series configuration and/or a parallel configuration. In a series configuration, the second sensor 152008b may be configured to directly affect the output of the first sensor 152008a. In a parallel configuration, second sensor 152008b may be configured to indirectly affect the output of first sensor 152008a.

In one embodiment, one or more parameters measured by first sensor 152008a are related to one or more parameters measured by second sensor 152008b. For example, in one embodiment, first sensor 152008a is configured to measure gap 152010 between anvil 152002 and second jaw member 152004. Gap 152010 represents the thickness and/or compressibility of the tissue segment clamped between anvil 152002 and staple cartridge 152006. The first sensor 152008a may include, for example, a Hall effect sensor configured to detect a magnetic field generated by the magnet 152012 coupled to the second jaw member 152004 and/or the staple cartridge 152006. The measurement at a single location accurately describes the compressed tissue thickness for full occlusion of corrected tissue, but may provide inaccurate results when a partial occlusion of tissue is disposed between the anvil 152002 and the second jaw member 152004. Partial occlusion of tissue (proximal partial occlusion or distal partial occlusion) changes the clamping geometry of the anvil 152002.

In some embodiments, the second sensor 152008b is configured to detect one or more parameters indicative of the type of tissue occlusion (eg, full occlusion, partial proximal occlusion, and/or partial distal occlusion). The measurements of the second sensor 152008b may be used to adjust the measurements of the first sensor 152008a to accurately represent the true compressed tissue thickness of the proximally or distally positioned portion of the occlusion. For example, in one embodiment, the second sensor 152008b includes a strain gauge such as a microstrain gauge configured to monitor strain amplitude in the anvil during the clamping condition. The strain amplitude of the anvil 152002 is used to modify the output of the first sensor 152008a (eg, a Hall effect sensor) to accurately represent the true compressive tissue thickness of the proximally or distally positioned portion of the occlusion. The first sensor 152008a and the second sensor 152008b can be measured in real time during the clamping operation. Real-time measurements allow time-based information to be analyzed, for example, by a host processor (eg, processor 462 (FIG. 12)) and used to select one or more algorithms and/or lookup tables, thereby identifying tissue properties and gripping Position to dynamically adjust tissue thickness measurements.

In some embodiments, tissue measurements from first sensor 152008a may be provided to an output device of surgical instrument 150010 coupled to end effector 152000. For example, in one embodiment, end effector 152000 is coupled to surgical instrument 150010 that includes, for example, a display (eg, display 473 (FIG. 12)). The measurement results of the first sensor 152008a are provided to a processor, such as a main processor. The main processor adjusts the measurement of the first sensor 152008a based on the measurement of the second sensor 152008b to reflect the true tissue thickness of the tissue segment clamped between the anvil 152002 and the staple cartridge 152006. The main processor outputs the adjusted tissue thickness measurement and an indication of full or partial occlusion to the display. The operator can determine whether to deploy the staples in staple cartridge 152006 based on the displayed values.

In some embodiments, the first sensor 152008a and the second sensor 152008b may be positioned in different environments, such as the first sensor 152008a being positioned within the patient at a treatment site and the second sensor 152008b being positioned outside the patient. The second sensor 152008b may be configured to correct and/or modify the output of the first sensor 152008a. The first sensor 152008a and/or the second sensor 152008b may include, for example, environmental sensors. Environmental sensors may include, for example, temperature sensors, humidity sensors, pressure sensors, and/or any other suitable environmental sensors.

Figure 54 is a logic diagram illustrating one embodiment of a process 152020 for adjusting measurements of first sensor 152008a based on input from second sensor 152008b. The first signal 152022a is captured by the first sensor 152008a. The first signal 152022a may be adjusted based on one or more predetermined parameters, such as a smoothing function, a lookup table, and/or any other suitable adjustment parameters. The second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as a main processor. The processor adjusts the measurement of the first sensor 152008a represented by the first signal 152022a based on the second signal 152022b from the second sensor. For example, in one embodiment, first sensor 152008a includes a Hall effect sensor and second sensor 152008b includes a strain gauge. The distance measurement of first sensor 152008a is adjusted by the strain amplitude measured by second sensor 152008b to determine the completeness of tissue engagement in end effector 152000. The adjusted measurements are displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

Figure 55 is a logic diagram illustrating one embodiment of a process 152030 for determining a lookup table for the first sensor 152008a based on input from the second sensor 152008b. The first sensor 152008a captures a signal 152022a indicative of one or more parameters of the end effector 152000. The first signal 152022a may be adjusted based on one or more predetermined parameters, such as a smoothing function, a lookup table, and/or any other suitable adjustment parameter. The second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as a main processor. The processor selects a lookup table from one or more available lookup tables 152034a, 152034b based on the value of the second signal. The selected lookup table is used to convert the first signal into a thickness measurement of the tissue positioned between the anvil 152002 and the staple cartridge 152006. The adjusted measurements are displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

Figure 56 is a logic diagram illustrating one embodiment of a process 152040 for calibrating the first sensor 152008a in response to input from the second sensor 152008b. The first sensor 152008a is configured to capture a signal 152022a indicative of one or more parameters of the end effector 152000. The first signal 152022a may be adjusted based on one or more predetermined parameters, such as a smoothing function, a lookup table, and/or any other suitable adjustment parameter. The second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as a main processor. The main processor corrects 152042 the first signal 152022a in response to the second signal 152022b. The first signal 152022a is corrected 152042 to reflect the completeness of tissue bite in the end effector 152000. The corrected signal is displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

57 is a logic diagram illustrating one embodiment of a process 152050 for determining and displaying the thickness of a tissue segment clamped between the anvil 152002 and the staple cartridge 152006 of the end effector 152000. Process 152050 includes obtaining a Hall effect voltage 152052 by, for example, a Hall effect sensor positioned at the distal end of anvil 152002. The Hall effect voltage 152052 is provided to an analog-to-digital converter 152054 and converted into a digital signal. The digital signal is provided to a processor, such as a main processor. The main processor corrects the curve input of the 152056 Hall effect voltage 152052 signal. Strain gauges 152058, such as microstrain gauges, are configured to measure one or more parameters of the end effector 152000, such as the amplitude of strain exerted on the anvil 152002 during the clamping operation. The measured strain is converted 152060 into a digital signal and provided to a processor, such as a main processor. The main processor utilizes one or more algorithms and/or lookup tables to adjust the Hall effect voltage 152052 in response to the strain measured by the strain gauge 152058 to reflect the true thickness and bite of the tissue clamped by the anvil 152002 and staple cartridge 152006 Completeness. The adjusted thickness is displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

In some embodiments, the surgical instrument may also include a load element or load sensor 152082. The load sensor 152082 may be located, for example, in the shaft assembly 150200 (as described above) or in the housing 150012 (also as described above). 58 is a logic diagram illustrating one embodiment of a process 152070 for determining and displaying the thickness of a tissue segment clamped between the anvil 152002 and the staple cartridge 152006 of the end effector 152000. The process includes obtaining the Hall effect voltage 152072 by, for example, a Hall effect sensor positioned at the distal end of the anvil 152002. The Hall effect voltage 152072 is provided to an analog-to-digital converter 152074 and converted into a digital signal. The digital signal is provided to a processor, such as a main processor. The main processor corrects the curve input of the 152076 Hall effect voltage 152072 signal. Strain gauges 152078, such as microstrain gauges, are configured to measure one or more parameters of the end effector 152000, such as the amplitude of strain exerted on the anvil 152002 during the clamping operation. The measured strain is converted 152080 into a digital signal and provided to a processor, such as a main processor. Load sensor 152082 measures the clamping force of anvil 152002 relative to staple cartridge 152006. The measured clamping force is converted 152084 into a digital signal and provided to a processor, such as a main processor. The main processor utilizes one or more algorithms and/or lookup tables to adjust the Hall effect voltage 152072 in response to the strain measured by the strain gauge 152078 and the clamping force measured by the load sensor 152082 to reflect the changes caused by the anvil 152002 and the staple cartridge. 152006True thickness of clamped tissue and completeness of occlusion. The adjusted thickness is displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

Figure 59 is a graph 152090 showing an adjusted Hall effect thickness measurement 152092 compared to an unmodified Hall effect thickness measurement 152094. As shown in Figure 59, the unmodified Hall effect thickness measurement 152094 indicates a thicker tissue measurement because a single sensor cannot compensate for the partial distal/proximal occlusion that results in incorrect Thickness measurement results. Adjusted thickness measurements 152092 are generated by, for example, process 152050 shown in FIG. 57 . The adjusted Hall effect thickness measurement is corrected 152092 based on input from one or more additional sensors, such as strain gauges. The adjusted Hall effect thickness 152092 reflects the true thickness of the tissue positioned between the anvil 152002 and the staple cartridge 152006.

Figure 60 illustrates one embodiment of an end effector 152100 including a first sensor 152108a and a second sensor 152108b. End effector 152100 is similar to end effector 152000 shown in FIG. 53 . The end effector 152100 includes a first jaw member or anvil 152102 pivotally coupled to a second jaw member 152104. The second jaw member 152104 is configured to receive the staple cartridge 152106 therein. End effector 152100 includes a first sensor 152108a coupled to anvil 152102. The first sensor 152108a is configured to measure one or more parameters of the end effector 152100, such as the gap 152110 between the anvil 152102 and the staple cartridge 152106. Gap 152110 may correspond to, for example, the thickness of tissue clamped between anvil 152102 and staple cartridge 152106. The first sensor 152108a may include any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152108a may include a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor and/or any other suitable sensor.

In some embodiments, end effector 152100 includes second sensor 152108b. The second sensor 152108b is coupled to the second jaw member 152104 and/or the staple cartridge 152106. The second sensor 152108b is configured to detect one or more parameters of the end effector 152100. For example, in some embodiments, the second sensor 152108b is configured to detect one or more instrument conditions, such as the color of the staple cartridge 152106 coupled to the second jaw member 152104, the length of the staple cartridge 152106, the end effector The clamping state of 152100, the number of uses/remaining uses of end effector 152100 and/or staple cartridge 152106, and/or any other suitable instrument state. The second sensor 152108b may include any suitable sensor for detecting one or more instrument conditions, such as a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor , capacitive sensor, optical sensor and/or any other suitable sensor.

End effector 152100 may be used with any of the processes shown in Figures 54-57. For example, in one embodiment, input from second sensor 152108b may be used to correct input from first sensor 152108a. The second sensor 152108b may be configured to detect one or more parameters of the staple cartridge 152106, such as the color and/or length of the staple cartridge 152106. The detected parameters, such as the color and/or length of the staple cartridge 152106, may correspond to one or more characteristics of the cartridge, such as the height of the cartridge platform, available/optimal tissue thickness for the staple cartridge, and/or the staple cartridge 152106 nail pattern in . Known parameters of the staple cartridge 152106 can be used to adjust the thickness measurement provided by the first sensor 152108a. For example, if staple cartridge 152106 has a higher deck height, the thickness measurement provided by first sensor 152108a may be reduced to compensate for the increased deck height. The adjusted thickness may be displayed to the operator via a display coupled to surgical instrument 150010, for example.

Figure 61 illustrates one embodiment of an end effector 152150 including a first sensor 152158 and a plurality of second sensors 152160a, 152160b. The end effector 152150 includes a first jaw member or anvil 152152 and a second jaw member 152154. The second jaw member 152154 is configured to receive a staple cartridge 152156. The anvil 152152 is pivotally moveable relative to the second jaw member 152154 to clamp tissue between the anvil 152152 and the staple cartridge 152156. The anvil includes a first sensor 152158. The first sensor 152158 is configured to detect one or more parameters of the end effector 152150, such as the gap 152110 between the anvil 152152 and the staple cartridge 152156. Gap 152110 may correspond to, for example, the thickness of tissue clamped between anvil 152152 and staple cartridge 152156. The first sensor 152158 may include any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152158 may include a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor and/or any other suitable sensor.

In some embodiments, the end effector 152150 includes a plurality of second sensors 152160a, 152160b. The second sensors 152160a, 152160b are configured to detect one or more parameters of the end effector 152150. For example, in some embodiments, the second sensors 152160a, 152160b are configured to measure the amplitude of strain exerted on the anvil 152152 during the clamping procedure. In various embodiments, the second sensors 152160a, 152160b may include magnetic sensors (such as Hall effect sensors), strain gauges, pressure sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors and/or any other suitable sensor. The second sensors 152160a, 152160b may be configured to measure one or more of the same parameter at different locations on the anvil 152152, different parameters at the same location on the anvil 152152, and/or at different locations on the anvil 152152. different parameters.

62 is a logic diagram illustrating one embodiment of a process 152170 for adjusting measurements of a first sensor 152158 in response to a plurality of second sensors 152160a, 152160b. In one embodiment, the 152172 Hall effect voltage is obtained, for example, by a Hall effect sensor. Convert the 152174 Hall effect voltage via an analog-to-digital converter. Correct the Hall effect voltage signal converted by 152176. The calibration curve represents the thickness of the tissue segment positioned between the anvil 152152 and the staple cartridge 152156. A plurality of second measurements of 152178a, 152178b are obtained by a plurality of second sensors, such as a plurality of strain gauges. The input of the strain gauge is converted 152180a, 152180b into one or more digital signals, for example by a plurality of electronic μStrain conversion circuits. The corrected Hall effect voltage and the plurality of second measurements are provided to a processor, such as a main processor. The host processor utilizes the second measurement and adjusts 152182 the Hall effect voltage, such as by applying an algorithm and/or utilizing one or more lookup tables. The adjusted Hall effect voltage represents the true thickness of tissue clamped by the anvil 152152 and staple cartridge 152156 and the completeness of the bite. The adjusted thickness is displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

Figure 63 illustrates one embodiment of a circuit 152190 configured to convert signals from a first sensor 152158 and a plurality of second sensors 152160a, 152160b into digital numbers that can be received by a processor, such as a host processor. Signal. Circuit 152190 includes analog-to-digital converter 152194. In some implementations, analog-to-digital converter 152194 includes a 4-channel, 18-bit analog-to-digital converter. Those skilled in the art will recognize that analog-to-digital converter 152194 may include any suitable number of channels and/or bits to convert one or more inputs from an analog signal to a digital signal. Circuit 152190 includes one or more level shifting resistors 152196 configured to receive input from a first sensor 152158, such as a Hall effect sensor. Level shifting resistor 152196 conditions the input from the first sensor, thereby converting the value to a higher or lower voltage depending on the input. Level shifting resistor 152196 provides the level shifting input from first sensor 152158 to the analog-to-digital converter.

In some embodiments, a plurality of second sensors 152160a, 152160b are coupled to a plurality of bridges 152192a, 152192b within circuit 152190. The plurality of bridges 152192a, 152192b may provide filtering of inputs from the plurality of second sensors 152160a, 152160b. After filtering the input signal, the plurality of bridges 152192a, 152192b provide input from the plurality of second sensors 152160a, 152160b to the analog-to-digital converter 152194. In some implementations, a switch 152198 coupled to one or more level shifting resistors may be coupled to an analog-to-digital converter 152194. Switch 152198 is configured to be able to correct one or more of the input signals, such as input from a Hall effect sensor. Switch 152198 may be used to provide one or more level shifting signals to adjust the input of one or more of the sensors, such as thereby correcting the input of a Hall effect sensor. In some embodiments, adjustment is not necessary and switch 152198 remains in the open position to disengage the level shifting resistor. Switch 152198 is coupled to analog-to-digital converter 152194. Analog-to-digital converter 152194 provides output to one or more processors, such as a main processor. The main processor calculates one or more parameters of the end effector 152150 based on input from the analog-to-digital converter 152194. For example, in one embodiment, the host processor calculates the thickness of tissue positioned between the anvil 152152 and the staple cartridge 152156 based on input from one or more sensors 152158, 152160a, 152160b.

Figure 64 illustrates one embodiment of an end effector 152200 including a plurality of sensors 152208a-152208d. End effector 152200 includes an anvil 152202 pivotally coupled to second jaw member 152204. The second jaw member 152204 is configured to receive the staple cartridge 152206 therein. Anvil 152202 includes a plurality of sensors 152208a-152208d thereon. A plurality of sensors 152208a-152208d are configured to detect one or more parameters of the end effector 152200, such as the anvil 152202. The plurality of sensors 152208a-152208d may include one or more of the same sensor and/or different sensors. The plurality of sensors 152208a-152208d may include, for example, magnetic sensors (such as Hall effect sensors), strain gauges, pressure sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors or their combination. For example, in one embodiment, the plurality of sensors 152208a-152208d may include a plurality of strain gauges.

In one embodiment, multiple sensors 152208a-152208d allow for a robust tissue thickness sensing process. By detecting various parameters along the length of anvil 152202, multiple sensors 152208a-152208d allow a surgical instrument, such as surgical instrument 150010, to calculate tissue thickness in the jaws regardless of occlusion, for example, partial occlusion or full occlusion. In some embodiments, the plurality of sensors 152208a-152208d includes a plurality of strain gauges. A plurality of strain gauges are configured to measure strain at various points on the anvil 152202. The strain amplitude and/or slope at each of the various points on the anvil 152202 can be used to determine the thickness of the tissue between the anvil 152202 and the staple cartridge 152206. Multiple strain gauges may be configured to optimize maximum amplitude and/or slope differences based on clamping dynamics to determine thickness, tissue placement, and/or material properties of the tissue. Time-based monitoring of multiple sensors 152208a-152208d during clamping allows a processor, such as a host processor, to utilize algorithms and lookup tables to identify tissue characteristics and clamping positions and dynamically adjust end effector 152200 and/or Tissue clamped between anvil 152202 and staple cartridge 152206.

Figure 65 is a logic diagram illustrating one embodiment of a process 152220 for determining one or more tissue properties based on a plurality of sensors 152208a-152208d. In one embodiment, the plurality of sensors 152208a-152208d generate 152222a-152222d a plurality of signals indicative of one or more parameters of the end effector 152200. The plurality of generated signals are converted 152224a-152224d into digital signals and provided to the processor. For example, in one embodiment including a plurality of strain gauges, a plurality of electronic μStrain (microstrain) conversion circuits convert the strain gauge signals 152224a-152224d into digital signals. The digital signal is provided to a processor, such as a main processor. The host processor determines 152226 one or more tissue characteristics based on the plurality of signals. The processor may determine one or more tissue characteristics by applying algorithms and/or lookup tables. The one or more tissue properties are displayed 152026 to the operator, such as through a display embedded in the surgical instrument 150010.

66 illustrates one embodiment of an end effector 152250 including a plurality of sensors 152260a-152260d coupled to a second jaw member 3254. The end effector 152250 includes an anvil 152252 pivotally coupled to the second jaw member 152254. Anvil 152252 is moveable relative to second jaw member 152254 to clamp one or more materials therebetween, such as tissue segment 152264. The second jaw member 152254 is configured to receive a staple cartridge 152256. A first sensor 152258 is coupled to anvil 152252. The first sensor is configured to detect one or more parameters of the end effector 152150, such as the gap 152110 between the anvil 152252 and the staple cartridge 152256. Gap 152110 may correspond to, for example, the thickness of tissue clamped between anvil 152252 and staple cartridge 152256. The first sensor 152258 may include any suitable sensor for measuring one or more parameters of the end effector. For example, in various embodiments, the first sensor 152258 may include a magnetic sensor (such as a Hall effect sensor), a strain gauge, a pressure sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor and/or any other suitable sensor.

A plurality of second sensors 152260a-152260d are coupled to the second jaw member 152254. The plurality of second sensors 152260a-152260d may be integrally formed with the second jaw member 152254 and/or the staple cartridge 152256. For example, in one embodiment, a plurality of second sensors 152260a-152260d are disposed on the outer rows of staple cartridge 152256 (see Figure 67). The plurality of second sensors 152260a-152260d are configured to detect one or more parameters of the end effector 152250 and/or the tissue segment 152264 clamped between the anvil 152252 and the staple cartridge 152256. Second plurality of sensors 152260a-152260d may include any suitable sensor for detecting one or more parameters of the end effector 152250 and/or tissue section 152264, e.g., magnetic sensors (such as Hall effect sensors), strain pressure sensor, inductive sensor (such as an eddy current sensor), resistive sensor, capacitive sensor, optical sensor and/or any other suitable sensor or combination thereof. The plurality of second sensors 152260a-152260d may include the same sensor and/or different sensors.

In some embodiments, the second plurality of sensors 152260a-152260d includes dual-purpose sensors and tissue stabilizing elements. The plurality of second sensors 152260a-152260d includes electrodes and/or sensing geometries configured to enable contact with the tissue segment when the plurality of second sensors 152260a-152260d, such as during a clamping operation. 152264 Produces a stable tissue state when engaged. In some embodiments, one or more of the plurality of second sensors 152260a-152260d may be replaced by a non-sensing tissue stabilizing element. The second sensors 152260a-152260d generate stable tissue conditions by controlling tissue flow, staple deformation, and/or other tissue conditions during clamping, suturing, and/or other processing procedures.

Figure 67 illustrates one embodiment of a staple cartridge 152270 including a plurality of sensors 152272a-152272h integrally formed therein. Staple cartridge 152270 includes a plurality of rows containing a plurality of holes for storing staples therein. One or more holes in the outer row 152278 are replaced by one of the plurality of sensors 152272a-152272h. A cross-sectional portion is shown to illustrate sensor 152272f coupled to sensor line 152276b. Sensor wires 152276a, 152276b may include a plurality of wires for coupling a plurality of sensors 152272a-152272h to one or more circuits of a surgical instrument, such as surgical instrument 150010. In some embodiments, one or more of the plurality of sensors 152272a-152272h includes a dual-purpose sensor and tissue stabilizing element having electrodes and/or sensing configured to provide tissue stabilization. geometry structure. In some embodiments, multiple sensors 152272a-152272h may be replaced and/or occupied by multiple tissue stabilizing elements. Tissue stabilization may be provided, for example, by controlling tissue flow and/or staple formation during the clamping and/or suturing process. The plurality of sensors 152272a-152272h provide signals to one or more circuits of the surgical instrument 150010 to enhance feedback of suturing performance and/or tissue thickness sensing.

68 is logic illustrating one embodiment of a process 152280 for determining one or more parameters of a tissue segment 152264 clamped within an end effector, such as the end effector 152250 shown in FIG. 66 picture. In one embodiment, the first sensor 152258 is configured to detect one or more parameters of the end effector 152250 and/or the tissue section 152264 positioned between the anvil 152252 and the staple cartridge 152256. A first signal is generated 152282 by a first sensor 152258. The first signal is indicative of one or more parameters detected by first sensor 152258. One or more second sensors 152260 are configured to detect one or more parameters of the end effector 152250 and/or the tissue section 152264. Like first sensor 152258, second sensor 152260 may be configured to detect the same parameter, additional parameters, or different parameters. The second signal 152284 is generated by the second sensor 152260. Second signal 152284 is indicative of one or more parameters detected by second sensor 152260. The first signal and the second signal are provided to a processor, such as a main processor. The processor adjusts 152286 the first signal generated by the first sensor 152258 based on the input generated by the second sensor 152260 . The adjusted signal may indicate, for example, the true thickness of the tissue section 152264 and the completeness of the bite. The adjusted signal is displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

Figure 69 illustrates one embodiment of an end effector 152300 that includes multiple redundant sensors 152308a, 152308b. End effector 152300 includes a first jaw member or anvil 152302 pivotally coupled to a second jaw member 152304. The second jaw member 152304 is configured to receive the staple cartridge 152306 therein. The anvil 152302 is moveable relative to the staple cartridge 152306 to grip material, such as a tissue segment, between the anvil 152302 and the staple cartridge 152306. A plurality of sensors 152308a, 152308b are coupled to the anvil. A plurality of sensors 152308a, 152308b are configured to detect one or more parameters of the end effector 152300 and/or the tissue segment positioned between the anvil 152302 and the staple cartridge 152306. In some embodiments, the plurality of sensors 152308a, 152308b are configured to detect the gap 152310 between the anvil 152302 and the staple cartridge 152306. Gap 152310 may correspond to, for example, the thickness of tissue positioned between anvil 152302 and staple cartridge 152306. The plurality of sensors 152308a, 152308b may detect the gap 152310 by, for example, detecting a magnetic field generated by the magnet 152312 coupled to the second jaw member 152304.

In some embodiments, the plurality of sensors 152308a, 152308b includes redundant sensors. The redundant sensors are configured to detect the same characteristics of the end effector 152300 and/or the tissue segment positioned between the anvil 152302 and the staple cartridge 152306. Redundant sensors may include, for example, a Hall effect sensor configured to detect the gap 152310 between the anvil 152302 and the staple cartridge 152306. Redundant sensors provide signals representative of one or more parameters, allowing a processor (eg, a main processor) to evaluate multiple inputs and determine the most reliable input. In some embodiments, redundant sensors are used to reduce noise, glitches, and/or drift. Each of the redundant sensors can be measured in real time during clamping, thereby allowing time-based information to be analyzed and algorithms and/or lookup tables utilized to dynamically identify tissue characteristics and clamping positioning. The input of one or more of the redundant sensors may be adjusted and/or selected to identify the true tissue thickness and engagement of the tissue segment positioned between the anvil 152302 and the staple cartridge 152306.

Figure 70 is a logic diagram illustrating one embodiment of a process 152320 for selecting the most reliable output from multiple redundant sensors, such as the multiple sensors 152308a, 152308b shown in Figure 69. In one embodiment, the first signal is generated by first sensor 152308a. Convert the 152322a first signal via an analog-to-digital converter. One or more additional signals are generated by one or more redundant sensors 152308b. The one or more additional signals are converted 152322b by an analog-to-digital converter. The converted signal is provided to a processor, such as a main processor. The main processor evaluates 152,324 redundant inputs to determine the most reliable output. The most reliable output may be selected based on one or more parameters, such as an algorithm, a lookup table, input from additional sensors, and/or instrument status. After selecting the most reliable output, the processor may adjust the output based on one or more additional sensors to reflect, for example, the true thickness and bite of the tissue segment positioned between the anvil 152302 and the staple cartridge 152306. The most reliable output of the adjustment is displayed 152026 to the operator via a display embedded in the surgical instrument 150010, for example.

Figure 71 illustrates one embodiment of an end effector 152350 that includes a sensor 152358 that includes a specific sampling rate to limit or eliminate spurious signals. End effector 152350 includes a first jaw member or anvil 152352 pivotally coupled to a second jaw member 152354. The second jaw member 152354 is configured to receive the staple cartridge 152356 therein. Staple cartridge 152356 includes a plurality of staples that can be delivered to a tissue segment positioned between anvil 152352 and staple cartridge 152356. Sensor 152358 is coupled to anvil 152352. Sensor 152358 is configured to detect one or more parameters of end effector 152350, such as gap 152364 between anvil 152352 and staple cartridge 152356. The gap 152364 may correspond to the thickness of the material (such as the tissue section) and/or the completeness of the bite of the material positioned between the anvil 152352 and the staple cartridge 152356. Sensors 152358 may include any suitable sensor for detecting one or more parameters of end effector 152350, for example, magnetic sensors (such as Hall effect sensors), strain gauges, pressure sensors, inductive sensors (such as eddy current sensors) , resistive sensors, capacitive sensors, optical sensors and/or any other suitable sensor.

In one embodiment, sensor 152358 includes a magnetic sensor configured to detect a magnetic field generated by electromagnetic source 152360 coupled to second jaw member 152354 and/or staple cartridge 152356. Electromagnetic source 152360 generates a magnetic field that is detected by sensor 152358. The strength of the detected magnetic field may correspond, for example, to the thickness and/or completeness of the bite of tissue positioned between the anvil 152352 and the staple cartridge 152356. In some implementations, electromagnetic source 152360 generates a signal of a known frequency, such as 1 MHz. In other embodiments, the signal generated by the electromagnetic source 152360 may be based on, for example, the type of staple cartridge 152356 installed in the second jaw member 152354, one or more additional sensors, algorithms, and/or one or more parameters. adjust.

In one embodiment, signal processor 152362 is coupled to end effector 152350, such as anvil 152352. Signal processor 152362 is configured to process signals generated by sensor 152358 to eliminate spurious signals and enhance input from sensor 152358. In some embodiments, signal processor 152362 may be positioned independent of end effector 152350, such as in handle 150014 of surgical instrument 150010. In some embodiments, signal processor 152362 is integrally formed with and/or includes an algorithm executed by a general-purpose processor, such as a main processor. Signal processor 152362 is configured to process signals from sensor 152358 at a frequency that is substantially equivalent to the frequency of the signal generated by electromagnetic source 152360 . For example, in one embodiment, electromagnetic source 152360 generates a signal at a frequency of 1 MHz. This signal is detected by sensor 152358. Sensor 152358 generates a signal indicative of the detected magnetic field provided to signal processor 152362. The signal is processed by signal processor 152362 at 1MHz to eliminate glitches. The processed signals are provided to a processor, such as a main processor. The main processor correlates the received signal with one or more parameters of the end effector 152350, such as the gap 152364 between the anvil 152352 and the staple cartridge 152356.

Figure 72 is a diagram illustrating a process 152370 for producing thickness measurements of a tissue segment positioned between an anvil and a staple cartridge of an end effector, such as end effector 152350 shown in Figure 71 Logic diagram of an implementation. In one embodiment of process 152370, a signal is generated 152372 by a modulated electromagnetic source 152360. The generated signal may include, for example, a 1 MHz signal. Magnetic sensor 152358 is configured to detect 152374 signals generated by electromagnetic source 152360. Magnetic sensor 152358 generates a signal indicative of the detected magnetic field and provides the signal to signal processor 152362. A signal processor 152362 processes 152376 the signal to remove noise, artifacts and/or enhance the signal. The processed signal is provided to an analog-to-digital converter for conversion 152378 into a digital signal. The digital signal may be corrected 152380, for example, by applying a correction curve input algorithm and/or a lookup table. Signal processing 152376, conversion 152378, and correction 152380 may be performed by one or more circuits. The corrected signal is displayed 152026 to the user, for example, through a display formed integrally with the surgical instrument 150010.

73 and 74 illustrate one embodiment of an end effector 152400 that includes a sensor 152408 for identifying different types of staple cartridges 152406. End effector 152400 includes a first jaw member or anvil 152402 pivotally coupled to a second jaw member or elongated channel 152404. Elongated channel 152404 is configured to operatively support staple cartridge 152406 therein. The end effector 152400 also includes a sensor 152408 positioned in the proximal region. Sensor 152408 may be any of an optical sensor, a magnetic sensor, an electrical sensor, or any other suitable sensor.

Sensor 152408 is operable to detect characteristics of staple cartridge 152406 and thereby identify staple cartridge 152406 type. Figure 74 shows an example where sensor 152408 is an optical emitter and detector 152410. The body of the staple cartridge 152406 can be of different colors such that the color identifies the staple cartridge 152406 type. Optical emitter and detector 152410 is operable to interrogate the color of the staple cartridge 152406 body. In the illustrated example, optical emitter and detector 152410 may detect white 152412 by receiving reflected light of equal intensity in the red, green, and blue spectrums. Optical emitter and detector 152410 can detect red 152414 by receiving very little reflected light in the green and blue spectrum while receiving higher intensity light in the red spectrum.

Alternatively or in addition, the optical emitter and detector 152410 or another suitable sensor 152408 may interrogate and identify some other symbols or markings on the staple cartridge 152406. The symbol or mark may be any of a barcode, a shape or character, a color-coded logo, or any other suitable mark. Information read by sensor 152408 may be communicated to a microcontroller in surgical device 150010, such as microcontroller (eg, microcontroller 461 (Fig. 12)). The microcontroller may be configured to communicate information about the staple cartridge 152406 to the operator of the instrument. For example, the identified staple cartridge 152406 may not be suitable for a given application; in this case, the operator of the instrument may be informed, and/or the functionality of the instrument is inappropriate. In this case, the microcontroller may optionally be configured to be able to disable the functionality of the surgical instrument that may be disabled. Alternatively or in addition, the microcontroller may be configured to be able to notify an operator of surgical instrument 150010 of parameters of the identified type of staple cartridge 152406, such as the length of staple cartridge 152406, or information about the staples, such as, height and length).

Figure 75 illustrates one aspect of a segmented flexible circuit 153430 configured to be fixedly attachable to a jaw member 153434 of an end effector. Segmented flexible circuit 153430 includes distal segment 153432a and lateral segments 153432b, 153432c that include individually addressable sensors for providing localized tissue presence detection. Segments 153432a, 153432b, 153432c are individually addressable to detect tissue and measure tissue parameters based on a single sensor located within each of the segments 153432a, 153432b, 153432c. Segments 153432a, 153432b, 153432c of segmented flexible circuit 153430 are mounted to jaw member 153434 and electrically coupled to an energy source, such as a circuit, via conductive element 153436. A Hall effect sensor 153438 or any suitable magnetic sensor is located on the distal end of jaw member 153434. Hall effect sensor 153438 operates in conjunction with a magnet to provide a measurement of the aperture defined by jaw member 153434, which may also be referred to as a tissue gap, as particularly shown in Figure 77. The segmented flex circuit 153430 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector.

Figure 76 illustrates one aspect of a segmented flex circuit 153440 configured to be mountable to the jaw member 153444 of an end effector. The segmented flexible circuit 153440 includes a distal segment 153442a and lateral segments 153442b, 153442c with individually addressable sensors for tissue control. Segments 153442a, 153442b, 153442c are individually addressable to process tissue and read a single sensor located within each of the segments 153442a, 153442b, 153442c. Segments 153442a, 153442b, 153442c of segmented flexible circuit 153440 are mounted to jaw member 153444 and electrically coupled to the energy source through conductive element 153446. A Hall effect sensor 153448 or other suitable magnetic sensor is disposed on the distal end of jaw member 153444. The Hall effect sensor 153448 operates in conjunction with a magnet to provide a measurement of the hole or tissue gap defined by the jaw member 153444 of the end effector, as particularly shown in Figure 77. Additionally, a plurality of laterally asymmetric temperature sensors 153450a, 153450b are mounted on or integrally formed with the segmented flexible circuit 153440 to provide tissue temperature feedback to the control circuitry. The segmented flex circuit 153440 can be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within the end effector.

Figure 77 illustrates one aspect of end effector 153460 configured to measure tissue gap G _T. End effector 153460 includes jaw member 153462 and jaw member 153444. The flex circuit 153440 depicted in Figure 76 is mounted to the jaw member 153444. Flexible circuit 153440 includes a Hall effect sensor 153448 that operates in conjunction with a magnet 153464 mounted to jaw member 153462 to measure tissue gap G _T . This technique can be used to measure the hole defined between jaw member 153444 and jaw member 153462. Jaw member 153462 may be a staple cartridge.

78 illustrates one aspect of an end effector 153470 including a segmented flex circuit 153468. End effector 153470 includes a jaw member 153472 and a staple cartridge 153474. Segmented flex circuit 153468 is mounted to jaw member 153472. Each sensor disposed within segments 1-5 is configured to detect the presence of tissue positioned between jaw member 153472 and staple cartridge 153474 and to represent tissue region 1-5. In the configuration shown in Figure 78, the end effector 153470 is shown in an open position ready to receive or grasp tissue between the jaw member 153472 and the staple cartridge 153474. Segmented flexible circuit 153468 may be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within end effector 153470.

Figure 79 shows the end effector 153470 shown in Figure 78 with the jaw member 153472 clamping tissue 153476 between the jaw member 153472 (eg, anvil) and the staple cartridge. As shown in Figure 79, tissue 153476 is positioned between segments 1-3 and represents tissue region 1-3. Thus, tissue 153476 is detected by the sensor in segment 1-3, and the absence of tissue (empty) is detected in segment 153469 by segment 4-5. Information regarding the presence and absence of tissue 153476 located within certain segments 1-3 and 4-5 respectively is communicated to a control circuit as described herein via, for example, an interface circuit. The control circuit is configured to detect tissue located in segments 1-3. It should be understood that segments 1-5 may include any suitable temperature, force/pressure and/or Hall effect magnetic sensors that measure tissue parameters of tissue located within certain segments 1-5 as well as deliver energy to certain segments 1-5 -5 electrodes for tissues. Segmented flexible circuit 153468 may be used to measure tissue thickness, force, displacement, compression, tissue impedance, and tissue position within end effector 153470.

Figure 80 is a schematic diagram of an absolute positioning system 153100 that may be used with a surgical instrument or system according to the present disclosure. Absolute positioning system 153100 includes a controlled motor drive circuit arrangement including a sensor arrangement 153102 in accordance with at least one aspect of the present disclosure. Sensor arrangement 153102 for absolute positioning system 153100 provides a unique position signal corresponding to the position of displacement member 153111. In one aspect, displacement member 153111 represents a longitudinally movable drive member coupled to a cutting instrument or knife (eg, cutting instrument, I-beam, and/or I-beam 153514 (Fig. 82)). In other aspects, the displacement member 153111 represents a firing member coupled to a cutting instrument or knife that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member 153111 represents a firing rod or I-beam, each of which may be adapted and configured to include a rack of drive teeth.

Thus, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or system as described herein, such as a drive member, firing member, firing rod, cutting instrument, knife, and/or I-beam, or Any element that can be moved. Therefore, the absolute positioning system 153100 may actually track the displacement of the cutting instrument I-beam 153514 (Fig. 82) by tracking the displacement of the longitudinally movable drive member. In various other aspects, the displacement member 153111 may be coupled to any sensor suitable for measuring displacement. Thus, a longitudinally movable drive member, firing member, firing rod or I-beam, or combination thereof, may be coupled to any suitable displacement sensor. The displacement sensor may include a contact displacement sensor or a non-contact displacement sensor. Displacement sensors may include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRT), sliding potentiometers, magnetic sensing systems including movable magnets and a series of linearly arranged Hall effect sensors, including A magnetic sensing system with a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical sensing system including a movable light source and a series of linearly arranged photodiodes or photodetectors, or a fixed light source and a series of Optical sensing system of movable linear arrangement of photodiodes or photodetectors, or any combination thereof.

The electric motor 153120 may include a rotatable shaft 153116 operably interfaced with a gear assembly 153114 mounted for meshing engagement with a set or rack of drive teeth on the displacement member 153111 . Sensor element 153126 is operatively coupled to gear assembly 153114 such that a single rotation of sensor element 153126 corresponds to some linear longitudinal translation of displacement member 153111 . The gearing and sensor 153118 arrangement may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. Power source 153129 supplies power to absolute positioning system 153100, and output indicator 153128 may display the output of absolute positioning system 153100.

A single rotation of sensor element 153126 associated with position sensor 153112 is equivalent to the longitudinal displacement d ₁ of displacement member 153111 , where d ₁ is the displacement member 153111 from point "a" moves to the longitudinal distance of point "b". The sensor arrangement 153102 may be connected via a gear reduction that causes the position sensor 153112 to complete one or more rotations for the full stroke of the displacement member 153111. The position sensor 153112 can complete multiple rotations for the full stroke of the displacement member 153111.

A series of switches 153122a-153122n (where n is an integer greater than one) may be used alone or in conjunction with gear reduction to provide a unique position signal for more than one rotation of position sensor 153112. The status of switches 153122a-153122n is fed back to controller 153110, which applies logic to determine a unique position signal corresponding to the longitudinal displacement _d1 + _d2 +... _dn of displacement member 153111. The output 153124 of the position sensor 153112 is provided to the controller 153110. The position sensor 153112 of the sensor arrangement 153102 may include a magnetic sensor, an analog rotation sensor (such as a potentiometer), an array of analog Hall effect elements that output a unique combination of position signals or values. Controller 153110 may be contained within a main controller or may be contained within a tool mounting portion housing of a surgical instrument or system in accordance with the present disclosure.

The absolute positioning system 153100 provides an absolute position of the displacement member 153111 when the surgical instrument or system is powered on without causing the displacement member 153111 to retract or advance to a reset (clear or home) position as may be required with conventional rotary encoders. The rotary encoder simply counts the number of steps forward or backward taken by the motor 153120 to deduce the position of the device actuator, drive rod, knife, etc.

The controller 153110 can be programmed to perform various functions such as precise control of the speed and position of the knife and articulation systems. In one aspect, controller 153110 includes processor 153108 and memory 153106. Electric motor 153120 may be a brushed DC motor with a gearbox and mechanical link to the articulation or knife system. In one aspect, motor driver 153110 may be an A3941 available from Allegro Microsystems, Inc. Other motor drives can be easily replaced for use in the absolute positioning system 153100.

The controller 153110 may be programmed to provide precise control of the speed and position of the displacement member 153111 and articulation system. Controller 153110 may be configured to be able to calculate responses in the software of controller 153110. The calculated response is compared to the measured response of the actual system to obtain the "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that equalizes the smooth continuous nature of the simulated response with the measured response, which can detect external effects on the system.

The absolute positioning system 153100 may include and/or may be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. The power source 153129 converts the signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include pulse width modulation (PWM) of voltage, current and force. In addition to the position measured by position sensor 153112, one or more other sensors 153118 may be provided to measure physical parameters of the physical system. In the digital signal processing system, the absolute positioning system 153100 is coupled to the digital data acquisition system, where the output of the absolute positioning system 153100 will have limited resolution and sampling frequency. The absolute positioning system 153100 may include comparison and combining circuitry to combine the calculated response with the measured response using algorithms, such as weighted averaging and theoretical control loops, that drive the calculated response toward the measured response. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, inductance and resistance, etc., to predict the state and output of the physical system from known inputs.

Motor driver 153110 may be the A3941 available from Allegro Microsystems, Inc. The A3941 driver 153110 is a full-bridge controller designed for use with external N-channel power metal-oxide-semiconductor field-effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Driver 153110 includes a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows the A3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor can be used to provide the above battery supply voltage required by the N-channel MOSFET. The high-side driver's internal charge pump allows DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation can occur through either the high-side or low-side FET. Power FETs are protected against breakdown by resistor-adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults, and can be configured to protect the power MOSFETs under most short-circuit conditions. Other motor drives can be easily replaced for use in the absolute positioning system 153100.

81 is a schematic diagram of a position sensor 153200 of an absolute positioning system 153100' including a magnetic rotational absolute positioning system in accordance with at least one aspect of the present disclosure. Absolute positioning system 153100' is similar to absolute positioning system 153100 in many respects. Position sensor 153200 may be implemented as an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. Position sensor 153200 interfaces with controller 153110 to provide absolute positioning system 153100’. The position sensor 153200 is a low voltage and low power component and includes four Hall effect elements 153228A, 153228B, 153228C, 153228D in a region 153230 of the position sensor 153200 that is located above a magnet positioned in conjunction with a displacement member such as (knife drive gear and/or closing drive gear) on the associated rotating element so that the displacement of the firing member and/or closing member can be accurately tracked. High-resolution ADC153232 and intelligent power management controller 153238 are also provided on the chip. The CORDIC processor 153236 (for the Coordinate Rotation DIgital Computer), also known as the bitwise method and Volder's algorithm, was designed to implement simple and efficient algorithms for computing hyperbolic and trigonometric functions that only Requires addition operations, subtraction operations, bit shift operations and table lookup operations. Angular position, alarm bits and magnetic field information are transmitted to the controller 153110 via a standard serial communication interface such as the SPI interface 153234. Position sensor 153200 offers 12 or 14 bit resolution. The position sensor 153200 is available as an AS5055 chip in a small QFN 16-pin 4×4×0.85mm package.

Hall effect elements 153228A, 153228B, 153228C, 153228D are located directly above the rotating magnet. The Hall effect is a well-known effect, and for convenience, it will not be described in detail in this article, but, in general, the Hall effect produces a voltage difference across an electrical conductor transverse to the current in the conductor (the Hall voltage) as well as vertically magnetic field due to current. The Hall coefficient is defined as the ratio of the induced electric field to the product of the current density and the applied magnetic field. It is a property of the material from which the conductor is made, since its value depends on the type, number and properties of the charge carriers that make up the current flow. In the AS5055 position sensor 153200, the Hall effect elements 153228A, 153228B, 153228C, 153228D are capable of generating a voltage signal that indicates the absolute position of the magnet based on the angle through which the magnet passes through a single rotation. This value of angle, which is a unique position signal, is calculated by the CORDIC processor 153236 and stored on-board on the AS5055 position sensor 153200 in a register or memory. In various techniques, the controller 153110 is provided with a value for the angle that indicates the position of the magnet through one rotation, such as at power-up or upon request from the controller 153110 .

The AS5055 position sensor 153200 requires only a few external components to operate when connected to the controller 153110. A simple application using a single power source requires six wires: two wires for power and four wires 153240 for the SPI interface 153234 that interfaces with the controller 153110. A seventh connection can be added to send an interrupt to the controller 153110 to notify that a new valid angle can be read. On power-up, the AS5055 Position Sensor 153200 performs a complete power-up sequence, including an angle measurement. Completion of the loop is indicated by INT output 153242, and the angle value is stored in an internal register. Once this output is set, the AS5055 position sensor 153200 suspends into sleep mode. The controller 153110 may respond to the INT request at the INT output 153242 by reading the angle value from the AS5055 position sensor 153200 via the SPI interface 153234. Once the controller 153110 has read the angle value, the INT output 153242 is cleared again. Sending a "read angle" command by the controller 153110 to the position sensor 153200 via the SPI interface 153234 also automatically powers up the chip and starts another angle measurement. As soon as the controller 153110 completes reading the angle value, it clears the INT output 153242 and stores the new result in the angle register. Completion of the angle measurement is again indicated by setting the INT output 153242 and the corresponding flag in the status register.

Due to the measuring principle of the AS5055 position sensor 153200, only a single angle measurement is performed within a very short time (~600 μs) after each power-on sequence. As soon as the measurement of an angle is completed, the AS5055 position sensor 153200 is suspended in the power-down state. On-chip filtering based on digitally averaged angle values is not implemented as this would require more than one angle measurement and therefore longer power-up time, which is undesirable in low power applications. Angle jitter can be reduced by averaging several angle samples in the controller 153110. For example, averaging four samples reduces jitter by 6dB (50%).

82 is a cross-sectional view of the end effector 153502 illustrating the firing stroke of the I-beam 153514 relative to tissue 153526 grasped within the end effector 153502, in accordance with at least one aspect of the present disclosure. End effector 153502 is configured to operate with any surgical instrument or system in accordance with the present disclosure. End effector 153502 includes an anvil 153516 and an elongated channel 153503 with a staple cartridge 153518 positioned in the elongated channel 153503. The firing rod 153520 is capable of translating distally and proximally along the longitudinal axis 153515 of the end effector 153502. When the end effector 153502 is not articulating, the end effector 153502 is aligned with the axis of the instrument. I-beam 153514 including cutting edge 153509 is shown at the distal portion of firing member 153520. The wedge slider 153513 is positioned in the staple cartridge 153518. As I-beam 153514 translates distally, cutting edge 153509 contacts and can cut tissue 153526 positioned between anvil 153516 and staple cartridge 153518. Furthermore, I-beam 153514 contacts wedge slider 153513 and pushes it distally, causing wedge slider 153513 to contact staple driver 153511. Staple driver 153511 can be driven upward into staples 153505, causing staples 153505 to advance through tissue and into pockets 153507 defined in anvil 153516, which shape the staples 153505.

An exemplary I-beam 153514 firing stroke is illustrated by diagram 153529 aligned with end effector 153502. Exemplary tissue 153526 aligned with end effector 153502 is also shown. The firing member stroke may include a start of stroke position 153527 and an end of stroke position 153528. During the I-beam 153514 firing stroke, the I-beam 153514 may be advanced distally from a start of stroke position 153527 to an end of stroke position 153528. I-beam 153514 is shown in one exemplary position at start of stroke position 153527. I-beam 153514 firing member travel diagram 153529 shows five firing member travel regions 153517, 153519, 153521, 153523, 153525. In the first firing stroke region 153517, the I-beam 153514 may begin to advance distally. In the first firing stroke region 153517, the I-beam 153514 may contact the wedge slide 153513 and begin to move it distally. However, in the first region, the cutting edge 153509 may not contact tissue, and the wedge slide 153513 may not contact the staple driver 153511. After overcoming stiction, the force driving the I-beam 153514 in the first region 153517 may be substantially constant.

In the second firing member travel region 153519, the cutting edge 153509 can begin to contact and cut tissue 153526. Furthermore, wedge slider 153513 may come into contact with staple driver 153511 to drive staple 153505. The force driving the I-beam 153514 can begin to ramp up. As shown, due to the manner in which anvil 153516 pivots relative to staple cartridge 153518, initially encountered tissue may be compressed and/or thinned. In the third firing member travel region 153521, the cutting edge 153509 can continuously contact and cut tissue 153526, and the wedge slider 153513 can repeatedly contact the staple driver 153511. The force driving the I-beam 153514 may level off in the third region 153521. Through the fourth firing stroke region 153523, the force driving the I-beam 153514 may begin to decrease. For example, tissue in the portion of end effector 153502 corresponding to fourth firing zone 153523 may be less compressed than tissue closer to the pivot point of anvil 153516, thereby requiring less cutting force. Furthermore, the cutting edge 153509 and wedge slide 153513 may reach the end of the tissue 153526 while in the fourth region 153523. When the I-beam 153514 reaches the fifth region 153525, the tissue 153526 can be completely severed. Wedge slider 153513 may contact one or more staple drivers 153511 at or near the end of the tissue. The force driving the I-beam 153514 through the fifth region 153525 may be reduced, and in some examples may be similar to the force driving the I-beam 153514 in the first region 153517. At the end of the firing member's stroke, the I-beam 153514 can reach the end-of-stroke position 153528. The positioning of firing member travel areas 153517, 153519, 153521, 153523, 153525 in Figure 82 is only one example. In some examples, different regions may begin at different locations along the end effector longitudinal axis 153515 based on the positioning of tissue between the anvil 153516 and the staple cartridge 153518, for example.

As described above and referring now to Figures 80-82, an electric motor 153120 positioned within the main controller of the surgical instrument may be utilized to align the shaft assembly's firing system (including the I-beam 153514) relative to the shaft assembly's end effector. 153502 is advanced and/or retracted to suture and/or cut into tissue captured within end effector 153502. The I-beam 153514 can advance or retract at a desired speed or within a desired range of speeds. Controller 153110 may be configured to control the speed of I-beam 153514. Controller 153110 may be configured to be able to predict the speed of I-beam 153514 based on various parameters such as power provided to electric motor 153120 (such as voltage and/or current) and/or other operating parameters or external influences of electric motor 153120 . Controller 153110 may be configured to be able to predict the current speed of I-beam 153514 based on previous values of current and/or voltage provided to electric motor 153120 and/or previous states of the system (such as speed, acceleration, and/or position). Controller 153110 may be configured to sense the speed of I-beam 153514 utilizing the absolute position sensor system described herein. The controller may be configured to compare the predicted speed of I-beam 153514 to the sensed speed of I-beam 153514 to determine whether the power of electric motor 153120 should be increased in order to increase the speed of I-beam 153514 and/or decrease power in order to reduce the speed of I-beam 153514.

Various techniques may be used to determine the forces acting on the I-beam 153514. The I-beam 153514 force may be determined by measuring the motor 153120 current, where the motor 153120 current is based on the load experienced by the I-beam 153514 while advancing distally. The I-beam 153514 force may be determined by positioning strain gauges on the proximal end of the drive member, firing member, I-beam 153514, firing rod, and/or cutting edge 153509. This can be achieved by monitoring the actual position of the I-beam 153514 moving at an expected speed based on the current set speed of the motor 153120 after a predetermined elapsed time period _T1 and comparing the actual position of the I-beam 153514 with the actual position of the I-beam 153514 based on the end of the time period _T1 The current set speed of the motor 153120 is compared to the expected position of the I-beam 153514 to determine the I-beam 153514 force. Therefore, if the actual position of I-beam 153514 is less than the expected position of I-beam 153514, the force on I-beam 153514 is greater than the nominal force. Conversely, if the actual position of I-beam 153514 is greater than the expected position of I-beam 153514, then the force on I-beam 153514 is less than the nominal force. The difference between the actual and expected positions of I-beam 153514 is proportional to the deviation of the force on I-beam 153514 from the nominal force.

Before turning to a description of closed loop control techniques of the closure tube and firing member, the description briefly turns to Figure 83. Figure 83 is a graph 153600 depicting two force-to-close (FTC) curves 153606, 153608 depicting the force applied to the closure member during the closure phase to close on thick and thin tissue, and two firing forces ( Graph 153601 of FTF) curves 153622, 153624 (which depicts the force applied to the firing member during the firing phase to fire through thick and thin tissue). Referring to Figure 83, graph 153600 depicts an example of the force applied to thick and thin tissue to close end effector 153502 relative to tissue grasped between anvil 153516 and staple cartridge 153518 during the closing stroke, where the closing force Plotted as a function of time. Draw closing force curves 153606, 153608 on both axes. The vertical axis 153602 indicates the closing force (FTC) of the end effector 153502 in Newtons (N). The horizontal axis 153604 indicates time in seconds and is labeled t ₀ to t ₁₃ for clarity of description. The first closing force curve 153606 is an example of the force applied to thick tissue to close the end effector 153502 relative to tissue gripped between the anvil 153516 and the staple cartridge 153518 during the closing stroke, and the second curve 153608 is An example of the force applied to thin tissue during the closing stroke to close end effector 153502 relative to tissue gripped between anvil 153516 and staple cartridge 153518. The first closing force curve 153606 and the second closing force curve 153608 are divided into three stages: closing stroke (CLOSE), waiting period (WAIT) and firing stroke (FIRE). During the closing stroke, the closing tube translates distally (direction "DD") to move the anvil 153516, for example, relative to the staple cartridge 153518 in response to actuation of the closing motor for the closing stroke. In other cases, the closing stroke involves moving the staple cartridge 153518 relative to the anvil 153516 in response to actuation of the closing motor, and in other cases, the closing stroke involves moving the staple cartridge 153518 and the anvil in response to actuation of the closing motor. 153516. Referring to the first closing force curve 153606, during the closing stroke the closing force 153610 increases from 0 to the maximum force F ₁ from time t ₀ to t ₁ . Referring to the second closing force curve 153608, during the closing stroke the closing force 153616 increases from 0 to the maximum force _F3 from time _t0 to _t1 . The relative difference between the maximum forces _F1 and _F3 is caused by the difference in closing force required for thick tissue relative to thin tissue, where a greater force is required to close the anvil to thick tissue compared to thin tissue. Organizationally.

The first closing force curve 153606 and the second closing force curve 153608 indicate that the closing force in the end effector 153502 increases during the initial clamping period ending at time (t ₁ ). The closing force reaches the maximum force (F ₁ , F ₃ ) at time (t ₁ ). The initial clamping period may be, for example, about one second. A waiting period can be imposed before initiating the firing stroke. The wait period allows fluid to flow from the tissue compressed by end effector 153502, which reduces the thickness of the compressed tissue, thereby creating a smaller gap between anvil 153516 and staple cartridge 153518, and reduces the amount of fluid at the end of the wait period. Less closing force. Referring to the first closing force curve 153606, there is a nominal decrease in closing force 153612 from F ₁ to F ₂ during the waiting period between t ₁ and t ₄ . Similarly, referring to the second closing force curve 153608, the closing force 153618 decreases nominally from _F3 to _F4 during the waiting period between _t1 and _t4 . In some examples, a waiting period (t ₁ to t ₄ ) selected from a range of about 10 seconds to about 20 seconds is typically employed. In the exemplary first closing force curve 153606 and the second closing force curve 153608, a time period of approximately 15 seconds is employed. The wait period follows the firing stroke, which typically lasts for a period of time selected from the range of, for example, about 3 seconds to, for example, about 5 seconds. As the I-beam 153514 advances through the firing stroke relative to the end effector, the closing force decreases. The closing forces 153614, 153620 exerted on the closing tube decrease sharply from about time _t4 to about time _t5 , as indicated by the closing forces 153614, 153620 of the first closing force curve 153606 and the second closing force curve 153608, respectively. Time t ₄ represents the moment when the I-beam 153514 is coupled into the anvil 153516 and begins to bear the closing load. Therefore, as shown in the first firing force curve 153622 and the second firing force curve 153624, the closing force decreases as firing force increases.

83 also depicts a graph 153601 of a first firing force curve 153622 and a second firing force curve 153624 plotting the force exerted to advance the I-beam 153514 during the firing stroke of a surgical instrument or system in accordance with the present disclosure. . Plot firing force curves 153622, 153624 on both axes. Vertical axis 153626 indicates the firing force in Newtons (N) exerted to propel the I-beam 153514 during the firing stroke. I-beam 153514 is configured to advance the knife or cutting element and energize the driver to deploy the staple during the firing stroke. Horizontal axis 153605 indicates time in seconds on the same time scale as horizontal axis 153604 of upper graph 153600.

As mentioned before, the closing tube force decreases sharply from time t ₄ to about time t ₅ , which indicates that the I-beam 153514 is coupled into the anvil 153516 and begins to bear the load and the closing force decreases as the firing force increases. moment, as shown in the first firing force curve 153622 and the second firing force curve 153624. As I-beam 153514 advances from the start of stroke position at time t ₄ , the firing force curve 153624 to the end of stroke position between t ₈ and t ₉ for thin tissue, and the firing force curve 153622 to t for thick tissue End of trip at _13:00 . As the I-beam 153514 advances distally during the firing stroke, the closure assembly relinquishes control of the staple cartridge 153518 and anvil 153516 to the firing assembly, which causes the firing force to increase and the closing force to decrease.

In the thick tissue firing force curve 153622, during the firing cycle (FIRE), the curve 153622 is divided into three different segments. The first segment 153628 indicates the firing force when the firing force increases from 0 at t ₄ to the peak force F ₁ ' just before t ₅ . The first segment 153628 is the firing force during the initial phase of the firing stroke, where the I-beam 153514 is advanced distally from the top of the closed ramp until the I-beam 153514 contacts tissue. The second segment 153630 indicates the firing force during the second phase of the firing stroke, where the I-beam 153514 is advancing distally, deploying the staples and cutting tissue. During the second stage of the firing stroke, the firing force decreases from F ₁ ' to F ₂ ' at approximately t ₁₂ . The third segment 153632 indicates the firing force during the third and final stage of the firing stroke, where the I-beam 153514 exits the tissue and advances to the end of the stroke in the tissue-free region. During the third stage of the firing stroke, the firing force drops from F ₂ ' to zero (0) at approximately t ₁₃ , where I-beam 153514 reaches the end of the stroke. In summary, during the firing stroke, the firing force increases sharply as I-beam 153514 enters the tissue area, decreases steadily in the tissue area during suturing and cutting operations, and as I-beam 153514 exits the tissue area and Firing power drops off sharply as the end of the stroke enters the unorganized zone.

Thin tissue firing force curve 153624 follows the same pattern as thick tissue firing force curve 153622. Therefore, during the first stage of the firing stroke, the firing force 153634 increases sharply from 0 to _F3 ' at about _t5 . During the second stage of the firing stroke, the firing force 153636 decreases steadily from _F3 ' to _F4 ' at about _t8 . During the final stage of the firing stroke, the firing force 153638 drops sharply from F' ₄ to 0 between t ₈ and t ₉ .

To overcome the sharp drop in closing force from time t ₄ to approximately time t ₅ , which represents the moment when I-beam 153514 couples into anvil 153516 and begins to take load and closing force decreases as firing force increases, as As shown in the first firing force curve 153622 and the second firing force curve 153624, the closure tube may be advanced distally at the same time as the firing member (such as the I-beam 153514) is advanced distally. The closing tube is represented as an actuator element that applies the closing force to the anvil 153516. As described herein, the control circuit applies the motor set point to the motor control which applies the motor control signal to the motor to drive the actuator element and advance the closure tube distally to apply a closure force to the anvil 153516 . A torque sensor coupled to the output shaft of the motor can be used to measure the force applied to the closed tube. Otherwise, the closing force may be measured with strain gauges, load cells, or other suitable force sensors.

84 is a schematic diagram of a control system 153950 configured to distally advance a firing member (e.g., I-beam 153514) and couple to a clamping arm (e.g., an anvil) in accordance with at least one aspect of the present disclosure. 153516) to provide a gradual closing of the closure member (e.g., closure tube), thereby reducing the closure force load on the closure member and reducing the firing force load on the firing member at a desired rate. In one aspect, control system 153950 may be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) that is used to continuously calculate an error value as the difference between a desired set point and a measured process variable, based on proportional, integral, and derivative terms (sometimes Denoted as P, I and D respectively) apply corrections. Nested PID controller feedback control system 153950 includes a primary controller 153952 in a primary (external) feedback loop 153954 and a secondary controller 153955 in a secondary (internal) feedback loop 153956. The primary controller 153952 may be a PID controller 153972 as shown in Figure 84, and the secondary controller 153955 may also be a PID controller 153972 as shown in Figure 85. Primary controller 153952 controls primary process 153958, and secondary controller 153955 controls secondary process 153960. The output 153966 (OUTPUT) of the primary process 153958 is the first summer 153962 subtracted from the main set point _SP1 . The first summer 153962 produces a single sum output signal that is applied to the main controller 153952. The output of the primary controller 153952 is the secondary set point SP ₂ . The output 153968 of the secondary process 153960 is the second summer 153964 subtracted from the secondary set point _SP2 .

In the case of controlling the displacement of the closing tube, the control system 153950 may be configured such that the main set point SP ₁ is the desired closing force value, and the main controller 153952 may be configured to obtain the desired closing force value from a torque sensor coupled to the output of the closing motor. The closing force is received and the set point SP ₂ motor speed of the closing motor is determined. In other aspects, the closing force may be measured with strain gauges, load cells, or other suitable force sensors. The closing motor speed set point _SP2 is compared to the actual speed of the closing tube, which is determined by the secondary controller 153955. The actual speed of the closed tube can be measured by comparing the displacement of the closed tube with the position sensor and measuring the elapsed time with a timer/counter. Other techniques such as linear or rotary encoders may be used to measure the displacement of the closed tube. The output 153968 of the secondary process 153960 is the actual velocity of the closed tube. This closed tube speed output 153968 is provided to the primary process 153958 which determines the force acting on the closed tube and feeds back to the summer 153962 which subtracts the measured closing force from the main set point _SP1 . The main set point SP ₁ can be an upper threshold or a lower threshold. Based on the output of the summer 153962, the main controller 153952 controls the speed and direction of the closed tube motor as described herein. The secondary controller 153955 controls the speed of the closing motor based on the actual speed of the closing tube measured by the secondary process 153960 and the secondary set point SP ₂ , which speed is based on the actual firing force and the upper and lower firing force thresholds. Compare.

Figure 85 illustrates a PID feedback control system 153970 in accordance with at least one aspect of the present disclosure. Primary controller 153952 or secondary controller 153955 or both may be implemented as PID controller 153972. In one aspect, PID controller 153972 may include proportional element 153974(P), integral element 153976(I), and derivative element 153978(D). The outputs of P element 153974, I element 153976, and D element 153978 are summed by summer 153986, which provides control variable u(t) to process 153980. The output of process 153980 is the process variable y(t). Summer 153984 calculates the difference between the desired set point r(t) and the measured process variable y(t). The PID controller 153972 continuously calculates the error value e(t) (e.g., the difference between the closing force threshold and the measured closing force) as the desired set point r(t) (e.g., the closing force threshold) and The difference between the measured process variables y(t) (e.g. the velocity and direction of the closed tube) and is calculated based on the proportional element 153974(P), the integral element 153976(I) and the derivative element 153978(D) respectively proportional, integral, and derivative terms to apply corrections. The PID controller 153972 attempts to minimize the time-varying error e(t) by adjusting the control variable u(t) (eg, the speed and direction of the closed tube).

According to the PID algorithm, the "P" element 153974 calculates the current value of the error. For example, if the error is large and positive, then the control output will also be large and positive. According to the present disclosure, the error term e(t) is different between the expected closing force of the closed tube and the measured closing force. "I" element 153976 calculates the past value of the error. For example, if the current output is not strong enough, the integral of the error will accumulate over time and the controller will respond by applying stronger action. "D" element 153978 calculates the possible future trend of this error based on its current rate of change. For example, continuing with the P example above, when a large positive control output succeeds in moving the error closer to zero, it also places the process in the path of a large negative error in the nearest future. In this case, the derivative becomes negative and the D module reduces the strength of the action to prevent this overshoot.

It should be understood that other variables and set points may be monitored and controlled in accordance with the feedback control systems 153950, 153970. For example, the adaptive closure member speed control algorithm described herein may measure at least two of the following parameters: firing member travel position, firing member load, cutting element displacement, cutting element speed, closure tube travel position, closure tube load etc.

86 is a logic flow diagram depicting a process 153990 of a control program or logic configuration for determining a speed of a closure member in accordance with at least one aspect of the present disclosure. The control circuitry of a surgical instrument or system in accordance with the present disclosure is configured to determine 153992 the actual closing force of the closing member. The control circuit compares 153994 the actual closing force to the threshold closing force and determines 153996 a set point speed to displace the closing member based on the comparison. The control circuit controls the actual speed of the 153998 closing member based on the set point speed.

Referring now also to Figures 84 and 85, in one aspect, the control circuit includes a proportional, integral, and derivative (PID) feedback control system 153950, 153970. PID feedback control systems 153950, 153970 include a primary PID feedback loop 153954 and a secondary PID feedback loop 153956. Primary feedback loop 153954 determines a first error between the actual closing force of the closing member and the threshold closing force SP ₁ and sets the closing member speed set point SP ₂ based on the first error. The secondary feedback loop 153956 determines a second error between the actual speed of the closing member and the set point speed of the closing member and sets the closing member speed based on the second error.

In one aspect, threshold closing force SP ₁ includes an upper threshold and a lower threshold. The set point speed _SP2 is configured to advance the closure member distally when the actual closure force is less than the lower threshold, and the set point speed is configured to retract the closure member proximally when the actual closure force is greater than the lower threshold. shrink. In one aspect, the set point speed is configured to maintain the closure member in place when the actual closure force is between the upper threshold and the lower threshold.

In one aspect, the control system also includes a force sensor (eg, any of sensors 472, 474, 476 (Fig. 12)) coupled to the control circuit. The force sensor is configured to measure this closing force. In one aspect, the force sensor includes a torque sensor coupled to an output shaft of a motor coupled to the closure member. In one aspect, the force sensor includes a strain gauge coupled to the closure member. In one aspect, the force sensor includes a load sensor coupled to the closure member. In one aspect, the control system includes a position sensor coupled to the closure member, wherein the position sensor is configured to measure a position of the closure member.

In one aspect, the control system includes a first motor configured to be coupled to the closure member, and the control circuit is configured to advance the closure member during at least a portion of the firing stroke.

The functions or methods 153990 described herein may be performed by any of the processing circuits described herein. Aspects of the motorized surgical instrument may be practiced without the specific details disclosed herein. Some aspects have been shown as block diagrams rather than details.

Portions of this disclosure may be presented as instructions that operate on data stored in a computer memory. An algorithm refers to a self-consistent sequence of steps leading to a desired result, where "step" refers to the manipulation of physical quantities, which may take the form of electrical or magnetic signals that can be stored, transferred, combined, compared, and otherwise manipulated. These signals can be called bits, values, elements, symbols, characters, terms, numbers. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities.

Generally speaking, various aspects described herein, which may be implemented individually and/or jointly with a variety of hardware, software, firmware, or any combination thereof, may be considered to be composed of various types of "electronic circuitry." Thus, "electronic circuit" includes an electronic circuit having at least one discrete circuit, an electronic circuit having at least one integrated circuit, an electronic circuit having at least one application specific integrated circuit, an electronic circuit forming a general purpose computing device configured by a computer program (e.g., A general-purpose computer or processor configured by a computer program that implements, at least in part, the processes and/or apparatus described herein), electronic circuitry forming a memory device (e.g., in the form of a random access memory), and/or forming a communication device (e.g., , modem, communication switch or optoelectronic device) electronic circuit. These aspects may be implemented in analog or digital form or a combination thereof.

The foregoing description has set forth aspects of apparatus and/or processes, which may include one or more functions and/or operations, through the use of block diagrams, flowcharts, and/or examples. Each function and/or operation within such block diagrams, flowcharts, or examples may be implemented individually and/or collectively by various hardware, software, firmware, or virtually any combination thereof. In one aspect, portions of the subject matter described herein may be implemented via application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), programmable logic devices (DSPs), circuits, registers and or implemented in software components (e.g., programs, subroutines, logic, and/or a combination of hardware and software components), logic gates, or other integrated formats. Some aspects disclosed herein may be implemented as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more computer programs running on one or more computer systems. One or more programs running on a processor (e.g., as one or more programs running on one or more microprocessors), as firmware, or as indeed any combination thereof wholly or partially on an integrated circuit It will be within the skill of those skilled in the art to design circuits and/or write code for software and/or hardware in light of the present disclosure.

The machinery of the subject matter disclosed herein can be distributed as a program product in a variety of forms, and the exemplary aspects of the subject matter described herein apply regardless of the specific type of signal-bearing medium used to actually implement the distribution. Examples of signal bearing media include recordable media, such as floppy disks, hard drives, compact discs (CDs), digital video discs (DVDs), digital tapes, computer memory, etc.; and transmission media, such as digital and/or analog communications Media (eg, fiber optic cables, waveguides, wired communications links, wireless communications links (eg, transmitters, receivers, transmit logic, receive logic), etc.).

The foregoing description of these aspects has been provided for the purposes of illustration and description. These detailed descriptions are not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations of the invention may be made in light of the above teachings. The aspects were chosen and described in order to illustrate the principles and practical application, thereby enabling one of ordinary skill in the art to utilize the various aspects and modify them as are suited to the particular use contemplated. The claims filed herewith are intended to define the full scope.

situational awareness

Situational awareness refers to the ability of some aspects of a surgical system to determine or infer information relevant to surgical procedures based on data received from databases and/or instruments. This information may include the type of procedure being performed, the type of tissue being operated on, or the body cavity that is the subject of the procedure. Utilizing background information relevant to a surgical procedure, a surgical system can, for example, improve the way the surgical system controls modular devices (e.g., robotic arms and/or robotic surgical tools) connected thereto and provide information to the surgeon during the course of the surgical procedure. Provide background information or advice.

Referring now to Figure 87, a timeline 5200 depicting situational awareness of a hub (eg, surgical hub 106 or 206) is shown. Timeline 5200 is an illustrative surgical protocol and background information that the surgical hub 106, 206 may derive from the data received from the data source at each step in the surgical protocol. Timeline 5200 depicts the typical steps that nurses, surgeons, and other medical personnel will take during a segmentectomy protocol, starting with establishing the operating room and ending with transferring the patient to the postoperative recovery room.

The situational awareness surgical hub 106, 206 receives data from data sources throughout the surgical procedure, including data generated each time a medical personnel utilizes the modular device paired with the surgical hub 106, 206. The surgical hub 106, 206 may receive this data from paired modular devices and other data sources and continually derive inferences (i.e., contextual information) about the ongoing procedure as new data is received, such as what is being performed at any given time. Which step of the procedure. The situational awareness system of the surgical hub 106, 206 can, for example, record data related to the process used to generate the report, verify the steps being taken by the medical staff, provide data or prompts (e.g., via a display screen) that may be related to specific protocol steps, Adjust the modular device based on the context (eg, activate a monitor, adjust the field of view (FOV) of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or an RF electrosurgical instrument), as well as take any other such action described above.

As a first step 5202 in this exemplary procedure, hospital staff retrieves the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.

In a second step 5204, staff scan the incoming medical supplies for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with lists of supplies used in various types of procedures and confirms that the supplied mixture corresponds to the thoracic procedure. Additionally, the surgical hub 106, 206 can also determine that the procedure is not a wedge procedure (because the incoming supplies lack certain supplies required for a chest wedge procedure or otherwise do not correspond to a chest wedge procedure).

In a third step 5206, the medical staff scans the patient band via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 may then confirm the patient's identity based on the scanned data.

The fourth step 5208, the medical staff turns on the auxiliary equipment. The auxiliary equipment utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case they include smoke evacuators, insufflators, and medical imaging devices. When activated, as part of its initialization process, the auxiliary device as a modular device can automatically pair with a surgical hub 106, 206 located in a specific vicinity of the modular device. The surgical hub 106, 206 may then derive contextual information about the surgical procedure by detecting the type of modular device paired with it during this preoperative phase or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on a combination of data from the patient's EMR, the list of medical supplies used in the procedure, and the type of modular device connected to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will perform. Once the surgical hub 106 , 206 knows what specific procedure is being performed, the surgical hub 106 , 206 can retrieve the steps for that procedure from memory or the cloud and then cross-reference them subsequently from connected data sources (e.g., modular devices and patients). Monitoring device) receives data to infer what steps of the surgical protocol the surgical team is performing.

In the fifth step 5210, the staff member attaches the EKG electrodes and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with surgical hubs 106, 206. When the surgical hub 106, 206 begins receiving data from the patient monitoring device, the surgical hub 106, 206 thereby confirms that the patient is in the operating room.

The sixth step 5212, medical staff induces anesthesia in the patient. The surgical hub 106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or combinations thereof. Upon completion of the sixth step 5212, the preoperative portion of the segmental lung resection protocol is completed and the surgical portion begins.

The seventh step 5214 is to fold the lung of the patient being operated on (while switching ventilation to the contralateral lung). For example, the surgical hub 106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The surgical hub 106, 206 can infer that the surgical portion of the protocol has begun because it can compare the detection of the patient's lungs to an expected step of the protocol (which may have been previously accessed or retrieved), thereby determining that collapsing the lungs is the specific step that caused the lungs to collapse. The first surgical step in the protocol.

Eighth step 5216, insert the medical imaging device (eg, endoscope) and start video from the medical imaging device. The surgical hub 106, 206 receives medical imaging device data (ie, video or image data) through its connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmental resection, rather than a lobectomy (note that the wedge procedure has been based on the surgical hub 106, 206 based on the data received at the second step 5204 of the protocol and excluded). Data from the medical imaging device 124 (FIG. 2) may be used to determine contextual information related to the type of procedure being performed in a number of different ways, including by determining the angle of the medical imaging device relative to the visual orientation of the patient's anatomy, monitoring the The number of medical imaging devices utilized (ie, activated and paired with the surgical hub 106, 206), and the type of visualization devices utilized are monitored. For example, one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest above the diaphragm, while a technique for performing a VATS segmental resection places the camera relative to the segmental cleft. Anterior intercostal location. For example, using pattern recognition or machine learning techniques, situational awareness systems can be trained to recognize the positioning of medical imaging devices based on visualization of patient anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmental resection utilizes multiple cameras. As another example, one technique for performing VATS segmental resections utilizes an infrared light source (which can be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmented clefts not used in VATS lung resections. . By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can therefore determine the specific type of surgical procedure being performed and/or the technology used for a particular type of surgical procedure.

In step nine 5218, the surgical team begins the dissection steps of the protocol. The surgical hub 106, 206 may infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or ultrasound generator indicating that the energy instrument is being fired. The surgical hub 106, 206 may intersect the received data with the retrieval steps of the surgical protocol to determine that the energy instrument fired at that point in the procedure (ie, after completion of the previously discussed protocol steps) corresponds to the dissection step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a robotic surgical system.

In the tenth step 5220, the surgical team continues with the protocol ligation steps. The surgical hub 106, 206 may infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired. Similar to the previous steps, the surgical hub 106, 206 may derive this inference by cross-referencing the receipt of data from the surgical stapling and cutting instruments with the retrieval steps in the process. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, perform the segmental resection portion of the protocol. The surgical hub 106, 206 may infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and cutting instruments, including data from their bins. The bin data may correspond to, for example, the size or type of staple fired by the instrument. Since different types of staples are used for different types of tissue, the bin data may indicate the type of tissue being sutured and/or transected. In this case, the type of staple that was fired was for parenchyma (or other similar tissue type), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is underway.

In the twelfth step 5224, the node dissection step is performed. The surgical hub 106, 206 may infer that the surgical team is dissecting the node and perform a leak test based on data received from the generator indicating that the RF or ultrasound instrument is being fired. For this particular procedure, the RF or ultrasound instrument used after transecting the parenchyma corresponds to the nodal dissection step that allows the surgical hub 106, 206 to make such inferences. It should be noted that surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (ie, RF or ultrasound) instruments according to specific steps in the protocol, as different instruments are better suited for specific tasks. Therefore, the specific sequence in which the stapling/cutting instrument and the surgical energy instrument are used may indicate the steps of the procedure being performed by the surgeon. Additionally, in some cases, robotic tools may be used for one or more steps in a surgical procedure, and/or handheld surgical instruments may be used for one or more steps of a surgical procedure. The surgeon(s) may, for example, alternate between robotic tools and handheld surgical instruments and/or may use the device simultaneously. Upon completion of step 12 5224, the incision is closed and the postoperative portion of the procedure begins.

Step 13, 5226, reverses the patient's anesthesia. For example, the surgical hub 106, 206 may infer that the patient is emerging from anesthesia based on, for example, ventilator data (ie, the patient's breathing rate begins to increase).

Finally, step fourteen 5228 is for the medical staff to remove various patient monitoring devices from the patient. Therefore, when the hub loses EKG, BP, and other data from the patient monitoring device, the surgical hub 106, 206 can conclude that the patient is being transferred to the recovery room. As can be seen from the description of this exemplary procedure, the surgical hub 106 , 206 may determine or infer each step of a given surgical procedure based on data received from various data sources communicatively coupled to the surgical hub 106 , 206 when it happens.

Situational awareness is further described in U.S. Provisional Patent Application Serial No. 62/611,341, titled "INTERACTIVE SURGICAL PLATFORM," filed on December 28, 2017, which is incorporated herein by reference in its entirety. In some cases, operation of a robotic surgical system, including various robotic surgical systems disclosed herein, may be performed, for example, by the hub 106 , 206 based on its situational awareness and/or feedback from its components and/or based on information from the cloud 104 information to control.

Safety system for smart powered surgical suturing

Various aspects of the present disclosure relate to improved safety systems capable of regulating, controlling, and/or tuning internal drive operations of a surgical instrument in response to tissue parameters detected via one or more sensors of the surgical instrument. According to at least one aspect, the force detected at the jaws of the end effector via one or more sensors may be a magnitude that inhibits one or more subsequent/additional functions of the end effector from being performed. According to another aspect, a metallic object inhibiting one or more subsequent/additional functions of the end effector from being performed may be detected via one or more sensors, such as within the jaws of the end effector. 88 illustrates a surgical system 23000 including a surgical instrument 23002, a surgical hub 23004, and a user interface 23006. In such aspects, the surgical instrument 23002 may include one or more sensors 23008 , and parameters detected by the one or more sensors 23008 of the surgical instrument 23002 may be transmitted/transmitted (eg, wirelessly) to the surgical hub 23004 Control circuit 23010. Additionally, in such aspects, surgical hub 23004 may be configured to be capable of determining surgical functions (e.g., dissection, clamping, coagulation, suturing, etc.) associated with components of surgical instrument 23002 (e.g., end effector, shaft, etc.) Whether cutting, rotation, articulation, etc.) can be performed safely based on parameters detected by one or more sensors 23008 of the surgical instrument 23002 . Notably, in such aspects, the surgical hub 23004 may be configured to be capable of transmitting one or more results associated with the determination (i.e., a warning associated with the surgical function, a reason to prevent the surgical function, etc.) Transmitted to user interface 23006. Additionally, in accordance with various aspects, various user interfaces disclosed herein may include selectable user interface features (eg, override element 23012) to continue surgical functionality despite any warnings and/or reasons supporting prevention. Notably, in such aspects, such user interface features (eg, overriding element 23012) may not be displayed (eg, performing surgical functions may endanger the patient).

Referring to Figure 89, in accordance with various aspects of the present disclosure, a surgical system 23100 may include control circuitry (23112, 23122, 23132, and/or 23142, e.g., one or more optional locations shown in dashed lines), a user interface (23118, 23128 , 23138, 23148, and/or 23158 (eg, optional locations shown in dashed lines), and a surgical instrument 23102 including, for example, a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. In such aspects, control circuitry may be integrated into one or more components (e.g., handle assembly 23110, shaft assembly 23120, and/or end effector assembly) of surgical instrument 23102 (e.g., 23112, 23122, and/or 23132) 23130, etc.) and/or integrated into a surgical hub 23140 (e.g., 23142) that is paired (e.g., wirelessly) with the surgical instrument 23102. Notably, according to various aspects, the surgical instrument 23102 and/or the surgical hub 23140 may be a situationally aware surgical instrument and/or a situationally aware surgical hub. Situational awareness refers to the surgical system (e.g., 23100) acting upon data received from a database (e.g., historical data associated with surgical procedures (e.g., 23149 and/or 23150)) and/or data received from surgical instruments (e.g., sensor data during a surgical procedure) to determine or infer information relevant to the surgical procedure. For example, the information determined or inferred may include the type of procedure being performed, the type of tissue being operated on, the body cavity that is the subject of the procedure, etc. Based on such background information related to the surgical procedure, the surgical system may control the pair of surgical instruments 23102 or components thereof (e.g., 23110, 23120, and/or 23130), for example, throughout the surgical procedure and/or provide the surgeon with Background information or suggestions (eg, via user interfaces 23118, 23128, 23138, 23148, and/or 23158). Additional details regarding situational awareness may be found, for example, under the heading "Situational Awareness" above.

Also in Figure 89, according to one aspect, a situational aware surgical hub 23140 is paired (eg, wirelessly) with a surgical instrument 23102 for performing a surgical procedure. In such aspects, the surgical instrument 23102 may include an end effector assembly 23130 including a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor 23134, The sensor is configured to detect parameters associated with the function of the end effector assembly 23130 (e.g., dissection, clamping, coagulation, cutting, suturing, etc.) and transmit the detected parameters to the control circuitry 23142 of the surgical hub 23140 .

Additionally, in such aspects, the surgical instrument 23102 may further include a shaft assembly 23120 including a sensor 23124 configured to detect parameters associated with the function of the shaft assembly 23120 (e.g., rotation, articulation, etc.) And transmit the detected parameters to the control circuit 23142 of the surgical hub 23140. Of note, it will be understood that, as referenced herein and in other disclosed aspects, a sensor may include a plurality of sensors configured to be capable of detecting a function associated with a plurality of end effector assemblies and/or shaft assemblies. of multiple parameters. Thus, in addition, in such aspects, the surgical hub control circuit 23142 may be configured to be capable of receiving detected parameters (eg, sensor data) from such sensors 23134 and/or 23124 throughout the surgical procedure.

Whenever an associated end effector assembly 23130 function (e.g., dissection, clamping, coagulation, cutting, suturing, etc.) and/or an associated shaft assembly 23120 function (e.g., rotation, articulation, etc.) is performed, Receive detected parameters. Surgical hub control circuitry 23142 may also be configured to receive data from an internal database (eg, surgical hub database 23149) and/or an external database (eg, from cloud database 23150) throughout a surgical procedure. According to various aspects, the data received from the internal database and/or the external database may include procedure data (eg, steps to perform a surgical procedure) and/or historical data (eg, data indicative of expected parameters based on historical data associated with the surgical procedure) ).

In various aspects, the protocol data may include current/accepted standard of care protocols for surgical procedures, and the historical data may include preferred/ideal parameters and/or preferred/ideal parameter ranges based on historical data associated with the surgical procedure (e.g., , system-defined constraints). Based on received data (eg, sensor data, internal and/or external data, etc.), the surgical hub control circuit 23142 may be configured to continuously derive inferences (eg, contextual information) about the ongoing surgical procedure. That is, the situationally aware surgical hub may be configured to be able to, for example, record data related to a surgical procedure used to generate a report, verify the steps a surgeon is taking to perform a surgical procedure, provide data or prompts that may be relevant to a specific procedure step ( For example, surgical instrument functions and the like are controlled via a user interface associated with a surgical hub and/or surgical instrument (eg, 23148, 23158, 23118, 23128, and/or 23138). According to various aspects, the situationally aware surgical hub 23140 may (eg, after performing an initial surgical function of the end effector assembly 23130 or the shaft assembly 23120) infer the procedure to be performed based on the procedure data received from the internal database 23149 and/or the external database 23150 of the next surgical feature.

Additionally, in such aspects, the situationally aware surgical hub 23140 may evaluate detected parameters (e.g., in response to initial surgical Function parameters received from sensors 23134 and/or 23124). Here, if the detected parameters do not exceed the preferred/ideal parameters and/or are within the corresponding preferred/ideal parameter ranges, the situationally aware surgical hub 23140 may allow the next surgical function to be performed and/or not prevent/control the execution of the next surgical function. A surgical function. Alternatively, the situation-aware surgical hub 23140 may proactively prevent the next surgical function from being performed if the detected parameter does exceed the preferred/ideal parameter and/or is not within the corresponding preferred/ideal parameter range.

According to another aspect of the present disclosure, the situationally aware surgical hub 23140 may receive communications (eg, from components of the surgical instrument 23102, such as 23130 and/or 23120) that a specific surgical function is being attempted/requested/activated. In such aspects, the situationally aware surgical hub 23140 may compare that particular surgical function to the inferred next surgical function to ensure that current/accepted standard of care protocols are followed. If so, the situationally aware surgical hub 23140 may then evaluate the detected parameter (eg, as described) before allowing the specific surgical function to continue (as described). If this is not the case, the situational-aware surgical hub 23140 may prevent the specific surgical function from being performed, or prevent the specific surgical function from being performed until an override is received (e.g., via user interface 23, 158, 23148, 23138, 23128, and/or 23118 , see, e.g., Figure 88, selectable user interface element 23012). In such aspects, if an override is received, the situationally aware surgical hub 23140 may then evaluate the detected parameters (as described above) before allowing the specific surgical function to continue.

Referring again to Figure 89, according to another aspect, a situationally aware surgical instrument 23102 may be used to perform a surgical procedure. In such aspects, surgical instrument 23102 may include a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. The end effector assembly 23130 may include a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor 23134 configured to detect functionality related to the end effector assembly 23130 ( e.g., dissecting, clamping, coagulating, cutting, suturing, etc.) and transmitting the detected parameters to the control circuitry (23112, 23122, 23132, and/or 23142, e.g., one or more of any selected location).

For example, in such aspects, the detected parameters may be transmitted to the control circuitry 23132 of the end effector assembly 23130. Here, the end effector assembly control circuit 23132 may be configured to receive detected parameters (eg, sensor data) from the sensor 23134 throughout the surgical procedure. Detected parameters may be received each time an associated end effector assembly 23130 function is performed (eg, dissection, clamping, coagulation, cutting, suturing, etc.).

The end effector assembly 23130 may also be configured to be able to retrieve data from an internal database (e.g., end effector memory 23136) and/or an external database (e.g., from a cloud database 23150 via a surgical hub 23140, from Surgical Hub Database 23149, etc.) receives data. According to various aspects, the data received from the internal database and/or the external database may include staple cartridge data (eg, size and/or type of staples associated with the staple cartridge positioned in the end effector assembly) and/or history Data (eg, data indicating the intended tissue and/or type of tissue to be sutured with those sizes and/or types of staples based on historical data). In various aspects, the received data may include preferred/ideal parameters and/or preferences associated with those sizes and/or types of staples or those expected tissues and/or tissue types based on historical data (e.g., system-defined constraints). ideal parameter range. Based on received data (eg, sensor data, internal and/or external data, etc.), the end effector control circuit 23132 may be configured to continuously derive inferences (eg, contextual information) regarding the ongoing surgical procedure. Notably, according to alternative aspects, the sensor 23134 of the end effector assembly 23130 may transmit the detected parameter to a component associated with another surgical instrument 23102 component (e.g., the handle assembly 23110 and/or the shaft assembly 23120). connected control circuit (e.g., 23112 and/or 23122). In such aspects, other surgical instrument component control circuits (eg, 23112 and/or 23122) may be similarly configured to perform various aspects of end effector control circuit 23132 as described above. Additionally, according to various aspects, the shaft assembly 23120 of the surgical instrument 23102 may include a sensor 23124 configured to detect a parameter associated with a function of the shaft assembly 23120 (e.g., rotation, articulation, etc.) and convert the detected The parameters are transmitted to a control circuit (eg, 23112) that is similarly configured to perform various aspects of the end effector control circuit 23132 as described above. Finally, the situationally aware surgical instrument 23102 may be configured to be able to alert its user of differences, for example, via the user interface 23138 of the end effector assembly 23130, via another surgical instrument 23102 component (e.g., the shaft assembly 23120 and/or A user interface (eg, 23128 and/or 23118) of the handle assembly 23110), and/or via a user interface 23148 and/or 23158) associated with the surgical hub 23140 coupled to the surgical instrument 23102. For example, the difference may include a detected parameter exceeding a preferred/ideal parameter and/or a preferred/ideal parameter range associated with those sizes and/or types of staples or those expected tissues and/or tissue types. As another example, the situationally aware surgical instrument 23102 may be configured to control surgical instrument 23102 functionality based on the difference. According to at least one aspect, the situationally aware surgical instrument 23102 may prevent surgical functionality based on the disparity.

Functional control of situational awareness

As highlighted herein, aspects of the present disclosure relate to a surgical instrument that performs a function (eg, clamping), detects a parameter associated with the function, and uses situational awareness aspects to evaluate the detected parameter via a control circuit that is below or above a predefined parameter (e.g., considered ideal/preferred) or below or above a predefined range for that parameter (e.g., considered normal), and in response to the detected parameter Perform actions outside defined parameters and/or predefined parameters/ranges (i.e., stop one or more functions, alert the user, notify the user of possible causes, etc.). For example, FIG. 90 illustrates an algorithm 23200 for implementing such aspects, in which control circuitry receives one or more detected parameters associated with a surgical function performed by a surgical instrument 23202 and extracts data from an internal and/or external database. 23204 Retrieve situational awareness data. The control circuitry then evaluates the one or more detected parameters based on the situational awareness data 23206 and performs actions based on the evaluation 23208 .

According to various aspects of the present disclosure, a force detected at the jaws of the end effector assembly (e.g., via one or more sensors) may be used to inhibit one or more subsequent/additional actions of the end effector assembly. The magnitude of the function being performed. For example, referring back to FIG. 12 , the force may be detected via sensors 474 , 476 , and/or 478 . In such aspects, sensor 474 may be a strain gauge coupled to the end effector, wherein the strain gauge is configured to measure a magnitude/amplitude of strain on one or more jaws of the end effector that is indicative of the applied The closing force applied to the jaw or jaws. Additionally, in such aspects, sensor 476 may be a load sensor configured to measure the closing force applied to the jaws by the closing drive system. Additionally, in such aspects, sensor 478 may be a current sensor configured to measure the current drawn by the motor in relation to the closing force applied to the jaws. Additionally or alternatively, referring back to Figure 17, the force may be detected via sensors 744a and/or 744b. In such aspects, sensors 744a and/or 744b may be torque sensors configured to provide a firing force feedback signal representative of the closing force applied to the jaw by the closing drive system.

In one aspect, referring back to Figure 58, load sensor 152082 (eg, positioned in the shaft assembly or handle assembly) can be configured to detect a load after the shaft assembly is attached to the handle assembly. In such aspects, the detected load may exceed the predefined load and/or the predefined load range. In such aspects, referring to Figure 89, for example, control circuitry associated with the surgical instrument (e.g., integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may evaluate detection load and use situational awareness (e.g., based on historical data) to determine that the shaft assembly and/or the end effector assembly is/must be damaged. In such aspects, the control circuitry may be configured to record the unique identifier associated with the shaft assembly 23120 and/or the end effector assembly 23130 and designate the unique identifier as prohibited from further use and/or attachment to Handle assembly 23110.

In another aspect, referring to Figure 89, for example, control circuitry associated with a surgical instrument (eg, integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may be configured To be able to evaluate the force detected/sensed at the jaw (eg, via one or more sensors as described) and determine the function/cycle to prevent the end effector assembly from firing. Specifically, the control circuit may use situational awareness (e.g., based on historical data) to determine that the force detected/sensed at the jaw (e.g., detected prior to the start of the firing function/cycle) exceeds a predefined force and/or Predefined force range. In such aspects, the control circuit may be configured to prevent the firing function/cycle from commencing. Additionally, in such aspects, referring again to Figure 89, the control circuitry may be configured to alert a user (e.g., via user interfaces 23138, 23128, and/or 23118 of components of the surgical instrument, and/or a user associated with a surgical hub) Interface 23148 and/or User Interface 23158) are unable to perform the firing function/cycle and/or notify the user of the possible reasons (e.g., so that the user can attempt to reduce the force detected/sensed at the jaws). According to various aspects, the control circuit may be configured to allow the firing function/cycle to begin if the force detected/sensed at the jaw decreases to a predefined force and/or is within a predefined force range.

In another aspect, referring to Figure 89, for example, control circuitry associated with a surgical instrument (e.g., integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may evaluate the The force detected/sensed at the jaw (eg, via one or more sensors, eg, load sensor, torque sensor, etc. as described) and initially determined allows the firing function/cycle of the end effector assembly. However, after initiating the firing function/cycle, the control circuit may use situational awareness (e.g., based on historical data) to determine that the firing force (e.g., the force detected during the firing function/cycle) exceeds the predefined firing force and/or Predefined firing force range. In such aspects, the control circuit may be configured to be able to cease the firing function/cycle (eg, prevent the firing function/cycle from continuing). Additionally, in such aspects, referring again to Figure 89, the control circuitry may be configured to be able to provide an alert to the surgeon regarding an exceeded firing force or range of firing forces (e.g., via a user interface 23138, 23128 of a component of the surgical instrument and/or 23118, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. According to various aspects, the control circuitry may also be configured to be able to receive an override command (eg, via one or more user interfaces, see, eg, Figure 88, selectable user interface element 23012) to allow the firing function/cycle to continue. In such aspects, the control circuit may use situational awareness (e.g., based on historical data) to determine that the second firing force (e.g., the force detected during the continued firing function/cycle) exceeds the second predefined firing force and/or A second predefined firing force range (e.g., higher threshold). In such aspects, the control circuit may be configured to again cease the firing function/cycle, alert the surgeon and/or receive an override command as described.

In another aspect, referring to Figure 89, for example, control circuitry associated with a surgical instrument (eg, integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may evaluate Force detected/sensed at the jaws (eg via one or more sensors as described). Additionally, the control circuit may also evaluate the force detected/sensed within the shaft assembly (ie, via one or more sensors as described). Here, according to various aspects, the control circuit may cross-reference the force detected/sensed at the jaws and/or the force detected/sensed within the shaft assembly while performing a surgical procedure. In accordance with such aspects, the control circuit may use situational awareness (eg, based on procedural data and/or historical data) to determine that a detected/sensed force within the shaft assembly exceeds a predefined axial force and/or a predefined axial force range. In one example, the shaft assembly may include a specialized shaft assembly configured for use with a specific tissue type in a specific surgical procedure. In such aspects, the control circuitry may use situational awareness (e.g., based on procedural data and/or historical data) to determine that the force detected/sensed within the specialized shaft assembly is too high (e.g., exceeds a predetermined value associated with the specialized shaft assembly). defined axial force and/or predefined axial force range) and/or the force detected/sensed at the jaws is not a predefined force and/or is not within a predefined range (e.g., historically associated with the surgical procedure being performed the expected power of the association). In such aspects, the control circuit may be configured to be able to stop the firing function/cycle (eg, prevent the firing function/cycle from starting and/or continuing). Additionally, in such aspects, referring again to Figure 89, the control circuitry may be configured to be able to provide an alert to the surgeon regarding exceeded axial force and/or axial force range (e.g., via user interface 23138, 23128 of a component of the surgical instrument and/or 23118, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. In various aspects, the alert may notify the surgeon to consider decoupling the specialized shaft assembly (e.g., 23120) from the handle assembly 23110 and detaching another shaft assembly (e.g., configured to detect/sense forces and encounter (routine reloading of tissue) is attached to handle assembly 23110. In such aspects, the control circuit may be configured to allow the firing function/cycle to begin and/or continue when the appropriate shaft assembly is attached.

In another aspect, referring to Figure 89, for example, control circuitry associated with a surgical instrument (e.g., integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may be performed at the surgical site. The force detected/sensed at the jaws is evaluated during the procedure (eg, via one or more sensors as described). According to such aspects, the control circuitry may use situational awareness (e.g., based on procedure data and/or historical data) to determine that the tissue creep wait time is less than a predefined creep associated with a specific thickness and specific tissue being clamped during the surgical procedure. Variable wait time and/or predefined creep wait time range. In other words, per Figures 83 and 84 herein, the initial closing force may have decayed and creep stability was reached sooner than expected with lower closing forces. In such aspects, the control circuit may be configured to be able to stop the firing function/cycle (eg, prevent the firing function/cycle from starting and/or continuing). Additionally, in such aspects, referring again to Figure 89, the control circuitry may be configured to be able to provide an alert to the surgeon regarding the shortened creep wait time (e.g., via user interfaces 23138, 23128, and/or 23118 of components of the surgical instrument , and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. In various aspects, the alert may notify the surgeon to consider decoupling the end effector assembly (e.g., 23130) from the handle assembly and attaching another end effector assembly (e.g., configured to handle patients with detected worms). The end effector assembly of tissue with varying latency) is attached to the handle assembly 23110. In such aspects, the control circuit may be configured to allow the firing function/cycle to begin and/or continue when the appropriate end effector assembly is attached.

In another aspect, referring to Figure 89, for example, control circuitry associated with a surgical instrument (eg, integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may evaluate Force detected/sensed at the jaws (eg via one or more sensors as described). Additionally, the control circuit may also evaluate the detected/sensed position for the articulating member (ie, via one or more sensors). For example, referring back to Figure 12, the position may be detected/sensed by sensor 472 coupled to the articulation member. In one aspect, sensor 472 may be a position sensor configured to measure linear displacement, where a single rotation of the sensor element corresponds to a specific linear displacement of the articulating member. In another example, referring back to Figure 17, the position may be detected/sensed by a position sensor 734 located in the end effector. Here, position sensor 734 may be a proximity sensor or a sensor configured to provide a series of pulses that can be tracked by the control circuit to determine the position of the articulating member. Here, according to various aspects, the control circuit may cross-reference the detected/sensed force at the jaws and/or the detected/sensed position for the articulating member while performing a surgical procedure. According to such aspects, the control circuitry may use situational awareness (e.g., based on procedure data and/or historical data) to determine that a detected/sensed position for the articulation member indicates that the articulation member has advanced (e.g., within the shaft assembly) beyond Predetermined push position and/or predetermined push position range. In various aspects, a predetermined advance position and/or a predetermined range of advance positions may be associated with a closing force detected/sensed at the jaw. In such aspects, the control circuit may be configured to be able to cease the firing function/cycle (eg, prevent the firing function/cycle from beginning and/or continuing) upon exceeding a specified predetermined advancement position. Additionally, in such aspects, referring again to Figure 89, the control circuitry may be configured to be capable of providing an alert to the surgeon regarding an exceeded advancement position and/or range of advancement positions (e.g., via user interface 23138, 23128 of a component of the surgical instrument and/or 23118, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. In various aspects, the alert may notify the surgeon to consider retracting the articulating member to a predetermined advanced position and/or within a predetermined range of advanced positions. Here, in one example, a predetermined advancement position and/or a predetermined range of advancement positions may historically achieve a corresponding desired closing force and/or successful firing function/cycle. In such aspects, the control circuit may be configured to allow the firing function/cycle to begin and/or continue when the appropriate thrust position is achieved.

In another aspect, referring to Figure 89, for example, control circuitry associated with a surgical instrument (e.g., integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may be performed at the surgical site. The force detected/sensed at the jaws is evaluated during the procedure (eg, via one or more sensors as described). According to such aspects, the control circuitry may use situational awareness (e.g., based on procedure data and/or historical data) to determine that the closing force is higher than a predefined closing force associated with the particular tissue being clamped during the surgical procedure and/or a predefined Closing force range. In other words, per Figures 83 and 84 herein, the closing force detected/sensed is higher than expected to allow the firing function/cycle to continue. In such aspects, the control circuit may be configured to be able to stop the firing function/cycle (eg, prevent the firing function/cycle from starting and/or continuing). Additionally, in such aspects, referring again to FIG. 89, the control circuitry may be configured to be capable of providing an alert to the surgeon regarding elevated closure forces (e.g., via user interfaces 23138, 23128, and/or 23118 of components of the surgical instrument, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. In various aspects, this alert may inform the surgeon to consider adjusting the firing motor speed. In one example, if the particular tissue is rigid, the alert may advise the surgeon to slow down the firing motor speed to avoid tearing the rigid tissue. In such aspects, the speed may be adjusted down based on historical data associated with the surgical procedure being performed. In another example, if the particular tissue is viscous tissue with low shear strength, the alert may advise the surgeon to increase the firing motor speed to ensure that the tissue is properly clamped. In such aspects, the speed may be adjusted upward based on historical data associated with the surgical procedure being performed. In such aspects, the control circuit may be configured to allow the firing function/cycle to begin and/or continue when an appropriate firing motor speed is set.

In another aspect, referring to Figure 89, for example, control circuitry associated with a surgical instrument (e.g., integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) may be performed at the surgical site. The force detected/sensed at the jaws is evaluated during the procedure (eg, via one or more sensors as described). According to such aspects, the control circuitry may use situational awareness (eg, based on procedure data and/or historical data) to determine that the cyclic force on the firing system during the surgical procedure is above a predefined cyclic force and/or a predefined cyclic force range. In other words, the detected/sensed cyclic force is higher than expected and may indicate impending motor failure based on historical data. In such aspects, the control circuit may be configured to be able to cease the firing function/cycle (eg, prevent the firing function/cycle from starting and/or continuing to advance). Additionally, in such aspects, referring again to Figure 89, the control circuit may be configured to be able to provide an alert to the surgeon regarding elevated circulatory forces and possible motor failure (e.g., via user interface 23138, 23128 of a component of the surgical instrument and/or 23118, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. According to various aspects, the control circuitry may also be configured to be able to receive an override command (eg, via the user interface, see, eg, Figure 88, selectable user interface element 23012) to allow the firing function/cycle to continue. In such aspects, the control circuit may continue to monitor whether the cyclic force on the firing system is above the predefined cyclic force and/or the predefined cyclic force range during the surgical procedure. In such aspects, the control circuit may be configured to again cease the firing function/cycle, alert the surgeon and/or receive an override command as described.

According to another aspect of the present disclosure, referring to Figure 89, for example, control circuitry associated with a surgical instrument (eg, integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) The force detected/sensed at the jaws may be evaluated (eg, via one or more sensors as described). In addition, the control circuit may also evaluate the force/torque that causes the end effector assembly 23130 to articulate. In such aspects, control may be performed via one or more sensors (e.g., a force sensor associated with the articulation member, a torque sensor associated with the articulation member, a motor configured to drive the articulation member). Current sensor, etc.) detects joint movement force/torque. For example, referring back to Figure 17, articulation force/torque may be detected/sensed by torque sensors 744d and/or 744e coupled to the articulation drive system. Additionally and/or alternatively, referring again to FIG. 17 , the articulation force/torque may be correlated to the current drawn by the motors 704d and/or 704e as measured by the sensor 736 . Here, according to various aspects, the control circuitry may cross-reference forces detected/sensed at the jaws and/or articulation forces/torques detected for the articulation members while performing a surgical procedure. In accordance with such aspects, the control circuitry may use situational awareness (e.g., based on protocol data and/or historical data) to determine that a detected articulation force/torque for the articulation member exceeds a predefined articulation force/torque and/or a predefined joint Movement force/torque range. In various aspects, the predefined articulation force/torque and/or the predefined articulation force/torque range may be associated with the detected/sensed force at the jaw. In such aspects, the control circuit may be configured to be capable of stopping articulation of the end effector assembly (eg, to prevent articulation from continuing) if a specified articulation force/torque is exceeded. Additionally, in such aspects, referring again to FIG. 89, the control circuit may be configured to be capable of providing an alert to the surgeon regarding excessive articulation forces/torques and/or articulation force/torque ranges (e.g., via components of the surgical instrument user interface 23138, 23128, and/or 23118, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. According to various aspects, the control circuitry may also be configured to be able to receive an override command (eg, via a user interface, see, eg, Figure 88, selectable user interface element 23012) to allow joint motion to continue. In such aspects, the control circuit may continue to monitor whether the joint motion force/torque is above the predefined joint motion force/torque and/or the predefined joint motion force/torque range during the surgical procedure. In such aspects, the control circuit may be configured to again stop joint motion, alert the surgeon, and/or receive an override command as described.

According to yet another aspect of the present disclosure, referring to Figure 89, for example, control circuitry associated with a surgical instrument (eg, integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) The force detected/sensed at the jaws may be evaluated (eg, via one or more sensors as described). Additionally, the control circuit may also evaluate the force/torque of the rotating shaft assembly 23120 (eg, shaft member). In such aspects, control may be performed via one or more sensors (e.g., a force sensor associated with the rotation/shaft member, a torque sensor associated with the rotation/shaft member, and a motor configured to rotate the rotation/shaft member). Associated current sensors, etc.) detect rotational force/torque. For example, referring back to Figure 17, rotational force/torque may be detected/sensed by a torque sensor 744c coupled to the rotation/shaft member drive system. Additionally and/or alternatively, referring again to FIG. 17 , the rotational force/torque may be correlated to the current drawn by the motor 704c as measured by the sensor 736 . Here, in accordance with various aspects, the control circuitry may cross-reference forces detected/sensed at the jaws and/or rotational forces/torques detected for the rotation/shaft member while performing a surgical procedure. In accordance with such aspects, the control circuit may use situational awareness (e.g., based on regulatory data and/or historical data) to determine that a detected rotational force/torque for the rotating/shaft member exceeds a predefined rotational force/torque and/or a predefined rotational force /torque range. In various aspects, the predefined rotational force/torque and/or the predefined rotational force/torque range may be associated with the detected/sensed force at the jaw. In other aspects, the predefined rotational force/torque and/or the predefined rotational force/torque range may correspond to the force/torque that the rotation/shaft member itself is capable of withstanding. In such aspects, the control circuit may be configured to be capable of stopping rotation of the shaft assembly (eg, preventing continued rotation of the rotation/shaft member) if a specified rotational force/torque is exceeded. Additionally, in such aspects, referring again to FIG. 89, the control circuit may be configured to be capable of providing an alert to the surgeon regarding an exceeded rotational force/torque and/or rotational force/torque range (e.g., via a user of a component of the surgical instrument Interfaces 23138, 23128, and/or 23118, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. According to various aspects, the control circuitry may also be configured to be able to receive an override command (eg, via the user interface, see, eg, Figure 88, selectable user interface element 23012) to allow rotation to continue. In such aspects, the control circuit may continue to monitor whether the rotational force/torque is above a predefined rotational force/torque and/or a predefined rotational force/torque range during the surgical procedure. In such aspects, the control circuit may be configured to stop rotation again, alert the surgeon and/or receive an override command as described.

According to yet another aspect of the present disclosure, referring to Figure 89, for example, control circuitry associated with a surgical instrument (eg, integrated into components of the surgical instrument 23132, 23122, and/or 23112, or integrated into a coupled surgical hub 23142) Can be configured to be able to evaluate the opening force detected/sensed at the jaws (eg, via one or more sensors as described) and determine to prevent the jaws from opening. Specifically, the control circuit may use situational awareness (eg, based on historical data) to determine that the opening force detected/sensed at the jaw exceeds a predefined opening force and/or a predefined opening force range. In such aspects, the control circuit may be configured to maintain the jaws in the clamping or partial clamping position. Additionally, in such aspects, referring again to FIG. 89, the control circuitry may be configured to alert a user (e.g., via user interfaces 23138, 23128, and/or 23118 of components of the surgical instrument, and/or a user associated with a surgical hub). Interface 23148 and/or user interface 23158) cannot open the jaws, and/or notify the user of the possible reasons (e.g., so that the user can attempt to reduce the opening force detected/sensed at the jaws). According to various aspects, the control circuit may be configured to allow the jaws to open if the opening force detected/sensed at the jaws is reduced to a predefined opening force and/or within a predefined opening force range.

Short circuit detection and function control

According to various other aspects of the present disclosure, functions of a surgical instrument may be controlled based on one or more sensors configured to detect short circuits. That is, if a metallic object is detected within the jaws, at least one surgical instrument function/actuation (eg, cutting, coagulation, etc.) may be prevented/disabled. For example, FIG. 91 illustrates an algorithm 23300 for implementing such aspects, wherein a control circuit receives one or more detected parameters indicating a short circuit 23302. Control circuitry may also retrieve internal and/or external database data 23304. The control circuitry then evaluates the one or more detected parameters and/or database data 23306 and performs actions based on the evaluation 23308 .

Referring again to Figure 89, in accordance with aspects of the present disclosure, surgical system 23100 may include control circuitry (23112, 23122, 23132, and/or 23142, e.g., one or more optional locations shown in dashed lines), a user interface (23118, 23128, 23138, 23148, and/or 23158 (eg, optional locations shown in dashed lines), and a surgical instrument 23100 including, for example, a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. In such aspects, control circuitry may be integrated into one or more components (e.g., handle assembly 23110, shaft assembly 23120, and/or end effector assembly) of surgical instrument 23102 (e.g., 23112, 23122, and/or 23132) 23130, etc.) and/or integrated into a surgical hub 23140 (e.g., 23142) that is paired (e.g., wirelessly) with the surgical instrument 23102. In such aspects, the end effector assembly 23130 may include a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor 23134 configured to detect contact with the end effector Parameters associated with the function of component 23130 (eg, dissecting, clamping, coagulating, cutting, suturing, etc.) and transmitting the detected parameters to the control circuitry (eg, 23112, 23122, 23132, and/or 23142). In various aspects, the first jaw can include an anvil and the second jaw can include an elongated channel configured to receive a staple cartridge. Additionally, in such aspects, the surgical instrument 23102 may further include a shaft assembly 23120 including a sensor 23124 configured to detect parameters associated with the function of the shaft assembly 23120 (e.g., rotation, articulation, etc.) and transmits the detected parameters to the control circuit (e.g., 23112, 23122, 23132, and/or 23142). In such aspects, the control circuit may be configured to receive detected parameters (eg, sensor data) from such sensors (eg, 23134 and/or 23124) throughout the surgical procedure. Whenever an associated end effector assembly 23130 function (e.g., dissection, clamping, coagulation, cutting, suturing, etc.) and/or an associated shaft assembly 23120 function (e.g., rotation, articulation, etc.) is performed, Receive detected parameters. The control circuitry may also be configured to enable data from internal databases (e.g., in the memories 23136, 23126, and/or 23116 of the components of the surgical instrument or in the surgical hub database 23149) and/or external databases (e.g., Receive data from surgical hub database 23149, cloud database 23150, etc.). According to various aspects, the data received from the internal database and/or the external database may include procedure data (eg, steps to perform a surgical procedure) and/or historical data (eg, data indicative of expected parameters based on historical data associated with the surgical procedure) ). In various aspects, the protocol data may include current/accepted standard of care protocols for surgical procedures, and the historical data may include preferred/ideal parameters and/or preferred/ideal parameter ranges based on historical data associated with the surgical procedure (e.g. , system-defined constraints). Based on received data (e.g., sensor data, internal and/or external data, etc.), control circuitry (e.g., 23112, 23122, 23132, and/or 23142) may be configured to continuously derive inferences about the ongoing protocol (e.g., 23112, 23122, 23132, and/or 23142). For example, background information). That is, the surgical instrument may be configured to be able to, for example, record data related to the surgical procedure used to generate the report, verify the steps the surgeon is taking to perform the surgical procedure, provide data or prompts that may be related to specific procedure steps (e.g., via A user interface associated with the surgical hub 23148 and/or user interface 23158 and/or user interfaces 23138, 23128, and/or 23118 associated with the surgical instrument, controls surgical instrument 23102 functionality, and the like.

Referring back to Figure 89, in one aspect, during and/or after clamping the target tissue between the jaws of the end effector assembly, the control circuitry (23112, 23122, 23132, and/or 23142) may be configured to enable Check continuity between jaws before allowing subsequent functions (e.g., firing, clotting, etc.). Here, according to various aspects, the surgical instrument may include an electrosurgical instrument including an electrode in at least one of the jaws (eg, integrated with an anvil and/or a staple cartridge). In such aspects, if a short circuit exists between the electrodes, it may be difficult to treat tissue grasped between the jaws with electrosurgical energy (eg, RF energy). In one example, a conductive object (eg, clamp, nail, metal component, etc.) between the electrodes may allow conduction between the jaws. In another example, if there is insufficient clearance between the jaws (eg, after clamping the target tissue), the electrodes may contact, thereby causing conduction between the jaws. Referring back to Figure 53, for example, in one aspect of the present disclosure, sensor 152008a is configured to measure the gap between the end effector jaws. In such aspects, the sensor 152008a of the first jaw may include a Hall effect sensor configured to detect the magnetic field generated by the magnet 152012 of the second jaw to measure the relationship between the first jaw and the second jaw. the gap between the mouths. Notably, the gap may represent the thickness of tissue clamped between the first jaw and the second jaw. Here, if there is conduction between the jaws, it may lead to undesirable surgical results (eg, incomplete tissue processing, overheating of conductive objects, etc.).

According to one aspect (eg, bipolar mode), the first jaw can include an anvil, and the second jaw can include an elongated channel configured to receive a staple cartridge, such as depicted in FIG. 25 . In one example, the staple cartridge can include active electrodes to deliver electrosurgical energy (eg, RF energy) to the grasped tissue, and at least a portion of the anvil can serve as a return electrode. In one example, the anvil can include an active electrode to deliver electrosurgical energy (eg, RF energy) to the grasped tissue, and at least a portion of the elongated channel can serve as a return electrode. According to another aspect (eg, monopolar mode), the first jaw can include an anvil and the second jaw can include an elongated channel configured to receive a staple cartridge. In one example, a staple cartridge can include active electrodes to deliver electrosurgical energy (eg, RF energy) to the grasped tissue, and return electrodes (eg, ground pads) can be individually positioned on the patient's body. In another example, the anvil may include active electrodes to deliver electrosurgical energy (eg, RF energy) to the grasped tissue, and return electrodes (eg, ground pads) may be separately positioned on the patient's body. Various configurations for detecting short circuits are described in U.S. Patent No. 9,554,854 entitled "DETECTING SHORT CIRCUITS INELECTROSURGICAL MEDICAL DEVICES," the entire disclosure of which is incorporated herein by reference.

Referring again to Figure 89, according to various aspects, the control circuit (23112, 23122, 23132, and/or 23142) may be configured to be able to check for conduction in a variety of ways. In one aspect, a generator that generates electrosurgical energy and/or a sensor integrated into a surgical instrument (e.g., 23134) can be configured to detect when the impedance between electrodes drops below a threshold for a threshold period of time (i.e., 23134). , indicating the impedance drop of a short circuit). Here, referring back to Figure 48, a sensor (eg, 23134) may be configured to be able to measure impedance as a function of time. In one example, when an electrode encounters a conductive nail wire, the current can spike while the impedance and voltage drop drop dramatically. In another example, conduction may appear as a current sink with minimal voltage change. Various alternative methods for checking continuity/detecting short circuits, such as those described in U.S. Patent No. 9,554,854 entitled "DETECTING SHORT CIRCUITSIN ELECTROSURGICAL MEDICAL DEVICES," are expressly incorporated herein by reference (e.g., compare impedance values at different locations within a series of pulses).

In such aspects, if conduction is detected, conductive objects (eg, clamps, staples, staple wires, metal elements, etc.) may be present/exposed in the tissue grasped between the jaws. Notably, such conductive objects may be from current surgical procedures and/or previous surgical procedures. In such aspects, the control circuitry may be configured to provide an alert to the surgeon regarding detection of the conductive object (e.g., via user interface 23138, 23128, and/or 23118 of a component of the surgical instrument, and/or associated with a surgical hub User interface 23148 and/or user interface 23158). For example, the alert may indicate that the surgeon repositions the end effector assembly 23130 so that the electrodes are not in contact with any conductive objects and/or removes the conductive objects causing the short circuit. According to various aspects, the control circuitry may also be configured to be able to receive override commands (e.g., via the user interface, see, e.g., Figure 88, selectable user interface element 23012) to allow subsequent functionality (e.g., cutting, coagulation, etc.), although Conductive objects detected (e.g., clamps, nails, staple wire, metal components, etc.).

According to one aspect, the control circuit (23112, 23122, 23132, and/or 23142) may be configured to be able to check for continuity to avoid tripping the clamp. In such aspects, upon detection of a short circuit, the control circuitry may be configured to provide an alert to the surgeon regarding the detection of a conductive object between the jaws (e.g., via user interfaces 23138, 23128 and/or components of the surgical instrument). or 23118, and/or user interface 23148 and/or user interface 23158) associated with the surgical hub. In one aspect, the surgeon can adjust the sensitivity of the control circuit via a user interface (eg, an interactive user interface element on a surgical instrument, surgical hub, generator, etc.). In such aspects, based on the adjustment, the control circuit may be configured to prevent firing if a conductive object is detected between the jaws.

Referring again to Figure 89, according to another aspect, control circuitry 23142 may be integrated into a surgical hub 23140 paired (eg, wirelessly) with an electrosurgical instrument 23102. In such aspects, the surgical hub 23140 may be preloaded with surgeon/user settings regarding detection of conductive objects between the jaws. In one example, surgeon/user settings include preventing firing if a conductive object is detected between the jaws. In another example, if a conductive object is detected between the jaws, surgeon/user settings include issuing an alert before allowing firing. In yet another aspect, the surgeon/user settings include allowing the surgeon/user to override alerts. In yet another aspect, the surgeon/user settings include a temporary reset, allowing the surgeon/user to correct the situation (eg, move jaws, remove conductive objects) before checking continuity again.

Referring again to Figure 89, according to yet another aspect, the control circuit (23112, 23122, 23132, and/or 23142) may be configured to be capable of checking for intentional conduction across the staple line. Here, in some surgical procedures it may be beneficial to have intersecting staple lines to ensure continuous transection (eg, lung resections, especially wedges from multiple angles, cannulation procedures, etc.). In such aspects, upon detecting conduction, the control circuit may be configured to provide an alert (e.g., audible and/or Visual cues) (e.g., via user interfaces 23138, 23128, and/or 23118 of components of the surgical instrument, and/or user interface 23148 and/or user interface 23158 associated with the surgical hub).

Referring again to Figure 89, according to other aspects, the control circuitry (23112, 23122, 23132, and/or 23142) may be configured to enable data from an internal database (e.g., memory 23136, 23126 and 23126) of components of the surgical instrument throughout a surgical procedure. Data is received from/in 23116 or surgical hub database 23149) and/or from external databases (eg, from surgical hub database 23149, cloud database 23150, etc.). According to various aspects, the data received from the internal database and/or the external database may include surgical history data (eg, data regarding previous surgical procedures performed on the patient, data regarding current surgical procedures, etc.). In one example, surgical history data may indicate where staples were used in a previous surgical procedure and/or where staples were used, and current surgical protocol data may indicate whether a clip applier has been used to apply a clip. Based on the received data (eg, surgical history data, etc.), the control circuitry (23112, 23122, 23132, and/or 23142) may be configured to continuously derive inferences (eg, contextual information) about the ongoing procedure. That is, the surgical instrument 23120 may be situationally aware and may be configured to be able to infer/determine that a detected conduction may be a staple line from a previous surgical procedure or a clamp from a current surgical procedure, for example. As another example, if the patient has never performed a surgical procedure, the clip applier has not been used for the current surgical procedure, and the staple cartridge has been fired during the current surgical procedure, the control circuit may be configured to be able to infer/determine detection between the jaws The conductive object reached is the previous nail line. As another example, if the patient has never performed a surgical procedure, the clip applier has been used for the current procedure, and no cartridge has been fired during the current surgical procedure, the control circuit can be configured to be able to infer/determine detection between the jaws The conductive objects found are clamps.

Example

Various aspects of the subject matter described herein under the title "SAFETY SYSTEMS FOR SMART POWEREDSURGICAL STAPLING" are set forth in the following examples:

Embodiment 1 - A surgical system including control circuitry and surgical instruments. A surgical instrument includes a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly coupled to a distal end of the shaft assembly. The end effector assembly includes a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor. The sensor is configured to detect a parameter associated with the function of the end effector and transmit the detected parameter to the control circuit. The control circuit is configured to analyze the detected parameter based on system-defined constraints and prevent at least one function of the surgical instrument based on the analysis results. The surgical system also includes a user interface configured to provide a current status regarding at least one prevented function of the surgical instrument.

Embodiment 2 - The surgical system of Embodiment 1, wherein the system-defined constraints include at least one of predefined parameters or predefined parameter ranges based on historical data associated with surgical procedures performed by the surgical system.

Embodiment 3 - The surgical system of embodiment 1 or 2, wherein the current status includes a first message that at least one function of the surgical instrument is prevented and a second message indicating a reason why at least one function of the surgical instrument is prevented.

Embodiment 4 - The surgical system of Embodiment 1, 2 or 3, wherein the user interface includes a user interface element selectable to override the control circuitry to enable at least one function of the surgical instrument.

Embodiment 5—The surgical system of Embodiment 1, 2, 3, or 4, wherein the sensor includes a force sensor coupled to the end effector, and wherein the detected parameter includes a first jaw applied to the end effector or the force of at least one of the second jaws, and wherein the at least one function prevented via the control circuit includes one or more of the following: preventing use of the attached shaft, preventing initiation of the firing cycle, preventing end execution joint movement of the tool, preventing shaft rotation, or preventing one or more of the first or second jaws from opening.

Embodiment 6—The surgical system of Embodiment 1, 2, 3, 4, or 5, wherein the function of the end effector associated with the sensed parameter includes a clamping function, and wherein the surgical system prevented via the control circuitry At least one function of the instrument includes one or more of the following: an anatomical function, a coagulation function, a suturing function, or a cutting function.

Embodiment 7 - The surgical system of Embodiment 1, 2, 3, 4, 5, or 6, further comprising a surgical hub communicatively coupled to the surgical instrument, wherein the surgical hub includes control circuitry.

Embodiment 8 - The surgical system of Embodiment 7, wherein one of the handle assembly or the surgical hub includes a user interface.

Embodiment 9—The surgical system of Embodiment 1, 2, 3, 4, 5, 6, 7, or 8, wherein one of the handle assembly, shaft assembly, or end effector assembly of the surgical instrument includes a control circuit.

Embodiment 10—The surgical system of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the shaft assembly includes a sensor configured to detect axis parameters and transmits the detected axis parameters to the control circuit. The control circuit is configured to prevent at least one function of the surgical instrument further based on the detected shaft parameter.

Embodiment 11 - A surgical system including a surgical hub and surgical instruments communicatively coupled to the surgical hub. A surgical instrument includes a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly coupled to a distal end of the shaft assembly. The end effector assembly includes a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor. The sensor is configured to detect parameters associated with the function of the end effector and transmit the detected parameters to the surgical hub. The surgical hub includes a processor and memory coupled to the processor. The memory stores instructions executable by the processor to analyze the detected parameters based on system-defined constraints and prevent at least one function of the surgical instrument based on the results of the analysis. The surgical system also includes a user interface configured to provide a current status regarding at least one prevented function of the surgical instrument.

Embodiment 12 - The surgical system of Embodiment 11, wherein the system-defined constraints include at least one of predefined parameters or predefined parameter ranges based on historical data associated with surgical procedures performed by the surgical system.

Embodiment 13 - The surgical system of embodiment 11 or 12, wherein the current status includes a first message that at least one function of the surgical instrument is prevented and a second message indicating a reason why at least one function of the surgical instrument is prevented.

Embodiment 14 - The surgical system of embodiment 11, 12, or 13, wherein the user interface includes a user interface element selectable to override the surgical hub to enable at least one function of the surgical instrument.

Embodiment 15 - The surgical system of embodiment 11, 12, 13, or 14, wherein the sensor includes a force sensor coupled to the end effector, and wherein the detected parameter includes a first or second jaw applied to the end effector. force of at least one of the two jaws, and wherein at least one function prevented via the surgical hub includes one or more of the following: preventing use of the attached shaft, preventing initiation of the firing cycle, preventing end effector Articulating, preventing shaft rotation, or preventing one or more of the first or second jaws from opening.

Embodiment 16—The surgical system of embodiment 11, 12, 13, 14, or 15, wherein the function of the end effector associated with the detected parameter includes a clamping function, and wherein the surgical hub is prevented At least one function of the instrument includes one or more of the following: an anatomical function, a coagulation function, a suturing function, or a cutting function.

Embodiment 17 - The surgical system of embodiment 11, 12, 13, 14, 15, or 16, wherein at least one of the handle assembly or the surgical hub includes a user interface.

Embodiment 18 - The surgical system of embodiment 11, 12, 13, 14, 15, 16 or 17, wherein the shaft assembly includes a sensor configured to detect a shaft parameter associated with a function of the shaft and to The detected axis parameters are transmitted to the surgical hub. The memory also stores instructions executable by the processor to prevent at least one function of the surgical instrument further based on the detected shaft parameter.

Embodiment 19 - A non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to analyze an endpoint of a surgical system based on system-defined constraints. The surgical system includes a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly coupled to a distal end of the shaft assembly. The end effector assembly includes a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor configured to detect the sensed parameter and transmit the sensed parameter to the machine. . The instructions, when executed, also cause the machine to prevent at least one function of the surgical system based on the results of the analysis and generate a user interface. The user interface provides a current status regarding at least one prevented function of the surgical system.

Embodiment 20—The non-transitory computer-readable medium of Embodiment 19, further comprising instructions that, when executed, further cause the machine to generate an overwrite element on the user interface. Override elements may be selected to enable at least one function of the surgical system.

Safety system for smart powered surgical suturing

Safety system for evaluating operating parameters

Various aspects of the present disclosure relate to improved safety systems capable of regulating, controlling, and/or tuning internal drive operations of a surgical instrument in response to tissue parameters detected via one or more sensors of the surgical instrument. More specifically, various aspects relate to sensing and indicating the appropriateness of current device parameters to sensed tissue parameters.

For example, sensed tissue parameters may include the type of tissue, thickness of the tissue, stiffness of the tissue, location of the tissue on the patient's anatomy, vascularization of the tissue, etc., and current device parameters may include cartridge color, cartridge type, attachment object, clamping load, gap, firing rate, etc. Accordingly, in accordance with aspects of the present disclosure, physiological sensing may indicate inappropriate use of a device or components thereof and/or inappropriate positioning of the device.

In one example, inappropriate use of the surgical instrument or components thereof and/or incorrect positioning of the surgical instrument may be based on detection via associated control circuitry via one or more sensors at the jaws of the end effector. Physiological sensing to determine. In such examples, the associated control circuitry may prevent performance of one or more functions of the end effector (eg, suturing) following determined inappropriate use and/or determined incorrect positioning. Additionally, in such examples, if the associated control circuitry determines that the surgical instrument or components thereof and/or the positioning of the surgical instrument has been rectified (e.g., incorrect staple cartridge replaced, surgical instrument repositioned, etc.) or overwritten has been received (e.g., via a user interface on the surgical instrument, a user interface on a surgical hub coupled to the surgical instrument, a user interface in the surgical operating room, etc.), then the associated control circuitry may allow the end effector to One or more than one function.

Referring to Figure 94, in accordance with various aspects of the present disclosure, a surgical system 24200 may include control circuitry (24212, 24222, 24232, and/or 24242, e.g., one or more optional locations shown in dashed lines), a user interface (24214, 24224 , 22234, 24244, and/or 24254 (eg, one or more optional locations are shown in dashed lines), and surgical instrument 24202. Surgical instrument 24202 includes multiple components, such as Part-A 24216 through Part-N 24218 of end effector assembly 24210, and similarly, for purposes of illustration, components of shaft assembly 24220 and handle assembly 24230, respectively, are included in abbreviated form. -A(C-A) to component-N(C-N). In various aspects, each component of surgical instrument 24202 can include at least one device parameter. For example, part-A 24216 of end effector assembly 24210 may include parameters PAa-PAn 24217, part-N 24218 of end effector assembly 24210 may include parameters PNa-PNn 24219, and so on. As another example, each of C-A through C-N of shaft assembly 24220 and each of C-A through C-N of handle assembly 24230 may similarly include at least one device parameter. Each component may be configured to communicate its one or more corresponding device parameters to the control circuit. Surgical instrument 24202 also includes sensors (24213, 24223, and/or 24233) configured to detect tissue parameters associated with the function of the surgical instrument and to communicate the detected tissue parameters to the control circuitry. The control circuitry may be configured to analyze the detected tissue parameters in cooperation with each respective device parameter based on system-defined constraints.

Referring again to FIG. 94 , in various aspects, control circuits 24212 , 24222 , and/or 24232 (eg, shown as elements of end effector assembly 24210 , shaft assembly 24220 , and handle assembly 24230 , respectively) may be integrated into surgical instrument 24202 One or more of a plurality of components (e.g., the handle of handle assembly 24230, the shaft of shaft assembly 24220, the end effector of end effector assembly 24210, the staple cartridge of the end effector assembly, etc.) or integrated into a surgical hub 24240 (eg, 24242) that is paired (eg, wirelessly) with the surgical instrument 24202. Similarly, one or more sensors 24213, 24223, and/or 24233; user interfaces 24214, 24224, and/or 24234; and in various aspects, memory 24215, 24225, and/or 24235 (e.g., each shown as an end effector Elements of assembly 24210, shaft assembly 24220, and handle assembly 24230) may be integrated into one or more than one of the multiple components. Notably, according to various aspects, the surgical instrument 24202 and/or the surgical hub 24240 may be a situationally aware surgical instrument and/or a situationally aware surgical hub. Situational awareness is when a surgical system (e.g., 24200) determines or Ability to infer information relevant to surgical procedures. For example, the information determined or inferred may include the type of procedure being performed, the type of tissue being operated on, the body cavity that is the subject of the procedure, etc. Based on such background information related to the surgical procedure, the surgical system may, for example, control pairs of surgical instruments or components thereof throughout the surgical procedure and/or provide background information or recommendations to the surgeon.

According to one aspect, a situationally aware surgical hub (eg, 24240) is paired (eg, wirelessly) with a surgical instrument 24202 for performing a surgical procedure. In such aspects, surgical instrument 24202 may include multiple components, including an end effector (eg, Part-A 24216). The end effector 24216 may include a first jaw, a second jaw pivotally coupled to the first jaw, a cutting blade, and an integrated sensor 24213 configured to detect interference with the end effector. and transmits the detected tissue parameters to the control circuit 24242 of the surgical hub 24240. Each of the plurality of components of the surgical instrument 24202 including the end effector 24216 (e.g., component-N 24218, such as a staple cartridge, etc.) is also configured to be capable of changing one or more of its corresponding device parameters (e.g., respectively for 24219 and 24217) to surgical hub 24240. Of note, it should be understood that, as referenced herein and in other disclosed aspects, a sensor (e.g., 24213) may include a plurality of sensors configured to be capable of detecting a sensor associated with a plurality of end effector 24216 functions. multiple organizational parameters. Accordingly, additionally, in such aspects, surgical hub control circuitry 24242 may be configured to be capable of receiving such parametric data throughout the course of a surgical procedure (e.g., one or more detected tissue parameters, including device parameters of each component, etc.). Detected tissue parameters may be received each time an associated end effector function is to be performed (eg, dissection, clamping, coagulation, cutting, suturing, etc.). Surgical hub control circuitry 24242 may also be configured to receive data from an internal database (eg, surgical hub database 24249) and/or an external database (eg, from cloud database 24269) throughout a surgical procedure. According to various aspects, data received from internal database 24249 and/or external database 24269 may include procedure data (e.g., steps to perform a surgical procedure, data indicating corresponding device parameters associated with the surgical procedure) and/or historical data (eg, data indicative of expected tissue parameters based on historical data associated with the surgical procedure, patient's surgical history data, etc.). In various aspects, the protocol data may include current/accepted standard of care protocols for surgical procedures and the historical data may include preferred/ideal tissue parameters for each received device parameter based on historical data associated with the surgical protocol and /or preferred/ideal tissue parameter ranges (e.g., system-defined constraints). Based on the received data (eg, parameter data, internal and/or external data, etc.), the surgical hub control circuit 24242 may be configured to continuously derive inferences (eg, contextual information) about the ongoing surgical procedure. That is, the situationally aware surgical hub may be configured to be able to, for example, record data related to a surgical procedure used to generate a report, verify the steps a surgeon is taking to perform a surgical procedure, provide data or prompts that may be relevant to a specific procedure step ( For example, surgical instrument functions and the like are controlled via user interface 24244 and/or user interface 24254 associated with the surgical hub and/or user interfaces 24214, 24224, and/or 24234) associated with the surgical instrument.

According to another aspect, a situationally aware surgical instrument (eg, 24202) may be used to perform a surgical procedure. In such aspects, surgical instrument 24202 may include multiple components, including end effector 24216, as described herein. The end effector may include a first jaw, a second jaw pivotally coupled to the first jaw, a cutting blade, and an integrated sensor 24213 configured to detect contact with the end effector 24216 functions (e.g., dissection, clamping, coagulation, cutting, suturing, etc.) associated tissue parameters and transmits the detected tissue parameters to the control circuitry. Notably, in such aspects, the detected tissue parameters may be communicated to the integrated control circuit 24212 of the end effector 24216. Each of the plurality of components of the surgical instrument including end effector 24216 (e.g., component-N 24218, such as staple cartridge, etc.) is configured to be capable of transmitting one or more of its corresponding device parameters to the integrated end effector. Control circuit 24212. In such aspects, the integrated end effector control circuit 24212 may be configured to receive such parametric data throughout the surgical procedure (e.g., one or more detected tissue parameters, including each of the end effector one or more device parameters of each component). Detected tissue parameters may be received each time an associated end effector function is to be performed (eg, dissection, clamping, coagulation, cutting, suturing, etc.). The integrated end effector control circuit 24212 may also be configured to enable data from an internal database (e.g., end effector memory 24215) and/or an external database (e.g., from a cloud database 24269 via a surgical hub 24240) throughout a surgical procedure. , receiving data from the surgical hub database 24249, etc.). According to various aspects, the data received from the internal database and/or the external database may include cartridge data (e.g., associated with a cartridge (e.g., 24218) for which one or more device parameters have been received by the end effector control circuit 24212 size and/or type of staples) and/or historical data (eg, data indicating the intended tissue and/or type of tissue to be sutured with those sizes and/or types of staples based on the historical data). In various aspects, the internal data and/or external data may include preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges for each received device parameter based on historical data associated with the surgical protocol (e.g., system defined constraints). In one example, based on historical data (eg, system-defined constraints), internal data and/or external data may include data for expected tissue and/or tissue type or for device parameters associated with a staple cartridge (eg, 24218) Preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges for size and/or type of staples. Based on the received data (eg, parameter data, internal and/or external data, etc.), the end effector control circuit 24212 may be configured to continuously derive inferences (eg, background information) about the ongoing protocol. Notably, according to alternative aspects, the integrated sensor 24213 of the end effector 24216 may transmit one or more detected tissue parameters to another surgical instrument component (e.g., the handle of the handle assembly 24230). Associated control circuitry (e.g., 24222 and/or 24232). In such aspects, other surgical instrument component control circuits (eg, 24222 and/or 24232) may be similarly configured to be capable of performing various aspects of the end effector control circuit 24212 as described above. Finally, a situationally aware surgical instrument (e.g., 24202) may be configured to be able to alert its user of differences, e.g., via the user interface of the end effector 24214, via the user interface of another surgical instrument component 24224 and/or 24234 (eg, the handle of the handle assembly 24230), or via the user interface 24244 associated with the surgical hub 24240 coupled to the surgical instrument 24202). For example, the difference may include detected tissue parameters exceeding preferred/ideal tissue parameters and/or preferred/ideal tissue parameter ranges associated with those sizes and/or types of staples or those expected tissues and/or tissue types. As another example, a situationally aware surgical instrument (eg, 24202) may be configured to control surgical instrument functionality based on the difference. According to at least one aspect, a situationally aware surgical instrument (eg, 24202) may prevent surgical functionality based on the disparity.

Improper device placement

According to various aspects of the present disclosure, physiological sensing (eg, detection via one or more sensors) may indicate device placement issues. More specifically, according to such aspects, physiological incompatibilities may exist within/between the first and second jaws of the end effector (e.g., after clamping) and may inhibit/prevent the end Other functions of the external actuator (e.g., coagulation, cutting, suturing, etc.).

According to various aspects, a surgical procedure may include resection of target tissue (eg, a tumor). Referring to Figure 92, for example, a portion of patient tissue 24000 may include tumor 24002. In such aspects, surgical margin 24004 may be defined around tumor 24002. Of note, during surgical procedures it is ideal to avoid resection of healthy tissue surrounding the tumor and/or to minimize such resection. However, to ensure complete tumor removal, current/accepted standard of care protocols associated with this surgical procedure may support resection of predetermined surgical margins defined by distance around the tumor and/or predefined surgical margins defined by a range of distances around the tumor. Defined surgical margin range. In one aspect, the surgical margin supported may be tumor-based (eg, based on type of tumor, size of tumor, etc.). On the other hand, the surgical margin supported may depend on the extent to which the tumor microinvades surrounding tissue. In other aspects, supported surgical margins may be associated with improved long-term survival based on historical data associated with the tumor and/or the surgical procedure. In other aspects, associated control circuitry (e.g., in a surgical instrument, in a component of the surgical instrument 24212, 24222, 24232, in a surgical hub coupled to the surgical instrument 24242, etc., according to Figure 94) may be based on data obtained from an internal database Active reconciliation of data received by 24215, 24225, and/or 24235 and/or external databases 24249 and/or 24269 (e.g., patient surgical history data, patient history data, standard of care procedures for recurrent tumors, etc., from the cloud, from a surgical hub, etc.) Supported surgical margins. In such aspects, referring back to Figure 92, a generally supported surgical margin (e.g., 24004) may be based on such received data (e.g., the patient's surgical history data and/or medical history data may indicate that the tumor may have further microinvasive Surrounding tissue, instances where the patient may have had recurrent tumors, etc.) make changes to the adjusted surgical margin (e.g., 24012) by a determined amount/distance (e.g., 24010).

Additionally, in various aspects, after a target surgical margin is established for a surgical procedure (e.g., 24004 and/or 24012), it may be difficult to effectively and/or accurately identify and resect a tumor and/or its target surgical margin during a surgical procedure. . Referring again to Figure 94, in accordance with various aspects of the present disclosure, an end effector (eg, 24216) of surgical instrument 24202 may include a first sensor (eg, 24213) configured to measure a first signal and to A signal is transmitted to associated control circuitry (eg, in the surgical instrument, in components 24212, 24222, and/or 24232 of the surgical instrument, in a surgical hub coupled to the surgical instrument 24242, etc.). In such aspects, a second sensor configured to measure and transmit the second signal to associated control circuitry may be positioned on/in the tumor prior to removal of the tumor using a surgical instrument (see Figure 92, e.g., Relative to the center position of the tumor 24006). Here, according to various aspects, the second sensor may be separate from the surgical instrument. Additionally and/or alternatively, in such aspects, the second sensor may comprise a sensor positioned at the periphery of the tumor (see Figure 92, eg, 24008) prior to removal of the tumor using a surgical instrument. According to another aspect, a plurality of second sensors may be positioned around the perimeter of the tumor. Here, in such aspects, the control circuit may be configured to be capable of dynamically calculating the distance between the first sensor and the second sensor based on the first signal and the second signal. According to various aspects, the first sensor may be positioned at/near the cutting blade of the end effector. Additional exemplary methods for detecting target surgical margins are described in U.S. Patent Application Publication No. 2016/0192960 entitled "SYSTEM AND METHOD FOR A TISSUE RESECTION MARGINMEASUREMENT DEVICE," the entire disclosure of which is incorporated by reference. incorporated into this article.

In one example, if the second sensor is positioned on/within the tumor (e.g., at central location 24006), the control circuitry may also be configured to be able to determine the distance between the second sensor and the target surgical margin established for the surgical procedure. edge distance. In such examples, the control circuitry may compare the dynamically calculated distance (e.g., the distance between the first sensor and the second sensor) to the determined edge distance to effectively and accurately move the end effector (e.g., the distance between the first sensor and the second sensor) to the determined edge distance. , the cutting blade) is positioned at the target surgical edge (eg, the end effector is correctly positioned when the dynamically calculated distance is equal to or substantially equal to the determined edge distance). The control circuitry may be configured to utilize such techniques to efficiently and accurately position an end effector (eg, cutting blade) around a target surgical edge (eg, during resection).

In another example, if a second sensor is positioned at the perimeter of the tumor or multiple second sensors are positioned around the perimeter of the tumor (eg, 24008), the control circuit may be further configured to be able to determine one or more second sensors. The edge distance between the sensor and the target surgical edge established for the surgical procedure. In such examples, the control circuitry may compare the dynamically calculated distance (e.g., the distance between the first sensor and the second sensor) to the determined edge distance to effectively and accurately move the end effector (e.g., the distance between the first sensor and the second sensor) to the determined edge distance. , the cutting blade) is positioned at the target surgical edge (eg, the end effector is correctly positioned when the dynamically calculated distance is equal to or substantially equal to the determined edge distance). The control circuitry may be configured to utilize such techniques to efficiently and accurately position an end effector (eg, cutting blade) around a target surgical edge (eg, during resection). Such aspects may be beneficial when tumors are abnormally shaped.

Referring again to Figure 94, according to various aspects, the control circuitry can be configured to notify the surgeon when the end effector (eg, or its cutting blade) is correctly positioned relative to the target surgical edge (eg, 24004 and/or 24012) (eg, real-time notification via user interfaces 24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and/or user interface 24254 in the surgical operating room, etc.). For example, the user interface may include at least one of: i) a video image of the surgical site with a digital overlay indicating the surgeon's target surgical margins to visually confirm that the end effector (e.g., 24216) is positioned at Navigation of the end effector (e.g., or its cutting blade) at and/or relative to the target surgical edge, ii) tactile feedback in the surgical instrument 24202 itself to indicate positioning of the end effector's cutting blade at the target surgical edge at the edge, and/or iii) auditory feedback to indicate that the cutting blade of the end effector is positioned at the target surgical edge.

Referring again to FIG. 94 , according to additional aspects, the control circuit may be configured to control when the end effector (eg, cutting blade) is too close to the cancer margin and/or within the cancer margin (eg, within the target surgical margin, close to the target surgical margin). Prevent surgical instrument 24202 from firing in the event of tumor microinvasion into surrounding tissue, etc.). In accordance with such aspects, the control circuitry may also be configured to be capable of receiving override commands (e.g., via user interfaces 24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and/or or user interface in the surgical operating room 24254, etc.) to allow firing to continue. In one example, such a user interface may include user interface elements selectable to allow firing to continue, such as 24251. In such aspects, the control circuit may continue to monitor the end effector (eg, or its cutting blade) relative to the cancer edge. Additionally, in such aspects, the control circuit may be configured to again cease firing, alert the surgeon, and/or receive an override command as described. According to other aspects, the control circuit may be configured to prevent firing until a reset event occurs (eg, opening the jaws of the end effector and repositioning the jaws of the end effector relative to the cancer edge).

Referring again to FIG. 94 , in accordance with other aspects of the present disclosure, one or more sensors of surgical system 24200 may detect/ blood flow within the tissue. For example, a Doppler imaging detector (e.g., integrated on end effector 24213, coupled to a surgical hub, e.g., parameter sensing component 24253 including a Doppler imaging detector, etc.) may be configured to be able to locate and identify possible Vessels that are not otherwise visible at the surgical site (eg, via red, green, and/or blue lasers), and speckle contrast analysis can be performed to determine blood flow and/or blood flow velocity through such vessels. Notably, in one example, it may be desirable to seal some blood vessels (eg, blood vessels associated with tumors) but not others (eg, blood vessels associated with healthy tissue/organs). Accordingly, associated control circuitry (e.g., in a surgical instrument, in components 24212, 24222, and/or 24232 of the surgical instrument, in a surgical hub coupled to the surgical instrument 24242, etc.) may be configured to enable control when blood flow exceeds Prevents surgical instrument 24202 from firing in the event of predetermined blood flow and/or blood flow velocity. In accordance with such aspects, the control circuitry may also be configured to be capable of receiving override commands (e.g., via user interfaces 24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and/or or user interface 24254 in the surgical operating room, etc.) to allow firing to continue (e.g., if blood flow is associated with a tumor). In one example, such a user interface may include user interface elements selectable to allow firing to continue, such as 24251. In such aspects, the control circuitry may continue to monitor blood flow to the clamped tissue. Additionally, in such aspects, the control circuit may be configured to again cease firing, alert the surgeon, and/or receive an override command as described. According to other aspects, the control circuitry may be configured to prevent firing until a reset event occurs (e.g., opening the jaws and repositioning the jaws of the end effector relative to a vessel that includes more than a predefined blood flow and/or flow rate of blood flow).

Referring again to Figure 94, in accordance with other aspects of the present disclosure, one or more sensors of surgical system 24200 may be used to clamp tissue between the first and second jaws of an end effector (eg, 24216) Detection of an increase in blood pressure simultaneously with and/or immediately thereafter. For example, a blood pressure monitor (eg, coupled to the surgical hub, eg, parameter sensing component 24253 that includes the blood pressure monitor, etc.) may detect an increase in blood pressure that occurs concurrently with clamping. According to various aspects, the surgical system 24200 is situationally aware, and it can be inferred that the detected increase in blood pressure is caused by clamping tissue between/within the jaws of the end effector. For example, vessels containing critical blood flow may have become trapped between/within the jaws, causing blood flow to constrict. Accordingly, in accordance with various aspects, associated control circuitry (e.g., in a surgical instrument, in components 24212, 24222, and/or 24232 of the surgical instrument, in a surgical hub coupled to the surgical instrument 24242, etc.) may be configured to enable Prevents surgical instrument 24202 from firing if blood pressure rises above a predetermined amount and/or a predetermined range. In accordance with such aspects, the control circuitry may also be configured to be capable of receiving override commands (e.g., via user interfaces 24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and/or or user interface in the surgical operating room 24254, etc.) to allow firing to continue (e.g., the surgeon observes that the blood pressure has dropped while the tissue is still clamped, the situationally aware surgical system attributes the increase in blood pressure to another cause wait). In one example, such a user interface may include user interface elements selectable to allow firing to continue, such as 24251. In such aspects, the control circuit may continue to monitor the patient's blood pressure. Additionally, in such aspects, the control circuit may be configured to again cease firing, alert the surgeon, and/or receive an override command as described. According to other aspects, the control circuit may be configured to prevent firing until a reset event occurs (eg, opening the jaws and repositioning the jaws of the end effector relative to the clamped tissue).

Referring again to Figure 94, in accordance with other aspects of the present disclosure, one or more sensors of the surgical system may detect a A large number of nerve bundles within a tissue. For example, a heart rate monitor (e.g., integrated onto end effector 24213, coupled to a surgical hub (e.g., parameter sensing component 24253 including the heart rate monitor), etc.) may be used while clamping tissue between the first jaw and the second jaw. An increase in heart rate is detected simultaneously and/or immediately after and between/within the two jaws. According to various aspects, the surgical system 24200 is situationally aware and provides information from internal databases 24215, 24225, 24235, 24249 and/or external databases 24249 and/or 24269 (e.g., associated with a surgical site for a surgical procedure being performed). Anatomical information), it can be inferred that the detected increase in heart rate is caused by clamping tissue between/within the jaws of the end effector. In accordance with such aspects, associated control circuitry (e.g., in a surgical instrument, in components 24212, 24222, and/or 24232 of the surgical instrument, in a surgical hub coupled to the surgical instrument 24242, etc.) may be configured to enable This corollary prevents Surgical Instrument 24202 from firing. Additionally, in accordance with such aspects, the control circuitry may be configured to be capable of receiving override commands (e.g., via user interfaces 24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and /or user interface 24254 in the surgical operating room, etc.) to allow firing to continue (e.g., the surgeon observes that the patient's heart rate has dropped while the tissue is still clamped, the situationally aware surgical system attributes the increased heart rate to another reason, etc.). In one example, such a user interface may include user interface elements selectable to allow firing to continue, such as 24251. In such aspects, the control circuit may continue to monitor the patient's heart rate. Additionally, in such aspects, the control circuit may be configured to again cease firing, alert the surgeon, and/or receive an override command as described. According to other aspects, the control circuit may be configured to prevent firing until a reset event occurs (eg, opening the jaws and repositioning the jaws of the end effector relative to the clamped tissue).

Referring again to Figure 94, in accordance with other aspects of the present disclosure, one or more sensors of surgical system 24200 may detect contact of surgical instrument 24202 with an energized device (eg, RF instrument/device). In one example, surgical instruments and powered devices are communicatively coupled to surgical hub 24240 in surgical system 24200. For example, referring back to FIG. 9 , device/instrument 235 and energy device 241 may be coupled to modular control tower 236 of surgical hub 206 . In such examples, any of the generator 240 that generates electrosurgical energy for the energized device 241 and/or the sensors integrated into the energized device may be configured to detect impedance associated with the energized device. When falls below the threshold for a threshold period of time (i.e., a drop in impedance indicating a short circuit). Similar to Figure 48, the integrated sensor of the energized device may be configured to be able to measure impedance as a function of time. Various alternative methods for detecting short circuits, such as those described in U.S. Patent No. 9,554,854 entitled "DETECTING SHORT CIRCUITSIN ELECTROSURGICAL MEDICAL DEVICES," are expressly incorporated herein by reference (e.g., comparing a series of pulses impedance values at different locations within the pulse, etc.). According to various aspects, the surgical system 24200 is situationally aware and provides instructions for surgical procedures involving the use of individual surgical instruments (e.g., electrosurgical instrument/device) and/or protocol data for the current step), it can be inferred that the detected short circuit was caused by a separate surgical instrument (e.g., the conductive surface of the surgical instrument may be related to the energized device contact, causing a short circuit). In accordance with such aspects, associated control circuitry (e.g., in the surgical instrument, in components 24212, 24222, and/or 24232 of the surgical instrument, in a surgical hub 24242 coupled to the surgical instrument and the energized device, etc.) may be configured It is possible to prevent surgical instrument 24202 from firing based on this inference. If a short circuit is present, it may be difficult to treat (eg, coagulate) tissue with electrosurgical energy (eg, RF energy) and may result in undesirable surgical outcomes (eg, incomplete tissue processing, overheating of conductive objects, etc.). In this case, the control circuitry may be configured to be able to notify the surgeon (e.g., via user interfaces 24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and/or The user interface 24254 in the surgical operating room is notified in real time) that a short circuit exists and firing of the surgical instrument 24202 has been paused. Additionally, in accordance with such aspects, the control circuitry may also be configured to be capable of receiving override commands (e.g., via user interfaces 24214, 24224, and/or 24234 on the surgical instrument, user interface 24244 on a surgical hub coupled to the surgical instrument, and/or user interface 24254 in the surgical operating room, etc.) to allow firing to proceed (e.g., the surgeon verifies that there is no short circuit, that the target tissue includes low impedance, etc.). In one example, such a user interface may include user interface elements selectable to allow firing to continue, such as 24251. In such aspects, the control circuit may continue to monitor for short circuits. Additionally, in such aspects, the control circuit may be configured to again cease firing, alert the surgeon, and/or receive an override command as described. According to other aspects, the control circuit may be configured to prevent firing until a reset event occurs (eg, the surgical instrument is repositioned relative to the energized device so that the two are no longer in contact).

Inappropriate device selection/proposed use

According to various aspects of the present disclosure, physiological sensing (eg, detection via one or more sensors) may indicate surgical instrument/device selection issues. More specifically, according to such aspects, surgical device-tissue incompatibility may exist and other functions of the end effector (eg, coagulation, cutting, suturing, etc.) may be inhibited/prevented.

Referring again to Figure 94, in accordance with one aspect of the present disclosure, control circuitry (e.g., in components 24212, 24222, and/or 24232 of the surgical instrument, in a surgical hub coupled to the surgical instrument 24242, etc.) may be configured to enable Any combination of a specific stapler (e.g., a vascular stapler) and sensed information (e.g., information detected via one or more sensors) indicates that the target tissue may not be suitable (e.g., counter-indicates) that the tissue-specific suturing Provides a warning in case of a server.

Figure 93 illustrates an example security process 24100 for resolving device selection issues in accordance with various aspects of the present disclosure. According to at least one aspect, safety process 24100 may be performed/implemented (eg, during a surgical procedure) by control circuitry (eg, 24242 of FIG. 94 ) associated with a situationally aware surgical hub of a surgical system (eg, 24200 of FIG. 94 ). . According to other aspects, the safety process 24100 may be performed/implemented by control circuitry (eg, 24212, 24222, and/or 24232 of FIG. 94) associated with a situationally aware surgical instrument of the surgical system (eg, 24200 of FIG. 94) (eg, during surgical procedures).

Referring to Figure 93, the tissue identification process 24108 may receive a selection including device selection 24102 (e.g., stapler selection, e.g., a stapler suitable for parenchymal firing, a stapler suitable for vascular firing, a stapler suitable for bronchial firing, etc.), by Various device measurements 24104 detected by one or more sensors (e.g., end effector closure angle, length of tissue in contact with end effector, closure force/compression curve, etc.) and situational awareness information 24106 (e.g., procedures information, surgeon preferences, etc.).

According to Figure 93, at device selection 24102, the control circuitry executing/implementing the safety process 24100 may be configured to receive device parameters from the selected suturer/device and/or receive information related to each of the selected suturer/device. Device parameters associated with a component (eg, staple cartridge) to indicate device selection. For example, device parameters associated with a staple cartridge may include the type of cartridge, color of the cartridge, appendages of the cartridge, clamping load limit of the cartridge, clearance range of the cartridge, firing rate of the cartridge, etc. According to one aspect, one or more device parameters may be transmitted by the stapler/device to the control circuitry when coupled to the surgical system. According to alternative aspects, device selections may be entered via a user interface (e.g., associated with a surgical hub and/or in a surgical suite, such as 24244 and/or 24254 of Figure 94) and/or from an internal database and/or external The database receives (eg, data regarding the surgical procedure being performed and/or available surgical instruments, eg, 24249 and/or 24269 of Figure 94).

Additionally, according to FIG. 93 , via methods associated with the end effector (eg, Part-A, 24216 of FIG. 94 ) and/or other components of the surgical instrument (Part-N, 24218 of FIG. 94 (eg, staple cartridge)) Device measurement 24104 is detected by one or more sensors coupled thereto (eg, as described in Figures 17, 18, 53, 78, etc. herein). For example, one or more tissue sensors may be positioned and configured to be capable of checking continuity and/or measuring tissue impedance along the length of the end effector to assess the length of tissue in contact with the end effector (e.g., One or more sensors 738 of Figure 17 determine tissue location and/or measure tissue impedance using segmented electrodes, sensor 153468 of Figure 78 determines the presence of tissue along the length of the end effector, etc.). As another example, one or more sensors may be positioned and configured to be able to detect/evaluate the jaw/end effector closing angle (e.g., a displacement sensor (e.g., position sensor 734 of Figure 17) to detect clamping resulting displacement of the actuator/driving member, a gap sensor (e.g., sensor 152008a of Figure 53) to detect the gap between the first and second jaws of the end effector, etc.). As another example, one or more sensors may be positioned and configured to detect a force compressing/closing tissue between the first jaw and the second jaw (e.g., between the first jaw and/or the second jaw). A force sensor (eg, sensor 738 of FIG. 17 including a force sensor) on the tissue surface of the jaws to detect the force when clamping the tissue, a sensor (eg, current sensor 736 of FIG. 17 ) to detect the force associated with the force applied to the tissue Related current consumption of the drive member, torque sensor (e.g., 744b of Figure 17) to measure closing force, etc.). Various other aspects for detecting the end effector closure angle, the length of tissue in contact with the end effector, and the closure force/compression curve have been discussed elsewhere in this article.

Next, according to FIG. 93 , the internal database 24249 and/or the external database 24269 associated with the surgical hub 24242 and/or via the internal databases 24215 , 24225 , 24235 and/or external associated with the surgical instrument 24202 may be used according to FIG. 94 Databases 24249, 24269, etc. receive surgical sensing information 24106.

Returning to Figure 93, tissue identification process 24108 is configured to determine the type of tissue encountered by the surgical instrument (eg, parenchymal, vascular, bronchial, etc.). In one example, the tissue identification process 24108 may determine tissue based on various inputs (e.g., tissue contact detected along the length of the jaw when the jaw is fully open, closure versus hole curve indicating tissue consistent with parenchyma, etc.) Type is substance. In another example, the tissue identification process 24108 may be based on various inputs (e.g., tissue contact detected almost immediately during closure, detected as being on only a small area of the stapler, and detected as being limited to the distal side) Tissue contact, initial detected closure force indicating tissue structure consistent with blood vessels, etc.) to determine the tissue type is a blood vessel (e.g., PA/PV). In another example, the tissue identification process 24108 may be based on various inputs (e.g., tissue contact detected almost immediately during closure, detected as over a small area of the stapler, and detected as defined distally and proximally Tissue contact on both, initial detected closing force indicating a rigid tissue structure consistent with a bronchus, etc.) to determine the tissue type is a bronchus. According to various aspects, such tissue type determination may also be based on factors including thickness of the tissue, stiffness of the tissue, location of the tissue (e.g., relative to the patient), and detection by measurements made via one or more sensors described herein. and/or tissue parameters of vascularization in tissue derived from measurements made via one or more sensors described herein. Notably, the tissue identification process 24108 may further evaluate such initial tissue determinations with additional inputs (e.g., stapler selections, surgical protocol information, surgeon preferences, etc.) before deriving tissue identification outputs/results. . This situational awareness ultimately produces organizational identification outputs/outcomes. Here, various aspects for identifying encountered tissue have been further discussed elsewhere herein (eg, thoracic surgery examples, etc.).

Referring back to Figure 93, the tissue identification output/results may be used to determine whether the selected stapler/device and/or each component of the selected stapler/device (eg, staple cartridge, shaft, etc.) is optimal for a surgical procedure. of 24110. In such aspects, the control circuitry may obtain data from an internal database and/or an external database (e.g., see FIG. 94 , internal database 24249 associated with surgical hub 24242 and/or external database 24269 , internal database 24215 associated with surgical instrument 24202 , 24225, 24235 and/or external databases 24249, 24269, etc.) to receive additional information 24112. More specifically, additional information 24112 may include other available staplers, other available energy devices, other stapler components (eg, staple cartridges, shafts, etc.) available for use with the selected stapler/device, etc. According to at least one aspect, availability may be subject to current inventory at the surgical location. Notably, additional information 24112 may also include information related to each other available stapler, each other available energy device, each other stapler component available for use with the selected stapler/device, etc. associated device parameters.

According to various aspects, when evaluating whether a selected suturer/device is optimal 24110, the control circuitry executing/implementing the safety process 24100 may be configured to be able to interact with each received suture associated with the selected suture based on system-defined constraints. Each detected tissue parameter (eg, detected via one or more sensors described herein) is analyzed in cooperation with the device parameters associated with the device/device 24102. Further, in accordance with such aspects, the control circuitry may be configured to utilize the energy received with each other available suturing device, each other available energy device, available with the selected suturing device/device based on system defined constraints. Each detected tissue parameter (eg, detected via one or more sensors described herein) is analyzed using the device parameters associated with each other stapler component and the like. In accordance with such aspects, the control circuitry may be configured to determine, based on the detected tissue parameters, the effectiveness of the selected stapler/device 24102 and/or the components of the selected stapler/device 24102 among other available staplers. one or more other available energy devices and/or other stapler components available for use with the selected stapler/device would be more optimal.

In various aspects, the one or more detected tissue parameters may include, for example, type of tissue, thickness of tissue, stiffness of tissue, location of tissue, vascularization in tissue, etc., and received device parameters may include, for example, staple The type of cartridge, the color of the cartridge, the attachments of the cartridge, the clamping load limit of the cartridge, the gap range of the cartridge, and the firing rate of the cartridge, etc. According to various aspects, system-defined constraints (eg, based on historical data and/or protocol data accessed in the situationally aware surgical system) may include preferred/ideal tissue parameters and/or preferred/ideal for each received device parameter. Organization parameter range. For example, a preferred/ideal tissue thickness and/or a range of preferred/ideal tissue thicknesses may be associated with each cartridge color. In such examples, each staple bin color may indicate the type and/or size of staples in the staple bin. Here, a staple cartridge that includes short staples may not be optimal for thick tissue. According to additional aspects, system-defined constraints (e.g., based on historical data and/or protocol data accessed in the situationally aware surgical system) may include preferred/ideal clamp load limits and/or for each detected tissue type. Preferred/ideal clamping load limit range. For example, each staple bin associated with its corresponding clamping load limit may indicate the type of tissue it can optimally suture. Here, the present disclosure contemplates receiving device parameters (e.g., type of cartridge, color of the cartridge, appendages of the cartridge, clamping load limit of the cartridge, gap range of the cartridge, firing rate of the cartridge etc.), and detected tissue parameters (e.g., type of tissue, thickness of tissue, stiffness of tissue, location of tissue, vascularization in tissue, etc.), and constraints defined by the established system (e.g., based on the situation Various combinations of historical data and/or procedure data accessed in the sensory surgical system associated with received device parameters and/or detected tissue parameters).

Referring again to Figure 93, if the selected device 24102 is determined to be optimal, the control circuitry executing/implementing the safety process 24100 may be configured to initially perform no operations (e.g., recommend later) and/or record that the analysis has Execution 24114. Conversely, if it is determined that the selected device 24102 is not optimal, the control circuitry may be configured to determine whether a safety issue exists 24116. According to various aspects, when evaluating the selected suturer/device 24102 for safety concerns, the control circuitry may be configured to be able to interact with each received suture associated with the selected suturer/device 24102 based on system-defined constraints. Device parameters collaborate to analyze each detected tissue parameter.

Similar to above, the detected tissue parameters may include, for example, the type of tissue, the thickness of the tissue, the stiffness of the tissue, the location of the tissue, vascularization in the tissue, etc., and the received device parameters may include, for example, the type of staple cartridge , the color of the nail cartridge, the attachments of the nail cartridge, the clamping load limit of the nail cartridge, the gap range of the nail cartridge, and the firing rate of the nail cartridge, etc. According to various aspects, system-defined constraints (eg, based on historical data and/or protocol data accessed in the situationally aware surgical system) may include preferred/ideal tissue parameters and/or preferred/ideal for each received device parameter. Organization parameter range. For example, a preferred/ideal tissue thickness and/or a range of preferred/ideal tissue thicknesses may be associated with each cartridge color. In such examples, each staple bin color may indicate the type and/or size of staples in the staple bin. Continuing the example here, if the received device parameters for the selected stapler/device 24102 include staple cartridge color (e.g., indicating short staples), and the detected tissue parameters indicate more than the selected stapler/device If the color of the staple cartridge 24102 is associated with the preferred/ideal tissue thickness and/or the tissue thickness within the preferred/ideal tissue thickness range, then the selected stapler/device 24102 has safety issues. Utilizing an inappropriate staple cartridge can result in less than satisfactory results and/or undesirable outcomes (eg, suture failure, oozing, bleeding, etc.). In this case, the control circuitry may be configured to be able to alert the surgeon 24118 (e.g., see FIG. 94 , via the user interface 24214 , 24224 , and/or 24234 on the selected stapler/device, via associated with the surgical hub There are security issues with user interfaces 24244, via user interfaces 24254 in surgical operating rooms, etc.). In such aspects, the control circuitry may also be configured to be capable of receiving the override command 24120 (e.g., via the user interface 24214, 24224, and/or 24234 on the selected stapler/device, via a user associated with the surgical hub). Interface 24244, via a user interface in the surgical operating room, etc. 24254) to allow the surgical procedure to continue. In one example, referring to Figure 94, such a user interface may include user interface elements that may be selected to allow the procedure to continue, such as 24251. In an alternative aspect, in response to the warning, the surgeon may correct the noted safety issue (eg, replace an inappropriate staple cartridge with another), at which time the device selection safety process 24100 may be performed/implemented again.

Similar to above, according to additional aspects, system-defined constraints (e.g., based on historical data and/or protocol data accessed in the situationally aware surgical system) may include preferred/ideal clamping for each detected tissue type Load limit and/or preferred/ideal clamping load limit range. For example, each staple bin associated with its corresponding clamping load limit may indicate the type of tissue it can optimally suture. Here, continuing the example, if the received device parameters for the selected stapler/device 24102 include its cartridge clamping load limit, and the tissue identified by the tissue identification process 24108 indicates the need for a stapler with a higher clamping load limit If the tissue type of the staple cartridge is different, the selected stapler/device 24102 may have safety issues. Utilizing an inappropriate staple cartridge can result in less than satisfactory results and/or undesirable outcomes (eg, suture failure, oozing, bleeding, etc.). In this case, the control circuitry may be configured to be able to alert the surgeon 24118 (e.g., see FIG. 94 , via the user interface 24214 , 24224 , and/or 24234 on the selected stapler/device, via associated with the surgical hub There are security issues with user interfaces 24244, via user interfaces 24254 in surgical operating rooms, etc.). In such aspects, the control circuitry may also be configured to be capable of receiving the override command 24120 (e.g., via the user interface 24214, 24224, and/or 24234 on the selected stapler/device, via a user associated with the surgical hub). Interface 24244, via user interface 24254 in the surgical operating room, etc.) to allow the surgical procedure to continue. In one example, referring to Figure 94, such a user interface may include user interface elements that may be selected to allow the procedure to continue, such as 24251. In an alternative aspect, in response to the warning, the surgeon may correct the noted safety issue (eg, replace an inappropriate staple cartridge with another), at which time the device selection safety process 24100 may be performed/implemented again. Likewise, the present disclosure contemplates receiving device parameters (e.g., type of cartridge, color of cartridge, cartridge attachments, cartridge clamping load limit, cartridge gap range, cartridge firing rate, etc. ), and detected tissue parameters (e.g., type of tissue, thickness of tissue, stiffness of tissue, location of tissue, vascularization in tissue, etc.), as well as constraints defined by the established system (e.g., based on situational awareness Various combinations of historical data and/or procedure data accessed in the surgical system associated with received device parameters and/or detected tissue parameters).

Referring back to Figure 93, if it is determined that there are no safety concerns with the selected stapler/device 24116, the control circuitry that performs/implements the safety process 24100 may be configured to provide recommendations 24122 to the surgeon. According to at least one aspect of the present disclosure, if another stapler is available, another energy device is available, and/or another stapler component (e.g., staple cartridge, shaft, etc. available for use with the selected stapler/device) 24112 More optimally or alternatively, the control circuitry may be configured to alert the surgeon (e.g., see Figure 94, via the user interface 24214, 24224, and/or 24234 on the selected stapler/device, via the surgical hub The associated user interface 24244, via user interface 24254 in the surgical operating room, etc.) its availability and recommends its use in the current surgical protocol. In such aspects, the control circuitry may also be configured to be capable of receiving (e.g., via user interface 24214, 24224, and/or 24234 on the selected stapler/device, via user interface 24244 associated with the surgical hub, via User interface in the surgical operating room 24254, etc.) acceptance of this recommendation. Upon acceptance, the control circuitry may be configured to render a more optimized performance with respect to other available staplers, other available energy devices, and/or other stapler components (see, e.g., FIG. 94, components A through N, e.g., may be used with Information 24124 on staple cartridges, shafts, etc.) 24112 used with the selected stapler/device. Upon rejection, the control circuitry may be configured to terminate 24126 the device selection security algorithm and/or perform subsequent processes.

According to various other aspects, although discussed specifically with respect to the staplers/devices herein, the present disclosure should not be limited thereto. More specifically, the disclosed aspects are similarly applicable to other surgical instruments, including energy devices (eg, RF and/or ultrasonic surgical instruments) and/or corresponding components thereof and/or endoscopic devices and/or or its corresponding parts.

Example

Various aspects of the subject matter described herein under the title "SAFETY SYSTEMS FOR SMART POWEREDSURGICAL STAPLING" are set forth in the following examples:

Embodiment 1 - A surgical system including control circuitry and surgical instruments. Surgical instruments include multiple components and sensors. Each of the multiple components of the surgical instrument includes device parameters. Each component is configured to transmit its corresponding device parameters to the control circuit. The sensor is configured to detect tissue parameters associated with the proposed function of the surgical instrument and to communicate the detected tissue parameters to the control circuitry. The control circuitry is configured to analyze the detected tissue parameter in cooperation with each corresponding device parameter based on system-defined constraints. The surgical system also includes a user interface configured to indicate whether the surgical instrument including the plurality of components is suitable to perform the proposed function.

Embodiment 2 - The surgical system of Embodiment 1, wherein the detected tissue parameters include at least one of type of tissue, thickness of tissue, stiffness of tissue, location of tissue, or vascularization of tissue.

Embodiment 3 - The surgical system of embodiment 1 or 2, wherein the components of the surgical instrument include a staple cartridge, and wherein the device parameters include a type of staple cartridge, a color of the staple cartridge, appendages of the staple cartridge, clips of the staple cartridge At least one of the holding load limit, the gap range of the nail cartridge, and the firing rate of the nail cartridge.

Embodiment 4—The surgical system of embodiment 1, 2, or 3, wherein the component of the surgical instrument includes an end effector, and wherein the detected tissue parameter includes at least one of the following: The angle of closure on the tissue, the length of tissue in contact with the tissue contacting surface of the end effector, and the force compressing the tissue within the end effector.

Embodiment 5 - The surgical system of Embodiment 4, wherein the control circuit is further configured to be able to identify the tissue as parenchyma, blood vessel, or bronchi based on at least one detected tissue parameter.

Embodiment 6 - The surgical system of embodiment 1, 2, 3, 4 or 5, wherein the control circuit is further configured to recommend at least one alternative component for use with the surgical instrument to perform the proposed function.

Embodiment 7 - The surgical system of Embodiment 1, 2, 3, 4, 5, or 6, wherein the system-defined constraints include predetermined tissue parameters or predetermined tissue associated with each transmitted device parameter At least one of the parameter ranges.

Embodiment 8 - The surgical system of embodiment 1, 2, 3, 4, 5, 6 or 7, wherein the control circuit is further configured to prevent the proposed functionality when system defined constraints are exceeded.

Embodiment 9 - The surgical system of Embodiment 8, wherein the user interface includes a user interface element selectable to override the control circuitry to allow proposed functionality of the surgical instrument.

Embodiment 10 - The surgical system of embodiment 1, 2, 3, 4, 5, 6, 7, 8 or 9, wherein the proposed functions of the surgical instrument include gripping tissue, coagulating tissue, cutting tissue and suturing. One or more than one member of an organization.

Embodiment 11 - The surgical system of Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, further comprising a surgical hub communicatively coupled to the surgical instrument, wherein the surgical hub includes control circuitry .

Embodiment 12 - The surgical system of Embodiment 11, wherein one of the surgical instrument or the surgical hub includes a user interface.

Embodiment 13 - A surgical system including a surgical hub and surgical instruments communicatively coupled to the surgical hub. Surgical instruments include multiple components and sensors. Each of the multiple components of the surgical instrument includes device parameters. Each component is configured to transmit its corresponding device parameters to the surgical hub. The sensor is configured to detect tissue parameters associated with the proposed function of the surgical instrument and transmit the detected tissue parameters to the surgical hub. The surgical hub includes a processor and memory coupled to the processor. The memory stores instructions executable by the processor to analyze the detected tissue parameters in cooperation with each respective device parameter based on system-defined constraints. The surgical system also includes a user interface configured to indicate whether the surgical instrument including the plurality of components is suitable to perform the proposed function.

Embodiment 14 - The surgical system of Embodiment 13, wherein the detected tissue parameters include at least one of a type of tissue, a thickness of the tissue, a stiffness of the tissue, a location of the tissue, or a vascularization of the tissue.

Embodiment 15 - The surgical system of embodiment 13 or 14, wherein the components of the surgical instrument include a staple cartridge, and wherein the device parameters include a type of staple cartridge, a color of the staple cartridge, appendages of the staple cartridge, clips of the staple cartridge At least one of the holding load limit, the gap range of the nail cartridge, and the firing rate of the nail cartridge.

Embodiment 16—The surgical system of embodiment 13, 14, or 15, wherein the component of the surgical instrument includes an end effector, and wherein the detected tissue parameters include an angle of closure of the end effector on the tissue, and At least one of a length of tissue contacted by the tissue contacting surface of the end effector and a force compressing the tissue within the end effector.

Embodiment 17 - The surgical system of embodiment 13, 14, 15 or 16, wherein the instructions are further executable by a processor of the surgical hub to recommend at least one alternative component for use with the surgical instrument to perform the proposed function.

Embodiment 18 - The surgical system of embodiment 13, 14, 15, 16, or 17, wherein the instructions are further executable by a processor of the surgical hub to prevent the proposed functionality when system-defined constraints are exceeded.

Embodiment 19 - A non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to interact with a surgical instrument of a surgical system based on system-defined constraints Device parameters of each of the plurality of components cooperate to analyze detected tissue parameters, where the detected tissue parameters are associated with a proposed function of the surgical instrument. A surgical system includes a surgical instrument that includes multiple components. Each component is configured to transmit its corresponding device parameters to the machine. The surgical system also includes a sensor configured to detect the detected tissue parameter and transmit the detected tissue parameter to the machine. The instructions, when executed, also cause the machine to generate a user interface, wherein the user interface provides an indication of whether a surgical instrument including a plurality of components is suitable for performing the proposed functions of the surgical system.

Embodiment 20—The non-transitory computer-readable medium of Embodiment 19, the instructions, when executed, further cause the machine to generate an override element on the user interface, wherein the overwrite element is selectable to allow all aspects of the surgical instrument. Proposed features.

Control surgical instruments based on sensed closure parameters

Determination of compressibility of tissue integrity

In various aspects, a surgical instrument can detect a variety of different variables or parameters associated with the closing of the jaws of the surgical instrument, which in turn can be used to adjust or influence various operating parameters that dictate how the surgical instrument operates. The rate at which the jaws of a surgical instrument transition from an open position to a closed position to clamp tissue therebetween may be defined as the clamping rate or closing rate. In various aspects, the closing rate may be variable or constant during the jaw closing instance. The threshold to which a specific parameter associated with the closing of the jaw is compared may be defined as the closing threshold.

Clamping tissue at an inappropriate closing rate or at an inappropriate closing threshold can result in damage to the tissue (e.g., the tissue can be torn due to the jaws applying excessive force to the tissue) and/or operational failure of the surgical instrument (For example, the staple may become deformed because the tissue is not held securely by the jaws when the staple is fired). Accordingly, in some aspects, a surgical instrument is configured to detect characteristics of tissue clamped by the surgical instrument and adjust one or more closure rates, one or more closure thresholds, and other operating parameters accordingly. Additionally, each surgical procedure may involve multiple different tissue types and/or tissue with different properties. Accordingly, in some aspects, a surgical instrument is configured to dynamically detect tissue properties each time the tissue is clamped and adjust one or more closure rates, one or more closure thresholds, and other operating parameters accordingly.

The present disclosure provides at least one solution wherein a surgical instrument is configured to detect parameters associated with compression of tissue clamped by an end effector. Surgical instruments may also be configured to differentiate between tissue exhibiting different integrity based on detected tissue compression properties. The motor can then be controlled to affect jaw closure rate and/or provide feedback to the user based on tissue integrity. For example, the surgical instrument may be configured to reduce the rate of closure of the jaws if the detected tissue compression properties indicate that the tissue is rigid and/or to provide utilization to the user if the tissue compression properties indicate that the tissue has low shear strength. Recommendations for appendage reinforcement.

Figure 95 shows a block diagram of a surgical instrument 21000 in accordance with at least one aspect of the present disclosure. In one aspect, surgical instrument 21000 includes control circuitry 21002 coupled to a motor 21006, a user interface 21010, and one or more sensors 21004. Motor 21006 is coupled to end effector 21008 such that motor 21006 causes the jaws of end effector 21008 (e.g., anvil 150306 and/or channel 150302 of surgical instrument 150010 shown in Figure 25) in a first or open configuration transition between the second or closed configuration, for example, as discussed with respect to Figure 26. One or more sensors 21004 can be communicatively coupled to the control circuit 21002 such that the control circuit 21002 receives data and/or signals therefrom. Control circuit 21002 can be communicatively coupled to motor 21006 such that control circuit 21002 controls operation of motor 21006 based on data and/or signals received, for example, from one or more sensors 21004 . User interface 21010 includes a device configured to provide feedback to a user of the surgical instrument, such as a display or speakers.

In various aspects, one or more sensors 21004 can be configured to detect compression parameters of tissue clamped at the end effector. In one aspect, one or more sensors 21004 may be configured to detect force closing (FTC) of the jaws of the end effector 21008, ie, the force exerted to transition the jaws from an open configuration to a closed configuration. For example, one or more sensors 21004 may include a motor current sensor configured to detect current drawn by the motor, such as discussed with respect to FIG. 12 , FIG. 18 , or FIG. 19 . For a DC motor, the current consumed by the motor corresponds to the motor torque (eg, the torque of the output shaft of motor 21006), which represents the FTC of end effector 21008. The FTC of the end effector 21008 corresponds to the tissue compression of the clamped tissue because it represents the force transmitted from the end effector 21008 to the clamped tissue as the end effector 21008 closes on the tissue. The greater the force applied to the tissue, the greater the tissue is compressed. In another aspect, one or more sensors 21004 includes a first electrode disposed on the end effector 21008, the first electrode being configured to receive an RF signal from a corresponding second electrode, such as with respect to FIGS. 38 discussed. The electrical impedance of the tissue may correspond to its tissue thickness, which in turn may correspond to the tissue compression of the clamped tissue. In yet another aspect, one or more sensors 21004 includes a force-sensitive transducer configured to be capable of determining an amount of force applied to one or more sensors 21004, such as discussed with reference to FIG. 24 . Similar to the discussion above with respect to FTC, the force detected by the transducer represents the force transmitted from the end effector 21008 to the clamped tissue as the end effector 21008 closes on the tissue. The greater the force applied to the tissue, the greater the tissue is compressed. User interface 21010 includes a device configured to provide feedback to a user of the surgical instrument, such as a display or speakers. In other aspects, one or more sensors 21004 may include various combinations of the aforementioned sensors and other such sensors capable of detecting compression parameters associated with tissue clamped at the end effector. For example, an end effector, such as end effector 15200 shown in Figure 53, may include a first sensor 152008a (including a force-sensitive transducer) and a second sensor 152008b (including an impedance sensor).

The control circuit 21002 may be configured to adjust the closing rate of the jaws of the end effector 21008 to accommodate different tissue types. The control circuit 21002 may be configured to monitor the compression force (eg, FTC) exerted on the tissue during the initial compression period or another parameter associated with the compression of the tissue (eg, tissue impedance), and based on the tissue compression parameter rate of change to adjust the jaw closing rate or time accordingly. For example, for more viscoelastic tissue, it may be beneficial to reduce the rate of closure or increase the time of closure, rather than applying a total compressive force over a short period of time, as discussed above with respect to Figure 22.

96 illustrates a logic flow diagram of a process 21050 for controlling a surgical instrument based on the integrity of clamped tissue in accordance with at least one aspect of the present disclosure. In the following description of process 21050, reference should also be made to Figure 95. The illustrated process may be performed by, for example, control circuitry 21002 of surgical instrument 21000. Accordingly, control circuitry 21002 performing the process receives 21052 data and/or signals (eg, digital or analog) from one or more sensors 21004 related to tissue compression parameters sensed thereby. In various aspects, tissue compression parameters may include parameters associated with the characteristics, type, properties, and/or status of the tissue being operated on; parameters associated with the internal operation and/or properties of the surgical instrument 21000; or components thereof . In one aspect, tissue compression parameters may include, for example, FTC of end effector 21008. In another aspect, the tissue compression parameters may include, for example, the thickness of the clamped tissue. Control circuitry 21002 may receive 21052 data related to tissue compression parameters as one or more discrete values transmitted by one or more sensors 21004 , which may then be associated with one or more value-related signals, etc.

Accordingly, control circuitry 21002 determines how the value of the sensed tissue compression parameter compares to one or more thresholds and then generates a response accordingly. In one aspect, control circuitry 21002 determines 21054 the value of the sensed tissue compression parameter relative to a first threshold. For example, control circuitry 21002 may determine 21054 whether the sensed tissue compression parameter exceeds or is greater than a first or higher threshold. In one aspect, if the sensed tissue compression parameter exceeds the first threshold, process 21050 continues along the "YES" branch and control circuit 21002 controls 21056 motor 21006 to increase the time taken to close the jaws of end effector 21008 length. The control circuit 21002 may control the 21056 motor 21006 to increase the jaw closing time by, for example, reducing the rate at which the jaws are closed and increasing the length of time the movement of the jaws is paused after initial clamping of the tissue (i.e., tissue creep wait time), or lower the stability threshold to end the clamping phase. If the sensed tissue compression parameter does not exceed the first threshold, process 21050 continues along the "NO" branch, and in various aspects, process 21050 may end or process 21050 may continue and control circuitry 21002 may The compressed values are compared to one or more additional thresholds or continue to receive 21052 tissue parameter data and/or signals.

In another aspect, the control circuit 21002 also determines 21058 the value of the sensed tissue compression parameter relative to the second threshold. For example, control circuitry 21002 may determine 21058 whether the sensed tissue compression parameter is below or less than a second or lower threshold. In one aspect, if the sensed tissue parameter is below the second threshold, process 21050 continues along the "yes" branch and control circuitry 21002 provides 21060 corresponding feedback via, for example, user interface 21010. The feedback provided 21060 may include, for example, visual feedback provided via a display or audio feedback provided by a speaker. In one aspect, the feedback may suggest that the user should take one or more corrective actions to ameliorate the situation causing the sensed tissue compression parameter to be unexpectedly low. Such corrective measures include, for example, the use of appendage reinforcements (i.e., tissue thickness compensators) such as those disclosed in U.S. Patent Application No. 8,657,176 entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER," which is hereby referred to as Incorporated herein by reference. In various aspects, the appendage reinforcement can include a layer or series of layers of compressible material configured to accommodate capture between anvil 150306 (FIG. 25) and staple cartridge 150304 (FIG. 25). tissue and/or apply additional compressive force to it.

The thresholds discussed above may include, for example, values for one or more parameters sensed by one or more sensors 21004 and/or derivatives of one or more parameters sensed by one or more sensors 21004 (e.g., sensed the time rate of change of the parameter to). Insofar as the tissue compression parameter includes the FTC of the end effector 21008, the first threshold may indicate such a delineation: above the first threshold, the clamped tissue is considered rigid. Rigid tissue can tear relatively easily due to the mechanical action of the jaws on the tissue, or in the case of lung tissue, during re-expansion. Additionally, the second threshold may indicate such a delineation: below the second threshold, the clamped tissue is considered to have weak shear strength (ie, viscous). During suturing and/or firing of the cutting member (i.e., I-beam 150178 having cutting edge 150182), it may be relatively difficult for end effector 21008 to securely grasp or otherwise retain tissue with weak shear strength. in place.

It should be noted that while the steps of the specific example of process 21050 in Figure 96 are depicted as occurring in a specific order or sequence, such depictions are for illustrative purposes only and the specific order of process 21050 is not intended, except in light of the above. A specific sequence of specific steps is explicitly required in the description. For example, in other aspects of process 21050, control circuitry 21002 may determine 21058 whether the sensed tissue compression parameter is below a second or lower threshold before determining 21054 whether the sensed tissue compression parameter exceeds a first or higher threshold. .

97 illustrates a first graph 21100 depicting end effector FTC 21104 over time 21102 for an exemplary firing of a surgical instrument 21000 in accordance with at least one aspect of the present disclosure. In the following description of the first graph 21100, reference should also be made to FIGS. 95-96. A first graph 21100 depicts a first firing 21110 and a second firing 21114 that are exemplary firings of a surgical instrument 21000 controlled by a control circuit 21002 that performs the operations described above with respect to FIG. 96 Process 21050. In this illustrative example, the first threshold 21106 includes a specific time rate change in FTC (ie, ΔFTC), and the second threshold 21108 includes a specific FTC. In various aspects, the thresholds 21106, 21108 may be fixed or predetermined values, defined relative to one or more other variables, or programmed or set by the user of the surgical instrument 21000.

For the first firing 21110, control circuitry 21002 executing the process shown in Figure 96 receives 21052 tissue compression parameter data and/or signals and determines 21058 that the FTC fell below a second threshold 21108 at time _t1 . Therefore, the control circuit 21002 provides 21060 feedback to the user, including advising the user to take certain actions and/or indicating that the end effector 21008 is grasping tissue with low shear strength. In one aspect, the feedback provided 21060 may include suggestions that the user release the end effector 21008 and utilize tissue compensators applied to the end effector 21008 to reinforce and/or compensate for low shear strength tissue (e.g., No. 8,657,176) to re-fire the surgical instrument 21000. In one aspect, the control circuit 21002 may be further configured to cause the motor 21006 to cease closing the jaws of the end effector 21008 if the FTC is below the second threshold. In another aspect, the control circuit 21002 may be configured to provide a recommendation for the user to cease closing the jaws of the end effector 21008 if the FTC is below the second threshold. The 21060 feedback provided may take a variety of forms, including, for example, prompts displayed on operating room displays 107, 109, 119 (FIG. 2) and/or surgical instrument displays, via speakers located in the operating room and/or on surgical instruments. audible messages, tactile feedback via surgical instruments, or a combination thereof.

For a second firing 21114 (which may be a firing using a tissue compensator after the first firing 21110), the control circuit 21002 executing the process 21050 shown in Figure 96 receives 21052 tissue compression parameter data and/or signals, and upon closing At any point in the process of end effector 21008 it is uncertain that the FTC falls below the second threshold or exceeds the first threshold. Therefore, the control circuit 21002 does not affect the jaw closing rate, provide no feedback to the user, and do not take any other such actions.

98 shows a second graph 21116 depicting end effector FTC 21102 over time 21104 for an exemplary firing of a surgical instrument 21000 in accordance with at least one aspect of the present disclosure. In the following description of the second graph 21116, reference should also be made to FIGS. 95 to 96 . The second graph 21116 depicts a third firing 21118, which is an exemplary firing of the surgical instrument 21000 controlled by the control circuit 21002, which performs the process 21050 described above with respect to FIG. 96. In this illustrative example, first threshold 21106 includes a specific time rate change in FTC (ie, ΔFTC).

For the third firing 21116, control circuitry 21002 executing the process shown in Figure 96 receives 21052 tissue compression parameter data and/or signals and determines 21058 that ΔFTC exceeds the first threshold 21106 at time _t2 . Accordingly, the control circuit 21002 controls 21056 the motor 21006 to increase the jaw closing time, such as by decreasing the jaw closing rate, which correspondingly decreases the rate at which the FTC 21102 increases. Increasing the jaw closure time may be beneficial, for example, by preventing damage to rigid tissue by preventing a larger amount of force from being exerted on the tissue in a short period of time. In one aspect, the first threshold 21106 may include a default rate of change of FTC (ΔFTC _D ), i.e., a default or baseline FTC rate for the surgical instrument 21000 without any modification of the FTC by a control algorithm based on tissue type and other such parameters. Revise. In this regard, if the FTC experienced by the surgical instrument 21000 exceeds FTC _D during the surgical procedure, the control circuit 21002 performing process 21050 may control 21056 the motor 21006 to increase the jaw closure time.

The timing at which control circuitry 21002 executing the aforementioned algorithm or process determines to compare parameters sensed by one or more sensors 21004 to one or more thresholds may include discrete instances during the firing stroke of surgical instrument 21000, a series of times during the firing stroke. Discrete instances and/or continuous time intervals during the firing stroke. Tissue compression parameters monitored by control circuitry 21002 and compared to thresholds may include, for example, FTC values (e.g., second threshold 21108 shown in Figure 97) or ΔFTC values (e.g., first threshold 21106 shown in Figures 97-98 ).

In one aspect, the control circuit 21002 may also be configured to store data related to firing of the surgical instrument 21000 and then optionally utilize data from previous firings to adjust an algorithm for determining the tissue integrity of the clamped tissue. For example, data from previous firings may be used to adjust the first threshold and/or the second threshold of process 21050 shown in Figure 96. In one aspect, the surgical instrument 21000 may be configured to be paired with the surgical hub 106 (Figs. 1-3) that implements a situational awareness system, as described above under the heading "Situational Awareness" and as discussed on March 29, 2018 As described in U.S. Patent Application No. 15/940,654, filed entitled "SURGICAL HUB SITUATIONAL AWARENESS," which is hereby incorporated by reference in its entirety. In this aspect, the situational awareness system may determine the type of tissue being operated on during the surgical procedure and adjust the algorithm used to determine the tissue integrity of the clamped tissue accordingly. In another aspect, surgical instrument 21000 may be configured to receive user input indicative of the type of tissue being operated on and adjust algorithms for determining tissue integrity accordingly. For example, the surgical instrument 21000 may be configured to be able to adjust the first threshold and/or the second threshold of the process 21050 shown in FIG. 96 from a default value based on the tissue type input by the user.

The techniques described above allow the surgical instrument 21000 to avoid damage to the clamped tissue and prevent operational malfunctions (eg, misshapen staples) caused by jaw closing rates that would be inappropriate for the specific characteristics of the tissue being operated on. Or less than ideal. Furthermore, the techniques described above improve the ability of surgical instruments to respond appropriately to the characteristics of tissue encountered during the course of a surgical procedure.

Organizational initial contact to determine organization type

Clamping tissue at an inappropriate closing rate or at an inappropriate closing threshold can result in damage to the tissue (e.g., the tissue can be torn due to the jaws applying excessive force to the tissue) and/or operational failure of the surgical instrument (For example, the staple may become deformed because the tissue is not held securely by the jaws when the staple is fired). Accordingly, in some aspects, a surgical instrument is configured to detect characteristics of tissue clamped by the surgical instrument and adjust one or more closure rates, one or more closure thresholds, and other operating parameters accordingly. Additionally, each surgical procedure may involve multiple different tissue types and/or tissue with different properties. Accordingly, in some aspects, a surgical instrument is configured to dynamically detect tissue properties each time the tissue is clamped and adjust one or more closure rates, one or more closure thresholds, and other operating parameters accordingly.

The present disclosure provides at least one solution wherein a surgical instrument is configured to characterize the tissue being clamped based on the degree of tissue contact against the jaw surface and the relative position of the jaws at the initial point of contact with the tissue type. The closing rate of the jaws and the threshold for adjusting the jaw closing rate can then be set to an appropriate level for the tissue type characterized by the detected tissue contact and the detected jaw position. For example, a surgical instrument may be configured to be able to differentiate between parenchyma and blood vessels because the parenchyma contacts the jaw surface to a greater extent and at a greater angle at the initial point of contact than the blood vessels. The surgical instrument can then control the motor to affect the rate of jaw closure and, accordingly, the adjustment threshold for the detected tissue type.

Referring back to FIG. 95 , in one aspect, a surgical instrument 21000 includes control circuitry 21002 coupled to a motor 21006 , a user interface 21010 , and one or more sensors 21004 . Motor 21006 is coupled to end effector 21008 such that motor 21006 causes the jaws of end effector 21008 (e.g., anvil 150306 and/or channel 150302 of surgical instrument 150010 shown in Figure 25) in a first or open configuration and the second or closed configuration, as discussed with respect to Figure 26. One or more sensors 21004 can be communicatively coupled to the control circuit 21002 such that the control circuit 21002 receives data and/or signals therefrom. Control circuit 21002 can be communicatively coupled to motor 21006 such that control circuit 21002 controls operation of motor 21006 based on data and/or signals received, for example, from one or more sensors 21004 .

In various aspects, one or more sensors 21004 may be configured to be capable of detecting physical contact of tissue against a jaw surface of end effector 21008 . In one aspect, one or more sensors 21004 may include one or more tissue contact sensors disposed along a tissue contact surface of the end effector 21008, such as an anvil and a cartridge or channel. The tissue contact sensor may comprise, for example, a plurality of sensors or segments of a segmented circuit arranged sequentially along the surface of the jaw, each sensor or segment being configured to be capable of determining whether tissue is positioned against the jaw, as described above with reference to Figures 75 to Figure 79 is discussed. In one aspect, one or more sensors 21004 include a plurality of electrodes, each electrode configured to receive an RF signal from a corresponding electrode disposed on an opposing jaw, such as discussed with reference to Figures 36-38. Accordingly, the control circuit 21002 may perform a continuity test along the length of the end effector 21008 to determine that tissue is present at the location corresponding to each electrode that is capable of receiving signals from its corresponding electrode (because of the signal transmission medium (i.e., tissue must be located between two electrodes in order for the electrodes to receive signals from their corresponding electrodes). In another aspect, one or more sensors 21004 includes a plurality of force-sensitive transducers, each force-sensitive transducer configured to determine an amount of force applied to the one or more sensors 21004, such as described with reference to FIG. 24 discussed. Accordingly, control circuitry 21002 may determine that tissue is present at a location corresponding to each force-sensitive transducer that detects a non-zero force thereagainst. In other aspects, one or more sensors 21004 include a plurality of load sensors, pressure sensors, and/or other sensors configured to be capable of detecting physical contact therebetween. Similar to the discussion above with respect to force-sensitive transducers, control circuitry 21002 may determine that tissue is present at a location corresponding to each load sensor, pressure sensor, and/or other sensor that detects non-zero force thereagainst. In yet another aspect, one or more sensors 21004 include a current sensor configured to detect an amount of current drawn by the motor 21006, such as discussed with reference to FIG. 12, FIG. 18, or FIG. 19. Therefore, the control circuit 21002 may determine the point at which the jaws of the end effector 21008 initially contact the tissue based on when the current drawn by the motor 21006 increases to compensate for when the jaws contact the tissue and begin to apply clamping force against it. 21006 Increased clamping load experienced, such as that discussed with respect to Figure 83 (i.e., FTC increases 153610, 153616 as the jaws clamp tissue, and FTC corresponds to motor current). Various aspects described above may be used alone or in combination with other aspects for determining the initial point of contact between the end effector 21008 and the tissue being clamped and/or between the tissue and the end effector 21008 degree of contact between them.

99 illustrates a logic flow diagram of a process 21200 for controlling a surgical instrument based on the physiological type of tissue being clamped, in accordance with at least one aspect of the present disclosure. In the following description of process 21200, reference should also be made to Figure 95. The illustrated process may be performed by, for example, control circuitry 21002 of surgical instrument 21000. Accordingly, control circuitry 21002 executing the illustrated process 21200 receives 21202 tissue contact data and/or signals from one or more sensors 21004, such as the tissue contact sensors discussed above and illustrated in Figures 100A-101B. The tissue contact data and/or signals received 21202 indicate whether tissue is contacting at least one of the sensors 21004 . Accordingly, the control circuit 21002 may determine 21204 the initial point of contact between the end effector 21008 and the tissue being clamped. In one aspect, control circuitry 21002 determines 21204 when initial tissue contact occurs by detecting when at least one of sensors 21004 disposed on each of the jaws detects tissue contact thereto.

Therefore, the control circuit 21002 determines 21206 the position of the jaws at the initial tissue contact point. In one aspect, the control circuit 21002 is communicatively coupled to a Hall effect sensor disposed on one of the jaws of the end effector 21008, the Hall effect sensor being configured to detect a corresponding magnetic element disposed on the opposing jaw. relative position, such as discussed with reference to Figure 77. Therefore, the control circuit 21002 may determine 21206 the position of the jaws based on the sensed distance or gap between the jaws. In another aspect, the control circuit 21002 is communicatively coupled to a position sensor configured to detect an absolute or relative position of the closure tube, the closure tube configured to detect when the closure tube is moved from a first or proximal position. The jaws are closed when driven to the second or distal position, such as discussed with reference to Figures 20-21 and 25. Therefore, the control circuit 21002 may determine 21206 the position of the jaws based on the sensed position of the closed tube. In yet another aspect, the control circuit 21002 is communicatively coupled to an angle sensor, such as a TLE5012B 360° angle sensor from Infineon Technologies, configured to detect at least one angle at which the jaws are oriented. Thus, the control circuit 21002 may determine 21206 the jaw position based on the sensed angle at which the jaws are oriented.

Accordingly, control circuitry 21002 determines 21208 the degree of contact between the grasped tissue and one or more tissue contacting surfaces of the jaws. The degree of tissue contact may correspond to the number or ratio of sensors 21004 that have detected the presence (or absence) of tissue, such as discussed with reference to FIG. 79 . In one aspect, control circuitry 21002 may determine the degree of tissue contact based on a ratio of one or more sensors 21004 that have detected the presence of tissue to one or more sensors 21004 that have not detected the presence of tissue.

Therefore, the control circuit 21002 sets 21210 control parameters for the motor 21006 based on the determined 21206 jaw position and the determined 21208 degree of tissue contact. Motor control parameters may include, for example, the time to close the jaws and/or one or more closing thresholds. In one aspect, control circuitry 21002 may be configured to perform runtime calculations and/or access memory (e.g., lookup tables) to retrieve information associated with a specific position of the jaw and a specific degree of tissue contact sensed via various sensors. Motor control parameters (e.g., jaw closing rate and closing threshold). In various aspects, the control circuit 21002 can control the motor 21006 by, for example, adjusting the rate at which the jaws transition from an open position to a closed position, adjusting the length of time the jaws pause after initial clamping of tissue (i.e., tissue creep wait time) And/or adjust the stability threshold of the end clamping phase to adjust the jaw closing time. In various aspects, the one or more closure thresholds may include, for example, the maximum allowed FTC of the end effector 21008 or the rate of change of FTC (i.e., ΔFTC) at which the control circuit 21002 stops driving the motor 21006 of jaw closure or takes other action, such as Discussed above under the heading "Compression Ratio for Determining Tissue Integrity". Control circuit 21002 may then control motor 21206 according to motor control parameter set 21210 through process 21200 .

The position of the jaws and the degree of contact with the tissue at the initial point of contact with the tissue corresponds to the thickness or geometry of the tissue being grasped, which in turn corresponds to the physiological type of tissue. Therefore, the control circuit 21002 may be configured to be able to differentiate between tissue types and then set 21210 the control parameters of the motor 21006 accordingly. For example, the control circuit 21002 may be configured to determine whether parenchymal or vascular tissue has been grasped by the end effector 21008 and then set 21210 motor control parameters appropriate for the type of tissue being detected.

In some aspects, the jaw closing rate can be selected for each tissue type to maintain the maximum FTC and/or ΔFTC below a specific closing threshold, which can also be selected for each tissue type. In one aspect, the control circuit 21002 may be configured to set a minimum clamping rate such that the closing movement of the jaws never permanently stops. In one aspect, the control circuit 21002 may be configured to control the maximum pause time to ensure that jaw closing proceeds at least at a default rate. In one aspect, the control circuit 21002 may be configured to stop the motor 21006 and/or provide feedback to the user when the closure threshold is exceeded or otherwise shelved during use of the surgical instrument 21000.

It should be noted that, although the steps of the specific example of process 21200 in Figure 99 are depicted as occurring in a specific order or sequence, such depictions are for illustrative purposes only and the specific order of process 21200 is not intended, except in light of the above. A specific sequence of specific steps is explicitly required in the description. For example, in other aspects of process 21200, control circuitry 21002 may determine 21208 the degree of tissue contact before determining 21206 the jaw position at the initial point of contact.

100A-101B illustrate various side elevation views of the end effector 21008 grasping parenchyma 21030 and blood vessel 21032 in both an initial contact position with tissue and a closed position in accordance with at least one aspect of the present disclosure. In the depicted aspect, the end effector 21008 includes a plurality of tissue contact sensors 21016 disposed along tissue contacting surfaces of the jaw, including the anvil 21012 and the channel 21014. In other aspects, the tissue contact sensor 21016 may be disposed along the cartridge 150304 (FIG. 25) in addition to or instead of being disposed along the channel 21014 of the surgical instrument 21000. For simplicity, in the following description, tissue contact sensor 21016 will be discussed as being disposed along channel 21014; however, it should be noted that the concepts discussed herein are equally applicable to aspects where tissue contact sensor 21016 is disposed along bin 150304. As mentioned above, tissue contact sensors 21016 may include, for example, impedance sensors, load sensors, force-sensitive transducers, and combinations thereof. During use of surgical instrument 21000 in a surgical procedure, tissue contact sensors 21016 may be depicted as activated sensors 21018 (ie, sensors that sense the presence of tissue) and inactive sensors 21020 (ie, sensors that do not sense the presence of tissue).

Figures 100A and 101A illustrate the initial contact points of end effector 21008 with parenchyma 21030 and vessel 21032, respectively. In one aspect, the initial point of contact between the end effector 21008 and tissue may be defined as the point on both the anvil 21012 and the channel 21014 where at least one activated sensor 21018 is present. As discussed above, tissue types can be distinguished based on the location of the jaws (ie, anvil 21012 and/or channel 21014) and the degree of contact between the tissue and the jaws at the initial point of contact with the tissue. For example, Figures 100A and 101A illustrate how parenchyma 21030 and blood vessels 21032 can be differentiated based on the proportion of sensors 21018 activated at the initial tissue contact point. That is, clamping vessel 21032 results in fewer activated sensors 21018 relative to clamping substance 21030. It should also be noted that the number of activated tissue sensors 21018 on the anvil 21012 and channel 21014 need not be equal at the initial tissue contact point. As another example, Figures 100A and 101A illustrate how parenchyma 21030 and vessels 21032 can be differentiated based on the angle at which anvil 21012 is oriented relative to channel 21014 at the initial tissue contact point. That is, the anvil 21012 is oriented at a first angle θ ₁ at the initial point of contact with the substance 21030 and at a second angle θ ₂ at the initial point of contact with the blood vessel 21032 . The difference between the proportion of activated sensors 21018 and the angle at which anvil 21012 is oriented can be used alone or in combination (e.g., by process 21200 shown in Figure 99) to characterize the physiological type of tissue being clamped and then Set the appropriate jaw closing rate, closing threshold, and other motor control parameters for that tissue type.

Figures 100B and 101B illustrate the point at which end effector 21008 has fully clamped parenchyma 21030 and vessel 21032, respectively. It can be seen that when end effector 21008 clamps tissue, changes in the number or ratio of activated sensors 21018 and inactive sensors 21020 can also be used to determine the tissue type and/or physical properties of the tissue, and the degree to which the tissue is compressed. and/or the distance between anvil 21012 and channel 21014, as well as various other parameters. For example, blood vessel 21032 deforms much more than parenchyma 21030 when fully clamped, which results in a relatively large change in the number of activated sensors 21018 when end effector 21008 clamps blood vessel 21032. In some aspects, the control circuitry may perform processes to determine a tissue type (i.e., physiological tissue type or tissue with certain physical properties) based on a change or rate of change in the number of sensors 21018 activated while the end effector 21008 is clamped. ). In some aspects, the control circuitry may perform processes to determine the extent to which tissue is compressed and/or deformed based on a change or rate of change in the number of sensors 21018 activated while the end effector 21008 is clamped.

In some aspects where surgical instrument 21000 includes control circuitry 21002 that performs process 21200 described above in Figure 99, when control circuitry 21002 determines that jaws 21013 have initially contacted tissue, control circuitry 21002 may be configured to detect or The spacing θ between the jaws and the length or degree of tissue contact L between the tissue and the jaws are measured. The closing threshold (eg, FTC threshold or ΔFTC threshold), initial closing speed, and one or more adjusted closing speeds (i.e., one or more closing speeds at which jaw 21013 closes after exceeding the closing threshold) may each be θ and L The function. As shown in Figures 100A-100B, the jaw spacing may be defined as _θ1 , and the degree of tissue contact may be defined as _L1 at the initial point of contact with the first tissue (eg, parenchyma 21030). As shown in Figures 101A-101B, the jaw spacing may be defined as _θ2 , and the degree of tissue contact at the initial point of contact with the second tissue (eg, blood vessel 21032) may be defined as _L2 . Therefore, in some aspects where θ ₁ >θ ₂ and L ₁ >L ₂ , parenchymal FTC threshold FTC _p > vessel FTC threshold FTC _v ; parenchymal ΔFTC threshold ΔFTC _p > vessel slope threshold ΔFTC _v ; and vessel initial closure velocity v _V1 > Substantial initial closing speed v _P1 . The operational differences between these thresholds are discussed in further detail below with reference to Figures 102-103.

Figure 102 shows a first graph 21300 and a second graph 21302 depicting exemplary firing, end effector FTC 21304 and closure, respectively, of a surgical instrument 21000 grasping a substance 21030 in accordance with at least one aspect of the present disclosure. Speed 21306 changes with time 21308. In the following description of the first graph 21300 and the second graph 21302, reference should also be made to FIG. 95 and FIGS. 99 to 100B. The exemplary firings described herein are for the purpose of demonstrating the concepts discussed above with reference to Figure 95 and Figures 99-100B and should not be construed as limiting in any way.

The first firing of the surgical instrument 21000 may be represented by a first FTC curve 21310 and a corresponding first velocity curve 21310', which respectively illustrate the changes in FTC and closure velocity over time during the first firing. The first firing may represent, for example, a default firing of the surgical instrument 21000 or a firing of the surgical instrument 21000 that does not include the control circuit 21002 performing the process 21200 shown in FIG. 99 . When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, causing the closing speed of the anvil 21012 to sharply increase 21318 to the initial or default closing speed v _d1 . When anvil 21012 is actuated from the open position, it comes into contact with the clamped tissue, which is parenchyma 21030 for this particular firing. When the anvil 21012 contacts the clamped tissue at time _t0 , the FTC increases by 21312 from an initial FTC (eg, zero) to a peak value of 21314 at time _t1 . At time t ₁ , the control circuitry 21002 of the surgical instrument 21000 determines that the FTC has reached or exceeded the FTC threshold (which may be, for example, a default threshold independent of tissue type), and controls the motor 21006 to stop the movement of the anvil 21012 , thereby causing the closing speed to decrease. 21320 to zero. Movement of the anvil 21012 may be paused for a duration p ₁ during which the closing speed remains 21322 zero. During the pause, FTC gradually decreases as the clamped tissue relaxes21316.

The second firing of the surgical instrument 21000 may be represented by a second FTC curve 21324 and a corresponding first velocity curve 21324', which respectively illustrate changes in FTC and closure speed over time during the course of the second firing. Compared to the first firing, the second firing may represent, for example, firing of the surgical instrument 21000, including the control circuit 21002 performing the process shown in Figure 99. When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, causing the closing speed of the anvil 21014 to increase sharply 21336 . Due to the relative thickness and/or geometry of the parenchyma 21030, the initial point of contact between the tissue (i.e., the parenchyma 21030) and the jaws 21013 occurs shortly after the anvil 21012 begins to be driven by the motor 21006; therefore, performing the steps shown in Figure 99 The control circuitry 21002 of the process 21200 is able to determine almost immediately that the substance 21030 is being clamped and set accordingly the time to close the jaws, one or more closing thresholds, and other closing parameters relatively early in the closing process. Therefore, the control circuit 21002 controls the motor 21006 to cause the closing speed of the anvil 21014 to sharply increase 21336 to an initial closing speed v _p1 specific to the parenchymal 21320 tissue.

When anvil 21012 is actuated from the open position, it comes into contact with the clamped tissue, which is parenchyma 21030 for this particular firing. When the anvil 21012 contacts the clamped tissue at time _t0 , the FTC increases 21326 from an initial FTC (eg, zero) to a first peak value 21328 at time _t2 . It should be noted that the FTC increases more slowly 21326 during the second firing compared to the first firing because the control circuit 21002 executing the process 21200 selects the type of tissue suitable for being clamped in the second firing first or initial closing speed v _p1 , thereby reducing the amount of force exerted on the tissue compared to unmodified firing of surgical instrument 21000 . At time t ₂ , the control circuit 21002 of the surgical instrument 21000 determines that FTC has reached or exceeded the FTC threshold FTC _p (this threshold has been set by the control circuit 21002 at or after t ₀ when the control circuit 21002 determines that parenchymal 21030 tissue is clamped. Certainly). The parenchymal FTC threshold FTC _p may represent, for example, the maximum force that can be safely or advantageously exerted on parenchymal 21030 tissue. Therefore, the control circuit 21002 controls the motor 21006 to stop the movement of the anvil 21012, causing the closing speed to decrease 21338 to zero. Movement of the anvil 21012 may be paused for a duration p ₂ during which the closing speed remains 21340 zero. During the pause, the FTC gradually decreases as the clamped tissue relaxes21330. Pause duration p ₂ may be equal to a default pause duration (eg, p ₁ ) or a closure parameter selected by control circuit 21002 for substantial 21030 tissue.

After pause duration p ₂ has elapsed at time t ₃ , control circuit 21002 reengages motor 21006 and resumes closing anvil 21012 . Therefore, the closing speed increases by 21342 to the second closing speed v _p2 . In some aspects, after first exceeding parenchymal FTC threshold FTC _p , control circuit 21002 reduces the closing speed of anvil 21012 closure to a second closing speed v _p2 specific to parenchymal 21030 tissue, where v _p2 < v _p1 . The control circuit 21002 may be configured to close the anvil 21012 at a lower speed after exceeding the substantial FTC threshold FTC _p as this may indicate that the tissue is thicker, more rigid, or otherwise thicker than expected for the detected tissue type. Resistant to closing force from anvil 21012. Therefore, it may be desirable to reduce the closing speed in an attempt to reduce the amount of closing force subsequently exerted on the clamped tissue.

When the anvil 21012 returns to closure at time _t3 , FTC again begins to increase until it reaches a peak value 21332 at time _t4 , and the substantial force threshold _FTCp is again reached or exceeded. At time _t 4 , control circuitry 21002 of surgical instrument 21000 determines that FTC has reached or exceeded FTC threshold FTC _p . Therefore, the control circuit 21002 controls the motor 21006 to stop the movement of the anvil 21012, causing the closing speed to decrease 21346 to zero. Movement of the anvil 21012 may be paused for a duration p ₃ during which the closing speed remains 21348 zero. During the pause, FTC gradually decreases as the clamped tissue relaxes21334.

103 illustrates a third graph 21350 and a fourth graph 21352 depicting exemplary firing, end effector FTC 21354 and closure, respectively, of a surgical instrument 21000 grasping a blood vessel 21032 in accordance with at least one aspect of the present disclosure. Speed 21356 changes with time 21358. In the following description of the third graph 21350 and the second graph 21352, reference should also be made to FIGS. 95, 99, and 101A to 101B. The exemplary firings described herein are for the purpose of demonstrating the concepts discussed above with reference to Figures 95, 99, 101A-101B and should not be construed as limiting in any way.

The third firing of the surgical instrument 21000 may be represented by a third FTC curve 21360 and a corresponding first velocity curve 21360', which respectively illustrate changes in FTC and closure speed over time during the course of the third firing. The third firing may represent, for example, a default firing of the surgical instrument 21000 or a firing of the surgical instrument 21000 that does not include control circuitry 21002 performing the process shown in FIG. 99 . When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, causing the closing speed of the anvil 21012 to sharply increase 21370 to the initial or default closing speed v _d2 . The initial closing speed v _d2 may or may not be equal to the initial closing speed v _d1 in Figure 102 . When the anvil 21012 is driven from the open position, it travels for a period of time before coming into contact with the clamped tissue, which for this particular firing is the blood vessel 21032. It should be noted that this is in contrast to firing of the surgical instrument 21000 clamping substance 21030, as shown in Figure 102. When the blood vessel 21032 is relatively thin, the anvil 21012 typically must travel a certain distance before initial contact with the blood vessel 21032, whereas the parenchyma 21032 is typically thicker than the blood vessel 21032, so the anvil 21012 typically makes initial contact with the blood vessel 21032 almost immediately. Therefore, the FTC is initially flat 21362 as the anvil 21012 travels for a period of time without contacting tissue. Once the anvil 21012 contacts the tissue at time _t0 , the FTC increases 21364 from an initial or flat 21376 FTC (eg, zero) to a peak value of 21366 at time _t2 . At time t ₂ , the control circuitry 21002 of the surgical instrument 21000 determines that the FTC has reached or exceeded the FTC threshold (which may be, for example, a default threshold independent of tissue type), and controls the motor 21006 to stop movement of the anvil 21012 , causing the closing speed to decrease. 21372 to zero. Movement of the anvil 21012 may be paused for a duration p ₄ during which the closing speed remains 21374 zero. During the pause, FTC gradually decreases as the clamped tissue relaxes21368.

The fourth firing of the surgical instrument 21000 may be represented by a second FTC curve 21375 and a corresponding first velocity curve 21375', which respectively illustrate changes in FTC and closure speed over time during the course of the second firing. Compared to the first firing, a fourth firing may represent, for example, firing of surgical instrument 21000, including control circuit 21002 executing process 21200 shown in Figure 99. When firing of surgical instrument 21000 begins, control circuit 21002 controls motor 21006 to begin driving anvil 21014 from its open position, causing the closing speed of anvil 21014 to increase sharply 21386. Due to the relative thinness and/or geometry of blood vessel 21032 (compared to, for example, parenchyma 21030), the initial point of contact between tissue (i.e., blood vessel 21032) and jaw 21013 is not until some time after anvil 21012 has been driven by motor 21006 occurs; therefore, the control circuit 21002 executing the process 21200 shown in Figure 99 is unable to determine that the blood vessel 21032 is being clamped and accordingly set the time to close the jaws, one or more closure thresholds, and other appropriate closure parameters, until the closing process has been performed for some time. Because the anvil 21012 does not contact the thin tissue of the blood vessel 21032 for a period of time, the control circuit 21002 is accordingly unable to detect the type of tissue being clamped, so the control circuit 21002 controls the motor 21006 to cause the anvil 21014 to close rapidly. Add 21386 to default speed v _d .

When the anvil 21012 is driven from the open position, the FTC is initially flat 21376 as the anvil 21012 travels for a period of time without contacting tissue. Once anvil 21012 contacts tissue at time _t0 , the FTC increases by 21378 from the initial FTC (eg, zero). After contacting the blood vessel 21032, the control circuit 21002 executing the process 21200 shown in Figure 99 can determine that the blood vessel 21032 is being clamped and accordingly set the time to close the jaws, one or more closure thresholds, and the timing of the closure at that point in the closure process. Other closure parameters. At time t ₁ , control circuit 21002 determines that ΔFTC has reached or exceeded ΔFTC threshold ΔFTC _v (this threshold had been set by control circuit 21002 at or after t ₀ when control circuit 21002 determined that blood vessel 21032 was clamped). The blood vessel ΔFTC threshold ΔFTC _v may represent, for example, the maximum rate of change in force that can be safely or advantageously exerted on the blood vessel 21032 tissue. Therefore, the control circuit 21002 controls the motor 21006 to decrease 21388 the closure speed to a vessel closure speed v _v1 specific to the vessel 2032 tissue, where v _v1 < v _d .

When the anvil 21012 is advanced at a lower vessel closure velocity v _v1 , the FTC increases 21380 more slowly than before until it reaches a peak value 21382 at time t ₃ . At time t ₃ , control circuit 21002 determines that FTC has reached or exceeded FTC threshold FTC _v (this threshold had been set by control circuit 21002 at or after t ₀ when control circuit 21002 determined that blood vessel 21032 was clamped). The vessel FTC threshold FTC _v may represent, for example, the maximum force that can be safely or advantageously exerted on vessel 21032 tissue. Therefore, the control circuit 21002 controls the motor 21006 to stop the movement of the anvil 21012, causing the closing speed to decrease 21932 to zero. The movement of the anvil 21012 may be paused for a duration p ₅ during which the closing speed remains 21394 zero. During the pause, FTC gradually decreases as the clamped tissue relaxes21384. Pause duration p ₅ may be equal to the default pause duration (eg, _pi ) or the closure parameter selected by control circuit 21002 for vessel 21032 tissue.

In summary, Figures 102-103 highlight the different ways in which surgical instrument 21000 functions with and without control circuitry 21002 performing process 21200 shown in Figure 99.

Figure 104 shows a fifth graph 21400 depicting end effector FTC 21402 and closure speed 21404 over time 21406 for an exemplary firing of a surgical instrument in accordance with at least one aspect of the present disclosure. In the following description of the fifth graph 21400, reference should also be made to FIG. 95 and FIGS. 99 to 101B. The exemplary firings described herein are for the purpose of demonstrating the concepts discussed above with reference to Figure 95 and Figures 99-101B and should not be construed as limiting in any way.

The fifth firing of the surgical instrument 21000 may be represented by a fifth FTC curve 21408 and a corresponding fifth velocity curve 21408&apos;, which respectively illustrate changes in FTC and closure speed over time during the course of the fifth firing. The fifth firing may represent, for example, the firing of surgical instrument 21000, including control circuit 21002 executing the process shown in Figure 99. When firing of the surgical instrument 21000 begins, the control circuit 21002 controls the motor 21006 to begin driving the anvil 21014 from its open position, causing the closing speed of the anvil 21014 to sharply increase 21416 until it stabilizes at 21418 the specified closing speed. As the anvil 21012 closes, the FTC increases by 21410 until it peaks at 21412 at a specific time. The FTC decreases 21414 from the peak value 21412 until the tissue is completely clamped, at which time the control circuit 21002 controls the motor 21006 to stop the closing of the anvil 21012, and the closing speed decreases 21420 to zero.

Thus, the fifth firing represents a firing of surgical instrument 21000 in which the FTC threshold, ΔFTC threshold, or any other closing threshold is not reached or exceeded during closure of jaw 21013 . In other words, the fifth firing remains within all control parameters during the jaw 21013 closing process. Therefore, the control circuit 21002 does not pause the anvil 21012, adjust the closing speed of the anvil 21012, or take any other corrective action during the closing process of the jaws 21013.

Figure 105 shows a sixth graph 21422 depicting end effector FTC 21402 and closure speed 21404 over time 21406 for an exemplary firing of a surgical instrument in accordance with at least one aspect of the present disclosure. In the following description of the sixth graph 21422, reference should also be made to FIG. 95 and FIGS. 99 to 101B. The exemplary firing described herein is for the purpose of demonstrating the concepts discussed above with reference to Figure 95 and Figures 99-101B and should not be construed as limiting in any way.

The sixth firing of the surgical instrument 21000 may be represented by a sixth FTC curve 21424 and a corresponding sixth velocity curve 21424&apos;, which respectively illustrate changes in FTC and closure speed over time during the course of the sixth firing. The sixth firing may represent, for example, the firing of surgical instrument 21000, including control circuit 21002 executing process 21200 shown in Figure 99. When firing of surgical instrument 21000 begins, control circuit 21002 controls motor 21006 to begin driving anvil 21014 from its open position, causing the closing speed of anvil 21014 to increase sharply 21432 until it reaches a specified closing speed. As the anvil 21012 closes, the FTC increases by 21426 until it peaks at 21428 at a specific time. In this particular example, the operator of surgical instrument 21000 elects to open jaws 21013 of surgical instrument 21000 in order to readjust the tissue therein. Therefore, the closing speed decreases 21434 until it reaches a negative closing speed, which indicates that the jaw 21013 is being opened to, for example, easily allow tissue to be readjusted within the jaw 21013. The closing speed then returns 21436 to zero and the jaws 21013 stop. Accordingly, the FTC decreases 21430 to zero as the jaws 21013 are released from the tissue.

Figure 106 shows a seventh graph 21438 depicting end effector FTC 21402 and closure velocity 21404 over time 21406 for an exemplary firing of a surgical instrument in accordance with at least one aspect of the present disclosure. In the following description of the seventh graph 21438, reference should also be made to FIG. 95 and FIGS. 99 to 101B. The exemplary firing described herein is for the purpose of demonstrating the concepts discussed above with reference to Figure 95 and Figures 99-101B and should not be construed as limiting in any way.

The seventh firing of the surgical instrument 21000 may be represented by a seventh FTC curve 21440 and a corresponding seventh speed curve 21440', which respectively illustrate changes in FTC and closure speed over time during the course of the seventh firing. The seventh firing may represent, for example, the firing of surgical instrument 21000, including control circuit 21002 executing process 21200 shown in Figure 99. When firing of surgical instrument 21000 begins, control circuit 21002 controls motor 21006 to begin driving anvil 21014 from its open position, causing the closing speed of anvil 21014 to increase sharply 21450 to a first closing speed v ₁ . As anvil 21012 closes, FTC increases by 21442 until time t ₁ . At time t ₁ , control circuit 21002 determines that ΔFTC has reached or exceeded ΔFTC threshold ΔFTC _T , which may be the default ΔFTC threshold or the ΔFTC threshold for a specific physiological tissue type detected by control circuit 21002 in accordance with process 21200 illustrated in FIG. 99 . As another example, ΔFTC _T may be set by another process performed by the control circuit 21002 of the surgical instrument 2100 and/or another control circuit in response to other sensed parameters or according to another algorithm. For example, if jaw closure proceeds within the operating parameters of process 21200 shown in Figure 99, but another sensor of surgical instrument 21000 and/or the process determines that the clamped tissue still deviates in some way from the expected parameters (e.g., the tissue thicker or thinner than expected for a given tissue type), the time to close jaw 21013, one or more closing thresholds, and other control parameters are set accordingly. In one example, the second sensor detects that the tissue is thinner than expected at time _t1 . Therefore, control circuit 21002 sets a new ΔFTC _T (which, in this example, is lower than the previous ΔFTC _T ), and control circuit 21002 then determines that the new value is reached or exceeded at time t ₁ .

Therefore, the control circuit 21002 controls the motor 21006 to decrease 21452 the closing speed of the anvil 21012 to a second closing speed v ₂ , where v ₁ >v ₂ . Starting from t ₁ , the decrease in closing speed causes FTC to increase at a slower rate 21444. FTC increases by 21444 until it peaks at 21446 below the FTC threshold FTC _T and then decreases. Since the seventh firing remains within all closing parameters after t ₁ , the closing speed remains 21454 at the second closing speed v ₂ until the tissue is fully clamped, at which time the control circuit 21002 controls the motor 21006 to stop the closing of the anvil 21012 , and the closing speed drops by 21456 to zero.

Figure 107 shows a graph 21500 depicting impedance 21502 over time 21504 to determine when the jaws of a surgical instrument contact tissue and/or staples in accordance with at least one aspect of the present disclosure. In the following description of seventh graph 21438, reference should also be made to FIG. 95. As discussed above, one or more sensors 21004 configured to detect a degree of compression of tissue clamped by end effector 21008 and/or configured to detect initial contact with the tissue may include, for example, impedance sensors. The impedance of the tissue and/or the rate of impedance change as detected by one or more impedance sensors may be used to determine the state of the clamped tissue. For example, if the detected impedance has stabilized at 21506 an impedance _ZOC indicating an open circuit state, control circuitry 21002 coupled to the impedance sensor may determine that the jaws are open and/or not in contact with tissue. As another example, when the detected impedance initially decreases 21508 from the open circuit impedance _ZOC , then the control circuit 21002 coupled to the impedance sensor may determine that initial contact with the tissue has been made. As another example, when the detected impedance decreases 21510 from the open circuit impedance _ZOC , the control circuit 21002 coupled to the impedance sensor may utilize the shape of the impedance curve over time and/or the detected rate of impedance change to determine the tissue compression rate and/or or the degree to which the tissue is compressed. As another example, if the detected impedance drops 21512 to zero, the control circuit 21002 coupled to the impedance sensor may determine that the jaws of the end effector 21008 have contacted the staple, which shorts the impedance detection system.

Example

Various aspects of the subject matter described herein under the heading "Controlling a Surgical Instrument Based on Sensed Closure Parameters" are illustrated in the following examples:

Embodiment 1 - A surgical instrument including an end effector including a jaw convertible between an open configuration and a closed configuration. The surgical instrument also includes a motor operatively coupled to the jaws. The motor is configured to convert the jaws between an open configuration and a closed configuration. The surgical instrument also includes a sensor configured to transmit at least one signal indicative of a tissue compression parameter associated with tissue between the jaws. The surgical instrument also includes control circuitry coupled to the sensors and motors. The control circuit is configured to receive the at least one signal and determine a value of a tissue compression parameter based on the at least one signal when the jaw transitions from an open configuration to a closed configuration, causing the motor to determine whether the value of the tissue compression parameter is higher than A first threshold is used to increase the time for the jaws to transition to a closed configuration, and feedback is provided based on whether the value of the tissue compression parameter is below a second threshold.

Embodiment 2 - The surgical instrument of Embodiment 1, wherein the tissue compression parameter includes a force exerted by a motor to transition the jaws to a closed configuration.

Embodiment 3 - The surgical instrument of Embodiment 1, wherein the tissue compression parameter includes a time rate of change in force exerted by the motor to transition the jaws to the closed configuration.

Embodiment 4 - The surgical instrument of embodiment 1, 2 or 3, wherein the feedback includes recommendations for appendage reinforcement.

Embodiment 5 - The surgical instrument of Embodiment 1, 2, 3, or 4, wherein the control circuit is configured to increase the rate at which the jaws transition to the closed configuration by reducing the rate at which the motor transitions the jaws to the closed configuration. type of time.

Embodiment 6 - The surgical instrument of Embodiment 1, 2, 3, or 4, wherein the control circuit is configured to increase the amount of time the jaws are transitioned by increasing the length of time the motor is paused while transitioning the jaws to the closed configuration. Time to closed configuration.

Embodiment 7 - The surgical instrument of Embodiment 1, 2, 3 or 4, wherein the control circuit is configured to increase the stability of the jaws by lowering the stability threshold to stop the motor when transitioning the jaws to the closed configuration. Time to transition to closed configuration.

Embodiment 8 - A surgical instrument including an end effector. The end effector includes jaws convertible between an open configuration and a closed configuration, and one or more sensors disposed along a tissue contacting surface of each of the jaws. The one or more sensors are configured to detect contact with tissue. The surgical instrument also includes a motor operatively coupled to the jaws. The motor is configured to convert the jaws between an open configuration and a closed configuration. The surgical instrument also includes control circuitry coupled to the one or more sensors and motor. The control circuit is configured to determine an initial point of tissue contact with the tissue contact surface of the jaws, determine the spacing between the jaws at the initial contact point, determine the degree of contact between the tissue contact surface and the tissue, and cause the motor to The jaws are transitioned to the closed configuration at a rate corresponding to the spacing between the jaws at the initial point of contact and the degree of contact between the tissue contact surface and the tissue, and the motor is caused to transition the jaws to the closed configuration in response to the force exerted by the motor. Whether the force of the jaw exceeds a threshold regulates the rate at which the jaw transitions to the closed configuration. The threshold corresponds to the spacing between the jaws at the initial point of contact and the degree of contact between the tissue contact surface and the tissue.

Embodiment 9 - The surgical instrument of Embodiment 8, wherein the one or more sensors comprise a pressure sensor.

Embodiment 10 - The surgical instrument of Embodiment 8, wherein the one or more sensors comprise an impedance sensor.

Embodiment 11 - The surgical instrument of embodiment 8, 9 or 10, wherein the spacing between the jaws includes an angle between the jaws.

Embodiment 12 - The surgical instrument of embodiment 8, 9 or 10, wherein the spacing between the jaws includes a gap between the jaws.

Embodiment 13 - A surgical instrument including an end effector. The end effector includes a jaw configured to transition between an open configuration and a closed configuration to grasp tissue, and a contact sensor assembly configured to sense contact against the Organization of sensor components. The surgical instrument also includes a position sensor configured to sense the configuration of the jaws and a motor coupled to the jaws. The motor is configured to convert the jaws between an open configuration and a closed configuration. The surgical instrument also includes control circuitry coupled to the contact sensor assembly, the position sensor, and the motor. The control circuit is configured to determine an initial contact point of tissue contacting the jaws, determine a configuration of the jaws at the initial contact point via a position sensor, and determine tissue between the tissue and the jaws at the initial contact point via the contact sensor assembly. The amount of contact, based on the configuration of the jaws and the amount of tissue contact at the initial contact point, sets the closing rate at which the motor transitions the jaws to the closed configuration, based on the configuration of the jaws and the amount of tissue contact at the initial contact point. A closing threshold is set, and the motor is controlled based on the force exerted by the motor to transition the jaws to a closed configuration relative to the threshold.

Embodiment 14 - The surgical instrument of Embodiment 13, wherein the sensor assembly includes a pressure sensor.

Embodiment 15 - The surgical instrument of Embodiment 13, wherein the sensor assembly includes an impedance sensor.

Embodiment 16 - The surgical instrument of embodiment 13, 14 or 15, wherein the configuration of the jaws corresponds to the angle between the jaws.

Embodiment 17 - The surgical instrument of embodiment 13, 14 or 15, wherein the jaws are configured to correspond to a gap between the jaws.

System for adjusting end effector parameters based on preoperative information

Aspects of the present disclosure are presented for adjusting the closure threshold and closure rate achieved by a closure control program executed by a control circuit of a surgical instrument, where the adjustment is based on preoperative information. Adjusting the closure threshold may be performed by a computer-implemented interactive surgical system (including one or more surgical systems 102 and a cloud-based analytical medical system such as the cloud 104 , 204 , which is referred to as the cloud 104 for clarity). An example. For example, the closure threshold may be adjusted to a patient-specific closure threshold based on perioperative information received from the cloud 104 or determined by the surgical hub or surgical instrument. As used herein, perioperative information includes preoperative information, intraoperative information, and postoperative information.

Preoperative information refers to information received before performing a surgical procedure using surgical instruments, while intraoperative information refers to information received during the surgical procedure (eg, while performing steps of the surgical procedure). Specifically, the computer-implemented interactive surgical system may determine or infer end effector closure parameters for a particular handheld smart surgical instrument, such as appropriate end effector closure thresholds and closure rate algorithms. This inference may be based on contextual information related to the surgical procedure to be performed and to the corresponding patient. Contextual information may include or be determined based on perioperative information. The surgical instrument may be any suitable surgical instrument described in this disclosure, such as surgical instrument 112, 600, 700, 750, 790, 150010. For clarity, reference is made to surgical instrument 112 .

Perioperative information, such as perioperatively diagnosed diseases and treatments, may affect the properties or characteristics of the tissue being treated by surgical instrument 112 . For example, a patient may have been previously diagnosed with cancer and received radiation therapy to treat the cancer. Therefore, this preoperative information would indicate that the patient's tissue may have increased stiffness properties. However, currently applied closure control procedures may not be able to account for this increased stiffness. Therefore, using a closure control program to perform surgical procedures based on a general closure rate algorithm can result in unnecessary trauma or damage to the tissue due to excessive compression of the patient's tissue. Additionally, during a surgical procedure, intraoperative information may be analyzed, such as by identifying which tissue type of multiple potential types of tissue is being processed. Different types of tissue can also have different tissue properties, such as tissue stiffness. Therefore, changes in intraoperative information can be used to perform intraoperative adjustments as an alternative to or in addition to perioperative adjustments. In summary, the closure control program may not consider that different closure rate thresholds should be applied based on perioperative information such as tissue type, surgical procedure being performed, and surgical steps that have been performed.

When performing a surgical procedure with surgical instrument 112, it may be desirable for the surgical instrument to take into account different tissue types and the various characteristics of these different tissue types. In particular, the surgical instrument 112 may be desired to effectively determine the tissue type and characteristics of the tissue type before and during the performance of a surgical procedure by a clinician with the surgical instrument.

Accordingly, in some aspects, a cloud-based analytical medical system (eg, computer-implemented interactive surgical system 100) is provided in which perioperative information can be considered to determine the type of tissue to be treated and characteristics of the tissue being treated prior to treatment. For example, the surgical procedure to be performed and other patient information may be instances of preoperative information retrieved prior to performing the surgical procedure. Previously performed surgical procedures, history of other surgeries, and changes in tissue type are examples of intraoperative information that may be considered. Generally, this perioperative information may be used in conjunction with sensor signals indicative of closure parameters to determine, infer, or adjust parameters of the end effector of surgical instrument 112 (eg, closure change rate and closure threshold). The end effector may be any end effector described in this disclosure, such as end effector 702, 151600, 150300, 151340, 152000, 152100, 152150, 152200, 152300, 152350, 152400, 153460, 153470, 153502. For clarity, reference is made to end effector 702 .

Analyzing perioperative information to obtain closure rate-related situational awareness can be accomplished in a variety of ways. Based on the perioperative information, the surgical instrument's control circuitry, such as control circuitry 500, 710, 760, 150700 (discussed above with reference to Figures 12, 15, 17, and Figures 29A-29B) can adjust the temperature at the selected Closure rate of change and closure threshold inputs used in the closure control program. For clarity, reference is made to control circuit 500. The control circuit 500 may also select different control procedures based on perioperative information. Additionally or alternatively, a surgical hub such as surgical hub 106, 206 (referred to as surgical hub 106 for clarity) may receive perioperative information from cloud 104 or surgical instrument 112. For example, the surgical hub 106 may receive the patient's electronic medical record (EMR) or initial tissue thickness measurements determined based on tissue contact or pressure sensors of the surgical instrument 112 (eg, as shown in FIG. 24 ) from the cloud 104 .

The surgical hub 106 may then analyze the received perioperative information. Based on this analysis, the surgical hub 106 may then transmit a signal to the surgical instrument 112 to adjust the closure change rate and closure threshold input for use in the selected closure control procedure. The surgical hub 106 may also instruct the surgical instrument 112 to select a different closure control program, such as through a control circuit. Selection of different control programs may be based on signals received from hub 106 or by surgical instrument 112 receiving updated control programs from hub 106 . Cloud 104 may also perform analysis for adjusting the closing rate and the maximum threshold used. Specifically, the processor of cloud 104 may analyze perioperative information to determine tissue types and characteristics, for example, for changing inputs to a closure control procedure or selecting a different appropriate closure control procedure to be performed by a surgical instrument.

In this manner, cloud 104 may instruct surgical instrument 112 (eg, via hub 106) to apply the appropriate closure rate algorithm and closure maximum threshold. Tissue type and characteristics may also be determined based on sensor signals indicative of closure parameters. The sensor may be a tissue contact or pressure sensor, force sensor, motor current sensor, position sensor, load sensor, or other suitable sensor, such as the sensors 472, 474, 476, 630, 734, 736, 738, 744a-744e, 784, described above. 788, 152408, 153102, 153112, 153118, 153126, 153200, 153438, 153448, 153450a, 153450b, 153474. For clarity, reference is made to sensor 474. Sensor 474 is configured to transmit sensor signals indicative of parameters of surgical instrument 112 . Some types of perioperative information may be stored in the cloud 104 prior to determining tissue type and characteristics. For example, the patient EMR may be stored in cloud 104 storage (eg, a cloud database). Generally speaking, surgical instrument 112, hub 106, or cloud 104 may analyze perioperative information to determine tissue types and characteristics for situational awareness.

Therefore, tissue type and properties determined based on perioperative information can be used to actively adjust the rate of closure and the maximum threshold used. That is, perioperative information may be used to predict more effective closure parameters (eg, end effector 702 parameters) such that the closure control procedure applied by the surgical instrument 112 uses one that takes into account the patient's specific tissue characteristics and the type of tissue being treated. Closing rate and threshold. Accordingly, using closure rate and threshold situational awareness as described herein may advantageously enable the surgical instrument 112 to apply adjusted closure rates and thresholds without over-compressing the tissue to be treated. Over-compression may be based on the first and second jaw members of end effector 702 . The first and second jaw members may be, for example, first jaw members 152002, 152152, 152154 and second jaw members 152204, 152254, 152304 respectively. The first and second jaw members may also be referred to as anvils 716, 766 and staple cartridges 718, 768. For clarity, the first jaw member is referred to as 152002 and the second jaw member is referred to as 152204. The first jaw member 152002 and the second jaw member 152004 may define a bore of the end effector 702 that is defined as the distance between the first jaw member 152002 and the second jaw member 152004 .

For example, when the bore of end effector 702 is unnecessarily small, unnecessary tissue damage or trauma may occur due to excessive compression. Reducing or preventing this over-compression may be accomplished by making adjustments using perioperative information and/or sensor signals from sensor 474 . Additionally, the compression applied during initial closure parameter measurements may be minimized, such as based on load sensor 474 (which measures closure force) and positioning sensor 474 (which measures the position of first jaw member 152002 and second jaw member 152004 ). Generally speaking, sensor 474 may be configured to measure the closing force exerted by end effector 702 of surgical instrument 112 . In addition to actively inferring tissue properties and types based on perioperative information, one or more of the surgical instrument 112, hub 106, and cloud 104 may use sensory measurements from sensors 474 (shown in Figure 12) to verify Or further adjust the applied closing force, closing rate and closing threshold if necessary. In particular, contact sensors may be used to determine undeformed tissue thickness. Additionally, the load sensor 474 in combination with the position sensor 474 may be used to determine tissue thickness based on the closing force applied relative to the position of the first jaw member 152002 and the second jaw member 152004 respectively. These verifications or further adjustments can be performed preoperatively or intraoperatively.

Closed parameter situational awareness can be performed continuously. Accordingly, the clinician or surgeon may continue to use perioperative information to adjust the closure parameters of the end effector 702 (eg, the closure parameters of the closure control procedure) as appropriate (eg, when performing steps of a surgical procedure). For example, perioperative information may be used to adjust closure parameters of the end effector 702 when it is determined based on clinical history (eg, the surgeon's routine) that the next step in the surgical procedure being performed involves vascular tissue. In this case, the situationally aware surgical instrument 112 may apply a closing force at a constant rate of change of closure. Such perioperative information may be used in conjunction with sensor signals indicative of closure parameters of the surgical instrument 112 to adjust closure parameters of the end effector 702 (eg, closure change rate and closure threshold of the control program). Perioperative information, such as intraoperative information, may indicate that the patient has been previously treated with radiation therapy.

Based on this information, the control circuit 500 can infer increased tissue stiffness, which is a tissue property that can be considered throughout the steps of the surgical procedure. In one example, this increased tissue stiffness may be perioperative information used to supplement sensor signals indicative of tissue thickness such that adjustment of more appropriate end effector 702 closure parameter values may be achieved. The perioperative information may also indicate that the surgical procedure applied was a lobectomy, which may be determined from data stored in cloud 104 . Based on an understanding of lobectomy, it can be determined that possible tissue types to be treated (eg, sutured) include blood vessels, bronchial tissue, and parenchymal tissue.

Therefore, based on the perioperative information, the specific tissue type and characteristics of the tissue currently being treated by surgical instrument 112 may be predicted or inferred before initiating therapeutic treatment of the tissue. For example, considering the initial tissue thickness (measured when the tissue currently being treated first contacts the end effector 702) in conjunction with treatment, diagnostic, and patient information may enable inference that previously irradiated parenchymal tissue is being treated. Because the type and characteristics of the tissue being treated may be contextually determined prior to commencing the surgical procedure, the closure control routine implemented by the control circuitry 500 of the surgical instrument 112 may be advantageously adjusted (e.g., by The inferred tissue type or properties change the input parameters) or change (e.g., by selecting a different control procedure). Specifically, the maximum tissue closure threshold may be reduced to account for the stiffness and fragility of the irradiated parenchyma being treated. The maximum threshold may refer to the maximum closing force that can be applied or the maximum rate of change of closure. Additionally, the closure algorithm of the closure control program can be adjusted to apply a slower, more conservative closure rate based on identification of the substance being illuminated.

Additionally, it may be determined whether the surgical instrument 112 is an appropriate suturing surgical instrument 112 for use with, for example, the irradiated substance. If the perioperative information indicates that the selected surgical instrument 112 is not suitable for its intended use, a warning may be generated. For example, if it can be inferred based on perioperative information that the tissue currently being treated is bronchial tissue and an inappropriate vascular anastomosis surgical instrument 112 is selected, a warning will be generated to the clinician. Generally speaking, the surgical instrument 112 may generate alerts based on determined, predicted, or inferred inconsistencies between the surgical instrument type, perioperative information, and sensor signals. Additionally, as mentioned above, intraoperative information can also be used to make adjustments throughout the surgical protocol. For example, the current step in the overall protocol may be to treat rigid bronchial tissue, which typically results in a slower rate of closure. Further adjustments can also be made after the initial adjustment. In particular, further adjustments may be made during operation, such as when additional intraoperative information (eg, sensed information) is analyzed and it is concluded that the closing force applied in the currently applied closing algorithm should be modified or adjusted, which will be slower The closing rate is adjusted to a faster closing rate. In some cases, this adjustment may also be performed postoperatively.

Thus, the closure rate and threshold may be advantageously adjusted based on the determined tissue type, tissue properties, and perioperative information before or during the initiation of a therapeutic treatment. Accordingly, such adjustment may advantageously avoid or minimize tissue damage caused by excessive strain and facilitate proper shaping of the staples from the suturing surgical instrument 112 .

108 and 109 are graphs 22000, 22100 illustrating various end effector closure threshold functions that may be used based on perioperative information and illustrating adjusted end effector in accordance with various aspects of the present disclosure. Device closure control algorithm. Graph 22100 is an enlarged view of graph 22000. In Figures 108 and 109, the clamping or closing force (FTC), which may be understood as the clamping force applied to the end effector 702, is indicated on the y-axis 22002, 22102 of the graphs 22000, 22100. Time elapsed through or across a surgical cycle is indicated on the x-axis 22004, 22104. For example, x-axis 22004 of graph 108 indicates that the period spans 13 seconds. In comparison, the x-axis 22104 of Figure 109 spans slightly less than 2 seconds. As shown in Figure 108, the default universal tissue closure threshold function (denoted FTC _d 22006) may generally be applied to control end effector 702 closure of surgical instruments 112 used in universal surgical procedures.

Other thresholds that are more conservative than the default FTC _d 22006 are also shown on graphs 22000, 22100. However, less conservative thresholds can also be used. As shown in FTC _L1 22008 and FTC _L2 22010, a more conservative closure threshold can be used to reduce the closure force of surgical instruments relative to the default closure force function. FTC _L1 22008 and FTC _L2 22010 may be thresholds stored in memory of the surgical instrument 112 , hub 106 , or cloud 104 . Additionally or alternatively, FTC _d 22006 may be dynamically adjusted at appropriate points during the surgical cycle. Dynamic adjustments may be performed by the control circuit 500, the corresponding hub 106, or the cloud 104. Additionally, graphs 22000, 22100 indicate the corresponding slopes of different closure threshold functions _FTCd , FTC _L1 and FTC _L2 22006, 22008, 22010. Because the closure threshold may change as a function of time during a corresponding surgical cycle, the slope of the closure threshold may be constant throughout the surgical cycle, or vary as appropriate during the surgical cycle.

In other words, the instantaneous rate of change defined by a specific closure threshold function may differ between different time frames of the surgical cycle. For example, a particular closure threshold function may define a relatively slow rate of increase near the beginning of the surgical cycle and a relatively fast rate of increase near the middle of the surgical cycle. Closed threshold functions ΔFTC _d , ΔFTC _L1 and ΔFTC _L2 22106, 22108, 22110 are enlarged views of the functions FTC _d , FTC _L1 and FTC _L2 22006, 22008, 22010 and the corresponding slopes of the closed threshold functions are shown. In terms of Figure 109, it can be seen that the slope is constant, although the slope can vary depending on the situation. The rate of change of closure can be adjusted based on the selected closure threshold function. One example of an adjustment is shown by the "x" in Figures 108 and 109, and is shown in larger size in the enlarged view of graph 22100. In this example, the closing rates as shown by lines 22012, 22112 are adjusted so that they do not exceed ΔFTC _L2 22110.

In one aspect, a motor of the surgical instrument 112 such as the motors 482, 704a-704e, 754, 150082, 150714 can move the first jaw member 152002 relative to the second jaw member 152004 of the end effector 702. For clarity, reference is made to motor 482. The motor 482 may move or close the end effector 702 based on the rate of change of closure represented by lines 22012, 22112 and the selected closure threshold. To this end, the control circuit 500 may adjust the current drawn by the motor 482 to vary the speed or torque of the motor 482 based on a selected threshold. For example, graphs 22000, 22100 illustrate how the control circuit 500 may adjust the motor 482 at point "x" (as shown on the graph) such that the closure rate parameter of the surgical instrument 112 changes to remain at a selected threshold. Within FTC _L2 22010. FTC _L2 22010, which may be a patient-specific threshold, may be selected and determined based on perioperative information.

The FTC thresholds 22006, 22008, 22010 depicted in the graphs 22000, 22100 may be parameters of different or the same closure control routine executed by the control circuit 500. These closure control programs may be stored locally on the memory of the surgical instrument 112 or remotely on the hub 106 or cloud 104 . In general, the closure threshold function defines how the closure threshold changes as a function of time during the cycle, thereby indicating the instantaneously applicable closure threshold at any point in time during the cycle. For example, the closure threshold may define the maximum closing force that can be applied to close the end effector jaws or the maximum rate of change in the closing force used. Figure 108 illustrates the use of a threshold as the maximum rate of change in closing force used. At selected time points on the graphs 22000, 22100, lines 22012, 22112 plotted against time on the x-axis 22004, 22104 and FTC on the y-axis 22002, 22102 indicate the application to close the jaw at that time point The instantaneous force of 152002 and 152004.

As shown in line 22012, the applied force increases over time from time zero to time t ₁ , after which the rate of increase slows to zero and then to the rate of decrease in force. Shortly before time t ₂ , the rate of decline is much faster. After time _t2 , the force applied to close the jaws begins to transition to zero rate and then decreases again at a non-zero rate. As shown by line 22112 of graph 22100, the closing force applied to close the jaws 152002, 152004 increases between time zero and a time slightly earlier than 0.5 seconds (shown on x-axis 22104). At a time corresponding to "x" on graph 22100, control circuit 500 may adjust motor 482 to adjust the selected closure algorithm such that the rate of increase in closure decreases. In this manner, the motor 482 may be controlled by the control circuit 500 to remain within the selected patient-specific threshold ΔFTC _L2 22110 . Additionally, as shown in graph 22100, the slower rate of increase in applied closing force becomes a constant rate after a time corresponding to "x."

In one aspect, the same total amount of applied FTC can be applied during the surgical cycle. However, the force exerted by the closing end effector may be applied more gradually or immediately, as appropriate. This is shown by the rate of change, represented by the closed rate of change of lines such as lines 22012, 22112. Although FIG. 109 shows each of the three depicted thresholds ΔFTC _d , ΔFTC _L1 , and ΔFTC _L2 22106 , 22108 , 22110 as an enlarged view of FTC _d , FTC _L1 , and FTC _L2 22006 , 22008 , 22010 , in some cases On the other hand, ΔFTC _d , ΔFTC _L1 and ΔFTC _L2 22106, 22108, 22110 represent different closed threshold functions. In other words, the control circuit 500 can adjust from any of the thresholds FTC _d , FTC _L1 , and FTC _L2 22006, 22008, 22010 to the thresholds ΔFTC _d , ΔFTC _L1 , and ΔFTC _L2 22106, 22108, 22110, where these thresholds are case would be a completely different threshold.

As mentioned above, it is possible that the slope of the closure threshold function changes during a surgical cycle. In this case, the dynamic slope can be adjusted consistently or individually throughout the surgical cycle. Generally speaking, the closing threshold parameter adjustment can be achieved by changing the parameters of the current closing control program (for example, directly changing the closing threshold function implemented by the control circuit 500 through the control circuit 500) or completely switching to a new closing control program. Switching or adjustment may be performed by control circuit 500, hub 106, or cloud 104 based on perioperative information. For example, control circuit 500 may switch from the current control program to a second closed control program received from cloud 104 . The second closure control program may also be transmitted from the cloud 104 to the hub 106 .

As described above, one or more of the surgical instrument 112 for treating tissue, the corresponding hub 106, and the cloud 104 may be used to receive, infer, or determine perioperative information in order to determine, infer, or predict the treatment currently being treated. The type and characteristics of the organization. These closure situation awareness inferences and predictions can be used to adjust closure change rate thresholds. Thus, in addition to FTC _d , ΔFTC _d 22006 , 22106 , graphs 22000 , 21000 also illustrate, for example, a second tissue closure change rate threshold function FTC _L1 , ΔFTC _L1 22008 , 22108 , the closure algorithm used by the surgical instrument 112 may Automatically combine this function. That is, the surgical instrument 112 may adjust input to the current closure control program or adjust to a different control program to be executed by the control circuit 500 . For example, the situationally aware surgical hub 106 may determine that the currently applied surgical procedure is a pulmonary surgical procedure based on the target region located in the chest cavity. The chest cavity may then be inferred as a target region based on ventilation output from another device used in the operating room, for example. Therefore, it was determined that the type of tissue processed was lung tissue. Therefore, the surgical instrument 112 may be adjusted from the previously used threshold FTC _d 22006 , 22106 to use the default closed threshold function FTC _L1 22008 , 22108 for lung tissue. Such adjustments may be made during the surgical cycle across the y-axes 22004, 22104.

For example, the situationally aware surgical hub 106 may predict that the patient's lungs will include relatively fragile tissue. Therefore, as shown in Figures 108 and 109, the closure threshold function can be adjusted to a lower FTC threshold function. The closing threshold may be, for example, the maximum allowed FTC value or the maximum allowed FTC rate of change applied by the end effector. The inference of the relatively high stiffness of lung tissue can be confirmed by other perioperative information. For example, a patient's EMR stored in cloud 104 may be analyzed to determine that the patient has been previously diagnosed with cancer and has received radiation therapy. This type of preoperative information can be used to infer the tissue properties of lung tissue, including relatively high stiffness and significant fluid content (e.g., percentage of water in the tissue).

In addition to confirming initial predictions, perioperative information can be used to adjust for inaccurate initial predictions. For example, the surgical instrument 112 may apply a suboptimal closure algorithm based on the erroneous assumption that the tissue has greater flexibility than it actually has. In this case, preoperative information on the patient's history can be used as part of the correction of incorrect assumptions. In general, perioperative information can be used in conjunction with sensor signals indicating closure parameters. Advantageously, perioperative information may confirm the initial closure algorithm determined based on the sensor signals or may be used to adjust the initial closure algorithm to a different, more appropriate closure algorithm. For example, the sensor signal may indicate a relationship between the sensed applied closing force and the end effector 702 aperture position (eg, the position of the first jaw 152002 relative to the second jaw 152004). This signal can be used to determine tissue stiffness and can be used in conjunction with other perioperative information to adjust closure algorithms before or during surgical procedures.

Accordingly, graphs 22000, 22100 of Figures 108 and 109 illustrate that the default lung tissue threshold function FTC _L1 can be further adjusted based on patient-specific tissue characteristics. As shown in Figures 108 and 109, the surgical instrument may be further adjusted from threshold function FTC _L1 22008 to FTC _L2 22010 or FTC _d 22006, for example based on patient-specific perioperative information. Thus, the adjustment may occur before the surgical procedure begins or during the surgical procedure. Furthermore, it is possible to adjust from FTC _d 22006 to FTC _L2 22010, or the threshold function FTC _L2 22010 can simply be implemented directly. It is possible to adjust between any available closure threshold functions based on perioperative information.

Although Figures 108 and 109 illustrate adjustments to lower thresholds, adjustments to higher thresholds are also possible. The threshold functions shown in Figures 108 and 109 may correspond to specific control processes that can be implemented by specific closing control procedures. Alternatively, the control procedures may correspond to different closing control procedures. For example, the control circuit 500 may directly modify the selected closure control algorithm itself, or switch to a different closure control algorithm. That is, a particular closure control algorithm, such as represented by lines 22012, 22112, or a particular closure threshold function of the applied closure change rate may be modified. Based on perioperative information, closure threshold function modification can be performed during the surgical procedure. Additionally, the threshold function may also be a function of some other parameter besides time, such as the nail size used.

Additionally or alternatively, closing adjustment may include adjusting the input only to a closing threshold function. For example, if a tissue property such as tissue thickness is an input to a closure threshold function, perioperative information can be used to predictively or inferentially modify the input to modify the output closure threshold based on the predicted or inferred tissue thickness input. Therefore, the closure threshold function applied can be modified based on perioperative information. As mentioned above, the closure threshold function applied is defined by the closure control algorithm applied. Additionally, the applied FTC or closing force lines 22012, 22112 may be adjusted based on perioperative information.

In one aspect, the FTC or closing force lines 22012, 22112 represent the closing change rate parameters of the corresponding closing control program executed by the control circuit 500. The FTC lines 22012, 22112 are also defined by the closure control algorithm applied. In one aspect, as shown by "x" in Figures 108 and 109, the closing force applied can be dynamically adjusted during the cycle of the surgical procedure being performed. This dynamic adjustment can also be an application of situational awareness. In other words, perioperative information can be combined to infer or predict adjustments to a threshold or threshold function during a surgical procedure. Thus, as shown in Figures 108 and 109, at one or more times corresponding to "x" represented in Figures 108 and 109, the applied FTC is adjusted or modified to remain within the corresponding instantaneous closure threshold. In summary, the closure control algorithm applied can include a closure threshold function and a closure change rate, both of which can be adjusted based on perioperative information.

Generally speaking, adjustments to different closure thresholds or different closure threshold functions may be performed based on determined, inferred, or predicted properties or types of tissue being treated. As discussed above, tissue properties or types may be determined, inferred, or predicted based on perioperative information. Adjustment of the other closure threshold may be understood as adjusting the maximum threshold with reference to the maximum torque generated by the motor 482 of the surgical instrument 112 or the rate of change of the motor speed. Various instances of perioperative information can be used to determine, infer, or predict tissue type or tissue properties. For example, the amount of water, muscle properties, and vasculature of the tissue can affect the closure rate algorithm (including closure threshold) that will be applied. In one aspect, these properties, along with other tissue type and tissue property properties, are used to determine the default closure threshold FTC _D 22006 or any other initial closure control program parameters.

Therefore, high vasculature may be a tissue property used to infer a default closure threshold function with a relatively low slope. In addition to determining initial control procedure parameters, if preoperative information such as the surgical protocol applied and the surgical history (e.g., the clinician's typical routine of performing the protocol with reference to the surgical steps of the protocol) can be used to infer that vascular tissue with high hemoglobin content is normal being targeted, the rate of change in closure applied by the surgical instrument can be adjusted to be slower. Therefore, these properties can be used to determine control procedure parameters preoperatively and intraoperatively. Additionally, perioperative information can be used to confirm that appropriate vascular staplers are used during vascular tissue procedures.

Figure 110 is a flow diagram 22200 of aspects of a computer-implemented interactive surgical system 100 adjusting closure rate algorithm in accordance with one aspect of the present disclosure. At step 22202, the current closing algorithm is determined. This may refer to determining the closure control procedure currently being executed by the control circuit 500 of the surgical instrument 112 . As described above in connection with Figures 108 and 109, the current closure algorithm or control program may include a closure threshold function (eg, a closure threshold parameter) and a force applied closure (FTC) function (eg, a closure rate of change parameter). Flowchart 22200 next proceeds to step 22204, where preoperative information is received and analyzed. As discussed above, preoperative information may include initial tissue thickness based on tissue contact sensor 474, patient history including previous diagnoses and treatments (e.g., listed on patient information EMR records stored in the hub or cloud), clinical history such as The surgeon's typical surgical routine, surgical instruments and related materials identified, and current surgical protocols identified. At step 22206, this preoperative information can be used to determine, infer, or predict tissue type or tissue properties.

For example, the undeformed initial tissue thickness as measured by tissue contact sensor 474 may be used to determine the initial closure algorithm. Preoperative information such as the patient's lung history may be used to determine that the surgical procedure currently being performed is a thoracic procedure and the tissue type is lung tissue. This preoperative information can also be used to determine adjustments to the initial closure algorithm. Additionally or alternatively, by comparing non-therapeutic (or quasi-non-therapeutic) initial tissue compression measurements with closure member position measurements (e.g., the positions of the first and second jaws of the end effector) The measured initial tissue stiffness can also be used in conjunction with preoperative information. Ventilation preoperative information received from the ventilation device in the surgical operating room can also be used to infer that the current protocol is thoracic surgery. Additional preoperative information may also be used to further predict the specific thoracic protocol performed. For example, based on the patient EMR record in the cloud indicating that the patient has cancer, it may be inferred at step 22206 that the chest procedure was a lobectomy to remove cancerous tissue in a lobe of the lung.

Additionally, patient EMR records may indicate that the patient's medical history indicates that the patient has previously received radiation therapy for the cancer. In this case, for example, it may be inferred or predicted that the irradiated lung tissue will be rigid, but also susceptible to the application of monopolar RF energy by the surgical instrument 112 . This would be an example of inferred organizational properties. Additionally, inferences from performing a lobectomy may also be used to determine possible tissues for suturing by surgical instrument 112 including blood vessels (PA/PV), bronchi, and parenchyma. At step 22208, an adjustment to the current closure algorithm is determined based on the preoperative information and applied. As mentioned above, the closure threshold and applied FTC can be adjusted based on tissue type and tissue properties. For example, high tissue stiffness may require a slower and more conservative rate of change of applied FTC (e.g., as represented by FTC lines 22012, 22112), and a closure threshold that typically outputs a lower maximum threshold (e.g., as represented by FTC _L2 22010 and ΔFTC _L2 22110).

The maximum threshold may indicate a threshold at which the first jaw member 152002 and the second jaw member 152004 are in a position sufficient for the surgical instrument 112 to fire the staples. For example, relatively thick tissue may correspond to a slower rate of change of closing force and generally a higher maximum closing threshold. Additionally, tissue type or structure may be inferred based on the determined surgical protocol and clinical history for use in identifying additional closure algorithm adjustments at step 22208. For example, the clinical history recorded by the attending surgeon may indicate which vasculature to treat first. It can be inferred that the tissue type and structure is vascular lung tissue with high blood content (ie, high vasculature). Based on this inferred tissue type and property information, it can be determined that modulation of a slower rate of change of applied FTC would be beneficial. In summary, at step 22208, an adjustment to the current closing algorithm is determined based on the inferred information, and the adjustment is applied. Therefore, the current surgical operation may be performed using the adjusted current closure algorithm and utilizing the surgical instrument 112 .

Flowchart 22200 then proceeds to decision operation 22210, where it is determined whether any steps of the identified surgical procedure remain. If there are no steps remaining (ie, the answer to decision operation 22210 is no), flowchart 22200 terminates in some respects. However, if the answer to decision operation 22210 is yes, there are additional steps of the surgical procedure remaining. Therefore, the current state of flowchart 22200 is Operational. In this case, the flowchart proceeds to step 22212 where intraoperative information can be received and analyzed. For example, intraoperative information may indicate that the type of tissue being treated during this step of the surgical procedure is parenchyma. Specifically, it may be inferred that the tissue is parenchymal based on clinical history, for example. This inference may be made in conjunction with the measurement of the tissue contact sensor 474 and the measurement of the closure member position by the load sensor 474. Additionally, the clinical history may indicate that the attending surgeon routinely completes the lung fissure (two-fold plication of the lung pleura, i.e., inward folding into the sheathing lung parenchyma) after dissection with monopolar RF energy surgical instruments. In this case, it can be deduced that the current step in the surgical protocol is lung parenchymal tissue based on the previously completed monopolar RF dissection.

Additionally, for example, the surgical hub 106 may determine whether the surgical instrument 112 being used is an appropriate stapler for substantial firing. The measurement of the initial tissue contact sensor 474 may indicate that the tissue is relatively thick, such as based on the length of contact with the first jaw member 152002 and the second jaw member 152004 when the end effector 702 is fully open (at the largest jaw aperture) organization, which may be consistent with the substance. Additionally, load sensor 474 measurements of closure member position (as represented by a comparison of the closure to jaw hole curves) may indicate relatively high tissue stiffness. This stiffness characteristic can be substantially consistent with being irradiated, a prediction that can be confirmed by reference to patient EMR data in the cloud. In this way, for example at step 22212, the sensor signals and perioperative information may be used in combination.

Based on this received and analyzed intraoperative information, it may be determined at decision operation 22214 that further adjustments are needed. On the other hand, if the answer at decision operation 22214 is no, the flowchart will return to decision operation 22210. When the answer at decision operation 22214 is yes, tissue type and tissue properties are inferred, such as determining substantial tissue structure and stiffness properties, similar to that described above at step 22206. Subsequently, an adjustment to the currently applied closing algorithm may be determined at step 22208 and applied. Specifically, the inference that rigid and fragile parenchymal tissue is being treated may lead to the regulation of a slower, more conservative rate of change in the applied closing force.

Therefore, the current closure algorithm can be tuned to one that minimizes the closure threshold and rate of change. That is, the adjusted threshold may have a reduced maximum closing force threshold, a more gradual rate of change of closing force, a reduced rate of change of closing force threshold, or some combination or subcombination of the foregoing. For example, a waiting time can be set in the event the clinician inadvertently exceeds the closure threshold. For example, exceeding the closure threshold may indicate that the compressed tissue or material is too thick for the firing nail, so this waiting time may be necessary. Therefore, the waiting time may allow some tissue material or fluid in the end effector 702 to drain or flow out. After an appropriate waiting time, it is determined that the tissue can be compressed appropriately to achieve a proper end effector 702 configuration such that the stapling surgical instrument 112 can fire the staples. Because the adjusted closing algorithm is more conservative, long wait times can be used. However, the clinician may be able to override this long wait time or conservatively adjusted closure algorithm by manually selecting a faster clamping protocol to use on the surgical instrument 112 .

When the modified closure algorithm is applied to parenchymal tissue at step 22208, the flowchart again proceeds to decision operation 22210. Here again, the answer may be "yes" since there are remaining steps of the surgical protocol. For example, a lobectomy may be followed by a vascular anastomosis step. Likewise, at step 22212, intraoperative information is received and analyzed. For example, the surgical hub may determine that the clinician has selected a vascular stapler surgical instrument. Additionally, the initial measurement from tissue contact sensor 474 may indicate that tissue contact occurs almost immediately during closure. Additionally, tissue contact may be determined as a small area surrounding the vascular stapler 112 and limited to the distal side of the stapler 112 . Load sensor 474 measurements may also be indicative of compliant tissue structure. Additionally, it can be inferred that the tissue may have a relatively low stiffness, which may be consistent with the pulmonary blood vessels of the lungs. Additionally, the clinical history may indicate that the attending surgeon typically applies the vascular stapler 112 to the blood vessels as a step after completing the lung fissure. Therefore, intraoperative information combined with, for example, closure parameter sensor signals can be used to infer tissue type and tissue properties. Specifically, it may be predicted that vascular tissue is being treated based on specific characteristics of the selected vascular stapler 112 . For example, initial tissue contact and measurements from load sensor 474 may confirm this initial prediction.

Accordingly, it may be determined at decision operation 22214 that further adjustments are required, causing flowchart 22200 to proceed to step 22206. At step 22206, the tissue may be inferred to be vascular tissue with relatively low tissue thickness and stiffness. Therefore, flowchart 22200 proceeds to step 22208, where the previously applied conservative closing algorithm is adjusted to a normal closing algorithm. The normal closing algorithm may include a constant rate of change of closing. Additionally, the closure threshold may be higher than the threshold used in control algorithms for parenchymal tissue. In other words, normal closure algorithms can achieve higher maximum applied closure forces, and the rate of closure change can be faster than parenchymal tissue. The surgical instrument may also notify the clinician of adjustments to the normal closure algorithm via appropriate indicators, such as light emitting diode (LED) indicators that display a specific color. In another example, it may be determined at step 22206 that the patient has completed fissures. Therefore, no nail firing of parenchymal tissue has yet to be performed during surgical protocol. In response to the determination, the surgical instrument may prompt the clinician to confirm that the inference is correct, such as via a display of the surgical instrument. The clinician can then manually select the appropriate closure control algorithm for that step or phase of the surgical protocol. Additionally or alternatively, the surgical instrument 112 may default to a conservative closure algorithm since the inference performed at step 22206 may not be conclusive. In any case, the adjusted closing algorithm is applied at step 22208.

Continuing with the description of the lobectomy example, the flowchart proceeds to decision operation 22210. At decision operation 22210, it may be determined that there are remaining steps of the surgical procedure. Therefore, at step 22212, intraoperative information is received and analyzed. Based on the intraoperative information, it can be inferred that the type of tissue being processed is bronchial tissue. Additionally, measurements from the initial tissue contact sensor 474 may indicate that tissue grasped between the end effectors 702 almost immediately contacts the first jaw member 15 2002 and the second jaw member during initial closure of the end effector 702 152004, and this contact corresponds to a small area of suturing surgical instrument 112. Additionally, this contact is limited to both sides of the jaw members 152002, 152004.

Therefore, it is predicted that this tissue contact corresponds to bronchial tissue. As discussed above, these initial tissue contact sensor 474 measurements may be non-therapeutic or quasi-non-therapeutic. Additionally, measurements from the closure load sensor 474 (as represented by a comparison of closure to jaw hole curves) may be indicative of a rigid tissue structure consistent with bronchial tissue. The surgical procedure history indicates that the vascular stapler 112 has been used during the surgical procedure, which may also mean that parenchymal staple firing has likely been performed and significant monopolar RF energy usage has occurred. For example, this history of surgical procedures considered in conjunction with clinical history can be used to predict which bronchial tissue a surgeon is treating. This prediction would be consistent with surgeons' routine practice of performing bronchial suturing as the final step in lobectomy. Based on analysis of this type of information and other appropriate intraoperative information at step 22212, it may be determined at decision operation 22214 that further adjustments are required. Since the answer to decision operation 22214 is yes, the flowchart proceeds to step 22206 where it is inferred that the tissue being treated is bronchial tissue with normal tissue stiffness and thickness.

In one aspect, it can be easily determined that the tissue being treated is bronchial tissue because the surgical instrument 112 is only configured for use with a specific tissue type. For example, the surgical instrument 112 may only be suitable for firing staples for the bronchus. Conversely, surgical instrument 112 may be adapted only for firing staples for parenchymal tissue. In this case, the warning may be generated by the surgical instrument 112 because the surgeon is attempting to treat bronchial tissue with staples designed for parenchymal tissue. The warning may be an audible warning, a visual warning, or some other appropriate warning. In another example, a warning may be provided by the vascular stapler 112 if the vascular stapler 112 is selected for use with bronchial tissue. As described above, it may be determined based on perioperative information that the tissue being treated is bronchial tissue for which the vascular stapler is disabled. Similarly, other perioperative information, such as closure load and cartridge selection, may be used to provide warnings when surgical instruments 112 are used with tissue types or properties with which they are incompatible. As mentioned above, inference using perioperative information can be performed in conjunction with closure parameter sensor signals. In all cases, safety checks may be implemented to ensure that the surgical instrument 112 being used is safe for the tissue being processed.

Based on the inferred tissue type and characteristics, at step 22208, the current closure algorithm is adjusted. Although a constant rate of closure may be determined to be appropriate, the rate of closure may be adjusted to be faster or slower depending, for example, on inferred bronchial tissue properties. The closure threshold can be modified in the same or similar manner. Additionally, the current closure algorithm may be adjusted such that a longer wait time is automatically enabled or recommended if and when the surgical instrument 112 exceeds the momentarily applicable closure threshold. For example, this waiting time may be longer for bronchial tissue than for parenchymal tissue. As mentioned above, the surgeon is notified of the selected adjustment to the closure algorithm, for example via an LED indicator. The clinician may also override the wait time to a longer time, allowing the surgeon to fire the stapler surgical instrument 112 if appropriate. Flowchart 22200 then proceeds to step 22212, where it may be determined that there are no additional steps of the surgical procedure remaining.

In one aspect, flowchart 22200 may be implemented by control circuitry. However, in other aspects, flowchart 22200 may be implemented by surgical hub 106 or cloud 104. Additionally, although steps 22204 and 22212 are described in terms of preoperative information and intraoperative information, respectively, they are not limited to this approach. Specifically, perioperative information may generally be received and analyzed, rather than specific preoperative or intraoperative information. As mentioned above, perioperative information encompasses preoperative, intraoperative, and postoperative information. Additionally, sensor signals can be combined with perioperative information for contextual and inferential closure algorithm regulation.

Example

Various aspects of the subject matter described herein under the heading "System for adjusting end effector parameters based on preoperative information" are set forth in the following examples:

Embodiment 1 - A surgical system including a surgical instrument. The surgical instrument includes an end effector including a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument also includes a motor configured to move the first jaw relative to the second jaw based on the closure change rate parameter and the closure threshold parameter. The surgical instrument also includes a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector. The surgical system also includes control circuitry communicatively coupled to the sensor. The control circuit is configured to receive perioperative information, wherein the perioperative information includes one or more of a type of perioperative disease, perioperative treatment, and surgical procedure. The control circuit is further configured to receive a sensor signal from the sensor and determine adjustments to the closure change rate parameter and the closure threshold parameter based on the perioperative information and the sensor signal.

Embodiment 2 - The surgical system of Embodiment 1, wherein the control circuit is further configured to determine characteristics of tissue to be treated by the surgical instrument based on one or more of perioperative information and sensor signals.

Embodiment 3 - The surgical system of Embodiment 2, wherein the tissue properties include one or more of tissue type properties, muscle properties, vasculature properties, water content properties, stiffness properties, and thickness properties.

Embodiment 4 - The surgical system of Embodiment 1, 2, or 3, wherein the control circuit is further configured to vary the speed of the motor based on the determined adjustments to the closure change rate parameter and the closure threshold parameter.

Embodiment 5 - The surgical system of Embodiment 1, 2, 3, or 4, wherein the control circuit is further configured to enable communication between the surgical instrument and one or more of perioperative information and sensor signals based on the type of surgical instrument. to generate an alert for inconsistencies.

Embodiment 6 - The surgical system of embodiment 1, 2, 3, 4 or 5, wherein the perioperative information further includes the type of tissue to be treated by the surgical instrument, tissue characteristics, clinical history, and use with the surgical instrument One or more of the types of nail bins.

Embodiment 7—The surgical system of embodiment 1, 2, 3, 4, 5, or 6, wherein the closure threshold parameter is a maximum closure force threshold, and the control circuit is further configured to disable based on reaching the maximum closure force threshold. The motor reaches a predetermined period of time.

Embodiment 8 - A surgical system including a surgical hub configured to receive perioperative information transmitted from a remote database of a cloud computing system. The surgical hub is communicatively coupled to the cloud computing system. The surgical system also includes surgical instruments communicatively coupled to the surgical hub. The surgical instrument includes an end effector including a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The end effector also includes a motor configured to move the first jaw relative to the second jaw based on the closure change rate parameter and the closure threshold parameter of the closure control program received from the surgical hub. The end effector also includes a sensor configured to transmit a sensor signal indicative of a closing parameter of the end effector. The surgical hub is further configured to receive sensor signals from the sensors and determine adjustments to the closure change rate parameter and the closure threshold parameter based on the perioperative information and the sensor signals.

Embodiment 9—The surgical system of Embodiment 8, wherein the closure control program is a first closure control program, the surgical hub is further configured to transmit a second closure control program to the surgical instrument, and the second closure control program defines Adjustment of the Closure Change Rate parameter and adjustment of the Closure Threshold parameter.

Embodiment 10 - The surgical system of Embodiment 9, wherein the cloud computing system is configured to transmit the second closure control program to the surgical hub and the adjustment of the closure rate of change parameter and the closure threshold of the second control program Adjustment of parameters is based on perioperative information.

Embodiment 11 - The surgical system of Embodiment 8, 9, or 10, wherein the surgical instrument is configured to be capable of based on inconsistencies between a type of surgical instrument and one or more of perioperative information and sensor signals. to generate an alert.

Embodiment 12—The surgical system of embodiment 8, 9, 10, or 11, wherein the closure threshold parameter is a maximum closure force threshold, and the surgical hub is further configured to be capable of disabling the motor based on reaching the maximum closure force threshold. time period.

Embodiment 13 - The surgical system of embodiment 8, 9, 10, 11 or 12, wherein the perioperative information includes perioperative disease, perioperative treatment, type of surgical procedure, clinical history, type of surgical instrument , one or more of the type of tissue being treated by the surgical instrument, and the characteristics of the tissue.

Embodiment 14 - The surgical system of Embodiment 9, wherein the surgical hub is further configured to be able to change the speed of the motor based on the determined adjustments to the closure change rate parameter and the closure threshold parameter.

Embodiment 15 - A surgical instrument including an end effector including a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument also includes a motor configured to move the first jaw relative to the second jaw based on the closure change rate parameter and the closure threshold parameter of the first closure control program received from the surgical hub. The surgical instrument also includes a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector, and control circuitry communicatively coupled to the sensor and the motor. The control circuit is configured to receive the sensor signal from the sensor and determine adjustments to the closure change rate parameter and the closure threshold parameter based on the perioperative information and the sensor signal.

Embodiment 16 - The surgical system of Embodiment 15, wherein the surgical instrument is configured to generate an alert based on an inconsistency between a type of surgical instrument and one or more of perioperative information and sensor signals.

Embodiment 17 - The surgical system of embodiment 15 or 16, wherein the control circuit is further configured to be capable of switching from the first closure control program to a second closure control program received from the cloud computing system, and based on the second closure control program The program changes the speed of the motor.

Embodiment 18—The surgical system of Embodiment 15, 16, or 17, wherein the control circuitry is further configured to determine tissue to be treated by the surgical instrument based on one or more of perioperative information and sensor signals. characteristics and types.

Embodiment 19 - The surgical system of embodiment 15, 16, 17 or 18, wherein the closure threshold parameter is a maximum closure force threshold.

Embodiment 20 - The surgical system of embodiment 19, wherein the closure threshold parameter is a maximum closure force threshold.

In various aspects, sensors of sensor arrays according to the present disclosure may be placed on a staple cartridge. The adhesive mask can be embedded with sensors at predetermined locations. In various aspects, the sensor is attached to lugs on the staple cartridge such that the sensor is positioned above the cartridge platform of the staple cartridge to ensure contact with tissue. For example, screen printing techniques can be used to mass-form an adhesive mask on a polyester substrate. Conductive pads can be printed into common locations.

In various examples, in addition to detecting proximity to cancerous tissue, end effectors of the present disclosure may be configured to be able to target specific cancer types in specific tissues. As noted in the journal publication Altenberg B and Greulich KO, Genomics, Volume 84, Issue 2004, Pages 1014-1020 (the text of which is incorporated herein by reference), some cancers regulate glycolysis genes through are characterized by overexpression of glycolytic genes, whereas other cancers are not characterized by overexpression of glycolytic genes. Therefore, the end effector of the present disclosure can be equipped with a sensor array with high specificity for certain cancer tissues characterized by overexpression of glycolytic genes, such as lung or liver cancer.

In various aspects, sensor readings from a sensor array in accordance with the present disclosure are communicated by a surgical instrument to a surgical hub (eg, surgical hub 106, 206) for additional analysis and/or for situational awareness.

The above detailed description has set forth various forms of apparatus and/or methods through the use of block diagrams, flowcharts, and/or examples. To the extent that such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, one skilled in the art will understand this to mean that each function and/or operation in such block diagrams, flowcharts, and/or examples or operations may be implemented individually and/or collectively by a variety of hardware, software, firmware, or indeed any combination thereof. Those skilled in the art will recognize that some aspects of the form disclosed herein may be implemented as one or more computer programs running on one or more computers (e.g., as a program running on one or more computer systems). one or more programs), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as Indeed any combination of them is equivalently implemented in whole or in part in an integrated circuit, and it will be within the skill of a person skilled in the art to design electronic circuits and/or code software and/or hardware in accordance with the present invention. Additionally, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as one or more program products in a variety of forms, and that the exemplary forms of the subject matter described herein are applicable regardless of the actual use for which What is the specific type of signal-carrying medium distributed.

Instructions for programming logic to perform various disclosed aspects may be stored in memory within the system, such as dynamic random access memory (DRAM), cache, flash memory, or other memory. Additionally, instructions may be distributed over a network or through other computer-readable media. Thus, a machine-readable medium may include a mechanism for storing or transmitting information in a form readable by a machine (eg, computer), but is not limited to floppy disk, optical disk, optical disk, read-only memory (CD-ROM), magneto-optical disk, Read-only memory (ROM), random-access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical card, flash memory, or via electronic A tangible, machine-readable storage device used by signals, optical signals, acoustic signals, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.) to transmit information over the Internet. Thus, non-transitory computer-readable media includes any type of tangible machine-readable media suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used in any aspect herein, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing units, processing microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), field programmable gate array (FPGA)), state machine Circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. Control circuits may be implemented collectively or individually as circuitry forming part of a larger system, such as an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer , servers, smart phones, etc. Thus, as used herein, "control circuit" includes, but is not limited to, an electronic circuit having at least one discrete circuit, an electronic circuit having at least one integrated circuit, an electronic circuit having at least one application specific integrated circuit, forming a general purpose computer configured by a computer program Electronic circuitry of a device (e.g., a general-purpose computer configured by a computer program that implements, at least in part, the methods and/or devices described herein, or a microcomputer configured by a computer program that implements, at least in part, the methods and/or devices described herein. processor), electronic circuits forming a memory device (e.g., forming a random access memory), and/or electronic circuits forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital fashion, or some combination thereof.

As used in any aspect herein, the term "logic" may refer to applications, software, firmware, and/or circuitry configured to perform any of the foregoing operations. Software may be embodied as a software package, code, instructions, sets of instructions and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or sets of instructions and/or data that are hardcoded (eg, non-volatile) in a memory device.

As used in any aspect herein, the terms "component," "system," "module" and the like may refer to a computer-related entity, hardware, a combination of hardware and software, software, or software in execution.

As used in any aspect herein, "algorithm" refers to a methodical sequence of steps leading to a desired result, where "steps" refers to the manipulation of physical quantities and/or logical states that may, but need not ) takes the form of electrical or magnetic signals capable of being stored, transferred, combined, compared and otherwise manipulated. Often used to refer to these signals, such as bits, values, elements, symbols, characters, terms, numbers, etc. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.

The network may include a packet-switched network. The communication devices may be able to communicate with each other using a selected packet-switched network communication protocol. An example communication protocol may include an Ethernet communication protocol that may allow communication using Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol may be compliant with or compatible with the Ethernet standard named "IEEE 802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and/or later versions of this standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using the X.25 communication protocol. The X.25 communication protocol may conform to or comply with standards promulgated by the Telecommunication Standardization Sector of the International Telecommunications Union (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a Frame Relay communication protocol. Frame Relay communications protocols may conform to or conform to standards published by the Committee for International Telephone and Telephone Consulting (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may comply with or be compatible with the ATM standard named "ATM-MPLS Network Interoperability 2.0" released by the ATM Forum in August 2001 and/or a higher version of the standard. Of course, this article also contemplates different and/or later developed connection-oriented network communication protocols.

Unless otherwise expressly stated in the above disclosure, it is understood that in the above disclosure, discussions using terms such as "processing", "estimate", "computing", "determining", "display", etc. refer to computer systems or similar The actions and processes of electronic computing equipment that manipulate and convert physical (electronic) quantities of data represented within the registers and memories of a computer system into similarly represented memory or registers of a computer system or other such information storage, transmission or other data showing physical quantities within the device.

One or more components may be referred to herein as "configured to be able to," "configured to be able to," "operable/operable," "suitable/adaptable," "able to," " Can be adapted/adapted to" etc. Those skilled in the art will recognize that "configured to be capable of" may generally encompass components in an active state and/or components in an inactive state and/or components in a standby state, unless the context dictates otherwise.

The terms "proximal" and "distal" are used herein with respect to a clinician manipulating the handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located away from the clinician. It will also be understood that, for the sake of brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in connection with the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not limiting and/or absolute.

Those skilled in the art will recognize that the terms used herein, generally, and in the appended claims in particular (e.g., the text of the appended claims) are generally intended to be "open" terms (e.g., the term " The term "including" shall be interpreted as "including but not limited to", the term "having" shall be interpreted as "having at least", the term "including" shall be interpreted as "including but not limited to", etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present . For example, as an aid to understanding, the following appended claims may contain use of the introductory phrases "at least one" and "one or more" to introduce the claim. However, the use of such phrases should not be taken to imply that the introduction of a claim expression by the indefinite article "a" or "an" limits any particular claim containing such an introduced claim expression to containing only one such expression. claims, even when the same claim includes the introductory phrases "one or more" or "at least one" and words such as "a" or "an" (for example, "a" and/or "an" generally should when interpreted as meaning "at least one" or "one or more"); this also applies to the use of the definite article used to introduce a claim expression.

The terms "comprise" (and any form of "comprise" such as "comprises" and "comprising"), "have" (and "have" any form, such as "has" and "having"), "include" (and any form of "include", such as "includes" and "including" ”), and “contain” (and any form of “contain,” such as “contains” and “containing”) are open copulas. Thus, a surgical system, device, or device that "comprises," "has," "includes" or "contains" one or more elements has, but is not limited to, having only these one or more elements. Likewise, an element of a system, apparatus, or device that "comprises," "has," "includes" or "contains" one or more features has those one or more features, but is not limited to having only those one or more features. A characteristic part.

Additionally, even if a specific number of an introduced claim recitation is expressly recited, those skilled in the art will recognize that such recitation should generally be interpreted to mean at least the recited number (e.g., in the absence of other modifiers, for " The bare narrative "two narratives" usually means at least two narratives, or two or more narratives). Furthermore, in those cases where a convention similar to "at least one of A, B, and C, etc." is used, generally speaking, such construction is intended to have a meaning that one skilled in the art would understand the convention to have ( For example, "a system having at least one of A, B, and C" would include, but is not limited to, having only A, only B, only C, A and B together, A and C together, B and C together, and/or A , B and C wait together). In those cases where a convention similar to "at least one of A, B, or C, etc." is used, generally speaking, such construction is intended to have a meaning that one skilled in the art will understand the convention (e.g., "A system with at least one of A, B, or C" shall include, but is not limited to, having only A, only B, only C, A and B together, A and C together, B and C together, and/or A, B system that waits together with C). Those skilled in the art will also understand that, generally, unless the context dictates otherwise, inflectional words and/or phrases whether presenting two or more alternative terms in the detailed description, claims, or drawings are to be understood to mean The possibility of including one of the stated terms, either of the stated terms, or both of the terms is contemplated. For example, the phrase "A or B" will generally be understood to include the possibilities of "A" or "B" or "A and B."

With regard to the appended claims, those skilled in the art will understand that the operations recited therein may generally be performed in any order. Additionally, although various flowchart operations are set forth in sequence(s), it will be understood that the various operations may be performed in an order other than that shown, or may be performed concurrently. Unless context dictates otherwise, examples of such alternative ordering may include overlapping, staggered, interrupted, reordered, incremental, preliminary, supplemental, simultaneous, reverse, or other altered ordering. Furthermore, terms like "responsive to," "relevant to," or other past tense adjectives generally are not intended to exclude such variations unless the context dictates otherwise.

It is worth mentioning that any reference to "an aspect", "an aspect", "an example" or "an example" means that a specific feature, structure or characteristic described in connection with the aspect is included in at least one aspect. Therefore, the phrases "in an aspect," "in an aspect," "in an example," and "in an example" appearing in different places throughout the specification do not necessarily all refer to the same aspect. Furthermore, specific features, structures or characteristics may be combined in any suitable manner in one or more aspects.

Any patent applications, patents, non-patent publications, or other published materials mentioned in this specification and/or listed in any application data sheet are hereby incorporated by reference to the extent that the incorporated material is inconsistently incorporated herein. Accordingly, and to the extent necessary, the disclosures expressly set forth herein supersede any conflicting material incorporated herein by reference. Any material, or portion thereof, purported to be incorporated herein by reference that conflicts with existing definitions, statements, or other disclosure material listed herein will not create a conflict only between the incorporated material and the existing disclosure material. Incorporated to the extent of conflict.

In summary, a number of beneficial effects resulting from the adoption of the concepts described herein have been described. The foregoing embodiments have been presented in one or more forms for the purposes of illustration and description. These detailed descriptions are not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations of the invention may be made in light of the above teachings. The form or forms were chosen and described in order to illustrate principles and practical application, thereby enabling one of ordinary skill in the art to utilize the various forms and various modifications as are suited to the particular use contemplated. It is intended that the claims filed herewith define the full scope.

Claims (16)

1. A surgical instrument, including: an end effector including a jaw convertible between an open configuration and a closed configuration; a motor operably coupled to the jaw, the motor configured to transition the jaw between the open configuration and the closed configuration; a sensor configured to transmit at least one signal indicative of a tissue compression parameter associated with tissue between the jaws; and a control circuit coupled to the sensor and the motor, the control circuit being configured to: receiving said at least one signal; determining a value of the tissue compression parameter based on the at least one signal when the jaw transitions from the open configuration to the closed configuration; causing the motor to increase a time for transitioning the jaws to the closed configuration based on whether the value of the tissue compression parameter is above a first threshold; and Feedback is provided based on whether the value of the tissue compression parameter is below a second threshold, wherein the feedback includes recommendations for appendage reinforcement. 2. The surgical instrument of claim 1, wherein the tissue compression parameter includes a force exerted by the motor to transition the jaws to the closed configuration. 3. The surgical instrument of claim 1, wherein the tissue compression parameter includes a time rate of change in force exerted by the motor to transition the jaws to the closed configuration. 4. The surgical instrument of claim 1, wherein the control circuit is configured to increase the rate at which the jaws transition to the closed configuration by reducing the rate at which the motor transitions the jaws to the closed configuration. the time of the closed configuration. 5. The surgical instrument of claim 1, wherein the control circuit is configured to increase the length of time the jaws are paused while transitioning the jaws to the closed configuration. The time at which the mouth transitions to the closed configuration. 6. The surgical instrument of claim 1, wherein the control circuit is configured to increase the stability of the jaw by lowering a stability threshold to stop the motor when transitioning the jaw to the closed configuration. The time at which the jaws transition to the closed configuration. 7. A surgical instrument comprising: End effector, the end effector includes: jaws convertible between an open configuration and a closed configuration; and one or more sensors disposed along the tissue contacting surface of each of the jaws, the one or more sensors configured to detect contact with tissue; a motor operably coupled to the jaw, the motor configured to transition the jaw between the open configuration and the closed configuration; and Control circuitry coupled to the one or more sensors and the motor, the control circuitry configured to: determining an initial point of contact of the tissue with the tissue contact surface of the jaw; determining the spacing between the jaws at the initial point of contact; determining the degree of contact between the tissue contacting surface and the tissue; causing the motor to transition the jaws to at a rate corresponding to the spacing between the jaws and the degree of contact between the tissue contact surface and the tissue at the initial point of contact the closed configuration; and causing the motor to adjust the rate at which the jaws transition to the closed configuration based on whether a force exerted by the motor to transition the jaws to the closed configuration exceeds a threshold; wherein said threshold corresponds to said spacing between said jaws and said degree of contact between said tissue contacting surface and said tissue at said initial point of contact. 8. The surgical instrument of claim 7, wherein the one or more sensors comprise a pressure sensor. 9. The surgical instrument of claim 7, wherein the one or more sensors comprise an impedance sensor. 10. The surgical instrument of claim 7, wherein the spacing between the jaws includes an angle between the jaws. 11. The surgical instrument of claim 7, wherein the spacing between the jaws includes a gap between the jaws. 12. A surgical instrument comprising: End effector, the end effector includes: jaws configured to transition between an open configuration and a closed configuration to grasp tissue; and a contact sensor assembly configured to sense the tissue against the contact sensor assembly; a position sensor configured to sense the configuration of the jaw; a motor coupled to the jaws, the motor configured to transition the jaws between the open configuration and the closed configuration; Control circuitry coupled to the contact sensor assembly, the position sensor, and the motor, the control circuitry configured to: determining an initial point of contact of the tissue with the jaw; determining the configuration of the jaw at the initial point of contact via the position sensor; determining an amount of tissue contact between the tissue and the jaw at the initial point of contact via the contact sensor assembly; setting a closing rate at which the motor transitions the jaws to the closed configuration based on the configuration of the jaws at the initial point of contact and the amount of tissue contact; setting a closure threshold based on the configuration of the jaws and the amount of tissue contact at the initial point of contact; and The motor is controlled based on the force exerted by the motor to transition the jaws to the closed configuration relative to a threshold. 13. The surgical instrument of claim 12, wherein the sensor assembly includes a pressure sensor. 14. The surgical instrument of claim 12, wherein the sensor assembly includes an impedance sensor. 15. The surgical instrument of claim 12, wherein the configuration of the jaws corresponds to an angle between the jaws. 16. The surgical instrument of claim 12, wherein the configuration of the jaws corresponds to a gap between the jaws.