JP2008100079A - Method and apparatus for treating spinal stenosis - Google Patents

Abstract

The present invention relates to spinal surgery, and more particularly, to a method for treating spinal stenosis and a device for treating spinal stenosis.
A system for treating spinal stenosis includes an interspinous process spacer 10, a spacer 12, a main spinous process tether 14, and two secondary tethers (only one of the two is shown in the figure). Is provided). The spacer 12 is substantially cylindrical and has a main chamber 16, a pair of insertion instrument openings, a fusion cutout 20, and a pair of tether string lumens.
[Selection] Figure 1

Description

(Cross-reference to related applications)
This application is a provisional US patent application entitled “Methods and Apparatus for Treating Spinal Stenosis” filed on September 28, 2005, based on Section 119 (e) of the US Patent Act. The priority of the filing date of serial number 60 / 722,065 is claimed.

  The present invention relates generally to spinal surgery, and in particular to methods and devices for treating spinal stenosis.

  Spine stenosis is a condition in which the distance between the spines is reduced, resulting in compression of the spinal cord and / or spinal nerve roots. Such disorders are usually associated with stenosis in one or more of the following sites. That is, (1) the spinal canal at the center of the spinal column from which the spinal cord and spinal nerve roots extend, (2) the tube near the nerve base or the nerve root of the nerve branching out from the spinal cord, and (3) the nerve is the spine Vertebrae that pass through on the way to various other parts of the body, such as openings between vertebrae. The pressure applied to one or both of the spinal cord and / or existing nerve roots depends on the position within the spine (eg, depending on the cervical, thoracic, lumbar, etc., limbs), or May cause pain or numbness in both legs and arms. Spine stenosis generally afflicts older people, but younger patients may suffer as well.

  Various treatments have been taken to alleviate or minimize the effects of spinal stenosis. One such technique is laminectomy, but laminectomy involves the removal of a lamina from the diseased area. By removing the thin layer, this procedure enlarges the spinal canal, thus relieving the pressure on the spinal cord and / or the nerve being compressed. Although generally effective, laminectomy is disadvantageous in that any procedure involved in bone resection can cause further damage to the post-operative spinal region from a mechanical point of view. Some people think. In addition, older patients may present with symptomatic morbidity that increases the likelihood of complications such as increased back pain, increased infection, and prolonged recovery. Many.

  Another effort in treating spinal stenosis is to indirectly depressurize the stenosis by installing a spacer device in the space between the spinous processes. Such a system is characterized by being secured to the upper and lower spinous processes. If you think that limiting spinal tension is the key to alleviating spinal stenosis, connecting both ends of the spacer device to the respective spinous processes limits both the flexion and tension of the spine at that location. It is disadvantageous in that it ends up. Furthermore, prior art interspinous spacers are typically constructed from a material (eg, metal) that has properties that are substantially different from those of the spinous processes themselves, with the spinous processes around the spacers. Questions arise as to whether or not the spinous process is reconstructed, whether or not the spinous process loses its ability to be distracted, and whether or not the spinous process is relieved to relieve spinal stenosis.

U.S. Patent No. 6,923,814

The present invention aims to overcome or at least improve the above-mentioned drawbacks of the prior art.
The present invention is directed to treating spinal stenosis and involves an interspinous process spacer sized to distract the space between spinous processes of stenosis and of adjacent spinous processes. It is further characterized in that it is fixed to only one of them and prevents the tension of the spine and allows the spine to bend. The interspinous process spacer of the present invention can be used at any one site or two or more sites among the cervical vertebra, the thoracic vertebra, and the lumbar vertebra. While it is illustrated and described throughout the present disclosure that the interspinous process spacer is secured to the upper spinous process, the interspinous process spacer of the present invention does not depart from the scope of the present invention when secured to the lower spinous process. I understand that. A variety of mechanisms are used to secure the interspinous process spacer of the present invention to a given spinous process, examples of which include one or more tethers (e.g., wires, cables, sutures, allogeneic). System graft tissue, one or more other striated members, etc.) one or more screws, various clamping mechanisms, etc., any one of them Alternatively, various combinations may be mentioned, but the present invention is not limited to these.

  According to an important aspect of the present invention, the interspinous process spacer of the present invention is designed to be fused to the spinous process, and as a result of the spacer being fixed to the spinous process for a period of time, one spacer is present. This is a state called “semi-fusion” because it is fused only to the spinous process. This is facilitated by stripping the surface of the spinous process (which preferably results in bleeding), in which case the stripped spinous process surface is associated with the interspinous process spacer of the present invention. This joint is fused after a period of time, but in part depends on either or both of the treatment design and interspinous spacer material of the present invention that allow fusion. Is. More particularly, the interspinous process spacer of the present invention is constructed from a bone (eg, allograft) material, but it is readily apparent that fusion can occur during implantation. Interspinous spacers may be composed of non-aggregate (eg, one or both of polyetheretherketone (PEEK) and polyetherketoneketone (PEKK)), but these materials promote fusion The physical design is as follows. This is accomplished, for example, with an interspinous spacer sized to receive a fusion-inducing substance and in contact with a given spinous process stripping surface. Specific examples of such fusion promoters include BMP, demineralized bone matrix, allograft cancellous bone, autograft bone, hydroxyapatite, wrinkles, and other highly porous Examples include, but are not limited to, one or various combinations among various substances.

  As a means of overcoming the shortcomings of the prior art, the present invention consists of a material that treats spinal stenosis and at the same time has properties that are substantially more similar to those of the spinous process itself than the prior art devices. There is a point that the spine can be bent using the graft. This is advantageous in that it minimizes the risk of spinous processes being reconstructed around the interspinous spacer of the present invention, but also prevents the risk of separately distracting due to reconstruction inhibition, or This is advantageous in terms of minimizing.

  Numerous advantages of the present invention will become apparent to those skilled in the art when the specification is read in conjunction with the accompanying drawings, wherein like reference numerals are used to refer to like elements throughout.

  Exemplary embodiments of the invention are described below. For clarity, not all features of the examples are described herein. Of course, in developing any of these embodiments, a number of decisions specific to each example must be made to achieve the developer's specific goals, an example of which However, it is understood that such constraints vary from embodiment to embodiment. Further, it can be seen that such development efforts are complex and time consuming, yet become routine work routine to those skilled in the art who would benefit from this disclosure. The spinal alignment system disclosed herein is proud to have a variety of inventive features and components that individually and in combination assure patent protection.

  FIG. 1 is a perspective view illustrating that an interspinous process spacer 10 of the present invention is used between two spinous processes of a subject spine. The spacer assembly 10 includes a spacer 12, a main spinous process tether 14, and two secondary tethers 15 (only one of the two is illustrated in FIG. 1). The spacer 12 is generally cylindrical as illustrated in FIGS. 2-6 and includes a main chamber 16, a pair of insertion instrument openings 18, a fusion notch 20, and a pair of tether lumens 22. Have. As will be described in more detail later, the spacer 12 is connected only to the upper spinous process (according to a preferred embodiment) and not to the lower spinous process. This secures the main spinous process tether 14 to the upper spinous process (as the first stage of fixation) and then each tether string lumen 22 at a position between the upper spinous process and the main spinous process tether 14. This is accomplished by passing the secondary tethers 15 one by one through and finally tightening the secondary tethers 15 until the spacers 12 generally cross the longitudinal axis of the spine. Only.

  The spacer 12 may be a bone structure or a non-bone structure. The bone embodiment is concerned with manufacturing the spacer 12 from a suitable allograft, and specific examples of such a graft include the clavicle, rib, radius, ulna, metacarpal, finger Examples include, but are not limited to, phalanx, femur, tibia, radius, metatarsal bone and the like. While non-bone embodiments are concerned with producing spacers 12 from suitable non-bone materials, specific examples of such non-bone materials include polyetheretherketone (PEEK), polyetherketoneketone (PEKK). ) Etc., but is not limited to these. In any case, the spacer 12 is designed to fuse to the upper spinous process over a period of time, resulting in the spacer 12 being fused to only one spinous process. It becomes a state called “fusion”. As a means for increasing this, a method of arranging several types of suitable fusion inducing substances inside the spacer 12 is adopted. Specific examples of such substances include BMP1, BMP2, BMP3, BMP4, BMP5, BMP6. , BMP7, BMP8, BMP9, BMP10, BMP11, BMP12, BMP13, BMP14, ... BMPn, demineralized bone matrix, allograft cancellous bone, autograft bone, hydroxyapatite, coral, it There are any one kind or a plurality of kinds of highly porous substances other than, but not limited to.

  Although illustrated and described with respect to the upper spinous process, it will be appreciated that the spacer 12 may be connected only to the lower spinous process without departing from the scope of the present invention. Once installed, the spacer 12 has the effect of distracting the space between the spinous processes, which has the advantage of restoring the nerve hole height of the stenotic patient and indirectly depressurizes the disc space. You can also

  The main chamber 16 extends through the side of the spacer 12 as described in FIGS. The main chamber 16 may be provided with any one of various suitable shapes in addition to the substantially cylindrical shape as shown in the figure. As specific examples of this shape, the main chamber 16 may be substantially elliptical, triangular, rectangular, and various types thereof. Any one or a plurality of combinations and the like may be mentioned, but the present invention is not limited to these. The main chamber 16 is sized to receive the fusion inducing material 32 as best illustrated in FIG. Again, such fusion inducers are treated with BMP1, BMP2, BMP3, BMP4, BMP5, BMP6, BMP7, BMP8, BMP9, BMP10, BMP11, BMP12, BMP13, BMP14, ... BMPn, demineralized. Bone matrix, allograft cancellous bone, autograft bone, hydroxyapatite, wrinkles, other highly porous materials, etc. It is not limited. The fusion-inducing substance is packed into the main chamber 16 before and / or after fixing the spacer 12 to the spinous process. The pair of insertion instrument openings 18 is disposed either on the rear side or the front side of the spacer 12 and extends over a part of the entire surface of the spacer 12. The fusion notch 20 is a slot or recess that accepts a portion of the upper spinous process or other vertebral body function to improve fusion. The notch 20 is preferably arranged on the top surface so as to face the middle portion of the spacer 12. The notch 20 serves to center the spacer 12 relative to the superior spinous process.

  According to another embodiment illustrated in FIGS. 9 to 11, the spacer 12 is provided with a second notch facing the fusion notch 21. The second notch 21 can be placed over the inferior spinous process in use, thereby helping to maintain the spacer 12 in a position that is completely centered with respect to the inferior spinous process. it can. As best illustrated in FIG. 9, the fusion cutout 20 is provided with a slot 23 that extends into the main chamber 16. When the spacer 12 is connected to the upper spinous process, a slot 23 establishes direct communication between the fusion-inducing composition provided inside the main chamber 16 and the lower surface of the upper spinous process, whereby the spacer This is advantageous because it increases the ability of the 12 to fuse to the superior spinous process (especially if the spacer 12 is made of non-bone material).

  As best illustrated in FIG. 6, the tether lumens 22 each extend at an angle and enter the main chamber 16 through the top surface of the spacer 12. Each of the anchoring lumens 22 can be provided so as to exhibit any one of various suitable shapes in addition to the illustrated cylindrical shape. Specific examples of the shape include an ellipse, a triangle, a rectangle, and the like. There are one type or a plurality of types of various combinations of the shapes of, but not limited to. The tethers 14, 15 may be any suitable material and may include any number of materials and configurations, for example, wires, cables, sutures (either permanent or bioabsorbable species). On the other hand, one or a plurality of types of allograft tissue, one or a plurality of other striate members, and the like may be mentioned, but the invention is not limited to these. The suture may contain any number of components as long as it can be attached to the spinous process, including various common sutures well known and used by those skilled in the art of wound sealing. However, it is not limited to these. The suture may be any length as long as it is necessary to effectively fuse the spacer 12 to a specific spinous process.

  The spacer 12 according to the present invention may be composed of allogeneic graft bone and may be formed in a substantially cylindrical shape. The spacer 12 of the present invention may be provided in any number of shapes and sizes as long as it has a suitable shape and size. Determined by strength characteristics. Whether the spacer 12 is sized to be used on either the cervical vertebra or the lumbar vertebra, or is sized to be used on both, it deviates from the scope of the present invention. There is no. The spacer 12 may be dimensioned such that the length range is between 6 and 20 millimeters and the height range is between 20 and 25 millimeters, but this is only an example.

  When the spacer 12 is composed of an allogeneic graft, the spacer 12 may be manufactured according to the following specific method. First, using a belt-type polishing machine, the ridges or imperfections are cut away to standardize the bone shape. Using a band saw, the allograft bone is cut to length. The main chamber 16 is created by removing the spongy material from the inner bone canal. The caliper is used to measure the struts and create a dimensional distribution of the spacers 12. The inserter opening 18 is machined. Set the standard vise and hold the entire width of the graft on the shaving machine. Use a 3/32 inch (3/32 ": approx. 2.38 mm) ball end mill to provide an insertion tool opening 18 (the same opening as a cervical allograft). Insert spacer 12 in a vise Calculate the centerline of the 20 mm or 25 mm long spacer 12. Make two holes 2.26 millimeters from each side of the centerline (from one hole to the other) 4.52 millimeters) A cutout 22 for spinous processes is provided, and an allograft retention fixture for the cervical spine is installed and the spacer 12 is mounted on the shaving machine using the insertion tool hole 18 and a vise. Retain the width. Make a notch 22 using a quarter-inch flat end mill (1/4 ": approx. 6.35 mm). The center line of the spacer 12 having a length of 20 mm or 25 mm is calculated. Insert the spacer 12 over the fixture using the inserter opening 18 and tighten the vise. This allows automatic verification of the exact dimensional setting and spacing setting of the insertion instrument opening 18. The height of the spacer 12 is measured. The cut depth is calculated to obtain the desired spacer 12 dimensions. Cut the flat portion of the spacer 12 to a desired depth. The spacer 12 is measured again to confirm that the depth of cut is appropriate. The lumen 22 angled on the surface of the spacer 12 is drilled. The spacer 12 is removed from the cervical allograft fixture and then tightened in a standard vise. Using a battery-powered drill or corded drill with a 1/16 inch (1/16 ": approx. 1.59 mm) drill bit attached, drill through the front side to the pipes on both sides. Then, the surface is polished by a belt-type polishing apparatus, and a flat surface is provided so that the drill bit engages with the spacer 12.

  Referring now to FIG. 11, one embodiment of a spacer 112 according to yet another embodiment of the present invention is illustrated in a perspective view. The spacer 112 includes a rear surface 113, a front surface 114, left and right side surfaces 115, a main chamber 116, and a fusion notch 120. The spacer 112 is further provided with a plurality of openings, and the three pairs of the insertion instrument openings 118a, the insertion instrument openings 118b, the insertion instrument openings 118c, the tether string lumen 122, and the fusion openings 124 are specifically illustrated as openings. Although it is an example, it is not necessarily limited to these.

  FIGS. 12-14 depict the spacer 112 being used in the gap between the patient's spinous processes. The spacer 112 is designed to fit between the upper spinous process and the lower spinous process, and may have any number of shapes and dimensions that are suitable for achieving this. . The spacer 112 is installed in any one site or a plurality of sites of the cervical vertebra, the thoracic vertebra, and the lumbar vertebra, and the size can be changed according to the site. When placed in place, the appropriately sized spacer 112 distracts the space between the spinous processes, restores the height of the nerve hole in the stenotic patient, and indirectly depressurizes the space between the vertebral bodies. By way of example only, spacer 112 may be sized to have a length range between 6 and 20 millimeters and a height range between 20 and 25 millimeters.

  The spacer 112 is preferably composed of non-bone material. Specific examples of suitable non-bone materials include, but are not limited to, polyetheretherketone (PEEK) and polyetherketoneketone (PEKK). Numerous advantages are obtained by constructing the spacer 112 from a material such as polyetheretherketone or polyetherketoneketone. The hardness characteristics of polyetheretherketone and polyetherketoneketone are almost identical to the hardness characteristics of bone. This reduces the substantial likelihood of potentially improving surgery as a result of rebuilding the spinous process around the spacer 112 and narrowing the width of the nerve hole again. Polyetheretherketone and polyetherketoneketone are also substantially radiolucent, which allows better visibility of the fusion between the graft and the upper spinous process after surgery. Finally, by using strategically installed openings in conjunction with non-bone material, fusion can be limited to areas where fusion is useful. Although only a specific example, the fusion opening of the spacer 112 is limited to a portion along the top surface (potentially, a portion along the rear surface 113), and the space between the upper spinous process and the spacer 112 is provided. It is possible to prevent fusion from occurring. In this way, even if the tension of the spine is constrained, there is no disadvantage that it is restrained by the bending of the spine.

  As depicted in FIG. 13, the main chamber 116 extends through the left and right side surfaces 115 of the spacer 112. In addition to the substantially cylindrical shape shown in the figure, the main chamber 116 may be provided in any of various shapes as long as it is suitable. For example, an oval shape, a triangle shape, a rectangular shape, and various combinations thereof. Any one type or a plurality of types may be mentioned, but not limited thereto. As best illustrated in FIG. 14, the main chamber 116 is sized to receive the fusion-inducing material 32. Again, as specific examples of such fusion inducers, BMP1, BMP2, BMP3, BMP4, BMP5, BMP6, BMP7, BMP8, BMP9, BMP10, BMP11, BMP12, BMP13, BMP14,... One or more of mineral-treated bone matrix, allograft cancellous bone, autograft bone, hydroxyapatite, wrinkles, other highly porous materials, etc. However, it is not limited to these. The fusion inducing material 32 is packed into the main chamber 116 before and / or after fixing the spacer 112 to the spinous process. The fusion-inducing substance 32 packed in the main chamber 116 passes through one or more of the insertion instrument openings 118 a, 118 b, 118 c, the fusion opening 124, and the tether string lumen 122, and the upper spine. Free communication with the protrusion. Such a contact state causes fusion from the upper spinous process into the main chamber 116, and the spacer 112 can be permanently fixed in place.

  Various characteristics of the spacer 112 will now be described in accordance with a preferred embodiment with reference to FIGS. FIG. 16 is a top view of the spacer 112. A fusion notch 120 is disposed substantially at the top surface and extends toward the center of the spacer 112. The fusion notch 120 is typically a slot or recess that is sized to receive the lower portion of the upper spinous process. The notch 120 helps to center the spacer 112 with respect to the superior spinous process and can help limit the lateral movement of the spacer 112 prior to fusing. The fusion notch 120 has a main fusion opening 124a. The main fusion opening 124a extends into the main chamber 116 and provides a main passage for fusion between the main chamber 116 and the upper spinous process. Secondary fusion openings 124 b are disposed near the four corners of the fusion cutout 120 along the top surface of the spacer 112 and extend into the main chamber 116. The secondary fusion opening 124b provides an additional path for the fusion to reach the upper spinous process. The tether opening 122 is disposed near both sides of the fusion notch 120 along the center of the top surface of the spacer 112. The size of the tether opening 122 is such that the tethers 14 and 15 are received and the spacer 112 is temporarily fixed in place by temporarily fixing the spacer 112 in place until fusion reaching the upper spinous process occurs. Is set to

  The main fusion opening 124a, the secondary fusion opening 124b, and the tether opening 122 are each provided so as to exhibit any one of various shapes in addition to the substantially circular shape shown in the figure. , Substantially square, rectangle, ellipse, triangle, various combinations thereof, and the like, but are not limited thereto.

  FIG. 16 illustrates the rear surface 113 of the spacer 112. The rear surface 113 is provided with three separate pairs of inserter openings 118a, 118b, 118c. As will be described in more detail later, the provision of three pairs of insertion instrument openings allows for a plurality of different instruments without having to prepare an alternative aperture shape and use one or both of separate instruments and spacers. The insertion approach path can be used. The insertion instrument opening extends into the main chamber 116 and functions as an additional fusing path after insertion, thereby making the fusing between the upper spinous process and the spacer 112 more robust and strong. Can do.

  FIG. 17 illustrates the front surface 114 of the spacer 112, and FIG. 18 illustrates the bottom surface of the spacer. It is preferable that there is no opening on the front surface 114 (with the exception that the secondary fusion opening 124b may be disposed near the top surface of the front spacer 112). The anterior surface 114 faces the spinal canal when placed in the space between the spinous processes. Bone growth along the anterior surface can potentially interfere with the spinal canal and the sensitive nerve tissue within it, resulting in pain or another surgical operation on the patient. Will be applied, or both. The inability to communicate with the main chamber 116 due to the lack of an opening in the front surface 114 is advantageous in that it prevents bone growth in that area. Similarly, no opening is provided in the bottom surface of the spacer 112 and the main chamber 116 is not in communication. This advantageously prevents bone growth in that region and does not cause fusion to the lower spinous processes. Again, this allows the stenosis to be corrected while still maintaining the ability of the spine portion to flex. It is preferable that a concave surface is provided on the bottom surface of the spacer 112 so that the distance from the top surface to the bottom surface of the spacer 112 increases at a position closest to the left and right side surfaces 115 and decreases near the center. This concave bottom surface rests along the inferior spinous process and helps maintain the spacer 112 in a centered position relative to the inferior spinous process. FIG. 19 again illustrates the main chamber 116 extending through one side 115.

  To assist in visualizing the spacer 112, the spacer 112 may be provided with at least one marker both at the time of surgery and after surgery. The spacer 112 preferably has one top marker 126 and two side markers 128. Markers 126 and 128 include biocompatible radiopaque materials, such as titanium (or other metals or polymers), but are merely specific examples. The marker 126 is installed along the center of the spacer 112 inside the fusion notch 120. The marker 126 preferably extends through the spacer 112 and reaches the bottom surface. The marker 128 is disposed below the main chamber 116 on both left and right sides. Both markers 128 can be utilized to align spacer 112 in the correct orientation during both and after spacer 112 installation.

  By utilizing one or more of X-ray fluoroscopic imaging from the viewpoint behind the spacer 112 (or the viewpoint on the patient's back side) and other various imaging techniques, the spacer 112 can be used. When properly installed, as illustrated in FIG. 30, the line between the upper and lower spinous processes is drawn by a marker 126 that is centered and extends from the fusion notch 120 to the bottom surface. It can be seen on the fluoroscopic screen. The markers 128 should be placed on the upper spinous process side and the lower spinous process side, respectively, in the space between the spinous processes. When properly installed, if an imaginary line is drawn between both markers 128 and this line is connected to an imaginary line extending from the marker 126, an upside-down T-shape is formed. From the side, the depth of the spacer 112 in the space between the spinous processes can be verified. The marker 126 extends along the rear surface 113 of the spacer 112. One or both of the markers 128 may be installed near the rear surface 113 on the side surface 115. In one embodiment, one marker 128 is placed near the rear surface 113 and the other marker 128 is placed near the front surface 114. On a side fluoroscopy imaged during surgery, the position of the marker 126 and the position of the marker 128 can be seen relative to the posterior end of the spinous process, and a more forward spacer 112 is secured. The position of the vertebrae to do is not so forward and not so much backward. When properly installed, if an imaginary line is drawn between both markers 128 and the line is connected to an imaginary line extending from the marker 126, as seen in FIG. An L-shape will be formed.

  The spinal device 10 of the present invention can be introduced into the target site of the spine using any of a variety of suitable instruments that can be removably fitted to the spacers 12 and 112. In a preferred embodiment, the insertion instrument allows the spacer 12 and spacer 112 to be quickly, directly and accurately placed between the upper and lower spinous processes. A specific insertion tool is illustrated and described in US Pat. No. 6,923,814, entitled “System and Method for Cervical Fusion”, which is the same as the patentee. However, it is expressly stated that the contents of this patent are incorporated herein by reference and constitute a part of this specification.

  FIGS. 21-23 illustrate a specific insertion tool 200 for use with the spacer 12 and spacer 112. The insertion instrument 200 is provided with a pair of protrusions 204 at the distal end 202, the dimensions of which are set to fit into the insertion instrument openings 18, 118a, 118b, 118c so that the spacer 12 and spacer 112 are It is temporarily attached to the distal end 202 for insertion. As illustrated in FIG. 24, a plurality of insertion instrument openings 118a are laterally aligned at the center of the spacer 112, such that the spacer 112 and the insertion instrument 200 are joined at approximately the center point of the spacer. This configuration is advantageous when approaching the space between the spinous processes from the approach path directly behind. As illustrated in FIG. 23, a plurality of insertion instrument openings 118b (also openings 118a) are vertically aligned near the sides of the spacer 112. Such a configuration is advantageous when approaching from the side.

  In order to use the spinal device 10 of the present invention in treating spinal stenosis, the physician must first specify the appropriate dimensions of the spacers 12,112. The physician can utilize the spinal device 10 for either an open spinal fusion procedure or a spinal fusion procedure with minimal open blood. In either type of treatment, a working channel is provided in the patient to reach the target spinal level. After providing the working channel, a space between the spinous processes is prepared. When the preparation is complete, the appropriate dimensions of spacer 12 and spacer 112 are measured using a dimension measuring instrument. An example of a specific dimension measuring device 300 is shown in FIGS. 24 to 27, but this is merely an example. The dimension measuring device 300 has a handle portion 302 and a graft portion 304. The handle portion 302 may be configured in any variety of shapes and dimensions as long as it is suitable. The graft portion 304 may be provided with dimensions that match the various dimensions of the spacer 112. As shown, the dimension measuring device can be seen to be asymmetric, but in this case, the height of the opposite side of the handle 302 is lower than the height of the side on which the handle 302 is attached. This allows the implant 304 to rotate the implant 304 in place with minimal interference from the spinous processes. Although not shown, it will be appreciated that the spacer 112 may also be provided in an asymmetric form.

  Preparing the interspinous gap includes drilling a hole in the interspinous ligament between the upper and lower spinous processes. If desired, the supraspinatric ligament is preferably transferred to an unobstructed place without touching it. Such a decisive part of the preparation includes the step of stripping the lower part of the upper spinous process, in which case the lower part comprises the fusion-inducing substance 32 packed in the main chambers 16, 116. Get in contact. Hard cortical bone is removed from the lower surface of the upper spinous process at the deprivation stage, leaving bleeding bone, which is more suitable for fusion. As new bone develops to heal the stripped portion, it grows into the main chamber 16, 116 and secures the spacers 12, 112 to the superior spinous process.

  In one embodiment, the spacers 12 and 112 are held in place by passing the tethers 14, 15 through the tether lumens 22, 122 and securing them to the spinous processes. According to an alternative embodiment, illustrated by way of example only in FIGS. 28 and 29, an alternative locking mechanism is used to lock the spacers 12, 112 in place. This alternative securing mechanism includes a zip cable 400 and a pair of locking bases 402, 404. The base 402 may be integrated with the cable 400. The base 402 is installed on the top surface of the spacers 12 and 112 adjacent to the fusion cutouts 20 and 120, and is fixed to the spacers 12 and 112 via the tether string lumens 22 and 122. The base 402 is installed so as to cover the tether string lumens 22 and 122, and a lock pin 406 is inserted into the tether string lumens 22 and 122 through the base. This step is repeated for the base 404 on the opposite side of the fusion notches 20, 120. When both bases are in place and the spacers 12, 112 are complete between the spinous processes, the zip cable 400 is wrapped around the upper spinous process and the opposing bases are placed. Sent through 404. The teeth 408 provided on the cable 400 prevent the cable 400 from loosening and thus hold the spacers 12, 122 in place so that fusion occurs. Any of a variety of suitable materials can be used to form the zip cable 400, the bases 402, 404, and the lock pin 406. In one embodiment, cable 400 and bases 402, 404 are constructed from nylon and lock pin 406 is constructed from titanium.

  When the spacers 12, 112 are positioned and inserted into the ready space between the spinous processes, the spacers force the spinous processes away from each other. When the spinous process is forced apart, the spine flexes, and when the spine flexes, the neural foramen and spinal canal are enlarged. The spinal device 10 advantageously holds the spinal column in a deflected position while at the same time preventing spinal cord tension but allowing it to flex.

  While the invention may be susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and have been described in detail herein. However, the description of specific embodiments herein is not intended to limit the invention to the particular forms disclosed, but rather is the essence of the invention as limited to the appended claims. And should be construed as including all modifications, equivalents, and alternatives falling within the spirit of spirit.

FIG. 3 is a perspective view illustrating that the interspinous process spacer according to the first embodiment of the present invention is used by being fixed to an upper spinous process of a subject spine. FIG. 2 is a perspective view of the interspinous process spacer of the present invention illustrated in FIG. 1. 2 is a side view of the interspinous spacer of the present invention as illustrated in FIG. FIG. 2 is a front view of an interspinous spacer of the present invention as illustrated in FIG. 2 is a top view of an interspinous spacer according to the present invention as illustrated in FIG. FIG. 6 is a cross-sectional view of the interspinous process spacer of the present invention taken along line AA in FIG. 5. FIG. 2 is a perspective view illustrating that the fusion promoting substance of the interspinous process spacer illustrated in FIG. 1 is disposed inside the inner lumen according to an aspect of the present invention. It is the perspective view which illustrated the interspinous process spacer by the 2nd Embodiment of this invention. FIG. 9 is a side view illustrating an interspinous spacer according to the present invention as illustrated in FIG. 10 is an end view illustrating an interspinous spacer according to the present invention as illustrated in FIGS. 8 and 9. FIG. FIG. 9 is a perspective view illustrating that an interspinous process spacer according to a third embodiment of the present invention is used while being fixed to an upper spinous process of a subject spine. FIG. 12 is a front view illustrating an interspinous process spacer according to the present invention as illustrated in FIG. 11 in place between two spinous processes. FIG. 12 is a side view illustrating an interspinous spacer according to the present invention as illustrated in FIG. 11 in place between two spinous processes. FIG. 12 is a side view illustrating that the interspinous process spacer according to the present invention as illustrated in FIG. 11 is in place between two spinous processes and at the same time the fusion inducer is clogged therein. . FIG. 12 is a front view illustrating an interspinous spacer according to the present invention as illustrated in FIG. 11. FIG. 12 is a top view illustrating an interspinous spacer according to the present invention as illustrated in FIG. 11. FIG. 12 is a rear view illustrating an interspinous spacer according to the present invention as illustrated in FIG. 11. FIG. 12 is a bottom view illustrating an interspinous spacer according to the present invention as illustrated in FIG. 11. 12 is a side view illustrating an interspinous spacer according to the present invention as illustrated in FIG. FIG. 12 is a perspective view illustrating that an interspinous spacer according to the present invention as illustrated in FIG. 11 includes a visualization marker. FIG. 12 illustrates a specific insertion instrument used in conjunction with the interspinous process spacer of FIG. 11 according to one embodiment of the present invention. FIG. 12 illustrates a specific insertion instrument used in conjunction with the interspinous process spacer of FIG. 11 according to one embodiment of the present invention. FIG. 12 illustrates a specific insertion instrument used in conjunction with the interspinous process spacer of FIG. 11 according to one embodiment of the present invention. FIG. 12 illustrates a specific sizing instrument for use in implanting an interspinous spacer as illustrated in FIG. 11 according to one embodiment of the present invention. FIG. 12 illustrates a specific sizing instrument for use in implanting an interspinous spacer as illustrated in FIG. 11 according to one embodiment of the present invention. FIG. 12 illustrates a specific sizing instrument for use in implanting an interspinous spacer as illustrated in FIG. 11 according to one embodiment of the present invention. FIG. 12 illustrates a specific sizing instrument for use in implanting an interspinous spacer as illustrated in FIG. 11 according to one embodiment of the present invention. FIG. 12 illustrates an alternative attachment device for use with the interspinous process spacer illustrated in FIG. 11 according to an alternative embodiment of the present invention. FIG. 12 illustrates an alternative attachment device for use with the interspinous process spacer illustrated in FIG. 11 according to an alternative embodiment of the present invention. FIG. 12 is a diagram exemplifying that the dorsal X-ray fluoroscope imaged during mounting of the interspinous process spacer of FIG. 11 proves that a plurality of markers are aligned (including T-shaped organization) and supports installation. is there. The positioning X-ray fluoroscope imaged during the mounting of the interspinous process spacer of FIG. 11 demonstrates the positions of a plurality of markers (including L-shaped knitting when viewed from the back side) to support the installation. FIG.

Claims (43)

A method for treating spinal stenosis comprising:
Approaching the space between the spinous processes located between the upper and lower spinous processes;
Stripping a portion of the upper spinous process;
Inserting the graft into the space between the spinous processes;
Connecting the graft to the upper spinous process;
A method characterized by comprising.   The method of claim 1, wherein the graft is provided with at least one opening to allow bone to grow into the graft.   The implant has an internal chamber in communication with the at least one aperture, and the method includes: inserting the implant into the chamber either before or after connecting the implant to the spinous process. The method of claim 2, further comprising the step of packing the fusion-inducing substance.   The fusion inducer includes any one of bone morphogenetic protein, demineralized bone matrix, allograft cancellous bone, autograft bone, hydroxyapetite, and heel. The method of claim 3, wherein:   4. The method of claim 3, wherein the at least one opening is placed in contact with the superior spinous process.   The implant is provided with an opening for connecting and detachably attaching an insertion tool, and the method further includes securing the insertion tool to the graft before inserting the graft. The method according to claim 1.   7. The insertion instrument is provided with a pair of protrusions, and the protrusions are fitted with a pair of insertion openings set to dimensions to receive the protrusions. The method described in 1.   The implant is provided with at least two pairs of apertures for mating with the insertion instrument, and the method further includes selecting which pair of apertures are mated. The method according to claim 7.   The method of claim 1, wherein the graft is connected to the superior spinous process with at least one of a tether, screw, clamp, zip cable, and the like.   The method of claim 9, wherein the tether is one of a wire, cable, suture, allograft tissue, and the like.   The graft is provided with at least one opening sized to receive the tether, and the method includes passing the tether through the at least one opening sized to receive the tether. 11. The method of claim 10, further comprising the step of binding to a spinous process.   A zip cable is used, the method comprising: securing the zip cable to the implant at least one time before and after inserting the graft; and wrapping the zip cable around an upper spinous process 10. The method of claim 9, further comprising: passing a zip cable through a base secured to the graft opposite the superior spinous process.   The graft includes a primary opening to allow bone to grow into the graft, and at least one secondary opening to allow bone to grow into the graft. The method according to claim 2, wherein: is provided.   The graft is provided with a notch sized to receive a portion of the upper spinous process, and the method includes either one of the dimensions and mold of the portion of the upper spinous process or the mold during insertion of the graft. The method of claim 2 further comprising the step of determining both.   15. The method of claim 14, wherein the at least one opening for allowing bone to grow into the graft is located inside the notch.   15. The method of claim 14, wherein a secondary notch is placed in the bottom surface of the graft, and the secondary notch interacts with a superior spinous process.   The method of claim 1, wherein the graft is made from non-bone material.   The method of claim 17, wherein the graft is made from one of polyetheretherketone and polyetherketoneketone.   The implant is provided with at least one radiopaque marker, and the method comprises imaging for viewing the marker element at one time during and after insertion of the implant. The method of claim 17, further comprising the step of ensuring that the marker elements are properly aligned using a technique.   The marker is placed in the anterior-posterior direction at the center of the implant, and the method further comprises aligning the top surface of the marker with the upper spinous process and aligning the bottom surface of the marker with the lower spinous process. The method according to claim 19, wherein:   An additional marker is placed on both sides of the graft, and the method further comprises placing the graft such that the additional marker is placed on both sides of the spinous process. Item 20. The method according to Item 19.   At least one of the additional markers on either side of the spinous process is placed in front of the graft, and the method ensures that the graft is not placed too close to the spinal canal The method of claim 21, further comprising: A system for treating spinal stenosis,
The size is set to fit between the upper spinous process and the lower spinous process, is configured to be easily fused to the upper spinous process, and is configured to prevent fusion to the lower spinous process. The graft being made,
At least one of a tether, a screw, a clamp, a zip cable, etc., wherein the graft is connected to the upper spinous process,
A system characterized by that.   24. The system of claim 23, wherein the graft is provided with at least one opening to allow bone to grow into the graft.   The implant has an internal chamber in communication with at least one opening, the chamber being one of before connecting the implant to the spinous process and after connecting the implant to the spinous process. 25. A system according to claim 24, characterized in that, at the time, the fusion-inducing substance is set to a receiving size.   The fusion inducer includes any one of bone morphogenetic protein, demineralized bone matrix, allograft cancellous bone, autograft bone, hydroxyapetite, and heel. 26. The system of claim 25, wherein:   26. The system of claim 25, wherein the at least one opening is positioned to contact the superior spinous process.   24. The system of claim 23, wherein the implant is provided with an opening for removably attaching an insertion device.   29. The insertion tool according to claim 28, wherein the insertion device is provided with a pair of protrusions, and the protrusions are fitted with a pair of insertion openings set to dimensions to receive the protrusions. The system described.   30. The system of claim 29, wherein the implant is provided with at least two pairs of openings for mating with the insertion instrument in a plurality of different orientations.   24. The system of claim 23, wherein the tether is one of a wire, a cable, a suture, an allograft tissue, and the like.   The implant is provided with at least one opening sized to receive the tether, and the method passes the tether through the at least one opening sized to receive the tether. 24. The system of claim 23, further comprising tying to a superior spinous process.   A zip cable is used, the zip cable includes a cable, two bases, and two lock pins, such that the cable wraps around the upper spinous process and is in fixed engagement with both bases. 24. The system of claim 23, wherein the system is set to a dimension.   The graft includes a primary opening to allow bone to grow into the graft, and at least one secondary opening to allow bone to grow into the graft. 25. The system according to claim 24, characterized in that is provided.   25. The system of claim 24, wherein the graft is provided with a notch sized to receive a portion of the superior spinous process.   36. The system of claim 35, wherein the at least one opening for allowing bone to grow into the implant is located inside the notch.   37. The system of claim 36, wherein a secondary notch is installed in the bottom surface of the implant, and the secondary notch is dimensioned to mate with a superior spinous process. .   24. The system of claim 23, wherein the graft is made from non-bone material.   40. The system of claim 38, wherein the implant is made from one of polyetheretherketone and polyetherketoneketone.   40. The system of claim 38, wherein the implant is provided with at least one radiopaque marker that can be viewed using imaging techniques.   The marker is installed in the front-rear direction at the center of the graft, and the marker can be aligned with the apical end of the upper spinous process and the apical end of the lower spinous process to ensure proper installation. 41. The system of claim 40.   Additional markers are placed on both sides of the graft, at least one of the additional markers on both sides is placed on the front of the graft, and the additional marker on one side placed on the front of the graft is attached to the spinal canal. 42. The system of claim 41, wherein the system can be aligned with respect to each other. A method for treating spinal stenosis comprising:
Approaching the space between the spinous processes located between the upper and lower spinous processes;
Stripping only a portion of one of the upper and lower spinous processes;
Inserting the graft into the space between the spinous processes;
Connecting the graft to the deprived spinous process;
A method characterized by comprising.

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