WO2019035944A1 - Rondelle de blocage de suture destinée à être utilisée avec un ancrage osseux, et procédé de support du pouce - Google Patents

Rondelle de blocage de suture destinée à être utilisée avec un ancrage osseux, et procédé de support du pouce Download PDF

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Publication number
WO2019035944A1
WO2019035944A1 PCT/US2018/000217 US2018000217W WO2019035944A1 WO 2019035944 A1 WO2019035944 A1 WO 2019035944A1 US 2018000217 W US2018000217 W US 2018000217W WO 2019035944 A1 WO2019035944 A1 WO 2019035944A1
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WO
WIPO (PCT)
Prior art keywords
sling
anchor
thumb
metacarpal
index
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2018/000217
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English (en)
Inventor
Sidney Fleischman
James Whayne
Izi Bruker
Jeanne L. DELSIGNORE
Kevin L. Ohashi
James Christopher HARBER
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CMC Group LLC
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CMC Group LLC
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Publication date
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Publication of WO2019035944A1 publication Critical patent/WO2019035944A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0403—Dowels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0404—Buttons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0448—Additional elements on or within the anchor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0459—Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied

Definitions

  • This invention relates to novel orthopedic medical devices for locking an elongated element
  • a suture e.g., a suture
  • a bone anchor e.g., a suture
  • a novel sling suspension system for supporting the thumb of a patient after basal joint arthroplasty.
  • novel orthopedic medical devices of the present invention may, alternatively, relate to tenodesis applications, or other soft tissue-to-bone attachment applications, in which conventional screw anchors (or other types of anchors), or other
  • implantable medical devices are augmented with novel suture attachment mechanisms that obviate the need to tie knots in the suture when attaching the suture to a bone anchor (or to another implantable medical device) or to tissue.
  • metacarpal joint of the thumb (sometimes referred to as “the basal joint") is a common debilitating
  • basal joint reconstruction In severe cases of basal joint arthritis, basal joint reconstruction may be required.
  • basal joint reconstruction involves trapezial excision (sometimes referred to as “basal joint arthroplasty”), which is required for pain relief, and subsequent soft tissue reconstruction in order to restore proper balance, alignment, longitudinal length and function to the thumb.
  • anatomical objects e.g., bone, soft tissue,
  • prostheses, etc. need to be attached to one another. And in many situations, it may be desirable to effect this attachment with suture. However, it can be desirable to effect this attachment with suture. However, it can be desirable to effect this attachment with suture. However, it can be desirable to effect this attachment with suture.
  • the present invention comprises the provision and use of novel suture-securing mechanisms that enable the tightening and locking (e.g., cinching) of suture to an anchor or other implantable medical device without the need to tie knots in the suture in order to adjustably secure the suture to the anchor or other implantable medical device.
  • novel suture-securing mechanisms that enable the tightening and locking (e.g., cinching) of suture to an anchor or other implantable medical device without the need to tie knots in the suture in order to adjustably secure the suture to the anchor or other implantable medical device.
  • suture-locking washers which are mounted to bone anchors, wherein the suture-locking washers comprise suture-securing mechanisms.
  • the present invention also comprises the
  • the invention comprises suture-locking washers comprising suture-securing mechanisms, wherein the suture-locking washers are utilized in combination with bone anchors to form a novel sling suspension system which can be used to join the thumb metacarpal to the index metacarpal, whereby to enable tightening and locking (e.g., cinching) of a sling (e.g., a suture) of the sling suspension system so as to support the thumb of a patient after basal joint arthroplasty.
  • a sling e.g., a suture
  • the present invention eliminates the specific complications and increased morbidity associated with tendon harvesting and transfer procedures, and also eliminates the complications and increased morbidity associated with those procedures that require temporary pin fixation or drill holes for tendon or suture passage.
  • the novel sling suspension system of the present invention provides secure and stable support for the thumb of a patient after performing basal joint arthroplasty so as to alleviate basal joint arthritis, and is fast and simple to use, since the suture-securing mechanism of the suture- locking washer eliminates the need to ' tie knots in the suture in order to secure the suture to a bone anchor.
  • a sling suspension system for supporting the thumb of a patient after basal joint arthroplasty, the sling suspension system comprising:
  • a sling e.g., a suture for securing the thumb metacarpal anchor to the index metacarpal anchor
  • the index metacarpal anchor comprising at least one bone-engaging element for securing the index metacarpal anchor to bone and a sling-engaging element for capturinq the sling to the index metacarpal anchor ;
  • the thumb metacarpal anchor comprising at least one bone-engaging element for securing the thumb metacarpal anchor to bone and a sling-engaging element for capturing the sling to the thumb metacarpal anchor ;
  • the sling comprising an elongated body having a first anchor-engaging element for securing the sling to the sling-engaging element of the index metacarpal anchor, and a second anchor-engaging element for securing the sling to the sling-engaging element of the thumb metacarpal anchor;
  • the at least one sling-engaging element of the thumb metacarpal anchor comprises at least one suture-locking washer for adjustably securing the sling to the thumb metacarpal anchor.
  • a method for supporting the thumb of a patient after basal joint arthroplasty comprising:
  • suture-securing mechanism of the thumb metacarpal anchor is provided via a suture-locking washer which is secured to the thumb metacarpal anchor.
  • the method comprising:
  • a sling e.g., a suture
  • suture-securing mechanism of the thumb metacarpal anchor is provided via a suture-locking washer which is secured to the thumb metacarpal anchor.
  • the suture-locking washer (which carries the suture- securing mechanism) is formed integral with the thumb metacarpal anchor.
  • the suture-locking washer (which carries the suture- securing mechanism) is mounted to a bone anchor (which may be used as the thumb metacarpal anchor, or as the index metacarpal anchor, or as an anchor for other locations within the body) or to another implantable medical device.
  • the suture-securing mechanism may be incorporated directly into a bone anchor (which may be used as the thumb metacarpal anchor, or as the index metacarpal anchor, or as an anchor for other locations within the body) or into another implantable medical device.
  • a sling suspension system for supporting the thumb of a patient after basal joint arthroplasty, the sling suspension system comprising:
  • said index metacarpal anchor comprising at least one bone-engaging element for securing said index metacarpal anchor to an index metacarpal, and a sling- engaging element for attaching said sling to said index metacarpal anchor;
  • said thumb metacarpal anchor comprising at least one bone-engaging element for securing said thumb metacarpal anchor to a thumb metacarpal, and a sling- engaging element for attaching said sling to said thumb metacarpal anchor;
  • At least one of said sling-engaging element of said thumb metacarpal anchor and said sling-engaging element of said index metacarpal anchor comprises a sling-securing mechanism which is
  • a method for supporting the thumb of a patient after basal joint arthroplasty comprising:
  • sling suspension system comprising:
  • said index metacarpal anchor comprising at least one bone-engaging element for securing said index metacarpal anchor to an index metacarpal, and a sling-engaging element for attaching said sling to said index metacarpal anchor;
  • said thumb metacarpal anchor comprising at least one bone-engaging element for securing said thumb metacarpal anchor to a thumb metacarpal, and a sling-engaging element for attaching said sling to said thumb metacarpal anchor;
  • At least one of said sling-engaging element of said thumb metacarpal anchor and said sling-engaging element of said index metacarpal anchor comprises a sling-securing mechanism which is
  • said apparatus comprising:
  • tubular structure disposed in said opening, said tubular structure comprising a side wall defining a passageway, a portion of said side wall of said tubular structure projecting into said passageway so as to provide one-way movement of a filament through said passageway.
  • said apparatus comprising:
  • tubular structure disposed in said opening, said tubular structure comprising a side wall defining a passageway, a portion of said side wall of said tubular structure projecting into said passageway so as to provide one-way movement of a filament
  • Fig. 1 is a schematic view showing the bone structure of the right hand of a human
  • Fig. 2 is a schematic view showing a basal joint reconstruction using the novel sling suspension system of the present invention
  • Fig. 3 is a schematic view showing a novel sling suspension system formed in accordance with the present invention, wherein the novel sling suspension system comprises an index metacarpal anchor with a suture secured thereto, and a thumb metacarpal anchor with a suture adjustably secured thereto, wherein the suture is adjustably sepured to the thumb metacarpal anchor via a suture-locking washer;
  • Figs. 4-11 are various views of selected portions of the novel sling suspension system shown in Fig. 3;
  • Fig. 12 is a flattened view of selected portions of the suture-securing mechanism of the suture-locking washer shown in Figs. 4-11;
  • Figs. 13-15 are schematic views showing another novel suture-securing mechanism formed in accordance with the present invention, wherein the suture- securing mechanism comprises a plurality of
  • Fig. 16 is an perspective schematic view of the suture-securing mechanism show in Figs. 13-15;
  • Figs. 17-23 are schematic views of another novel suture-locking washer formed in accordance with the present invention.
  • Figs. 24-27 are various schematic sectional views of the suture-locking washer of Figs. 17-23;
  • Figs. 28-30 are schematic views of a deployment assembly for deploying the novel sling suspension system of the present invention.
  • Figs. 31 and 32 are schematic views of another deployment assembly for deploying the novel sling suspension system of the present invention.
  • Figs. 33-53 are schematic views illustrating another novel suture-locking washer and thumb
  • Figs. 54-57 are schematic views illustrating
  • metacarpal anchor formed in accordance with the
  • Figs. 58-61 are schematic views illustrating how the suture-securing mechanisms of the present
  • inventions may be mounted within the suture-locking washers ;
  • Figs. 62-65 are various schematic views of a
  • Fig. 66 is a schematic view showing another novel sling suspension system formed in accordance with the present invention.
  • Fig. 67 is a schematic view showing another novel system formed in accordance with the present invention and useful for effecting a surgical repair.
  • Fig. 68-72 are schematic views showing exemplary surgical repairs performed in accordance with the
  • Fig. 1 there is shown the right hand 5 of a human. As seen in the figure, the basal joint 10' is formed at the junction of the thumb metacarpal 15 and the trapezium 20. Note also the location of the adjacent index metacarpal 25.
  • the present invention provides a new approach for effecting basal joint reconstruction after performing basal joint arthroplasty in order to alleviate basal joint arthritis.
  • the present invention comprises the provision and use of a novel sling suspension system 30 that joins the thumb metacarpal to the index metacarpal so as to support the thumb of a patient after basal joint arthroplasty.
  • novel sling suspension system 30 generally comprises an index metacarpal anchor 35 having a sling (e.g., a suture) 40 fixedly secured thereto, and a thumb metacarpal anchor 45 having sling (e.g., a suture) 40 adjustably secured thereto.
  • a sling e.g., a suture
  • thumb metacarpal anchor 45 having sling (e.g., a suture) 40 adjustably secured thereto.
  • novel sling suspension system 30 may be used in a procedure to alleviate basal joint arthritis, wherein:
  • the trapezium of a patient is excised; the index metacarpal anchor is positioned in the index metacarpal;
  • the thumb metacarpal anchor is positioned in the thumb metacarpal
  • the sling is tightened by pulling a free end of the sling relative to a suture-securing mechanism of the thumb metacarpal anchor so that the sling is fixedly secured to the thumb metacarpal anchor, whereby the sling fixedly connects the thumb
  • the novel sling suspension system of the present invention provides secure and stable support for the thumb of a patient after performing basal joint arthroplasty in order to alleviate basal joint
  • invention comprises the provision and use of a novel sling suspension system comprising a knotless sling attachment that can be used to join the thumb
  • the present invention eliminates the specific
  • the novel sling suspension system comprises at least one suture- locking washer for use with a bone anchor, wherein the at least one suture-locking washer comprises at least one suture-securing mechanism to enable tightening and securing (e.g., cinching) of a suture (i.e., the
  • sling once appropriate anchors (e.g., an index finger screw anchor, a thumb screw anchor, etc.) are positioned in the anatomy so as to provide stable support for the thumb of a patient after performing basal joint arthroplasty, whereby to alleviate basal joint arthritis.
  • the novel sling suspension system of the present invention is relatively fast and simple to i implement .
  • Fig. 3 shows a novel sling suspension system 30 for disposition in and between an index finger and a thumb of a human hand.
  • Sling suspension system 30 generally comprises index metacarpal anchor 35 for deployment in index metacarpal 25, thumb metacarpal anchor 45 for
  • sling 40 e.g., a suture
  • thumb metacarpal anchor 45 to index metacarpal anchor 35
  • sling 40 may comprise substantially any elongated flexible element, and is not intended to be limited to suture.
  • sling 40 may comprise structure in addition to an elongated flexible element (e.g., a suture).
  • sling 40 may comprise a hammocklike structure mounted to one or more elongated flexible elements (e.g., .sutures), such that the one or more elongated flexible elements (e.g., sutures) may be mounted to index metacarpal anchor 35 and thumb metacarpal anchor 45, and the hammock-like structure may engage and support portions of thumb metacarpal Index metacarpal anchor 35 is intended to be deployed in (e.g., screwed into or pushed into) a drill hole (i.e., a bone hole) formed at or near the base of index metacarpal 25. See Fig. 2.
  • a drill hole i.e., a bone hole
  • index metacarpal anchor 35 may comprise a self-tapping anchor, in which case the bone hole is formed during delivery of the bone anchor into the index metacarpal.
  • index metacarpal anchor 35 comprises a body 50 having at least one bone-engaging element 55 (e.g., screw threads, ribs, etc.) (see Fig. 3) formed thereon for engaging the side wall of the bone hole, i.e., for engaging index metacarpal 25.
  • bone-engaging element 55 e.g., screw threads, ribs, etc.
  • index metacarpal anchor 35 can be secured to index metacarpal 25.
  • Index metacarpal anchor 35 further comprises a sling-engaging element 60 (e.g., a recessed eyelet) (see Fig. 3) for capturing sling 40 to index metacarpal anchor 35.
  • Thumb metacarpal anchor 45 is intended to be deployed in (e.g., screwed into or pushed into) a drill hole (i.e., a bone hole) formed at or near the base of thumb metacarpal 15. See Fig. 2.
  • thumb metacarpal anchor 45 may comprise a self-tapping anchor, in which case the bone hole is formed during delivery of the bone anchor into the thumb metacarpal.
  • thumb metacarpal anchor 45 comprises a body 65 having at least one bone-engaging element 70 (e.g., screw threads, ribs, etc.) (see Fig. 3) formed thereon for engaging the side wall of the bone hole, i.e., for engaging thumb metacarpal 15.
  • bone-engaging element 70 e.g., screw threads, ribs, etc.
  • Thumb metacarpal anchor 45 further comprises a suture-locking washer 75 (i.e., a sling-engaging element) for mounting to thumb
  • suture-locking washer 75 comprises a body having a hole formed therein (see Fig. 7) for mounting the suture-locking washer to thumb metacarpal anchor 45.
  • suture-locking washer 75 is rotatably secured to thumb metacarpal anchor 45 so that suture-locking washer 75 is able to traverse (i.e., rotate) 360 degrees around the longitudinal axis of body 65 of thumb metacarpal anchor 45.
  • suture-locking washer 75 is rotatably mounted to thumb metacarpal anchor 45 with a screw 77 (see Fig. 3) which passes through a hole 78 (see Fig. 7) formed in suture-locking washer 75 and into thumb metacarpal anchor 45.
  • Sling 40 secures thumb metacarpal anchor 45 to index metacarpal anchor 35, whereby to provide, in combination with thumb metacarpal anchor 45 and index metacarpal anchor 35, a sling suspension system for supporting the thumb of a patient after basal joint arthroplasty has been performed to alleviate basal joint arthritis.
  • sling 40 comprises an elongated flexible body (e.g., a suture) having a first end 80 and a second end 85. See Fig. 3. And in one
  • sling 40 includes an anchor-engaging element (not shown), e.g., a knot or looped section of the sling, for securing sling 40 to index metacarpal anchor 35 such that the sling is attached to index metacarpal anchor 35.
  • anchor-engaging element e.g., a knot or looped section of the sling
  • sling 40 comprises first end 80 and second end 85 which engage suture- locking washer 75 (which is itself mounted to thumb metacarpal anchor 45), and an intermediate portion of the elongated flexible body (e.g., the suture) which engages index metacarpal anchor 35. See Fig. 3.
  • Suture-locking washer 75 comprises one or more adjustable suture-securing mechanisms 95 (see Figs. 9- 11) for securing sling 40 to suture-locking washer 75 of thumb metacarpal anchor 45 such that the sling is adjustably attached to thumb metacarpal anchor 45, as will hereinafter be discussed.
  • the elongated body of sling 40 may comprise a flexible filament (e.g., a suture, a rope, a web, a tape, etc.), or some other flexible elongated
  • sling 40 comprises a suture.
  • suture can be a hollow or solid core braided suture, a
  • sling 40 may be
  • index metacarpal anchor 35 and thumb metacarpal anchor 45 both of which are fixedly secured to bone.
  • index metacarpal anchor 35 and thumb metacarpal anchor 45 both comprise screw anchors that engage the bone of a metacarpal and remain affixed to a metacarpal as the associated sling 40 (which is coupled to index metacarpal anchor 35 and thumb metacarpal anchor 45) is tightened and secured (i.e., cinched) to thumb metacarpal anchor 45.
  • sling 40 preferably comprises two suture strands (preferably high- strength, high-density polyethylene suture or the equivalent) which are looped or tied (or otherwise secured) to the base (i.e., the proximal end) of index metacarpal anchor 35.
  • sling 40 may comprise a single strand of suture which is looped through (or otherwise secured to) the base (i.e., the proximal end) of index metacarpal anchor 35, e.g., such as by looping the suture through sling- engaging element 60 (e.g., a recessed eyelet).
  • the free ends 80, 85 of sling 40 are threaded through suture-securing mechanism 95 of suture-locking washer 75.
  • Suture-locking washer 75 is mounted to thumb metacarpal anchor 45 which, in one preferred form of the invention, comprises a screw anchor. It should be appreciated that, if desired, suture-locking washer 75 may, alternatively and/or additionally, be coupled to index metacarpal anchor 35. However, due to the clinical ease of pulling the sling relative to the thumb metacarpal anchor 45, in the preferred form of the present invention, suture-locking washer 75 is secured to thumb metacarpal anchor 45 as shown in Fig
  • Suture-locking washer 75 is mounted to the base (i.e., the proximal end) of thumb metacarpal anchor 45, and comprises the aforementioned at least one suture-securing mechanism 95. See Figs. 9-11.
  • Suture-securing mechanism 95 is shown in greater detail in Figs. 9-12. In one preferred form of the invention, two suture-securing mechanisms 95 are utilized, each of which allows the passage and attachment of a free end 80, 85 of sling 40 to suture- locking washer 75, as will hereinafter be discussed in further detail.
  • index metacarpal anchor 35 is secured to the index metacarpal
  • thumb metacarpal anchor 45 is positioned in the thumb metacarpal
  • the free end(s) 80, 85 of sling 40 are retracted (i.e., pulled, or "cinched") as the thumb is positioned relative to the index finger.
  • Suture-securing mechanisms 95 shown in flattened form in Fig.
  • suture-holding elements 100 e.g., barbs
  • suture-securing mechanisms 95 prevent sling 40 from sliding in the opposite direction of tightening, thereby preventing slipping of sling 40 and affixedly attaching sling 40 (and thus thumb metacarpal 15 and index metacarpal 25) into stable 8 000217
  • the suture-securing mechanisms 95 shown in Figs. 9-12 generally comprise tubular structures 102 (Fig.
  • tubular structures 102 start as a flat sheet of material, have suture-holding
  • tubular structure 102 a tubular structure
  • suture- securing mechanisms 95 are fixedly secured in holes 103 formed in suture-locking washer 75, whereby to fix suture- securing mechanisms 95 relative to suture-locking
  • tubular structures 102 of suture-securing mechanisms 95 are press-fit into holes 103.
  • suture-securing mechanisms 95 may also comprise protrusions 105 that may be positioned to engage the outer surfaces of suture- locking washer 75 so as to maintain the position of the suture-securing mechanisms 95 relative to suture- locking washer 75. If desired, one or both ends of holes 103 may be provided with a counterbore 110 (Fig. 14) for receiving protrusions 105.
  • suture- securing mechanisms 95 may comprise two “rows” and four “columns” (i.e., relative to the longitudinal axis of the suture-securing mechanism 95) of suture- holding elements (barbs or teeth) 100 that are offset from one another in order to prevent compressing sling 40 between the "points" of opposing barbs or teeth 100.
  • Four columns are preferable in order to allow pre-positioning of the barbs or teeth 100 inwardly.
  • barbs or teeth 100 Fewer or more rows of barbs or teeth 100 may be used, provided that the desired pull force is achieved and the height of anchor washer 75 (which is partially determined by the length of the suture-securing mechanism) is small enough to limit the profile of the thumb metacarpal anchor 45 (including the suture- locking washer 75 mounted thereto) from extending above the base of thumb metacarpal 15 upon deployment of thumb metacarpal anchor 45.
  • suture- securing mechanisms 95 may comprise fewer columns with longer barb or teeth widths so that the barbs or teeth 100 do not fracture or weaken upon deflecting, and/or barbs or teeth 100 may be pre-positioned inwardly so as to allow engagement of sling 40. Such a pattern of barbs or teeth 100 increases the pull force while limiting damage to sling 40.
  • Sling suspension system 30 may be used in the following manner to support the thumb of a patient after a basal joint arthroplasty has been performed to alleviate basal joint arthritis.
  • the patient's trapezium is excised (see Fig. 2) to alleviate the basal joint arthritis.
  • Index metacarpal 25 and thumb metacarpal 15 are prepared to receive index metacarpal anchor 35 and thumb metacarpal anchor 45, respectively.
  • a bone hole is drilled into the thumb side of index metacarpal 25, and a bone hole is drilled into the base of thumb metacarpal 15. Note that the space created by the excised trapezium allows easy access to the base of thumb metacarpal 15 and to the thumb side of index metacarpal 25.
  • Sling 40 is attached to index metacarpal anchor 35 using sling-engaging element 60 (e.g., an eyelet) of index metacarpal anchor 35 and an anchor- engaging element (e.g., a knot) of sling 40, and sling 40 is attached to suture-locking washer 75 and suture- locking washer 75 is attached to thumb metacarpal anchor 45, if they are not already in this
  • sling-engaging element 60 e.g., an eyelet
  • anchor- engaging element e.g., a knot
  • Index metacarpal anchor 35 is sequred in the bone hole formed in index metacarpal 25.
  • Thumb metacarpal anchor 45 is secured in the bone hole formed in the base of thumb metacarpal 15.
  • the free end(s) 80, 85 of sling 40 is/are tensioned (i.e., cinched), whereby to correctly position thumb metacarpal anchor 45 relative to index metacarpal anchor 35, and hence to correctly position thumb metacarpal 15 relative to index metacarpal 25, so as to provide the desired reconstructed basal joint. See Fig. 3.
  • Free end(s) 80, 85 of secured sling 45 can then be cut with an appropriate instrument if desired.
  • Figs. 17-27 show an alternative suture-locking washer 75A wherein the one or more suture-securing mechanisms 95 are formed integral with the body of suture-locking washer 75A (i.e., the side walls of suture-securing mechanisms 95 are the side walls of holes 103 passing through the suture-locking washer) . See Figs. 19 and 24-26. In this form of the
  • suture-locking washer 75A comprises multiple holes 103 for sling 40 (i.e., a suture) to pass through, with at least one of the holes 103 including suture-holding elements (barbs or teeth) 100 positioned so as to allow passage of sling 40 in one direction while preventing slippage of the sling in the opposite direction.
  • Others of holes 103 may omit barbs or teeth 100 (i.e., others of holes 103 may comprise smooth inside walls) .
  • deployment assembly 115 which may be used to deploy sling suspension system 30. More particularly, deployment assembly 115 may be used to set index metacarpal anchor 35 into index metacarpal 25 (e.g., to insert index metacarpal anchor 35 into a bone hole formed in index metacarpal 25) and/or to set thumb metacarpal anchor 45 into thumb metacarpal 15 (e.g., to insert thumb metacarpal anchor 45 into a bone hole formed in thumb metacarpal 15) .
  • index metacarpal anchor 35 into index metacarpal 25
  • thumb metacarpal anchor 45 into thumb metacarpal 15
  • deployment assembly 115 preferably comprises a shaft 120 having a drive feature (e.g., a hex driver) 121 (Fig. 29) at its distal end for engaging (i) a drive feature (e.g., a hex driver) 121 (Fig. 29) at its distal end for engaging (i) a drive feature (e.g., a hex driver) 121 (Fig. 29) at its distal end for engaging (i) a drive feature (e.g., a hex driver) 121 (Fig. 29) at its distal end for engaging (i) a drive feature (e.g., a hex driver) 121 (Fig. 29) at its distal end for engaging (i) a drive feature (e.g., a hex driver) 121 (Fig. 29) at its distal end for engaging (i) a drive feature (e.g., a hex driver) 121 (Fig. 29) at its distal end for engaging (i) a drive feature
  • counterpart drive feature e.g., a hexagonal recess
  • a counterpart drive feature e.g., a hexagonal recess
  • a counterpart drive feature e.g., a hexagonal recess
  • a counterpart drive feature e.g., a hexagonal recess
  • a handle 125 (Fig. 28) is provided at the proximal end of shaft 120 of deployment assembly 115.
  • suture- locking washer 75A is affixed to thumb metacarpal anchor 45 at the time of manufacture, so that the surgeon does not have to worry about fixing the suture-locking washer to the thumb metacarpal anchor at the time of use. See Fig. 28.
  • index metacarpal anchor 35 is pre-loaded onto the distal end of shaft 120 of deployment assembly 115 at the time of system assembly, e.g., as shown in Figs. 28 and 29.
  • Thumb metacarpal anchor 45, with suture-locking washer 75A pre-affixed thereto, is preferably pre-loaded onto handle 125 of deployment assembly 115 (Figs. 28 and 30) .
  • thumb metacarpal anchor 45 (with suture-locking washer 75A pre-affixed thereto) is loaded on the distal end of shaft 120 of deployment assembly 115 and deployment assembly 115 is then used to set thumb metacarpal anchor 45 (with suture-locking washer 75A pre-affixed thereto) into thumb metacarpal 15.
  • deployment assembly 115 is preferably provided with a channel 130 (Figs. 28 and 30) that allows passage of sling 40 along shaft 120 to a suture-locking washer 75A mounted onto a thumb metacarpal anchor 45.
  • Figs. 31 and 32 show another form of deployment assembly 115A, wherein thumb metacarpal anchor 45 is loaded onto shaft 120 of deployment assembly 115A (as opposed to thumb metacarpal anchor 45 being loaded onto handle 125 of deployment assembly 115).
  • Figs. 33-53 show still another form of suture- locking washer and thumb metacarpal anchor formed in accordance with the present invention. More
  • a suture-locking washer 75B comprising at least two suture-securing mechanisms 95B. See Fig. 33.
  • Suture-locking washer 75B is configured to mount to the proximal end of a screw-type thumb metacarpal anchor 45, whereby to permit the suture to be
  • Anchor washer 75B is generally C-shaped (Figs. 39-41) and preferably comprises a bore 132 and a counterbore 133, wherein bore 132 receives the shaft 134 of thumb metacarpal anchor 45 (Fig. 43) and counterbore .133 receives the head 135 of thumb metacarpal anchor 45, whereby to facilitate mounting anchor washer 75B to the proximal end of thumb metacarpal anchor 45.
  • suture-securing mechanisms 95B preferably comprise a connecting bar 145 (see Figs.
  • anchor washer 75B may be secured to thumb metacarpal anchor 45 and/or sling 40 and/or deployment assembly 115 at the time of manufacture and may be sterilized as a unit prior to delivery to an end user (e.g., a surgeon) .
  • suture-locking washers 75, 75A and 75B are disclosed as having suture-securing mechanisms 95 mounted to the suture- locking washer such that (a) free end(s) of sling 40 (e.g., the free end(s) of a suture) can be passed through a given suture-securing mechanism 95 which is, in turn, mounted to a given suture-locking washer 75, 75A or 75B, whereby to facilitate knotless securement of the free end(s) of sling 40 to a suture-locking washer 75, 75A, 75B.
  • suture-securing mechanisms 95 mounted to the suture- locking washer such that (a) free end(s) of sling 40 (e.g., the free end(s) of a suture) can be passed through a given suture-securing mechanism 95 which is, in turn, mounted to a given suture-locking washer 75, 75A or 75B, whereby to facilitate knotless securement of the free end(s) of sling 40 to a
  • suture-locking washers 75, 75A and 75B are disclosed as having one or more suture-securing mechanisms 95 disposed parallel to the longitudinal axis of an anchor to which the suture-locking washer 75, 75A and 75B is attached. See, for example, Figs. 9, 30 and 53.
  • the one or more holes 103 formed in the suture-locking washer which are configured to receive the one or more suture-securing mechanisms 95 may be disposed perpendicular (rather than parallel) to the longitudinal axis of an anchor to which the suture- locking washer is mounted.
  • suture-securing mechanisms 95 are disposed perpendicular to the longitudinal axis of an anchor to which the suture locking washer is mounted.
  • holes 103 preferably comprise stepped bores 151 and 152, which together define a shoulder 153 formed therein. Shoulder 153 provides a stop for seating a suture-securi-ng mechanism 95 within a hole 103. Note that, if desired, similar shoulders may be provided in holes 103 of suture-locking washers 75, 75A and 75B.
  • suture-securing mechanism 95 may also comprise the aforementioned protrusions 105 for securing suture-securing mechanisms 95 to suture- locking washers 75C, i.e., in the manner previously discussed. See Fig. 57. It should also be appreciated that, in this form of the invention, suture-securing mechanism 95 may also comprise the aforementioned protrusions 105 for securing suture-securing mechanisms 95 to suture- locking washers 75C, i.e., in the manner previously discussed. See Fig. 57. It should also be appreciated that, in this form of the invention, suture-securing mechanism 95 may also comprise the aforementioned protrusions 105 for securing suture-securing mechanisms 95 to suture- locking washers 75C, i.e., in the manner previously discussed. See Fig. 57. It should also be
  • shoulder 153 may be cut-away as appropriate to enable one or more protrusions 105 to extend out of bores 151.
  • suture-securing mechanisms 95 may be mounted to suture-locking washer 75C (or to suture-locking washers 75, 75A or 75B) before sling 40 is passed through suture-securing mechanisms 95.
  • sling 40 may.be passed through suture-securing
  • suture-securing mechanisms 95 are mounted to sling 40, e.g., a suture (Fig. 58), the free ends of sling 40 (e.g., the free ends of a suture (Fig. 58), the free ends of sling 40 (e.g., the free ends of a suture (Fig. 58), the free ends of sling 40 (e.g., the free ends of a suture (Fig. 58), the free ends of sling 40 (e.g., the free ends of a
  • suture are threaded through holes 103 in suture- locking washer 75C (Fig. 59), and then suture-securing mechanisms 95 are "towed” into place within holes 103 (Fig. 60) and secured to the suture-locking washer
  • Figs. 62-65 show a component which may be
  • a component 154 that comprises a housing 155 which includes a pair of openings 160
  • a suture-securing mechanism 95 may be
  • Component 154 is configured so that it may be incorporated into a suture-locking washer of the sort described above, whereby to adjustably secure a sling (e.g., a suture) 40 to component 154, and hence to adjustably secure a sling (e.g., a suture) 40 to a suture-locking washer and bone anchor .
  • sling suspension system 30 may comprise an index metacarpal anchor 35 for deployment in index metacarpal 25, a thumb metacarpal anchor 45 for deployment in thumb metacarpal 15, and a sling 40 (e.g., a suture) for securing thumb metacarpal anchor 45 to index metacarpal anchor 35.
  • sling 40 is secured to index metacarpal anchor 35, and sling 40 is slidable relative to thumb metacarpal anchor 45.
  • a suture-locking washer 75D is slidably mounted onto sling 40.
  • Suture-locking washer 75D comprises two suture-securing mechanisms 95, wherein the two suture-securing mechanisms 95 are configured to allow suture movement in opposite directions. More particularly, the suture-securing mechanism 95 receiving the portion of sling 40 extending between index metacarpal anchor 35 and thumb metacarpal anchor 45 allows suture movement toward thumb metacarpal anchor 45 but prevents suture
  • index metacarpal anchor 35 is disposed in index metacarpal 25
  • thumb metacarpal anchor 45 is disposed in thumb metacarpal 15
  • thumb metacarpal 15 is positioned in the
  • suture-locking washer 75D is seated against thumb metacarpal 15.
  • the locking engagement of suture-locking washer 75D with sling 40 keeps thumb metacarpal 15 locked against movement relative to index metacarpal 25.
  • suture-securing mechanisms 95 may be incorporated directly into a bone anchor, e.g., holes 103 may be formed in the head of a bone anchor, and suture-securing mechanisms 95 may be disposed in holes 103. In this way, a bone anchor may be provided with a suture-locking facility without requiring the use of a separate element (i.e., a suture-locking washer) .
  • suture-securing mechanisms 95 may be incorporated into other medical devices, e.g., bone plates, etc.
  • holes 103 may be formed in the medical device, and suture- securing mechanisms 95 may be disposed in holes 103. In this way, a medical device may be provided with a suture-locking facility.
  • basal joint arthroplasties which may be conducted for purposes other than alleviating basal joint arthritis, e.g., such as in the case of disease and/or trauma.
  • suture-locking washer 75 (and suture- locking washers 75B, 75C and 75D) and suture-securing mechanisms 95 (and suture-securing mechanism 95B) may be applicable to alternative applications that use bone anchors or other applications which use suture-locking washer 75 (and suture- locking washers 75B, 75C and 75D) and suture-securing mechanisms 95 (and suture-securing mechanism 95B) may be applicable to alternative applications that use bone anchors or other applications which use
  • suture-locking washers 75 may be utilized to provide knotless suture attachment to screw anchors during virtually all orthopedic procedures requiring fixation of suture, utilized to reposition or support the position of tendon, or other soft tissue, relative to bone .
  • a bone anchor is disposed in the second object, the suture extending away from the bone anchor is passed through an opening in the first object, and then the suture-locking washer 75 (or suture locking washer 75B, 75C or 75D) , containing a suture-securing mechanism 95 (or suture-securing mechanism 95B) , is loaded onto the free end of the suture and pushed against the far side of the first object so as to cinch the first object against the second . object .
  • the bone anchor, suture and suture-locking washer can be used to secure the first object to the second object.
  • Apps of the apparatus and methods of the present invention include, but are not limited to rotator cuff repair, tenodesis, medial (ulnar) collateral ligament reconstruction (the "Tommy John Procedure"), lateral ulnar collateral ligament reconstruction, Carpal instability treated with scapholunate and lunotriquetral ligament
  • carpometacarpal arthroplasty (ligament reconstruction with tendon interposition-LRTI ) , chronic thumb ulnar collateral ligament reconstruction (Gamekeeper's thumb) , chronic thumb radial collateral ligament reconstruction, finger metacarpophalangeal ligament reconstruction, medial collateral ligament
  • collateral ligament reconstructions (Watson- Jones/Chrisman Snook) , or other applications involving securing suture strand (s) to bone in order to secure tendons or other soft tissue to bone.
  • Fig. 68 which shows a hallux valgus repair using the apparatus and methods of the present invention
  • Fig. 69 which shows another, hallux valgus repair using the apparatus and methods of the present invention
  • Fig. 70 which shows an anterior cruciate ligament (ACL) repair using the apparatus and methods of the present invention
  • Fig. 71 which shows acromioclavicular joint repair using the apparatus and methods of the present
  • Fig. 72 which shows an ankle
  • a sling suspension system for supporting the thumb of a patient after basal joint arthroplasty, and the sling suspension system is disclosed as comprising a sling which may comprise a suture.
  • the apparatus comprises a sling or suture.
  • washers 75A, 75B, 75C and 75D, mechanisms 95 and 95B, and elements 100 are equally capable of locking or securing or holding non- suture elongated elements and filaments.
  • suture-locking washers 75A, 75B, 75C and 75D may also be appropriately referred to as “elongated element-locking” washers or “filament-locking” washers
  • suture-securing mechanisms 95 and 95B may also be appropriately referred to as “elongated element-securing” mechanisms or “filament- securing” mechanisms
  • suture-holding elements 100 may also be appropriately referred to as “elongated element-holding” elements or “filament-holding” elements .
  • suture- locking washers 75A, 75B, 75C and 75D should also be considered to be “elongated element-locking” washers or “filament-locking” washers
  • suture-securing mechanisms 95 and 95B should also be considered to be “elongated element-securing” mechanisms or “filament- securing” mechanisms
  • suture-holding elements 100 should also be considered to be “elongated element- holding” elements or “filament-holding” elements.

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

L'invention concerne des procédés, des dispositifs, un appareil et des systèmes chirurgicaux pour supporter le pouce d'un patient après une arthroplastie de l'articulation basale. Les modes de réalisation de l'invention comprennent au moins un ancrage métacarpien de l'index, au moins un ancrage métacarpien du pouce, au moins une attelle pour positionner l'ancrage métacarpien du pouce par rapport à l'ancrage métacarpien de l'index, et au moins une rondelle d'ancrage pour serrer et fixer la ou les attelles sans avoir besoin de nouer le ou les composants de suture de la ou des attelles. Les ancrages métacarpiens d'index et de pouce comprennent au moins un élément de prise avec l'os pour venir en prise avec le métacarpe correspondant. La rondelle d'ancrage peut incorporer un ou plusieurs mécanismes d'engagement d'attelle. L'augmentation du nombre de mécanismes d'engagement d'attelle associés à la rondelle d'ancrage augmente la surface de la ou des attelles et fournit de multiples éléments d'attelle pour obtenir une redondance et augmenter la force de traction de la ou des fixations de la ou des attelles utilisées pour fixer les ancrages métacarpiens du pouce et de l'index dans une position relative l'un par rapport à l'autre.
PCT/US2018/000217 2017-08-16 2018-08-16 Rondelle de blocage de suture destinée à être utilisée avec un ancrage osseux, et procédé de support du pouce Ceased WO2019035944A1 (fr)

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WO2020243181A1 (fr) * 2019-05-28 2020-12-03 The General Hospital Corporation Systèmes et méthodes de réparation de syndesmose de la cheville
WO2025155338A1 (fr) * 2024-01-19 2025-07-24 Arthrex, Inc. Conceptions de ferrule de verrouillage pour réaliser des interventions chirurgicales sans nœuds tensionnables
WO2025155339A1 (fr) * 2024-01-19 2025-07-24 Arthrex, Inc. Systèmes de verrouillage de sutures pour la réalisation d'interventions chirurgicales sous tension sans nœud

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