Tension adjustable knotless anchor and method for tissue repair - Patents.com

Abstract

A tension-adjustable, knot-free, self-locking surgical construct and method for surgical repair is disclosed. A soft suture anchor and a flexible strand (flexible coupler) are provided integrally as a one-piece mechanical taper construct. The repair system may include one or more shuttle / pull devices. The sutures exit a cannulated sheath and are braided into a smaller diameter round suture, which is then passed back through the sheath. The braided suture may be bifurcated or branched to provide multiple passing sutures.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Patent Application No. 17 / 709,840, filed March 31, 2022, which is incorporated herein by reference in its entirety. [Background technology]

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to the field of surgery, and more particularly to knotless anchor constructs and related tissue repair methods. Summary of the Invention [Means for solving the problem]

[0003] Reconstruction systems, assemblies and methods for soft tissue fixation are disclosed.

[0004] The tension-adjustable, knotless surgical construct can create a knotless, self-locking, reinforced repair. The tension-adjustable, knotless, self-locking surgical construct is made entirely of suture(s) and achieves fixation to bone without a separate anchor body. This design allows for placement and fixation within bone with the suture tail(s) remaining outside the bone for tension adjustment and / or other uses. The knotless surgical construct may also be used for knotless fixation of a first tissue to a second tissue, for example, fixation of a tendon to a bone.

[0005] A method of tissue repair is also disclosed. In one embodiment, a knotless surgical construct provides tissue fixation without the formation of knots by providing an all-suture soft anchor device that does not require a separate anchor body or similar structure. [Brief description of the drawings]

[0006] [Figure 1] FIG. 1 shows a schematic diagram of the surgical construct. [Diagram 2]FIG. 2 shows a schematic diagram of the surgical construct. [Diagram 3] FIG. 3 shows a schematic diagram of the surgical construct. [Figure 4] FIG. 4 shows a schematic diagram of the surgical construct. [Diagram 5] FIG. 5 shows a schematic diagram of the surgical construct. [Figure 6] FIG. 6 shows a schematic repair using the surgical construct of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] Tension-adjustable, knotless, self-locking surgical constructs can create knotless, reinforced repairs.

[0008] The soft tissue repair system includes a tension-adjustable, knot-free, self-locking surgical construct having a fixation device and flexible strands (flexible couplers) provided as an integral mechanical taper construct. The repair system can include one or more shuttle / pull devices.

[0009] In one embodiment, the soft suture anchor comprises a knotless anchor consisting of a single suture, and a soft anchor sheath is provided integral with the repair suture(s) ("single suture knotless FiberTak® soft anchor"). The suture exits a cannulated sheath and is braided into a smaller diameter round suture, which is then passed back through the sheath. The braided suture may be bifurcated / branched / forked (e.g., bifurcated or trifurcated, etc.) to provide multiple passing sutures.

[0010] The construct secures tissues (using an arthroscope or endoscope) with sutures that do not require the surgeon to tie knots. The construct pulls the soft tissues together. The branch(es) in the suture allow the construct to improve tissue cut-through resistance (by reducing the "cheese wire" effect), which is important in many clinical applications. Knotless surgical constructs may be used for knotless fixation of a first tissue to a second tissue, for example, fixation of soft tissue to bone.

[0011] Also disclosed is a method of knotless tissue repair. In one embodiment, a surgical construct provides knotless fixation of a first tissue to a second tissue, for example, knotless fixation of soft tissue (ligaments, tendons, grafts, etc.) to bone without forming knots and in a simple and rapid manner.

[0012] The sheath and braided suture can be made from any flexible material, such as multifilament, braided, knitted, woven sutures, or including ultra-high molecular weight polyethylene (UHMWPE) fibers or FiberWire® sutures (disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is hereby incorporated by reference in its entirety). The surgical construct can be used with any type of flexible material or suture known in the art. The shuttle / pull device can be a suture passer or a shuttle link, such as a FiberLink® or a Nitinol loop.

[0013]

[0023] Referring now to the drawings, in which like elements are designated with like reference numerals, FIGS. 1-5 show exemplary surgical constructs 100, 200, 300, 400, 100a (implantable devices 100, 200, 300, 400, 100a; surgical assemblies 100, 200, 300, 400, 100a; surgical systems 100, 200, 300, 400, 100a; suture anchors 100, 200, 300, 400, 100a; tension-adjustable, knotless constructs 100, 200, 300, 400, 100a; tension-adjustable, knotless, self-locking surgical anchors 100, 200, 300, 400, 100a), including an exemplary fixation device 10 with an exemplary knotless, self-locking, tension-adjustable mechanism 199 within the body of the fixation device 10. FIG. 6 illustrates an exemplary soft tissue repair 101 using the surgical construct 100.

[0014] As described in more detail below, the surgical constructs 100, 200, 300, 400, 100a are implantable devices made entirely from sutures or threads that achieve fixation to bone without a separate anchor body. The design allows for fixation by placement within the bone, with a single tail or multiple tails of the suture outside the bone for tension adjustment and alternative use.

[0015] The surgical construct 100 of Figure 1 includes a fixation device 10 integrally formed (integrally machined) with a flexible coupler 20 (flexible strand 20, suture 20, repair suture 20). One or more shuttle / pull devices 40 (suture passer 40, suture passer 40, shuttle link 40, FiberLink® 40, Nitinol loop 40) are provided attached to the fixation device 10.

[0016] As shown in FIG. 1, the fixation device 10 may be in the form of a soft anchor (soft suture anchor, or all-suture soft knotless anchor) provided with a soft anchor sleeve 10 (sheath or tubular member 10) and a cannula 11 (not shown) having two ends 12, 13. One of the two ends, e.g., end 12, is open. The other of the two ends, e.g., end 13, terminates in and continues with a flexible coupler 20. That is, the flexible coupler exits the cannulated sheath 10 (soft anchor sleeve or sheath) and is braided into a smaller diameter strand 20 having a single flexible end 21. In one embodiment, the diameter of the flexible coupler 20 may be the same diameter or a smaller diameter suture having a round diameter. In one embodiment, the flexible coupler 20 is a single strand of #5 or #2 mechanical taper suture.

[0017] The flexible coupler 20 is passed back through the cannula 11 of the sheath 10 to form at least one flexible, closed, knotless, continuous, adjustable loop 50 having an adjustable circumference and an adjustable length.

[0018] FIG. 1 also illustrates one or more shuttle / pull devices 40 extending through the sleeve 10. When more than one shuttle / pull device 40 is provided, the shuttle / pull devices may extend through the sheath 10 in similar or different directions and / or orientations and / or positions. Details of an exemplary soft suture anchor having a soft anchor sleeve (sheath or tubular member) and flexible shuttling strand are described, for example, in U.S. Patent Application No. 15 / 998,516, entitled "Methods of Tissue Repairs," filed August 16, 2018 (issued December 1, 2020 as U.S. Patent No. 10,849,734), the disclosure of which is incorporated herein by reference in its entirety. The flexible coupler, and one or more shuttle / pull devices may extend through the sleeve in similar or different directions and / or orientations and / or positions.

[0019] The flexible coupler 20 is provided with a single end 21. The end 21 is a flexible end (free end 21) that is integrally formed with the end 13 of the sheath 10. The flexible coupler 20 exits the cannulated sheath 10 and is braided into a round suture having a diameter "d" that may be smaller than the diameter "D" of the sheath 10. Differentiation and bifurcation of the suture diameter occurs during the manufacturing process (i.e., braiding, weaving, sewing, stitching, etc.). In one embodiment, the flexible coupler 20 is of integral mechanical taper construction with the sheath 10 and has the form of a round single suture strand of #5 or #2 mechanical taper suture. The sheath 10 acts as a soft sheath. A shuttle suture 40 (shuttle / pulling device 40) passes through the sheath 10. Shuttle suture 40 (shuttle / pulling device 40) is attached to sheath 10 and / or flexible coupler 20, for example, by being spliced ​​to the flexible coupler.

[0020] As described in more detail below, end 21 may form one or more flexible, closed, knotless, continuous, adjustable loops 50a, 50b, 50c... (for simplicity, referred to as "flexible, closed, knotless, continuous, adjustable loops 50") having an adjustable circumference and an adjustable length.

[0021] FIG. 1 illustrates one exemplary shuttle / pull device 40 in the form of a suture passing instrument or suture threader, such as a FiberLink® 40 or a Nitinol loop 40. However, the present disclosure is not limited to this exemplary embodiment only and contemplates an implantable device comprising multiple shuttle / pull devices. If more than one shuttle / pull device 40 is employed, the multiple shuttle / pull devices can reside within the sheath 10 independent of one another. The suture passing device 40 includes an eyelet / loop 43 for threading the flexible coupler 20. If multiple shuttle / pull devices are employed, each of the multiple shuttle / pull devices can include a corresponding eyelet / loop 43 for passing the flexible coupler 20. The shuttle / pull devices may be similar to one another or different from one another.

[0022] The flexible coupler 20 can be threaded through at least a portion of the fixation device body 10, e.g., the complete cannulation of the fixation device, or can enter and / or exit the fixation device body at a location other than the most distal and most proximal ends of the fixation device, e.g., position A in FIG. 1.

[0023] As described in more detail below, the device is inserted into the bone via a self-drilling driver, or alternatively, following insertion of the fixation device 10 of the surgical construct 100 into a drill hole in the bone 90, the flexible coupler 20 and shuttle / pull device 40 are released from the driver and the driver is removed. The free end 21 of the flexible coupler 20 is then passed around or through the tissue 80 and then through the eyelet / loop 43 of the suture passing device 40. The suture passing device 40 is then pulled, thereby drawing the free end 21 of the flexible coupler 20 towards the body of the fixation device, inside the sheath 10, and then exiting the cannula 11 of the sheath 10 to form another flexible, closed, knot-free, continuous, adjustable loop 50. The free end 21 forms a splice within the sheath 10. The suture end 21 of the flexible coupler 20 can then be tensioned and cut.

[0024] 2-4 illustrate soft suture anchors 200, 300, 400 that are generally similar to the soft suture anchor 100 of FIG 1 in that they are also of integral mechanical taper construction and include a single end portion 21 formed integrally with the sheath 10 and flexible couplers 20a and 20b with a shuttle / pull device 40 that passes through the sheath 10. However, the suture anchor 200 includes flexible couplers 20a and 20b that bifurcate from the sheath 10 and provide multiple loops.

[0025] As in the previous embodiment, each of the legs 20a, 20b passes through the cannulated body of the sheath 10 to form first and second flexible, closed, knotless, continuous, adjustable loops 50a, 50b. The free end 21 of the flexible coupler 20 can then be passed around or through the tissue 80 and then through the eyelet / loop 43 of the suture passing device 40. The suture passing device 40 is then pulled, thereby pulling the free end 21 of the flexible coupler 20 (along with the bifurcated legs 20a, 20b) towards the body of the fixation device, inside the sheath 10, and then exiting the sheath 10 to form additional flexible, closed, knotless, continuous, adjustable loops 50c, 50d (not shown). The suture ends 21 of the flexible coupler 20 can then be tensioned and cut. Alternatively, removal of suture end 21 allows legs 20a, 20b to be free to form additional loops (if additional shuttle / pulling devices 40 are provided) or to be employed for additional surgical steps as needed.

[0026] 3 shows a construct 300 that is also an integral mechanical taper construct, in which a flexible sheath 10 terminates in two suture legs 20a, 20b. One of the two suture legs (e.g., suture leg 20b) passes through the sheath 10 to form a flexible, closed, knotless, continuous, adjustable loop 50. The free end 20b can then pass around and / or through tissue 80 and then through the eyelet / loop 43 of the suture threader 40. The suture threader 40 is then pulled, thereby pulling leg 20b towards the body of the fixation device, pulling it inside the sheath 10, and then exiting the sheath 10 to form an additional flexible, closed, knotless, continuous, adjustable loop. The suture leg 20a can be used for other tissue repairs, which may include knotted repairs, such as, for example, lateral tissue compression with an associated interference anchor.

[0027] FIG. 4 shows a construct 400 that is also an integral mechanical taper construct, in which a flexible sheath 10 terminates in two suture legs 20a, 20b. One of the two suture legs (e.g., suture leg 20b) passes through the sheath 10 to form a flexible, closed, knotless, continuous, adjustable loop 50. The other leg (e.g., suture leg 20a) passes through the sheath 10 and exits at position B to form another loop 51 for additional reinforcement of the construct. The free end 20b can then pass around or through tissue 80 and then through the eyelet / loop 43 of the suture threading device 40. The suture threading device 40 is then pulled, which pulls the leg 20b towards the body of the fixation device, pulling it inside the sheath 10, and then exiting the sheath 10 to form an additional flexible, closed, knotless, continuous, adjustable loop. Suture legs 20a may be used for other tissue repairs, which may include knotted repairs, lateral tissue compression performed with associated interference anchors, and the like.

[0028] Figure 5 shows yet another soft suture anchor 100a that is generally similar to the soft suture anchor 100 of Figure 1 in that it is also an integral mechanical taper construction including a flexible coupler 20 with a single distal end 21 formed integrally with the sheath 10 and a shuttle / pull device 40 that passes through the sheath 10. However, the suture anchor 100a differs in the manner in which the coupler 20 penetrates and exits the sheath 10, i.e., it enters the sheath 10 at the same end 13 where it exits to form a first loop or eyelet 50a, passes through the cannula 11 of the sheath 10, exits at the other end 12 at location A, and returns through the first loop 50 to form another loop 50b.

[0029] The construct 100a of FIG. 5 is a one-piece mechanical taper construct sheath 10 that includes a proximal eyelet / loop 50a and exits at location A to form another loop 50b for additional reinforcement of the construct. The free end 21 can then be passed around or through tissue 80 and then through the eyelet / loop 43 of the suture passing device 40. The suture passing device 40 is then pulled, thereby pulling the legs 21 towards the body of the fixation device, pulling them inside the sheath 10, and then exiting the sheath 10 to form an additional flexible, closed, knot-free, continuous, adjustable loop. The suture legs 21 can be used for other tissue repairs. The fixation device 10 can be in the form of a soft anchor (soft suture anchor, or all-suture soft knotless anchor) with a soft anchor sleeve 10 (sheath or tubular member 10) and a cannula 11 (not shown) having two ends 12, 13. One of the two ends, e.g., end 12, is an open end. The other of the two ends, e.g., end 13, terminates in a flexible coupler 20 which is subsequently braided into smaller diameter strands 20 that exit the cannulated sheath 10 (soft anchor sleeve or sheath) and terminate in a single flexible end 21. In one embodiment, the flexible coupler 20 may or may not have a smaller diameter suture with a round diameter. In one embodiment, the flexible coupler 20 is a single strand suture.

[0030] 6 illustrates a schematic tissue repair 101 (e.g., tendon or ligament repair) using the exemplary surgical construct 100 of FIG. 1 to secure a first tissue 80 (e.g., soft tissue such as tendon 80) to a second tissue 90 (e.g., bone 90). Once the flexible sheath 10 of the surgical construct 100 is inserted and secured within a hole in the bone 90, the flexible end 21 of the flexible coupler 20 passes around or through the tissue 80 and then through the eyelet 43 of the shuttle / pulling device 40. The shuttle / pulling device 40 is then withdrawn from the fixation device 10 and withdrawn from the surgical site, allowing the flexible coupler 20 to pass through the cannula 11 of the sheath 10 (passing through itself and forming a splice within the body of the sheath 10) to form a flexible, tension-adjustable, continuous, adjustable, self-locking and tightening closed loop 50 around the tissue 80.

[0031] The free end 21 of the flexible coupler 20 can be pulled to contract the construct and the flexible, closed, knotless, continuous, adjustable loop 50, compressing the tendon to the bone and providing a final repair / construct 101 with increased tissue compression.

[0032] The constructs, systems and assemblies of the present disclosure may be used for multiple knotless soft tissue repair and fixation, for example, fixation of soft tissue to bone.

[0033] The soft anchor consists essentially of a flexible tubular member or sheath 10 terminating in a smaller diameter suture 20. The soft anchor is formed as an integral mechanical taper construction. The suture 20 is a round suture. The suture forms at least one splice within the flexible tubular member 10 and at least one adjustable knot-free closed continuous loop 50 around a second tissue 80 which is secured to a first tissue 90.

[0034] A method of soft tissue repair is disclosed that does not require knot tying, allows adjustment of both suture tension and tissue position relative to bone, and has a self-locking mechanism. The method of knotless tissue repair specifically includes the steps of securing a flexible cannulated sheath 10 of an integrated tapered construct 100, the integrated tapered construct 100 being preloaded with a shuttle / pull device 40, to a first tissue 90, and threading a flexible coupler 20 woven from the sheath 10 around or through the second tissue 80 to form an adjustable, knotless, closed, adjustable, flexible continuous loop 50 around the second tissue 80, using the shuttle / pull device to position the flexible coupler 20 against the first tissue 90 and then through the fixation device 10. The knotless, closed, adjustable, flexible continuous loop 50 may have an adjustable perimeter. The flexible coupler may be passed through the body of the sheath 10 multiple times.

[0035] As detailed above, when the anchor sheath is inserted, it has at least one repair suture limb (secured to the anchor and manufactured at the same time as the anchor as a unitary construct) and one or more shuttle links. The anchor sheath resides within the bone. The repair suture limb(s) reside on top of the bone. The repair suture is shuttled around or through the tissue and then into the anchor where it is spliced. This step can be repeated again if additional links are present.

[0036] The sheath 10 and braided suture 20 may be any flexible material, such as multifilament, braided, knitted, woven, or ultra-high molecular weight polyethylene (UHMWPE) fibers, or may comprise FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is hereby incorporated by reference in its entirety). FiberWire® suture is formed from an advanced high strength fiber material, namely, ultra-high molecular weight polyethylene (UHMWPE), sold under the trademarks Spectra (Honeywell) fibers and Dyneema (DSM) fibers, braided with at least one other fiber, natural or synthetic, to form a length of suture material.

[0037] The flexible coupler 20 may also be formed of a rigid material or a combination of rigid and flexible materials, depending particularly on the area of ​​the coupler that is threaded / spliced ​​to the coupler body and whether additional fixation devices are employed. Additionally, the sheath 10 and flexible coupler 20 may be coated and / or provided in different colors for easy manipulation during the surgical procedure. The knotless construction and self-locking soft anchors of the present disclosure may be used with any type of flexible material or suture that may be woven or threaded onto itself.

[0038] Various structural elements of the surgical constructs 100, 200, 300, 400, 100a may be visually coded to make the sheaths and suture legs easier to identify and handle. Easy in situ identification of sutures is advantageous in surgical procedures, particularly arthroscopic, endoscopic, and laparoscopic procedures.

[0039] The surgical constructs of the present disclosure may be used in endoscopic surgery. The term "endoscopic surgery" refers to surgical procedures within a patient's body through small openings, as opposed to traditional open surgery with large incisions. Additionally, the surgical constructs disclosed herein may be utilized in other general surgical procedures and specialized procedures, such as soft tissue repair.

[0040] The term "high strength suture" is defined as any elongated flexible member, with material and size selection depending on the particular application. By way of example and without limitation, the term "suture" as used herein may be a cable, filament, thread, wire, fabric, or any other flexible member suitable for tissue fixation within the body. [Explanation of symbols]

[0041] 10 Fixation device 11 Cannula 12, 13 End 20 Flexible strands, flexible couplers, repair sutures 20a, 20b Legs 21 End 40 Shuttle / Pull Device, Suture Threader, Suture Threader, Shuttle Link, FiberLink®, Nitinol Loop 43 Eyelets / Loops 50 Loops 50a, 50b, 50c Loop 80 First Organization 90 Second Organization 100, 200, 300, 400, 100a Surgical constructs, implantable devices, surgical assemblies, surgical systems, suture anchors, tension adjustable knotless constructs, tension adjustable knotless self-locking surgical anchors, 101 Tissue repair 199 Knotless self-locking tension adjustable mechanism A position B position

Claims

1. A soft anchor comprising a flexible tubular member terminating in a smaller diameter suture.

2. The soft anchor of claim 1 , wherein the soft anchor is formed as an integral mechanical taper construction.

3. The soft anchor of claim 1 , wherein the suture is a round suture.

4. The soft anchor of claim 1 , wherein the suture is a #5 or #2 round suture.

5. 10. The soft anchor of claim 1, wherein the flexible tubular member resides within bone and the smaller diameter suture forms at least one loop around soft tissue to be attached to the bone.

6. The soft anchor of claim 1 , wherein the suture passes through the flexible tubular member multiple times.

7. The soft anchor of claim 1 , wherein the suture forms at least one splice within the flexible tubular member.

8. A soft anchor, a flexible sheath having a first end and a second end, one of the first end and the second end being open; a flexible coupler provided at the other of the first end and the second end, the flexible coupler being integrally manufactured with the flexible sheath and provided as a unitary construction.

9. 9. The soft anchor of claim 8, wherein the flexible sheath is a suture tube and the flexible coupler is a round suture formed by braiding the suture that forms the suture tube.

10. 10. The soft anchor of claim 9, wherein the round suture is tapered and forms at least one knotless closed continuous loop by passing the suture through the suture tube at least once in a direction generally parallel to the longitudinal axis of the suture tube.

11. The soft anchor of claim 9, wherein the round suture has a diameter smaller than a diameter of the suture tube.

12. The soft anchor of claim 9, wherein the round suture has a diameter approximately equal to the diameter of the suture tube.

13. The soft anchor of claim 8 , wherein the flexible coupler is bifurcated into multiple flexible limbs.

14. The soft anchor of claim 8 , wherein the other of the first end and second end terminates in the flexible coupler.

15. The soft anchor of claim 8, wherein the soft anchor is of integral mechanical taper construction.

16. The soft anchor of claim 8 , wherein the soft anchor is a single-suture knotless anchor comprising a single suture.

17. 10. The soft anchor of claim 8, further comprising a shuttle / pull device.

18. 1. A method of knotless tissue repair, comprising: securing a soft anchor comprising a suture and a flexible sheath terminating in at least one shuttle / pulling device in a first tissue; passing the suture around or through a second tissue positioned relative to the first tissue, and then passing the suture through the flexible sheath by forming at least one knotless closed continuous loop around the second tissue using the at least one shuttle / pulling device.

19. threading the suture through the body of the flexible sheath to form a closed continuous loop without splices or knots; Thereafter, passing the suture around or through the second tissue; threading the suture through the body of the flexible sheath using the at least one shuttle / pull device to form a splice and the at least one knotless closed continuous loop around the second tissue; 20. The method of claim 18, further comprising:

20. 19. The method of claim 18, wherein the first tissue is bone and the second tissue is tendon or ligament.

21. 20. The method of claim 18, wherein the soft anchor is an all-suture anchor formed from a single piece of suture material.

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