Soft anchor lock staples and tissue repair methods

Abstract

A method for tissue repair using a soft anchor lock staple is disclosed. The lock staple is created in a surgical construct without requiring an additional tensioning step, using two soft anchors connected by a fixed length of suture.

Description

Technical Field

[0001] The present disclosure relates to the field of surgery, and more particularly, to anchor constructs and related tissue repair methods.

Summary of the Invention

Means for Solving the Problems

[0002] Disclosed are surgical constructs, assemblies, and methods for fixing soft tissue.

[0003] The surgical construct can create tissue staples. The surgical construct may be configured to include two or more soft anchors connected by sutures of a fixed length. The surgical construct can create a knotless, self-tensioning, self-locking, reinforced repair. The surgical construct may be used for knotless fixation of a first tissue to a second tissue, for example, fixing soft tissue to bone.

[0004] Also disclosed is a method of tissue repair. The knotless surgical construct can provide fixation between tissues that has no knot formation, fewer passage steps, and no secondary tensioning step that increases fixation and compression of soft tissue.

Brief Description of the Drawings

[0005] [Figure 1] FIG. 1 shows a top view of a surgical construct according to an exemplary embodiment. [Figure 2] FIG. 2 shows the surgical construct of FIG. 1 attached to an inserter. [Figure 3] FIG. 3 shows a top view of the surgical construct of FIG. 1 at the repair site. [Figure 4] FIG. 4 shows a schematic side view of the surgical construct of FIG. 1 (at the pre-insertion stage). [Figure 5]Figure 5 shows a schematic side view of the surgical structure shown in Figure 4 at a later stage (post-insertion stage). [Figure 6] Figure 6 shows an exemplary step of tissue repair using the surgical construct shown in Figure 1. [Figure 7] Figure 7 shows illustrative steps of tissue repair using the surgical construct shown in Figure 1. [Figure 8] Figure 8 shows illustrative steps of tissue repair using the surgical construct shown in Figure 1. [Figure 9] Figure 9 shows illustrative steps of tissue repair using the surgical construct shown in Figure 1. [Figure 10] Figure 10 shows a top view of another tissue repair using the surgical construct shown in Figure 1. [Modes for carrying out the invention]

[0006] Knot-free, self-tensioning, self-locking surgical repair systems, assemblies, and constructs can create knot-free, self-tensioning, reinforced repairs without requiring additional, secondary tensioning steps, and without requiring suture management or suture cutting steps.

[0007] The surgical construct may consist of a fixed-length flexible strand (fixed length of the loop), with two or more soft anchors loaded onto and connected to the fixed-length flexible strand. In one embodiment, two soft anchors are connected to the fixed length of the flexible strand. The flexible strand forms a flexible, continuous, uninterrupted loop having a fixed length. The flexible strand may be sutures. The two or more soft anchors can be all-suture knotless anchors. The surgical construct may be used for knotless fixation of a first tissue to a second tissue, for example, for fixation of soft tissue to bone. The surgical construct may essentially consist of a fixed-length flexible strand (fixed length of the loop) having two soft anchors.

[0008] A method for surgical tissue repair is also disclosed. In one embodiment, a surgical structure provides knotless fixation of a first and second tissue with no secondary tensioning steps, no knot formation whatsoever, fewer insertion steps, and increased fixation and soft tissue compression. The surgical structure includes two soft anchors connected by a fixed length of flexible coupler (fixed length of suture loop). The surgical structure is inserted into the tissue in a simple manner to lock the structure in place and tension the structure without requiring an additional tensioning step during insertion. The surgical structure creates a soft anchor locking "staple" consisting of soft anchors connected by a flexible coupler. The ease of insertion without suture management or suture cutting results in increased tissue repair and increased strength and soft tissue (such as tendons) compression.

[0009] In one embodiment, a first tissue is brought into contact with a second tissue by a knotless, self-tensioning, self-locking surgical construct that includes two full-suture soft anchors connected by a fixed-length suture. The two suture-connected soft anchors are loaded onto the tip of an inserter, such as a fork-shaped inserter. The soft anchors are inserted into the tissue, and once the insertion depth is achieved, the fixed tissue pushes down on the suture bridge, and the resulting tension causes the soft anchors to achieve a donut shape for fixation within the tissue. Alternative suture routes can form different fixation shapes. Elastic sutures can add compression. The step can be repeated for additional soft anchors.

[0010] A method for soft tissue repair is also disclosed that does not require knotting and allows tension to be applied during insertion. An exemplary method includes, in particular, (i) preparing a surgical structure formed from two soft anchors attached to a fixed length of a flexible coupler, and (ii) inserting the surgical structure into the bone such that each of the two soft anchors changes its shape from a first configuration to a second configuration, creating fixation during insertion and forming a soft anchor locking "staple". The method may further include (iii) applying tension to the surgical structure during the insertion of the soft anchors without requiring an additional tensioning step. Tensioning is produced by the force of the tissue being fixed pushing the suture bridge in a direction opposite to the direction of insertion of the soft anchors. The tissue force may push the suture bridge in the opposite direction to the direction of insertion of the soft anchors. Depending on the degree of repair and the surgeon's preference, the step can be repeated to form additional soft anchor locking "staples".

[0011] Referring here to drawings in which similar elements are indicated by similar reference numbers, Figures 1–10 show surgical structures 100, 100a (FiberTak® staples 100, 100a, FiberTak® soft anchor staples 100, 100a, structures 100, 100a) used in exemplary methods of tissue repair 200, 300 (FiberTak® staple repair 200, 300, soft anchor lock staple repair 200, 300) of the present disclosure.

[0012] The surgical structure 100 in Figure 1 includes two fixation devices 10, 20 connected by a fixed-length flexible coupler 50 (flexible strand 50). Each of the two fixation devices 10, 20 (shown in more detail in Figure 4) can be in the form of a flexible anchor sleeve 11 (sheath or tubular member 11) and a flexible anchor (flexible suture anchor, or fully sutured flexible knotless anchor) having two open ends 12, 13. At least one flexible coupler 50 extends through at least one region of each of the two fixation devices 10, 20. The flexible coupler 50 can enter the first tubular sheath of the first soft anchor 10 in a first position, extend along the longitudinal axis of the tubular sheath, and then exit the first tubular sheath of the first soft anchor 10 in a second position, and thereafter enter the second tubular sheath of the second soft anchor 20 in a first position, extend along the longitudinal axis of the tubular sheath, and then exit the second tubular sheath of the second soft anchor 20 in a second position. The flexible coupler 50 can also enter and exit the first and second tubular sheaths of the first and second soft anchors 10 and 20 through the open ends 12 and 13 of the anchors 10 and 20, respectively.

[0013] The flexible coupler 50 can be extended through the sleeve (tubular sheath) of each fixing device 10, 20 in similar or different directions, and / or orientations, and / or positions. Further details of exemplary flexible suture anchors having a flexible anchor sleeve (sheath or tubular member) and a flexible shuttle strand are described, for example, in U.S. Patent No. 10,849,734, entitled “Methods of Tissue Repairs,” issued 1 December 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0014] The flexible coupler 50 may include any flexible material, strand or ribbon, for example, sutures or tapes or combinations thereof, such as multifilament, braided, knitted, or woven sutures, or fibers of ultra-high molecular weight polyethylene (UHMWPE) or FiberWire® sutures (disclosed in U.S. Patent No. 6,716,234, the disclosure of which is incorporated herein by reference in its entirety). The flexible coupler 50 may also be formed from suture tapes, for example, Arthrex FiberTape®, a high-strength suture tape that is braided, has a rectangular cross-section, and is disclosed in U.S. Patent No. 7,892,256 (the disclosure of which is incorporated herein by reference in its entirety). The flexible coupler 50 may also be formed from an elastic material such as PEEK. The surgical construct can be used with any type of flexible material, elastic material, or suture known in the art.

[0015] In one embodiment, the flexible coupler 50 is formed from a single strand of material that is loop-shaped / joined to form a loop 55 and an optional knot 51. The loop 55 is a fixed-length, continuous, and uninterrupted flexible loop 55 formed from a material such as suture thread. In one embodiment, the periphery of the loop 55 is fixed. In one embodiment, the loop 55 may be formed from suture thread having a round cross-section. The suture thread may be configured to have the same or different diameters. The loop 55 may also be formed by joining flexible strands through itself, or by other methods known in the art such as knot formation, fusion, adhesion, joining, bonding, braiding, and linking.

[0016] Figure 2 shows a surgical construct 100 loaded onto an inserter 110 to form an assembly 99. The inserter 110 may be a fork-shaped inserter that allows each of the fixation devices 10, 20 to rest and be fixed to one of two inserter tines. The assembly 99 allows the fixation devices 10, 20 to be introduced into a first tissue 90 (bone 90) and to fix and tension a second tissue 80 (soft tissue 80) to the first tissue 90, as detailed below.

[0017] Figure 3 shows a side-by-side comparison of two versions of the surgical constructs 100 and 101 of this disclosure (Fibertak Staple concept), as well as the “rigid” staple concept 70. The comparison demonstrates the advantage of having no material that could cause problems above tissue 80 to be fixed to another tissue, such as bone 90.

[0018] Figures 4 and 5 show schematic side views of the surgical structure of Figure 1 in the pre-insertion and post-insertion stages, respectively. The flexible coupler 50 extends into the two soft anchors 10 and 20, connecting the two soft anchors 10 and 20 between them.

[0019] In the pre-insertion stage of FIG. 4, the two soft anchors 10, 20 are relaxed, and the two open ends 12, 13 of each soft anchor are positioned at a distance “D” from each other (i.e., the soft anchors 10, 20 have a first shape or configuration around a U-shaped perimeter). In the post-insertion stage of FIG. 5, the two soft anchors 10, 20 are inserted into the bone 90 such that the flexible coupler 50 is placed on the soft tissue 80 fixed to the bone 90. When the tissue force F of the bridge 59 of the flexible coupler 50 is pressed against the tissue 80, each soft anchor sleeve 11 (sheath or tubular member 11) of the two soft anchors 10, 20 becomes more rigid and achieves a “donut” shape for fixation (i.e., the soft anchors 10, 20 have a second shape or configuration). When a depth “H” is achieved within the bone 90, the fixed tissue presses against the suture bridge 59. Due to that tension, the soft anchors 10, 20 form a “donut” shape for fixation, bringing the two open ends 12, 13 of each soft anchor closer together, i.e., achieving a distance “d" between them that is smaller than the distance “D” in the pre-insertion stage.

[0020] Alternative suture paths of the flexible coupler 50 connecting the two soft anchors 10, 20 can form different fixation shapes with respect to the soft anchors 10, 20 inserted into and fixed to the bone. Further, the elastic suture can apply compression to the tissue 80. Regardless of the suture path or suture material, the surgical construct forms a soft tissue staple construct (formed by the two soft anchors 10, 20 connected by the suture 50) that is simple to insert and locks in place without a secondary tensioning step to achieve the repair 200 (FIG. 5).

[0021] Conventional devices and known constructs do not have a construct that can be tensioned (such as a finger trap or a pre - tied knot, or other means), or an actively engaging means to create fixation during insertion. Surgical constructs 100, 100a are soft anchors connected by a fixed length of suture loop 55 (where the tensionable rim cannot slip out), such that, depending on the nature of the loop's path, the anchor deforms when suture tension is applied depending on the depth of insertion.

[0022] Figures 6 - 9 show schematic subsequent steps of tissue repair 200 to better illustrate the tensioning of the repair during insertion.

[0023] Figure 6: The FiberTak® staple 100 (surgical construct 100) is loosened / relaxed on an inserter (not shown) and positioned near the second tissue 80 to be fixed to the first tissue 90 (bone 90).

[0024] Figure 7: A pilot hole 90a is prepared through the tissue 80 into the bone 90. The FiberTak® staple 100 begins to be tapped into place (into the bone 90).

[0025] Figure 8 illustrates the point at which the suture between the FiberTak® staples 100 contacts the second tissue 80 and begins to create tension (tension) in the construct.

[0026] Figure 9: Compression of the second tissue 80 pulls the FiberTak® sheath for fixation, into a deformed shape (doughnut shape or second configuration). The inserter can be removed, fixing the tissue 80.

[0027] Figure 10 illustrates an exemplary repair 300 using two FiberTak® staples 100 to secure an exemplary silicone piece 81 instead of a tubular concept. Any number of FiberTak® staples 100 (surgical constructs 100) can be used to attach a first tissue to a second tissue, for example, soft tissue 80 to bone 90. Any number of flexible couplers (such as flexible coupler 50) can be used to connect the soft anchors 10, 20. If multiple couplers are employed, the couplers may be similar or different and may pass through and through the soft anchors 10, 20 via similar or different paths.

[0028] The surgical structures 100, 100a may include a fixed length of the flexible coupler 50 (the fixed length of the loop 55), and two or more flexible anchors 10, 20 are mounted on and connected to the fixed length of the flexible coupler 50. In one embodiment, two flexible anchors 10, 20 are connected to the fixed length of the flexible coupler 50. The flexible coupler 50 forms a flexible, continuous, uninterrupted loop 55 having a fixed length. The flexible, continuous, uninterrupted loop 55 may be knotless. The flexible, continuous, uninterrupted loop 55 may have knots. The flexible coupler 50 may be sutures. The flexible coupler 50 may be made of an elastic material. The flexible coupler 50 may be elastic sutures. Two or more flexible anchors 10, 20 can be all-suture knotless anchors. The surgical structures 100, 100a may be used for knotless fixation between tissues, for example, for fixing soft tissue 80 to bone 90. The surgical structures 100, 100a may essentially consist of a fixed length (fixed length of loop) of a flexible coupler 50 having two soft anchors 10, 20.

[0029] A method for surgical tissue repair is also disclosed. In one embodiment, surgical structures 100, 100a provide knotless fixation of a first and second tissue with no secondary tensioning steps, no knot formation whatsoever, fewer through steps, and increased fixation and soft tissue compression. The surgical structures 100, 100a include two soft anchors 10, 20 connected by a fixed length of a flexible coupler 50 (fixed length of suture loop 55). The surgical structures 100, 100a are inserted into the tissue 90 in a simple manner, locking the structure in place and applying tension to the structure without requiring an additional tensioning step during insertion. The surgical structures 100, 100a create a soft anchor locking “staple” constructed from the soft anchors 10, 20 connected by the flexible coupler 50. Ease of insertion without suture management or suture cutting leads to increased tissue repair and increased strength and compression of soft tissues (such as tendons).

[0030] In one embodiment, a second tissue 80 is brought into contact with a first tissue 90 using knotless, self-tensioning, self-locking surgical constructs 100, 100a, which include two full suture soft anchors 10, 20 connected by a fixed length of suture 50. The two suture-connected soft anchors are loaded onto the tip of an inserter 110, such as a fork-shaped inserter 110. The soft anchors 10, 20 are inserted into the tissue 90, and once the insertion depth is achieved, the tissue 80 to be fixed pushes against the suture bridge 59, and the resulting tension deforms the soft anchors 10, 20, achieving a donut shape for fixation within the tissue 90. Alternative suture routes can form different fixation shapes. Elastic sutures can add compression. The step can be repeated for additional soft anchors.

[0031] Methods for soft tissue repair 200, 300 that do not require knotting and allow tensioning during insertion are also disclosed. Exemplary methods include, in particular, (i) preparing surgical structures 100, 100a formed from two soft anchors 10, 20 attached to a fixed length of a flexible coupler 50 and connected thereby, and (ii) inserting the surgical structures 100, 100a into bone 90 such that each of the two soft anchors 10, 20 changes its shape from a first configuration to a second configuration, creating fixation during insertion and forming a soft anchor locking "staple". The method may further include (iii) tensioning the surgical structures 100, 100a during insertion of the soft anchors without requiring an additional tensioning step.

[0032] Tensioning is caused by the force of the fixed tissue 80 pushing the suture bridge 59 in a direction different from the insertion direction of the soft anchors 10, 20. The tissue force may push the suture bridge 59 in the opposite direction to the insertion direction of the soft anchors 10, 20 into the bone 90. Depending on the extent of the repair and the surgeon's preference, the step can be repeated to form additional soft anchor locking "staples".

[0033] The flexible coupler 50 (strand 50) may consist of a single filament or fiber, or it may consist of multiple continuous filaments, segments, or regions of filaments having different configurations (e.g., different diameters and / or different compositions). Each region / segment of filaments may be homogeneous (i.e., formed from the same material) or a combination of homogeneous and heterogeneous (i.e., formed from multiple materials). Exemplary materials include suture thread, silk, cotton, nylon, polypropylene, polyethylene, ultra-high molecular weight polyethylene (UHMWPE), polyethylene terephthalate (PET), and polyester, as well as copolymers thereof, or combinations thereof. The flexible coupler may consist of essentially one or more elastic materials.

[0034] In one embodiment, the flexible coupler 50 may be constructed from any known suture structure, such as multifilament, braided suture, knitted suture, or woven suture, or it may be constructed from ultra-high molecular weight polyethylene (UHMWPE) fibers or FiberWire® suture (disclosed in US6,716,234, the disclosure of which is incorporated herein by reference in its entirety). The flexible strand may also be formed from suture tape, for example, Arthrex FiberTape®, a high-strength suture tape that is braided, has a rectangular cross-section, and the disclosure of which is incorporated herein by reference in its entirety. The flexible coupler 50 may also be constructed from any type of material (such as suture, nylon, silk, UHMWPE, metal, or bioabsorbable material) that can allow the flexible strand to form a loop, or it may be constructed using such materials.

[0035] The flexible coupler 50 may be configured to be (partially or completely) coated with, for example, wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning silicone fluid 202A or others), silicone rubber (Nusil Med 2245, Nusil Med 2174 including a binding catalyst, or others), PTFE (Teflon, Hostaflon, or others), PBA (polybutyrate), ethylcellulose (Filodel), or other coatings to improve the lubricity, loop safety, flexibility, ease of handling, or abrasion resistance of the suture.

[0036] The flexible coupler 50 may also be configured with colored tracing strands, or it may remain a simple solid color, or display a different tracing pattern, to visually contrast with other areas / regions of the structure. Various structural elements of the flexible coupler 50, such as the loop 55 and / or bridge 59, may be visually coded to simplify the identification and handling of the sutures. Easy identification of sutures in situ is advantageous in surgical procedures.

[0037] The term “high-strength suture” is defined as any elongated flexible member, the choice of material and size depending on the specific application. For illustrative purposes only and without limitation, the term “suture” as used herein may be a cable, filament, thread, wire, fabric, or any other flexible member suitable for fixing tissues within the body. [Explanation of symbols]

[0038] 10. First soft anchor 11. Flexible anchor sleeves, tubular members 12 Open end 13 Open end 20. Second soft anchor 50 sutures, flexible strands, flexible couplers 51 knots 55 Suture loops, flexible loops 59 Bridge 70 Staple Concept 80 Second organization 81 Silicone pieces 90 First Organization 90a Pilot hole 99 Assembly 100 Surgical Constructs 100a Surgical structures 101 Surgical constructs 110 Inserter 200 Tissue Repair 300 Tissue Repair

Claims

1. A surgical structure comprising a fixed-length flexible coupler connected to a first soft anchor and a second soft anchor.

2. The surgical structure according to claim 1, wherein the fixed length of the flexible coupler forms a staple over the tissue fixed by the first soft anchor and the second soft anchor.

3. The surgical structure according to claim 1, wherein the surgical structure is self-tensioning.

4. The surgical structure according to claim 1, wherein the fixed length of the flexible coupler is secured to the first soft anchor and the second soft anchor by a knot.

5. The surgical structure according to claim 1, wherein the fixed length of the flexible coupler passes through the first tubular sheath of the first soft anchor at least once and through the second tubular sheath of the second soft anchor at least once to form a closed, continuous flexible loop having a fixed circumference.

6. The surgical structure according to claim 5, wherein the fixed-length flexible coupler enters the first tubular sheath at a first position, extends within the first tubular sheath, and exits the first tubular sheath at a second position, the second position being different from the first position.

7. The surgical structure according to claim 6, wherein the fixed-length flexible coupler enters the second tubular sheath at a first position, extends within the second tubular sheath, and exits the second tubular sheath at a second position, the second position being different from the first position.

8. The surgical structure according to claim 1, wherein each of the first soft anchor and the second soft anchor is a full suture anchor, and the flexible coupler is a round suture.

9. Surgical structures, A first flexible anchor having a first flexible sheath having a first open end and a second open end, A second flexible anchor having a second flexible sheath having a first open end and a second open end, A surgical structure comprising: a flexible coupler for connecting the first flexible anchor to the second flexible anchor, having a fixed length, and forming at least one closed, flexible continuous loop by passing the first flexible sheath of the first flexible anchor at least once and the second flexible sheath of the second flexible anchor at least once.

10. The surgical structure according to claim 9, wherein the first flexible sheath is a first suture tube, the second flexible sheath is a second suture tube, and the flexible coupler is a round suture.

11. The surgical structure according to claim 9, wherein the first soft anchor and the second soft anchor are located within the bone, and a portion of the flexible coupler forms a bridge on the tissue fixed to the bone.

12. The surgical structure according to claim 11, wherein the tissue is soft tissue.

13. The surgical structure according to claim 11, wherein the tissue is a tendon, ligament, or graft.

14. The surgical construct according to claim 9, wherein the flexible coupler is formed from suture thread, silk, cotton, nylon, polypropylene, polyethylene, ultra-high molecular weight polyethylene (UHMWPE), polyethylene terephthalate (PET), polyester, copolymer, or a combination thereof.

15. The surgical structure according to claim 9, wherein the flexible coupler is made of an essentially elastic material.

16. Surgical repair, A first soft anchor fixed to a first tissue at a first position, and a second soft anchor fixed to the first tissue at a second position, A surgical repair comprising: a first soft anchor and a second soft anchor, and a suture bridge extending above the second tissue.

17. The surgical repair according to claim 16, wherein the first tissue is bone, and the second tissue is soft tissue attached to the bone.

18. The surgical repair according to claim 16, wherein the suture bridge has a fixed length and forms a lock staple having the first and second soft anchors.

19. The surgical repair according to claim 16, wherein at least one of the first soft anchor and the second soft anchor fixed to the first tissue has a donut shape.

20. A method of self-tensioning tissue repair, Inserting a first flexible anchor and a second flexible anchor through a first tissue and through a second tissue, wherein the first flexible anchor is connected to the second flexible anchor by a flexible coupler having a fixed length. A method comprising fixing the first soft anchor in a first position and the second soft anchor in a second position in the second structure.

21. The method according to claim 20, wherein the first soft anchor and the second soft anchor are fixed simultaneously with the tensioning of the repair, without requiring additional tensioning.

22. The flexible coupler is passed through the first tubular sheath of the first soft anchor at least once. Subsequently, the flexible coupler is passed at least once through the second tubular sheath of the second soft anchor to form a flexible, closed, continuous loop having a fixed perimeter connecting the first soft anchor to the second soft anchor. The first soft anchor and the second soft anchor are fixed to a fork-shaped inserter, Passing the first soft anchor and the second soft anchor through the first tissue and the second tissue, The first soft anchor is fixed simultaneously in the first position at the first opening in the second tissue, and the second soft anchor is fixed simultaneously in the second position at the second opening in the second tissue, thereby enabling tensioning of the repair on the first tissue without additional tensioning steps. The method according to claim 20, further comprising:

23. The method according to claim 22, wherein the flexible, closed, continuous loop extends over the surface of the first tissue, enabling the first tissue to achieve a desired tension relative to the second tissue.

24. The method according to claim 20, wherein the first tissue is a tendon, ligament, or graft, and the second tissue is bone.

25. The method according to claim 20, wherein each of the first and second soft anchors is a full suture anchor formed from a single suture material, and the flexible coupler is an elastic suture.

Images