WO2024158906A1

WO2024158906A1 - Tensionable knotless surgical techniques

Info

Publication number: WO2024158906A1
Application number: PCT/US2024/012772
Authority: WO
Inventors: Peter J. Dreyfuss; Amr W. Elmaraghy; Gautam P. Yagnik; Andrew C. PETRY; Christopher R. Adams
Original assignee: Arthrex Inc
Current assignee: Arthrex Inc
Priority date: 2023-01-24
Filing date: 2024-01-24
Publication date: 2024-08-02
Anticipated expiration: 2025-07-24
Also published as: MX2025008603A; KR20250136403A; AU2024211498A1

Abstract

A surgical construct having cinch loops and stoppers that do not require tying of knots are disclosed. A surgical construct includes a loop with a racking hitch terminating in a single tail. Mechanical pressure is applied to the single tail to deform an area of the surgical construct and form a bulge that acts as a stopper. A ferrule with internal features can be attached to a cerclage construct adjacent a racking hitch to act as a stopper and prevent the cerclage construct from loosening.

Description

TENSIONABLE KNOTLESS SURGICAL TECHNIQUES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Patent Application No. 18/158,614, which was filed on January 24, 2023, and also claims priority to U.S. Patent Application No. 18/420,828, which was filed on January 24, 2024 and claims the benefit of United States Provisional Application No. 63/586,076, which was filed on September 28, 2023, the entire disclosures of which are incorporated herein by reference in their entirety.

BACKGROUND

[0002] The disclosure relates to the field of surgery and, more specifically, to tensionable knotless surgical constructs and associated knotless surgical techniques.

SUMMARY

[0003] Surgical constructs and tissue repairs are disclosed. A surgical construct can create a knotless, tensionable, self-locking repair without the need to tie any knots. A surgical construct can include (i) a loop; (ii) a loop interconnection; and (iii) a locking mechanism. A surgical construct can be a suturing construct. A surgical construct can be a cerclage construct.

[0004] A loop of a surgical construct can be a closed, flexible, continuous suture loop. A loop of a surgical construct can be a cerclage loop. A loop interconnection can be in the form of an interconnecting loop link such as a racking hitch or half hitch. A loop interconnection can be located between a loop and a locking mechanism. A locking mechanism can be a stopper. A stopper can be a suture bulge or deformation formed by applying mechanical pressure to a suture construct. A stopper can be a ferrule with internal features that allow one way tensioning of a cerclage construct.

[0005] A surgical construct can be employed to re-attach anatomical structures, for example, a first tissue to a second tissue, such as bone to bone, soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a self-locking, knotless, tensionable mechanism. A self-locking construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices. [0006] Methods of knotless, tensionable surgical repairs are also disclosed. In an embodiment, a portion of a flexible strand can be deformed by applying mechanical pressure and/or compression to form at least one bulge or deformation adjacent a racking hitch. The at least one bulge or deformation creates obstruction of sutures loosening through a racking hitch type of knot. The suturing technique eliminates tying knots.

[0007] In another embodiment, a ferrule with internal features is attached to a cerclage repair adjacent a cerclage locking mechanism, to tension the cerclage repair and lock down the cerclage material. A cerclage locking mechanism can be an interconnecting cerclage loop link such as a racking hitch or half hitch.

[0008] In another embodiment, An exemplary locking ferrule for performing tissue repairs may include a body including an outer diameter wall, an inner diameter wall, and a cannulation that is circumscribed by the inner diameter wall. A plurality of locking barbs extend into the cannulation and are configured to lock a suture that is received through the cannulation relative to the body.

[0009] An exemplary surgical method may include loading a suture through a cannulation of a locking ferrule, tensioning the suture in a first direction, and locking the suture within the cannulation to prevent movement of the suture in a second direction.

[0010] Another exemplary surgical method may include loading a suture through a cannulation of a locking ferrule, inserting the locking ferrule into a socket formed in a bone, tensioning the suture in a first direction relative to the bone, and locking the suture within the cannulation to prevent movement of the suture in a second direction relative to the bone.

[0011] The embodiments, examples, and alternatives of the preceding paragraphs, the claims, or the following description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible.

[0012] The various features and advantages of this disclosure will become apparent to those skilled in the art from the following detailed description. The drawings that accompany the detailed description can be briefly described as follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 illustrates a surgical construct employed in tissue repair according to an exemplary embodiment.

[0014] FIGS. 2, 3, and 4 illustrate schematic steps of forming the surgical construct of FIG.

1.

[0015] FIGS. 5, 6, 7, 8, 9, 10, and 11 illustrate schematic subsequent steps of a tissue repair with the surgical construct of FIG. 1.

[0016] FIG. 12 illustrates a surgical construct employed in tissue repair according to another exemplary embodiment.

[0017] FIG. 13 is an enlarged view of a locking mechanism of the surgical construct of FIG. 12.

[0018] FIG. 14 illustrates a locking ferrule that can be used for performing various tensionable knotless tissue repairs.

[0019] FIG. 15 is an end view of the locking ferrule of FIG. 14.

[0020] FIG. 16 is a cross-sectional view through section 3-3 of FIG. 14.

[0021] FIG. 17 is a cross-sectional view through section 4-4 of FIG. 15.

[0022] FIG. 18 schematically illustrates loading a suture through a locking ferrule.

[0023] FIG. 19 schematically illustrates locking a suture relative to a locking ferrule.

[0024] FIGS. 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing a tissue repair.

[0025] FIGS. 30, 31, and 32 schematically illustrate another exemplary surgical method for performing a tissue repair.

[0026] FIG. 33 illustrates a suture locking system.

[0027] FIGS. 34A, 34B, 34C, and 34D illustrate another exemplary suture locking system.

DETAILED DESCRIPTION

[0028] Surgical constructs, assemblies and methods for knotless fixation of tissue are disclosed. [0029] A surgical construct can create a knotless, tensionable, self-locking repair. A surgical construct can include (i) a loop; (ii) a loop interconnection; and (iii) a locking mechanism. A surgical construct can be a suturing construct. A surgical construct can be a cerclage construct.

[0030] A suturing construct can include: (i) a closed, flexible, adjustable, continuous suture loop; (ii) an interconnecting loop link such as a racking hitch or half hitch; and (iii) a locking mechanism (a stopper). A stopper can be a suture bulge or deformation formed by applying mechanical pressure to the suturing construct. A suturing construct can consist essentially of suture. A suturing construct can consist essentially of a braid with a monofilament core. A suturing construct can be employed to attach or re-attach anatomical structures, for example, a first tissue to a second tissue, such as soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a self-locking, knotless mechanism. A suturing construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more knotted or knotless suture anchors.

[0031] A cerclage construct can include: (i) a cerclage loop; (ii) an interconnecting cerclage loop link such as a racking hitch or half hitch; and (iii) a locking mechanism (a stopper). A stopper can be a ferrule with internal features that allow one way tensioning of the cerclage construct. A cerclage construct can consist essentially of cerclage suture. A cerclage construct can consist essentially of cerclage suture tape. A cerclage construct can be employed to re-attach anatomical structures, for example, bone to bone. A cerclage construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices such as bone plates, screws and/or implants.

[0032] Methods of surgical repairs are also disclosed. An exemplary method includes inter alia the steps of (i) passing a flexible construct through and/or around tissue to be repaired; (ii) passing a tail of the flexible construct through a loop of the flexible construct to form a cinch; and (iii) stopping the flexible construct from loosening by forming a locking mechanism adjacent the cinch. The flexible construct can be a suturing construct. The flexible construct can be a bone cerclage construct.

[0033] In an exemplary embodiment, a portion of a suturing construct can be deformed by applying mechanical pressure and/or compression to form at least one bulge, enlargement, or deformation in the suture adjacent a racking hitch knot. The at least one bulge enlargement, or deformation creates obstruction of the sutures loosening through the racking hitch type of knot. The suturing technique eliminates tying knots. Tension is applied to the racking hitch and subsequently, mechanical pressure is applied to the suture. The mechanical pressure creates one or more monofilament bulges out and through the braid, which act as a stopper.

[0034] In another exemplary embodiment, a cerclage repair can be conducted with cerclage material (such as cerclage tape) secured by a racking hitch type of knot. A ferrule with internal features is slipped over ends of the cerclage tape and tensioned down to the hitch where it locks in a one-way manner. The hitch holds much of the tension of the repair, while the ferrule acts as a stopper.

[0035] An exemplar)' surgical construct may include a flexible strand including a loop and a single tail. The single tail is arranged through the loop to establish a loop interconnection. A stopper is positionable adjacent to the loop interconnection and configured to lock the flexible strand from loosening through the loop interconnection.

[0036] In any further embodiment, the surgical construct is a knotless, tensionable, selflocking suturing construct.

[0037] In any further embodiment, the stopper includes at least one bulge or deformation formed by applying a mechanical pressure or a mechanical force to the flexible strand.

[0038] In any further embodiment, the flexible strand includes a braid with a monofilament core.

[0039] In any further embodiment, the flexible strand is a suture tape.

[0040] In any further embodiment, the surgical construct is a cerclage construct.

[0041] In any further embodiment, the stopper includes a ferrule that allows one way passage of the flexible strand, and the ferrule includes internal features that allow the one way passage of the flexible strand.

[0042] In any further embodiment, the loop interconnection is a cinch.

[0043] In any further embodiment, the loop interconnection is a racking hitch or a half hitch. [0044] In any further embodiment, the stopper is a bulge having a width that is greater than a width of the flexible construct, and the flexible construct includes a monofilament core that protrudes through a braid to establish the bulge and the braid is formed of ultrahigh molecular weight polyethylene (UHMWPE).

[0045] A locking ferrule that includes a one-way locking mechanism may be utilized as part of the tensionable knotless tissue repairs for tensioning and locking one or more strands of suture.

[0046] An exemplary locking ferrule for performing tissue repairs may include a body including an outer diameter wall, an inner diameter wall, and a cannulation that is circumscribed by the inner diameter wall, and a plurality of locking barbs extending into the cannulation and configured to lock a suture that is received through the cannulation relative to the body.

[0047] In any further embodiment, the plurality of locking barbs are integral features of the body.

[0048] In any further embodiment, each of the plurality of locking barbs includes a pointed tip.

[0049] In any further embodiment, the body extends along a longitudinal axis between a proximal end and a distal end.

[0050] In any further embodiment, each of the plurality of locking barbs is angled in a direction toward the proximal end.

[0051] In any further embodiment, the plurality of locking barbs each protrude inwardly from the inner diameter wall.

[0052] In any further embodiment, the plurality of locking barbs are arranged in at least a first row and a second row.

[0053] In any further embodiment, a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row.

[0054] In any further embodiment, the plurality of locking barbs are arranged across an entire length of the body. [0055] In any further embodiment, the suture includes a varying thickness.

[0056] Referring now to the drawings, where like elements are designated by like reference numerals, FIGS. 1-12 illustrate surgical constructs 100, 200 employed in surgical tissue repairs according to exemplary embodiments. FIGS. 1-4 illustrate surgical construct 100 employed in a suturing repair according to an exemplary embodiment. FIGS. 5-11 illustrate subsequent steps of a tissue suturing repair 101 with the surgical construct 100 of FIG. 1. FIGS. 12 and 13 illustrate surgical construct 200 employed in bone cerclage repair according to another exemplary embodiment of the present disclosure.

[0057] Suturing construct 100 (surgical construct 100; suture 100; self-locking construct 100; knotless, tensionable construct 100; knotless closure suture 100; flexible construct 100; side- to-side knotless suture 100) is formed of a flexible strand 50 (flexible material 50, suture construct 50, suturing construct 50) employed for fixation of first tissue to second tissue. In an exemplary embodiment, suturing construct 100 is formed of flexible strand 50 which includes a central strand of core suture 10 (first strand or filament; inner strand) and an outer strand of suture 11 (second strand or filament; outer strand; coreless suture) covering the central strand. The central strand 10 can be a monofilament core. In an embodiment, the outer strand 11 covers completely the central strand 10 in at least two directions, a longitudinal direction and a transversal direction. Additional details of flexible strand 50 are shown in FIG. 4.

[0058] Suturing construct 100 also includes one or more loop interconnections 66 and one or more locking mechanisms 77 (stopping mechanism 77). In an embodiment, and as shown in FIGS. 5-7, suturing construct 100 is provided with a small loop 51 for creating racking hitch 66 (racking hitch knot 66; cinch 66; luggage tag 66; luggage tag stitch 66) and flexible, closed, adjustable, self-locking, tensionable loop 55. Small loop 51 may be formed integrally to, or separate from, the suturing construct. Loop 51 may be part of outer strand 11 or, alternatively, part of inner strand 10. In yet another embodiment, loop 51 may be part of both strands 10, 11. In additional embodiments, small loop 51 may be attached to the suturing construct (for example, to one or both of the outer and inner strands) by any methods known in the art. Small loop 51 can be integral to the flexible strand 50.

[0059] Reference is now made to FIGS. 3 and 4. Subsequent to the formation of loop interconnection 66, locking mechanism 77 is formed by applying mechanical pressure, compression, or force F to an area of the suturing construct 100 adjacent the loop interconnection 66, to form a smashed or crimped area 77 (stopping or locking mechanism 77) in the flexible strand 50. The locking mechanism 77 acts as a stopper. FIGS. 4(a) and 4(b) illustrate enlarged views of the strands 10, 11 before and after application of the mechanical pressure and compression. Bulge 77 of FIG. 4(b) is formed after the application of mechanical pressure or mechanical force to the flexible strand 50. When mechanical pressure is applied, the monofilament core 10 bulges out and through the braid 11 (the UHMWPE braid 11), piercing the braid 11 as clearly shown in FIG. 4(b). Bulge 77 can be any deformation, enlargement, expansion, protuberance, or flattened area/region of the flexible strand 50 with a size which does not allow movement or passage through the loop interconnection 66. The monofilament suture 11 with the solid core 10 can be flattened to distort its cross-sectional view and achieve a more oval cross-sectional view.

[0060] While bulge 77 locks the construct 100, it is important to note that bulge 77 acts primarily as a stopper for the suture, creating an obstruction of the suture loosening through the racking hitch type of knot 66. In this manner, without using any electrically powered sources of welding/deformation of the suture, the mechanical pressure alone eliminates tying of knots while providing a secure, reinforced locking of the suture 50.

[0061] Reference is now made to FIGS. 8-11 which illustrate a suturing repair 101 (FIG. 11) with exemplary surgical construct 100. Flexible strand 50 is passed through first tissue 90 (soft tissue 90) attached to second tissue 80 (bone 80) with a suturing instrument 40, for example, needle 40.

[0062] FIGS. 9 and 10 illustrate the formation of loop interconnection 66 (racking hitch knot 66) and passing of single tail of flexible strand 50 through the racking hitch knot 66. Tension is applied by pulling on the single tail of flexible strand 50 to tension the construct. Mechanical force and/or pressure and/or compression is applied to a region of the flexible strand 50 adjacent the loop interconnection 66 to form stopping/locking mechanism 77 (bulge or deformation 77) in the strand 50.

[0063] Final repair 101 includes suturing construct 100 with bulge or enlargement 77 formed in the flexible strand 50 by applying mechanical pressure and locked into place by racking hitch 66, unable to slip or slide out of the loop formed around first tissue 90 (for example, soft tissue 90) attached to second tissue 80 (for example, bone 80). [0064] Flexible strand 50 (suturing construct 50) can include a single filament, or fiber, or can include multiple continuous filaments, segments or regions of filaments that have different configurations (for example, different diameters and/or different compositions) and allow formation of at least one bugle 77 by application of mechanical pressure and/or compression.

[0065] Flexible strand 50 can be made of any known suture construct, such as multifilament, braided, knitted, woven suture, or including fibers of ultrahigh molecular weight polyethylene (UHMWPE) or the FiberWire® suture (disclosed in US 6,716,234, the disclosure of which is hereby incorporated by reference in its entirety herein). The flexible strand can be also formed of suture tape, for example, Arthrex FiberTape®, which is a high strength suture tape that is braided and rectangular-like in cross section and as disclosed in US 7,892,256, the disclosure of which is incorporated by reference in its entirety herein.

[0066] FIGS. 12 and 13 illustrate schematic views of surgical construct 200 of the present disclosure. Surgical construct 200 of FIG. 12 is about similar to surgical construct 100 detailed above in that it is also a knotless, tensionable, self-locking construct that includes a loop 150 with one or more loop interconnections 166 such as a racking hitch knot 166 and one or more stopping/locking mechanisms 177. However, surgical construct 200 differs from construct 100 in that (i) surgical construct 200 is a cerclage construct with flexible strand 150 formed of cerclage materials such as metals and/or tapes such as suture tape, among others; and (ii) surgical construct 200 includes a ferrule 177 or collet 177 with internal features 178 forming stopping/locking mechanism.

[0067] A cerclage repair with cinch 166 (racking hitch 166) is created around bone 80 and/or tissue 90. Ferrule 177 has internal features 178 that permit one way tensioning and one way suture direction and movement. Ferrule 177 slipped over the ends of the flexible strand 150 (cerclage tape 150) is tensioned down to the hitch 166 where it locks in a one-way manner. The hitch 166 holds much of the tension of the cerclage repair while the ferrule 166 acts as a stopper. The cerclage repair of the present disclosure is tensionable and knotless in that it eliminates tying knots from suturing techniques such as cerclage and side-to-side repairs. With the racking hitch geometry of the cerclage technique disclosed above, the ferrule 177 no longer needs to hold the entire force of the repair, but instead acts as a stopper. This aspect alone provides additional strength to the overall cerclage repair. [0068] A suturing construct 100 can include: (i) a closed, flexible, adjustable, continuous suture loop 55; (ii) an interconnecting loop link 66 such as a racking hitch 66 or half hitch 66 or cinch 66; and (iii) a locking mechanism 77 or stopper 77. A stopper 77 can be a suture bulge or deformation formed by applying mechanical pressure to the suturing construct. A suturing construct 100 can consist essentially of suture 50. A suturing construct 100 can consist essentially of a braid 11 with a monofilament core 10. A suturing construct 10 can be employed to attach or re-attach anatomical structures, for example, a first tissue 90 to a second tissue 80, such as soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a self-locking, knotless mechanism. A suturing construct 100 can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices.

[0069] A cerclage construct 200 can include: (i) a cerclage loop 150; (ii) an interconnecting cerclage loop link 166 such as a racking hitch 166 or half hitch 166 or cinch 166; and (iii) a locking mechanism 177 or stopper 177. A stopper 177 can be a ferrule 177 provided with internal features 178 that allow one way tensioning of a cerclage construct. A cerclage construct 200 can consist essentially of suture tape 150. A cerclage construct 200 can be employed to re-attach anatomical structures, for example, bone to bone, or bone to soft tissue. A cerclage construct 200 can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices such as bone plates, anchors, screws and/or implants.

[0070] Flexible strands 50, 150 may be in the form of any elongated members, fibers, or materials, or combinations thereof. Flexible strands 50, 150 may be coated (partially or totally) with wax (beeswax, petroleum wax. polyethylene wax, or others), silicone (Dow Corning silicone fluid 202A or others), silicone rubbers (Nusil Med 2245, Nusil Med 2174 w'ith a bonding catalyst, or others) PTFE (Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose (Filodel) or other coatings, to improve lubricity of the suture, loop security, pliability, handleability or abrasion resistance, for example.

[0071] Flexible strands 50, 150 can be made of any known suture construct, such as multifilament, braided, knitted, woven suture, or including fibers of ultrahigh molecular weight polyethylene (UHMWPE) or the FiberWire® suture (disclosed in US 6,716,234, the disclosure of which is hereby incorporated by reference in its entirety herein). Flexible strands 50, 150 can be also formed of suture tape, for example, Arthrex FiberTape®, which is a high strength suture tape that is braided and rectangular-like in cross section and as disclosed in US 7,892,256, the disclosure of which is incorporated by reference in its entirety herein.

[0072] Flexible strands 50, 150 can be also provided with tinted tracing strands, or otherwise contrast visually with other areas/regions of the construct, which remains a plain, solid color, or displays a different tracing pattern, for example. Various structural elements of flexible strands 50, 150 such as loops 55, 155 and/or tails may be visually coded, making identification and handling of the suture loops and ends simpler. Easy identification of suture in situ is advantageous in surgical procedures.

[0073] The term “high strength suture” is defined as any elongated flexible member, the choice of material and size being dependent upon the particular application. For the purposes of illustration and without limitation, the term “suture” as used herein may be a cable, filament, tape, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body.

[0074] The term “luggage tag stitch” is defined as any cinch or loop that is formed by the luggage tag technique.

[0075] FIGS. 14-19 illustrate an exemplary locking ferrule 210 that can be used when performing various tensionable knotless tissue repairs. For example, the locking ferrule 210 could be utilized during surgical methods for attaching tissue (e.g., ligament, tendon, graft, etc.) to bone or for repairing any other type of tissue effect. The locking ferrule 210 could be used in conjunction with a variety of orthopedic surgical repairs, including but not limited to rotator cuff repairs, Achilles tendon repairs, patellar tendon repairs, and biceps tendon repairs, among many others.

[0076] The locking ferrule 210 may include a body 212 that extends along a longitudinal axis A between a proximal end 214 and a distal end 216. The body 212 may be tubular shaped and may be constructed from either metallic materials or plastic materials. However, the specific size, shape, and material make-up of the body 212 are not intended to limit this disclosure.

[0077] A cannulation 218 may extend through the body 212 and may establish an internal passageway for accommodating one or more strands of suture 220 (see, for example, FIGS. 18 and 19). The cannulation 218 may extend across an entire length of the body 212 and thus extends from the proximal end 214 to the distal end 216. The longitudinal axis A may bisect the cannulation 218. [0078] The body 212 may include an outer diameter wall 222 and an inner diameter wall 224. The outer diameter wall 222 may be smooth or could alternatively include threads, barbs, or other features for facilitating bone fixation. The inner diameter wall 224 may circumscribe the cannulation 218. In some embodiments, the cannulation 218 may taper in a direction toward the distal end 216 and is therefore narrower within the distal end 216 compared to within the proximal end 214.

[0079] A plurality of locking barbs 226 may protrude inwardly from the inner diameter wall 224. The locking barbs 226 may therefore occupy at least a portion of the open space of the cannulation 218. In an embodiment, the locking barbs 226 are integrally formed (e.g., molded) features of the body 212 of the locking ferrule 210. The locking barbs 226 may be provided along an entire length of the cannulation 218 or at only select portions thereof. The locking barbs 226 may be either rigid or flexible structures.

[0080] The locking barbs 226 may be arranged in multiple rows along the length of the cannulation 218. For example, the locking barbs 226 may be arranged in a least a first row R1 and a second row R2 (see FIG. 17). In an embodiment, the locking barbs 226 of the second row R2 are staggered relative to the locking barbs 226 of the first row R1 (see FIG. 17).

[0081] Each locking barb 226 may include a sharp or pointed tip 228, and each locking barb 226 may be angled in a direction toward the proximal end 214. The locking barbs 226 may therefore establish a one-way locking mechanism that permits one or more sutures 220 to pass through the cannulation in a first direction DI while preventing the suture(s) 220 from being tensioned or otherwise moved in a second direction D2. The staggered relationship of the rows of locking barbs 226 may provide for maximum engagement with the suture 220 one it is passed through the cannulation 218.

[0082] Referring now primarily to FIGS. 18 and 19, with continued reference to FIGS. 14- 17, one or more sutures 220 may be passed through the cannulation 218. The suture 220 may be FiberWire®, FiberTape®, or any other suitable suture product. FiberWire® and FiberTape® are suture products marketed and sold by Arthrex, Inc. However, other suture products could be utilized for the suture 220 within the scope of this disclosure. The size and type of suture utilized in conjunction with the locking ferrule 210 are not intended to limit this disclosure.

[0083] The suture 220 may include a varying thickness. The suture 220 may therefore include one or more tapered regions 230 where the suture 220 transitions between a thickened section 232 and a thinned section 234. The thinned sections 234 can facilitate passing the suture 220 through the cannulation 218, such as via a suitable suture loader 236 that can be provided as part of a suture locking system that includes the locking ferrule 210, for example, and the thickened sections 232 can provide greater surface area for the locking barbs 226 to engage in order to sufficiently lock the suture 220 relative to the locking ferrule 210.

[0084] In an embodiment, the thickened sections 232 of the suture 220 are about twice as thick as the thinned sections 234. However, other ratios (e.g., 1.5:1, 3:1, etc.) between the relative thicknesses (e.g., outer diameters) of the thickened section 232 and the thinned section 234 are contemplated within the scope of this disclosure.

[0085] The one or more sutures 220 may be passed through the cannulation 218 of the locking ferrule 210 using the suture loader 236. An eyelet 238 of the suture loader 236 may be passed through the cannulation 218 (e.g., by inserting the eyelet 238 at the distal end 216 of the body 212 and then moving the suture loader 236 in the second direction D2). One or more thinned sections 234 of the suture 220 may then be loaded through the eyelet 238. The suture loader 236 may then be pulled, via a handle 240, in the first direction DI to pass the suture 220 through the cannulation 218.

[0086] Once the suture 220 has been passed through the cannulation 218, the suture 220 may be further tensioned in the first direction DI to lock the suture 220 relative to the locking ferrule 210. The locking barbs 226 prevent the suture 220 from backing up or otherwise moving in the second direction D2. The pointed tips 228 of the locking barbs 226 may interdigitate with one or more of the thickened sections 232 to lock the suture 220 and prevent it from moving in the second direction D2.

[0087] Although shown as locking a single folded suture 220 in the above implementations, the locking ferrule 210 could be configured to receive and lock multiple strands of suture and/or sutures of varying sizes.

[0088] In the implementation described above, a single locking ferrule 210 is utilized to tension and knotlessly fixate the suture 220. However, two or more of the locking ferrules 210 could be utilized together for establish a suture locking system 299 for tensioning and knotlessly fixating the suture 220 (see, e.g., FIG. 33).

[0089] The locking ferrule 210 described above and shown in FIG. 14-19 may be utilized to tension and knotlessly fixate one or more sutures 220 as part of various surgical methods. FIGS. 20-29 schematically illustrate one such surgical method for attaching a tissue 242 to a bone 244. The tissue 242 may have torn away from the bone 244 during vigorous exercise or sporting activities, for example. When such tears occur, reattachment is often necessary to repair the tissue defect.

[0090] The surgical method schematically illustrated in FIGS. 20-29 could be used in conjunction with a variety of orthopedic surgical repairs, including but not limited to rotator cuff repairs, for example. The bone 244 may therefore be associated with any joint of the human musculoskeletal system (e.g., shoulder, knee, hip, ankle, etc.).

[0091] In an embodiment, the surgical method is performed as an arthroscopic procedure by working through various arthroscopic portals. However, the exemplary surgical method could alternatively be performed as an open procedure within the scope of this disclosure. The exemplary surgical method may be employed to reduce and then knotlessly attach the tissue 242 to the bone 244 in a manner that enhances footprint compression to maximize tissue-to-bone contact.

[0092] Referring first to FIG. 20, after appropriately preparing the bone 244 (e.g., by debriding, creating a bleeding bone bed, preparing bone sockets, etc.), a medial row of fixation devices may be implanted into the bone 244. The medial row of fixation devices may include one or more suture anchors 246. The suture anchors 246 may be knotless suture anchors that do not require the need to tie any knots in the various structures for reducing and securing the tissue 242 to the bone 244 or could be traditional knot tying style suture anchors. In addition, the suture anchors 246 could be “soft” anchors made exclusively of soft, suture -based materials or could be relatively rigid structures made of plastics or metals.

[0093] In an embodiment, the suture anchors 246 of the medial row are placed at the articular margin of the bone 244. However, other implantation locations could be selected based on the performing surgeon’s preferences. Notably, although two suture anchors 246 are illustrated as being part of the medial row in the illustrated embodiment, a greater or fewer number of suture anchors (or other fixation devices) could be utilized as part of the surgical method within the scope of this disclosure. For example, the medial row could include only a single suture anchor 246.

[0094] Each suture anchor 246 may be pre-loaded with one or more sutures 220. The sutures 220 may include individual suture strands, multiple suture strands, suture tape, or any other suture-like product. As shown in FIG. 21, the sutures 220 may be passed upwardly through the tissue 242 after each suture anchor 246 of the medial row is adequately fixated within the bone 244.

[0095] Referring now to FIG. 22, the surgical method can proceed by implanting a lateral row of fixation devices into the bone 244. The lateral row of fixation devices may include one or more suture anchors 248. The suture anchors 248 may include an anchor body 250 and a shuttle device 252 received through the anchor body 250. The anchor body 250 may be a “soft” body made exclusively of soft, suture-based materials or could be a relatively rigid plastic or metallic body. The shuttle device 252 may be a passing wire or another suture, for example.

[0096] The suture anchors 248 of the lateral row may be placed laterally from an edge 254 of the tissue 242 and slightly distal to the greater tuberosity of the bone 244. The suture anchors 248 may therefore be placed laterally from the suture anchors 246 of the medial row. However, other implantation locations could be selected based on the performing surgeon’s preferences and depending on the type of orthopedic procedure being performed. Notably, although two suture anchors 248 are illustrated as being part of the lateral row in the illustrated embodiment, a greater or fewer number of lateral fixation devices could be utilized as part of the surgical method within the scope of this disclosure.

[0097] The anchor body 250 of each suture anchor 248 may be inserted into a socket 264 formed in the bone 244. Each socket 264 may be a preformed opening formed in the bone 244 that is sized for receiving the anchor body 250 of one of the suture anchors 248.

[0098] The surgical method may next proceed by shuttling the sutures 220 from the suture anchors 246 of the medial row through the anchor bodies 250 of the suture anchors 248 of the lateral row. For example, as shown in FIG. 23, one limb 256 of the suture 220 from each suture anchor 246 may be may be passed through an eyelet 255 of the shuttle device 252 of a first of the suture anchors 248, and then a free end 260 of the shuttle device 252 may be pulled (e.g., in the direction of arrow 262) to allow the limbs 256 to pass through the anchor body 250 of the suture anchor 248. This shuttling process may be repeated to shuttle additional limbs 258 of the sutures 220 from each suture anchor 246 through the anchor body 250 of a second of the suture anchors 248 of the lateral row (see FIG. 24). The limbs 256, 258 may therefore be arranged in a crisscross pattern P that provides a desired area of footprint compression over top of the tissue 242 (see FIG. 25). [0099] At this point of the surgical method, the sutures 220 of the suture anchors 246 are preliminarily fixated relative to the bone 244 by the suture anchors 248. The sutures 220 may subsequently be further tensioned and locked in place using the locking ferrule 210. For example, as shown in FIGS. 26 and 27, after loading the thinned sections 234 of the limbs 256 that are connected to the first of the suture anchors 248 through the cannulation 218 of the locking ferrule 210 (e.g., in the manner shown in FIGS. 18-19), the limbs 256 may be tensioned in the direction DI to allow the locking ferrule 210 to slide down the limbs 256 in the direction D2 and be received within the socket 264. Further tension of the limbs 256 in the direction DI allows the pointed tips 228 of the locking barbs 226 to interdigitate with the thickened sections 232 of the sutures 220 to lock the sutures 220 and prevent them from sliding in the second direction D2. Once positioned in the socket 264, the locking ferrule 210 may be positioned over top of the first of the suture anchors 248 of the lateral row (see FIG. 28).

[00100] The process shown in FIGS. 26-28 may be repeated to tension and lock the limbs 258 associated with the second of the suture anchors 248 with an additional locking ferrule 210. The final construct achieved by the surgical method is shown in FIG. 29. The excess length of the sutures 220 that extend outside of the cannulation 218 of the locking ferrules 210 may be removed (e.g., cut) once tensioning and locking is complete.

[00101] FIGS. 30-32 schematically illustrate another surgical method in which the locking ferrule 210 of FIGS. 14-19 may be utilized to tension and lock suture during a surgical repair. In this embodiment, the surgical method may involve securing a tissue 266 (e.g., a tendon) to a bone 268, such as part of a subpectoral biceps tenodesis procedure, for example.

[00102] Referring first to FIGS. 30, the surgical method may include creating a looping stitch 270 (e.g., with suture) within the tissue 266 and inserting a suture button 272 within the bone 268 at a desired attachment point for the tissue 266. The suture button 272 may include a button body 274 in the form of a sheath and a shuttle device 276 received through the button body 274. The shuttle device 276 may be a passing wire or a suture, for example.

[00103] The button body 274 of the suture button 272 may be inserted into a socket 278 formed in the bone 268. The socket 278 may be a preformed opening formed in the bone 268 that is sized for receiving the button body 274 of the suture button 272.

[00104] The surgical method may next proceed by shuttling a suture limb 280 of the looping stitch 270 through the button body 274 of the suture button 272. For example, the suture limb 280 may be passed through an eyelet 282 of the shuttle device 276 of the suture button 272. A free end 286 of the shuttle device 276 may then be pulled (in the direction of arrow 284) to allow the suture limb 280 to pass through the button body 274 of the suture button 272.

[00105] At this point of the surgical method, the tissue 266 is reduced into place relative to the bone 268. The suture limb 280 may subsequently be tensioned and locked in place using the locking ferrule 210. For example, as shown in FIG. 31, after loading the suture limb 280 through the cannulation 218 of the locking ferrule 210, the suture limb 280 may be tensioned in the direction DI to allow the locking ferrule 210 to slide in the direction D2 down and into the socket 278. Further tension of the suture limb 280 allows the pointed tips 228 of the locking barbs 226 to interdigitate with the section of the suture limb 280 accommodated within the cannulation 218, thereby locking the suture limb 280 in place and preventing it from sliding back in the second direction D2. The tissue 266 is therefore securely tensioned and fixated relative to the bone 268. Once positioned in the socket 278, the locking ferrule 210 may be positioned over top of the suture button 272 (see FIG. 32).

[00106] FIGS. 34A-34D illustrate an exemplary suture locking system 399. The suture locking system 399 may include one or more locking ferrules 210 and a suture loader 336 for shuttling a suture 220 through the locking ferrule 210. The locking ferrule 210 may include the design shown in FIGS. 14-17, for example.

[00107] The suture loader 336 may include a handle 340 and an eyelet 338. The handle 340 may include a first handle section 390 and a second handle section 392 that is disengageable from the first handle section 390. A proximal section 394 of the eyelet 338 may pass through the first handle section 390 and may be attached to the second handle section 392 such that movement of the second handle section 392 results in moving the eyelet 338. The eyelet 338 may be received through the cannulation 218 of the locking ferrule 210 prior to shuttling the suture 220 therethrough. In an embodiment, the locking ferrule 210 and the suture loader 336 are preassembled to one another prior to performing the suture shuttling procedure.

[00108] The thinned section 234 of the suture 220 may be loaded through the eyelet 338 (see FIG. 34B). The second handle section 392 may then be disconnected from the first handle section 390 and then moved in the first direction DI to shuttle the suture 220 through the cannulation 218 of the locking ferrule 210. Once the suture 220 has been passed through the cannulation 218 of the locking ferrule 210, the suture 220 may be tensioned in the first direction DI to lock the suture 220 relative to the locking ferrule 210 and prevent movement in the second direction D2 in the manner described above.

[00109] In an embodiment, the locking ferrule 210 may be received within a recessed opening 396 of the first handle section 390 of the suture loader 336 prior to shuttling the suture 220 through the locking ferrule 210 (see FIG. 34C). In another embodiment, the locking ferrule 210 may be preloaded within a separate surgical device 398 (e.g., a sleeve, a button, a suture anchor, a screw, a bone plate, an arthroplasty implant, etc.) of the suture locking system 399 prior to shuttling the suture 220 through the locking ferrule 210 (see FIG. 34D).

[00110] The locking ferrules of this disclosure may be utilized with one or more additional fixation devices (e.g., anchors, buttons, etc.) for performing various tensionable knotless tissue repairs. The locking ferrules provide for tensioning and retensioning suture(s) at various points of the tissue repair, including subsequent to implantation of the accompanying fixation devices, thus providing numerous advantages over prior tissue repair techniques.

[00111] Although the different non-limiting embodiments are illustrated as having specific components or steps, the embodiments of this disclosure are not limited to those particular combinations. It is possible to use some of the components or features from any of the non-limiting embodiments in combination with features or components from any of the other non-limiting embodiments.

[00112] It should be understood that like reference numerals identify corresponding or similar elements throughout the several drawings. It should further be understood that although a particular component arrangement is disclosed and illustrated in these exemplary embodiments, other arrangements could also benefit from the teachings of this disclosure.

[00113] The foregoing description shall be interpreted as illustrative and not in any limiting sense. A worker of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure. For these reasons, the following claims should be studied to determine the true scope and content of this disclosure.

Claims

CLAIMS What is claimed is:

1. A surgical construct, comprising: a flexible strand including a loop and a single tail; the single tail arranged through the loop to establish a loop interconnection; and a stopper positionable adjacent to the loop interconnection and configured to lock the flexible strand from loosening through the loop interconnection.

2. The surgical construct as recited in claim 1, wherein the surgical construct is a knotless, tensionable, self-locking suturing construct.

3. The surgical construct as recited in claim 1 or 2, wherein the stopper includes at least one bulge or deformation formed by applying a mechanical pressure or a mechanical force to the flexible strand.

4. The surgical construct as recited in any preceding claim, wherein the flexible strand includes a braid with a monofilament core.

5. The surgical construct as recited in any preceding, wherein the flexible strand is a suture tape.

6. The surgical construct as recited in any preceding claim, wherein the surgical construct is a cerclage construct.

7. The surgical construct as recited in claim 1, wherein the stopper includes a ferrule that allows one way passage of the flexible strand, and further wherein the ferrule includes internal features that allow the one way passage of the flexible strand.

8. The surgical construct as recited in any preceding claim, wherein the loop interconnection is a cinch.

9. The surgical construct as recited in any preceding claim, wherein the loop interconnection is a racking hitch or a half hitch.

10. The surgical construct as recited in claim 1, wherein the stopper is a bulge having a width that is greater than a width of the flexible construct, and further wherein the flexible construct includes a monofilament core that protrudes through a braid to establish the bulge and the braid is formed of ultrahigh molecular weight polyethylene (UHMWPE).

11. A locking ferrule for performing tissue repairs, comprising: a body including an outer diameter wall, an inner diameter wall, and a cannulation that is circumscribed by the inner diameter wall; and a plurality of locking barbs extending into the cannulation and configured to lock a suture that is received through the cannulation relative to the body.

12. The locking ferrule as recited in claim 11, wherein the plurality of locking barbs are integral features of the body.

13. The locking ferrule as recited in claim 11 or 12, wherein each of the plurality of locking barbs includes a pointed tip.

14. The locking ferrule as recited in any of claims 11 to 13, wherein the body extends along a longitudinal axis between a proximal end and a distal end.

15. The locking ferrule as recited in claim 14, each of the plurality of locking barbs is angled in a direction toward the proximal end.

16. The locking ferrule as recited in any of claims 11 to 15, wherein the plurality of locking barbs each protrude inwardly from the inner diameter wall.

17. The locking ferrule as recited in claim 16, wherein the plurality of locking barbs are arranged in at least a first row and a second row.

18. The locking ferrule as recited in claim 17, wherein a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row.

19. The locking ferrule as recited in claim 16, wherein the plurality of locking barbs are arranged across an entire length of the body.

20. The locking ferrule as recited in any of claims 11 to 19, wherein the suture includes a varying thickness.