Adjustable tension knotless surgical technique

Abstract

A surgical construct having a cinch loop and a stopper is disclosed that does not require knot tying. The surgical construct includes a loop with a rack hitch that terminates in a single tail. Mechanical pressure is applied to the single tail to deform a region of the surgical construct, forming a bulge that acts as a stopper. A ferrule with an internal configuration can be attached to the tibial construct adjacent the racking hitch to act as a stopper and prevent the tibial construct from loosening.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 18 / 158,614, filed January 24, 2023, which in turn claims priority to U.S. Patent Application No. 18 / 420,828, filed January 24, 2024, and claims the benefit of U.S. Provisional Patent Application No. 63 / 586,076, filed September 28, 2023, the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure relates to the field of surgery, and more particularly to tensionable knotless surgical constructs and related knotless surgical techniques. Summary of the Invention

[0003] Surgical constructs and tissue repairs are disclosed. The surgical constructs can create knotless, tension-adjustable, and self-locking repairs without the need for tying knots. The surgical constructs can be configured to include (i) loops, (ii) loop interconnections, and (iii) locking mechanisms. The surgical constructs can be suture constructs. The surgical constructs can be cervical constructs.

[0004] The loop of the surgical construct may be a closed, flexible, continuous suture loop. The loop of the surgical construct may be a cervical loop. The loop interconnection may be in the form of an interconnected loop link, such as a rack hitch or a half hitch. The loop interconnection may be a configuration disposed between the loop and a locking mechanism. The locking mechanism may be a stopper. The stopper may be a suture bulge or deformation formed by applying mechanical pressure to the suture construct. The stopper may be a ferrule having an internal configuration that allows for unidirectional tension of the cervical construct.

[0005] The surgical constructs can be used to reattach anatomical structures, e.g., first tissue, to a second tissue, such as bone to bone, soft tissue, tendon, ligament, and / or bone, to each other, and / or to any combination of each other, by employing a self-locking, knotless, tension-adjustable mechanism. The self-locking constructs can be used as stand-alone constructs or with additional fixation devices, e.g., attached to one or more fixation devices.

[0006] A method for knotless tension-adjustable surgical repair is also disclosed. In one embodiment, a portion of the flexible strand can be deformed by applying mechanical pressure and / or compression to form at least one bulge or deformation adjacent to a racking hitch. The at least one bulge or deformation creates an occlusion of the suture loosening through the racking hitch-type knot. The suturing technique eliminates the need for a binding knot.

[0007] In another embodiment, a ferrule having an internal structure is attached to the tibial repair adjacent the tibial locking mechanism to tension the tibial repair and lock the tibial material. The ceramic locking mechanism may be interconnected ceramic loop links such as a rack hitch or half hitch.

[0008] In another embodiment, an exemplary locking ferrule for performing tissue repair may include a body including an outer diameter wall, an inner diameter wall, and a cannula surrounded by the inner diameter wall, with a plurality of locking barbs extending into the cannula and configured to lock a suture received through the cannula relative to the body.

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

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

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

[0012] Various features and advantages of the present 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 explanation of the drawings]

[0013] [Figure 1] FIG. 1 illustrates a surgical construct used for tissue repair according to an exemplary embodiment. [Figure 2] 2, 3 and 4 show schematic diagrams of the steps for forming the surgical construct of FIG. [Figure 3] 2, 3 and 4 show schematic diagrams of the steps for forming the surgical construct of FIG. [Figure 4] 2, 3 and 4 show schematic diagrams of the steps for forming the surgical construct of FIG. [Figure 5] 5, 6, 7, 8, 9, 10, and 11 show schematic diagrams of steps in tissue repair using the surgical construct of FIG. [Figure 6] 5, 6, 7, 8, 9, 10, and 11 show schematic diagrams of steps in tissue repair using the surgical construct of FIG. [Figure 7]5, 6, 7, 8, 9, 10, and 11 show schematic diagrams of steps in tissue repair using the surgical construct of FIG. [Figure 8] 5, 6, 7, 8, 9, 10, and 11 show schematic diagrams of steps in tissue repair using the surgical construct of FIG. [Figure 9] 5, 6, 7, 8, 9, 10, and 11 show schematic diagrams of steps in tissue repair using the surgical construct of FIG. [Figure 10] 5, 6, 7, 8, 9, 10, and 11 show schematic diagrams of steps in tissue repair using the surgical construct of FIG. [Figure 11] 5, 6, 7, 8, 9, 10, and 11 show schematic diagrams of steps in tissue repair using the surgical construct of FIG. [Figure 12] FIG. 12 shows a schematic diagram of a surgical construct for use in tissue repair, according to another exemplary embodiment. [Figure 13] FIG. 13 is an enlarged view of the locking mechanism of the surgical construct of FIG. [Figure 14] FIG. 14 shows a locking ferrule that can be used to perform a variety of adjustable tension knotless tissue repairs. [Figure 15] FIG. 15 is an end view of the locking ferrule of FIG. [Figure 16] FIG. 16 is a cross-sectional view taken along line 3-3 in FIG. [Figure 17] FIG. 17 is a cross-sectional view taken along line 4-4 of FIG. [Figure 18] FIG. 18 schematically illustrates loading a suture through a locking ferrule. [Figure 19] FIG. 19 is a schematic diagram illustrating locking of a suture to a locking ferrule. [Figure 20] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 21]Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 22] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 23] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 24] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 25] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 26] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 27] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 28] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 29] Figures 20, 21, 22, 23, 24, 25, 26, 27, 28, and 29 schematically illustrate a surgical method for performing tissue repair. [Figure 30] 30, 31, and 32 schematically illustrate another exemplary surgical method for performing tissue repair. [Figure 31]30, 31, and 32 schematically illustrate another exemplary surgical method for performing tissue repair. [Figure 32] 30, 31, and 32 schematically illustrate another exemplary surgical method for performing tissue repair. [Figure 33] FIG. 33 shows a suture locking system. [Figure 34A] 34A, 34B, 34C, and 34D illustrate another exemplary suture locking system. [Figure 34B] 34A, 34B, 34C, and 34D illustrate another exemplary suture locking system. [Figure 34C] 34A, 34B, 34C, and 34D illustrate another exemplary suture locking system. [Figure 34D] 34A, 34B, 34C, and 34D illustrate another exemplary suture locking system. DETAILED DESCRIPTION OF THE INVENTION

[0014] Surgical constructs, assemblies, and methods for knotless fixation of tissue are disclosed.

[0015] The surgical construct can create a knotless, tension-adjustable, self-locking repair. The surgical construct can be configured to include (i) a loop, (ii) a loop interconnection, and (iii) a locking mechanism. The surgical construct can be a suture construct. The surgical construct can be a cervical construct.

[0016] The suture construct may include (i) a closed, flexible, adjustable continuous suture loop, (ii) interconnecting loop links such as a rack hitch or half hitch, and (iii) a locking mechanism (stopper). The stopper may be a suture bulge or deformation formed by applying mechanical pressure to the suture construct. The suture construct may consist essentially of suture. The suture construct may consist essentially of a braid with a monofilament core. The suture construct can be used to attach or reattach anatomical structures, such as a first tissue, to a second tissue, such as soft tissue, tendon, ligament, and / or bone, to each other, and / or any combination of each other, by employing a self-locking knotless mechanism. The suture construct may be used as a standalone construct or with additional fixation devices, for example, attached to one or more knotted or knotless suture anchors.

[0017] The cervical construct may include (i) a cervical loop, (ii) interconnecting cervical loop links, such as a rack hitch or half hitch, and (iii) a locking mechanism (stopper). The stopper may be a ferrule with an internal configuration that allows for unidirectional tensioning of the cervical construct. The cervical construct may consist essentially of cervical sutures. The cervical construct may consist essentially of cervical suture tape. For example, the cervical construct may be used to reattach anatomical structures to bone. The cervical construct may be used as a standalone construct or with additional fixation devices attached to one or more fixation devices, such as bone plates, screws, and / or implants.

[0018] Also disclosed are methods of surgical repair. Exemplary methods include, among other steps, (i) passing a flexible construct through and / or around the tissue to be repaired, (ii) threading a tail of the flexible construct through a loop of the flexible construct to form a cinch, and (iii) preventing the flexible construct from loosening by forming a locking mechanism adjacent the cinch. The flexible construct may be a suture construct. The flexible construct may be a bone neck construct.

[0019] In an exemplary embodiment, a portion of the suture construct may be deformed by applying mechanical pressure and / or compression to form at least one bulge, expansion, or deformation in the suture adjacent to the racking hitch knot. The at least one bulge, expansion, or deformation creates a blockage of the suture loosening through the racking hitch knot. The suture technique eliminates the knot tying. Tension is applied to the racking hitch, and then mechanical pressure is applied to the suture. The mechanical pressure causes one or more monofilaments, acting as stoppers, to bulge out of and through the braid.

[0020] In another exemplary embodiment, a ceramic restoration can be performed using a ceramic material (e.g., ceramic tape) secured by a racking hitch-type knot. A ferrule with an internal configuration slides over the end of the cervical tape and tensions the hitch, which locks in one direction. The hitch carries most of the tension of the restoration, and the ferrule acts as a stop.

[0021] An exemplary surgical construct may include a flexible strand including a loop and a single tail, the single tail being disposed through the loop to establish a loop interconnection, and a stopper positionable adjacent the loop interconnection and configured to lock the flexible strand from loosening through the loop interconnection.

[0022] In any further embodiment, the surgical construct is a knotless, tension-adjustable, self-locking suture construct.

[0023] In an optional further embodiment, the stopper includes at least one bulge or deformation formed by applying mechanical pressure or force to the flexible strand.

[0024] In any further embodiment, the flexible strand comprises a braid having a monofilament core.

[0025] In any further embodiment, the flexible strand is suture tape.

[0026] In any further embodiment, the surgical construct is a cervical construct.

[0027] In any further embodiment, the stopper includes a ferrule that allows for unidirectional passage of the flexible strand, the ferrule including an internal configuration that allows for unidirectional passage of the flexible strand.

[0028] In any further embodiment, the loop interconnect is a cinch.

[0029] In an optional further embodiment, the loop interconnection is a racking hitch or a half hitch.

[0030] In any further embodiment, the stopper is a bulge having a width greater than the width of the flexible construct, the flexible construct including a monofilament core protruding through a braid to establish the bulge, and the braid is formed of ultra-high molecular weight polyethylene (UHMWPE).

[0031] A locking ferrule including a one-way locking mechanism may be utilized as part of an adjustable tension knotless tissue repair to tension and lock one or more strands of suture.

[0032] An exemplary locking ferrule for performing tissue repair may include a body including an outer diameter wall, an inner diameter wall, and a cannulation portion surrounded by the inner diameter wall, and a plurality of locking barbs extending into the cannulation portion and configured to lock a suture received through the cannulation portion to the body.

[0033] In any further embodiment, the plurality of locking barbs are an integral part of the body.

[0034] In any further embodiment, each of the plurality of locking barbs includes a pointed tip.

[0035] In any further embodiment, the body extends along a longitudinal axis between the proximal and distal ends.

[0036] In any further embodiment, each of the plurality of locking barbs is angled in a direction toward the proximal end.

[0037] In an optional further embodiment, each of the plurality of locking barbs projects inwardly from the inner diameter wall.

[0038] In any further embodiment, the plurality of locking barbs are arranged in at least a first row and a second row.

[0039] In any further embodiment, a first portion of the plurality of locking barbs in the first row are staggered relative to a second portion of the plurality of locking barbs in the second row.

[0040] In any further embodiment, the plurality of locking barbs are disposed along the entire length of the body.

[0041] In any further embodiment, the suture has a varying thickness.

[0042] Referring now to the drawings, where like elements are designated by like reference numerals, Figures 1-12 show surgical constructs 100, 200 for use in surgical tissue repair according to exemplary embodiments. Figures 1-4 show a surgical construct 100 for use in suture repair according to an exemplary embodiment. Figures 5-11 show subsequent steps of tissue suture repair 101 using the surgical construct 100 of Figure 1. Figures 12 and 13 show a surgical construct 200 for use in bone neck repair according to another exemplary embodiment of the present disclosure.

[0043] The suture construct 100 (surgical construct 100, suture 100, self-locking construct 100, knotless tension-adjustable construct 100, knotless closure suture 100, flexible construct 100, left and right knotless suture 100) is formed of flexible strands 50 (flexible material 50, suture construct 50, suture construct 50) used to secure a first tissue to a second tissue. In an exemplary embodiment, the suture construct 100 is formed of flexible strands 50, including a central strand (first strand or filament, inner strand) of a core suture 10 that covers the central strand, and outer strands (second strand or filament, outer strand, coreless suture) of a suture 11. The central strand 10 can be a monofilament core. In one embodiment, the outer strands 11 completely cover the central strand 10 in at least two directions: longitudinally and transversely. Further details of flexible strand 50 are shown in FIG.

[0044] The suture construct 100 also includes one or more loop interconnects 66 and one or more locking mechanisms 77 (stop mechanisms 77). In one embodiment, as shown in FIGS. 5-7 , the suture construct 100 includes a rack hitch 66 (rack hitch knot 66, cinch 66, luggage tag 66, luggage tag stitch 66) and a small loop 51 for creating a flexible, closed, adjustable, self-locking, tension-adjustable loop 55. The small loop 51 may be integral with or separate from the suture construct. The loop 51 may be part of the outer strand 11 or, alternatively, part of the inner strand 10. In yet another embodiment, the loop 51 may be part of both strands 10, 11. In additional embodiments, the small loop 51 may be attached to the suture construct (e.g., to one or both of the outer and inner strands) by any method known in the art. The small loop 51 may be integral with the flexible strand 50.

[0045] Referring now to Figures 3-4, following the formation of the loop interconnections 66, the locking mechanism 77 is formed by applying mechanical pressure, compression, or force F to a region of the suture construct 100 adjacent to the loop interconnections 66 to form a crushed or crimped region 77 (stop or locking mechanism 77) within the flexible strand 50. The locking mechanism 77 acts as a stopper. Figures 4(a) and 4(b) show enlarged views of the strands 10, 11 before and after the application of mechanical pressure and compression. The bulge 77 in Figure 4(b) is formed after the application of mechanical pressure or mechanical force to the flexible strand 50. Upon application of mechanical pressure, the monofilament core 10 bulges through and penetrates the braid 11 (UHMWPE braid 11), as clearly shown in Figure 4(b). The bulge 77 may be any deformation, enlargement, expansion, protrusion, or flattened area / region of the flexible strand 50 that has a size that does not allow movement or passage through the loop interconnect 66. A monofilament suture 11 having a solid core 10 can be flattened to distort its cross-sectional profile and achieve a more elliptical cross-sectional profile.

[0046] It is important to note that while bulge 77 locks construct 100, bulge 77 primarily acts as a stopper for the suture, creating an obstacle for the suture to loosen through racking hitch type knot 66. In this way, mechanical pressure alone, without the use of any powered source of welding / deforming the suture, provides a secure and reinforced locking of suture 50 while eliminating the need for a tying knot.

[0047] Reference is now made to Figures 8-11, which illustrate a suture repair 101 (Figure 11) using an exemplary surgical construct 100. A flexible strand 50 is passed through a first tissue 90 (soft tissue 90) attached to a second tissue 80 (bone 80) using a suturing instrument 40, such as, for example, a needle 40.

[0048] 9 and 10 show the formation of a loop interconnection 66 (rack hitch knot 66) and the passage of a single tail of a flexible strand 50 through the rack hitch knot 66. Tension is applied by pulling on the single tail of the 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 a stop / locking feature 77 (bulge or deformation 77) in the strand 50.

[0049] The final repair 101 includes a suture construct 100 having a bulge or expansion 77 formed in the flexible strand 50 by applying mechanical pressure, which is locked in place by the rack hitch 66 and cannot slip out or slip out of the loop formed around the first tissue 90 (e.g., soft tissue 90) attached to the second tissue 80 (e.g., bone 80).

[0050] The flexible strand 50 (suture construct 50) may comprise a single filament or fiber, or may comprise multiple continuous filaments, segments of filaments, or regions having different configurations (e.g., different dimensions and / or different compositions), allowing for the formation of at least one bulge 77 upon application of mechanical pressure and / or compression.

[0051] The flexible strands 50 may be made from any known suture construction, such as multifilament, braided, knitted, woven suture, or may comprise fibers of ultra-high molecular weight polyethylene (UHMWPE) or FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is incorporated herein by reference in its entirety). The flexible strands may also be formed from suture tape, such as Arthrex FiberTape®, a braided, rectangular-like cross-section, high-strength suture tape disclosed in U.S. Pat. No. 7,892,256, the disclosure of which is incorporated herein by reference in its entirety.

[0052] 12 and 13 show schematic diagrams of a surgical construct 200 of the present disclosure. The surgical construct 200 of FIG. 12 is generally similar to the surgical construct 100 detailed above in that it is also a knotless, tension-adjustable, self-locking construct including loops 150 having one or more loop interconnections 166, such as a rack hitch knot 166 and one or more stop / locking mechanisms 177. However, the surgical construct 200 differs from the construct 100 in that (i) the surgical construct 200 is a surgical construct having flexible strands 150 formed of, among other things, a surgical material such as metal and / or suture tape, and (ii) the surgical construct 200 includes a ferrule 177 or collet 177 having an internal configuration 178 that forms the stop / locking mechanism.

[0053] A cinch 166 (racking hitch 166) tibial repair is created around bone 80 and / or tissue 90. The ferrule 177 has an internal configuration 178 that allows for unidirectional tension and unidirectional suture direction and movement. The ferrule 177, slipped over the end of the flexible strand 150 (ceramic tape 150), tensions the unidirectionally locking hitch 166. The hitch 166 carries most of the tension in the tibial repair while the ferrule 166 acts as a stop. The disclosed cervical repair is tension-adjustable and knotless, eliminating tying knots from suture techniques such as cervical repair and side-to-side repair. With the racking hitch configuration of the cervical technique disclosed above, the ferrule 177 no longer needs to carry the full strength of the repair, instead acting as a stop. This aspect alone provides additional strength to the overall cervical repair.

[0054] The suture construct 100 may include (i) a closed, flexible, adjustable continuous suture loop 55, (ii) an interconnecting loop link 66, such as a rack hitch 66, a half hitch 66, or a cinch 66, and (iii) a locking mechanism 77 or stopper 77. The stopper 77 may be a suture bulge or deformation formed by applying mechanical pressure to the suture construct. The suture construct 100 may consist essentially of a suture 50. The suture construct 100 may consist essentially of a braid 11 having a monofilament core 10. The suture construct 10 employs a self-locking, knotless mechanism to reattach anatomical structures, such as a first tissue 90, to a second tissue 80, such as soft tissue, tendon, ligament, and / or bone, to each other, and / or to any combination of each other. The suture construct 100 may be used as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices.

[0055] The cervical construct 200 may include (i) a cervical loop 150, (ii) interconnecting cervical loop links 166, such as a rack hitch 166, a half hitch 166, or a cinch 166, and (iii) a locking mechanism 177 or stopper 177. The stopper 177 may be a ferrule 177 provided with an internal feature 178 that allows for unidirectional tensioning of the cervical construct. The cervical construct 200 may be comprised essentially of a suture tape 150. The tibial construct 200 may be used to reattach anatomical structures, such as bone to bone or bone to soft tissue. The cervical construct 200 may be used as a standalone construct or with additional fixation devices attached to one or more fixation devices, such as bone plates, anchors, screws, and / or implants.

[0056] The flexible strands 50, 150 may be in the form of any elongated member, fiber, or material, or a combination thereof. The flexible strands 50, 150 may be coated (partially or completely) with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning Silicone Fluid 202A or others), silicone rubber (Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others), PTFE (Teflon, Hostaflon, or others), PBA (polybutyrate acid), ethyl cellulose (Filodel), or other coatings to improve the lubricity, loop security, flexibility, ease of handling, or abrasion resistance of the suture, for example.

[0057] The flexible strands 50, 150 may be made from any known suture construction, such as multifilament, braided, knitted, woven suture, or may comprise fibers of ultra-high molecular weight polyethylene (UHMWPE) or FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is incorporated herein by reference in its entirety). The flexible strands 50, 150 may also be formed from suture tape, such as Arthrex FiberTape®, a braided, rectangular-like cross-section, high-strength suture tape disclosed in U.S. Pat. No. 7,892,256, the disclosure of which is incorporated herein by reference in its entirety.

[0058] The flexible strands 50, 150 can also be provided with colored tracing strands or otherwise visually contrast with other areas / regions of the construct, which may, for example, remain a simple solid color or display a different tracing pattern. Various structural elements of the flexible strands 50, 150, such as the loops 55, 155 and / or tails, may be visually coded to make identification and handling of the suture loops and ends simpler. Easy identification of sutures in situ is advantageous during surgical procedures.

[0059] The term "high strength suture" is defined as any elongated flexible member, the selection of material and size depending on the particular application. For 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 within the body.

[0060] The term "luggage tag stitch" is defined as any fastening or loop formed by the technique of a luggage tag.

[0061] 14-19 illustrate an exemplary locking ferrule 210 that may be used when performing various tension-adjustable knotless tissue repairs. For example, the locking ferrule 210 may be utilized during surgical procedures for attaching tissue (e.g., ligaments, tendons, grafts, etc.) to bone or for repairing any other type of tissue effect. The locking ferrule 210 may be used in conjunction with various orthopedic surgical repairs, including, but not limited to, rotator cuff repair, Achilles tendon repair, patellar tendon repair, and biceps tendon repair, among others.

[0062] The locking ferrule 210 may include a body 212 extending along a longitudinal axis A between a proximal end 214 and a distal end 216. The body 212 may be tubular in shape and constructed from either a metallic or plastic material. However, the particular size, shape, and material composition of the body 212 are not intended to limit the present disclosure.

[0063] A cannula 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 cannula 218 may be configured to extend the entire length of the body 212, and thus may extend from the proximal end 214 to the distal end 216. The longitudinal axis A may be configured to bisect the cannula 218.

[0064] Body 212 may include an outer diameter wall 222 and an inner diameter wall 224. Outer diameter wall 222 may be smooth or, alternatively, may include threads, barbs, or other features to promote bone fixation. Inner diameter wall 224 may surround cannula 218. In some embodiments, cannula 218 may be tapered toward distal end 216, and thus narrower at distal end 216 compared to proximal end 214.

[0065] A plurality of locking barbs 226 may project inward from inner diameter wall 224. As such, locking barbs 226 may occupy at least a portion of the open space of cannula 218. In one embodiment, locking barbs 226 are integrally formed (e.g., molded) parts of body 212 of locking ferrule 210. Locking barbs 226 may be provided along the entire length of cannula 218, or only on selected portions thereof. Locking barbs 226 may be either rigid or flexible in construction.

[0066] The locking barbs 226 may be arranged in multiple rows along the length of the cannula 218. For example, the locking barbs 226 may be arranged in at least a first row R1 and a second row R2 (FIG. 17). In one embodiment, the locking barbs 226 in the second row R2 are staggered relative to the locking barbs 226 in the first row R1 (FIG. 17).

[0067] Each locking barb 226 may be configured to include a sharp or pointed tip 228, and each locking barb 226 may be angled toward the proximal end 214. Thus, the locking barbs 226 may be configured to establish a one-way locking mechanism that allows one or more sutures 220 to pass through the cannula 218 in a first direction D1, but prevents the sutures 220 from being placed under tension or otherwise moving in a second direction D2. The staggered relationship of the rows of locking barbs 226 may provide maximum engagement with the sutures 220 passing through the cannula 218.

[0068] 18 and 19, with continued reference to FIGS. 14-17, one or more sutures 220 may pass through cannula 218. Suture 220 may be FiberWire®, FiberTape®, or any other suitable suture product. FiberWire® and FiberTape® are suture products sold and distributed by Arthrex, Inc. However, other suture products may be utilized for suture 220 within the scope of the present disclosure. The size and type of suture utilized in conjunction with locking ferrule 210 is not intended to limit the present disclosure.

[0069] Suture 220 may be configured with a varying thickness. Accordingly, suture 220 may include one or more tapered regions 230 where suture 220 transitions between a thickened section 232 and a thinned section 234. Thinned section 234 may facilitate threading of suture 220 through cannula 218, such as via a suitable suture loader 236, which may be provided as part of a suture locking system that includes locking ferrule 210, and thickened section 232 may provide a larger surface area for locking barb 226 to engage in order to sufficiently lock suture 220 relative to locking ferrule 210.

[0070] In one embodiment, thickened section 232 of suture 220 is approximately twice as thick as thinned section 234. However, other ratios between the relative thickness (e.g., outer diameter) of thickened section 232 and thinned section 234 (e.g., 1.5:1, 3:1, etc.) are also contemplated within the scope of the present disclosure.

[0071] One or more sutures 220 may be threaded through the cannula 218 of the locking ferrule 210 using a suture loader 236. The eyelet 238 of the suture loader 236 may be passed through the cannula 218 (e.g., by inserting the eyelet 238 into the distal end 216 of the body 212 and then moving the suture loader 236 in the second direction D2). One or more thin sections 234 of the suture 220 may then be loaded through the eyelet 238. The suture loader 236 may then be pulled in the first direction D1 via the handle 240, threading the suture 220 through the cannula 218.

[0072] Once suture 220 passes through cannula 218, suture 220 may be configured to be further tensioned in first direction D1 to lock suture 220 relative to locking ferrule 210. Locking barb 226 prevents suture 220 from backing up or otherwise moving in second direction D2. Pointed tip 228 of locking barb 226 may be configured to interfit with one or more thickened sections 232 to lock suture 220 and prevent suture 220 from moving in second direction D2.

[0073] Although shown in the above implementation as locking a single folded suture 220, the locking ferrule 210 may be configured to receive and lock sutures of various sizes and / or multiple strands of suture.

[0074] In the implementation described above, a single locking ferrule 210 is utilized to tension and knotlessly secure the suture 220. However, two or more of the locking ferrules 210 may be configured to be utilized together to establish a suture locking system 299 for tensioning and knotlessly secure the suture 220 (e.g., FIG. 33).

[0075] The locking ferrule 210 described above and shown in Figures 14-19 may be configured to be utilized to tension and knotlessly secure one or more sutures 220 as part of various surgical procedures. Figures 20-29 schematically illustrate one such surgical method for attaching tissue 242 to bone 244. Tissue 242 can be torn away from bone 244 during, for example, strenuous exercise or sporting activities. When such a tear occurs, reattachment is often necessary to repair the tissue defect.

[0076] 20-29 can be used in conjunction with a variety of orthopedic surgical repairs, including, but not limited to, rotator cuff repair, and bone 244 associated with any joint of the human musculoskeletal system (e.g., shoulder, knee, hip, ankle, etc.).

[0077] In one embodiment, the surgical method is performed as an arthroscopic procedure by working through various arthroscopic portals. However, the exemplary surgical method may alternatively be performed as an open procedure within the scope of the present disclosure. The exemplary surgical method may be used to reduce and then knotlessly attach tissue 242 to bone 244 in a manner that enhances footprint compression to maximize tissue-to-tissue contact.

[0078] 20 , after the bone 244 has been properly prepared (e.g., by fracturing, creating a bleeding bone bed, preparing a bone socket, etc.), an inner row of fixation devices may be implanted into the bone 244. The middle row of fixation devices may comprise one or more suture anchors 246. The suture anchors 246 may be knotless suture anchors that do not require the tying of knots in various configurations to reduce and secure the tissue 242 to the bone 244, or may be traditional knot-style suture anchors. Furthermore, the suture anchors 246 may be “soft” anchors made solely from soft suture-based materials, or may be relatively rigid structures made from plastic or metal.

[0079] In one embodiment, the medial row of suture anchors 246 are positioned at the articular margin of the bone 244. However, other implantation locations may be selected based on surgeon preference. Notably, although two suture anchors 246 are shown as part of the medial row in the illustrated embodiment, a greater or lesser number of suture anchors (or other fixation devices) may be utilized as part of a surgical method within the scope of the present disclosure. For example, the medial row may include only a single suture anchor 246.

[0080] Each suture anchor 246 may be preloaded with one or more sutures 220. The sutures 220 may comprise individual suture strands, multiple suture strands, suture tape, or any other suture-like product. As shown in FIG. 21 , the sutures 220 may be threaded upwardly through the tissue 242 after each suture anchor 246 in the medial row is properly anchored within the bone 244.

[0081] 22 , the surgical method can proceed by implanting a transverse row of fixation devices into bone 244. The transverse row of fixation devices can include one or more suture anchors 248. The suture anchors 248 can include an anchor body 250 and a shuttle device 252 received through the anchor body 250. The anchor body 250 can be a “soft” body made solely of a soft suture-based material, or can be a relatively rigid plastic or metal body. The shuttle device 252 can be, for example, a pass-through wire or another suture.

[0082] The lateral row of suture anchors 248 may be positioned laterally from the edge 254 of the tissue 242 and slightly distal to the greater tuberosity of the bone 244. Thus, the suture anchors 248 may be positioned laterally from the medial row of suture anchors 246. However, other implantation locations may be selected based on surgeon preference and depending on the type of orthopedic surgical procedure being performed. Notably, although two suture anchors 248 are shown as part of the lateral row in the illustrated embodiment, more or fewer lateral fixation devices may be utilized as part of a surgical method within the scope of the present disclosure.

[0083] The anchor body 250 of each suture anchor 248 may be configured to be inserted into a socket 264 formed in the bone 244. Each socket 264 may be a pre-formed opening formed in the bone 244 that is sized to receive the anchor body 250 of one of the suture anchors 248.

[0084] The surgical method may then proceed by shutting the suture 220 from the medial row of suture anchors 246 through the anchor bodies 250 of the lateral row of suture anchors 248. For example, as shown in FIG. 23 , one limb 256 of the suture 220 from each suture anchor 246 may be passed through the eyelet 255 of the shuttle device 252 of the first suture anchor 248, after which the free end 260 of the shuttle device 252 may be pulled (e.g., in the direction of arrow 262) to allow the limb 256 to pass through the anchor body 250 of the suture anchor 248. This shutting process may be repeated to shuttle additional limbs 258 of the suture 220 from each suture anchor 246 through the anchor body 250 of the second suture anchor 248 in the lateral row (see FIG. 24 ). Thus, the limbs 256, 258 may be configured to be arranged in a crisscross pattern P that provides a desired footprint compression area over the top of the tissue 242 (see FIG. 25).

[0085] At this point in the surgical method, the suture 220 of the suture anchor 246 is pre-secured to the bone 244 by the suture anchor 248. The suture 220 may then 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 section 234 of the first connected rim 256 of the suture anchor 248 through the cannula 218 of the locking ferrule 210 (e.g., in the manner shown in FIGS. 18-19), the rim 256 may be tensioned in direction D2 to allow the locking ferrule 210 to slide the rim 256 in direction D1 and be received within the socket 264. Further tension on limb 256 in direction D1 allows pointed tips 228 of locking barbs 226 to interdigitate with thickened sections 232 of sutures 220, locking sutures 220 and preventing them from sliding in second direction D2. After being positioned within sockets 264, locking ferrules 210 may be configured to be positioned over first tops of transverse row of suture anchors 248 (see FIG. 28 ).

[0086] 26-28 may be repeated to tension and lock a second associated limb 258 of the suture anchor 248 with an additional locking ferrule 210. The final construct achieved by the surgical method is shown in FIG. 29. The excess length of suture 220 extending outside the cannula 218 of the locking ferrule 210 may be removed (e.g., cut) once tensioning and locking is complete.

[0087] 30-32 schematically illustrate another surgical method in which the locking ferrule 210 of FIGS. 14-19 may be utilized to tension and lock sutures during surgical repair. In this embodiment, the surgical method may include securing tissue 266 (e.g., tendon) to bone 268, such as part of a biceps tenodesis.

[0088] 30 , a surgical method may include creating a loop stitch 270 (e.g., with a suture) in tissue 266 and inserting a suture button 272 into bone 268 at a desired attachment point of tissue 266. Suture button 272 may include a button body 274 in the form of a sheath and a shuttle device 276 received through button body 274. Shuttle device 276 may be, for example, a pass-through wire or a suture.

[0089] The button body 274 of the suture button 272 may be configured to be inserted into a socket 278 formed in the bone 268. The socket 278 may be a pre-formed opening formed in the bone 268 sized to receive the button body 274 of the suture button 272.

[0090] The surgical method may then proceed by shuttling the suture rim 280 of the loop stitch 270 through the button body 274 of the suture button 272. For example, the suture rim 280 may be threaded through the eyelet 282 of the shuttle device 276 of the suture button 272. The free end 286 of the shuttle device 276 may then be pulled (in the direction of arrow 284) to allow the suture rim 280 to pass through the button body 274 of the suture button 272.

[0091] At this point in the surgical method, the tissue 266 is reduced in place against the bone 268. The suture rim 280 may then be tensioned and locked in place using the locking ferrule 210. For example, as shown in FIG. 31 , after loading the suture rim 280 through the cannula 218 of the locking ferrule 210, tension may be applied to the suture rim 280 in direction D1, allowing the locking ferrule 210 to slide downward into the socket 278 in direction D2. Further tensioning of the suture rim 280 allows the pointed tip 228 of the locking barb 226 to interdigitate with the section of the suture rim 280 housed within the cannula 218, thereby locking the suture rim 280 in place and preventing it from moving back in the second direction D2. Thus, the tissue 266 is securely tensioned and secured against the bone 268. Once positioned within the socket 278, the locking ferrule 210 may be positioned over the top of the suture button 272 (see FIG. 32).

[0092] 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 shutting the suture 220 through the locking ferrules 210. The locking ferrules 210 may include, for example, the designs shown in FIGS.

[0093] 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 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 movement of the eyelet 338. The eyelet 338 may be configured to receive the suture 220 through the cannula 218 of the locking ferrule 210 prior to shutting the suture 220 therethrough. In one embodiment, the locking ferrule 210 and the suture loader 336 are pre-assembled together prior to performing the suture shuttering procedure.

[0094] 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 decoupled from the first handle section 390 and then moved in a first direction D1 to shuttle the suture 220 through the cannula 218 of the locking ferrule 210. After the suture 220 passes through the cannula 218 of the locking ferrule 210, tension may be applied to the suture 220 in the first direction D1 to lock the suture 220 relative to the locking ferrule 210 and prevent movement in the second direction D2 in the manner described above.

[0095] In one embodiment, the locking ferrule 210 may be configured to be received within a recessed opening 396 in the first handle section 390 of the suture loader 336 prior to shutting the suture 220 through the locking ferrule 210 (see FIG. 34C). In another embodiment, the locking ferrule 210 may be pre-loaded within a separate surgical device 398 (e.g., a sleeve, button, suture anchor, screw, bone plate, arthroplasty implant, etc.) of the suture locking system 399 prior to shutting the suture 220 through the locking ferrule 210 (see FIG. 34D).

[0096] The locking ferrules of the present disclosure may be utilized in conjunction with one or more additional fixation devices (e.g., anchors, buttons, etc.) to perform a variety of adjustable tension knotless tissue repairs. The locking ferrules provide tension and retention of the suture(s) at various points in the tissue repair, including after implantation of the associated fixation device, and therefore offer many advantages over previous tissue repair techniques.

[0097] Although different non-limiting embodiments are illustrated as having particular components or steps, embodiments of the present disclosure are not limited to those particular combinations. It is possible to use components or portions of configurations from any of the non-limiting embodiments in combination with configurations or components from any of the other non-limiting embodiments.

[0098] It should be understood that like reference numerals identify corresponding or similar elements throughout the several views. It should be further understood that while particular component configurations are disclosed and illustrated in these exemplary embodiments, other configurations may also benefit from the teachings of the present disclosure.

[0099] The foregoing description should be construed as illustrative and not in any limiting sense. Those skilled in the art will understand that certain variations may fall within the scope of the present disclosure. For these reasons, the following claims should be studied to determine the true scope and content of the present disclosure.

Claims

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

2. The surgical construct of claim 1 , wherein the surgical construct is a knotless, tension-adjustable, self-locking suture construct.

3. 3. The surgical construct of claim 1 or 2, wherein the stopper comprises at least one bulge or deformation formed by applying mechanical pressure or force to the flexible strand.

4. The surgical construct of any one of claims 1 to 3, wherein the flexible strand comprises a braid having a monofilament core.

5. The surgical construct of any one of claims 1 to 4, wherein the flexible strand is a suture tape.

6. The surgical construct according to any one of claims 1 to 5, wherein the surgical construct is a cervical construct.

7. 2. The surgical construct of claim 1, wherein the stopper includes a ferrule that allows unidirectional passage of the flexible strand, and further wherein the ferrule includes an internal configuration that allows the unidirectional passage of the flexible strand.

8. The surgical construct of any one of claims 1 to 7, wherein the loop interconnections are cinches.

9. The surgical construct of any one of claims 1 to 8, wherein the loop interconnection is a racking hitch or a half hitch.

10. 2. The surgical construct of claim 1, wherein the stopper is a bulge having a width greater than a width of the flexible construct, and further wherein the flexible construct includes a monofilament core protruding through a braid to establish the bulge, and the braid is formed of ultra-high molecular weight polyethylene (UHMWPE).

11. 1. A locking ferrule for performing tissue repair, comprising: a body including an outer diameter wall, an inner diameter wall, and a cannula surrounded by said inner diameter wall; a plurality of locking barbs extending into the cannula and configured to lock a suture received through the cannula relative to the body.

12. The locking ferrule of claim 11 , wherein the plurality of locking barbs are integral components of the body.

13. 13. The locking ferrule of claim 11 or 12, wherein each of the plurality of locking barbs has a pointed tip.

14. The locking ferrule of any one 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 of claim 14 , wherein each of the plurality of locking barbs is angled in a direction toward the proximal end.

16. The locking ferrule of any one of claims 11 to 15, wherein each of the plurality of locking barbs projects inwardly from the inner diameter wall.

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

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

19. 17. The locking ferrule of claim 16, wherein the plurality of locking barbs are disposed along the entire length of the body.

20. The locking ferrule of any one of claims 11 to 19, wherein the suture has a varying thickness.

Images