Adjustable tension knotless surgical technique

Abstract

The surgical construct includes a loop with a racking hitch terminating 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 stop. A ferrule with an internal configuration can be attached to the tibial construct adjacent the racking hitch to act as a stop 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. [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. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 illustrates a surgical construct used for tissue repair according to an exemplary embodiment. [Figure 2] 2-4 show schematic diagrams of the steps for forming the surgical construct of FIG. [Figure 3] 2-4 show schematic diagrams of the steps for forming the surgical construct of FIG. [Figure 4] 2-4 show schematic diagrams of the steps for forming the surgical construct of FIG. [Figure 5] 5-11 show schematic diagrams of the steps in tissue repair using the surgical construct of FIG. 1. [Figure 6]5-11 show schematic diagrams of the steps in tissue repair using the surgical construct of FIG. 1. [Figure 7] 5-11 show schematic diagrams of the steps in tissue repair using the surgical construct of FIG. 1. [Figure 8] 5-11 show schematic diagrams of the steps in tissue repair using the surgical construct of FIG. 1. [Figure 9] 5-11 show schematic diagrams of the steps in tissue repair using the surgical construct of FIG. 1. [Figure 10] 5-11 show schematic diagrams of the steps in tissue repair using the surgical construct of FIG. 1. [Figure 11] 5-11 show schematic diagrams of the steps in tissue repair using the surgical construct of FIG. 1. [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. DETAILED DESCRIPTION OF THE INVENTION

[0009] Surgical constructs, assemblies, and methods for knotless fixation of tissue are disclosed.

[0010] 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.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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).

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] The term "luggage tag stitch" is defined as any fastening or loop formed by the technique of a luggage tag.

[0035] 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.

[0036] 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.

[0037] 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 interconnect and configured to lock the flexible strand from loosening through the loop interconnect.

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. The surgical construct of claim 1 , wherein the stopper includes a ferrule that allows unidirectional passage of the flexible strand.

8. The surgical construct of claim 7 , wherein the ferrule includes an internal configuration that allows for the unidirectional passage of the flexible strand.

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

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

11. The surgical construct of claim 1 , wherein the stopper is a bulge having a width greater than a width of the flexible construct.

12. The surgical construct of claim 11 , wherein the flexible construct includes a monofilament core protruding through a braid to establish the bulge.

13. The surgical construct of claim 12, wherein the braid is formed from ultra-high molecular weight polyethylene (UHMWPE).

14. 14. The surgical construct of any one of claims 1 to 13, wherein the flexible strands are formed from suture, silk, cotton, nylon, polypropylene, polyethylene, ultra-high molecular weight polyethylene (UHMWPE), polyethylene terephthalate (PET), polyester, or copolymers, or combinations thereof.

15. The surgical construct of any one of claims 1 to 14, wherein the flexible strand comprises a closed, adjustable flexible, continuous suture loop.

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