WO2026059719A1

WO2026059719A1 - Transverse compressible sutures and methods of making and use

Info

Publication number: WO2026059719A1
Application number: PCT/US2025/043333
Authority: WO
Inventors: Matthew R. HERRINGTON; Shaun G. LEBLANC; Jr. Thomas Dooney; Michael N. SCHMIDT; Derek C. Sullivan
Original assignee: Arthrex Inc
Current assignee: Arthrex Inc
Priority date: 2024-09-11
Filing date: 2025-08-25
Publication date: 2026-03-19
Anticipated expiration: 2027-03-11

Abstract

Surgical compressible constructs, assemblies, and methods of manufacturing, as well as methods for tissue repairs are disclosed. A suture includes one or more portions or regions provided with an elastically compressible component as part of its core. A suture can be manufactured by braiding a jacket or sheath around an elastically compressible material, or by inserting an elastically compressible material within a coreless region of a coreless suture.

Description

Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 IN THE UNITED STATES PATENT AND TRADEMARK OFFICE U.S. PATENT APPLICATION Title: TRANSVERSE COMPRESSIBLE SUTURES AND METHODS OF MAKING AND USE Inventors: Matthew R. Herrington Shaun G. LeBlanc Thomas Dooney, Jr. Michael Schmidt Derek C. Sullivan Gabriela I. Coman Potomac Law Group, PLLC 1717 Pennsylvania Avenue, NW Washington, D.C. 20006 Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 TRANSVERSE COMPRESSIBLE SUTURES AND METHODS OF MAKING AND USE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to US Provisional Application No. 63/693,307 filed on September 11, 2024, the disclosure of which is hereby incorporated by reference in its entirety herein. BACKGROUND [0002] The disclosure relates to the field of surgery and, more specifically, to surgical suture constructs and methods of making, and tissue repairs for reconstructive surgeries. SUMMARY [0003] Surgical compressible flexible couplers, methods of making, and methods of tissue repairs are disclosed. [0004] A surgical flexible coupler can include a suture provided around an elastically compressible material. An elastically compressible material can be any static compressible material such a rubber, silicone, or polyurethane, or any material that can provide a squashable element within a suture core. [0005] An elastically compressible material can be employed in lieu of suture material to stuff a repair suture. The compressible material maximizes the interface between the repair suture and a splice. The compressible material allows the suture to compress when squished, so that the suture becomes compressible in a transverse direction relative to a longitudinal axis of the suture. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 [0006] Methods of manufacturing sutures are also disclosed. A suture can be manufactured by providing a braid/suture sheath around one or more elastically compressible materials. A suture can be manufactured by braiding around a piece of elastically compressible material such as elastic. A suture can be manufactured by inserting an elastically compressible material within a coreless suture. [0007] Methods of knotless, tensionable tissue repairs with flexible couplers are also disclosed. A suture with an elastically compressible material can provide increased knotless tissue fixation, to allow for dynamic repairs with the ability to move and rebound when necessary. A suture with an elastically compressible material can allow for suture squeezing and better bunching and fixation for anchor sheaths. A suture with an elastically compressible material can provide an overall more secure locking mechanism over the repair area for any tensionable knotless anchor. DESCRIPTION OF THE DRAWINGS [0008] FIG. 1 illustrates a flexible coupler with an elastically compressible material. [0009] FIG. 2 illustrates a knotless mechanism with a flexible coupler provided with an elastically compressible material. [0010] FIGS. 3(a)-(e) illustrate various cross-sectional views of an elastically compressible portion of a flexible coupler. [0011] FIG. 4 illustrates a partial cut-out view of the flexible coupler and knotless mechanism of FIG. 2. [0012] FIG. 5 illustrates a surgical construct with a flexible coupler with an elastically compressible material. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 [0013] FIG. 6 illustrates a tissue repair with a flexible coupler with an elastically compressible material. [0014] FIG. 7 illustrates another tissue repair with a flexible coupler with an elastically compressible material. DETAILED DESCRIPTION [0015] The disclosure provides surgical flexible couplers, assemblies, constructs with elastically compressible materials, and methods for manufacturing, as well as tissue repairs and reconstructions. [0016] A surgical flexible coupler can be a suture braided around an elastically compressible material. A surgical flexible coupler can be a coreless suture with an elastically compressible material inserted within at least a portion of the coreless suture. [0017] A compressible elastic material is an elastically compressible material that can be an elastic such a rubber, silicone, or polyurethane, or any material that can provide a squashable element within a suture core. By providing an elastically compressible material within a suture, and once a splice is created as part of a tensionable knotless construct, the elastically compressible material (the suture stuffing) compresses as the stuffing is pulled into the knotless mechanism, providing a more consistent engagement and improving the fixation strength with more reproducible results. [0018] An exemplary method of making a compressible flexible coupler includes the step of incorporating an elastically compressible material into at least a portion of the coupler by, for example, by braiding around the elastically compressible material, or by inserting the elastically compressible material with a needle within a coreless suture such as a coreless braid. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 [0019] In an embodiment, a braiding machine can braid around a piece of elastically compressible material in the portion of the suture that would engage the splice. The shape of the elastically compressible material (stuffing material) can be one consistent diameter, tapered, or any varying diameter. The diameter shape can be circular or have any number of sides, such as a square, pentagon, hexagon, star shape, or similar shapes, to allow for enhanced compression of the elastically compressible portion. [0020] As detailed below, an elastically compressible material is employed in lieu of suture material to stuff a suture. The elastically compressible material maximizes the interface between the repair suture and splice and allows compressibility only in a transversal direction relative to a longitudinal axis of the suture (and not in a longitudinal direction along the longitudinal axis of the suture). [0021] Methods of tissue repairs with compressible flexible couplers are also disclosed. An exemplary method includes inter alia the steps of: (i) incorporating an elastically compressible material into at least a core region of a flexible coupler; and (ii) employing the flexible coupler for one or more tissue repair applications. Step (i) can be conducted by braiding a suture braid around an elastically compressible material, or by inserting an elastically compressible material within a core region of a flexible coupler with an inserter such as a needle, for example. The one or more tissue repair applications can include soft tissue repairs. The one or more tissue repair applications can include one or more knotless cerclage and/or tensionable mechanisms. A tensionable mechanism can be a knotless or knotted tensionable mechanism. [0022] Referring now to the drawings, where like elements are designated by like reference numerals, FIGS. 1-7 illustrate exemplary surgical flexible coupler 100 including at least one elastically compressible component 126 provided within at least a region of the flexible coupler. FIGS. 6-8 Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 illustrate construct 200 and tissue repairs 101, 102 with a flexible coupler such as flexible coupler 100. [0023] Flexible coupler 100 can be elastically compressible suture; stuffed compressible suture; compressible elastic suture; compressible suture; round compressible suture; round compressible suture/tape construct; round-to- flat compressible suture; compressible elastic tape. Elastically compressible component 126 can be compressibility component; elastomer; elastically compressible stuffing; elastically compressible filler; elastic filler; squeezable component. [0024] Exemplary compressible suture 100 of FIG. 1 includes a first portion 25 (first segment 25; first region 25; first length 25) adjacent to a second portion 26 (second segment 26; second region 26; second length 26) adjacent to a third portion 27 (third segment 27; third region 27; third length 27). In one embodiment, one of the first, second, and third portions is compressible and the others of the first, second, and third portions are non- compressible. In one embodiment, suture segment 26 is compressible and suture segments 25, 27 are non-compressible. In one embodiment, portions or segments of compressible and non-compressible segments can alternate in a pattern along the length of the suture. In one embodiment, portions or segments of compressible and non-compressible segments can alternate in a random manner along the length of the suture. In yet additional embodiments, regular patterns (of compressible and non-compressible segments) can alternate with randomly provided segments (compressible and non- compressible segments) along the length of the suture. [0025] Although the embodiments below will be detailed with reference to repair suture 100 provided with an elastically compressible region adjacent a non-elastically compressible region (to better explain improvement in the knotless self-locking mechanism), it must be understood that the present disclosure contemplates a repair suture that is provided with an elastically Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 compressible material along its full length, i.e., not only at predetermined portions and/or regions along its length. [0026] In the illustrative-only embodiment of FIG. 1, second suture portion 26 is a suture portion stuffed/packed/filled with an elastically compressible material 126 (elastically compressible material 126; stuffing material 126). The stuffing region 26 and the elastically compressible material 126 extend longitudinally along the length of suture 100 and for a predefined length. The elastically compressible material 126 can be any material which acts as elastically compressible stuffing 126 (squeezable stuffing or squeezable material 126). The material 126 can be elastane, rubber, silicone, polyurethane, polyester, compressible fillers, or any material that allows the suture 100 to be squeezed when pinched/pressed/clasped/wedged. In an exemplary-only embodiment, the compressible material 126 is rubber providing flexibility to the flexible coupler 100 in a transversal direction (i.e., when user squishes the stuffing region 26, the suture becomes compressible and/or squeezable only along a direction about transversal to the longitudinal axis of the flexible construct). Stuffing material 126 is elastically compressible in that it can compress and can also elastically spring back to its original diameter. [0027] Stuffing region 26 can consist essentially of one or more elastically compressible materials. Stuffing region 26 can consist essentially of elastomeric material. Stuffing region 26 can consist essentially of elastane material. Stuffing region 26 can consist essentially of an elastically compressible material. Stuffing region 26 can comprise of a plurality of elastically compressible materials. [0028] In an embodiment, and as shown in FIG. 1, the first region 25 is a splice region and the third region 27 is a tail region of a repair suture. Third region 27 can be a tapered tail region. The first and third regions 25, 27 are suture portion that are non-stuffed with an elastically compressible material. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 In one embodiment, the first and third regions are non-compressible and non- elastic. [0029] In an embodiment, flexible coupler 100 includes a sheath, braid, or jacket 10 that can have a tubular configuration. In an exemplary embodiment, jacket 10 can be a braided structure that covers elastically compressible material 126 at region 26. Jacket 10 can completely cover elastically compressible material 126. Braid or jacket 10 can be formed of a high strength suture material such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., and described in US 6,716,234, the disclosure of which is incorporated by reference herein. In an embodiment, braid or jacket 10 can consist essentially of ultra-high molecular weight polyethylene (UHMWPE). During fabrication, and in one exemplary embodiment, braid or jacket 10 can be braided over the elastically compressible material 126. [0030] Reference is now made to FIG. 2. Region 26 of the flexible coupler 100 can be part of a tensionable mechanism 50. In an embodiment, and as shown in FIG. 2, tensionable mechanism 50 is a knotless, self-locking, adjustable, tensionable mechanism. The repair suture stuffed with elastically compressible material 126 is passed around tissue (for example, soft tissue) and then passed through splice region 25 to form a flexible, continuous, adjustable, knotless, self-locking, tensionable loop 55 and splice 125. The diameter and perimeter of loop 55 are adjustable. When tension is released, the knotless mechanism is engaged by elastically compressible portion 26 and the elastically compressible material 126 of suture 100. [0031] The shape of elastically compressible region 26 of the stuffed suture 100 can be of consistent diameter, tapered, or any varying diameter. The cross-section of the elastically compressible portion 26 of suture 100 can be circular or oval or could have a geometry with any number of sides, such as a square (FIG. 3(a)), pentagon (FIG. 3(b)), hexagon (FIG. 3(c)), star shape Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 (FIG. 3(d)), or similar shapes, to allow for enhanced compression of the elastically compressible portion 26. [0032] Reference is now made to FIG. 4 which illustrates a partial cut- out view of the flexible coupler 100 and knotless mechanism 50 of FIG. 2. Once splice 125 has been formed, tension is released. The elastically compressible portion 26 expands and engages the knotless mechanism. Once tension is released, the elastically compressible material 126 expands, taking up the area within the splice 125, engaging the knotless mechanism 50. [0033] The elastically compressible portion 26 of suture 100 increases the diameter in the splice section by at least 10%. The diameter of the region 26 of the suture 100 decreases up to about 25% under tension, as the elastically compressible material 126 is compressed/squeezed. The length of the elastically compressible portion 26 as well as the length of the suture 100 remain about constant, as the braid or jacket 10 does not elongate. When tension is released, the suture 100 relaxes and creates additional holding strength and less slippage in the construct (in the “not-under-tension” or relaxed configuration). [0034] Reference is now made to FIG. 5 which illustrates an exemplary fixation device 200 (soft anchor 200; soft suture anchor 200; soft anchor construct 200) with exemplary tensionable, self-locking, knotless mechanism 50 of FIG. 2 and incorporating a flexible strand with an elastically compressible material, such as suture 100 with elastically compressible material 126. Tensionable knotless mechanism 50 with elastically compressible material 126 is compressible and provides more holding strength and less slippage in the mechanism. Compressible suture 100 can be passed through sheath 220 to form at least one flexible, continuous, adjustable, knotless, tensionable loop such as loop 55. While tensioning the repair suture 100, the compressible and elastic properties of the stuffed suture region 26 would allow squeezing and passing through the knotless mechanism. When Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 tension is released, the elastically compressible material 126 would relax and create additional holding strength and less slippage in the construct. This aspect can be provided in both hard and soft anchor constructs. [0035] Elastically compressible suture portion 26 of suture 100 can be also in the form of a compressible repair suture tape with a tapered tail. [0036] The elastically compressible structures, constructs, and assemblies of the present disclosure have applicability to various surgical techniques and tissue repairs where the “compressible/squashable/squeezable” stuffed suture replaces the current static suture used in the art. [0037] FIGS. 6 and 7 illustrate exemplary repairs 101, 102 with sutures of the present disclosure, such as suture 100 provided with elastically compressible material 126. One or more compressible sutures 100 can be incorporated into, and/or employed with, fixation devices such as any anchors, for example, knotted anchors, knotless anchors, or all-suture anchors or any devices that confer secure attachment and fixation of soft tissue over bone and that allow sliding of compressible suture within a body of fixation device. [0038] A fixation device can be a knotless suture anchor such as a two- piece Arthrex PushLock® anchor, disclosed in US 7,329,272, or an Arthrex SwiveLock® anchor, disclosed in US 8,012,174 and US 9,005,246, the disclosures of both of which are fully incorporated by reference in their entirety herein. A fixation device can be a soft anchor or an “all-suture” anchor (such as anchor 200). A soft anchor (soft suture anchor or all-suture soft knotless anchor) is provided with a soft anchor sleeve (sheath or tubular member) with two open ends, and at least two flexible shuttling strands extending through the soft anchor sleeve (sheath). The flexible strands may extend through the sleeve in similar or different directions and/or orientations and/or locations. The flexible tubular sleeve with the shuttling strands may be secured into or onto bone, and flexible strands may pass over soft tissue (rotator cuff) and are secured into bone to approximate soft tissue to bone. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 Details of an exemplary soft suture anchor with a soft anchor sleeve (sheath or tubular member) and flexible shuttling strands are set forth, for example, in US Patent 10,849,734 issued Dec. 1, 2020, entitled “Methods of Tissue Repairs,” the disclosure of which is incorporated by reference in its entirety herein. [0039] FIG. 6 illustrates a schematic soft tissue repair 101 (e.g., tendon or ligament repair) with exemplary surgical construct 200, to secure a first tissue 80 (for example, soft tissue such as tendon 80) to a second tissue 90 (for example, bone 90). Soft suture anchor 200 of FIG. 6 includes a soft anchor sleeve 220 (sheath or tubular member 220) that can be employed with any flexible coupler 100. The flexible coupler incorporating one or more elastically compressible materials and the one or more shuttle/pull devices can extend through the sleeve 220 in similar or different directions and/or orientations and/or locations. [0040] Once flexible sheath 220 of surgical construct 200 has been inserted and secured within a hole in bone 90, the compressible flexible coupler 100 is passed around or through tissue 80 and then through an eyelet of a shuttle/pull device (not shown). The shuttle/pull device is then pulled out of the fixation device 220 and out of the surgical site, to allow the flexible coupler 100 to pass through the cannulation of sheath 220 and passing through itself at the splice region 25 to form splice 125 within the body of sheath and at least one flexible, tensionable, continuous, adjustable, self-locking, cinching, closed loop 55 around tissue 80. [0041] Any free end of the compressible flexible coupler 100 can be pulled to shrink the construct and the flexible, closed, knotless, continuous, adjustable loops 55, and to compress the tendon 80 to bone 90, providing a final repair/construct 101 with increased compression of tissue. [0042] FIG. 7 illustrates an exemplary tissue repair 102 which is a labrum repair 102. Exemplary steps of a labrum repair 102 comprise inter alia the steps of: mobilize labrum 80; create a bone socket for anchor by placing a Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 cannula on glenoid rim 90 and drill with a bone cutting instrument; insert anchor 220 into bone 90; pull on suture tails to confirm the anchor is set in the cortical bone; retrieve repair suture 100 through the anterosuperior portal using a suture retriever; insert a suture passer (for example, a curved SutureLasso™ suture passer) into the anteroinferior cannula and pass it through the capsulolabral tissue inferior to the anchor 220; advance a nitinol wire loop into the joint and load the compressible repair suture tail 100 through the nitinol wire loop; retract the wire loop through the SutureLasso™ suture passer to pull the repair suture 100 to the distal end of the suture passer inside the joint; remove the suture passer and wire loop together, to shuttle the repair suture 100 through the labral tissue; retrieve the repair suture 100 and shuttle suture through the anterosuperior portal; load the repair suture 100 through the loop of the shuttle suture and pull the shuttle suture to transfer the repair suture 100 back into the anchor body 220 through the same portal where it was inserted; advance the shuttle suture until the repair suture 100 is passed through the suture splice locking mechanism and back out of the cannula; pull the free end of the repair suture 100 until the desired repair tension is achieved. A tissue grasper can be used to position the labrum 80 in its desired location while applying tension. The steps can be repeated for additional soft anchors 220 and repair suture 100 for the final labrum repair 102. [0043] Methods of manufacturing flexible couplers with elastically compressible materials are also disclosed. In one embodiment, a compressible suture can be manufactured by providing a braid or suture sheath around an elastically compressible material (e.g., a braiding machine could braid around a piece of compressible material such as elastic; the elastic in this case would not be stretched out; once the knotless mechanism is converted, the splice can be engaged from the outer portion of the splice compressing the elastic). In one embodiment, a compressible suture can be manufactured by inserting (with a needle, for example) an elastically compressible material within a core of a coreless suture (for example, a coreless braid). Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 [0044] Compressible flexible couplers (such as compressible suture 100) in the form of compressible round and/or flat tape sutures can be manufactured via braiding weaving and/or knitting processes, or combination of these processes, with an elastically compressible component incorporated in/within them. The elastically compressible component provides the compressibility while the other components like the sheath material provide the strength and limit the elongation of the suture. Complex suture structures manufactured by the present disclosure include regular and non-regular braid patterns (i.e., links, loops, splits, different size holes in the structure, downsized, takeout, bi- furcation, tri-furcation, quad-furcation, multiple-furcation, etc.). The elastically compressible component provides flexibility, elasticity and compressibility to the flexible coupler only in a transversal direction (or a direction non-parallel to the longitudinal axis of the flexible construct). [0045] In one embodiment, suture 100 can be manufactured using a braiding machine to braid around an elastic. In this case, the braiding machine would braid around a piece of elastically compressible material. The elastically compressible material in this case would not be stretched out. Once the knotless mechanism is converted, the splice would be engaged from the outer portion of the splice compressing the elastically compressible portion. [0046] In one embodiment, suture 100 can be a woven coreless suture constructed with a parallel, twisted and/or braided, knitted, woven material in the warp or weft direction, with one or multiple filaments with/without compressible material composing the balance of the construction. Compressible behavior can be manipulated via providing the woven coreless suture over elastically compressible material during the weaving process. [0047] In another embodiment, suture 100 can be a warp knitted coreless suture constructed with a parallel, twisted and/or braided, knitted, woven material in the structure with one or multiple filaments with/without compressible material composing the balance of the construction. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 Compressible behavior can be manipulated via providing the woven coreless suture over elastically compressible material during the warp knitting process. [0048] In another embodiment, suture 100 can be a weft knitted suture constructed with a parallel, twisted and/or braided, knitted, woven material in the structure with one or multiple filaments with/without compressible material composing the balance of the construction. Compressible behavior can be manipulated via providing the woven coreless suture over elastically compressible material during the weft knitting process. [0049] Round and/or tape style suture 100 can be manufactured via braiding, weaving and/or knitting processes with an elastically compressible component incorporated within at least a region of the round and/or tape suture. In an embodiment, surgical compressible suture 100 can include a stuffed elastically compressible region and a UHMWPE jacket covering the stuffed elastically compressible region. In an embodiment, surgical compressible suture 100 can include a stuffed elastically compressible region and a polyester/UHMWPE jacket covering the stuffed elastically compressible region. [0050] Exemplary sutures 100 the present disclosure can be manufactured as a one-piece suture construct. Exemplary sutures 100 can be securely engaged to and disengaged from one or more fixation devices, such as hard body or soft body fixation devices. The fixation device can be a suture anchor that provides at least one anchoring point of a first tissue affixed to a second tissue, for example, soft tissue to bone. Exemplary sutures 100 can be attached to one or more fixation devices by sliding through at least a portion of the fixation device, for example, by extending/sliding through at least a portion of a body of the fixation device. [0051] A flexible strand 100 can be suture 10 with at least one region 26 provided with an elastically compressible material 126 as a core (or part of its core). The elastically compressible material 126 allows the compressible Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 region 26 to compress when squished so that the suture becomes compressible in a transversal direction relative to a longitudinal axis of the suture. [0052] An elastically compressible region 26 of a flexible strand 100 can form a splice 125 of a tensionable knotless mechanism 50, providing consistent engagement in the tensionable knotless mechanism, by allowing the suture 100 to convert easier through the splice 125. An elastically compressible material 126 can be provided into a repair suture that is part of a tensionable knotless construct used in soft and hard bodied anchors. [0053] Methods of manufacturing suture 100 are also disclosed. A compressible suture 100 can be manufactured by providing a braid/suture sheath 10 around an elastically compressible material 126. A compressible suture can be manufactured by braiding a sheath 10 around a piece of elastic 126. A compressible suture 100 can be manufactured by inserting an elastically compressible material 126 within a coreless coupler, i.e., within a core region of a coreless flexible coupler such as a coreless braid. The elastically compressible material 126 can be inserted within the coreless braid with an inserter instrument such as a needle, for example. [0054] Methods of knotless, tensionable tissue repairs 101, 102 with flexible couplers 100 are also disclosed. A suture 10 with an elastically compressible material 126 can provide increased knotless tissue fixation, to allow for dynamic repairs with the ability to move and rebound when necessary. A suture with an elastically compressible material can allow for suture squeezing and better bunching and fixation for anchor sheaths. A suture with an elastically compressible material can provide an overall more secure locking mechanism over the repair area for any tensionable knotless anchor. [0055] The elastically compressible material can be elastane, rubber, silicone, polyurethane, polyester, elastic fillers, or combinations thereof, or any material that allows the suture to be squeezed/compressed under pressure to Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 engage a knotless mechanism and then, when tension is released, to allow the knotless mechanism to be engaged by the compressible portion of the suture. [0056] The embodiments above have described with reference to a knotless FiberTak® soft anchor (for example, a knotless 1.8 FiberTak® soft anchor) which includes any of the compressible couplers 100 and provides advanced self-locking technology with simple steps of passing, cinching, and cutting. An exemplary embodiment of a knotless FiberTak® soft anchor which includes any of the couplers 100 is knotless, self-locking, tensionable soft anchor 200. [0057] Soft suture anchors can be also employed with a compressible tape-style stuffed suture, round or flat, which can be similar in size and shape to a suture tape such as FiberTape® suture tape. A stuffed flexible coupler can be in the form of flat tape (suture tape) with an elastically compressible flat region (stuffed body region) and with two tails incorporated within the body. At least one of the two tails can be round. At least one of the two tails can be elastically compressible. At least one of the two tails can be non-elastic and non-compressible. The two tails can be round tails that extend in a direction about parallel to a longitudinal axis of the body of the compressible tape. [0058] The disclosed sutures and tapes of the present disclosure can be employed in various surgical applications such as knot tying; InternalBrace™ repair (using a compressible suture/tape with a certain amount of compressibility built into the construct for flexibility offers a definite stop where the compressible portion is expands and the UHMWPE sheath acts as the stopping point); soft tissue repair; knotless cerclage/tensionable knotless mechanisms (compressible FiberTape® suture tape cerclage system is an all- suture alternative to metal wires and cables traditionally used for circumferential fracture fixation; compressible FiberTape® suture tape can be any FiberTape® suture tape modified with an elastically compressible component, for example, elastically compressible material 126); racking half Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 hitch (the elastically compressible stuffed suture with a non-compressible non- elastic sheath can hold without the need to tie additional half hitches to lock the racking hitch). [0059] An exemplary fixation device can be an anchor (knotted anchor, knotless anchor, or all-suture anchor), implant, button, screw or any fixation device that confers secure attachment and fixation of soft tissue 80 over bone 90 and that allow sliding of compressible sutures within a body of fixation device. The fixation device can be a knotless suture anchor such as a two- piece Arthrex PushLock® anchor, disclosed in US 7,329,272, or an Arthrex SwiveLock® anchor, disclosed in US 8,012,174 and US 9,005,246, the disclosures of both of which are fully incorporated by reference in their entirety herein. Another exemplary fixation device is a soft anchor or an “all- suture” anchor. [0060] The flexible couplers, surgical assemblies and compressible constructs detailed above have applicability to any tissue repair and surgical procedure such as, for example, rotator cuff repairs, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction, hip and shoulder reconstruction procedures, and applications for compressible suture used in or with suture anchors. The surgical stuffed constructs and repair methods of the present disclosure can be employed in tissue repairs that do not involve knot tying, for example, for use with suture anchors (such as PushLock® and/or SwiveLock® suture anchors) or for knotless arthroscopic suture repairs (such as knotless single row rotator cuff repair, or SpeedBridge™ repairs using no knots and only suture passing steps), among many others. [0061] An exemplary SutureBridge™ tendon repair technique, developed by Arthrex, Inc., and disclosed in US 8,012,174 (the disclosure of which is herein incorporated by reference in its entirety) consists of a tied medial row constructed with two threaded suture anchors, combined with knotless lateral fixation using two Arthrex PushLocks® constructs. The Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 construct enhances footprint compression and promotes tendon healing-to- bone with minimal knot tying. [0062] An exemplary SpeedBridge™ technique, also developed by Arthrex, Inc., and disclosed in US 9,005,246 (the entire disclosure of which is herein incorporated by reference) uses a threaded swivel anchor which can be combined with any compressible flexible coupler 100 in lieu of or in addition to FiberTape® suture tape to create a quick and secure SutureBridge™ construct with no knots and only two suture passing steps. [0063] Fixation devices with surgical compressible suture can be employed to fixate soft tissue to bone by a SpeedFix™ or SpeedBridge™ configuration. The SpeedFix™ and SpeedBridge™ techniques, both developed by Arthrex, Inc., use a threaded swivel anchor, such as Arthrex SwiveLock® C anchor combined with FiberTape® (disclosed in US Patent 7,892,256) to create a quick and secure SpeedFix™ construct (a knotless single row repair) or a SpeedBridge™ construct (a knotless double row repair) with no knots and very few suture passing steps. [0064] In the SpeedFix™ technique, FiberTape® suture is passed in an inverted mattress using a SutureLasso™ or Scorpion™ suture passer. The two suture limbs of the mattress stitch can then be inserted into the SwiveLock® anchor eyelet. The loaded eyelet is inserted into a prepared lateral bone socket until the anchor body contacts bone, and the tension is adjusted if necessary. The SwiveLock® C driver is rotated in a clockwise direction to complete the insertion. Using an open ended FiberWire® cutter, the FiberTape® tails are cut to complete the technique. [0065] A surgical assembly for tissue reinforcement and/or repair comprises a flexible coupler 100; and at least one fixation device attached to the flexible coupler 100. The fixation device can be a knotless suture anchor. The tissue can be rotator cuff. The fixation device can be a hard body anchor. The fixation device can be a soft anchor 220. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 [0066] A method of soft tissue reconstruction comprises attaching soft tissue 80 to bone 90 with at least one flexible coupler 100. The method can further comprise: slidingly attaching the at least one flexible coupler 100 to a fixation device 220; and securing the fixation device 220 to bone 90. The at least one flexible coupler 100 can be a one-piece construct consisting essentially of a suture 10 with an elastically compressible material 126. The at least one flexible coupler 100 can be a one-piece construct consisting essentially of an elastically compressible material 126 provided/inserted within a coreless region of a flexible coupler. The at least one flexible coupler 100 can be a one-piece construct consisting essentially of a braid or sheath braided around an elastically compressible material 126. The fixation device can be a soft suture anchor. [0067] Flexible couplers 100 can comprise suture tape such as FiberTape® suture tape (as disclosed in US 7,892,256, the disclosure of which is incorporated in its entirety herewith) or collagen tape, or wide “tape like” material, or combinations thereof, at least a region of which is stuffed with an elastically compressible material. [0068] Flexible couplers 100 can include a braid or sheath 10 formed of a high strength suture material such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., and described in US 6,716,234, the disclosure of which is incorporated by reference herein. FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames Spectra® (Honeywell International Inc., Colonial Heights, Va.) and Dyneema® (DSM N.V., Heerlen, the Netherlands), braided with at least one other elastic fiber, natural or synthetic, to form lengths of suture material. [0069] Flexible coupler 100 can consist essentially of suture material and elastically compressible material. In an embodiment, flexible coupler 100 can Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 be provided as a suture which is braided, knitted or woven around a compressible material. [0070] Flexible coupler 100 can be also coated and/or provided in different colors. In an embodiment, parts (or all) of flexible coupler 100 can 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 with 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 and/or tape, pliability, handleability or abrasion resistance, for example. [0071] Flexible coupler 100 can be also provided with tinted tracing strands, or otherwise contrast visually with other parts of the construct, which remain a plain, solid color, or displays a different tracing pattern, for example. Various structural elements of the surgical constructs may be visually coded, making identification and handling of the suture legs simpler. Easy identification of suture in situ is advantageous in surgical procedures. [0072] 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, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body.

Claims

Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 CLAIMS [0073] What is claimed is: 1. A suture comprising a braid or sheath around an elastically compressible material.

2. The suture of claim 1, wherein the elastically compressible material and the braid or sheath form a compressible suture region.

3. The suture of claim 2, wherein the compressible suture region is adjacent a non-elastic and non-compressible suture region.

4. The suture of claim 3, wherein the non-elastic and non- compressible suture region is a splice region or a tail region of the braid or sheath.

5. The suture of claim 1, wherein the elastically compressible material consists essentially of elastane.

6. The suture of claim 1, wherein the elastically compressible material is rubber, silicone, polyurethane, or combinations thereof.

7. The suture of claim 1, wherein the braid or sheath comprises non- elastic and non-compressible material.

8. The suture of claim 1, wherein the braid or sheath comprises UHMWPE.

9. The suture of claim 1, wherein the braid or sheath does not extend longitudinally when under tension.

10. The suture of claim 1, wherein the suture is part of a knotless, self- locking, tensionable suture anchor. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01

11. The suture of claim 1, wherein the suture is attached to a fixation device.

12. The suture of claim 11, wherein the fixation device is an all-suture soft anchor.

13. The suture of claim 1, wherein the braid or sheath is braided around the elastically compressible material.

14. The suture of claim 1, wherein the elastically compressible material is inserted into a core region of the braid or sheath.

15. A surgical assembly for soft tissue repairs, comprising a flexible coupler attached to a knotless fixation device, wherein at least a region of the flexible coupler includes an elastic material to form an elastically compressible region, wherein the elastically compressible region compresses under pressure and wherein the flexible coupler does not stretch longitudinally when under tension.

16. The surgical assembly of claim 15, wherein the knotless fixation device is a knotless soft suture anchor, and wherein the elastically compressible region is passed through the flexible coupler to form a splice within the knotless soft suture anchor.

17. The surgical assembly of claim 15, wherein the knotless fixation device is an anchor inserted into bone, and wherein a diameter of the elastically compressible region decreases by up to about 25% when under pressure while a length of the flexible coupler remains unchanged under tension.

18. A method of soft tissue repair, comprising attaching soft tissue to bone with a flexible coupler, wherein at least a portion of the Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01 flexible coupler includes an elastically compressible material forming a compressible suture region.

19. The method of claim 18, further comprising: attaching the flexible coupler to a fixation device; securing the fixation device to the bone; passing the compressible suture region through the flexible coupler to form a splice and a tensionable, knotless mechanism; pulling on the flexible coupler to tension the soft tissue repair; and releasing the tension so that the compressible suture region expands in diameter at the splice and engages the tensionable, knotless mechanism, wherein all steps above are conducted without changing a length of the flexible coupler.

20. The method of claim 18, wherein the soft tissue is rotator cuff and the fixation device is a lateral or medial fixation device for rotator cuff repair.

21. The method of claim 18, wherein the flexible coupler is braided suture, the elastically compressible material is rubber, silicone or polyurethane, and the fixation device is an all-suture soft anchor.

22. A method of manufacturing a suture, comprising braiding a jacket or sheath around an elastically compressible material.

23. The method of claim 22, wherein the suture does not change its length when under tension. Arthrex 2024-102-SES-PCT Docket No.2464-0216WO01

24. The method of claim 22, wherein the jacket or sheath fully covers the elastically compressible material.

25. The method of claim 22, wherein the jacket or sheath consists essentially of UHMWPE.

26. The method of claim 22, wherein the elastically compressible material consists essentially of an elastic.

27. A method of manufacturing a suture, comprising providing an elastically compressible material within a suture jacket or sheath.

28. The method of claim 27, wherein the suture does not change its length when under tension.

29. The method of claim 27, wherein the elastically compressible material is inserted into a core of the suture jacket or sheath with a needle.

30. The method of claim 27, wherein the suture jacket or sheath consists essentially of UHMWPE and wherein the suture jacket or sheath completely covers the elastically compressible material.

31. The method of claim 27, wherein the elastically compressible material consists essentially of an elastic.