Elastic stuffing sutures and methods of making and use

Abstract

Surgical elastic stuffing constructs, assemblies, and methods of manufacturing, as well as methods for tissue repairs are disclosed. An elastic stuffing suture includes at least one portion or region stuffed with elastic. An elastic stuffing suture extends and stretches longitudinally when under tension and, when tension is released, the elastic stuffing suture returns to its normal state.

Description

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE U.S. PATENT APPLICATION Title: ELASTIC STUFFING SUTURES AND METHODS OF MAKING AND USE Inventors: Matthew R. Herrington Shaun G. LeBlanc Thomas Dooney, Jr. Derek C. Sullivan Gabriela I. Coman Potomac Law Group, PLLC 1717 Pennsylvania Avenue, NW Washington, D.C. 20006Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 ELASTIC STUFFING SUTURES AND METHODS OF MAKING AND USE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Application No. 63 / 693,327 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 elastic flexible couplers, methods of making, and methods of tissue repairs are disclosed.

[0004] A surgical flexible coupler can be an elastic stuffing suture to allow for improved fixation in a tensionable knotless construct. An elastic stuffing suture can be elastic along the longitudinal axis of the suture. An elastic stuffing suture can stretch and elongate longitudinally to convert easier through a splice of the knotless construct. Once tension is released, the elastic bunches back up, taking up the area within the splice, and engaging the knotless mechanism of the tensionable knotless construct. An elastic stuffing suture can be a repair suture. An elastic stuffing allows a repair suture to stretch and elongate when tensioned, increasing the length and decreasing the diameter of the suture.

[0005] An elastic stuffing region of a flexible strand can be passed through a splice of a tensionable knotless mechanism, providing consistent engagement in the tensionable knotless mechanism, by allowing the suture to stretch to convert easier through the splice. Once tension is released, the elastic bunches back up, taking up the area within the splice, and engaging theArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 knotless mechanism. An elastic stuffing can be inserted into a lumen of a repair suture that is part of a tensionable knotless construct used in soft and hard bodied anchors.

[0006] Methods of manufacturing an elastic stuffing suture are also disclosed. An elastic stuffing suture can be manufactured by shuttling elastic material through a lumen of a repair suture to stuff at least a portion of the repair suture.

[0007] Methods of knotless, tensionable tissue repairs with elastic stuffing flexible couplers are also disclosed. An elastic stuffing suture can provide increased knotless tissue fixation, to allow for dynamic repairs with the ability to move and rebound when necessary. An elastic stuffing suture can allow for suture stretching along a longitudinal direction and better bunching and fixation for anchor sheaths. An elastic stuffing suture 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 an elastic stuffing flexible coupler.

[0009] FIG. 2 illustrates a knotless mechanism with the elastic stuffing flexible coupler of FIG. 1.

[0010] FIG. 3(a) illustrates an elastic stuffing flexible coupler under no tension.

[0011] FIG. 3(b) illustrates the elastic stuffing flexible coupler of FIG. 3(a) under tension.

[0012] FIGS. 4(a)-(c) illustrate side views of elastic stuffing flexible couplers.Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01

[0013] FIG. 5 illustrates a surgical construct with an elastic stuffing flexible coupler.

[0014] FIG. 6 illustrates a tissue repair with an elastic stuffing flexible coupler.

[0015] FIG. 7 illustrates another tissue repair with an elastic stuffing flexible coupler. DETAILED DESCRIPTION

[0016] The disclosure provides surgical flexible elastic couplers, assemblies, constructs, and methods for manufacturing, as well as tissue repairs and reconstructions.

[0017] An elastic stuffing flexible coupler can be a surgical suture that includes an elastic (elastic component or elastic material) which is stuffed within at least a region of the suture. An elastic stuffing suture provides consistent engagement when employed in a tensionable mechanism (for example, a tensionable knotless mechanism), by allowing the suture to stretch and elongate to convert easier through a splice. Once tension is released, the elastic bunches back up, taking up the area within the splice, and engaging the knotless mechanism.

[0018] The elastic stuffing suture allows for fixation of tissue to tissue (for example, soft tissue to bone) with dynamic fixation by providing high strength with reduced stiffness. In an embodiment, the elastic stuffing can be loaded into a repair suture that is part of a tensionable knotless construct used in soft and hard bodied anchors. The elastic stuffing allows the stuffed suture portion to stretch and expand longitudinally when tensioned, increasing the length and decreasing the diameter of the stuffed portion.

[0019] In an embodiment, the stuffed portion is passed through a splice location of a tensionable knotless mechanism of the elastic stuffing suture toArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 form a splice. Once tension is released, the stuffed portion expands and engages the knotless mechanism, providing increased fixation to the overall repair.

[0020] The stuffing suture material can be any material that allows the suture to stretch and expand longitudinally under tension to engage the knotless mechanism and then, when tension is released, to allow the knotless mechanism to be engaged by the elastic portion of the stuffed suture. The stuffing suture material can be any elastic material. The stuffing suture material can be any type of rubber, silicon, or polyurethane, for example. The stuffing suture material can be any elastic such as elastane, rubber, silicone, polyurethane, polyester, or elastic fillers. The shape of the elastic stuffing suture can be of consistent diameter, tapered, or any varying diameter. The cross-section of the elastic portion of the elastic stuffing suture can be circular or oval or could have various geometries.

[0021] The elastic stuffing suture can be fully elastic along its longitudinal axis, i.e., the whole length of the suture can be elastic. The elastic stuffing suture can be partially elastic along its longitudinal axis, i.e., only certain portions of the length of the suture can be elastic.

[0022] Methods of manufacturing elastic stuffing flexible couplers / sutures are also disclosed. In an embodiment, an elastic stuffing suture can be manufactured by providing elastic material within at least a portion of a repair suture. Elastic material can be shuttled through a suture sheath, e.g., by employing a needle or by using a preplaced shuttling suture which is placed in the lumen of a repair suture and used to shuttle the elastic, to stuff the repair suture. A method of making an elastic stuffing flexible coupler can include the step of incorporating an elastic into at least a portion of a flexible coupler via stuffing, filling, and / or packing.

[0023] Methods of tissue repairs with elastic stuffing flexible couplers are also disclosed. An exemplary method includes inter alia the steps of: (i)Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 incorporating an elastic into at least a region of a flexible coupler via stuffing and / or filling and / or packing to form an elastic stuffing flexible coupler; and (ii) employing the elastic stuffing flexible coupler for one or more tissue repair applications. 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.

[0024] Referring now to the drawings, where like elements are designated by like reference numerals, FIGS. 1-4 illustrate exemplary surgical elastic stuffing suture 100, 100a, 100b, 100c (elastic suture 100, 100a, 100b, 100c; repair suture 100, 100a, 100b, 100c; elastic stuffing coupler 100, 100a, 100b, 100c; elastic stuffing flexible coupler 100, 100a, 100b, 100c; round stuffing suture 100, 100a, 100b, 100c; round elastic stuffing suture / tape construct 100, 100a, 100b, 100c; round-to-flat elastic stuffing suture 100, 100a, 100b, 100c; elastic stuffing tape 100, 100a, 100b, 100c) including at least one elastic component (elastic; elasticity component; elastomer; elastic stuffing; elastic filler) provided within at least a region of a flexible coupler. FIGS. 5-7 illustrate construct 200 and tissue repairs 101, 102 with elastic stuffing coupler 100, 100a, 100b, 100c.

[0025] Exemplary elastic stuffing coupler 100 of FIG. 1 is an elastic stuffing repair suture 100 that 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 an embodiment, one of the first, second, and third portions is elastic and the others of the first, second, and third portions are non-elastic. In an embodiment, suture segment 26 is elastic and suture segments 25, 27 are non-elastic. In an embodiment, portions or segments of elastic and non-elastic segments can alternate in a pattern along the length of the suture. In an embodiment, portions or segments of elastic and non-elastic segments can alternate in a random manner along the length of theArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 suture. In yet additional embodiments, regular patterns (of elastic and non- elastic segments) can alternate with randomly provided segments (elastic and non-elastic segments) along the length of the suture.

[0026] Although the embodiments below will be detailed with reference to elastic stuffing repair suture 100 provided with an elastic region adjacent a non-elastic region (to better explain improvement in the knotless self-locking mechanism), it must be understood that the present disclosure contemplates an elastic repair suture that is provided with an elastic along its full length, i.e., not only at predetermined portions and / or regions along its length.

[0027] In the illustrative-only embodiment of FIG. 1, second suture portion 26 is a suture portion stuffed / packed / filled with an elastic 126 (elastic stuffing region 26). The elastic stuffing region 26 and the contained elastic 126 extend longitudinally along the length of elastic stuffing suture 100 and for a predetermined length. The elastic 126 is an elastic material which acts as elastic stuffing 126 (elastic stuffing suture material 126). The stuffing suture material 126 can be elastane, rubber, silicone, polyurethane, polyester, elastic fillers, combinations of such materials, or any material that allows the elastic suture 100 to stretch in a longitudinal direction under tension.

[0028] In an exemplary-only embodiment, the elastic 126 is silicone that can be inserted / introduced into a lumen of a coreless suture 10 (such as a coreless round suture) to fill the coreless suture region corresponding to the elastic stuffing location and form elastic stuffing region 26. The elastic 126 provides flexibility to the elastic suture 100 in a longitudinal direction (i.e., provides elongation in a direction about parallel to the longitudinal axis of the suture construct). Elastic stuffing region 26 can consist essentially of elastomeric material. Elastic stuffing region 26 can consist essentially of elastane material. Elastic stuffing region 26 can consist essentially of elastic material. Elastic stuffing region 26 can comprise one or more elastic materials.Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01

[0029] 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-stuffing with elastic. In an embodiment, the first and third regions are non-elastic. The first and third regions 25, 27 are coreless regions of a coreless suture 10 (i.e., a suture 10 without a core). In an embodiment, the first and third regions 25, 27 can be slightly elastic. Elasticity to first and third regions 25, 27 can be imparted by, for example, including one or more elastic fibers into the braid / sheath during the manufacturing process.

[0030] In an embodiment, elastic stuffing suture 100 can be manufactured by stuffing round coreless suture 10 with elastic 126. Suture 10 can include a sheath, braid, or jacket 10 that can have a tubular configuration and provided with a lumen. Stuffing of suture 10 can be achieved by shuttling elastic 126 through suture sheath 10 with a needle or a similar passing instrument. Alternatively, a preplaced shuttling suture can be placed in the lumen of repair suture 10 and used to shuttle the elastic 126, to stuff the repair suture 10 and form elastic stuffing suture 100. In an embodiment, suture 10 can be a braided structure that covers elastic 126 at region 26. Suture 10 can completely cover elastic 126. Suture 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 suture 10 can consist essentially of ultra-high molecular weight polyethylene (UHMWPE).

[0031] Reference is now made to FIG. 2. Region 26 of elastic stuffing suture 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 elastic portion 26 of repair suture 100 is passed around tissue (for example, soft tissue) and then passed through splice region 25 (not stuffed with elastic 126) to form a flexible, continuous,Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 adjustable, knotless, self-locking, tensionable loop 55 and splice 125. The diameter and perimeter of loop 55 are adjustable.

[0032] When tension is released, the elastic stuffing portion 26 expands and engages the knotless mechanism. Once tension is released, the elastic 126 bunches back up, taking up the area within the splice 125, engaging the knotless mechanism 50. FIG. 2 illustrates the repair suture 100 (elastic stuffing suture 100) around tissue and passed through splice location 25 to form splice 125. In this manner, the elasticity and elongation conferred by the elastic stuffing provides consistent engagement in the tensionable knotless mechanism, by allowing the suture 100 to stretch to convert easier through the splice.

[0033] The stuffing portion 26 of the stuffing elastic suture 100 increases the diameter in the splice section by at least 10%. The diameter of the portion 26 of the elastic stuffing suture 100 decreases up to about 25% under tension. The length of the stuffing portion 26 increases up to about 30% under tension. When tension is released, the elastic stuffing suture 100 returns to its normal state (the “not-under-tension” or relaxed configuration).

[0034] Reference is now made to FIGS. 3(a) and 3(b) which illustrate the degree of flexibility and elasticity of the stuffing region 26 of repair suture 100. FIG. 3(a) illustrates stuffing region 26 of stuffing elastic suture 100 (with elastic 126) in a first, relaxed, under no tension position (configuration or state) and with an exemplary first lengths L1 of about 3.5 cm.

[0035] FIG. 3(b) illustrates the stuffing region 26 of stuffing elastic suture 100 (with elastic 126) in a second, elongated, tensioned position (configuration or state) and with an exemplary second lengths L2 of about 4.5 cm.

[0036] FIGS. 4(a)-(c) illustrate various views of stuffing suture shape. The shape of the stuffing suture can be one consistent diameter, tapered, or anyArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 varying diameter. Exemplary side views of stuffing elastic sutures 100a, 100b, 100c having stuffing regions 26a, 26b, 26c are shown in FIGS. 4(a)-(c).

[0037] The elastic stuffing suture described above allows for fixation of soft tissue to bone with dynamic fixation by providing high strength with less stiffness compared to predicate devices. The elastic stuffing is loaded into a repair suture which is part of a tensionable knotless construct used in soft and hard bodied anchors. The elastic stuffing allows the stuffed suture portion to stretch when tensioned which increases the length and decreases the diameter of the stuffed portion. The stuffed portion is passed through the splice of a tensionable knotless mechanism. Once tension is released, the stuffed portion expands and engages the knotless mechanism. Stuffing suture material can be any type of rubber, silicone, or polyurethane, or a material that allows suture to stretch longitudinally under tension to engage the knotless mechanism and then when tension is released, the knotless mechanism is engaged by the elastic portion of the stuffing suture. The shape of the stuffing suture can be of consistent diameter, tapered, or any varying diameter.

[0038] The elastic component provides the elasticity while other components of the suture (such as the material of the repair suture) provide the strength and can enhance the elongation of the strand. When the suture relaxes, the elastic component relaxes and the other suture components compress giving the suture its elastic property. When the suture is under tension, the body of the suture shrinks / narrows and, when released, it expands to lock in the place. The elastic suture can be completed with varying and controlled elasticity based on the application.

[0039] 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 an elastic stuffing flexible strand such as elastic stuffing suture 100, 100a, 100b, 100c. Tensionable knotless mechanism 50Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 with elastic stuffing material 126 is elastic and provides more holding strength and less slippage in the mechanism. Elastic stuffing suture 100 is passed through sheath 220 to form at least one flexible, continuous, adjustable, knotless, tensionable loop such as loop 55. Sheath 220 of the knotless anchor 200 can be made from elastic providing better fixation in bone. Sheath 220 can consist essentially of elastic material. While tensioning the repair suture 100, the elastic properties of the elastic stuffing suture region 26 allow the suture to elongate longitudinally and pass through the knotless mechanism; when the desired tension is achieved, the elastic suture 26 relaxes and creates additional holding strength and less slippage in the construct. This aspect can be provided in both hard and soft anchor constructs.

[0040] Elastic stuffing suture portion 26 of elastic stuffing suture 100 can be also in the form of an elastic repair suture tape with a tapered tail. Elastic stuffing suture 100 can include an elastic stuffing tape portion and a tapered tail. Tapered tail can be elastic or non-elastic. The tape portion can be stuffed with elastic throughout and along its whole length, or along only a predetermined length. The tape portion can be partially elastic along its length, i.e., can contain elastic segments and non-elastic segments. As detailed above, the elastic and non-elastic segments can alternate and be provided in a pattern.

[0041] In an additional embodiment, sheath 220 of exemplary FiberTak® soft anchor 200 can be also made with elastic material, or to incorporate elastic material within at least a portion of the sheath. This aspect allows the sheath to stretch and elongate on insertion and then expand after final anchor setting.

[0042] An elastic stuffing suture comprises a suture strand, wherein at least a region of the suture strand is stuffed with elastic material to form an elastic stuffing region. A suture strand can have an elastic region, wherein the elastic region has varying diameters when the strand is tensioned. The elastic can be part of the braid and not necessarily stuffed into it. The entire braidArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 could also be elastic with intent of inserting the braid into a suture splice to lock the elastic suture into the splice. The suture splice can be a normal or another elastic suture.

[0043] The elastic structures, constructs, and assemblies of the present disclosure have applicability to various surgical techniques and tissue repairs where the “elastic / stretchy / elongated” stuffing suture replaces the current static suture used in the art.

[0044] FIGS. 6 and 7 illustrate exemplary repairs 101, 102 with elastic stuffing sutures of the present disclosure, such as elastic stuffing suture 100, 100a, 100b, 100c. One or more elastic stuffing sutures 100, 100a, 100b, 100c 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 elastic suture within a body of fixation device.

[0045] 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. 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 USArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 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.

[0046] FIG. 6 illustrates soft tissue repair 101. A first tissue 80 (for example, soft tissue 80) is attached to a second tissue 90 (for example, bone 90) using fixation device 200 with exemplary tensionable, self-locking, knotless mechanism 50 and an elastic stuffing flexible strand such as exemplary elastic stuffing suture 100. Soft suture anchor 200 of FIG. 6 includes a soft anchor sleeve 220 (sheath or tubular member 220) that can be employed with any elastic stuffing coupler 100. The elastic stuffing coupler 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.

[0047] FIG. 6 illustrates schematic 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). Once flexible sheath 220 of surgical construct 200 has been inserted and secured within a hole in bone 90, the elastic stuffing 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 elastic stuffing flexible coupler 100 to pass through the cannulation of sheath 220 and to pass through itself at the splice region 25 to form splice 125 within the body of sheath and as part of at least one flexible, tensionable, continuous, adjustable, self-locking, cinching, closed loop 55 around tissue 80.

[0048] Any free end of the elastic stuffing 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. The elastic stuffing suture 100 allows a dynamic fixation of soft tissue 80 to bone 90Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 providing high strength and less stiffness when the knotless mechanism is engaged by the elastic portion 26 of the stuffing suture.

[0049] 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 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 elastic stuffing 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 repair suture tail 100 through the nitinol wire loop; retract the wire loop through the SutureLasso™ suture passer to pull the elastic stuffing suture 100 to the distal end of the suture passer inside the joint; remove the suture passer and wire loop together, to shuttle the elastic stuffing suture 100 through the labral tissue; retrieve the elastic stuffing suture 100 and shuttle suture through the anterosuperior portal; load the elastic stuffing suture 100 through the loop of the shuttle suture and pull the shuttle suture to transfer the elastic stuffing suture 100 back into the anchor body 220 through the same portal where it was inserted. Advance the shuttle suture until the elastic stuffing suture 100 is passed through the suture splice locking mechanism and back out of the cannula; pull the free end of the elastic stuffing 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 elastic stuffing suture 100 for the final labrum repair 102.

[0050] 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 elastic stuffing couplers 100, 100a, 100b, 100c and provides advanced self-locking technology with simple steps ofArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 passing, cinching, and cutting. An exemplary embodiment of a knotless FiberTak® soft anchor which includes any of the elastic stuffing coupler 100, 100a, 100b, 100c is knotless, self-locking, tensionable soft anchor 200.

[0051] Soft suture anchors can be also employed with an elastic tape- style stuffing suture, round or flat, which can be similar in size and shape to a suture tape such as FiberTape® suture tape. An elastic stuffing flexible coupler (elastic stuffing suture) can be in the form of flat tape (suture tape) with an elastic stuffing flat region (stuffing 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 elastic. At least one of the two tails can be non-elastic. The two tails can be round tails that extend in a direction about parallel to a longitudinal axis of the body of the elastic stuffing tape.

[0052] The elastic stuffing tape allows for specific amount of stretch and / or elasticity for a dynamic repair. When fully extended, the elastic stuffing suture has a positive stop from the non-elastic portion of the suture, providing additional strength.

[0053] The elastic stuffing suture and elastic stuffing tape of the present disclosure can be employed in various surgical applications such as knot tying; InternalBrace™ repair (using an elastic stuffing suture / tape with a certain amount of elasticity built into the construct for flexibility offers a definite stop where the elastic stuffing portion is fully extended and the UHMWPE sheath acts as the stopping point); soft tissue repair with our without splice formation; knotless cerclage / tensionable knotless mechanisms (elastic stuffing FiberTape® suture tape cerclage system is an all-suture alternative to metal wires and cables traditionally used for circumferential fracture fixation; elastic stuffing FiberTape® suture tape can be any FiberTape® suture tape modified with an elastic component, for example, elastic material 126); racking half hitch (the elastic stuffing suture with a non-elastic sheath can hold without the need to tie additional half hitches to lock the racking hitch).Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01

[0054] Elastic stuffing flexible couplers (such as elastic suture 100, 100a, 100b, 100c) can be manufactured by providing at least one elastic material within a lumen of coreless suture. Elastic behavior can be manipulated via insertion of elastic material within a coreless sheath which creates elastic / non-elastic segments along the body. Elastic material can be inserted into a lumen of a repair suture with a needle that shuttles, pulls, and positions elastic material within one or more desired regions within the lumen. Elastic material can be also inserted into a lumen of a repair suture with a preplaced shuttling suture (or similar shuttling device) that is employed to shuttle the elastic stuffing to stuff the repair suture.

[0055] Exemplary elastic stuffing sutures 100, 100a, 100b, 100c of the present disclosure can be manufactured as a one-piece suture construct. Exemplary elastic sutures 100, 100a, 100b, 100c 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 elastic stuffing sutures 100, 100a, 100b, 100c 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.

[0056] 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 elastic suture 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.Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01

[0057] The elastic stuffing sutures, surgical assemblies and elastic 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 elastic suture used in or with suture anchors. The elastic stuffing 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.

[0058] 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 construct enhances footprint compression and promotes tendon healing-to- bone with minimal knot tying.

[0059] 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 elastic stuffing flexible coupler 100, 100a, 100b, 100c 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.

[0060] Fixation devices with surgical elastic stuffing 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 PatentArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 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.

[0061] 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.

[0062] A surgical assembly for tissue reinforcement and / or repair comprises an elastic stuffing flexible coupler 100, 100a, 100b, 100c; and at least one fixation device attached to the elastic stuffing flexible coupler 100, 100a, 100b, 100c. 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.

[0063] A method of soft tissue reconstruction comprises attaching soft tissue 80 to bone 90 with at least one elastic stuffing flexible coupler 100, 100a, 100b, 100c. The method can further comprise: slidingly attaching the at least one elastic stuffing flexible coupler 100, 100a, 100b, 100c to a fixation device 220; and securing the fixation device 220 to bone 90. The at least one elastic stuffing flexible coupler 100, 100a, 100b, 100c can be a one-piece construct consisting essentially of a coreless suture 10 with elastic 126 stuffed within at least a region 25 of the suture. The fixation device can be a soft suture anchor.

[0064] Elastic flexible couplers 100, 100a, 100b, 100c 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, orArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 wide “tape like” material, or combinations thereof, at least a region of which is stuffing with an elastic material.

[0065] Elastic stuffing flexible couplers 100, 100a, 100b, 100c 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.

[0066] Elastic stuffing flexible coupler 100, 100a, 100b, 100c can consist essentially of suture material and elastic (such as any elastic material that can be stuffing / inserted / packed / filled within at least a coreless region of the flexible coupler).

[0067] Elastic stuffing flexible couplers 100, 100a, 100b, 100c can be also coated and / or provided in different colors. In an embodiment, parts (or all) of elastic stuffing flexible couplers 100, 100a, 100b, 100c 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.

[0068] Elastic stuffing flexible couplers 100, 100a, 100b, 100c 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 handlingArthrex 2023-077-SES-PCT Docket No.2464-0197WO01 of the suture legs simpler. Easy identification of suture in situ is advantageous in surgical procedures.

[0069] 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 2023-077-SES-PCT Docket No.2464-0197WO01 CLAIMS What is claimed is:

1. An elastic stuffing suture comprising a suture strand, wherein at least a region of the suture strand is stuffed with elastic material to form an elastic stuffing region.

2. The elastic stuffing suture of claim 1, wherein the elastic stuffing region extends longitudinally when under tension and from a first length to a second length, wherein the second length is greater than the first length.

3. The elastic stuffing suture of claim 2, wherein the elastic stuffing region returns to the first length when the tension is released.

4. The elastic stuffing suture of claim 1, wherein the elastic stuffing region is adjacent a non-elastic suture region.

5. The elastic stuffing suture of claim 4, wherein the non-elastic suture region is a splice region or a tail region of the suture strand.

6. The elastic stuffing suture of claim 1, wherein a diameter of the elastic stuffing region is greater than a diameter of the suture strand by at least 5%.

7. The elastic stuffing suture of claim 1, wherein, under tension, a diameter of the elastic stuffing region decreases by about 5% up to about 25%.

8. The elastic stuffing suture of claim 1, wherein, under tension, a length of the elastic stuffing region increases from about 5% up to about 30%.Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 9. The elastic stuffing suture of claim 1, wherein the elastic material consists essentially of elastane.

10. The elastic stuffing suture of claim 1, wherein the elastic material of the elastic stuffing region is rubber, silicone, or polyurethane.

11. The elastic stuffing suture of claim 1, wherein the suture strand comprises elastic material.

12. The elastic stuffing suture of claim 1, wherein the elastic stuffing region is part of a knotless mechanism.

13. The elastic stuffing suture of claim 12, wherein the knotless mechanism is part of a knotless, self-locking, tensionable suture anchor.

14. The elastic stuffing suture of claim 1, wherein the suture strand is attached to a fixation device.

15. The elastic stuffing suture of claim 14, wherein the fixation device is an all-suture soft anchor.

16. 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 is stuffed with elastic to form an elastic stuffing region, wherein the elastic stuffing region is configured to stretch longitudinally when under tension.

17. The surgical assembly of claim 16, wherein the knotless fixation device is a knotless soft suture anchor, and wherein the elastic stuffing region is passed through the flexible coupler to form a splice within the knotless soft suture anchor.Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 18. The surgical assembly of claim 17, wherein the knotless fixation device is an anchor inserted into bone, and wherein a diameter of the elastic stuffing region decreases by up to about 25% when under tension, and wherein a length of the elastic stuffing region increases by up to about 30% when under tension.

19. A method of soft tissue repair, comprising attaching soft tissue to bone with a flexible coupler, wherein at least a portion of the flexible coupler is stuffed with elastic material to form an elastic stuffing region.

20. The method of claim 19, further comprising: attaching the flexible coupler to a fixation device; securing the fixation device to the bone; passing the elastic stuffing 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 to decrease a diameter of the elastic stuffing region by up to 25% and increase a length of the elastic stuffing region by up to 30%; and releasing the tension so that the elastic stuffing region expands in diameter at the splice and engages the tensionable, knotless mechanism.

21. The method of claim 19, wherein the soft tissue is rotator cuff and the fixation device is a lateral or medial fixation device for rotator cuff repair.Arthrex 2023-077-SES-PCT Docket No.2464-0197WO01 22. The method of claim 19, wherein the flexible coupler is suture, the elastic material is rubber, silicone or polyurethane, and the fixation device is an all-suture soft anchor.

23. A method of manufacturing an elastic stuffing suture, comprising: passing a needle attached to elastic material through a lumen of a suture; and inserting the elastic material within the lumen of the suture to form the elastic stuffing suture.

24. The method of claim 23, wherein the elastic stuffing suture increases its length when under tension.

25. A method of manufacturing an elastic stuffing suture, comprising: passing a preplaced shuttling suture through a lumen of a suture; attaching an elastic material to the preplaced shuttling suture; and pulling the preplaced shuttling suture attached to the elastic material through the lumen of the suture, to insert the elastic material within the lumen of the suture and form the elastic stuffing suture.

26. The method of claim 25, wherein the elastic stuffing suture increases its length when under tension.

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