Elastic suture, method of manufacture, and method of use

Abstract

Surgical elastic structures, assemblies, and methods for manufacturing them, as well as methods for tissue repair, are disclosed. Elastic sutures include elastic components that enable knotless suture structures and eliminate the need to tie knots required with standard sutures. Elastic sutures may include a silicone core and a polyester / UHMWPE jacket. Elastic sutures may have irregular braided, woven, or knitted patterns. Elastic sutures may be manufactured with varying and controlled elasticity based on specific applications.

Description

Background Art

[0001] The present disclosure relates to the field of surgery, and more specifically to surgical suture structures, manufacturing methods, and tissue repair for reconstructive surgery.

Summary of the Invention

[0002] A surgical elastic flexible coupler, a manufacturing method, and a tissue repair method are disclosed.

[0003] The surgical flexible coupler can be an elastic suture. The elastic suture includes an elastic component, enables a knotless suture structure, and eliminates the need to tie knots required by standard sutures. The elastic suture can include a silicon core and a polyester / UHMWPE jacket. The elastic suture can have an irregular, braided, woven, or knitted pattern, or a combination thereof. The elastic suture can be manufactured with various elasticities and controlled elasticity based on specific applications.

[0004] A method of knotless and tension-adjustable tissue repair using an elastic flexible coupler is also disclosed. The elastic suture can provide knotless tissue fixation and enable dynamic repair with the ability to move or rebound as needed. The elastic suture can allow for suture elongation to secure knots. The elastic suture can enable better braiding and fixation of the anchor sheath. The elastic suture can provide a more secure locking mechanism overall over the repair area of any tension-adjustable knotless anchor.

Brief Description of the Drawings

[0005] [Figure 1] FIG. 1 shows a front view of a flexible elastic coupler. [Figure 2] FIG. 2 is a side view of the flexible elastic coupler of FIG. 1. [Figure 3] FIG. 3 shows a perspective view of another flexible elastic coupler. [Figure 4]Figure 4 shows a front view of another flexible elastic coupler. [Figure 5] Figure 5 is an enlarged view of the elastic / inelastic joint of the flexible elastic coupler shown in Figure 4. [Figure 6] Figure 6 shows a front view of another flexible elastic coupler. [Figure 7] Figure 7 is an enlarged view of the elastic / inelastic joint of the flexible elastic coupler shown in Figure 6. [Figure 8] Figure 8 shows the flexible elastic coupler in the relaxed position. [Figure 9] Figure 9 shows the flexible elastic coupler of Figure 8 in the extended position. [Figure 10] Figure 10 shows another flexible elastic coupler. [Figure 11] Figure 11 shows the steps of tissue repair (knot tying) using a flexible elastic coupler. [Figure 12] Figure 12 shows the steps of tissue repair (knot tying) using a flexible elastic coupler. [Figure 13] Figure 13 shows tissue repair (internal bracing) using a flexible elastic coupler. [Figure 14] Figure 14 shows tissue repair (internal bracing) using a flexible elastic coupler. [Figure 15] Figure 15 shows the subsequent steps following the tissue repair (internal brace) in Figure 14. [Figure 16] Figure 16 shows the subsequent steps following the tissue repair (internal bracing) in Figure 14. [Figure 17] Figure 17 shows the subsequent steps following the tissue repair (internal brace) in Figure 14. [Figure 18] Figure 18 shows the subsequent steps following the tissue repair (internal brace) in Figure 14. [Figure 19] Figure 19 shows a surgical structure with a flexible elastic coupler. [Figure 20] Figure 20 shows a surgical structure with a flexible elastic coupler. [Figure 21] Figure 21 shows another flexible elastic coupler. [Figure 22] Figure 22 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 23] Figure 23 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 24] Figure 24 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 25] Figure 25 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 26] Figure 26 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 27] Figure 27 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 28] Figure 28 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 29] Figure 29 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 30] Figure 30 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 31] Figure 31 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 32] Figure 32 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 33] Figure 33 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 34] Figure 34 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 35] Figure 35 shows subsequent steps of tissue repair (labral repair) using a flexible elastic coupler. [Figure 36]Figure 36 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 37] Figure 37 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 38] Figure 38 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 39] Figure 39 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 40] Figure 40 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 41] Figure 41 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 42] Figure 42 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 43] Figure 43 shows subsequent steps of tissue repair (reduction of fragmentation and fixation by tape circumscription) using a flexible elastic coupler. [Figure 44] Figure 44 shows a side view of the repair using a flexible elastic coupler. [Figure 45] Figure 45 shows a side view of another repair using a flexible elastic coupler. [Figure 46] Figure 46 shows steps of another tissue repair (lacing half hitch) using a flexible elastic coupler. [Figure 47] Figure 47 shows steps of another tissue repair (lacing half hitch) using a flexible elastic coupler. [Figure 48] Figure 48 shows steps of another tissue repair (lacing half hitch) using a flexible elastic coupler. [Figure 49] Figure 49 shows the steps of another tissue repair (racking half hitch) using a flexible elastic coupler. [Figure 50] Figure 50 shows the steps of another tissue repair (racking half hitch) using a flexible elastic coupler. [Modes for carrying out the invention]

[0006] This disclosure provides surgical flexible elastic couplers, assemblies, structures, and methods for manufacturing them, as well as tissue repair and reconstruction.

[0007] Flexible couplers can be surgical elastic sutures that enable knotless suture structures and include elastic components that eliminate the need to tie knots required with standard sutures.

[0008] Round and / or tape sutures can be manufactured through braiding, weaving, and / or knitting processes that incorporate elastic components. In one embodiment, an elastic suture may include an elastane core and a polyester / UHMWPE jacket, or a combination of elastane, polyester, and UHMWPE in the core and / or jacket. The elastic components provide elasticity, while the other components provide strength and limit the elongation of the suture. When the suture is relaxed, the elastic components contract and the other components compress, giving the suture its elastic properties. When the suture is relaxed, the core relaxes and the jacket compresses, giving the suture its elastic properties and limits from the jacket. When the suture is under tension, the body of the suture contracts / narrows, and when released, expands and locks in place. Elastic sutures can be completed with a range of elasticities and controlled elasticities, depending on the application. Complex suture structures can be constructed / manufactured by providing irregular braiding patterns, such as links, loops, divisions, holes of different sizes within the structure, downsizing, cutouts, bifurcations, trifurcations, quadrucurations, etc. Irregular braiding patterns can be provided by themselves or in combination with regular patterns.

[0009] Methods for manufacturing elastic flexible couplers are also disclosed. An exemplary method for manufacturing an elastic flexible coupler includes the step of incorporating elastic components into the coupler via braiding, weaving, and / or knitting. The method may include the step of providing an irregular braided pattern to the elastic coupler.

[0010] Methods for tissue repair using elastic flexible couplers are also disclosed. Exemplary methods include, in particular, (i) incorporating elastic components into a flexible coupler via braiding, weaving, and / or knitting to form an elastic flexible coupler; and (ii) using the elastic coupler for one or more tissue repair applications. These applications may include, among others, knotting, soft tissue repair, internal brace repair, circulage repair, and racking half-hitch repair. The one or more tissue repair applications may include one or more knotless circulages and / or tension-adjustable knotless mechanisms.

[0011] Referring here to the drawings, similar elements are designated by similar reference numerals, and Figures 1-10 illustrate surgical elastic flexible couplers 100, 200, 300, 400, 500, 600 (elastic sutures 100, 200, 300, 400) including at least one elastic component 125, 215, 225, 315, 325, 415, 425, 515, 525 (elastic component; elastomer; elastic fiber) of the present disclosure. Figures 11-50 show the steps of exemplary tissue repair 101, 201, 301, 401, 501, 601 with elastic flexible couplers 100, 200, 300, 400, 501, 601.

[0012] Elastic sutures - types and manufacturing As detailed below, elastic flexible couplers in the form of elastic rounded and / or flat tape sutures can be manufactured together with elastic components through braiding, weaving, and / or knitting processes, or a combination thereof. The elastic components provide elasticity, while the other components provide strength and limit the elongation of the suture. When the flexible coupler (suture) is relaxed, the elastic material contracts and the other components are compressed, giving the flexible coupler (suture) its elastic properties. Elastic flexible couplers (sutures) can be manufactured with varying elasticity and controlled elasticity depending on the application. Complex suture structures manufactured by this disclosure include regular and irregular braiding patterns (i.e., links, loops, divisions, holes of different sizes in the structure, downsizing, cutouts, bifurcations, trifurcations, quadrubrations, multifurcations, etc.). The elastic component provides flexibility to the flexible coupler in two different directions: longitudinal (i.e., extension in a direction substantially parallel to the longitudinal axis of the suture structure) and in another direction, for example, a direction not parallel to the longitudinal axis of the flexible structure.

[0013] Figure 1 shows one embodiment of an elastic flexible coupler 100 in the form of an elastic suture 100 having an elastic tubular structure. In an exemplary embodiment, the elastic suture 100 has a braided structure, i.e., comprising a braid or jacket 115 covering an elastic core 125. The elastic core 125 may essentially consist of elastic fibers. The elastic core 125 may essentially consist of an elastane material. The braid or jacket 115 may essentially consist of polyester and ultra-high molecular weight polyethylene (UHMWPE).

[0014] The elastic suture 200 in Figure 3 is a warp-woven suture structure constructed of twisted and / or braided, knitted, or woven elastane material parallel to the warp or weft directions, having one or more filaments having / not having non-elastan woven material constituting the remainder of the structure. Elastic behavior can be manipulated by the insertion or removal of elastic material within the same suture, generating elastic / inelastic segments within the body. The elastic suture 200 includes an elastic braid or jacket 215 and a core formed of elastic material 225 (elastic segments 225; elastic fibers 225) and inelastic material 226 (inelastic segments 225; inelastic fibers 225). At least one of the elastic material 225 (elastic segments 225; elastic fibers 225) may be elastane.

[0015] Figures 4–10 show additional, rounded, flat, and rounded-to-flat, as well as complex sutures 300, 400, and 500. The suture 300 in Figures 4 and 5 is an exemplary elastic flexible coupler in the form of an elastic flat (tape), having an elastic flat body 315, two elastic, rounded tails 325 and one inelastic, rounded tail 326 incorporated within the body 315. As shown in Figure 4, the two elastic, rounded tails 325 extend in a direction substantially parallel to the longitudinal axis of the body 315.

[0016] The suture 400 in Figures 6 and 7 is an exemplary tubular and flat elastic suture having an elastic flat body 415 and a tubular elastic tail 426 (and also incorporating two elastic, rounded tails 425 incorporated within the body 415 and extending substantially parallel to the longitudinal axis of the body 415).

[0017] Figures 8 and 9 illustrate the flexibility and elasticity of the elastic sutures of this disclosure. The length D2 of the exemplary elastic coupler 300 in Figure 9 is greater than the length D1 of the elastic coupler 300 in Figure 8. The width W2 of the elastic coupler 300 in Figure 9 is smaller than the width W1 of the elastic coupler 300 in Figure 8.

[0018] Figure 10 shows yet another exemplary elastic flexible coupler 500 of the present disclosure. The flexible coupler 500 is an elastic suture 500 comprising a first portion 525 (first segment 525, or first length 525) adjacent to a second portion 526 (second segment 526, or second length 526). In one embodiment, one of the first portion 525 and the second portion 526 is elastic, and the other of the first portion 525 and the second portion 526 is inelastic. In one embodiment, the suture segment 525 is elastic. In one embodiment, the suture segment 526 is inelastic. In one embodiment, portions or segments of the elastic and inelastic segments may alternate in a pattern along the length of the suture. In one embodiment, portions or segments of the elastic and inelastic segments may alternate randomly along the length of the suture. In further embodiments, the regular pattern (of elastic and inelastic segments) may alternate with segments (elastic and inelastic segments) provided randomly along the length of the suture.

[0019] Elastic sutures 100, 200, 300, 400, and 500 may be woven sutures constructed of twisted and / or braided, knitted, or woven elastane material parallel to the warp or weft directions, with one or more filaments having or not having non-elastane woven material constituting the remainder of the structure. Elastic behavior may be manipulated by the insertion or removal of elastic material within the same suture, which generates elastic / inelastic segments within the body.

[0020] In another embodiment, the elastic sutures 100, 200, 300, 400, 500 may be warp-woven suture structures constructed of parallel, twisted, and / or braided, knitted, or woven elastane material within a structure having one or more filaments, with or without non-elastane woven material constituting the remainder of the structure. Elastic behavior may be manipulated by the insertion or removal of elastic material within the same suture, generating elastic / inelastic segments within the body.

[0021] In another embodiment, the elastic sutures 100, 200, 300, 400, 500 may be weft-knit suture structures constructed of parallel, twisted, and / or braided, knitted, or woven elastane material within a structure having one or more filaments, with or without non-elastane woven material constituting the remainder of the structure. Elastic behavior may be manipulated by the insertion or removal of elastic material within the same suture, generating elastic / inelastic segments within the body.

[0022] Rounded / flat / rounded to flat / complex sutures 100, 200, 300, 400, 500 may be constructed with one or more filaments, parallel or twisted elastane cores, having / not having a non-elastane woven material jacket.

[0023] Rounded / flat / rounded to flat / complex sutures 100, 200, 300, 400, 500 may be constructed of one or more parallel or twisted elastane warps having non-elastane woven material that constitutes the remainder of the structure.

[0024] Rounded / flat / rounded to flat / complex sutures 100, 200, 300, 400, 500 may be constructed of one or more filaments, parallel or twisted elastane warps and cores, having or not having non-elastane woven material that constitutes the rest of the structure.

[0025] Rounded / flat / rounded to flat / complex stitching threads 100, 200, 300, 400, 500 may be constructed with elastane material within a braided jacket, with or without non-elastane woven material constituting the remainder of the structure.

[0026] Rounded / flat / rounded to flat / complex suture threads 100, 200, 300, 400, 500 may be constructed of elastane material within a braided jacket and within the warp(s) of a braid, with or without non-elastane woven material constituting the remainder of the structure.

[0027] Rounded / flat / rounded to flat / complex suture threads 100, 200, 300, 400, 500 may be constructed of elastane material within a braided jacket and within a braided core(s), with or without non-elastane woven material constituting the remainder of the structure.

[0028] Rounded / flat / rounded to flat / complex sutures 100, 200, 300, 400, 500 may be constructed of parallel or twisted elastane, jackets, warp(s), and core(s), having one or more filaments, having / not having non-elastane woven material that constitutes the remainder of the structure.

[0029] Rounded / flat / rounded-to-flat / complex sutures 100, 200, 300, 400, and 500 can be constructed so that elastic material can be turned, inserted, or removed at desired locations, regardless of the suture configuration which produces elastic / inelastic segments within the same suture.

[0030] Rounded and / or tape-style sutures 100, 200, 300, 400, and 500 may be manufactured through braiding, weaving, and / or knitting processes, with elastic components incorporated into them. In one embodiment, surgical elastic sutures 100, 200, 300, 400, and 500 may include an elastane core and a polyester / UHMWPE jacket, or a combination of elastane (elastic), polyester, and UHMWPE in the core and / or jacket.

[0031] Elastic components provide elasticity, while other components provide strength and limit the elongation of the suture. When the suture is relaxed, the elastic components contract and the other components compress, giving the suture its elastic properties. When the suture is relaxed, the core relaxes and the jacket compresses, giving the suture its elastic properties and limits from the jacket. When the suture is under tension, the body of the suture contracts / narrows, and when released, it expands and locks into place. Elastic sutures can be completed with various elasticities and controlled elasticities, depending on the application. Complex suture structures can be constructed / manufactured by providing irregular braiding patterns, e.g., links, loops, divisions, holes of different sizes within the structure, downsizing, cutouts, bifurcations, trifurcations, quadruflexions, etc.

[0032] Elastic sutures 100, 200, 300, 400, 500 - Applicable Knotting - The knot is under tension, the tail is relaxed, and they are bundled together, preventing the knot from retracting. The tail is less likely to slide within the tension of the knot, resulting in a stronger knot and fewer knots needed to secure the tissue.

[0033] Internal bracing - Using elastic sutures / tapes with a certain amount of elasticity incorporated into the structure provides a clear stopping point where the elastic portion extends fully and the polyester / UHMWPE acts as the stopping point.

[0034] Soft tissue repair - Sutures can provide consistent, longer-lasting pressure on the tissue, allowing for dynamic repair that moves with the soft tissue. This aspect also provides a self-tensioning effect if the repair loosens.

[0035] The knotless circulage / tension-adjustable knotless mechanism - Chinese Finger Trap - is elastic and provides greater retention strength and less slippage within the mechanism. Another option for tension-adjustable knotless is to make the repair suture elastic to allow for additional retention strength to the tissue and dynamic repair.

[0036] Racking Half Hitch - Elastic sutures designed with a coarse sheath can be held in place without the need for an additional half hitch and can be secured with a racking hitch.

[0037] The following provides a more detailed explanation of the applications and / or structures listed above.

[0038] Soft tissue repair / Knotless lateral repair Soft tissue repairs, such as knotless transverse repairs, can be performed using any and / or all flexible elastic couplers 100, 200, 300, 400, and 500. (See Figure 10, which shows an exemplary elastic suture 500.) The suture can provide the tissue with consistent, longer-lasting pressure and a dynamic repair that moves with the soft tissue. This embodiment also provides a self-tensioning effect if the repair becomes loose. Using splicing techniques with the elastic suture, the suture 500 is enabled to produce a knotless repair, where the suture narrows when pulled to the repair position and then slackens to lock the suture in place.

[0039] The suture structure 500 may be made of a rounded or flat tape-style suture having a combination of poly / UHMWPE and elastane (elastic). The elastic portion 525 of the suture may be spliced ​​back through itself to produce a knotless repair 5, locking splice 555.

[0040] While tension is applied, the elastic properties of the suture allow it to stretch and pass through the locking splice 555. When released at the desired tension, the elastic suture 525 relaxes, generating additional holding strength and less slippage within the structure.

[0041] The jacket of the elastic portion 525 of the suture 500 may be configured differently to increase retention strength. A suture passer flag / link / device 580 may hold the locking splice 555 in an open state to facilitate conversion. A tail(s) 526 may pass through the locking splice 555 using the passer device to complete the knotless repair. The structure can be tightened and the tissue fixed. The elastic suture 525 stretches / constricts during tension / tightening, and then slackens to capture / fix in place.

[0042] Knotting Referring here to Figures 11 and 12, only the elastic suture 100 is shown for simplification, but any of the elastic flexible couplers 100, 200, 300, 400, or 500 may be used for knotting. The elastic suture 100 passes through the first tissue 80 (e.g., soft tissue 80 adjacent to bone 90) adjacent to the second tissue 90, forming a knot 105 of the repair 101. The knot is under tension, the tails are relaxed, they are bundled together, and prevent the knot from retracting. The tails are less likely to slide within the tension of the knot, resulting in a stronger knot and fewer knots needed to secure the tissue 80.

[0043] The elastic suture 100 can be passed through the tissue 80 using a needle or inserter. One or more selected knots (preferred knots) are tied to the tail of the suture. The elastic suture 100 stretches when a knot is tied and then relaxes when not under tension. An exemplary knot 105 is locked in place and cannot be loosened, resulting in a smaller and tighter knot stack(s).

[0044] Internal bracing Referring here to Figures 13-18, only elastic suture 300 is shown for simplification, but any of elastic sutures 100, 200, 400, or 500 can be used for internal brace repair 201 (Figures 13 and 14). Using elastic suture / tape 300, in which a certain amount of elasticity is incorporated into the structure for flexibility, provides a clear anchor point where the elastic portion extends fully and a non-elastane material (e.g., a UHMWPE / polyester combination) acts as the anchor point. As shown in Figures 13 and 14, the elastic suture / tape 300 is attached to an exemplary fixation device 60 (e.g., two suture anchors 60 inserted into the bone 90).

[0045] The fixation device 60 may be any anchor, such as a knotted anchor, a knotless anchor, or a full suture anchor, or any device that provides secure attachment and fixation of soft tissue 80 on bone 90 and allows the sliding of elastic sutures within the body of the fixation device. The fixation device 60 may also be a knotless suture anchor, such as the two-piece Arthrex PushLock® anchor disclosed in U.S. Patent No. 7,329,272, or the Arthrex SwiveLock® anchor disclosed in U.S. Patents No. 8,012,174 and 9,005,246, all of which are fully incorporated herein by reference.

[0046] Rounded or flat elastic tape-style sutures may be similar in size and shape to suture tapes such as FiberTape® suture tapes. Elastic tapes are designed and manufactured to allow a specific amount of stretch and / or elasticity for dynamic repair. When fully extended, the elastic suture 300 has a positive stop from the non-elastic portion of the suture, providing additional strength.

[0047] Figures 15-18: UCL repair of the elbow using the UCL Elastic InternalBrace™ system. Repair of the medial collateral ligament (UCL) of the elbow can be performed using one of the elastic flexible couplers 100, 200, 300, 400, or 500.

[0048] Figure 15: Load a 3.5 mm PEEK SwiveLock® anchor 60 using an elastic coupler 300 (elastic FiberTape® suture tape, or elastic collagen-coated FiberTape® suture tape) and FiberWire® suture repair stitches. Insert the anchor 60 into the socket until the anchor body contacts the bone 90. Holding the thumb pad, rotate the screwdriver handle clockwise until the anchor 60 is flush with the bone 90.

[0049] Figure 16: Repair the original ligament 80 using FiberWire® sutures and return it to the uncuspid nodule. Cut the sutures using FiberWire® sutures and repair any incision in the ligament with transverse stitches.

[0050] Figure 17: Position the drill guide at the proximal base point of the UCL on the medial epicondyle. Drill the socket using a 2.7 mm drill. Tap the socket with the red handle tap.

[0051] Figure 18: Load the tail end of the FiberTape® suture tape 300 from the distal anchor into the 3.5 mm PEEK SwiveLock® anchor 60. Flex the arm to approximately 35° to 45°. Insert the anchor 60 into the socket until the anchor body makes contact with the bone 91. Move the elbow through its full range of motion to ensure sufficient tension. Holding the thumb pad, rotate the screwdriver handle clockwise until the anchor 60 is flush with the bone 91. Use the remaining FiberWire® suture to suture the FiberTape® suture tape 300 to the underlying ligament, completing repair 201 (shown in Figures 13 and 14).

[0052] Adjustable elastic tension and knotless mechanism Refer here to Figures 19 and 20. An exemplary tension-adjustable, knotless mechanism (TKL) 301 may incorporate any of the elastic sutures 100, 200, 300, 400, or 500. The TKL 301 is elastic and provides greater retention strength and less slippage within the mechanism. Elastic repair sutures also allow for additional retention strength, as well as dynamic repair to the tissue. The sheath 333 of the knotless anchor 350 may be made from an elastic material that provides better fixation to the bone.

[0053] In an additional embodiment, both the repair suture 100 and the TKL mechanism 301 may be made of elastic suture. While tension is applied to the repair suture, the elastic properties of the suture stretch, pass through the TKL mechanism, and are released. When the desired tension is applied, the elastic suture relaxes, generating additional holding strength and less slip within the structure. This embodiment can be carried out in both hard anchor structures and soft anchor structures.

[0054] In further additional embodiments, the sheath 333 of the exemplary FiberTak® soft anchor 350 may be made of an elastic material. This embodiment allows the sheath to stretch and extend during insertion, and then expand after the final anchor setting.

[0055] Figure 21 shows a perspective view of an elastic flexible coupler 600 in the form of an elastic repair suture having a tapered tail. The elastic coupler 600 includes an elastic tape portion 615 and a tapered tail portion 625. The tapered tail portion 625 may be elastic or inelastic. The tape portion 615 may be elastic throughout its entire length and along its course. The tape portion 615 may also be partially elastic along its length, i.e., it may contain elastic segments and inelastic segments. As detailed above, the elastic segments and inelastic segments may be provided alternately in a certain pattern.

[0056] Figures 22–25 show a series of subsequent steps for repairing the lip 80 using the knotless, self-locking, tension-adjustable soft anchor 350 shown in Figure 19, which can be used with any elastic coupler 100, 200, 300, 400, 500, or 600.

[0057] Figures 26-35: Elastic, knotless FiberTak® soft anchors for labral repair (with knotless simple stitches or knotless mattress stitches). The following embodiments are described with reference to a knotless FiberTak® soft anchor (e.g., a knotless 1.8 FiberTak® soft anchor) that includes any of the elastic couplers 100, 200, 300, 400, 500, and 600 and provides advanced self-locking technology having simple steps of passing, tightening, and cutting. An exemplary embodiment of a knotless FiberTak® soft anchor including any of the elastic couplers 100, 200, 300, 400, 500, and 600 is a knotless, self-locking, tension-adjustable soft anchor 350.

[0058] Figure 26: Move the lip portion 80 to pass the spear through the cannula and position it on the glenoid fossa rim 90. Create a bone socket for the anchor by advancing the drill through the spear until the collar contacts the spear handle.

[0059] Figure 27: Insert the anchor 350 by gently impacting it into the bone 90 through the spear until the inserter handle is flush with the back surface of the spear.

[0060] Figure 28: Remove the inserter handle and spear, then pull all three suture tails to confirm that the anchor is fixed within the cortical bone.

[0061] Figure 29: Exemplary elastic repair sutures 100, 600 are retrieved through the anterosuperior portal using a suture retrieval device. A curved SutureLasso® suture passer is inserted into the anteroinferior cannula and passed through the articular labral tissue below the anchor. The Nitinol wire loop 22 is advanced into the joint. The wire loop 22 is retrieved through the anterosuperior portal using a suture retrieval device.

[0062] Figure 30: Load the tails 100 and 600 of the repair sutures through the Nitinol wire loop 22. Retract the wire loop through the SutureLasso® suture passer and pull the sutures toward the distal end of the suture passer within the joint. Remove the suture passer and wire loop together and shuttle the repair sutures through the labral tissue.

[0063] Figure 31: The repair sutures 100, 600, and shuttle suture 33 are retrieved through the anterior upper portal. The repair sutures 100 and 600 are loaded through the loop of the shuttle suture 33.

[0064] Figure 32: Pull the shuttle suture 33 to return the repair sutures 100, 600 to the anchor body 333 through the same portal into which they were inserted. Advance the shuttle suture 33 until the repair sutures 100, 600 pass through the suture splice locking mechanism and return from the cannula.

[0065] Figure 33: Pull the free ends of the repair sutures 100, 600 until the desired repair tension is achieved. A tissue gripper can be used to position the lip in the desired location while applying tension to the repair.

[0066] Figures 34 and 35 show the final lip restoration 401.

[0067] Fracture reduction and fixation using Circlagi The following embodiments are described with reference to elastic circulage sutures in the form of elastic circulage sutures, such as elastic FiberTape® circulage sutures. The elastic FiberTape® circulage suture system is a full suture that replaces metal wires and cables conventionally used for circumferential fracture fixation. Superior fracture reduction and fixation can be achieved using elastic FiberTape® circulage suture technology, as detailed below. Elastic FiberTape® circulage sutures can be any FiberTape® circulage suture modified with elastic components, e.g., elastic flexible couplers 300, 400, 600. An exemplary elastic FiberTape® circulage suture may be an elastic, 2 mm FiberTape® circulage suture.

[0068] Figures 36-45: Elastic FiberTape® suture tape, CircleG Elastic Circlage sutures (Elastic FiberTape® suture tapes) may be manufactured and packaged (configured) in a card 44 having pre-tied knots and shuttle sutures 33 (for example, as shown in Figures 37 and 38).

[0069] Figure 36: Load the tail end of the circrege suture 300 through the eyelet of the needle 45. A pass-through hook may be used instead of the needle. Pass the needle or pass-through hook around the humerus 91.

[0070] Figure 37: The tail end of the circulage suture 300 is loaded into the needle-shaped suture shuttle. The circulage suture 300 is then shuttled a second time around the humerus 91.

[0071] Figure 38: Load the tail end of the circlazy suture 300 through the suture shuttle 33 (#1 on the card). Hold the card in the bullseye (#2 on the card) and pull the loop on the opposite side (#3 on the card) to shuttle the circlazy suture 300 through the pre-tied knot. Remove the card 44 and discard the suture shuttle 33.

[0072] Figure 39: Reduce the knot near humerus 91 and remove slack from the circulage loop.

[0073] Figure 40: When tape 300 is cut, two rims are created. Insert the rims into the tensioner.

[0074] Figure 41: Place the tensioner against the knot and begin applying tension to the tape. Continue applying tension until the slack is removed from the loop.

[0075] Figure 42: Press the tensioner release button to remove the suture limb. Tie a half hitch. Reload the suture limb into the tensioner and apply final tension. Tie alternating half hitches to complete repair 501.

[0076] Figure 43: Repeat the sequence for the subsequent circulage suture following repair 501.

[0077] Figure 44 shows the above-described exemplary elastic circulage repair 501, used in conjunction with a modified long humeral stem to provide stronger repair for periarthritis of the joint.

[0078] Figure 45 shows the exemplary elastic circulage repair 501 described above, which was used prophylactically to help prevent proximal femoral fracture during total hip arthroplasty.

[0079] Racking half hitch Refer to Figures 46 to 50 here. The racking half-hitch repair may be performed using any of the elastic sutures 100, 200, 300, 400, 500, or 600. As shown below, the exemplary elastic suture 100 of repair 601 (Figure 49) may consist of a sheath that holds the racking hitch without the need to tie an additional half-hitch 455 to secure it.

[0080] The jacket of the elastic suture is designed to be held over the section where the knot 455 of the racking half hitch is located. The suture tails can be swaged together for easy passage. A suture passer flag / card / device 460 (Figures 46 and 47) can hold the racking half hitch open. The tail(s) can be passed through the racking half hitch using the passer device to complete the knot 455. The knot 455 is then tightened to secure the tissue 80. The elastic suture stretches / constricts during tension / tightening, and then slackens to capture / secure in place.

[0081] The elastic structures, structures, and assemblies of this disclosure are applicable to a variety of surgical techniques and tissue repairs in which “elastic / stretchable” sutures replace current static sutures used in the art. Illustrative applications of the “elastic / stretchable” sutures of this disclosure are as follows:

[0082] Flexible tension-adjustable knotless anchors—elastic / stretchable components—can be incorporated into restorative sutures to act as fillings or dynamic repairs, either to allow for a more secure locking mechanism or to prevent overtightening of the repair area.

[0083] Any sheath for all (or any) suture anchors may be made with elastic / stretch sutures to allow for better bundling and fixation.

[0084] Any internal brace repair - FiberTape® suture tape can replace elastic / stretch sutures, enabling dynamic repair and potentially possessing the ability to move and rebound as needed.

[0085] Any FiberTape® circling structure – the entire suture, or a portion of the suture, can be made from elastic / stretchable suture to secure the knot.

[0086] The exemplary elastic sutures 100, 200, 300, 400, 500, and 600 of this disclosure may be manufactured as a single-piece suture structure. The exemplary elastic sutures 100, 200, 300, 400, 500, and 600 may be firmly engaged with and disengaged from one or more fixation devices, such as fixation device 60. Fixation device 60 may be a suture anchor providing at least one fixation point of a first tissue (e.g., soft tissue attached to bone) attached to a second tissue. The exemplary elastic sutures 100, 200, 300, 400, 500, and 600 may be attached to one or more fixation devices by sliding through at least a portion of the fixation device, for example, by extending and sliding through at least a portion of the body of the fixation device.

[0087] Example fixation devices may be anchors (knotted anchors, knotless anchors, or full suture anchors), implants, buttons, screws, or any fixation device that provides a firm attachment and fixation of soft tissue 80 on bone 90 and allows the sliding of elastic sutures within the body of the fixation device. The fixation device may also be a knotless suture anchor, such as the two-piece Arthrex PushLock® anchor disclosed in U.S. Patent No. 7,329,272, or the Arthrex SwiveLock® anchor disclosed in U.S. Patents No. 8,012,174 and U.S. Patent No. 9,005,246, all of which are fully incorporated herein by reference.

[0088] Another exemplary fixation device is a soft anchor, or "full suture" anchor. A soft anchor (soft suture anchor, or full suture soft knotless anchor) comprises a soft anchor sleeve (sheath, or tubular member) having two open ends and at least two flexible shuttle 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 positions. The flexible tubular sleeve with shuttle strands may be fixed into or on bone, and the flexible strands may pass through soft tissue (rotator cuff) and be fixed to bone, causing the soft tissue to approximate bone. Details of exemplary soft suture anchors having a soft anchor sleeve (sheath, or tubular member) and a flexible shuttle strand are described, for example, in U.S. Patent Application No. 10,849,734, “Methods of Tissue Repairs,” filed December 1, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0089] The elastic flexible couplers, surgical assemblies, and elastic structures detailed above are applicable to any tissue repair and surgical procedure, such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL / PCL reconstruction, hip and shoulder joint reconstruction, and the use of elastic sutures used within or with suture anchors. The surgical elastic structures and repair methods of this disclosure may, in particular, be used in tissue repair that does not involve knotting, for example, in suture anchors (e.g., PushoLock® and / or SwiveLock® suture anchors) or for knotless arthroscopic suture repairs (e.g., knotless single-row rotator cuff repair, or SpeedBridge® repair, which is knotless and uses only a suture passer step).

[0090] Developed by Arthrex, Inc. and disclosed in U.S. Patent No. 8,012,174 (the disclosure of which is incorporated herein by reference in its entirety), the exemplary SutureBridge® tendon repair technique consists of a knotted medial row constructed with two threaded suture anchors, combined with knotless lateral fixation using two Arthrex PushLock® structures. The structures enhance footprint compression and promote tendon-to-bone healing with minimal knotting.

[0091] The exemplary SpeedBridge® technology, developed by Arthrex, Inc. and disclosed in U.S. Patent No. 9,005,246 (the entire disclosure of which is incorporated herein by reference), may utilize threaded swivel anchors, which, in place of or in addition to FiberTape® suture tapes, can be combined with any elastic flexible coupler 100, 200, 300, 400, 500, or 600 to produce a quick and secure SutureBridge® structure that is knotless and involves only two suture passer steps.

[0092] An exemplary fixation device 60 may be two exemplary Arthrex SwiveLock® anchors 60 (e.g., Arthrex 4.75-mm BioComposite SwiveLock® anchors) fixed to bones 90, 91 (e.g., humerus 91). The fixation device 60 can be used to fix soft tissue to bone by a SpeedFix® or SpeedBridge® configuration. The SpeedFix® and SpeedBridge® technologies developed by Arthrex, Inc. use threaded swivel anchors, such as Arthrex SwiveLock® C anchors, in combination with FiberTape® (disclosed in U.S. Patent No. 7,892,256), to produce knotless, single-row or SpeedBridge® structures (knotless double-row restorations) that are fast and secure, with very few suture passer steps.

[0093] In the SpeedFix® technique, FiberTape® sutures are passed through the reverse mattress using a SutureLasso® or Scorpion® suture passer. The two suture limbs of the mattress stitch can then be inserted into a SwiveLock® anchor eyelet. The loaded eyelet is inserted into a prepared lateral bone socket until the anchor body contacts the bone, and tension is adjusted as needed. The SwiveLock® C driver is rotated clockwise to complete the insertion. The FiberTape® tail is cut using an open-end FiberWire® cutter to complete the technique.

[0094] A surgical assembly for tissue reinforcement and / or repair comprises elastic flexible couplers 100, 200, 300, 400, 500, and 600, and at least one fixation device 60 attached to the flexible couplers 100, 200, 300, 400, 500, and 600. The fixation device 60 may be a knotless suture anchor. The tissue may be the rotator cuff. The fixation device 60 may be a hard body anchor. The fixation device 60 may be a soft anchor.

[0095] A method of soft tissue reconstruction includes attaching soft tissue 80 to bone 90, 91 using at least one elastic flexible coupler 100, 200, 300, 400, 500, 600. The method may further include slidably attaching at least one elastic flexible coupler 100, 200, 300, 400, 500, 600 to a fixation device 60, and fixing the fixation device 60 to bone 90, 91. At least one elastic flexible coupler 100, 200, 300, 400, 500, 600 may be an integral structure essentially made of elastic suture. The fixation device 60 may be a knotless anchor.

[0096] Elastic flexible couplers 100, 200, 300, 400, 500, and 600 may include suture tapes such as FiberTape® suture tape (disclosed in U.S. Patent No. 7,892,256, the entire disclosure of which is incorporated herein), or collagen tape, or a wide range of “tape-like” materials, or combinations thereof.

[0097] Elastic flexible couplers 100, 200, 300, 400, 500, and 600 can be formed from high-strength suture materials, such as FiberWire® sutures, marketed by Arthrex, Inc. (Naples, Florida) and described in U.S. Patent No. 6,716,234, the disclosure of which is incorporated herein by reference. FiberWire® sutures are formed from advanced high-strength fiber materials, namely ultra-high molecular weight polyethylene (UHMWPE), marketed under the trademarks of Spectra® (Honeywell International Inc., Colonial Heights, Virginia) and Dyneema® (DSM NV, Netherlands, Heerlen), and braided with at least one other fiber, natural or synthetic, to form the length of the suture material.

[0098] The elastic flexible couplers 100, 200, 300, 400, 500, and 600 may consist essentially of a suture material and elastane, or essentially of a combination of a suture material, elastane, and other materials, such as long-chain synthetic polymers like polyester and nylon, or materials such as PET, silk nylon, or absorbable polymers, or coating materials (such as wax, silk, or silicone products). The elastic flexible couplers 100, 200, 300, 400, 500, and 600 may consist of strands having cross-sections of various shapes and geometric shapes, including, among other things, circular, elliptical, rectangular, or flat, or combinations of such shapes and geometric shapes. In one embodiment, at least one of the elastic flexible couplers 100, 200, 300, 400, 500, and 600 may be provided as a braided, knitted, or woven suture.

[0099] Elastic flexible couplers 100, 200, 300, 400, 500, and 600 may also be coated and / or supplied in different colors. In one embodiment, some (or all) of the elastic flexible couplers 100, 200, 300, 400, 500, and 600 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 binding catalyst, or others), PTFE (Teflon, Hostaflon, or others), PBA (polybutyrate), ethylcellulose (Filodel), or other coatings to improve the lubricity, flexibility, ease of handling, or abrasion resistance of sutures and / or tapes, for example.

[0100] Elastic flexible couplers 100, 200, 300, 400, 500, and 600 may also feature colored tracing strands or be visually contrasted with other parts of the structure, remaining, for example, a simple solid color or displaying a different tracing pattern. Various structural elements of the surgical structure may be visually coded to facilitate the identification and handling of the suture legs. Easy identification of sutures in situ is advantageous in surgical procedures.

[0101] The term “high-strength suture” is defined as any stretched, flexible member, the choice of material and size determined by the specific application. For illustrative purposes only and without limitation as used herein, the term “suture” may be a cable, filament, thread, wire, fabric, or any other flexible member suitable for fixing tissues within the body. [Explanation of symbols]

[0102] 22 Nitinol Wire Loops 33 Shuttle sutures 44 cards 45 needles 60 Suture anchors 80 Ligament 90. Joint fossa margin 91. Humerus 100 Surgical Elastic Flexible Couplers 101 Tissue repair 105 knots 115 Jacket 125 elastic core 200 Surgical Elastic Flexible Couplers 201 Internal brace repair 215 Jacket 225 Elastic materials 226 Inelastic materials 300 Surgical Elastic Flexible Couplers 301 TKL mechanism 315 Elastic components 325 Elastic components 326 Tail 333 Sheath 350 Knotless Anchors 400 Surgical Elastic Flexible Couplers 401 Final lip repair 415 Elastic components 425 Elastic components 426 Tubular elastic tail 455 Half Hitch 460 devices 500 Surgical Elastic Flexible Couplers 501 Tissue repair 515 Elastic components 525 First Segment 526 Second Segment 555 Locking splice 580 devices 600 Surgical Elastic Flexible Couplers 601 Tissue repair 615 Elastic tape portion 615 Tape portion 625 Tapered tail

Claims

1. Elastic suture, Elastic core and An elastic suture comprising a tubular jacket covering the elastic core, the tubular jacket being essentially made of polyester and UHMWPE.

2. The elastic suture according to claim 1, wherein the elastic core is essentially made of elastane.

3. The elastic suture according to claim 1, wherein the elastic core comprises an elastic material and a non-elastic material.

4. The elastic suture according to claim 1, wherein the tubular jacket is elastic.

5. The elastic suture according to claim 1, wherein the tubular jacket is non-elastic.

6. The elastic suture according to claim 1, wherein the elastic suture is braided, woven, or knitted.

7. The elastic suture according to claim 1, wherein the elastic suture is manufactured as an integral structure.

8. The elastic suture according to claim 1, wherein at least one of the elastic core and the tubular jacket comprises elastane.

9. The elastic suture according to claim 1, wherein at least one region of the elastic suture is attached to a fixing device.

10. The elastic suture according to claim 9, wherein the fixing device is a knotless suture anchor.

11. It is a suture tape, Elastic flat tape and Two elastic, rounded tail portions, which are substantially parallel to each other and extend within the body of the elastic flat tape, A suture tape, including a non-elastic, rounded tail.

12. The suture tape according to claim 11, wherein the two elastic, rounded tail portions and the non-elastic, rounded tail portion are connected together to form a single tubular elastic tail portion.

13. A surgical assembly for soft tissue repair, equipped with an elastic and flexible coupler attached to a knotless fixation device.

14. The surgical assembly according to claim 13, wherein the elastic flexible coupler is an elastic suture comprising a silicone core and a jacket covering the silicone core, the jacket essentially consisting of polyester and UHMWPE, and the knotless fixation device is a knotless suture anchor.

15. The surgical assembly according to claim 13, wherein the knotless fixation device is an anchor inserted into the bone.

16. A method of soft tissue reconstruction, comprising attaching soft tissue to bone using at least one elastic and flexible coupler.

17. The at least one elastic and flexible coupler is attached to the fixed device, The method according to claim 16, further comprising fixing the fixation device to the bone.

18. The method according to claim 17, wherein the at least one elastic flexible coupler is an elastic suture.

19. The method according to claim 18, wherein the elastic suture includes a jacket covering an elastic core, the jacket being essentially made of polyester and UHMWPE.

20. The method according to claim 19, wherein the elastic core is essentially made of an elastane material.

21. The method according to claim 17, wherein the fixing device is a knotless anchor.

22. The method according to claim 17, wherein the soft tissue is a rotator cuff, and the fixation device is a lateral or medial fixation device for rotator cuff repair.

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