Knotless Closing Suture and Tissue Fixation Method

Abstract

The present invention discloses a surgical suturing structure, a suture anchor assembly and a tissue fixation method. The suturing structure includes a jagged suture. The suturing structure may include one or more small loops at the distal end. The suturing structure may include a joint terminating in a tapered portion / region at the proximal end. The jagged suture of the suturing structure may form a knotless, closed, self-locking loop around the tissue.

Description

Technical Field

[0001] The present disclosure relates to the field of surgery, and more particularly, to improved suture and tissue fixation methods. Summary of the invention

[0002] Disclosed herein are suture constructions and methods for knotless fixation of tissue.

[0003] The suture construction may include a jagged suture. The suture construction may include one or more small loops at the distal end. The suture construction may include a joint terminating in a tapered portion / region at the proximal end. The jagged suture of the suture construction may form a knotless closed self-locking loop around the tissue.

[0004] The fixation of tissue is achieved by utilizing at least one suture structure that bypasses or passes through tissue (e.g., bone or soft tissue). The suture structure may include a jagged suture that allows a closed knotless self-locking loop to be formed around the tissue and lock the device. The suture structure may be fixed to the bone with additional fixation devices (such as one or more suture anchors). The suture structure may be used with soft anchors or hard anchors. The structure may be used with a knotless or knotted fixation device. Tissue fixation is achieved with an overall reduction in steps and minimal knotting requirements. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figure 1 An exemplary suture configuration is shown.

[0006] Figure 2 Another exemplary suture configuration is shown.

[0007] Figure 3 Another exemplary suture configuration is shown.

[0008] Figure 4 Shows Figure 1 The inner strand of an exemplary suture construction.

[0009] Figure 5 Shows Figure 1 Another view of an exemplary suture construction.

[0010] Figure 6 and Figure 7 Shown using Figure 5 The suture is constructed in the subsequent steps of an exemplary method for performing a knotless repair.

[0011] FIG. 8 shows schematic steps for forming a knotless loop using an exemplary suture configuration.

[0012] Figure 9-11 Subsequent steps in an exemplary method of forming a knotless closed self-locking loop with a suture construction are shown.

[0013] Figure 12-Figure 15 Subsequent steps in an exemplary method of performing a knotless repair with a suture construct are shown.

[0014] Fig.16 Another exemplary suture configuration is shown.

[0015] Fig.17 Shows Fig.16 An enlarged view of section A of an exemplary suture construction.

[0016] Fig.18 Shown is a shuttle device Figure 1 Another view of an exemplary suture construction.

[0017] Fig.19 A shoulder repair with a suture construction is shown.

[0018] Figure 20-24 Various exemplary suture anchor assemblies are shown.

[0019] Fig.25 The method of fixing a first tissue to a second tissue is shown. Fig. 20 Suture anchor assembly.

[0020] Fig.26 The method of fixing a first tissue to a second tissue is shown. Fig.23 Suture anchor assembly.

[0021] Fig. 27 An exemplary soft suture anchor assembly is shown.

[0022] Fig.28 Another exemplary suture anchor assembly is shown. DETAILED DESCRIPTION

[0023] The present disclosure provides methods and suture constructs for securing tissue (eg, soft tissue) to bone.

[0024] Suture structures, suture anchor assemblies and methods for fixing soft tissue are disclosed herein. The suture structure can include a locking suture and a jagged suture of a repair portion. The suture structure can include one or more small loops or orifices at the distal end. The suture structure can include a joint terminating in a tapered portion / region at the proximal end. The suture structure can be pre-loaded on a soft suture anchor or a hard anchor (fixing device).

[0025] The uneven suture may include a plurality of enlargements, which may be a series of protuberances, barbs, knots, beads, tumors, projections, ridges or similar structures (or combinations thereof) added to the coreless suture as a core. The enlargement may be knotted and / or arranged as a series of protuberances (chains) along the inner wire. The suture may be composed of a centerline strand of a cored suture (inner wire) having fixed knots, beads and / or spinous processes at defined intervals, similar to a bathroom drain chain. The spinous processes may be symmetrical or asymmetrical, with the tapered end facing the cinch. The inner wire with the enlargement may be arranged in the coreless suture (e.g., inserted into the coreless suture) to form a suture with an uneven core. The protuberance may be a knotted protuberance to provide at least one spinous process point. The enlargement may be a portion of the inner strand or inner wire covered by the coreless suture (outer sheath).

[0026] The loop may be provided at one end of the jagged suture. The jagged suture may be used to form a racking hitch (tie knot) around tissue. The jagged suture may be used to form a knotless, closed, self-locking loop around tissue. Once the closed loop is formed, the enlargement of the suture construction prevents the suture construction from sliding backward (backing off). The joint portion may be provided with a plurality of enlargements on one side near the loop at the distal end of the suture.

[0027] Fixation of soft tissue is achieved by using at least one suture structure around or through the tissue without the need for a nitinol wire loop or similar device. The tapered portion / region of the structure allows the suture structure to be retrieved after passing through the tissue. After forming the rail hanger or band suture and / or locking with the enlarged portion near the loop, the suture structure can be fixed to the bone with additional fixation devices (such as one or more suture anchors). The structure can be used with a knotless or knotted fixation device. Tissue fixation is achieved with an overall reduction in steps and minimal knotting requirements.

[0028] According to one embodiment, the suture construction may include a suture with an enlargement in the form of a series of ridges, barbs, knots, beads, knobs or similar structures (or any combination thereof) added to a coreless suture as a core. The enlargement may be knotted and / or arranged as a series of ridges (chains) along the inner wire.

[0029] The suture construction can be composed of a center strand of a cored suture with an enlargement (i.e., fixed knots, beads, barbs and / or spinous processes at defined intervals), similar to a bathroom drain chain. The spinous processes can be symmetrical or asymmetrical, with the tapered ends facing the cinch. An inner wire with an enlargement can be inserted into a coreless suture to form a suture with an uneven core. The enlargement can be a knotted protuberance to provide at least one spinous process point. The enlargement is a portion of the inner strand that is completely covered by the coreless suture (outer sheath). The enlargement is thicker than the coreless suture, i.e., the enlargement has an outer diameter that is greater than the outer diameter of the coreless suture.

[0030] According to an embodiment, the connector portion may be provided with a plurality of expansions on one side near the loop at the distal end of the suture. The loader is pre-threaded through the loop to load the suture tail back through the loop after it has passed through the soft tissue. Once the suture has passed through the soft tissue, the tail is threaded through the loop using the loader by folding the tapered end and shuttling it through the loop. The suture is then pulled through until it is fully tightened. As it tightens, the expansion, which is thicker than the coreless suture, is pulled into the loop and prevents the suture from backing out.

[0031] According to another embodiment, the suture structure may include: a flexible strand having one or more small loops or orifices at its distal end, a tapered proximal end (tapered tail), and a joint region disposed between the small loop and the tapered proximal end. The joint region is provided with a plurality of expansions (completely covered by the coreless suture) within the coreless suture at the distal end of the suture. The expansions may be any knots, beads, ridges, protrusions, knobs or similar elements, or combinations thereof. The expansions may be formed by any method known in the art, such as knotting, braiding, weaving or gluing, thereby providing a series of beads on a rope, attaching a series of beads or similar elements to a rope, etc.

[0032] In one embodiment, the suture structure includes a string of enlargements, which are added to the coreless suture as a core (concave and convex core). The enlargement can be knotted, or is set to a series of protuberances (chains), or is set to a series of unidirectional barbs or similar structures along the inner wire. The enlargement and / or the inner wire can be formed by various materials, such as metal or plastic, or suture material, etc. The inner wire with the enlargement is arranged in (e.g., inserted into) the coreless suture to form a suture with a concave and convex core.

[0033] The expansion can have various designs and / or configurations, such as circular, triangular, oval or cylindrical cross-sections and many other shapes known in the art. The expansion can be arranged at various positions along the length of the interior wire. The expansion can be arranged in various directions along the length of the interior wire, such as a bidirectional expansion or a multidirectional expansion. The expansion can be arranged as a unidirectional barb.

[0034] In another embodiment, the suture construction may consist of a center strand of cored suture with fixed "spinuses" at defined intervals, similar to a bathroom drain chain. The spinuses may be asymmetrical, with the tapered ends facing the band (as described in detail below). After the working distance length is appropriately defined, the suture will be attached to the cored #2 Same, then tapers to a smaller 2.0 To facilitate loading in the banding mechanism and forming a knotless suture configuration with a joint and joint forming mechanism. Once the suture is passed through the soft tissue, the tail (tapered end) is passed through the small hole / opening at the distal end by shuttling it through the small hole / opening. The suture is then pulled through until it is fully tightened. As it tightens, the thicker protuberance / spinous process engages the small hole / opening and locks the suture under tension, thereby preventing the suture from backing off and coming loose.

[0035] The shuttling device may be pre-loaded onto the loop to load the tapered suture tail back through the loop after it has passed through soft tissue. The flexible coreless strand may be a suture, ribbon, wire, or any flexible material known in the art. The shuttling device may be a suture passing instrument, a suture passer, a shuttling / pulling device, a loader, a shuttling wire, or any passing instrument, such as a FiberLink TM Or a nitinol ring. The central core can be a suture, a ribbon, a wire, or any flexible material known in the art. The central core can be flexible or rigid.

[0036] Once the flexible strand has passed through the soft tissue, the tapered tail is passed through the loop of the shuttle by folding the tapered end and shuttling it through the loop. The flexible strand is then pulled through until it is fully tightened. As it tightens, the enlargement from the thicker connector portion pulls into the loop and prevents the flexible strand from backing out.

[0037] The flexible strands may be standard braided coreless sutures, may be tapered, and may include three exemplary different widths throughout their length, with one or more enlargements / knobs in one of the portions of the suture to create a ridge or bump. The suture may be provided with a locking mechanism, such as one or more small loops, eyelets, openings, slits, etc., to allow the suture to be pulled through until the enlargement (ridge / bump / protrusion / knot) engages and locks the suture under tension.

[0038] The loop is large enough to allow the tapered end and a portion of the joint area to pass through it and then lock onto the loop to form a band suture around soft tissue. The flexible strands may be coreless to allow insertion of an inner wire with an enlargement, or in certain applications, portions of the coreless strands may have a core. The loop may be formed by splicing or other methods known in the art, such as braiding, weaving, or gluing.

[0039] In another embodiment, the suture cinch includes a coreless suture or a covering envelope that contains (completely covers) an inner core, which is a smaller suture with an enlargement (knot / bead / barb, etc.). The suture may terminate in a loop to allow for the formation of at least one rail hanger. The enlargement provides a spinous point to prevent the rail hanger from slipping off.

[0040] Referring now to the drawings, wherein like elements are represented by like reference numerals, Figure 1-Figure 19 Exemplary suture constructions 100, 200, 300, 400 of the present disclosure are shown (sutures 100, 200, 300, 400; suture constructions 100, 200, 300, 400; edge-to-edge knotless sutures 100, 200, 300, 400; knotless closing sutures 100, 200, 300, 400). Figure 20-28 Suture constructions 100 , 200 , 300 , 400 are shown as part of a suture anchor assembly 111 , 112 , 113 , 114 , 115 , 116 , 117 for securing a first tissue to a second tissue.

[0041] As described in detail below, each suture construction 100, 200, 300, 400 includes a center strand 50 (first strand or filament; inner strand) of a cored suture and an outer strand 10 (second strand or filament; outer strand; coreless suture) of the suture covering the center strand. The center strand 50 includes a plurality of enlarged portions 55, 155, 255, 355. In one embodiment, the outer strand 10 completely covers the center strand 50 and the enlarged portions 55, 155, 255, 355 in at least two directions (longitudinal direction and transverse direction).

[0042] The expansion 55, 155, 255, 355 may include a ridge, a knot, a bead, a barb, a protrusion or a tumor, or any combination thereof. The expansion 55, 155, 255, 355 may have a variety of designs and / or configurations, such as circular, oval or cylindrical and many other shapes known in the art. The expansion may be arranged at various positions along the length of the inner wire 50 (center line strand 50). The expansion may be arranged at various positions along the predetermined length of the inner wire 50 (i.e., only along a portion of the length of the center line strand 50). The expansion may be arranged in various directions along the length of the inner wire, such as a bidirectional expansion, wherein a first plurality of expansions are oriented in a first direction relative to the longitudinal axis of the strand 50, and wherein a second plurality of expansions are oriented in a second direction relative to the longitudinal axis of the strand 50, the first direction being different from the second direction. The expansion may be formed at any angle to the surface of the center line strand, for example, at a 45 degree angle to the tangent of the outer surface of the center line strand. The expansions may all be similar or different, i.e., may have similar or different shapes, forms and configurations. The enlarged portions may all be formed from similar or different materials.

[0043] Figure 1 Only exemplary embodiments of the present disclosure are shown, in which a suture construction 100 includes a centerline strand 50 having an enlarged portion 55 having a generally trapezoidal shape and extending at approximately regular intervals along the length of the centerline strand 50. The enlarged portion 55 may extend along the entire length of the inner strand 50, or only along a portion of the length of the inner strand 50. The outer suture 10 is a coreless suture (coreless strand) covering the centerline strand 50 and the enlarged portion 55. The outer suture 10 is a coreless suture (coreless strand) that completely covers the centerline strand 50 having the enlarged portion 55 at least in the transverse direction, i.e., the outer surface of each enlarged portion 55 is completely covered by the outer suture 10. Preferably, the outer suture 10 covers the centerline strand 50 having the enlarged portion 55 in both directions, i.e., in the longitudinal direction and the transverse direction. The center strand 50 with the enlarged portion 55 can be disposed within the interior space / volume of the coreless suture 10 (e.g., by being inserted into the coreless suture 10) to form the suture construction 100 (the coreless suture 10 is no longer coreless after the insertion step). Once the inner strand 50 with the enlarged portion 55 is disposed within the outer strand 10, the outer strand 10 will acquire a "bumpy" feel because the enlarged portion will apply pressure along the inner surface of the outer strand 10 but will not penetrate the outer surface of the outer strand 10.

[0044] Figure 2 and Figure 3 Suture constructions 200, 300 are shown with enlarged portions 155, 255 similar to Figure 1 The suture 50 is also provided with enlarged portions 55, which are also spaced apart along the length of the suture 50 and are completely covered by the outer sheath 10, but differ in the shape of the enlarged portions. For example, the enlarged portion 155 is in the form of a bead or spherical structure, while the enlarged portion 255 is in the form of a teardrop shaped structure. The enlarged portion 255 is a "spinous process" fixed at defined intervals along the inner strand 50, similar to a bathroom drain chain. The spinous processes can be asymmetrical, with the tapered ends facing the drawstring (as described in detail below). After the working distance length is appropriately defined, the suture will be connected to the cored #2 Same, then tapers to a smaller 2.0 To facilitate loading in the drawstring mechanism and forming a knotless suture configuration with a joint and joint forming mechanism. Once the suture is passed through the soft tissue, the tail (tapered end) is passed through the small hole / opening at the distal end by shuttling it through the small hole / opening. The suture is then pulled through until it is fully tightened. As it tightens, the thicker ridges engage the small hole / opening and lock the suture under tension, preventing the suture from moving in any direction.

[0045] Figure 4-Figure 7 A suture construction 400 is shown having an enlargement 355 in the form of a knot 355 extending along the centerline strand 50 ( Figure 4 ). Figure 4 The inner core 50 shown is a smaller suture with a knot 355. The coreless suture or the covering envelope 10 (outer strand 10) covers the inner core 50. The outer strand 10 completely covers the inner center strand 50 with the knot 355 to form Figure 5 Suture configuration 400 is shown.

[0046] The fixing / interference of the enlarged portion can be achieved in various ways and with various locking structures. Figure 5-Figure 7 As shown, the exemplary suture construction 400 is provided with a loop 11 for forming a rail hanger 166. The knot 355 (knot ridge 355) provides a spinous point to prevent the rail hanger from slipping off. Figure 7 A schematic diagram of a final repair portion made with a suture construction 400 having an enlarged portion 355 is shown, wherein the enlarged portion is locked in place by a rail hanger 166, that is, it cannot slip or slide out of the loop formed around a first tissue 90 (e.g., soft tissue 90) attached to a second tissue 80 (e.g., bone 80).

[0047] The loop 11 may be formed integrally with the suture construction, or may be separate from the suture construction. The loop 11 may be part of the outer strand 10, or alternatively part of the inner strand 50. In yet another embodiment, the loop 11 may be part of both strands 10, 50. In yet other embodiments, the loop 11 may be attached to the suture construction (e.g., to one or both of the outer and inner strands) by any method known in the art. For example, Fig.28 An exemplary loop 11a is shown attached to the exemplary construction 100 and further securely attached to the rigid body of the knotless fixation device. In yet another embodiment, the outer strand 10 is spliced ​​into itself to form a small loop 11 (or double loop) and a joint. The small loop 11 can be integral with the suture strand 10.

[0048] The fixation / interference of the enlarged portion can be achieved in other ways, for example, in any way where the enlarged portion 55, 155, 255, 355 can be locked into, such as a pre-tie, or a slit, or any "eyelet" that provides a tight interference for the enlarged portion.

[0049] FIG8 shows an exemplary suture construction 100 with a pre-tie 166 through structure A, which may be part of structure 100, such as part of outer strand 10. Pre-tie 166 is an interference point for "catching" an enlargement (ridge, bead, etc.). Structure A is a rail hook hitch. Structures B and C provide additional interference points, similar to the pre-tie of structure A (where they also "catch" any enlargement / ridge / bead passing therethrough), but with different configurations, i.e., slits 103 (structure B) or eyelets 104 (structure C).

[0050] Figure 9-11The formation of a closed self-locking ring 99 formed in the configuration of the present disclosure is shown. Fig. 9 yes Figure 5 Magnified view of the loop 11 of the suture, which allows the formation of the rail hook hitch. The hook is formed by starting with a loop 11 pre-made at the end of the suture, or by doubling on a single strand. Fig.10 In the embodiment of the present invention, the tail is passed through loop 11 to form a "luggage tag" type drawstring knot, which becomes a pre-tie 166 and forms loop 99a.

[0051] Reference now Fig.11 , the tail is passed through the pre-tied rail / tie knot 166. A closed self-tightening and self-locking loop 99 is thereby formed. As described in detail below, this loop can be formed around bone or soft tissue. The tighter the large loop is pulled against the tissue, the tighter the rail / tie knot around the suture limb passing through it. This is where the uneven suture passes through, but the enlargement / ridge will prevent the suture from sliding backward (like a tightening band). The enlargement / ridge allows the construction to "self-lock" and prevents the suture construction from moving in any direction.

[0052] Figure 12-Figure 15 Subsequent steps in a method of tissue fixation using the disclosed constructs are shown.Suture construct 100 is passed through first tissue 90 to be attached to second tissue 80 (eg, soft tissue 90 to be attached to bone 80). Fig.13 The rail / tie knot is shown adjacent to the first tissue 90. The tail 25 passes through the rail / tie knot to form a closed, adjustable, self-locking, self-tightening, knotless flexible loop 99 around the tissue 90 to be attached to the tissue 80.

[0053] Fig.16 and Fig.17 Another exemplary embodiment of a construction 400 is shown in the form of a flexible strand 10 having at least one small closed loop 15 (e.g., two exemplary small closed loops 15) at one end 13 (e.g., the distal end) and a tapered elongated portion / region 25 at the other end 12 (e.g., the proximal end). An enlargement 355 is provided on the enlarged portion (belt section) 165 of the construction 400, as described in detail above with respect to the previously discussed embodiments. Fig.17 Shows Fig.16 Schematic enlarged view of section A of , which shows an enlarged portion 355 having a specific configuration (i.e., an elongated teardrop shape). The enlarged portion 355 is completely covered by the coreless suture strand 10, so that the outer surface of each enlarged portion 355 is completely covered by the inner surface of the strand 10.

[0054] The suture structures 100, 200, 300, 400 of the present disclosure may also be provided with a shuttle device 60, which may be a suture passing instrument, a loader, a shuttle wire or a passing instrument, such as a FiberLink TM 60 or Nitinol ring 60 wherein a closed loop or eyelet 61 is attached to the outer strand 10 of the suture construction.

[0055] like Fig.18 As shown, the shuttle device 60 is preloaded onto the closed loop 11 of the exemplary suture construction 100 (threading through the closed loop 11). In a specific and merely exemplary embodiment, the shuttle device 60 is a suture passing device 60. The shuttle device 60 is configured to allow the tapered portion 25 of the outer strand 10 to pass through the eyelet or loop 61 of the shuttle device 60 and through the small loop 11 to form a knotless closed adjustable loop 99 with adjustable length and circumference. The loop 99 is self-locking and self-tightening.

[0056] Suture construction 100 includes a series of enlargements 55, which may be located at the distal end 13 of the outer strand 10 on one side near the loop 11, i.e., on or around portion 65 (band section 5; joint section 65). The enlargements (ridges and / or barbs and / or ridges and / or knobs) roughen the outer strand 10 (suture 10) for knotless locking. Once the outer strand 10 has passed through the soft tissue, the tail 25 is passed through the loop 61 using a loader 60 by folding the tapered end 25 and shuttling it through the loop 11. The flexible strand 10 is then pulled through until it is fully tightened. As it tightens, the thicker enlarged rough portion 60 with the enlargements is pulled into the loop 11 and prevents the flexible strand 10 from backing out. In this way, the flexible closed adjustable loop 99 is locked by the engagement of the enlargements 55 with the inner surface of the loop 11.

[0057] In an exemplary embodiment, the loop 11 has a very small length and / or circumference to allow the tail 25 to pass through the loop and form a closed, knotless, adjustable loop 99. The loop 11 can have a length of about 10 mm. The tapered portion / region 25 has a length of about 2-3 inches. The total length of the suture construction can be about 3 to 10 inches, preferably about 5 inches (for an exemplary rotator cuff repair involving attaching the labrum to the glenoid). The loop portion is formed by splicing (in a preferred embodiment), but it can also be formed by other methods known in the art, such as by braiding, weaving or gluing. The loop 15 can be flexible, foldable, and have a fixed circumference of about 10 mm.

[0058] As described in detail above, the loop 11 can also be a rail hanging loop. The tail 25 passes through / is loaded through the small loop 11 of the flexible strand 10, such as Figure 3 The tail is pulled through until a small opening is left ( Figure 4). A suture loader 60 is added to pull the tail through the rail hanger after it has passed through the tissue.

[0059] In an exemplary embodiment, the flexible strand 10 of the suture construction 100, 200, 300, 400 is a suture formed primarily of a braid, such as The outer strands 10 are sutures formed primarily of polyester or a similar material. For example, the outer strands 10 may be formed of polyester yarn (twisted yarn of polyester) or a polyester suture in the form of a coreless braid or sheath, which may be a multifilament, braided, knitted, or woven polyester construction, wherein the polyester is provided alone or in combination with any other known suture material. In an exemplary embodiment only, the outer strands 10 are braided coreless sutures having approximately 100% polyester.

[0060] For example, at least one or all of the suture segments of the exemplary suture constructions 100, 200, 300, 400 may be coated (partially or fully) with wax (beeswax, petroleum wax, polyethylene wax, or other), silicone (Dow Corning Silicone Fluid 202A or other), silicone rubber (Nusil Med 2245, Nusil Med 2174 with adhesion catalyst, or other), PTFE (Teflon, Hostaflon, or other), PBA (polybutyrate), ethyl cellulose (Filodel), or other coatings to improve the lubricity, knot security, softness, maneuverability, or abrasion resistance of the resulting suture construction.

[0061] The elongated tapered region 25 of the surgical construct of the present disclosure allows the flexible strand / suture to be pushed through small and very small diameter tubes and cannulas (e.g., such as lasso instruments), but is not easily accessible with a fixation device (e.g., such as a (Push-Lock) anchors) are used to securely secure.

[0062] The surgical suturing structures 100, 200, 300, 400 can have cross-sections of various forms and geometries, including, in particular, circular, oval, rectangular or flat, etc., or combinations of these forms and geometries. The diameter of the structures 100, 200, 300, 400 can be constant or can vary. The tapered region 25 can include a plurality of adjacent tapered regions, each region having a diameter different from that of an adjacent region. In an exemplary embodiment only, the region 25 can include three adjacent regions, each region having a taper different from that of an adjacent region.

[0063] At least a portion of the fibers of suture constructions 100, 200, 300, 400 may comprise strands of a high-strength suture material, such as the Arthrex® suture disclosed in U.S. Pat. No. 6,716,234. The suture, the disclosure of which is incorporated herein by reference in its entirety, has selectable colored strands to assist the surgeon in distinguishing between various suture lengths.

[0064] The surgical suture structures 100, 200, 300, 400 (by themselves or in any combination) are suitable for suturing applications, which can be used in surgical procedures, such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL / PCL reconstruction, hip and shoulder reconstruction surgery, and suture applications for use with or in conjunction with suture anchors. In exemplary embodiments only, the suture structures 100, 200, 300, 400 can be used in suture applications that do not involve tying knots, for example, with suture anchors (e.g., and / or suture anchors) or for knotless arthroscopic suture repairs (e.g., knotless single-row rotator cuff repairs or SpeedBridge with knotless and suture-only procedures TM Repair), etc., but the suture application has simplified steps because no nitinol wire or similar structure is required.

[0065] In exemplary embodiments only, one or more structures 100, 200, 300, 400 are used to combine a first tissue portion (e.g., a first soft tissue) with a second tissue portion (e.g., a second soft tissue) in a side-to-side closed repair. The structure first passes through the first tissue portion. The tail (tapered region 25) passes through or around the second tissue portion, and then the shuttle (loader) passes through the locking structure / mechanism / device (e.g., a ring, eyelet, slit, or a combination thereof) by folding the tapered end 25 and shuttling it through the locking structure. The flexible strand 10 (suture 10) is then pulled until it tightens and achieves the desired tension on the closed adjustable loop 55. As the flexible strand 10 is tightened, the enlarged portion 65, 165 (thicker) of the construction 100, 200, 300, 400 is pulled into the locking mechanism (loop 11, 15, 166, 103, 104) and locks the enlarged portion 55, 155, 255, 355 to the inner surface of the loop 11, 15, 166, 103, 104 (locked to the flexible strand 10) to prevent the outer strand 10 from backing out. In an exemplary embodiment, the enlarged portion is a plurality of ridges / ridges / barbs / bumps that engage and lock the suture 10 under tension. The outer strand can be a standard braided suture that is tapered and has three different widths throughout its length. The outer strand can be flexible. The outer strand 10 can be flexible before and after the inner core 50 with the enlarged portion 55, 155, 255, 355 is disposed within the outer strand 10. The inner strand 50 can be rigid or flexible.

[0066] Fig.19 A schematic diagram of a surgical site undergoing a method of fixing soft tissue to bone (or fixing soft tissue to soft tissue) according to the method of the present disclosure is shown. In an exemplary embodiment only, the surgical site is a shoulder, and the tissue is a labrum 90 to be attached to a glenoid 80 using an exemplary surgical construct 100. Although the following embodiments will be described with reference to the exemplary construct 100 for simplicity, the present disclosure has applicability to any surgical construct 100, 200, 300, 400 (used alone or in any number, and also in any combination of these surgical constructs).

[0067] Fixing soft tissue to bone (such as fixing the labrum to the glenoid) typically involves making an incision to access the surgical site and then reattaching the soft tissue. When the soft tissue is attached to the bone, the surgeon drills a cavity in the bone and inserts a fixation device (such as a bone anchor). Typically, the bone anchor is formed of metal, composite material, plastic, or bioabsorbable material and is held in place by threads or barbs. If an anchor is used, the anchor typically includes an eyelet through which the structure 100 is then threaded / passed.

[0068] In forming the band suture ( Fig.19) and locking the configuration of the inner surface area of ​​the penetrating ring 11 with the enlarged portion 55, 155, 255, 355, by passing the tapered end region 25 through the eyelet of the anchor (not shown) and then securing the knotless fixation device 70 in the bone with the suture configuration 100, one or more fixation devices (such as Fig.19 The suture structure 100 is fixed to the bone 80 by one or more suture anchors such as the anchor 70 of FIG. 1 , thereby obtaining the final repair part 600 ( Fig.19 ).

[0069] The flexible strands may also be secured by using any number of knotless or other fixation devices, such as two fixation devices, such as two knotless fixation devices 70 with two eyelets (instead of one fixation device). This technique may be repeated multiple times at different locations in the bone (i.e., multiple banding sutures at different locations around the labrum).

[0070] A method of fixing a first tissue to a second tissue with a suture structure 100, 200, 300, 400, including, inter alia, the steps of: (i) passing a suture structure 100, 200, 300, 400 through or around a first tissue, the suture structure including an outer strand 10 containing an inner strand 50 having a plurality of enlargements 55, 155, 255, 355; and (ii) locking the suture structure by forming a band around the tissue and locking at least one enlargement 55, 155, 255, 355 to the inner surface of a locking structure 11, 15, 166, 103, 104. The method may further include the steps of: (iii) attaching the suture structure 100, 200, 300, 400 to a knotless fixation device 70; and (iv) placing the knotless fixation device 70 with the attached suture structure 100, 200, 300, 400 into the second tissue. The method may further include the step of: (v) threading the tapered end 25 of the suture construct 100, 200, 300, 400 through the eyelet of the knotless fixation device. The eyelet may be closed (closed opening) or open (ie, bifurcated opening).

[0071] A method of securing a first tissue to a second tissue using a suture structure 100, 200, 300, 400, particularly comprising the steps of: (i) passing a suture structure 100, 200, 300, 400 through or around a first tissue, the suture structure comprising: a length of outer strand 10 having a first end and a second end; a locking structure 11, 15, 166, 103, 104 formed at the first end; a tapered region 25 formed at the second end; a joint / enlarged region 65, 165 located between the first end and the locking structure 11, 15, 166, 103, 104; and (ii) passing a suture structure 100, 200, 300, 400 through or around a first tissue. 03, 104, wherein the enlarged area (or the area adjacent to the locking structure 11, 15, 166, 103, 104) includes a plurality of enlarged portions that prevent the outer strand 10 from retreating; and a shuttling device 60 having a shuttling ring 61 attached to the outer strand 10; (ii) passing the tapered end 25 of the flexible strand through the shuttling ring 61; and (iii) pulling the shuttling device to allow the flexible strand to form a tightening loop 99 around the tissue 80, 90 and lock the enlarged portions 55, 155, 255, 355 to the inner surface of the locking structure 11, 15, 166, 103, 104. The method may further include the following steps: (iv) attaching the suture structure 100, 200, 300, 400 to the knotless fixation device 70 by threading the tapered end 25 of the suture structure 100, 200, 300, 400 through the eyelet of the knotless fixation device; and (v) placing the knotless fixation device 70 together with the attached suture structure 100, 200, 300, 400 into a second tissue.

[0072] The suture constructions 100, 200, 300, 400 may be used in surgical procedures, such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, etc. Although the present invention has been described with reference to a specific application (i.e., securing the labrum to the glenoid in a shoulder repair), it must be understood that the suture constructions of the present invention are suitable for use in any type of repair (any repair other than a shoulder repair), and therefore, the present invention is not limited to such merely exemplary embodiments.

[0073] In an exemplary embodiment only, the fixation device 70 is a knotless suture anchor, such as the two-piece Arthrex® disclosed in US Pat. No. 7,329,272. Anchors, or Arthrex as disclosed in US8,012,174 issued on September 6, 2011, US9,005,246 issued on April 14, 2015, and US2013 / 0296936 published on November 7, 2013 Anchors, the disclosures of all of these patents are incorporated herein by reference in their entirety.

[0074] Suture structures 100, 200, 300, 400 may also be used with knotted fixation devices, such as knotted anchors. Thus, the present disclosure is not limited to using suture structures 100, 200, 300, 400 with knotless fixation devices, such as fixation device 70, and the present disclosure contemplates using suture structures 100, 200, 300, 400 with any type of fixation device (knotless or knotted, or a combination of knotless and knotted fixation devices). Exemplary structures of the present disclosure may be used in various tissue repairs, such as using SpeedBridge TM and SpeedFix TM Knotless rotator cuff repair of repair techniques, or similar soft tissue to bone reattachment techniques in arthroscopic rotator cuff repair (using knotless fixation devices to form single-row, double-row or multi-row configurations), or demanding applications such as AC joint reconstruction and other areas where tissue retraction may be considered.

[0075] The strands 10, 50 may be made of any known suture construction, such as multifilament, braided, knitted, woven suture, or fibers including ultra-high molecular weight polyethylene (UHMWPE) or Suture (disclosed in US 6,716,234, the disclosure of which is incorporated herein by reference in its entirety). The suture is formed from an advanced high strength fiber material, namely ultra high molecular weight polyethylene (UHMWPE), tradenamed Spectra (Honeywell) and Dyneema (DSM), which is woven with at least one other natural or synthetic fiber to form a certain length of suture material. The suture comprises a core of twisted yarns of UHMWPE within a hollow braided structure. The strands 10, 50 may also be formed from suture tape, such as Arthrex This is a high strength suture tape that is braided and rectangular in cross-section and as disclosed in US 7,892,256, the disclosure of which is incorporated herein by reference in its entirety.The surgical constructs 100, 200, 300, 400 may be used with any type of flexible material or suture known in the art.

[0076] Depending on the intended application, the strands may also be formed of a rigid material or a combination of rigid and flexible materials. The strands may also be painted and / or arranged in different colors. The strands may also be provided with colored tracer strands, or may be arranged to visually contrast with the remaining elements of the construction in other ways, for example, this may be a solid color, a solid color, or display different tracer patterns. The various structural elements of the surgical constructions 100, 200, 300, 400 may be visually coded to make identification and handling of the suture legs simpler. In surgery, particularly during arthroscopic (such as endoscopic and laparoscopic) surgery, easy identification of sutures is particularly advantageous.

[0077] The surgical structures 100, 200, 300, 400 may include surgical sutures or similar materials, for example, surgical sutures or similar materials may be coated (partially or fully) with wax (beeswax, petroleum wax, polyethylene wax, or other), silicone (Dow Corning Silicone Fluid 202A or other), silicone rubber (Nusil Med 2245, Nusil Med 2174 with adhesion catalyst, or other), PTFE (Teflon, Hostaflon, or other), PBA (polybutyrate), ethyl cellulose (Filodel), or other coatings to improve the lubricity, knot security, softness, maneuverability, or wear resistance of the suture or band.

[0078] Preferably, the elongated tapered end portion 25 may have a very fine end, for example, which is coated, impregnated or hardened with a material such as plastic.

[0079] The disclosed suture construction has a centerline strand of cored suture with fixed "spinous processes" at defined intervals, similar to a bathroom drain chain. Preferably, the spinous processes / enlargements are asymmetrical, with the tapered ends facing the band. After the working distance length is appropriately defined, the suture will be attached to the cored Same, then tapers to a smaller To facilitate loading into the cinch mechanism.

[0080] The suture constructions 100, 200, 300, 400 of the present disclosure discussed above may be used alone, as described above, and may also be used with various soft and / or hard anchor devices to form suture anchor assemblies 111, 112, 113, 114, 115, 116, 117 described in detail below.

[0081] For example, Fig. 20 Suture anchor assembly 111 is shown having a fixation device or anchor 71 and an exemplary suture construct 100 coupled to the anchor body by a locking ring 100a. Locking ring 100a is located on top of anchor 71 but secured to the anchor body by a static knot 72, for example.

[0082] Fig.21 A suture anchor assembly 112 is shown that includes a fixation device or anchor 71 and an exemplary suture construct 100 coupled to the anchor body. The suture construct 100 extends within the body of the anchor 71 and around a post 73 or similar structure located at the distal end of the anchor body. When the uneven suture 100 is pulled in (by pulling in a tightening direction such as the direction of arrow "A1"), the suture construct 100 is pulled inwardly. Fig.21 )), the uneven suture is locked in / inside the anchor body. The anchor 71 can be pre-placed into a bone hole or opening.

[0083] Fig. 22 A suture anchor assembly 113 is shown that includes a fixation device 75 in the form of a button 75 and an exemplary suture construct 100 coupled to the button 75. The button 75 is shown as having two through holes or apertures 75a that, together with the enlarged portion 55 of the construct 100, can securely lock the suture construct 100; however, the present disclosure contemplates any device / button having any shape / construction (i.e., an oval, circular, elliptical, S-shaped button, etc.) and having any number of openings / apertures that can accommodate at least a portion of the exemplary construct 100.

[0084] Fig.23 An exemplary suture construction 100 is shown, which is coupled to a knotless anchor to form an exemplary suture anchor assembly 114. The jagged suture (suture construction) 100 is captured within the body of the knotless anchor as part of the knotless anchor. The suture construction 100 is securely secured to the anchor body by a static knot 72, and forms a loop 290a and a joint 65 within the body of the anchor. The joint can be formed by employing a shuttle device (such as the shuttle device 60 with loop 61 discussed above). The loop 290a can be a closed, flexible, knotless adjustable loop having an adjustable circumference and partially located within the body of the anchor 71. The joint 65 can be located entirely within the body of the anchor 71. The suture construction 100 can be wrapped around a post 73 (or similar structure) located at the distal end of the knotless anchor body.

[0085] Suture anchor assembly 115 ( Fig.24 ) includes an exemplary suture construct 100 positioned between the anchor body 71 and the bone (ie, positioned on the outer surface of the anchor) to provide enhanced tissue fixation.

[0086] Fig.25 and Fig.26Exemplary suture anchor assemblies 111 and 114 are shown, respectively, for attaching a first tissue 90 to a second tissue 80, such as attaching soft tissue 90 to bone 80. The disclosed suture anchor assemblies 111, 112, 113, 114, 115 provide simplified tissue repair while ensuring secure fixation of the first tissue to the second tissue.

[0087] An exemplary suture anchor assembly 111 formed of an anchor 71 preloaded with a suture construction 100 (rough suture 100) is installed in a pre-drilled hole / socket / opening 82 formed in a bone 80. Insertion of the anchor 71 into the bone preferably forms a tight fit to anchor the suture construction 100 therein. Once the suture anchor assembly 111 is installed into the bone hole 82, the tissue fixation end 100b of the suture construction 100 remains outside the bone hole 82. The tissue fixation end 100b passes through the soft tissue 90 and the loop 100a, and is then tightened in the tightening direction A1 ( Fig.25 ) is pulled away from the bone 80, thereby allowing the enlarged portion 55, 155, 255, 355 to lock the device in place and prevent the strands 10 / 50 of the suture structure 100 from moving in the opposite direction (i.e., in the loosening direction) and forming the final repair portion 190.

[0088] Fig.26 The final repair 290 is shown in which the suture anchor assembly 114 is installed in the bone hole 82, wherein the tissue fixation end 100b of the suture construct 100 is retained outside the bone hole 82 and forms a closed, knotless, flexible, adjustable loop 290a around the tissue 90. The closed, knotless, adjustable loop 290a is locked in place by the enlarged portion 55, 155, 255, 355, which prevents the suture end from moving in the opposite direction of A1 (i.e., in the direction opposite to the tightening direction A1).

[0089] The suture constructions 100, 200, 300, 400 of the present disclosure described above may be used alone and / or with an anchor having a hard body (as described above), and may also be used with a soft anchor to form the suture constructions described below. Fig. 27 An exemplary soft anchor assembly 116 is described in detail.

[0090] Fig. 27A soft suture anchor 40 preloaded with a suture structure 100 is shown. The soft suture anchor 40 is a soft anchor that may include a tubular sheath, such as disclosed in U.S. Pat. No. 9,463,011 to Dreyfuss et al., the entire disclosure of which is incorporated herein by reference in its entirety. The tubular sheath 40 may be formed of a flexible material such as suture or polyester, and may be a woven, braided or knitted structure, and / or may be formed of yarn, fiber, silk, suture, braid or similar material or a combination thereof. The tubular sheath 40 has two opposing open ends through which the suture structure 100 exits. One or both ends of the suture structure 100 may be coupled to various structures, such as a shuttle, another fixing device, a ring, etc., thereby allowing the ends to pass through and / or around soft tissue and secure the soft tissue to bone.

[0091] As detailed in U.S. Pat. No. 9,463,011 to Dreyfuss et al., a tubular sheath preloaded with a suture structure 100 is inserted and secured to the bone, for example, by being inserted and secured to a pre-drilled hole / socket / opening formed in the bone so that the tubular sheath is bunched within the bone hole and thereby securely fixed to a suitable position in the bone hole. To facilitate the insertion and installation of the tubular sheath 40 into the bone, an inserter having a forked end and / or a mallet-like tool may be used.

[0092] Once the tubular sheath 40 is inserted into the bone hole, at least one end of the suture structure 100 passes through / around the soft tissue to allow a closed, knotless, flexible, adjustable loop to be formed around the soft tissue 90 and to allow the engagement of the enlarged portion 55, 155, 255, 355 to lock the device in place and prevent the strands 10 / 50 of the structure 100 from moving in the opposite direction (i.e., in the loosening direction). The enlarged portion 55, 155, 255, 355 can also engage the tubular sheath 40 to lock the final repair portion in place, thereby ensuring that the soft tissue is attached to the bone. The enlarged size of the enlarged portion 55, 155, 255, 355 relative to the strands 10 / 50 prevents the final repair portion from loosening.

[0093] Fig.28 Yet another exemplary suture anchor assembly 117 of the present disclosure is shown. As in the previous embodiments, and for simplicity, the suture anchor assembly 117 is explained with reference to the exemplary configuration 100; however, the present disclosure can be applied to any configuration 100, 200, 300, 400 in any combination and / or by itself / or with other additional fixation devices. As described in detail below, the exemplary anchor assembly 117 includes one or more convex and concave sutures loaded into a pre-placed anchor, which is then tensioned internally and secured with a spline insert.

[0094] Fig.28The suture anchor assembly 117 includes a fixing device or anchor 71a and an exemplary suture construction 100 coupled to the anchor body by a loop 11a. The loop 11a is located within the body of the anchor 71a and at the distal end of the body of the anchor 71a. The loop 11a can be insert molded into the anchor body and / or can be fixed to the anchor body by, for example, a static knot 72a.

[0095] An exemplary suture construction 100 is coupled to the anchor body of the device 71a. The suture construction 100 extends within the body of the anchor 71a and through the loop 11a located at the distal end of the anchor body. Fig.28 As shown, the uneven suture 100 passes through the loop 11a and extends along the first longitudinal channel 74 and the second longitudinal channel 74a located in the anchor body and communicating with each other. The diameter D1 of the first channel 74 is greater than the diameter D2 of the second channel 74a. The first channel 74 and the second channel 74a can extend along the longitudinal axis of the anchor body of the anchor 71 and can be optionally concentrically positioned relative to each other.

[0096] The suture construction 100 of the assembly 117 can be optionally and additionally secured with a locking element, for example, an insert 73 provided with a plurality of arms / legs / forks 73a extending from a threaded body 73b. The body 73b of the insert 73 is designed to matingly engage the distal-most threaded end of the driver 76. The insert 73 can be deployed within the anchor body of the anchor 71. For example, the insert 73 can be provided with deployable or extendable arms / legs / forks 73a, which are in a first, non-deployed or closed state when in a first position, and in a second, deployed or open state when in a second position.

[0097] In an exemplary embodiment only, the insert 73 is provided with arms / legs / forks 73a, which are in a first state (unexpanded or closed) in a first position and when inserted through the second passage 74a, and in a second state (expanded or open) in a second position and when inserted into the first passage 74. When in the expanded position, the arms / legs / forks 73a are completely located within the first passage 74 and exert lateral pressure on the longitudinal inner wall of the first passage 74 and on the portion of the uneven suture 100 located within the first passage 74. The body 73b of the insert 73 has an outer diameter approximately equal to the diameter D2 of the second passage 74a. When in the expanded state, the maximum outer diameter of the arms / legs / forks 73a is approximately equal to the diameter D1 of the first passage 74. In this way, the insert 73 internally secures and locks the suture construction 100 in place, i.e., the uneven suture is locked in / within the anchor body. The enlarged portion 55, 155, 255, 355 is locked in place by the insert 73 (i.e., locked between the inner wall of the first channel 74 and the arm / leg / fork 73a of the insert 73) and prevents the final repair portion from loosening. The anchor 71 can be pre-placed into the bone hole or opening. In this exemplary embodiment, the suture structure 100 is fixed and fixed / locked to the anchor 71 by the ring 11a and the insert 73.

[0098] The term "high-strength suture" is defined as any elongated flexible member, the choice of material and size depending on the specific application. For illustrative and non-limiting purposes, the term "suture" as used herein can be a rope, silk, thread, wire, fabric or any other flexible member suitable for tissue fixation in vivo.

Claims

1. A suture structure comprising: a coreless suture terminating in a first end and a second end opposite the first end, wherein the second end is a tapered end portion; An inner wire having a plurality of enlarged portions, wherein the plurality of enlarged portions form a series of ridges along the inner wire, wherein each of the plurality of enlarged portions has an outer diameter greater than an outer diameter of the coreless suture, so that when the inner wire having the plurality of enlarged portions is inserted into the coreless suture, the inner wire and the plurality of enlarged portions between the first end and the second end of the coreless suture are completely covered by the coreless suture and form an uneven structure; and A locking mechanism at the first end, wherein the locking mechanism of the coreless suture is a closed loop.

2. The suture structure according to claim 1, wherein: The plurality of enlarged portions do not penetrate an outer surface of the coreless suture.

3. The suture structure according to claim 1, wherein: The plurality of enlarged portions are barbs, knots, beads, knobs or combinations thereof.

4. The suture structure according to claim 1, wherein: The plurality of enlargements allow for locking of the suture structure.

5. The suture structure according to claim 1, wherein: Each of the plurality of enlarged portions has an outer diameter greater than an outer diameter of the inner wire.

6. The suture structure according to claim 1, wherein: Each of the plurality of enlarged portions has an outer diameter that is greater than an outer diameter of the coreless suture.

7. The suture structure according to claim 1, wherein: The coreless suture is a coreless braid or sheath formed from twisted yarns of ultra-high molecular weight polyethylene braided together.

8. The suture structure according to claim 1, wherein: The coreless suture is a coreless braid or sheath formed of polyester yarn.

9. The suture structure according to claim 1, wherein: The closed loop is formed by splicing the first end through the coreless suture to form a joint and a closed loop.

10. The suture structure according to claim 1, wherein: The closed loop is a rail frame hanging ring.

11. The suturing construction of claim 1 further comprising a shuttling device attached to the closed loop.

12. The suture structure according to claim 11, wherein: The shuttling device is a nitinol ring.

13. The suture structure according to claim 1, wherein: The tapered end portion has three different widths.

14. The suture construction of claim 1, further comprising a coating disposed on the coreless suture.

15. The suture construction according to claim 14, wherein: The coating is a silica gel or collagen coating.

16. The suture construction according to claim 1, wherein: The coreless suture is passed through at least one eyelet of the knotless fastening device.

17. The suture construction according to claim 16, wherein: The knotless fixing device is a rotating anchor or a push-lock anchor.

18. The suture construction according to claim 16, wherein: The knotless fixation device includes an anchor body and an anchor tip rotatably attached to the anchor body, and wherein the anchor body is configured to be inserted over the anchor tip to secure the fixation device into bone.

19. The suture construction according to claim 18, wherein: The anchor body is a sleeve interference screw.

20. The suture construction of claim 1, wherein: The coreless suture is coupled to the anchor body.

21. The suture construction according to claim 20, wherein: The anchor body is soft.

22. The suture construction of claim 20, wherein: The anchor body is hard.

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