Suture structure and method of tissue fixation

Abstract

A knotless structure and a method of tissue repair are disclosed in this document. The suture loop can be formed of a suture having a hollow core. The suture loop can be folded into an "S", "U", or "W" configuration. The suture loop can be loaded with a tension adjustable mechanism to assist in knotless tension adjustable tissue repair.

Description

Background Art

[0001] The present disclosure herein relates to surgical constructs, and more particularly, to knotless suture constructs and related methods of tissue repair.

Summary of the Invention

Means for Solving the Problems

[0002] Knotless constructs, surgical systems, assemblies, and methods of tissue repair are disclosed. The construct can create a knotless repair. In one embodiment, the construct described herein can be self-locking. The soft tissue repair system includes a tension adjustable construct having a fixation device in the form of a suture loop pre-loaded with a flexible connector, and a shuttle / pull device attached to the flexible connector. The construct can include a plurality of interconnected adjustable loops. The flexible connector can be a tape such as a suture tape. The suture loop can be flexible. The suture loop can be formed of a suture thread having a hollow core. The suture loop can include a braided strand of suture thread and at least one radiopaque agent. The suture loop can include a braided suture thread of ultra-high molecular weight polyethylene and polyester. The suture loop can consist essentially of an ultra-high molecular weight polyethylene suture thread and bismuth trioxide.

[0003] A method of tissue repair is also disclosed. A first tissue is brought close to a second tissue with a knotless surgical construct that includes at least one tension adjustable construct having a mechanism. One of the two free ends of a flexible connector (suture thread or tape) is passed through the body of the fixation device (a folded flexible soft suture loop) at different positions. The two ends of the flexible connector are spliced and interconnected to form an adjustable closed tension adjustable flexible loop. The ends can be pulled to apply tension to the construct and lock it.

Brief Description of the Drawings

[0004]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

[0005] The present disclosure provides a surgical adjustable loop structure, suture loop mechanism, and method for fixing a first tissue to a second tissue (e.g., soft tissue to bone or bone to bone) using a tension adjustable structure that includes an adjustable knot-free flexible closed loop.

[0006] The surgical structure can be a suture having a hollow core and having a picks per inch (ppi) of 52 or less. The suture can have 40 ppi or less. The suture can have 25 ppi or less. The suture can have 15-20 ppi. The suture can have 18 ppi. The suture can have 32 gauge or less.

[0007] In one embodiment, the suture structure has 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, or 15 ppi. In one embodiment, the suture structure is an enclosed loop configured to be folded into an "S", "U", or "W" configuration. Embodiments of the suture structure can be attached to another suture structure (e.g., a TightRope® structure) using a tissue graft. The suture structures described herein can fix the structure to bone, where the "S", "U", or "W" configuration is in the same plane on the surface of the bone and is relatively low profile. Such suture structures seated on the bone completely seal the bone tunnel and lock in biologics. Thus, the suture structures described herein used as fixation devices on the surface of the bone can lead to faster healing. Such suture structures can be used in place of metal buttons, thereby being safer and more biomimetic for use with MRI.

[0008] In one embodiment, the present disclosure provides a suture structure. The orthopedic implant structure is utilized for attachment or reattachment of normal anatomical structures, tissue to tissue, bone to bone, and / or bone to soft tissue. The structure can be composed of a single continuous flexible connector in the form of a suture attached to a suture loop, round, and / or flat suture. The flexible connector forms a continuous flexible closed adjustable loop having an adjustable perimeter without a plurality of knots. The ends of the flexible connector exit the suture loop. The structure can contract when both ends are pulled. When the ends are pulled, the structure contracts, i.e., the perimeter of the continuous flexible closed adjustable loop without knots decreases. The tension adjustable structure enables a user (e.g., a surgeon) to control the tension of the flexible connector applied to a first tissue (e.g., soft tissue) and attach it to a second tissue (e.g., bone).

[0009] A soft tissue repair system includes a fixation device in the form of a soft, flexible suture button, a flexible connector having two flexible ends (a first end and a second end), the first end forming a first splice and loop, a suture passer attached to the loop, and a shuttle / pull device attached to the second end of the flexible connector. A plurality of interconnected, adjustable and continuous flexible loops are formed by passing the suture passer through the fixation device such that the first end of the flexible connector exits the fixation device, passing the second end of the flexible connector through the loop at the first end and then through a small hole in the shuttle / pull device, pulling on the shuttle / pull device to pass the second end through the flexible connector to form a second splice, centering the fixation device with respect to the first and second splices, and pulling on the first and second ends to apply tension to and lock the structure. The flexible connector can be a suture or a suture tape. The suture button can be a transplantable suture button or a cortical suture button. The suture button can be formed of a suture having a hollow core with a ppi of 52 or less and a gauge of 32 or less. The suture button can include braided strands of suture having one or more radiopaque agents. The suture button can include braided suture of ultrahigh molecular weight polyethylene and polyester. The suture button can consist essentially of ultrahigh molecular weight polyethylene suture and a radiopaque material such as bismuth trioxide and barium sulfate.

[0010] The flexible connector forms a plurality of closed, knot - free, continuous and adjustable flexible loops with an adjustable perimeter, and the loops are located between the loop interconnections and the two ends. The suture loops are provided at the ends and are provided adjacent to each flexible loop that is closed, knot - free, continuous and adjustable. The structure can be knot - free. Using the structure, by employing a mechanism, a normal anatomical structure, i.e., a first tissue, can be re - attached to a second tissue such as soft tissue, tendon, ligament, and / or bone, to each other, and / or to any combination of each other. The flexible connector can be a suture and / or a tape. The structure can be used as a stand - alone structure or, for example, together with additional fixation devices attached to additional implants, anchors, screws, plates, buttons (such as metal buttons or another suture loop), etc.

[0011] A suture button structure for knot - free repair is disclosed. The suture structure includes a flexible connector of either a round or flat design passing through a folded suture loop. The flexible connector passes through the folded suture loop and then through itself to create two interconnected, flexible, continuous and adjustable knot - free closed suture loops with an adjustable perimeter. The suture loop can be fixed to tissue. By applying tension to the ends of the flexible connector, the loop that brings the suture loop and the tendon / ligament and / or soft tissue together can be contracted / closed while locking the structure in place. The suture loop can include braided strands of suture material having one or more radiopaque agents. The suture loop can include braided suture of ultra - high - molecular - weight polyethylene and polyester. The suture loop can consist essentially of ultra - high - molecular - weight polyethylene suture and bismuth trioxide. The suture loop can have a hollow core and be formed of suture having a ppi of 52 or less. The suture loop can be formed of a hollow core and suture of size 32 gauge or less.

[0012] Referring now to the drawings, where like elements are indicated by like reference numerals, FIGS. 1-21 show the structural elements of surgical assemblies 100, 200, 300 (surgical structures 100, 200, 300, structures 100, 200, 300, knotless structures 100, 200, 300, knotless flexible button structures 100, 200, 300) formed from tension adjustable structures 20, 30, 40 attached to a fixation device 10.

[0013] The fixation device 10 (suture ring 10, loop of suture 10, FiberRing™ suture 10, FiberRing™ 10, ring 10, suture button 10, folded suture ring 10, anchor 10, soft anchor 10, implant 10, flexible button 10) is shown in FIGS. 1-9.

[0014] The fixation device 10 is a soft, flexible suture button in the form of a ring. In one embodiment, the fixation device 10 is a ring formed essentially from suture. In one embodiment, the fixation device 10 is formed from a hollow core and a suture having 52 picks or less per inch within the enclosed ring. The suture can have 40 ppi or less. The suture can have 25 ppi or less. The suture can have 15-20 ppi. The suture can have 18 ppi. The suture can have 32 gauge or less. In one embodiment, the suture structure has 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, or 15 ppi. In one embodiment, the suture structure is an enclosed ring configured to be folded into an "S", "U", or "W" configuration.

[0015] In one embodiment, the fixation device 10 is a loop formed of braided suture. In one embodiment, the fixation device 10 is a loop formed of a braided suture strand and at least one radiopaque agent. In one embodiment, the braided suture may include fibers of ultra-high molecular weight polyethylene (UHMWPE) braided with polyester. UHMWPE is easy to splice and pierce, allowing the structure to deform and remain in the deformed shape. Even at high PPI, it has minimal rubbing and snagging and a low coefficient of friction. Polyester is difficult to splice without fraying the suture, allows the structure to retain its initial form, and is difficult to pierce and pass a TightRope (registered trademark) suture without fraying or snagging, and has a high coefficient of friction.

[0016] In one embodiment, the fixation device 10 is a full suture loop braided from fibers of UHMWPE having a radiopaque material. In one embodiment, the radiopaque material can be bismuth trioxide, barium sulfate, iodine, nickel, nitinol, and combinations thereof. Optimizing the fiber size, braiding density, and loop length can create a low-profile button with performance equivalent to that of a metallic counterpart. In one embodiment, the concentration of the sample is about a 50% mixture, but the optimal amount of UHMWPE containing bismuth trioxide depends on the visualization and placement of the anchor in the body. In one embodiment, the fixation device 10 may include braided sutures of ultra-high molecular weight polyethylene and polyester. In one embodiment, essentially, the fixation device 10 can consist of ultra-high molecular weight polyethylene suture and bismuth trioxide. In one embodiment, the fixation device 10 can consist of ultra-high molecular weight polyethylene suture and bismuth trioxide.

[0017] Referring now to FIGS. 3-5, the fixation device 10 can be any device that allows a flexible connector to pass therethrough (e.g., through a plurality of positions formed within and / or along the body of the fixation device), forming at least one flexible adjustable loop. In an exemplary embodiment, the fixation device 10 is a suture loop 10 having an S-shaped configuration that allows passage of the flexible connector 11 (as well as any formation of loops and interconnections). The fixation device 10 (suture loop 10) can be folded into three sections to achieve an exemplary "S" configuration and secure it to the suture passageway. The fixation device 10 can be penetrated by the flexible connector 11 at various angles and / or positions relative to the longitudinal axis 10a of the loop to achieve the exemplary configurations of FIGS. 3-5.

[0018] FIGS. 7 and 8 schematically illustrate a method of forming the loop 10 of the suture 8. The loop 10 can be created from a loop 9 of the suture 8, which is folded and then punctured to create a complex structure with a configurable packing factor. The suture 8 can be marked at five positions: splice point 1, splice point 2, splice point 3, splice point 4, and splice point 5. Pass-through tails 1 and 2 are provided on each side of the suture 8 to assist in forming the loop 10. The method of forming the loop 10 can include inserting pass-through tail 1 into splice point 4 on side A, directing pass-through tail 1 towards splice point 3, exiting pass-through tail 1 at splice point 3 on side B, inserting pass-through tail 2 into splice point 3 on side B, directing pass-through tail 2 towards splice point 3, and exiting pass-through tail 2 at splice point 3 on side B. The method can further include folding the loop 10 into three sections to form an "S", "U", or "W" configuration. The loop 10 has opposing splices that allow tightening and locking as pass-through tails 1 and 2 are pulled.

[0019] Referring now to FIGS. 9 - 19, which show the suture loop 10 used with additional elements for forming assemblies 100, 200, 300. The additional adjacent elements can be in the form of a tension - adjustable structure. The additional elements can include TightRope® devices for passage, FiberWire® and TigerWire® suture threads, and FiberTape® suture threads for InternalBrace® fixation of bone - to - bone or soft - tissue - to - bone, and are intended to serve as fixation posts, distribution bridges, or to distribute suture tension across a ligament or tendon repair area.

[0020] FIGS. 9 - 12 show exemplary steps of assembling the fixation device 10 (suture loop 10) with a tension - adjustable structure 20 to form an assembly 100 (FIG. 12). The tension - adjustable structure 20 can be an exemplary TightRope® structure. The assembly process can be started by passing the tension - adjustable structure 20 attached to a suture passer 12 through the suture loop 10. The suture passer 12 can be, for example, a needle having a passage loop such as a nitinol loop, or any similar suture - threading device. FIG. 9 shows the unassembled fixation device 10 and tension - adjustable structure 20. FIGS. 10 - 12 show the assembled fixation device 10 and tension - adjustable structure 20.

[0021] The tension-adjustable structure 20 can be formed from one continuous flexible connector 22 (connector 22, flexible material 22, flexible strand 22, flexible tape) in the form of either a round and / or flat suture (e.g., suture tape). The flexible connector 22 comprises two ends, a first end 21 and a second end 23. One of the two ends 21, 23 (e.g., the first end 21) is spliced at a first splice 55a to form a first suture loop 50a. The other of the two ends 21, 23 (e.g., the second end 23) has a shuttle / pull device 40 spliced thereon at a second splice 55b. An exemplary shuttle / pull device 40 can be in the form of a suture passer or suture threader such as FiberLink™ 40 or Nitinol loop 40. The suture passing device 40 includes a hole / loop 43 for passing the flexible connector 22 therethrough.

[0022] FIG. 10 shows a tension-adjustable structure 20 passing through the body 11 of the fixing device 10 with the suture passer 12 removed from the first suture loop 50a. The suture passer 12 can be removed when the loop 50a passes distally (far side) of the fixing device 10.

[0023] FIG. 11 shows the loading of the long free tail 23 (second end 23) of the flexible coupler 22 through the open loop 50a. Next, the long free end 23 passes through the small hole 43 of the shuttle / pull device 40. The shuttle / pull device 40 is withdrawn from the flexible coupler 22 and pulls the long end 23 through the second splice region 55b to form the second loop 50b. Then, the fixing device 10 (FiberRing™ 10) can be opened by pulling at the center, and the splices 55a, 55b and the tails 21, 23 gather at the center (FIG. 12). The ring 10 is closed by pushing the ends of the ring together. The splices 55a, 55b are locking splices. The length of each locking splice 55a, 55b can be variable (at least about 3 mm up to the length of the ring 10). The distance between the splices 55a, 55b can be variable, for example, between about 0 mm and about 3 mm. The terminations of the splices 55a, 55b can be present within the inner lumen or can exit the lumen (hollow core). Further, instead of a double locking splice, a stationary knot can be formed and the tails can be pushed into the corresponding lumens.

[0024] As shown in FIG. 12, loops 50a, 50b are formed by flexible coupler 22 and are thus connected by an interconnect 59 (loop interconnect 59 or intertwined region 59) that forms another flexible loop 50. At least two loops 50, 50a, 50b are flexible, closed, knotless, continuous adjustable loops, each having an adjustable perimeter. Interconnect 59 is located at one end of assembly 100 while fixture 10 (FiberRing™ 10) is located at the other end of assembly 100 (e.g., the end opposite one end). Surgical assembly 100 is a tension adjustable structure that can contract when both terminations 21, 23 are pulled to reduce the perimeter of at least one of the flexible, closed, knotless adjustable loops 50, 50a, 50b. Additional flexible strands can be attached to assembly 100 by passing the flexible strands through any of loops 50, 50a, 50b, 9. The additional strands can be, among other things, FiberWire® suture, TigerWire® suture, FiberTape® suture tape.

[0025] Assembly 100 can be used by itself or in conjunction with additional structures and / or fixtures, such as additional flexible couplers, anchors, implants, and / or buttons, to form additional surgical structures. For example, FIG. 13 shows an assembly 200 that includes an assembly 100 having an additional flexible coupler 30 in the form of a FiberTape® suture tape for an InternalBrace™ procedure. Assembly 200 also includes two passing sutures 28, 29 (passing tails 28 and passing tail 29).

[0026] FIGS. 14 and 15 show an assembly 300 having a fixture 10 (folded anchor structure 10) with a suture 330 in the form of a FiberTape® suture tape 330 for an InternalBrace™ procedure.

[0027] Figures 16 - 19 show additional views of the assembly 100 of FIG. 12. FIG. 16 shows a direct side view of the implant 100 with tension applied over a bone hole (e.g., a 3.5 mm hole), showing the leg of the button structure moving over the top of the tension hole. FIG. 17 is an angled isometric view detailing the control of deformation after releasing the tension from the passing blue and white sutures. FIG. 18 is a top view detailing the "S" configuration before loading the TightRope® structure and pulling the leg under the upper strand of the button. FIG. 19 is a top - down, angled view detailing the removal of one of the passing sutures (the passing suture 28) to show the position L where the InternalBrace 30 (flexible connector 30) can be routed.

[0028] The assemblies 100, 200, 300 of FIGS. 1 - 19 are adjustable loop structures. The fixation device 10 of the assemblies 100, 200, 300 may be in the form of a suture button / loop structure in the form of an orthopedic implant structure, which can be used, inter alia, to attach or re - attach a first tissue to a second tissue, for example, normal anatomical structures, bone - to - bone, tissue - to - tissue, and / or bone - to - tissue.

[0029] FIG. 20 shows an exemplary method of tissue repair using the surgical structure of the present disclosure. An exemplary assembly 100 (surgical structure 100) having a fixation device 10 (FiberRing™ 10) and a tension - adjustable structure 20 is used for an exemplary ACL reconstruction. An exemplary graft 70 is looped over the interconnect 59. The graft 70 can be, for example, an ACL or PCL graft. The surgical structure 100 attaches a first tissue (e.g., the graft 70) to a second tissue (e.g., the femur 80). The surgical structure 100 extends into a femoral tunnel 83 formed within the femur 80, allowing the graft 70 to pass through the loop 50 of the structure and the over - loop interconnect 59 and be further fixed within a tibial tunnel or socket formed within the tibia. The fixation device 10 (FiberRing™ 10) can pass through the femoral tunnel 83, exit the femoral cortex, and remain thereon.

[0030] The femoral socket 83 of the femur 80 can be drilled tibially, or through the medial portal, or by a retrograde technique. The femoral socket 83 is drilled into the femur 80 to a depth approximately equal to the amount of the desired graft in the femoral socket. After creating a tibial tunnel in the tibia (not shown), the fixation device 10 (FiberRing™ 10) of the assembly 100 is pulled through the femur 80 until it exits the outer cortex and achieves fixation. The graft advances and tension is applied to the termini 21, 23. The termini can form a knot and / or can be cut with a cutting instrument such as an arthroscopic cutter. This technique proceeds with tibial fixation with another fixation device of another assembly 100, for example, an interference screw or another fixation device 10 (second FiberRing™ 10). The assembly 100 can also be used for all-inside ACL reconstruction. The adjustability of the implant simplifies graft length determination and allows tension to be applied to the graft from the femoral side.

[0031] The flexible loop (tension-adjustable structure 100) of the assembly 100 is adjustable under tension when the surgeon simply pulls on both termini of the final structure 100 to adjust the length of the flexible loop and thus tighten the structure. The fixation device 10 (FiberRing™ 10) can be withdrawn from the cortical bone using a passing suture (discarded later) and can be inverted onto the cortex as soon as it exits.

[0032] The ACL reconstruction detailed above provides adjustable cortical fixation for cruciate ligament reconstruction in a self-locking manner. The self-locking mechanism of the knotless structure 100 resists cyclic displacement and provides a maximum load equal to that of a closed-loop device. The present disclosure eliminates the need for metal fixation devices and facilitates complete graft filling of the bone tunnel opening closure common to anatomical ACL drilling.

[0033] The above-mentioned ACL reconstruction structure preferably includes a suture tape such as an ACL TapeRope. The device is used to reattach soft tissue to bone, bone to bone, and ligaments and / or tendons to bone. As detailed above, the device includes a flat tape (suture tape) passing through a flexible suture button. One continuous loop is passed through the suture button and woven back through itself to create a self-locking adjustable loop structure. The device can be assembled, disassembled, and provided with or without additional fixation devices and flexible connectors to facilitate the passage of bone plugs and / or to pass through before button attachment.

[0034] The fixation device 10 in the form of a flexible ring can be folded and compressed from a first configuration (round or unfolded configuration) to a second configuration (S-shaped or folded configuration), but the S-shaped configuration, which is only exemplary, is a non-limiting example, and it should be understood that the fixation device 10 can be folded / changed into a structure having other shapes and configurations. To maximize the amount of suture material that fits into the small space above the bone opening, the hollow suture ring can be folded to control the dimensions of the folded ring (the folded ring should be small enough to be present above the bone but large enough to avoid passing through the bone opening (hole or tunnel)). Therefore, the ring may also be folded into a "U" configuration or a "W" configuration in addition to the "S" configuration for a significant packing ratio.

[0035] The use of loops in assemblies 100, 200, 300 maintains the passage and reciprocation of sutures typically used in rigid anchor implantation and enables accurate positioning and anchor placement control. Since the prior art shows the use of suture anchors in bone tunnels or bone sockets and soft tissues, the novel suture button 10 can be used for suspension fixation. Fixation at the upper part of the bone can be achieved by a flexible button configuration that resists pulling at the upper part of the rigid hole. The flexible button 10 expands horizontally relative to vertically compared to other button designs. Prior art button designs formed a large "knot" that was palpable under the skin. In contrast, the flexible button of the present disclosure allows for specific adjustment of the height relative to the bone surface.

[0036] Conventional metal, rigid cortical suspension fixation devices are constructed of titanium. The present disclosure utilizes a polymeric flexible braided strand to create a soft, flexible button. By utilizing suture material, deformation of the designed button is possible, resulting in a high degree of control over the strength and clinical performance of the construct. Specifically, the design element that enables such improved anchor placement control is a continuous loop of suture that is then folded and secured to adjacent / additional elements. Further, the material selection of the button 10 allows for the use of a radiopaque agent (i.e., a material having a higher electron density contrast compared to the surrounding material so as to absorb X-ray energy) used as a filler within the polymeric structure, enabling custom adjustment of the contrast and sharpness of the construct under fluoroscopy or X-ray imaging. The advantages of this construct for the patient include the absence of protruding metal hardware left in the body that can cause soft tissue irritation, less scar tissue formation, a lower risk of impingement of the IT band, and more rapid healing enabled by the immediate enclosure of the bone tunnel.

[0037] In one embodiment, the suture button 10 is a soft, flexible all-suture button braided from fibers of UHMWPE having bismuth trioxide. The fiber size, braiding density, and loop length are optimized to create a low-profile button having performance equivalent to that of a metallic counterpart. In one embodiment, the concentration of the sample is about a 50% mixture, although the optimal amount of UHMWPE containing bismuth trioxide depends on the indication and placement of the anchor within the body. In one embodiment, the suture button 10 is formed of a suture having a hollow core, 52 picks per inch or less, and 32 gauge or less.

[0038] The fixation device 10 can be any device that allows a flexible connector to pass through it (e.g., through a plurality of positions formed within and / or along the body of the fixation device) to form a plurality of continuous, knot-free, flexible, adjustable loops. In an exemplary embodiment, the fixation device is a suture loop having an S-shaped configuration that allows passage of the flexible connector (as well as any formation of loops and interconnections).

[0039] The above embodiments have been described with reference to specific ACL reconstruction techniques, but the present disclosure is not limited to this exemplary embodiment. Thus, the present disclosure also contemplates embodiments in which the suture button implant and novel mechanism of the present disclosure are used for additional tissue positioning and / or tissue conditioning applications, for example, in the fixation of bone to bone (such as in small joint applications or acromioclavicular joint fixation techniques) employing two fixation devices (e.g., two flexible suture buttons) joined by a continuous suture loop formed by a continuous flexible connector. In these applications, a second fixation device (e.g., a second suture button) can be used in combination with the first suture button, the flexible connector, and an additional flexible tension-adjustable loop between the two suture buttons to complete a self-locking repair.

[0040] Although only in exemplary embodiments, the fixation device 10 of the assemblies 100, 200, 300 of the present disclosure can be employed in a method of bunion repair and / or a method of Lisfranc repair. Similarly, the fixation device 10 of the assemblies 100, 200, 300 can be used in a method of bone fixation.

[0041] The fixation device 10 of the assemblies 100, 200, 300 can create a knotless self-locking repair. A self-locking suture loop implant is provided for self-locking soft tissue repair, such as self-locking tendon reattachment. Also disclosed is a self-locking device incorporating a locking mechanism (a knotless flexible adjustable continuous non-disruptive tape suture loop locking mechanism) for locking flexible strands, particularly suture tapes. The locking mechanism can be used with any suture tape, i.e., SutureTape, LabralTape, FiberTape® etc.

[0042] Using the self-locking suture loop implant and the self-locking mechanism, soft tissue (tendon) can be attached to bone, such as in shoulder repair or graft fixation in ACL or PCL reconstruction, in a self-locking manner, for example. Thus, the self-locking suture loop implant and the self-locking mechanism can be used in surgical procedures such as, among many others, rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL / PCL reconstruction, hip and shoulder reconstruction procedures, AC joint reconstruction, ligamentous union reconstruction, quadriceps tendon / patellar tendon rupture repair, hallux valgus repair, proximal and / or distal biceps tendon repair, humerus and radius repair, any other tendon repair to bone, etc., all performed in a self-locking manner. Any of the tension adjustable structures 20, 30, 330, the fixation device 10 (FiberRing™ 10), and the surgical assemblies 100, 200, 300 can be used in a method of self-locking repair.

[0043] Surgical assemblies 100, 200, 300 include a fixation device 10 and an unknotted adjustable self-locking tension adjustable structure 20, 30, 330 pre-loaded on the fixation device 10. The tension adjustable structure 20 includes at least one flexible connector 22 having a first end 21 and a second end 23, a loop interconnect 59 between the first end 21 and the second end 23, and first and second closed adjustable continuous flexible loops 50a, 50b. The fixation device 10 is a flexible suture ring having an S configuration adjacent to the first and second closed adjustable continuous flexible loops 50 and adjacent to the first and second ends 21, 23.

[0044] Surgical assembly 100 includes a flexible connector 22 that forms at least two flexible adjustable closed unknotted loops 50a, 50b having an adjustable perimeter through the body of the fixation device 10 in the form of a suture ring 10, a loop interconnect 59, and two terminations 21, 23. The flexible connector 22 may be a suture tape, and the fixation device 10 may be a transplantable ring formed from polyester, e.g., UHMWPE suture braided with bismuth trioxide. The flexible connector 22 can connect a first tissue to a second tissue. The first tissue may be bone 80 and the second tissue may be soft tissue 70. The soft tissue 70 may be attached to the loop interconnect 59 and the bone 80 may be attached to the fixation device 10. The terminations 21, 23 are pulled to reduce the distance between the fixation device 10 and the soft tissue 70 and to reduce the length and perimeter of the flexible adjustable closed unknotted loops 50, 50a, 50b.

[0045] The self-locking tension-adjustable assembly 100 includes a flexible connector 22 having a first end 21 and a second end 23, a loop interconnect 59 between the first end and the second end, first and second closed adjustable and continuous flexible loops 50a, 50b, first and second splice regions 55a, 55b, and a flexible suture loop 10 adjacent to the adjustable and continuous flexible loops 50a, 50b, the first and second splice regions 55a, 55b, and the first and second ends 21, 23. The flexible suture loop, the first and second splice regions, and the first and second ends are located on the end of the structure facing the loop interconnect. The flexible suture loop 10 is located between the first splice region 55a and the second splice region 55b. The flexible connector 22 is a suture, suture tape, or ribbon. The flexible connector 22 is a suture tape having a plurality of sections of different cross-sections and / or tapers. The flexible connector 22 is a suture tape having a round suture and a flat suture tape. The first and second ends 21, 23 lock a tension-adjustable structure when pulled. The tension-adjustable structure 20 can essentially consist of the flexible connector 22. The flexible suture loop 10 can essentially consist of a braided suture loop. The flexible suture loop 10 can essentially consist of a hollow core and suture 8 of 52 picks / inch or less within the enclosed loop, and the flexible loop 10 is configured to be folded into an "S", "U", or "W" configuration. The suture can include 32 gauge or less. The flexible suture loop 10 can include suture strands braided with polyester. The flexible suture loop 10 can essentially consist of UHMWPE suture and bismuth trioxide. The fixing device 10 is a transplantable button, and the flexible connector 22 is a suture tape. Each terminal is configured to be pulled to lock a surgical structure. Each terminal is configured to be pulled to reduce the length and circumference of at least two flexible, continuous, closed, adjustable, knot-free loops 50a, 50b. Tissue repair is rotator cuff repair, AC joint repair, ligamentous repair, Achilles tendon repair, patellar tendon repair, ACL / PCL reconstruction, hip and shoulder reconstruction, AC joint reconstruction, ligamentous reconstruction, quadriceps tendon / patellar tendon rupture repair, or hallux valgus repair.

[0046] The method of tissue repair includes passing a flexible connector 22 through different regions of a flexible suture loop 10 having an S-shaped configuration, passing one of the ends 21, 23 of the flexible connector 22 through the loop 50a of the flexible connector 22 and then through a small hole 43 of a shuttle / pull device 40 attached to the flexible connector 22 to form at least two flexible, knotless, continuous and closed adjustable loops 50, 50a, 50b having an adjustable perimeter and loop interconnect 59, attaching a first tissue 70 to the loop interconnect and / or the flexible connector, fixing a fixing device 10 to a second tissue 80 (e.g., bone 80), and pulling the ends 21, 23 to lock the flexible connector 22.

[0047] A method of forming a knotless self - locking repair involves attaching a flexible connector 22 having a first end 21 and a second end 23 to a fixing device 10 by passing one end 21 of the first end 21 and the second end 23 through a first passing device 12 to the fixing device 10, wherein at this time the other end 23 of the first end 21 and the second end 23 is attached to a second passing device 40, the attaching; passing the other end 23 of the first and second ends 21, 23 through a first loop 50a of the first end 21 and through a small hole 43 of the second passing device 40; pulling out the second passing device 40 from the second end 23 and pulling the second end 23 through the flexible connector 22 to form a plurality of flexible, continuous, adjustable, knotless loops 50, 50a, 50b; and bringing the fixing device 10 towards the center with respect to the first and second ends 21, 23 and with respect to the first and second splice regions 55a, 55b. The flexible, continuous, adjustable, knotless loops 50a, 50b are separated by a loop interconnect 59. At least one of the first passing device 12 and the second passing device 40 is a suturing device. The suturing device can be a needle. The method may further include attaching a first tissue 70 to the flexible connector 22, attaching the fixing device 10 to a second tissue 80, and pulling the first and second ends 21, 23 of the flexible connector 22 to adjust the tension of the first and second flexible, continuous, adjustable, knotless loops 50a, 50b to bring the first tissue 70 closer to the second tissue 80. The first tissue can be soft tissue and the second tissue can be bone.

[0048] A method of forming a loop 10 of a suture 8 involves inserting a passing tail 1 into a splice point 4 on side A, directing the passing tail 1 towards splice point 3, exiting the passing tail 1 at splice point 3 on side B, inserting a passing tail 2 into splice point 3 on side B, directing the passing tail 2 towards splice point 3, and exiting the passing tail 2 at splice point 3 on side B. The method may further include folding the loop 10 into a plurality of sections to form a structure having an "S", "U", or "W" configuration.

[0049] The disclosed structures and surgical assemblies utilize flexible braided strands of polymer to create a soft, flexible suture button 10. By using suture material, the design button can be deformed, providing a high degree of control over the strength and clinical performance of the structure. Specifically, the design element enabling such control is a continuous loop of suture, which is then folded and secured to adjacent elements.

[0050] Furthermore, the button material selection allows for the use of radiopaque agents used as fillers within the polymer structure, enabling custom adjustment of the contrast and sharpness of the structure under fluoroscopy or x-ray imaging. Advantages of this structure for the patient include the absence of protruding metal hardware left in the body that can cause soft tissue irritation, less scar tissue formation, a lower risk of IT band entrapment, and more rapid healing enabled by the immediate enclosure of the bone tunnel.

[0051] The tension-adjustable structures 20, 30, 330 can be formed from a flexible connector that is a flexible material and strand such as a flat suture, ribbon, or flat tape (e.g., a suture tape), or a combination of suture and tape. The flexible strand / connector may have cross-sections of various forms and geometric shapes, including, among other things, circular, elliptical, rectangular, or flat, or combinations of such forms and geometric shapes. Although only in exemplary embodiments, the flexible connector 22 can be a suture such as a braided, knitted, or woven flat suture tape. The flexible connector 22 can be formed of a high-strength suture material such as FiberWire® suture, sold by Arthrex, Inc. (Naples, Florida) and described in U.S. Patent No. 6,716,234, the disclosure of which is incorporated herein by reference. The FiberWire® suture is formed from an advanced high-strength fiber material, namely, ultra-high molecular weight polyethylene (UHMWPE) sold under the trademarks Spectra® (Honeywell International Inc. (Colonial Heights, Virginia)) and Dyneema® (DSM N.V. (Heerlen, the Netherlands)), and braided with at least one other natural or synthetic fiber to form the length of the suture material. The flexible connector 22 can be a braided or multifilament suture such as FiberTape® suture tape (disclosed in U.S. Patent No. 7,892,256, the entire disclosure of which is incorporated herein), or a collagen tape, or a wide "tape-like" material, or a combination thereof. When a suture tape is employed, the tape can have sections with different tapers (e.g., two or three sections that gradually taper or gradually change in width) to facilitate the easy formation of splice regions 55a, 55b and loops 50, 50a, 50b. For example, the splice regions 55a, 55b (FIG. 11) can be round sutures, while the loop 50a can be formed of a flat section.

[0052] The various elements of the surgical assemblies 100, 200, 300 may be provided with a coating and / or a colored tracing strand or otherwise visually contrasted with the suture loop of the structure, which may, for example, remain a simple single color or exhibit different tracing patterns. The various structural elements of the surgical assemblies 100, 200, 300 may be visually coded to make the identification and handling of the legs and / or loop structures of the suture easier. Easy identification of the suture in situ is advantageous in surgical procedures such as endoscopy and laparoscopy, particularly arthroscopic surgery.

[0053] The term "high-strength suture" means any elongated flexible member, and the choice of material and size depends on the particular application. For purposes of illustration and without limitation, the term "suture" as used herein may be a cable, filament, thread, wire, cloth, or any other flexible member suitable for tissue fixation within the body.

[0054] Example 1

[0055] For tensile fatigue, the configurations of various structures were tested. The behavior of the structures was analyzed by software to determine the effects of the following various factors.

[0056] Method

[0057] In Minitab, a multi-factor design of experiments (DOE) for the experiment was created, and different factors and levels were evaluated for all suture structures. Cyclic displacement and final load outcome were used for factor analysis. The factors and levels included the following: 1) Sheath (yarn) size: 375D, 435D, and 495D, 2) Sheath ring length: 26 mm, 33 mm, and 40 mm, 3) Bridge length: 0 mm, 1.5 mm, and 3 mm, 4) Test medium: 20 pcf Sawbone, 40 pcf Sawbone, 80 pcf aluminum plate estimate, 5) Hole size: 3.0 mm, 3.625 mm, 4.25 mm, 6) Deployment tension (hand tension): 20 lbf, 60 lbf, and 100 lbf, 7) Hole angle: 0°, 30°, and 60°, and 8) Position of the TightRope® structure relative to the end of the loop: 0, 5, 10 (unitless, only the positions shown in Figure 21).

[0058] 20 pcf and 40 pcf Sawbone® blocks were prepared with a mill, and the underside of the blocks was cut at an inclination angle of 0° (i.e., no cut), 30°, or 60°. The tunnels were drilled vertically into the blocks through the newly cut inclined surfaces from the flat upper surface. At 30° and 60° inclinations, the tunnels formed elliptical exit holes. The drill bits used were φ = 0.116 inches, 0.144 inches, and 0.166 inches, which are close to the desired diameters of 3.0 mm, 3.625 mm, and 4.25 mm, respectively. Before inserting the TightRope® construct, the pre-tensioned diameter of the suture was determined by passing the suture through a cannula-shaped anchor spear with a known inner diameter. If the diameters were the same and the suture could not be advanced further, the inner diameter was recorded. The prototype of the TightRope® construct was inserted into each Sawbone® block such that the exposed loop was on the upper surface and the anchor was in the same plane as the inclined surface. For samples prepared using aluminum box fixtures, the prototype of the TightRope® construct was inserted into the upper box surface at a 0° orientation. The upper box surface was machined with hole openings of 3.0 mm, 3.625 mm, or 4.25 mm. The box fixtures were placed in a vise with an adjustable angle to achieve similar 0°, 30°, and 60° inclinations. The same gauge length was used regardless of the test medium. The exposed suture loop was passed around the dab rod, while the two free ends (used for tension adjustment) adjacent to the anchor were inserted into Tensioner 0, and tension was applied up to either 20, 60, or 100 lbf. After applying the tension, the length, width, and height of the suture anchor were measured and recorded via calipers.

[0059] Tensile fatigue test:

[0060] For the TightRope® construct loaded in the aluminum box fixture, the box fixture was angled at either 0°, 30°, or 60° with an adjustable-angle vise on the Instron base plate. For the TightRope® construct loaded in the Sawbone® block, the aluminum box fixture fixed to the Instron® base plate secured the block. Regardless of the test medium, a hook fixture attached to the Instron® load cell was used to apply tension to the construct. Using WaveMatrix® software, each construct was loaded under tension to 30 N, followed by 10 cycles of a pre-cycle at 10 N and 1 Hz. Subsequently, the construct was loaded to 150 N, followed by 500 cycles at 2 Hz from 50 N to 250 N. After the cycles, the construct was pulled at 20 mm / min until failure. Microsoft Excel and Origin software were used to record the cyclic displacement (excluding pre-cycles) and the final load.

[0061] Results:

[0062] The data was compiled into a matrix format and a DOE analysis was performed with Minitab® software. Specimen 42 was an extreme outlier with respect to cyclic displacement that was likely due to pre-test anchor damage. As a result, the trends observed in the DOE were skewed. To address this, two different DOE screening models were used. The first DOE model removed the three lowest-performing specimens from each of the 17 groups. The second DOE model replaced the outlier with the average value from the other two specimens within that group.

[0063] Using the Response Optimizer, target values, weights, and importance values for the desired results were set as follows: 3.5 mm for the thickness / height of the anchor with hand tension applied, 600 N for the final load, and 2.5 mm for the cyclic displacement. The weights and importance for each of these outputs were set to 5, 1, and 1, respectively. Then, based on the inputs from the intended use of the product, constraints were added to the Response Optimizer. These were a test medium of 40 pcf (i.e., healthy bone), a hole size of 4.25 mm, a deployment tension of 20 lbf, and a hole angle of 40°. The variable ranges of each factor incorporating the constraint values and starting values are shown in Figure 7 and applied to both DOE screening methods.

[0064] After setting the response optimization inputs, DOE analysis was performed for both screening models, and the ideal solution was output as a combination of research factors and levels. Additional information (trend charts, factor analysis, etc.) can be viewed in the Minitab® file attached to the APT.

[0065] Table 1. Parameters used in the DOE screening response optimizer for both models. [Table 1]

[0066] Table 2. DOE solution #1 based on experimental data and response optimizer inputs. [Table 2]

[0067] Table 3. DOE solution #2 based on experimental data and response optimizer outputs. [Table 3]

[0068] Conclusion

[0069] In this study, the DOE solutions were limited to specific factor levels to approximate the results based on appropriate clinically intended uses. Since it simulates good bone quality, a 40 pcf Sawbone® model was selected. Since it is the drill bit size that can be used for tunneling, a hole size of 4.25 mm was selected. Since it approximates the hand tension load and the use of a tensiometer (i.e., for higher tension loads) is not desirable in clinical applications, a deployment tension of 20 lbf was selected.

[0070] The target values were selected by the DOE response optimizer based on a preliminary analysis of the data and input from the product management for what is considered clinically acceptable. The DOE solutions were weighted at a ratio of 5:1:1 for thickness / height vs. final load and cyclic displacement. A higher weighting of thickness / height means a higher priority for minimizing the protrusion of the implant. The composite desirability of the DOE was high (>0.96) for both models.

[0071] To address the presence of outliers, two different models were analyzed. Although the methods for excluding outliers were different, the two models mostly converged.

Claims

**Claim 1** A surgical construct comprising a suture containing a hollow core and 52 or fewer picks per inch within the enclosed loop, wherein the construct is configured to be folded into an "S", "U", or "W" configuration. **Claim 2** The surgical construct of claim 1, wherein the suture has 40 or fewer picks per inch. **Claim 3** The surgical construct of claim 1, wherein the suture has 25 or fewer picks per inch. **Claim 4** The surgical construct of claim 1, wherein the suture has 15 to 20 picks per inch. **Claim 5** The surgical construct of claim 1, wherein the suture has 18 picks per inch. **Claim 6** The surgical construct of claim 1, wherein the suture has a size of 32 gauge or less. **Claim 7** A method of forming a loop of suture, comprising: a) inserting a passing tail 1 into a splice point 4 on side A; b) directing the passing tail 1 towards splice point 3; c) exiting the passing tail 1 at splice point 3 on side B; d) inserting a passing tail 2 into splice point 3 on side B; e) directing the passing tail 2 towards splice point 3; f) exiting the passing tail 2 at splice point 3 on side B; g) (wherein steps (a)-(f) form a loop); h) folding the loop into three sections to form an "S", "U", or "W" configuration. **Claim 8** A surgical assembly for tissue repair, comprising: a fixation device in the form of a flexible loop containing a suture with a hollow core, wherein the suture has 52 or fewer picks per inch and a size of 32 gauge or less; and a tension adjustable structure loaded onto the fixation device. **Claim 9** The surgical assembly of claim 8, wherein the fixation device consists essentially of a ultra-high molecular weight polyethylene suture and at least one radiopaque agent. **Claim 10** The surgical assembly of claim 8, wherein the fixation device consists essentially of a ultra-high molecular weight polyethylene suture and bismuth trioxide. **Claim 11** The surgical assembly of claim 8, wherein the tension adjustable structure comprises a flexible connector and at least one closed, adjustable, continuous flexible loop having an adjustable perimeter. **Claim 12** The surgical assembly of claim 11, wherein the flexible connector is a suture or suture tape.

13. The surgical assembly of claim 11, wherein the tension adjustable structure includes two closed adjustable continuous flexible loops and a loop interconnect.

14. The surgical assembly of claim 8, wherein the tissue repair is a rotator cuff repair, an AC joint repair, a ligamentous repair, an Achilles tendon repair, a patellar tendon repair, an ACL / PCL reconstruction, a hip and shoulder reconstruction, an AC joint reconstruction, a ligamentous reconstruction, a quadriceps tendon / patellar tendon rupture repair, or a hallux valgus repair.

15. The surgical assembly of claim 8, wherein the flexible loop is configured to be folded into an "S", "U", or "W" configuration.

16. The flexible loop is providing a suture strand having a first end terminating in a first passage tail and a second end terminating in a second passage tail; inserting the first passage tail into a first splice point and out of the suture strand at a third splice point into a second splice point; inserting the second passage tail into the third splice point and out of the suture strand at the first splice point into the second splice point; and trimming the first passage tail and the second passage tail to a next splice point. The surgical assembly of claim 8 is formed by.

Images