Surgical fixation systems and associated methods

Abstract

The present disclosure relates to surgical fixation systems and methods. The surgical fixation systems of the present disclosure may include various combinations of fixation devices, soft suture constructs, and / or adjustable loops and are configured for use in various knotless surgical procedures, including, but not limited to, syndesmosis, AC joint, UCL, bunion, anterior cruciate ligament (ACL), and posterior cruciate ligament (PCL) surgical procedures.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to U.S. Provisional Application No. 62 / 813,903, filed on March 5, 2019, and claims priority to U.S. Provisional Application No. 62 / 813,904, filed on March 5, 2019, the entire disclosures of which are incorporated herein by reference. Background Art

[0003] The present disclosure relates to surgical fixation systems and methods for performing knotless surgical repair and reconstruction.

[0004] Sutures and various fixation devices (e.g., buttons, anchors, etc.) are commonly used in the field of orthopedic surgery to perform joint stabilization, tissue repair, tissue reconstruction, fracture repair, and other similar surgical procedures. These types of surgical procedures typically involve fixing damaged tissue or realigning bones in order to restore function to a joint. Summary of the Invention

[0005] The present disclosure relates to surgical fixation systems and methods. The surgical fixation systems may include one or more fixation devices and an adjustable ring. The surgical fixation systems may be used in various knotless surgical procedures, including but not limited to syndesmosis, acromioclavicular (AC) joint, ulnar collateral ligament (UCL), bunion, anterior cruciate ligament (ACL), and posterior cruciate ligament (PCL) procedures.

[0006] A surgical fixation system according to an exemplary aspect of the present disclosure may include, inter alia, a first fixation device and an adjustable loop connected to the first fixation device. The freely braided strands are configured to adjust the size of the adjustable loop. A first locking mechanism is established by a spliced ​​section of the adjustable loop, and a second locking mechanism, independent of the first locking mechanism, is established by a combination of features of the first fixation device and the adjustable loop.

[0007] A surgical method according to another exemplary aspect of the present disclosure may, among other things, include performing syndesmotic reduction using a surgical fixation system. The surgical fixation system may include a first fixation device and an adjustable loop connected to the first fixation device. The freely braided strands are configured to adjust the size of the adjustable loop. A first locking mechanism is established by a spliced ​​section of the adjustable loop, and a second locking mechanism, independent of the first locking mechanism, is established by a combination of features of the first fixation device and the adjustable loop.

[0008] According to another exemplary aspect of the present disclosure, a surgical fixation system may include, among other things, a first fixation device, a first adjustable ring connected to the first fixation device, and a soft suture construct comprising a sheath and a second adjustable ring connected to the sheath. The first adjustable ring is a separate adjustable ring from the second adjustable ring. The first freely braided strand is configured to adjust the size of the first adjustable ring, and the second freely braided strand is configured to adjust the size of the second adjustable ring. A first locking mechanism is established by a first spliced ​​section of the first adjustable ring, and a second locking mechanism is established by a second spliced ​​section of the second adjustable ring.

[0009] A surgical method according to another exemplary aspect of the present disclosure may, in particular, include performing a syndesmotic reduction or acromioclavicular reduction using a surgical fixation system. The surgical fixation system may include a first fixation device, a first adjustable ring connected to the first fixation device, and a soft suture structure, the soft suture structure including a sheath and a second adjustable ring connected to the sheath. The first adjustable ring is an adjustable ring separate from the second adjustable ring. The first free braided strand is configured to adjust the size of the first adjustable ring, and the second free braided strand is configured to adjust the size of the second adjustable ring. The first locking mechanism is established by a first spliced ​​section of the first adjustable ring, and the second locking mechanism is established by a second spliced ​​section of the second adjustable ring. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 A surgical fixation system for performing a knotless surgical approach is shown in accordance with an embodiment of the present disclosure.

[0011] Figure 1B Another exemplary surgical fixation system is shown.

[0012] Figure 2 yes Figure 1 A perspective view of a first fixation device of a surgical fixation system.

[0013] Figure 3 yes Figure 2 A top view of the first fixing device.

[0014] Figure 4 A surgical fixation system according to a second embodiment of the present disclosure is shown.

[0015] Figure 5 Shown Figure 1 Additional features of the surgical fixation system.

[0016] Figure 6 Shows that it can be Figure 1 An exemplary adjustable ring for use with a surgical fixation system.

[0017] Figure 7 Shows that it can be Figure 1 Another exemplary adjustable ring for use with a surgical fixation system.

[0018] Figure 8 An exemplary delivery device for a surgical fixation system is shown.

[0019] Figure 9 Another exemplary delivery device for a surgical fixation system is shown.

[0020] Figure 10 、 11 , 12 and 13 schematically show that Figure 1 An exemplary surgical method for a surgical fixation system.

[0021] Figure 14 Another exemplary surgical approach is schematically illustrated.

[0022] Figure 15 Yet another exemplary surgical method is schematically illustrated.

[0023] Figure 16 A surgical fixation system for performing a knotless surgical approach according to another embodiment of the present disclosure is shown.

[0024] Figure 17 yes Figure 16 Cross-sectional view of a surgical fixation system.

[0025] Figure 18 yes Figure 16 A perspective view of a first fixation device of a surgical fixation system.

[0026] Figure 19 yes Figure 18 A top view of the first fixing device.

[0027] Figure 20 Shows that it can be Figure 16 An exemplary adjustable ring for use with a surgical fixation system.

[0028] Figure 21 Shows that it can be Figure 16 Another exemplary adjustable ring for use with a surgical fixation system.

[0029] Figure 22 Shown Figure 16 An exemplary soft suture construct for a surgical fixation system.

[0030] Figure 23 Shows that it can be Figure 16 Another exemplary soft suture construct for use with a surgical fixation system.

[0031] Figure 24 Shows that it can be Figure 16 Another exemplary soft suture construct for use with a surgical fixation system.

[0032] Figure 25 Shows that it can be Figure 16 Another exemplary soft suture construct for use with a surgical fixation system.

[0033] Figure 26 Shows that it can be Figure 16 Another exemplary soft suture construct for use with a surgical fixation system.

[0034] Figure 27 Shows that it can be Figure 16 Another exemplary soft suture construct for use with a surgical fixation system.

[0035] Figure 28 Shows that it can be Figure 16 Another exemplary soft suture construct for use with a surgical fixation system.

[0036] Figure 29 The deployed state of the soft suture construct of the surgical fixation system is shown.

[0037] Figure 30 、 31 , 32, 33, 34 and 35 schematically show the Figure 16 An exemplary surgical method for a surgical fixation system.

[0038] Figure 36 Another exemplary surgical approach is schematically illustrated.

[0039] Figure 37 Yet another exemplary surgical method is schematically illustrated.

[0040] Figure 38 A surgical fixation system for performing a knotless surgical approach according to yet another embodiment of the present disclosure is shown.

[0041] Figure 39 Shows that it can be Figure 38 An exemplary adjustable ring for use with the surgical fixation system of the invention or any other surgical fixation system described herein.

[0042] Figure 40 shows that it can be used to form Figure 39 An exemplary flexible strand for an adjustable loop of the or any other adjustable loop described herein.

[0043] Figure 41 shows that it can be used to form Figure 39 Another exemplary flexible strand for an adjustable loop of or any other adjustable loop described herein.

[0044] Figure 42 Schematically shows the possible Figure 38 An exemplary surgical method for a surgical fixation system. DETAILED DESCRIPTION

[0045] The present disclosure relates to surgical fixation systems and methods. The surgical fixation systems may include one or more fixation devices and adjustable rings and may be used in various knotless surgical procedures, including but not limited to syndesmosis, acromioclavicular (AC) joint, ulnar collateral ligament (UCL), bunion, anterior cruciate ligament (ACL), and posterior cruciate ligament (PCL) procedures.

[0046] A surgical fixation system according to an exemplary aspect of the present disclosure may include, inter alia, a first fixation device and an adjustable loop connected to the first fixation device. The freely braided strands are configured to adjust the size of the adjustable loop. A first locking mechanism is established by a spliced ​​section of the adjustable loop, and a second locking mechanism, independent of the first locking mechanism, is established by a combination of features of the first fixation device and the adjustable loop.

[0047] In another embodiment, the first fixation device of the surgical fixation system is a first button, and the second fixation device is connected to the adjustable ring of the surgical fixation system and is configured as a second button.

[0048] In another embodiment, a first button of a surgical fixation system includes a first hole, a second hole, and a suture return hole, wherein a free braided strand of an adjustable loop extends from a spliced ​​section of the adjustable loop, through the suture return hole, and then under a fixed loop section of the adjustable loop, which rests over a bridge of the first button disposed between the first and second holes to establish a second locking mechanism. In the locked position of the second locking mechanism, the free braided strand is tensioned by the fixed loop section against an outer surface of the bridge.

[0049] In another embodiment, the first fixation device of the surgical fixation system is a button.The second fixation device of the surgical fixation system can be connected to the adjustable ring and configured as a screw or a suture anchor.

[0050] In another embodiment, the first locking mechanism of the surgical fixation system is a finger capture mechanism of the adjustable ring.

[0051] In another embodiment, an adjustable loop of a surgical fixation system includes a spliced ​​segment, free braided strands extending from the spliced ​​segment, a first locking mechanism, a single adjustable grommet ring extending from the spliced ​​segment in a first direction, and a single fixed loop segment extending from the spliced ​​segment in a second direction.

[0052] In another embodiment, the filaments of the surgical fixation system are separate from the adjustable ring and extend between the fixed ring section of the adjustable ring and the fixation device. The filaments can be tensioned to move the fixed ring section, thereby releasing free braided strands for adjusting the size of the adjustable ring.

[0053] In another embodiment, an adjustable ring of a surgical fixation system includes a flat-round configuration.

[0054] According to another exemplary aspect of the present disclosure, a surgical fixation system may include, among other things, a first fixation device, a first adjustable ring connected to the first fixation device, and a soft suture construct comprising a sheath and a second adjustable ring connected to the sheath. The first adjustable ring is a separate adjustable ring from the second adjustable ring. The first freely braided strand is configured to adjust the size of the first adjustable ring, and the second freely braided strand is configured to adjust the size of the second adjustable ring. A first locking mechanism is established by a first spliced ​​section of the first adjustable ring, and a second locking mechanism is established by a second spliced ​​section of the second adjustable ring.

[0055] In another embodiment, the first fixing device of the surgical fixation system is a button. The button includes a first hole, a second hole, and a suture return hole. The first free-braided strand extends from the splice section of the first adjustable loop, through the suture return hole, and then under the fixed loop section of the first adjustable loop, which rests above the bridge of the button disposed between the first hole and the second hole. In the locked position, the first free-braided strand is tensioned by the fixed loop section against the outer surface of the bridge. The second free-braided strand extends from the second splice section of the second adjustable loop, through the first locking mechanism of the first adjustable loop, through the suture return hole, and then under the fixed loop section of the first adjustable loop.

[0056] In another embodiment, the second freely braided strand of the second adjustable loop of the surgical fixation system is spliced ​​through the first spliced ​​section of the first adjustable loop.The second locking mechanism and the second spliced ​​section of the second adjustable loop are at least partially positioned within the lumen of the sheath of the soft suture construct.

[0057] In another embodiment, the first adjustable loop of the surgical fixation system is passed through a sheath of the soft suture construct.

[0058] In another embodiment, the sheath, the first adjustable ring, and the second adjustable ring of the soft suture construct of the surgical fixation system are each made exclusively of a soft suture-type material.

[0059] In another embodiment, tensioning the second freely braided strands of the surgical fixation system reduces the size of the second adjustable loop, thereby configuring the sheath of the soft suture construct into an anchoring cluster.

[0060] In another embodiment, the first adjustable ring of the surgical fixation system includes a flat-round configuration.

[0061] Figure 1 An exemplary surgical fixation system 10 is shown. The surgical fixation system 10 can be used to perform a variety of surgical procedures. The surgical procedure can include any procedure involving, for example, repairing torn tissue or realigning bone. The surgical fixation system 10 can be used in any surgical procedure involving the ankle, foot, hand, shoulder, or knee. Syndesmosis, AC joint, hallux valgus (i.e., bunion), and ulnar collateral ligament (UCL) repair are non-limiting examples of the types of surgical procedures that can benefit from the surgical fixation system 10 of the present disclosure.

[0062] In an embodiment, the surgical fixation system 10 is used to perform a "knotless" surgical approach. In this disclosure, the term "knotless" indicates a surgical repair that can be performed without requiring the surgeon to tie any knots with the various flexible materials or sutures utilized during the surgical approach.

[0063] In this example, the surgical fixation system 10 can include a first fixation device 12, a second fixation device 14, and an adjustable ring 16. The adjustable ring 16 can extend between the first and second fixation devices 12, 14 and be connected to each of the first and second fixation devices.

[0064] The first fixation device 12 can provide cortical bone fixation relative to the first bone after the adjustable ring 16 of the surgical fixation system 10 has been positioned within the bone tunnel. In an embodiment, the first fixation device 12 is a button. However, fixation devices having various other configurations can be used instead. The first fixation device 12 can be oblong or circular and can be made of a metal material or a polymer material within the scope of the present disclosure. Figure 2 and Figure 3 An exemplary design of the first fixing device 12 is described in more detail.

[0065] In an embodiment, the first fixation device 12 includes one or more holes 18 formed through the body of the first fixation device 12. The holes 18 can be constructed and arranged to receive the adjustable ring 16. Some of the holes 18 can optionally carry one or more additional filaments for manipulating or controlling the first fixation device 12 or enhancing fixation during the surgical procedure. For example, a suture tape 25 can be passed through the holes 18 and carried by the first fixation device 12 in addition to being carried by the adjustable ring 16 (see, e.g., FIG. Figure 1B ).

[0066] After the adjustable ring 16 of the surgical fixation system 10 has been positioned within the bone tunnel, the second fixation device 14 can provide cortical or internal bone fixation relative to the second bone. In an embodiment, the second fixation device 14 is a button. In another embodiment, the second fixation device 14 is a screw or suture anchor (see Figure 4 ). However, other similarly configured fixtures may be utilized instead or in addition. The second fixture 14 may include any shape and may be made of a metal material or a polymer material within the scope of the present disclosure. In an embodiment, the second fixture 14 is configured differently from the first fixture 12.

[0067] In an embodiment, the second fixation device 14 includes one or more holes 19 formed through the body of the second fixation device 14. The holes 19 can be constructed and arranged to receive the adjustable ring 16. For example, some of the holes 19 can optionally carry one or more additional filaments for manipulating or controlling the second fixation device 14 during a surgical procedure.

[0068] In an embodiment, the adjustable loop 16 is made of a flexible material and, in some instances, includes adjustable length and / or circumference. The adjustable loop 16 includes a single free-braided strand 20. The single free-braided strand 20, which may also be referred to as a shortening strand, can be pulled to reduce the size of the adjustable loop 16. For example, the adjustable loop 16 can be adjusted in a first direction by pulling the single free-braided strand 20, but prevented from loosening in the opposite direction due to the applied internal tensile force.

[0069] In an embodiment, a single free braided strand 20 extends from a spliced ​​section 22 of the adjustable loop 16. The spliced ​​section 22 may include a first locking mechanism 24 (e.g., a finger catch mechanism) for preventing unintentional loosening of the single free braided strand 20. The adjustable loop 16 may additionally include a single adjustable grommet loop 26 that may be formed by splicing flexible material that is used to form the adjustable loop 16 by itself at the spliced ​​section 22. In this embodiment, two strands extend from the spliced ​​section 22 to form the single adjustable grommet loop 26. Thus, Figure 1 The adjustable ring 16 is considered a bi-pronged ring. The bi-pronged ring design minimizes the amount of bone that must be removed to accommodate the adjustable ring 16 within the bone tunnel.

[0070] Before the adjustable loop 16 is fully formed, the adjustable loop 16 can be connected to the first and second securing devices 12, 14. The single free braided strand 20 can be pulled to restrict the size of the single adjustable grommet loop 26, and thus the overall size of the adjustable loop 16 can be changed.

[0071] Now refer to Figure 1-3, the adjustable ring 16 and the first fixation device 12 can cooperate to establish a second locking mechanism 28 of the surgical fixation system 10. The second locking mechanism 28, which is independent of the first locking mechanism 24, is adapted to lock the size and position of the adjustable ring 16 relative to the first fixation device 12, thereby increasing the strength of the surgical fixation system 10 at the interface between the adjustable ring 16 and the first fixation device 12. In an embodiment, the second locking mechanism 28 is a byproduct of the combination of features of the adjustable ring 16 and the first fixation device 12, while the first locking mechanism 24 is established solely by the adjustable ring 16.

[0072] First fixture 12 may include a top surface 30, a bottom surface 32, and a sidewall 34 extending therebetween. Top surface 30, bottom surface 32, and sidewall 34 together establish the body of first fixture 12. In the illustrated embodiment, the body of fixture 12 is circular. However, in alternative embodiments, the body of the fixture may include an oval or various other shapes. In another embodiment, top surface 30 and bottom surface 32 are substantially flat surfaces, and sidewall 34 is a curved surface.

[0073] A first hole 18A, a second hole 18B, and a third hole 18C can be formed through the first fixture 12 and can extend completely through both the top surface 30 and the bottom surface 32. The first hole 18A and the second hole 18B can be axially aligned with each other and can extend along the longitudinal axis A1, and the third hole 18C can be offset to either side of the first hole 18A and the second hole 18B and extend along the longitudinal axis A2. In an embodiment, the first hole 18A, the second hole 18B, and the third hole 18C are oval. However, the size and shape of the holes 18A-18C are not intended to limit the present disclosure.

[0074] The first hole 18A and the second hole 18B can be constructed and arranged to receive the adjustable ring 16 of the surgical fixation system 10. The bridge 36 can separate the first hole 18A and the second hole 18B from each other to provide a surface for carrying the adjustable ring 16 of the surgical fixation system 10. The bridge 36 can include: an outer surface 38 that is flush with the top surface 30 of the first fixation device 12 (i.e., the outer surface 38 is not countersunk relative to the top surface 30); and, for example, a pair of angled surfaces 40 that diverge in a direction toward the bottom surface 32 of the first fixation device 12. In an embodiment, the outer surface 38 of the bridge 36 extends along, for example, a longitudinal axis A3 that is substantially perpendicular to the longitudinal axis A1 (see, e.g., FIG. 2 ). Figure 3 ).

[0075] The third hole 18C can be used as a suture return hole for receiving the single free braided strand 20 of the adjustable loop 16. The third hole 18C can be located adjacent to the first hole 18A and the second hole 18B. In an embodiment, the longitudinal axis A3 extending through the outer surface 38 of the bridge 36 intersects the center of the third hole 18C (see, e.g., FIG. Figure 3 ).

[0076] The first fixation device 12 and the adjustable ring 16 can be configured to establish the second locking mechanism 28 of the surgical fixation system 10. In an embodiment, a single free braided strand 20 extends from the spliced ​​section 22 of the adjustable ring 16 and, in this example, passes upward through the third hole 18C (i.e., in a direction extending from the bottom surface 32 toward the top surface 30 of the first fixation device 12). The single free braided strand 20 can then be threaded into the fixed loop section 42 of the adjustable ring 16 (see FIG. Figure 1 ) passes underneath, the fixing loop segment may, for example, rest on top of the bridge 36 (ie, a single free braided strand 20 passes between the fixing loop segment 42 and the bridge 36) to establish the second locking mechanism 28.

[0077] In the locked position of the second locking mechanism 28, the single free braided strand 20 is held in tension by the fixed loop section 42 of the adjustable loop 16 directly against the outer surface 38 of the bridge 36. This tension can be created, for example, by applying a tensioning force T1 to any portion of the adjustable loop 16 that is located below the first securing device 12. Thus, the single free braided strand 20 can be held against the type of movement required to limit the size of the single adjustable grommet ring 26 of the adjustable loop 16.

[0078] In the unlocked position of the second locking mechanism 28, the tensioning force T1 holding the fixed loop segment 42 against the single free braided strand 20 is released, thereby allowing the single free braided strand 20 to slide between the bridge 36 and the fixed loop segment 42. Once the tension applied by the fixed loop segment 42 is removed, the tensioning force T2 can be applied to the single free braided strand 20 to limit the size of the single adjustable grommet ring 26. Thus, the tension applied by the surgical fixation system 10 can be easily adjusted by unlocking the second locking mechanism 28.

[0079] Now refer to Figure 5, the surgical fixation system 10 can optionally include an additional filament 44 for allowing the user to more easily release the tension T1 on the single free braided strand 20. The additional filament 44 is completely separate from the adjustable ring 16 and can be looped under the fixed ring segment 42 so that a portion of the additional filament 44 is axially positioned between the fixed ring segment 42 and the single free braided strand 20. A tensioning force T3 can be applied to the additional filament 44 to pull the fixed ring segment 42 away from the bridge 36, thereby allowing the single free braided strand 20 to more easily slide between the bridge 36 and the fixed ring segment 42.

[0080] As mentioned above, Figure 1 The adjustable ring 16 comprises a double-stranded configuration. However, other adjustable ring configurations are additionally contemplated within the scope of the present disclosure.

[0081] For example, Figure 6 The adjustable loop 16 can be made of a flexible material and can include a first free braided strand 20A and a second free braided strand 20B. The first free braided strand 20A and the second free braided strand 20B can be pulled to reduce the size of the adjustable loop 16. In an embodiment, the first free braided strand 20A extends from a first spliced ​​section 22A of the adjustable loop 16, and the second free braided strand 20B extends from a second spliced ​​section 22B of the adjustable loop 16. The first spliced ​​section 22A may include a first locking mechanism 24A, and the second spliced ​​section 22B may include a second locking mechanism 24B. The first locking mechanism 24A and the second locking mechanism 24B prevent the first free braided strand 20A and the second free braided strand 20B from being unintentionally released. A third locking mechanism 28 can be established at the interface between the first fixing device 12 and the adjustable loop 16 in a manner similar to that described above.

[0082] The adjustable loop 16 may further include two adjustable grommet loops 26A, 26B. The two adjustable grommet loops 26A, 26B may be interconnected at an interconnection 35. The two adjustable grommet loops 26A, 26B may be formed by splicing a flexible material, with the adjustable loop 16 itself (i.e., by each of the spliced ​​sections 22A, 22B). In this embodiment, two strands extend from each of the spliced ​​sections 22A, 22B to form each of the adjustable grommet loops 26A, 26B. Thus, the adjustable loop 16 is considered a four-strand loop. Figure 6 Increasing the number of strands of the adjustable ring 16 may increase the overall fixation strength that may be provided by the surgical fixation system 10 .

[0083] exist Figure 7In yet another embodiment shown in FIG, the adjustable loop 16 may include a first free braided strand 20A and a second free braided strand 20B. The first free braided strand 20A and the second free braided strand 20B may be pulled to reduce the size of the adjustable loop 16. In an embodiment, the first free braided strand 20A extends from a first spliced ​​section 22A of the adjustable loop 16, and the second free braided strand 20B extends from a second spliced ​​section 22B of the adjustable loop 16. In this embodiment, the first spliced ​​section 22A and the second spliced ​​section 22B are positioned at the end of the adjustable loop 16 opposite the first securing device 12.

[0084] The first splice section 22A may include a first locking mechanism 24A, and the second splice section 22B may include a second locking mechanism 24B. The first locking mechanism 24A and the second locking mechanism 24B prevent the first free braiding strand 20A and the second free braiding strand 20B from being unintentionally loosened. A third locking mechanism 28 may be established at the interface between the first securing device 12 and the adjustable ring 16 in a manner similar to that described above.

[0085] Figure 7 The adjustable loop 16 may further include two adjustable grommet loops 26A, 26B. The two adjustable grommet loops 26A, 26B may be interconnected at interconnection 35. The two adjustable grommet loops 26A, 26B may be formed by splicing flexible material, with the adjustable loop 16 itself (i.e., by each of the spliced ​​sections 22A, 22B). In this embodiment, three strands extend from each of the spliced ​​sections 22A, 22B to form each of the adjustable grommet loops 26A, 26B. Thus, the adjustable loop 16 is considered a six-strand loop. Figure 7 The increased amount of strands of the adjustable loop 16 may further increase the overall fixation strength that may be provided by the surgical fixation system 10 .

[0086] The surgical fixation system 10 may additionally include one or more delivery devices for shuttling the adjustable ring 16 through one or more prepared bone tunnels. Figure 8 A first delivery device 99A is shown that can be used with the surgical fixation system 10. The first delivery device 99A can include a needle 46. The needle 46 can be connected to the second fixation device 14 of the surgical fixation system 10 by a passing filament 48. The needle 46 can be passed through the prepared bone tunnel or multiple bone tunnels to push the second fixation device 14 through the bone tunnel.

[0087] The second delivery device 99B used with the surgical fixation system 10 is Figure 9. The second delivery device 99B may include a handle 50 and a shaft 52 extending from the handle 50. The first fixation device 12 of the surgical fixation system 10 can be releasably retained in a groove 54 located near the distal end 56 of the handle 50. The second fixation device 14 of the surgical fixation system 10 can be releasably retained at the distal end 58 of the shaft 52. The handle 50 may include a release mechanism 60 (e.g., a button) that can be pressed to release the second fixation device 14 from the shaft 52. The free braided strands 20 and optional additional filaments 44 can be wrapped around the release mechanism 60 for suture management. In use, the shaft 52 of the second delivery device 99B can be used to push the second fixation device 14 through a prepared bone tunnel, for example, when performing a syndesmosis repair method.

[0088] Continue to refer Figure 1-9 , Figure 10-13 The surgical fixation system 10 employed in an exemplary surgical method is schematically illustrated. In the illustrated embodiment, the surgical method is a syndesmotic repair method involving a human ankle joint. Of course, the surgical fixation system 10 of the present disclosure can be used in other surgical methods.

[0089] Figure 10-13 An exemplary embodiment of a method for performing a knotless surgery is shown in sequence. Fewer or additional steps than those described below may be performed within the scope of the present disclosure. Additionally, Figure 10-13 The order in which the steps are enumerated as shown in the accompanying drawings is not intended to limit the present disclosure.

[0090] First reference Figure 10 , a bone tunnel 62 can be formed through a tibia 64 (e.g., a first bone) and a fibula 66 (e.g., a second bone). The bone tunnel 62 can be drilled through each of the tibia 64 and the fibula 66 using any suitable drill bit 68. In an embodiment, the bone tunnel 62 is formed through each of the tibia 64 and the fibula 66 using a single drill bit and in a single surgical step. The bone tunnel 62 can be drilled from the inside to the outside or from the outside to the inside.

[0091] Next, if Figure 11 and Figure 12 , the second fixation device 14 of the surgical fixation system 10 can be passed through the bone tunnel 62. In an embodiment, a needle 46 can be used as part of the surgical fixation system 10 to advance the second fixation device 14 through the bone tunnel 62. Once the needle 46 has passed through both the fibula 66 and the tibia 64, the passing filament 48 can be further tensioned at a position outward from the outside of the tibia 64 to shuttle the second fixation device 14 substantially horizontally through the bone tunnel 62 (see FIG. Figure 12 In an alternative embodiment, the second fixing means 14 may be used Figure 9 The second delivery device 99B is pushed horizontally through the bone tunnel 62.

[0092] Once the second fixation device 14 exits the bone tunnel 62, a slight countertraction force may be applied to the adjustable ring 16 to flip or pivot the second fixation device 14, thereby seating the second fixation device 14 against the medial cortex 70 of the tibia 64 (see FIG. Figure 13 ). After the second fixation device 14 is positioned at the medial cortex 70, the first fixation device 12 can be tensioned downward against the lateral cortex 72 of the fibula 66 by applying a traction force F to the free braided strands 20 of the adjustable loop 16. The traction force F adjusts the size of the adjustable loop 16, thereby restoring the syndesmosis of the ankle joint without the need to tie any knots. The completed syndesmosis repair is shown in FIG. Figure 13 shown.

[0093] refer to Figure 14 Bone plate 74 can be used as another component of surgical fixation system 10 for performing an exemplary syndesmosis repair method. In an embodiment, bone plate 74 is used to perform syndesmosis restoration associated with fracture fixation, such as when fibula 66 is ruptured.

[0094] The bone plate 74 can be contoured for receipt with respect to the lateral cortex 72 of the fibula 66. The bone plate 74 can include at least one hole 76 for receiving the first fixation device 12 of the surgical fixation system and at least one hole 78 for receiving a threaded fastener 80. In an embodiment, the threaded fastener 80 is a non-locking screw configured to secure the bone plate 74 to the fibula 66.

[0095] In another embodiment, the bone plate 74 includes at least two holes 76 and at least two holes 78. In such an embodiment, the hole 76 is located axially between the holes 78. The total number of holes 76, 78 formed through the bone plate 74 is not intended to limit the present disclosure.

[0096] Figure 15 Another exemplary surgical method is schematically shown. In this embodiment, the surgical method is a tricortical syndesmotic repair method. Figure 4 The surgical fixation system 10 including a screw or suture anchor as the second fixation device 14 can be used to perform Figure 15 surgical method.

[0097] The second fixation device 14 of the surgical fixation system 10 can be at least partially passed through the bone tunnel 62. In an embodiment, the bone tunnel 62 is formed through both cortices (i.e., both the lateral and medial sides) of the fibula 66, but only through a single (i.e., lateral) cortex of the tibia 64. Thus, the bone tunnel 62 passes completely through the fibula 66 but only partially through the tibia 64.

[0098] In an embodiment, the Figure 9The second delivery device 99B is pushed or screwed horizontally into the second fixation device 14 through the bone tunnel 62. The second fixation device 14 is inserted until it is in place adjacent to the bottom surface 82 of the bone tunnel 62 at a position inside the tibia 64.

[0099] Once the second fixation device 14 is fully inserted into the bone tunnel 62, the first fixation device 12 can be tensioned downwardly against the lateral cortex 72 of the fibula 66 (or within the hole 76 of the bone plate 74) by applying a traction force F to the free braided strands 20 of the adjustable loop 16. The traction force F adjusts the size of the adjustable loop 16, thereby restoring the syndesmosis of the ankle joint without the need to tie any knots.

[0100] Figure 16 and Figure 17 Another exemplary surgical fixation system 110 is shown. The surgical fixation system 110 can be used to perform a variety of surgical procedures. Surgical procedures that can be performed using the surgical fixation system 110 can include, for example, any procedure involving the repair of torn tissue or the realignment of bone. The surgical fixation system 110 can be used in any surgical procedure related to the ankle, foot, hand, shoulder, or knee. Syndesmosis, AC joint, hallux valgus (i.e., bunion), and ulnar collateral ligament (UCL) repair are non-limiting examples of the types of surgical procedures that can benefit from the surgical fixation system 110 of the present disclosure.

[0101] In an embodiment, the surgical fixation system 110 is used to perform a “knotless” surgical procedure. The term “knotless” indicates that the surgical procedure can be performed and completed without requiring the surgeon to tie any knots with the various flexible materials or sutures used within the surgical fixation system 110.

[0102] In this example, the surgical fixation system 110 can include a first fixation device 112, a soft suture construct 114 serving as a second fixation device of the surgical fixation system 110, and an adjustable ring 116. The adjustable ring 116 can extend between and be connected to each of the first fixation device 112 and the soft suture construct 114.

[0103] The first fixation device 112 can provide cortical bone fixation relative to the first bone, and after the adjustable ring 116 of the surgical fixation system 110 is positioned within the bone tunnel, the soft suture structure 114 can provide internal bone fixation relative to the second bone. In an embodiment, the first fixation device 112 is a button. However, fixation devices with various other configurations may alternatively be used within the scope of the present disclosure. The first fixation device 112 can be oblong or circular and can be made of a metal material or a polymer material within the scope of the present disclosure. Figure 18 and Figure 19An exemplary design of the first fixture 112 is described in more detail.

[0104] In an embodiment, the first fixation device 112 includes one or more holes 118 formed through the body of the first fixation device 112. The holes 118 can be constructed and arranged to receive the adjustable ring 116. For example, some of the holes 118 can optionally carry one or more additional filaments for manipulating or controlling the first fixation device 112 during a surgical procedure.

[0105] In an embodiment, the adjustable loop 116 is made of a flexible material and, in some instances, includes adjustable length and / or circumference. The adjustable loop 116 may include a first free-braided strand 120A and a second free-braided strand 120B. The first free-braided strand 120A and the second free-braided strand 120B, which may also be referred to as shortening strands, may be pulled to reduce the size of the adjustable loop 116. For example, the adjustable loop 116 may be adjusted in a first direction by pulling the free-braided strands 120A, 120B, but may be prevented from loosening in the opposite direction due to the applied internal tensile force.

[0106] In an embodiment, a first free-braiding strand 120A extends from a first spliced ​​section 122A of the adjustable loop 116, and a second free-braiding strand 120B extends from a second spliced ​​section 122B of the adjustable loop 116. The first spliced ​​section 122A may include a first locking mechanism 124A (e.g., a first finger catch mechanism), and the second spliced ​​section 122B may include a second locking mechanism 124B (e.g., a second finger catch mechanism). The first and second locking mechanisms 124A, 124B substantially prevent the first and second free-braiding strands 120A, 120B from being unintentionally unfastened. The adjustable loop 116 may further include a single adjustable grommet loop 126, which may be formed by splicing flexible material, which is used to form the adjustable loop 116 at each of the spliced ​​sections 122A, 122B. In this embodiment, a single strand extends from each of the spliced ​​sections 122A, 122B to form the single adjustable grommet loop 126. therefore, Figure 16 The adjustable ring 116 is considered a bi-pronged ring. The bi-pronged ring design minimizes the amount of bone that must be removed to accommodate the adjustable ring 116 within the bone tunnel.

[0107] Before the adjustable loop 116 is fully formed, the adjustable loop 116 can be connected to the first securing device 112 and the soft suture construct 114. The free braided strands 120A, 120B can be pulled out to restrict the size of the single adjustable grommet loop 126 and thus change the overall size of the adjustable loop 116.

[0108] Now refer to Figure 16-19, the adjustable ring 116 and the first fixation device 112 can cooperate to establish a third locking mechanism 128 of the surgical fixation system 110. The third locking mechanism 128, which is independent of the first locking mechanism 124A and the second locking mechanism 124B, is adapted to lock the size and position of the adjustable ring 116 relative to the first fixation device 112, thereby increasing the strength of the surgical fixation system 110 at the interface between the adjustable ring 116 and the first fixation device 112. In an embodiment, the third locking mechanism 128 is a byproduct of the combination of features of the adjustable ring 116 and the first fixation device 112, while the first locking mechanism 124A and the second locking mechanism 124B are established solely by the adjustable ring 116.

[0109] First fixture 112 may include a top surface 130, a bottom surface 132, and a sidewall 134 extending between top surface 130 and bottom surface 132. Top surface 130, bottom surface 132, and sidewall 134 together establish the body of first fixture 112. In the illustrated embodiment, the body of fixture 112 is circular. However, in alternative embodiments, the body of the fixture may include an oval or various other shapes. In another embodiment, top surface 130 and bottom surface 132 are substantially flat surfaces, and sidewall 134 is a curved surface.

[0110] A first hole 118A, a second hole 118B, and a third hole 118C may be formed through the first fixture 112 and may extend completely through both the top surface 130 and the bottom surface 132. The first hole 118A and the second hole 118B may be axially aligned with each other and may extend along the longitudinal axis A1, and the third hole 118C may be offset to either side of the first hole 118A and the second hole 118B and extend along the longitudinal axis A2. In an embodiment, the first hole 118A, the second hole 118B, and the third hole 118C are oval in shape. However, the size and shape of the holes 118A-118C are not intended to limit the present disclosure.

[0111] The first hole 118A and the second hole 118B can be constructed and arranged to receive the adjustable ring 116 of the surgical fixation system 110. The bridge 136 can separate the first hole 118A and the second hole 118B from each other to provide a surface for carrying the adjustable ring 116 of the surgical fixation system 110. The bridge 136 can include: an outer surface 138 that is flush with the top surface 130 of the first fixation device 112 (i.e., the outer surface 138 is not countersunk relative to the top surface 130); and, for example, a pair of angled surfaces 140 that diverge in a direction toward the bottom surface 132 of the first fixation device 112. In an embodiment, the outer surface 138 of the bridge 136 extends along, for example, a longitudinal axis A3 that is substantially perpendicular to the longitudinal axis A1 (see, e.g., FIG. 2 ). Figure 18 ).

[0112] The third hole 118C can be used as a suture return hole for receiving the first free braided strand 120A and the second free braided strand 120B of the adjustable loop 116. The third hole 118C can be positioned adjacent to the first hole 118A and the second hole 118B. In an embodiment, the longitudinal axis A3 extending through the outer surface 138 of the bridge 136 intersects the center of the third hole 118C (see, e.g., FIG. 1 ). Figure 18 ).

[0113] The first fixation device 112 and the adjustable ring 116 can be configured to establish a third locking mechanism 128 of the surgical fixation system 110. In an embodiment, the free braided strands 120A, 120B extend from the spliced ​​sections 122A, 122B of the adjustable ring 116, in this example, upwardly through the third hole 118C (i.e., in a direction extending from the bottom surface 132 toward the top surface 130 of the first fixation device 112). The free braided strands 120A, 120B can then be passed through the fixed loop section 142 of the adjustable ring 116 (see FIG. Figure 17 ), the fixing loop segment may, for example, rest on top of the bridge 136 (ie, the free braided strands 120 pass between the fixing loop segment 142 and the bridge 136) to establish the third locking mechanism 128.

[0114] In the locked position of the third locking mechanism 128, the free braided strands 120A, 120B are held in tension by the fixed loop section 142 of the adjustable loop 116 directly against the outer surface 138 of the bridge 136. This tension can be generated, for example, by applying a tensioning force T1 to any portion of the adjustable loop 116 that is located below the first securing device 112. Thus, the free braided strands 120A, 120B can be held against the type of movement required to limit the size of the single adjustable grommet ring 126 of the adjustable loop 116.

[0115] In the unlocked position of the third locking mechanism 128, the tensioning force T1 holding the fixation loop segment 142 against the free braided strands 120A, 120B is released, thereby allowing the free braided strands 120A, 120B to slide between the bridge 136 and the fixation loop segment 142. Once the tension applied by the fixation loop segment 142 is removed, the tensioning force T2 can be applied to the free braided strands 120A, 120B to limit the size of the single adjustable grommet loop 126. Thus, the tension applied by the surgical fixation system 110 can be easily adjusted by unlocking the third locking mechanism 128.

[0116] As mentioned above, Figure 20 The adjustable ring 116 includes a double-stranded configuration. However, other adjustable ring configurations are also contemplated within the scope of the present disclosure.

[0117] For example, Figure 20The adjustable loop 116 can be made of a flexible material and can include a first free-braided strand 120A and a second free-braided strand 120B. The first free-braided strand 120A and the second free-braided strand 120B can be pulled to reduce the size of the adjustable loop 116. In an embodiment, the first free-braided strand 120A extends from a first spliced ​​section 122A of the adjustable loop 116, and the second free-braided strand 120B extends from a second spliced ​​section 122B of the adjustable loop 116. The first spliced ​​section 122A may include a first locking mechanism 124A, and the second spliced ​​section 122B may include a second locking mechanism 124B. The first locking mechanism 124A and the second locking mechanism 124B prevent the first and second free-braided strands 120A, 120B from being unintentionally released. A third locking mechanism 128 can be established at the interface between the first securing device 112 and the adjustable loop 116 in a manner similar to that described above.

[0118] The adjustable loop 116 may further include two adjustable grommet loops 126A, 126B. The two adjustable grommet loops 126A, 126B may be interconnected at interconnection 135. The two adjustable grommet loops 126A, 126B may be formed by splicing flexible material, with the adjustable loop 116 itself (i.e., by each of the spliced ​​sections 122A, 122B). In this embodiment, two strands extend from each of the spliced ​​sections 122A, 122B to form each of the adjustable grommet loops 126A, 126B. Thus, the adjustable loop 116 is considered a four-strand loop. Figure 20 Increasing the number of strands of the adjustable ring 116 may increase the overall fixation strength that may be provided by the surgical fixation system 110 .

[0119] exist Figure 21 In yet another embodiment shown in FIG, the adjustable loop 116 may include a first free braided strand 120A and a second free braided strand 120B. The first free braided strand 120A and the second free braided strand 120B may be pulled to reduce the size of the adjustable loop 116. In an embodiment, the first free braided strand 120A extends from a first spliced ​​section 122A of the adjustable loop 116, and the second free braided strand 120B extends from a second spliced ​​section 122B of the adjustable loop 116. In this embodiment, the first spliced ​​section 122A and the second spliced ​​section 122B are positioned at the end of the adjustable loop 116 opposite the first securing device 112.

[0120] The first splice section 122A may include a first locking mechanism 124A, and the second splice section 122B may include a second locking mechanism 124B. The first locking mechanism 124A and the second locking mechanism 124B prevent the first free braided strand 120A and the second free braided strand 120B from being unintentionally loosened. A third locking mechanism 128 may be established at the interface between the first securing device 112 and the adjustable ring 116 in a manner similar to that described above.

[0121] Figure 21 The adjustable loop 116 may further include two adjustable grommet loops 126A, 126B. The two adjustable grommet loops 126A, 126B may be interconnected at interconnection 135. The two adjustable grommet loops 126A, 126B may be formed by splicing flexible material, with the adjustable loop 116 itself (i.e., by each of the spliced ​​sections 122A, 122B). In this embodiment, three strands extend from each of the spliced ​​sections 122A, 122B to form each of the adjustable grommet loops 126A, 126B. Thus, the adjustable loop 116 is considered a six-strand loop. Figure 21 The increased amount of strands of the adjustable loop 116 may further increase the overall fixation strength that may be provided by the surgical fixation system 110 .

[0122] Now refer to Figure 16-17 and Figure 22 , the soft suture construct 114 of the surgical fixation system 110 may include a sheath 146 and one or more flexible strands 148 that can be passed through the sheath 146 to form an adjustable loop 150. In this embodiment, the adjustable loop 150 of the soft suture construct 114 is a completely separate ring from the adjustable loop 116 of the surgical fixation system 110. In other words, in this embodiment, the adjustable loop 116 and the adjustable loop 150 are made of separate and different filaments. However, other embodiments in which the adjustable loop 116 and the adjustable loop 150 are made of the same filament are also contemplated (see, e.g., Figure 24 embodiment).

[0123] The sheath 146 can include a tubular body 152 extending between opposite ends 154A, 154B. The opposite ends 154A, 154B can be open ends. The tubular body 152 establishes a bore 156 extending between the opposite ends 154A, 154B. The bore 156 can be configured to accommodate portions of both the adjustable ring 116 and the adjustable ring 150.

[0124] In an embodiment, the sheath 146 is a tubular sleeve made of a flexible material, such as a braided, woven, or knitted structure made of yarn, fiber, filament, suture, or other similar material or a combination of these materials. In another embodiment, the sheath 146 is made of a polyester suture material. However, other flexible materials may also be suitable for constructing the sheath 146.

[0125] In another embodiment, the flexible strand 148 used to form the adjustable loop 150 is a filament, such as a suture. Non-limiting examples of suitable sutures include or sutures, each of which is available from Arthrex, Inc., but any type of suture may be used, including cored or coreless sutures. In another embodiment, the flexible strand 148 is a flat suture, such as or It is also available from Arthrex, Inc. The flexible strands 148 may comprise any soft, flexible strand of material.

[0126] The flexible strand 148 can be passed through the bore 156 in one or more passes to configure the flexible strand 148 into the adjustable loop 150. In an embodiment, the flexible strand 148 can exit the tubular body 152 through the opposing ends 154A, 154B of the sheath 146. In another embodiment, the flexible strand 148 can be spliced ​​through a wall portion of the sheath 146 at a location spaced apart from the opposing ends 154A, 154B.

[0127] The adjustable ring 150 can be held in position relative to the sheath 146 by forming a securing suture portion 155 (e.g., a knot) in the flexible strand 148. In an embodiment, the securing suture portion 155 is formed in the end of the flexible strand 148. Although the securing suture portion 155 can take the form of a knot in the example, the surgical fixation system 110 is still considered to provide "knotless" fixation because the surgeon does not need to form a knot during the surgical procedure. The securing suture portion 155 can alternatively be formed during the manufacturing process.

[0128] The flexible strand 148 can be spliced ​​to itself at one or more splice sections 158 to form the adjustable loop 150. Each splice section 158 can include a locking mechanism 160 (e.g., another finger capture mechanism) that can establish a fourth locking mechanism of the surgical fixation system 110. In embodiments, the splice sections 158 can be at least partially positioned within the bore 156 of the sheath 146. A free braided strand 162 can extend from the splice sections 158 and can be tensioned to limit the size of the adjustable loop 150.

[0129] After the soft suture construct 114 has been inserted into the bone tunnel, the tensioning free braided strands 162 can additionally assist in deploying the sheath 146 to achieve internal bone fixation. For example, the tensioning free braided strands 162 can cause the sheath 146 to bunch up and thereby collapse, expand, and / or change shape to secure the soft suture construct 114 inside the bone tunnel.

[0130] In another embodiment, the free braided strands 162 of the adjustable loop 150 may optionally be conveyed through one of the locking mechanisms 124A, 124B of the adjustable loop 116, such as by splicing the free braided strands 162 through one of the spliced ​​sections 122A, 122B of the adjustable loop 116 (see FIG. Figure 17 ). This additional splicing can improve the fixation strength and overall mechanical stability potential of the soft suture construct 114. After being transmitted through the locking mechanism 124A or 124B, in this example, the free braided strand 162 can be passed upwardly through the third hole 118C of the first fixation device 112 and then passed under the fixed loop section 142 of the adjustable loop 116. Thus, the free braided strand 162 of the adjustable loop 150 of the soft suture construct 114 can be linked to the third locking mechanism 128 to releasably maintain tension in the free braided strand 162 for the type of movement required to limit the size of the adjustable loop 150.

[0131] Figure 16-17 and Figure 22 The soft suture construct 114 depicted in FIG is an exemplary construct for use within the surgical fixation system 110. However, other soft suture construct configurations are additionally contemplated within the scope of the present disclosure.

[0132] For example, Figure 23 The soft suture construct 114 may include a sheath 146 and a flexible strand 148 passing through the sheath 146 to form an adjustable loop 150 including both a first adjustable loop portion 150A and a second adjustable loop portion 150B. Figure 23 150, but the flexible strand 148 may be passed through the bore 156 to form any number of adjustable loop portions within the adjustable loop 150. The flexible strand 148 may be passed through the bore 156 of the sheath 146 multiple times to form the first and second adjustable loop portions 150A, 150B.

[0133] In an embodiment, the second adjustable loop portion 150B includes a shorter initial loop length than the first adjustable loop portion 150A. The adjustable loop portions 150A, 150B can be held in place relative to the sheath 146 by forming a securing suture portion 155 (e.g., a knot) in the flexible strand 148.

[0134] The flexible strand 148 can be spliced ​​by itself at one or more splice sections 158 to form the first adjustable loop portion 150A and the second adjustable loop portion 150B. The splice sections 158 can each include a locking mechanism 160 (e.g., a finger capture mechanism) that can be incorporated to establish additional locking mechanisms (e.g., a fourth, fifth, etc.) of the surgical fixation system 110. A single free braided strand 162 can extend from the splice section 158 and can be tensioned to reduce the size of the first and second adjustable loop portions 150A, 150B.

[0135] After the soft suture construct 114 has been inserted into the bone tunnel, the tensioning free braided strands 162 can additionally deploy the sheath 146 to achieve internal bone fixation. For example, the tensioning free braided strands 162 can adjust the size of each of the adjustable loop portions 150A, 150B, thereby causing the sheath 146 to bunch together and thereby collapse, expand, and / or change shape to secure the soft suture construct 114 within the bone tunnel. Providing more than one adjustable loop portion within the adjustable ring 150 can facilitate easier deployment of the sheath 146 to achieve improved internal bone fixation.

[0136] Figure 24 Another exemplary soft suture construct 114 that can be used as part of a surgical fixation system 110 is shown. Similar to the constructs described above, Figure 24 The soft suture construct 114 can include a sheath 146 and an adjustable loop 150. However, in this embodiment, the adjustable loop 150 is part of and constructed from the same flexible material that forms the adjustable loop 116. For example, the flexible material of the adjustable loop 116 can be passed through the lumen 156 of the sheath 146 in a manner that forms the adjustable loop 150 before the adjustable loop 116 is fully formed.

[0137] The adjustable ring 150 may include a bridging strand 164 that bridges the distance between the opposing ends 154A, 154B of the sheath 146. The adjustable ring 150 may be held in position relative to the sheath 146 by forming a securing suture portion 155 within the bridging strand 164.

[0138] The portion of the flexible strand used to form the adjustable loop 150 can be spliced ​​onto itself at a splice section 158 to form the adjustable loop 150. The splice section 158 can include a locking mechanism 160 (e.g., a finger capture mechanism) that can be incorporated to establish another locking mechanism of the surgical fixation system 110. In an embodiment, the splice section 158 can be at least partially positioned within the bore 156 of the sheath 146. A single free braided strand 162 can extend from the splice section 158 and can be tensioned to reduce the size of the adjustable loop 150 and reduce the size of the adjustable loop 116.

[0139] After the soft suture construct 114 has been inserted into the bone tunnel, tensioning the free braided strands 162 can assist in deploying the sheath 146 to achieve internal bone fixation. For example, tensioning the free braided strands 162 can adjust the size of the adjustable loop 150, thereby causing the sheath 146 to bunch up and thereby collapse, expand, and / or change shape to secure the soft suture construct 114 inside the bone tunnel.

[0140] In another embodiment, Figure 24 The free braided strands 162 of the adjustable loop 150 may optionally be transmitted through one of the locking mechanisms 124A, 124B of the adjustable loop 116 (see Figure 17 ), such as by splicing the free braided strand 162 through one of the spliced ​​sections 122A, 122B of the adjustable loop 116. This additional splicing can improve the fixation strength and overall mechanical stability potential of the soft suture construct 114. After being delivered through the locking mechanism 124A or 124B, in this example, the free braided strand 162 can be passed upwardly through the third hole 118C of the first fixation device 112 and then passed under the fixed loop section 142 of the adjustable loop 116. Thus, the free braided strand 162 can be linked to the third locking mechanism 128 to releasably maintain tension in the free braided strand 162 for the type of movement required to limit the size of the adjustable loop 150 and the adjustable loop 116.

[0141] Another exemplary soft suture structure 114 is Figure 25 In this embodiment, the soft suture structure 114 may include a sheath 146 and Figure 22 Adjustable ring 150 and Figure 23 Thus, the soft suture construct 114 can include two or more separate adjustable rings 150, wherein each adjustable ring 150 includes its own fixed suture portion 155 and free braided strands 162.

[0142] In an embodiment, the fixed suture portion 155 of the adjustable ring 150 is located on the same end of the sheath 146 (see FIG. Figure 25 In another embodiment, the fixed suture portion 155 is located on the opposite end of the sheath 146 (see Figure 26 ).

[0143] exist Figure 27In another embodiment shown, the soft suture structure 114 can further include one or more filaments 166 passing through the sheath 146 in addition to the adjustable ring 116 and the adjustable ring 150. The filaments 166 can be, for example, sutures or suture tapes that are separate from the adjustable ring 116 and the adjustable ring 150. The filaments 166 can provide additional fixation / deployment options when using the surgical fixation system 110. The additional filaments 166 can also reduce the overall stress on any single strand of the surgical fixation system, thereby improving the overall dynamic mechanical stability and achieving a higher ultimate failure strength.

[0144] Figure 28 Yet another configuration is shown where multiple soft suture constructs 114 can be linked together via their respective adjustable loops 150. In embodiments, two or more soft suture constructs 114 can be linked together to provide multiple adjustable loop bridges between different anchor fixation points.

[0145] Figure 29 Shown in a deployed state within a bone tunnel 168 Figure 16-17 168. The soft suture construct 114 of the surgical fixation system 110 is shown in FIG. After the soft suture construct 114 is positioned within the bone tunnel 168, the free braided strands 162 can be tensioned to deploy the soft suture construct 114. Tensioning the free braided strands 162 causes the sheath 146 of the soft suture construct 114 to bunch together, thereby forming an anchor cluster 170 within the bone tunnel 168. The anchor cluster 170 facilitates securing the soft suture construct 114 within the bone within which the bone tunnel 168 is formed.

[0146] Continue to refer Figure 16-29 , Figures 30-35 The surgical fixation system 110 used in an exemplary surgical method is schematically shown. In the embodiment shown, the surgical method is a tricortical syndesmotic repair method involving a human ankle joint. Of course, the surgical fixation system 110 of the present disclosure can be used in other surgical methods.

[0147] Figures 30-35 An exemplary embodiment of a method for performing a knotless surgery is shown in sequence. Fewer or additional steps than those described below may be performed within the scope of the present disclosure. Additionally, Figures 30-35 The order in which the steps are enumerated as shown in the accompanying drawings is not intended to limit the present disclosure.

[0148] First reference Figure 30, a bone tunnel 180 can be formed through the fibula 182 (e.g., a first bone) and partially through the tibia 184 (e.g., a second bone). In an embodiment, the bone tunnel 180 is formed through both cortices (i.e., both the lateral and medial sides) of the fibula 182, but only through a single (i.e., lateral) cortex of the tibia 184. Thus, the bone tunnel 180 passes completely through the fibula 182 but only partially through the tibia 184. The bone tunnel 180 can be drilled using any suitable drill bit 186. In one embodiment, the bone tunnel 180 is formed in each of the fibula 182 and the tibia 184 using a single drill bit and in a single surgical step.

[0149] Next, if Figure 31 , the soft suture construct 114 of the surgical fixation system 110 can be advanced into the bone tunnel 180. The soft suture construct 114 can be advanced horizontally using a delivery device 188 through the portion of the bone tunnel 180 formed in the fibula 182 and then into the portion of the bone tunnel 180 formed in the tibia 184. The soft suture construct 114 can be advanced until it is seated near a bottom surface 190 of the portion of the bone tunnel 180 positioned inside the tibia 184.

[0150] The free braided strands 162 can then be freed by applying a pulling force F1 to the free braided strands 162 (see Figure 32 ) to tension the free braided strands 162 of the adjustable loop 150 of the soft suture construct 114 so as to deploy the soft suture construct 114 and achieve internal bone fixation within the bone tunnel 180. As discussed above, tensioning the free braided strands 162 adjusts the size of the adjustable loop 150, thereby causing the sheath 146 to bunch and thereby collapse, expand, and / or change shape to secure the soft suture construct 114 within the bone tunnel 180.

[0151] Once the soft suture construct 114 is fully deployed within the portion of the bone tunnel 180 within the tibia 184, the first fixation device 112 may be tensioned downwardly against the lateral cortex 192 of the fibula 182 by applying a traction force F2 to the freely braided strands 120A, 120B of the adjustable loop 116 (see FIG. Figure 33 The traction force F adjusts the size of the adjustable ring 116, thereby restoring the syndesmosis of the ankle joint without tying any knots.

[0152] Independent tensioning adjustments may optionally be applied to the free braided strands 120A, 120B and the free braided strand 162 according to the surgeon's preference to optimize the repair (see Figure 34 ). The free braided strands 120A, 120B and 162 of the surgical fixation system 110 can then be cut at a location proximal to the first fixation device 112. The completed syndesmotic repair is shown in FIG. Figure 35 shown.

[0153] refer to Figure 36 Bone plate 194 can be used as another component of surgical fixation system 110 for performing an exemplary syndesmosis repair method. In an embodiment, bone plate 194 is used to perform syndesmosis restoration associated with fracture fixation, such as when fibula 182 is ruptured.

[0154] The bone plate 194 can be contoured for receiving the lateral cortex 192 of the fibula 182. The bone plate 194 can include at least one hole 196 for receiving the first fixation device 112 of the surgical fixation system 110 and at least one hole 198 for receiving the threaded fastener 100. In an embodiment, the threaded fastener 100 is a non-locking screw configured to secure the bone plate 194 to the fibula 182.

[0155] In another embodiment, the bone plate 194 includes at least two holes 196 and at least two holes 198. In such an embodiment, the hole 196 is located axially between the holes 198. The total number of holes 196, 198 formed through the bone plate 194 is not intended to limit the present disclosure.

[0156] Figure 37 Another exemplary surgical method is schematically shown. In this embodiment, the surgical method is an acromioclavicular (AC) joint repair method.

[0157] A bone tunnel 102 can be prepared through the clavicle 104 and at least partially into the coracoid process 106 of the scapula. A soft suture construct 114 of the surgical fixation system 110 can be advanced into the bone tunnel 102. The soft suture construct 114 can be pushed longitudinally through the portion of the bone tunnel 102 formed in the clavicle 104 and then into the portion of the bone tunnel 102 formed in the coracoid process 106 of the scapula. The soft suture construct 114 can be pushed until it is seated near the floor 108 of the bone tunnel 102.

[0158] The freely braided strands 162 of the adjustable loop 150 of the soft suture construct 114 can then be tensioned by applying traction to the freely braided strands 162 to deploy the soft suture construct 114 and achieve internal bone fixation within the bone tunnel 102. Once the soft suture construct 114 is fully deployed within the portion of the bone tunnel 102 within the coracoid process 106 of the scapula, the first fixation device 112 can be tensioned downwardly against the upper surface 109 of the clavicle 104 by applying traction to the freely braided strands 120A, 120B of the adjustable loop 116. The traction adjusts the size of the adjustable loop 116, thereby reducing the spacing between the clavicle 104 and the coracoid process 106 of the scapula.

[0159] Figure 38 and Figure 39Yet another exemplary surgical fixation system 210 is shown. The surgical fixation system 210 can be used to perform a variety of surgical procedures. The surgical procedure can include any procedure involving, for example, repairing torn tissue or realigning bone. The surgical fixation system 210 can be used in any surgical procedure related to the ankle, foot, hand, shoulder, or knee. ACL and PCL repair and reconstruction are non-limiting examples of the types of surgical procedures that can specifically benefit from the surgical fixation system 210. In an embodiment, the surgical fixation system 210 is used to perform a "knotless" surgical procedure, which can be performed without requiring the surgeon to tie knots with the various flexible materials or sutures used during the surgical procedure. However, the surgeon can still tie a knot if desired.

[0160] In an embodiment, the surgical fixation system 210 may include a first fixation device 212 and an adjustable ring 216 connected to the first fixation device 212. Figures 38-39 Although depicted with the first fixation device 212, the adjustable ring 216 or any other exemplary adjustable ring described in this disclosure may be used alone to perform a knotless surgical approach within the scope of the present disclosure.

[0161] For example, after the adjustable ring 216 of the surgical fixation system 210 has been positioned within a bone tunnel, such as a femoral or tibial bone tunnel, the first fixation device 212 can provide cortical bone fixation relative to the first bone. In an embodiment, the first fixation device 212 is a button. However, fixation devices having various other configurations can alternatively be used. The first fixation device 212 can be oblong or circular and can be made of a metal material or a polymer material.

[0162] In an embodiment, the first fixation device 212 includes one or more holes 218 formed through the body of the first fixation device 212. The holes 218 can be constructed and arranged to receive the adjustable ring 216. Some of the holes 218 can optionally carry one or more additional filaments for manipulating or controlling the first fixation device 212 or enhancing fixation during the surgical procedure. For example, the threaded filament 248 can be passed through one of the holes 218 and carried by the first fixation device 212 in addition to the adjustable ring 216. Furthermore, although not shown in this embodiment, additional fixation devices can optionally be connected to the adjustable ring 216.

[0163] In an embodiment, the adjustable loop 216 is made of a flexible material and may include adjustable length and / or circumference. The adjustable loop 216 may include a first free-braided strand 220A and a second free-braided strand 220B. The first free-braided strand 220A and the second free-braided strand 220B may be pulled to reduce the size of the adjustable loop 216. In an embodiment, the first free-braided strand 220A extends from a first spliced ​​section 222A of the adjustable loop 216, and the second free-braided strand 220B extends from a second spliced ​​section 222B of the adjustable loop 216. The first spliced ​​section 222A may include a first locking mechanism 224A, and the second spliced ​​section 222B may include a second locking mechanism 224B. The first locking mechanism 224A and the second locking mechanism 224B prevent the first and second free-braided strands 220A, 220B from being unintentionally loosened.

[0164] The adjustable ring 216 may additionally include two adjustable grommet rings 226A, 226B (at Figure 39 22B). The two adjustable grommets 226A, 226B can be interconnected at interconnection 235. The two adjustable grommets 226A, 226B can be formed by splicing flexible material, forming the adjustable loop 216 by itself (i.e., by each of the spliced ​​sections 222A, 222B). In this embodiment, two strands extend from each of the spliced ​​sections 222A, 222B to form each of the adjustable grommets 226A, 226B. Therefore, the adjustable loop 216 is considered a four-strand loop. However, the adjustable loop 216 can be configured in various other configurations, including but not limited to similar Figure 1 The double-strand configuration of the adjustable ring is similar to Figure 7 The adjustable rings can be in a six-strand configuration or any other configuration.

[0165] The adjustable loop 216 can be connected to the first fixture 212 before fully forming the adjustable loop 216. The first and second free braiding strands 220A, 220B can be pulled to restrict the size of the adjustable grommet loops 226A, 226B and thus change the overall size of the adjustable loop 216.

[0166] The adjustable ring 216 may also include one or more transition regions 281 where the flexible material of the adjustable ring 216 transitions between a flat section 283 and a round (i.e., tubular) section 285. Thus, the adjustable ring 216 may be referred to as a flat-round adjustable ring construction having a flat-round configuration.

[0167] In an embodiment, the first and second free braided strands 220A, 220B and the adjustable grommets 226A, 226B establish a flat section 283 of the adjustable loop 216, and the first and second spliced ​​sections 222A, 222B establish a rounded section 285 of the adjustable loop 216. The flat-round configuration of the adjustable loop 216 can provide numerous benefits and advantages. For example, the relatively wide flat section 283 of the adjustable grommets 226A, 226B provides increased surface area for receiving a graft and, once looped on the interconnect 235, is "softer" on the graft. Additionally, the relatively wide flat section 285 of the first and second free braided strands 220A, 220B provides increased surface area for gripping and is generally less abrasive than conventional sutures when gripped by a surgeon or other surgical staff. Furthermore, the flat sections 285 of the first and second free braided strands 220A, 220B are more easily accommodated within the tubular cross-sections of the rounded sections 285 of the first and second spliced ​​sections 222A, 222B, thereby simplifying the splicing process and overall use of the adjustable ring 216 .

[0168] Figure 40 An exemplary flexible strand 287 is shown that can be used to form the adjustable loop 216 or any of the other adjustable loops described herein. The flexible strand 287 can be a filament, such as a suture or any other soft, flexible material strand, that includes both a flat section 289 and one or more rounded sections 291. In embodiments, both the flat section 289 and the rounded sections 291 can be braided. The flat section 289 can resemble the shape and configuration of a flat suture tape, and the rounded sections 291 can resemble the shape and configuration of a cored or coreless tubular suture. Once the desired splicing operation is performed on the flexible strand 287, the flat section 289 creates the flat section 283 of the adjustable loop 216, and the rounded sections 291 create the rounded sections 285 of the adjustable loop 216. During the splicing operation, the flat section 289 can be passed through a pre-formed opening formed in the rounded sections 291 or between individual braids of the rounded sections 291.

[0169] In an embodiment, the rounded section 291 is an intermediate section of the flexible strand 287 disposed between the two flat sections 289 (see FIG. Figure 40 In another embodiment, the flexible strand 287 alternates between flat sections 289 and rounded sections 291 throughout its length (see Figure 41 ). The total number of flat sections 289 and rounded sections 291 provided within the flexible strand 287 can vary depending on the design of the adjustable ring 216. Therefore, other configurations for the flexible strand 287 are further contemplated within the scope of the present disclosure. Additionally, Figure 40 and Figure 41The flexible strand 287 is not drawn to scale, and thus, the relative proportions between the flat section 289 and the rounded section 291 are not intended to be limiting of the present disclosure.

[0170] Continue to refer Figures 38-41 , Figure 42 A surgical fixation system 210 is schematically illustrated as being employed within an exemplary surgical procedure. In the illustrated embodiment, the surgical procedure is an ACL reconstruction procedure involving a human knee. However, it should be understood that the present disclosure is not limited to ACL reconstruction procedures, and that the surgical fixation system 210 may be employed in a variety of repair and / or reconstruction procedures within the scope of the present disclosure.

[0171] The surgical fixation system 210 can be implanted within a joint 245 (e.g., a knee joint) to repair torn tissue (e.g., a torn ACL). Prior to positioning the surgical fixation system 210 within the joint 245, a first bone tunnel 293 (e.g., a socket or passageway) is formed in a first bone 295 (e.g., a femur), and a second bone tunnel 297 (e.g., a socket or passageway) is formed in a second bone 299 (e.g., a tibia). The first bone tunnel 293 and the second bone tunnel 297 can be formed using known drilling techniques to create voids within the first bone 295 and the second bone 299 for accommodating the surgical fixation system 210.

[0172] In an exemplary embodiment, the surgical fixation system 210 is implanted by passing the fixation device 212 through the first bone tunnel 293 and the second bone tunnel 297. The fixation device 212 can be pulled through the first bone tunnel 293 and the second bone tunnel 297 using a passing filament 248, and the fixation device is configured to self-rotate onto the cortex of the first bone 295 once tension is released on the passing filament 248.

[0173] After threading and inverting the fixation device 212, the adjustable ring 216 is positioned within the first bone tunnel 293. The free braided strands 220A, 220B can be pulled to adjust the size of the adjustable ring 216 and help position the graft 300 within the first bone tunnel 293. The adjustable ring 216 can suspend the graft 300 within portions of the first bone tunnel 293 and the second bone tunnel 297. The graft 300 can be a soft tissue graft, a bone-tendon-bone (BTB) graft, or any other suitable graft.

[0174] Fixation of the graft 300 relative to the second bone 299 can be achieved in a variety of ways. For example, the graft 300 can be fixed within the second bone tunnel 297 using additional fixation devices such as interference screws, suture anchors, or buttons.

[0175] The surgical fixation system of the present disclosure provides a knotless, adjustable suture loop-based arthroscopic soft tissue repair device and associated methods for performing joint stabilization, tissue repair, tissue reconstruction, and other similar surgical methods. In some embodiments, the exemplary surgical fixation system provides a combination of two or more locking mechanisms for increasing fixation strength. Compared to isolated button or suture locking constructs that require multiple loop strands, the improved construct stability allows the number of loading strands to be reduced (e.g., a 2-strand loop design) to achieve similar strength. The reduced suture loop material of the 2-strand loop embodiment can also reduce the bone tunnel diameter, thereby reducing the risk of tissue (e.g., bone) fracture / failure caused by repair / reconstruction.

[0176] In other embodiments, exemplary surgical fixation systems can provide repair / reconstruction optimization by providing the ability to re-tension the adjustable loop after implantation. The re-tensioning feature provides the surgeon with more flexible intraoperative management options after primary fixation, which is beneficial compared to final fixation achieved by knot tying. Single-loop tensioning and equally distributed load within the adjustable suture loop construction reduce the risk of suture loop overload.

[0177] In other embodiments, an exemplary surgical fixation system may include at least two adjustable-length loops having separate locking mechanisms for enabling independent soft suture construct deployment and tissue repair / reconstruction. The separate locking mechanisms of the proposed surgical fixation system design allow for maintaining tension in the adjustable loop construct, thereby improving the pull-out strength of the soft suture construct. Additionally, improved internal bone fixation and overall mechanical stability of the soft suture construct can be achieved by routing the freely braided strands of the adjustable loops of the soft suture construct through the locking mechanisms of the separate repair / reconstruction adjustable loops.

[0178] In other embodiments, the exemplary surgical fixation system may employ a flat-round adjustable ring configuration. The flat-round configuration of the adjustable ring provides increased strength, increased graft receiving surface area, and increased surface area to improve grip of the ring for shortening the thigh.

[0179] Although different non-limiting embodiments are described as having specific components or steps, the embodiments of the present disclosure are not limited to those specific combinations. It is possible to use some components or features from any non-limiting embodiment in combination with features or components from any other non-limiting embodiment.

[0180] It should be understood that throughout the several drawings, like reference numerals identify corresponding or similar elements.It should also be understood that although particular component arrangements are disclosed and shown in these exemplary embodiments, other arrangements may also benefit from the teachings of this disclosure.

[0181] The foregoing description should be interpreted as illustrative rather than in any restrictive sense. It will be appreciated by those skilled in the art that certain modifications may fall within the scope of this disclosure. For these reasons, the following claims should be studied to determine the true scope and content of this disclosure.

Claims

1. A surgical fixation system comprising: a first fixing device; an adjustable ring connected to the first fixing device; a single freely braided strand configured to adjust the size of the adjustable loop; a first locking mechanism established by a single spliced ​​section of the adjustable ring; as well as a second locking mechanism, the second locking mechanism being independent of the first locking mechanism, wherein the second locking mechanism is established by a combination of features of the first fixing device and the adjustable ring, wherein the first securing device is a first button, and the system includes a second securing device connected to the adjustable ring and configured as a second button, wherein the first button includes a first hole, a second hole and a suture return hole, and the single free-braided strand extends from the single spliced ​​section of the adjustable loop, through the suture return hole and then under the fixed loop section of the adjustable loop, the fixed loop section resting on top of a bridge member of the first button disposed between the first hole and the second hole to establish a second locking mechanism, and further wherein, in the locked position of the second locking mechanism, the single free-braided strand is tensioned by the fixed loop section against the outer surface of the bridge member.

2. The system of claim 1, wherein the first fixation device is a button and the system comprises a second fixation device connected to the adjustable ring and configured as a screw or suture anchor.

3. The system of claim 1, wherein the first locking mechanism is a finger capture mechanism of the adjustable ring.

4. The system of claim 1 , wherein the adjustable ring comprises: said single spliced ​​segment; a single free braided strand extending from the single spliced ​​section; the first locking mechanism; a single adjustable grommet ring extending from the single splicing section in a first direction; as well as A retaining ring segment extends from the single spliced ​​segment in a second direction.

5. The system of claim 1 , comprising a filament separate from the adjustable loop, the filament extending between a fixed loop section of the adjustable loop and the first securing device, and wherein the filament is capable of being tensioned to move the fixed loop section, thereby releasing the single free braided strand for use in adjusting the size of the adjustable loop.

6. The system of claim 1, wherein the adjustable ring comprises a flat-round configuration.

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