Devices and methods for joint repair

Abstract

Method and device for tissue fixation. A cortical button with a rib between two slotted openings. The rib increases the structural rigidity of the cortical button without increasing palpability. The adjustable loop structure provides manageable loop shortening and improved tissue coupling by having two independent locking passages. The adjustable loop structure may be coupled to tissue via a pass-through structure. An assembly including a shortening bar, a button, and an adjustable loop structure is prepared in an assembled state in a disassembly first configuration to guide steps for tissue fixation. A shortening bar may be assembled to the shortening bar to shorten the adjustable loop structure.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a PCT application claiming priority to U.S. Provisional Application No. 63 / 179,654, filed April 26, 2021, entitled "DEVICES AND METHODS FOR TISSUE REPAIR," and U.S. Provisional Application No. 63 / 278,644, filed November 12, 2021, entitled "DEVICES AND METHODS FOR TISSUE REPAIR," which are incorporated by reference in their entireties herein.

[0002] The present disclosure relates to methods and devices for joint repair, including implant fixation in surgical repair. [Background technology]

[0003] Damaged natural soft tissues (such as ligaments and tendons of a joint) may generally be replaced or repaired arthroscopically. In some joint repairs, a tissue fixation system having an adjustable loop structure may be coupled to the graft (and / or natural soft tissue) and inserted along the bone tunnel. The adjustable loop structure may then be adjusted or shortened to position the graft at a target location along the bone tunnel and secured in place using a tissue anchor such as a cortical button. The cortical button may define a thin body that supports a fixation load on the adjustable structure while lying flat on the outer bone surface to limit palpability. The related art cortical button may bend under this fixation load. The related art adjustable loop structure may loosen due to loop slip or creep under such load. The related art adjustable loop structure may require significant force to shorten the adjustable loop structure to position the graft. The related art fixation system may require complex assembly and management to proceed through each step of the procedure. The fixation systems of the related art may require a large amount of force to couple the implant to the system, which may result in damage to the tissue and / or implant, or to the adjustable loop structure. Thus, there is a need for an improved fixation system with associated methods that addresses the shortcomings of the related art. Summary of the Invention

[0004] Described herein are various improvements in methods and devices for tissue fixation using loop structures that may be adjustable and formed from flexible strands. The flexible strands may include sutures, suture tapes, cables, wires, or ribbons. The sutures may include hollow braided sutures. Such improvements may include examples of tissue anchors that are partially assembled using adjustable loop structures, or may include examples of tissue anchors that are further assembled after the adjustable loop structures are bonded to tissue, grafts, or second tissue anchors. The tissue anchors are preferably configured to retain sufficient stiffness to withstand tissue fixation loads. Such improvements may include adjustable loop structures that allow for shortening of the loop using easily accessible manual tension, and also provide a knotless locking configuration that withstands physiological cyclic loads. Such improvements may include an assembly including a shortening handle having a tissue anchor and an adjustable loop structure housed therein, the assembly configured in a manner to manage a step for removing the adjustable loop structure and anchor from the shortening handle for coupling the adjustable loop to tissue, a graft, or a second tissue anchor. The handle may also be configured to be reassembled to the adjustable loop structure for shortening the adjustable loop and positioning the tissue, a graft, or a second tissue anchor. Such improvements may include a pass-through structure operably coupled to the adjustable structure in a configuration that reduces a pass-through force required to pass the adjustable loop strand through the tissue or graft. Such improvements may include a method for attaching soft tissue or graft to the adjustable loop structure, which creates a low-bulk end of the soft tissue or graft while simultaneously providing a secure attachment.

[0005] For example, disclosed herein is a cortical button having an oval body with a length greater than its width. The oval body extends from a first end to a second end and defines a longitudinal axis. The width extends from a first sidewall to a second sidewall, the first and second sidewalls extending along and on opposite sides of the longitudinal axis between the first and second ends. The body also includes a bottom surface configured to engage an outer bone surface. The body further includes a pair of slotted openings extending through the entire thickness of the body for receiving a loop of flexible strand therethrough. The button includes a rib extending from the bottom surface of the body and disposed between the pair of slotted openings and coaxial with the pair of slotted openings along the longitudinal axis. The cortical button is configured to pass through a bone tunnel in a longitudinal orientation.

[0006] Some exemplary button embodiments may also include a pair of enclosed openings adjacent the pair of slotted openings. The rib may also be disposed between the pair of enclosed openings and may be coaxial along the longitudinal axis with the pair of enclosed openings. The cortical button may also include a first end opening disposed between the pair of slotted openings and the first end, and a second end opening disposed between the pair of enclosed openings and the second end. The first end opening and the second end opening may be axially spaced from the rib. The rib may be an oval solid body and may have a longitudinal axis aligned with and parallel to the longitudinal axis of the cortical button. Each of the pair of slotted openings may define an inner surface extending through a thickness of the cortical button and continuous with a side of the rib. Each of the pair of slotted openings may define a lateral opening through one of the first side wall or the second side wall, the rib being configured to compensate for a loss of structural integrity of the cortical button that is a result of the lateral opening. The rib may extend perpendicularly from the bottom surface less than 2 mm from the oval body of the cortical button. The rib may extend from the bottom surface and may define a rib thickness less than the thickness of the body.

[0007] Another exemplary cortical button is disclosed, the cortical button being an oval body having a length greater than a width, the length extending from a first end to a second end, and a longitudinal axis extending between the first end and the second end. The width extending from a first sidewall to a second sidewall, the first and second sidewalls extending along and on opposite sides of the longitudinal axis between the first end and the second end. The body also includes a bottom surface configured to engage an outer bone surface. The body also includes a pair of slotted openings extending through the entire thickness of the body for receiving a loop of flexible strand therethrough. The button anchor is a rib extending from the bottom surface and disposed between the pair of slotted openings, the rib further including a rib coaxial along the longitudinal axis with the pair of slotted openings. The width of the body is intended to define the minimum diameter of a bone tunnel that may pass through the cortical button, and the ribs are configured to increase the structural integrity of the cortical button while preserving the minimum diameter.

[0008] In some exemplary embodiments, each of the pair of slotted openings defines a lateral opening through one of the first side wall or the second side wall, and the rib is configured to increase structural integrity and compensate for reduced structural integrity due to the lateral openings. The body may also include a pair of enclosed openings adjacent the pair of slotted openings, and the rib is disposed between the pair of enclosed openings and is coaxial along the longitudinal axis with respect to the pair of enclosed openings. Each of the pair of slotted openings may define a lateral opening through one of the first side wall or the second side wall, and the rib is coaxial along the longitudinal axis with respect to the lateral openings. The body of the button may also include a first end opening and a second end opening axially spaced apart from the rib. The rib may be an oval solid body. The rib may be an oval body having a longitudinal axis aligned with and parallel to the longitudinal axis of the cortical button. Each of the pair of slotted openings may define an inner surface that extends through the thickness of the cortical button and is continuous with a side of the rib. The rib may extend perpendicularly from the bottom surface less than 2 mm from the body of the cortical button. The rib may extend from the bottom surface a distance less than the thickness of the body.

[0009] An adjustable tissue repair system is also disclosed that includes a tissue anchor having a plurality of apertures therethrough. The system also includes an adjustable loop structure formed from a flexible strand and coupled to the tissue anchor via the plurality of apertures. The adjustable loop structure includes a first adjustable eye splice loop extending through a first pair of the plurality of apertures. The adjustable loop structure also includes a second adjustable eye splice loop configured to couple to a second pair of the plurality of apertures. The adjustable loop structure also includes a saddle portion extending between the first and second adjustable eye splice loops and disposed at an end of the adjustable loop structure opposite the tissue anchor. The adjustable loop structure also includes a first limb and a second limb, the first limb being tensionable to shorten the first adjustable eye splice loop and the second limb being tensionable to shorten the second adjustable eye splice loop.

[0010] In some exemplary embodiments, each of the first and second eye splice loops includes a locking passage, each locking passage having two lengths of flexible strand therethrough. The saddle portion may define three lengths of flexible strand extending along the saddle portion between the locking passages. One of the three lengths of flexible strand may be a static strand, such that the static strand does not slide when adjusting the adjustable loop structure. The static strand defines a fixed or non-adjustable length portion of the adjustable loop structure. The fixed length portion may be between 0.10 inches and 0.5 inches. The fixed length portion during ACL repair may be about 0.25 inches. The tissue repair system may also include a passing structure including a threading member and a flexible loop, the flexible loop coupled to the saddle portion of the adjustable loop structure. The saddle portion may include three lengths of flexible strands, and the flexible loop may be threaded between the three lengths as a composite loop to limit sliding of the flexible loop along the adjustable loop structure. The flexible loop may be threaded between the three lengths of flexible strands of the saddle portion to stagger insertion of the three lengths along the graft. The flexible loop may be coupled to the saddle portion and may form a figure-of-eight loop around the three lengths of flexible strands. The figure-of-eight loop may include a first loop looped around a static length of the three lengths of flexible strands and a second loop looped around two dynamic lengths of the three lengths of flexible strands. The plurality of openings through the tissue anchor may include a pair of side slotted openings configured to selectively receive the second adjustable eye splice loop therethrough. The saddle portion may be directly coupled to the graft or tissue.Each of the first and second eye splice loops may extend from a corresponding first and second locking passage, with both the first eye splice loop and the first limb extending from a first end of the first locking passage and both the second eye splice loop and the second limb extending from a first end of the second locking passage.

[0011] Another adjustable tissue repair system embodiment is disclosed that includes a tissue anchor having a plurality of apertures therethrough and an adjustable loop structure formed from a flexible strand and coupled to the tissue anchor via the plurality of apertures. The adjustable loop structure may include a first adjustable eye splice loop extending from a first locking passage, the first adjustable eye splice loop extending through a first pair of apertures of the plurality of apertures. The adjustable loop structure may include a second adjustable eye splice loop extending from a second locking passage, the second adjustable eye splice loop configured to couple to a second pair of apertures of the plurality of apertures. The adjustable loop structure may include a saddle portion extending between the first and second adjustable eye splice loops and disposed at an end of the adjustable loop structure opposite the tissue anchor. The adjustable loop structure may include a first limb and a second limb, the first limb being tensionable to shorten the first adjustable eye splice loop and the second limb being tensionable to shorten the second adjustable eye splice loop. The system may include a pass-through structure including a threading member coupled to the flexible loop, the flexible loop being coupled to the saddle portion.

[0012] In some exemplary embodiments, the saddle portion includes three lengths of flexible strand. One of the three lengths of flexible strand may be a static length extending between and contiguous with the first and second locking passages. The static length may be between 0.10 inches and 0.5 inches long. Flexible loops of the pass-through structure may be threaded between the three lengths of flexible strand in the saddle portion to stagger insertion of the three lengths through the graft. The flexible loop may be coupled to the saddle portion and may form a figure-of-eight loop around the three lengths. The figure-of-eight loop may define a first loop looped around a static length of the three lengths of flexible strand and a second loop looped around two dynamic lengths of the three lengths of flexible strand. The first eye splice loop and the first limb may both extend from the first end of the first locking passage, and the second eye splice loop and the second limb may both extend from the first end of the second locking passage.

[0013] An exemplary method for coupling an adjustable tissue repair structure to an implant is also disclosed, the method including providing an adjustable tissue repair structure including a button, an adjustable loop structure, and a pass-through structure. The button includes a number of apertures therethrough. The adjustable loop structure is formed with a flexible strand and is coupled to the button at a first end of the adjustable loop structure via the number of apertures. The pass-through structure includes a flexible strand loop and a threading member, the flexible strand loop being formed separately from the adjustable loop structure and coupled to a second end of the adjustable loop structure opposite the first end. The method includes forming a stitch region in the graft by passing a passing structure through the graft in a first orientation toward a clamped end of the graft to attach an adjustable loop structure to the graft, and passing the passing structure through the graft in a second orientation opposite the first orientation toward a free end of the graft to attach a flexible strand loop to the graft.

[0014] In some exemplary methods, passing the passing structure in a first direction further includes pulling the adjustable loop structure through and around the graft at a location spaced apart from both the clamped end and the free end. The method may include passing the passing structure through the graft at a location adjacent to the adjustable loop structure threaded around the graft, thereby locking the adjustable loop structure in place along the graft. Passing the passing structure in a reverse direction may wrap a flexible strand loop around the graft and may also wrap a flexible strand loop over and around the adjustable loop structure. Passing the passing structure in a reverse direction may form at least two whipstitches along and through the graft.

[0015] The method may also include advancing the passing structure in the second direction to an edge of the free end of the graft, forming a knot in the flexible strand loop at the edge of the free end, removing the threading member from the flexible strand loop to leave a remainder length in the flexible strand loop, and pulling the free end of the graft through the remainder length and through and along the prepared bone tunnel.

[0016] The flexible strand loop may form a figure-eight loop, a first loop of the figure-eight loop at a second end around a first strand of the plurality of strands of the adjustable loop structure and a second loop of the figure-eight loop around a second strand of the plurality of strands, and passing the pass structure in a first orientation first passes the second loop, and therefore the second strand, through the graft and thereafter passes the first loop, and therefore the first strand, through the graft. Passing the pass structure in a second orientation may leave the first loop of the figure-eight loop on a first side of the graft and may pass the second loop of the figure-eight loop through the graft.

[0017] Another exemplary method is disclosed for coupling a suspension fixation system to an implant, the suspension fixation system including an adjustable loop structure and a pass-through structure coupled to the adjustable loop structure. The method includes inserting the pass-through structure through the implant and further advancing the pass-through structure in a first orientation toward a clamped end of the implant to stitch the adjustable loop structure through and along the implant to form a first stitched region along the implant. The method also includes inserting the pass-through structure through the implant and further advancing the pass-through structure in a second orientation toward a free end of the implant to stitch a flexible loop of the pass-through structure through and along the implant to form a second stitched region overlapping the first stitched region.

[0018] In some of these exemplary methods, advancing the pass structure in a first direction is initiated along a length of the graft spaced from the free end. Forming the first stitch region may be initiated about 2 cm from the free end of the graft. Inserting the pass structure through the graft and advancing the pass structure in a first direction may include inserting the pass structure through the graft a first time to stitch an adjustable loop structure through the graft and then inserting the pass structure through the graft a second time to secure the adjustable loop structure in place along the graft. Advancing the pass structure in a second direction may include inserting the pass structure through the graft a third and fourth time at axially spaced locations to form multiple stitches through the graft with the flexible loop. Passing the pass structure a third time may position the flexible loop onto the adjustable loop structure of claim 54, and inserting the pass structure a first, second, third, and fourth time through the graft may include passing the needle a first, second, third, and fourth time from the top outer surface of the graft to the bottom outer surface of the graft. After forming the first and second stitch regions, the method may include forming the free end of the graft into a tapered cylindrical shape by applying tension to the flexible loop. The method may also include first pulling the flexible loop through the prepared bone tunnel and then pulling the free end of the graft into the prepared bone tunnel.

[0019] In some exemplary methods, the flexible loop may form a composite loop, where a first loop of the composite loop is looped around a first strand of the plurality of strands of the adjustable loop structure and a second loop of the composite loop is looped around a second strand of the plurality of strands, and forming a first stitch area by first inserting the second loop through the graft and then inserting the first loop, thereby staggering the insertion of the plurality of strands to reduce the force required to form the first stitch area. By forming a second stitch area, the first loop of the composite loop may remain on the top surface of the graft and the second loop of the composite loop may be passed through the graft. The flexible loop may include a composite loop including a first loop and a second loop, where each loop is looped around a different strand of the adjustable loop structure, and only one of the first loop or the second loop may be advanced by advancing the passing structure in a second direction.

[0020] Also disclosed herein is a shortening bar for managing an adjustable loop structure with a pass-through structure and a button attached to the pass-through structure, the shortening bar including a plurality of channels, a spool, a recess, and a slot therethrough. The shortening bar accommodates the pass-through structure, the adjustable loop structure, and the button in a first configuration within the plurality of channels, slots, and spool in a configuration for gradual removal of the assembled components. To couple the adjustable loop structure to tissue, a graft, or a tissue anchor, the pass-through structure may first be removed from the shortening bar, then the adjustable loop structure may be removed, and then the button may be removed. After disassembly, the shortening bar may be reassembled with the adjustable loop structure in a second configuration different from the first configuration. In this second configuration, the shortening bar may be used to shorten the loop of the adjustable loop structure and may pull the tissue, graft, or tissue anchor toward the button when tension is applied to the adjustable loop structure via the shortening bar.

[0021] In some exemplary embodiments, the shortening bar includes a slot extending along a longitudinal axis of the shortening bar, the slot being contiguous with a recess, the slot being configured to retain a threading member of the passing structure, and the recess being configured to allow access to an end of the threading member for removal from the shortening bar. In the second configuration, the first looped rim of the adjustable loop structure may encircle a segment of a first spool of the shortening bar, the segment being defined by a notch through the first spool. In the second configuration, driving the shortening bar in rotation about the longitudinal axis of the shortening bar may initially form a fold along the first looped rim to limit slippage of the first looped rim around the first spool. The shortening bar may receive a button, exposing two slotted openings of the button. The shortening bar may receive a first portion of the adjustable loop structure around a first spool of the multiple spools and a second portion of the adjustable loop structure around a second spool of the multiple spools.

[0022] Another exemplary embodiment of a shortening handle for receiving and managing an adjustable loop structure is disclosed. The adjustable loop structure includes a first end assembled to a cortical button and a second end coupled to a threading member for coupling the second end to tissue, a graft, or a tissue anchor. The shortening handle defines a longitudinal axis and opposing lateral ends and includes a slot at one of the lateral ends for holding the cortical button. The slot may also orient a slotted opening of the cortical button to selectively receive the second end of the adjustable loop therethrough. The shortening handle may also include means for receiving the threading member and means directly adjacent to the threading member for accessing and selectively removing the threading member from the shortening handle. The shortened handle may also include first and second spools extending around an exterior surface of the handle, the first and second loops of the adjustable loop structure being receivable in the corresponding first and second spools, respectively.

[0023] In some exemplary embodiments, the means for accommodating the threading member includes a plurality of circumferential ribs defining channels on an exterior surface of the foreshortened handle, with cavities in the handle at the ends of the channels defining means for accessing and selectively removing the threading member. Each of the first and second spools may define an outermost channel defining a first path, each outermost channel intersecting a corresponding notch defining a second path around a segment of the first path on each spool. The first loop of the adjustable loop structure may be receivable along a notch in the first spool to position the first loop along the second path around the first spool. The second loop of the adjustable loop structure may be receivable along a notch in the second spool to position the first loop along the second path around the second spool. The second path around each spool may be configured to form a crease in each of the first and second loops to limit rotation of the first and second loops when the handle is rotationally driven about the longitudinal axis of the handle.

[0024] Also disclosed is a method for repairing tissue using a shortening bar pre-assembled with an adjustable loop structure, a cortical button, and a threading member. The method may include detaching the adjustable loop structure and the threading member from the shortening bar and coupling the adjustable loop structure to tissue, a graft, or a tissue anchor. The method may include coupling a first loop end and a second loop end of the adjustable loop structure to the shortening bar after it has been detached. Thereafter, tension may be applied to the first loop end and the second loop end via the shortening bar to shorten the adjustable loop structure and pull the tissue, graft, or tissue anchor toward the cortical button.

[0025] In some exemplary methods, removing the adjustable loop structure and the threading member may include removing the threading member from a channel of the shortening bar and thereafter unwinding a first portion of the adjustable loop structure from a first spool of the shortening bar. Coupling the adjustable loop structure may include inserting the adjustable loop structure through tissue, a graft, or a tissue anchor using the threading member. Removing the adjustable loop structure and the threading member from the shortening bar may be performed while holding a button housed within the shortening handle. Coupling may also include coupling a free looped end of the adjustable loop structure to a cortical button after coupling the adjustable loop structure to the tissue, a graft, or a tissue anchor. Coupling the free looped end may include inserting the threading member through an opening in a button housed within the shortening bar using an opening in the exterior of the shortening handle.

[0026] Coupling the first and second looped ends may include inserting the first looped end along a first notch of the shortening bar to position the first looped end around a segment of the first spool on the shortening bar, and inserting the second looped end along a second notch of the shortening bar to position the second looped end around a segment of the second spool on the shortening bar. The method may also include rotating the shortening bar about a longitudinal axis to wind the first and second looped ends around an outermost surface of the corresponding first and second spools, thereby shortening a length of the first and second looped ends. Rotating the shortening bar and applying tension to the first and second looped ends may be performed sequentially and repeatedly. The method may include removing the button after coupling the adjustable loop structure to the tissue, graft, or tissue anchor and before coupling the first and second looped ends to the shortening bar.

[0027] These and other features and advantages will become apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are illustrative and are not restrictive of the aspects set forth in the claims. [Brief description of the drawings]

[0028] The present disclosure will be more fully understood from the following detailed description taken in conjunction with the drawings, in which:

[0029] [Figure 1A] FIG. 1A illustrates a perspective view of a ribbed cortical button according to the present disclosure. [Figure 1B] FIG. 1B illustrates a bottom view of a ribbed cortical button according to the present disclosure. [Figure 1C] FIG. 1C illustrates an end view of a ribbed cortical button according to the present disclosure. [Figure 1D] FIG. 1D illustrates a side view of a ribbed cortical button according to the present disclosure. [Figure 1E] FIG. 1E illustrates a cross-sectional view of a ribbed cortical button along BB (shown in FIG. 1B) in accordance with the present disclosure. [Figure 1F] FIG. 1F illustrates a cross-sectional view of a ribbed cortical button along AA (shown in FIG. 1B) in accordance with the present disclosure. [Figure 1G] FIG. 1G illustrates an offset cross-sectional view (from the longitudinal axis) of a ribbed cortical button along the CC (shown in FIG. 1B) in accordance with the present disclosure. [Figure 2A] FIG. 2A illustrates a perspective view of another ribbed cortical button embodiment according to the present disclosure. [Figure 2B] FIG. 2B illustrates a bottom view of a ribbed cortical button according to the present disclosure. [Figure 3A]Figures 3A, 3B, 3C, 3D, 3E, and 3F illustrate an exemplary method for coupling an implant to a ribbed cortical button according to the present disclosure. Figure 3G illustrates a ribbed cortical button assembled using an adjustable loop structure and further assembled using a bone tunnel according to the present disclosure. [Figure 3B] Same as above. [Figure 3C] Same as above. [Figure 3D] Same as above. [Figure 3E] Same as above. [Figure 3F] Same as above. [Figure 3G] Same as above. [Figure 4A] FIG. 4A illustrates a top view of a thin cortical button according to the present disclosure. [Figure 4B] FIG. 4B illustrates a perspective view of a thin cortical button according to the present disclosure. [Figure 4C] FIG. 4C illustrates a bottom view of a thin cortical button according to the present disclosure. [Figure 4D] FIG. 4D illustrates a side view of a low-profile cortical button according to the present disclosure. [Figure 4E] FIG. 4E illustrates a cross-sectional view of a thin cortical button according to the present disclosure. [Figure 5A] FIG. 5A illustrates a perspective view of a thin cortical button according to the present disclosure. [Figure 5B] FIG. 5B illustrates another perspective view of a low profile cortical button according to the present disclosure. [Figure 5C] FIG. 5C illustrates a top view of a thin cortical button according to the present disclosure. [Figure 5D] FIG. 5D illustrates a bottom view of a low-profile cortical button according to the present disclosure. [Figure 5E] FIG. 5E illustrates a side view of a low profile cortical button according to the present disclosure. [Figure 6A] FIG. 6A illustrates a diagram of an adjustable loop structure coupled to a low-profile cortical button in accordance with the present disclosure. [Figure 6B]FIG. 6B illustrates a close-up view of an adjustable loop structure coupled to a low-profile cortical button in accordance with the present disclosure. [Figure 7] FIG. 7 illustrates an adjustable loop structure having two locking passages in accordance with the present disclosure. [Figure 8A] 8A, 8B, and 8C illustrate a method for forming the adjustable loop structure of FIG. 7 according to the present disclosure. [Figure 8B] Same as above. [Figure 8C] Same as above. [Figure 9A] FIG. 9A illustrates another adjustable loop structure having two locking passages in accordance with the present disclosure. [Figure 9B] 9B and 9C illustrate the formation of an adjustable loop structure having two locking passages in accordance with the present disclosure. [Figure 9C] Same as above. [Figure 10] FIG. 10 illustrates another adjustable loop design having four locking passages in accordance with the present disclosure. [Figure 11A] FIG. 11A illustrates a perspective view of a shortening bar according to the present disclosure. [Figure 11B] FIG. 11B illustrates a front view of a shortening bar according to the present disclosure. [Figure 11C] FIG. 11C illustrates another view of a shortened bar with buttons assembled thereto according to the present disclosure. [Figure 11D] FIG. 11D illustrates a bottom view of a shortened bar with assembled button anchors according to the present disclosure. [Figure 11E] FIG. 11E illustrates a top view of a shortening bar with assembled button anchors according to the present disclosure. [Figure 12A] FIG. 12A illustrates a suspension fixation system and portions thereof according to the present disclosure. [Figure 12B] 12B and 12C illustrate a portion of a suspension fixation system assembled to a shortening bar in accordance with the present disclosure. [Figure 12C] Same as above. [Figure 13A] FIG. 13A illustrates an adjustable loop structure assembled to a shortened bar in a shortened configuration in accordance with the present disclosure. [Figure 13B] FIG. 13B illustrates a cross section of a shortened bar spool assembled to a loop formed by a limb of an adjustable loop structure in accordance with the present disclosure. [Figure 13C] FIG. 13C illustrates the loop ends relative to the rim of an adjustable loop structure wrapped around the periphery of a cross section of a shortened bar spool in accordance with the present disclosure. [Figure 13D] FIG. 13D illustrates a method for shortening the rim length of an adjustable loop structure (Step 1) and a method for shortening the circumferential length of an adjustable loop structure (Step 2) in accordance with the present disclosure. [Figure 14] FIG. 14 illustrates an adjustable loop structure coupled with a pass-through loop structure in accordance with the present disclosure. [Figure 15] FIG. 15 illustrates a saddle portion of an adjustable loop structure with a pass-through loop structure joined in a figure-of-eight configuration in accordance with the present disclosure. [Figure 16A] 16A and 16B illustrate views of a saddle portion in an adjustable loop structure with a pass-through structure joined in a split luggage tab configuration in accordance with the present disclosure. [Figure 16B] Same as above. [Figure 17A] 17A, 17B, 17C, 17D, 17E, 17F, 17G, 17H, 17I, and 17J illustrate methods for coupling adjustable loop structures and pass-through loop structures to an implant according to the present disclosure. [Figure 17B] Same as above. [Figure 17C] Same as above. [Figure 17D] Same as above. [Figure 17E] Same as above. [Figure 17F] Same as above. [Figure 17G] Same as above. [Figure 17H] Same as above. [Figure 17I] Same as above. [Figure 17J] Same as above. [Figure 18A] FIG. 18A illustrates a top view of the stitch configuration after a first pass (FIG. 17E) according to the method disclosed in FIGS. 17A, 17B, 17C, 17D, 17E, 17F, 17G, 17H, 17I, and 17J. [Figure 18B] FIG. 18B illustrates a top view of the final stitch configuration according to the method disclosed in FIGS. 17A, 17B, 17C, 17D, 17E, 17F, 17G, 17H, 17I, and 17J. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] In the following description, like components are provided with the same reference numerals, whether shown in different examples. To illustrate the example(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features described and / or illustrated with respect to one example may be used in the same or similar manner in one or more other examples and / or may be used in the same or similar manner in combination with or instead of features of the other examples.

[0031] When used in the specification and claims, for purposes of describing and defining the present invention, the terms "about" and "substantially" are used to express the inherent degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" are also used herein to express the degree to which a quantitative representation may vary from a specified standard without causing a change in the basic functionality of the subject matter under consideration. The plural forms of "comprise", "include", and / or are open ended and include the recited items, and may include additional items that are not recited. "And / or" is open ended and includes one or more of the recited items, and includes combinations of the recited items. The use of "upper", "lower", "upward" and similar terms is intended only to aid in the clarity of the disclosure, and is not intended to limit in any manner the structure, positioning, and / or operation of the disclosure.

[0032] Some of the structures disclosed herein include "locking passages," which may sometimes be referred to in the art as splices, eye splices, cradles, suture locking regions, cinches, finger cinches, finger traps, longitudinal passages, or expansion regions. These are defined by lengths of braided flexible strands having a hollow core through which a long strand may be received. The long strand may be another portion of the flexible strand or may be another separate flexible strand, and further, the long strand may extend along a path that extends from the outside of the braided flexible strand (and outside of the locking passage) and then through the braids to enter the hollow core (lumen) and also along a path that leads out through the braid wall a distance along the braided flexible strand. Multiple lengths of the flexible strand may extend along and through the hollow core at spaced locations, thereby defining multiple locking passages. Multiple lengths of the elongate strand may extend along and through the hollow core at the same location. The braided flexible strand may first expand to form an expanded or laterally extending length and then receive the elongate member therein. The locking passage is configured such that tension on the braided hollow flexible strand contracts its radius, thereby locking or tightening around the elongate strand extending therethrough, thereby locking the elongate strand in place. This defines a "locking passage." The flexible strand may be a suture, suture tape, ribbon, or a flexible tubular cable.

[0033] Cortical Button Embodiment FIG. 1A illustrates a perspective view of a cortical button 100 (hereinafter, "button 100") according to an exemplary embodiment. The button 100 operably couples to a flexible strand 30 (shown in FIGS. 3A, 3B, 3C, 3D, 3E, 3F, 3G, and 3H) via a plurality of openings forming a passageway through the button 100. The flexible strand 30 may be a suture, tape, wire, or cable, and may be formed in an adjustable loop structure as disclosed in more detail below. The button 100 and flexible strand 30 may be coupled to an implant and may suspend the implant along a bone tunnel, for example, to repair an ACL in a patient's knee. In other exemplary joint repairs, the button 100 and flexible strand 30 may be coupled to another tissue anchor, such as a second button, a soft anchor, or other tissue anchor known in the art. When coupled to another tissue anchor, the button 100 and flexible strand 30 may couple a first bone to a second bone, or a first bone segment to a second bone segment, where both segments may be parts of the same bone. For example, the button 100 may form part of a repair structure for an AC joint or for an ankle syndesmosis repair.

[0034] The button 100 may define a pass-through button, in that it is generally an oval body with a width smaller than its length. The pass-through button may be oriented in a pass-through direction to pass through the bone tunnel, which approximates the anchor width and thus maintains a minimal opening size. After passing through the bone tunnel, flipping the button 100 to the deployed configuration (shown in FIG. 3G) prevents the button 100 from moving retrogradely into the tunnel, since the button length is greater than the opening size of the bone tunnel. In the deployed configuration, the button 100 engages against the outer surface of the cortical bone. The button 100 may be a flat, oval, unitary body with rounded edges. The button 100 is preferably thin to limit palpability on the surface of the cortical bone.

[0035] The button 100 may include a number of openings therethrough, each sized to receive a flexible strand 30 therethrough and to couple the flexible strand 30 to the button. The flexible strand 30 may be formed, at least in part, into a number of loops in the form of an adjustable loop structure (further described in Figures 3A, 3B, 3C, 3D, 3E, 3F, 3G, and 3H), and the number of openings may couple the adjustable loop structure to the button 100. The number of openings may be sized to allow the flexible strand 30 to slide therethrough.

[0036] More specifically, the button 100 can be rotated 360 degrees ( °) may include a pair of openings 110a, 110b that may define an encircling hole. The openings 110a, 110b may be located directly opposite one another on opposite sides of the button with respect to the longitudinal axis LL. The openings 110a, 110b may define an oval or elliptical opening with a length along the longitudinal axis LL greater than a corresponding width. The openings 110a, 110b may be sized and spaced apart to slidably receive a first loop of an adjustable loop structure formed from the flexible strand 30. The first loop may be pre-assembled and prepared with respect to the button 100 and may therefore be referred to as a pre-assembled loop. The button 100 may also include a pair of slotted openings 120a, 120b, each having a side opening (121a, 121b) for receiving a second loop of the adjustable loop structure therethrough so that the second loop can be assembled to the button 100 during a procedure. The slotted openings 120a, 120b may be spaced apart from the second loop, which may be introduced through the side openings 121a, 121b during a surgical procedure so that the second loop can be assembled to the button 100. The second loop may thus be referred to as a free loop. The slotted openings 120a, 120b may define an oval or elliptical opening, similar to the openings 110a, 110b, having a length along a longitudinal axis greater than its width. The slotted openings 120a, 120b may be located directly opposite one another on opposite sides of the button relative to the longitudinal axis LL. The slotted openings 120a, 120b and openings 110a, 110b may have the same opening size and shape, except that the slotted openings 120a, 120b include side openings 121a, 121b.

[0037] The button 100 defines an elongated body having opposed curvilinear ends 105a, 105b and lateral sides 106a, 106b. The openings 110a, 110b, 120a, 120b may be spaced from the ends 105a, 105b toward a central portion 138 of the button 100. The button also includes another pair of openings 135a, 135b. The opening 135a is located between the central portion 138 and the lateral end 105a. The openings 135a, 135b may be larger in size than the openings 110a, 110b, 120a, 120b and may define oval openings as defined herein.

[0038] The button 100 also defines a top surface 108 and a bottom surface 107, both of which may be smooth surfaces. The top surface 108 and the bottom surface 107 may define planes parallel to one another. The bottom surface 107 of the button is configured to engage an outer portion of a bone. In some embodiments, the bottom surface 107 of the button may be contoured to match the outer surface of the target bone surface. Buttons with apertures and slotted apertures, as well as exemplary adjustable loop structures, are disclosed in commonly-owned PCT Patent Application No. PCT / US20 / 038401, filed June 18, 2020, entitled "METHODS AND DEVICES FOR TISSUE GRAFT FIXATION," which is commonly-owned and incorporated herein by reference in its entirety.

[0039] As described herein, a surgical fixation system using a cortical button may operate to couple and suspend an implant within and along a bone tunnel of a joint, and thus may be loaded during use. Assembling the button to an adjustable loop structure during a procedure, as opposed to a button being prepared in a fully pre-assembled state, may provide an improved method for coupling the fixation system to an implant. However, the side openings 121a, 121b that allow for assembly during a procedure may reduce the structural integrity of the button compared to an enclosed opening (a hole that is enclosed 360 degrees). This may be compensated for by increasing the overall thickness (T) of the button body, but increasing the thickness is less preferred as it may increase tactility or localized tissue irritation. Thus, the button 100 includes an oval rib 140 extending from the bottom surface 107 that is configured to increase the stiffness of the button and to compensate for the button being configured to receive a free loop of the flexible strand 30 during a procedure. The ribs 140 are sized to fit within and extend along the bone tunnel with surface 107 engaged against the outer cortical surface of the bone surrounding the bone tunnel. The ribs 140 are configured to increase the structural stiffness of the button under functional loads without increasing the thickness (T) of the button that protrudes from the outer bone surface. The ribs 140 may be configured to compensate for reduced structural integrity while maintaining a minimum thickness T.

[0040] The ribs 140 may also assist in centering the elongated button 100 and in preventing the button from moving relative to the bone tunnel axis. Thus, the ribs 140 have a length that extends substantially across the opening size (diameter) of the bone tunnel and extends substantially axially along and into the bone tunnel while still conforming along the restricted bone tunnel diameter, where the restricted bone tunnel diameter is defined by the width of the button body as shown in FIG. 1C. In other words, referring to FIG. 1C, the cross section of the button including the button body and the ribs has an outer perimeter boundary located within a diameter (φD) defined by the width of the button body. For example, if the diameter of the tunnel opening is 4.5 mm, the width of the button body is 4.2 mm, and the length of the ribs is preferably less than 4.0 mm and greater than 2.0 mm. More specifically, in this example, the length of the ribs is a length L R The rib 140 may be at least 1.5 mm (T R ). Ribs 140 may be solid or hollow in cross section, as their purpose is to maintain the position of the button relative to the bone tunnel rather than structural rigidity. Thus, exemplary ribs may be annular oval rings, or may be a number of small spaced apart posts configured to lie inside the target bone tunnel and maintain the position of the button relative to the bone tunnel axis.

[0041] 1B, the rib 140 is disposed along the longitudinal axis LL and between the openings 110a, 110b, 120a, 120b. The rib 140 is also disposed along the central portion 138 of the button 100. The rib 140 may be equally spaced apart from the ends 105a, 105b. The rib 140 has a length L extending along the longitudinal axis LL. R1, with the openings 135a, 135b located adjacent the ends of the rib 140. The rib 140 and the openings 135a, 135b may lie along a longitudinal axis LL. The longitudinal axis may divide the rib 140 and the openings 135a, 135b in two. The rib 140 is axially spaced from both the openings 135a, 135b. The rib 140 may have a width narrower than the corresponding widths of the openings 135a, 135b. The length L of the rib R The rib length L may approximate the diameter of the bone tunnel, allowing the surface 107 to engage against the outer bone surface while fitting inside the bone tunnel. R The rib 140 may axially overlap at least a portion of both openings 110a, 110b and 120a, 120b. The rib 140 may preferably axially overlap the side openings 121a and 121b. The rib 140 may axially overlap the entire side openings 121a, 121b. Stated differently, the rib 140 defines an elongated body having a first end 141a and a second end 141b, where the second end 141b is generally disposed axially closer to the button end 105b than both the side openings 121a, 121b. The second end 141b may also be generally disposed axially closer to the button end 105b than both the slotted openings 120a, 120b. The ribs 140 are configured to add structural reinforcement to the button 100 while allowing the thickness T to be maintained low above the bone surface. The ribs 140 may compensate for the loss of structural integrity due to the side openings 121 a, 121 b.

[0042] As seen most clearly in Figures 1A and 1G, the rib 140 may define planar sides 143a, 143b that may be parallel to the longitudinal axis LL and parallel to each other. The planes 143a, 143b may coincide with the inner edge surfaces 111a, 111b, 122a, 122b of the slotted openings 120a, 120b and the openings 110a, 110b. Each of the planes 143a, 143b may be continuous with the inner edge surfaces 111a, 111b of the openings 110a, 110b and with the inner edge surfaces 122a, 122b of the slotted openings 120a, 120b. All of the inner edge surfaces 111a, 122a and the planes 143a may lie in a single planar vertical plane. The inner edge surfaces 111b, 122b and the plane 143b may all lie in a single planar vertical plane.

[0043] 1E and 1F, the ribs 140 may extend from the bottom surface 107 and define a solid cross section without voids. The ribs 140 may extend perpendicularly from the bottom surface 107 of the button, thereby defining a rib thickness T R The thickness of the button "T" and the thickness of the rib "T R The sum of "φD" and "φD" may be less than or equal to the width of the button 100 to fit along the bone tunnel (FIG. 1C). FIG. 1C illustrates an exemplary bone tunnel having a diameter "φD" in contrast to the button 100 in a long (pass-through) orientation. The ribs 140 are 1-3 mm (T R ). Rib 140 may define a bottom surface 142 that is planar, and bottom surface 142 is parallel to bottom surface 107. In other embodiments, bottom surface 142 may be curved.

[0044] In other embodiments, the cortical buttons may include four apertures in locations similar to apertures 110a, 110b, 120a, 120b that define a hole that is surrounded by 360 degrees. These exemplary cortical buttons may be oval, may be pass-through buttons as defined herein, and may include oval ribs similar to rib 140. In this embodiment, compensation for slots such as slots 121a, 121b is not required, although the inventors have found that these buttons also benefit from the centering surface provided by rib 140.

[0045] 2A and 2B illustrate another exemplary ribbed button 200, which is similar to embodiment 100 except where noted. In this embodiment, the openings 210a, 210b, 220a, 220b may define circular shaped openings. The ribs 240 may define sides 243a, 243b that coincide with the inner edge surfaces 211a, 211b, 222a, 222b of the openings 210a, 210b, 220a, 220b. The sides 243a, 243b may be concave. The side surfaces 243a, 243b may be continuous with the inner edge surfaces 211a, 211b, 222a, 222b of the openings 210a, 210b, 120a, 220b, and each opening 210a, 210b, 120a, 220b may define a single curved vertical surface through the thickness of the button 200 including the rib 240. In other words, the rib 240 may conform to the shape of the inner surface of the opening. The rib 240 preferably overlaps axially at least the slot side openings 221a, 221b. The rib 240 may extend toward both ends 205a, 205b of the button compared to the openings 210a, 210b, 220a, 220b.

[0046] An exemplary tissue repair method using the button 100 is illustrated in Figures 3A, 3B, 3C, 3D, 3E, 3F, and 3G. The button 200 may alternatively be used. In preparation for tissue repair, a tunnel 14 (Figure 3G) may first be formed through at least one bone 10 of the joint, and an implant 5 may be prepared with a bone block 6. A hole 6a may be drilled through the bone block 6. A suspension fixation system 280 may be prepared that includes the button 100 partially assembled to a flexible strand 30, which is formed into an adjustable loop structure 32. The adjustable loop structure 32 may include a first limb or first looped end 33a, a second limb or second looped end 33b, an assembled adjustable loop 35a, and a free adjustable loop 35b. The assembled adjustable loop 35a may be pre-assembled or prepared for the button 100 through two openings similar to openings 110a, 110b. The button 100 may include ribs 140 (not shown in FIGS. 3A and 3B for ease of illustration). At least one locking passage 38 (as defined herein) may be formed by the flexible strand 30. The button 100 may be passed through the bone tunnel 14 with the assembled adjustable loop 35a pre-assembled. The button 100 may then be inverted to engage against the outer cortical surface of the bone 10 (FIG. 3G).

[0047] The second looped end 33b and the free adjustable loop 35b may be coupled to the tissue graft 5. The second looped end 33b and the free adjustable loop 35b may be provided or prepared coupled to the pass-through structure 300. The pass-through structure 300 may be passed through the bone block hole 6a to pull the looped end 33b and the free adjustable loop 35b through the bone block 6. The pass-through structure 300 may be passed through the bone block hole 6a to pull the locking passage 38 through the bone block hole 6a to position the locking passage 38 within the bone block hole 6a. The bone block hole 6a may be sized to receive the locking passage 38, and the locking passage 38 may include at least three lengths of the flexible strand 30. After the adjustable loop structure 32 is coupled to the graft 5, the free adjustable loop 35b may be separated from the pass-through structure 300 (FIG. 3B) and looped up the top surface 108 of the button (button 100 is shown) and into the slotted openings 120a, 120b as shown in FIGS. 3C and 3D. The looped end 33b may remain coupled to the pass-through structure 300 while the free adjustable loop 35b is being inserted into the slotted openings 120a, 120b. The looped end 33b may then be inserted through the opening 135b (FIGS. 3E and 3F) using the pass-through structure 300, after which the pass-through structure 300 is separated from the looped end 33b. The suspension structure is now coupled to the graft 5 in a closed assembly configuration with the loop end 33b and the adjustable loop end 35b assembled to the button 100 and the pass-through structure 300 separated from the button 100. The suspension structure in the closed assembly configuration may then be passed through the bone tunnel 14.

[0048] The looped end 33b may be inserted through the opening 135b using the threading member 305 of the pass-through loop structure 300 (FIG. 3G). Tension on the rim ends 33a, 33b may shorten the adjustable loop structure 32, pulling the graft 5 towards the button 100. FIG. 3G illustrates the button 100 engaged onto a bone tunnel 14 formed through the bone 10 and against the cortical layer of the bone 12. The ribs 140 extend into the bone tunnel 14. For a tunnel diameter of 4.5 mm, the ribs 140 are preferably of length L less than 4.5 mm. R The ribs 140, 240 may have a length L R The width of the rib 140 may be approximately 3.5 mm, leaving room for the rim ends 33a, 33b to extend around the ribs 140, 240 and through the openings 135a, 135b. The ribs 140 may be between 1 mm and 2 mm wide, and more preferably about 1.3 mm wide. The ribs 140, 240 may extend 1 mm to 2 mm into the bone tunnel 14.

[0049] In an alternative method, the adjustable loop structure 32 may be coupled to another tissue anchor instead of or in addition to the tissue graft 5. For example, the method may include coupling another tissue anchor to the adjustable loop structure 32 and then coupling the tissue anchor to a second bone. The second bone may be a different bone than bone 10 or may be a different segment of bone 10. The adjustable loop structure 32 may pull the other tissue anchor toward the button 100 to secure the second bone in place. The other tissue anchor may be a second cortical button or a second soft anchor.

[0050] 4A, 4B, 4C, 4D, 4E, 5A, 5B, 5C, 5D, and 5E illustrate exemplary cortical buttons 400 and 500 that may have a circular profile. These cortical buttons 400, 500 define a generally circular outer boundary that is configured to engage against the outer bone surface and prevent the buttons 400, 500 from passing into the bone tunnel. However, in contrast to the buttons 100 and 200, the buttons 400 and 500 are defined non-passing buttons in that they are not configured to have a smaller cross-sectional profile than when deployed to provide the ability to pass through a bone tunnel of limited diameter. Although a larger bone tunnel may be formed to pass these buttons (400, 500), the tunnel diameter for the circular profile buttons also removes the outer bone surface as the buttons engage after button inversion. Thus, the buttons 400 and 500 are configured to remain outside the bone tunnel throughout the procedure. Buttons 400 and 500 may be similar to some embodiments disclosed in commonly assigned PCT patent application No. PCT / US20 / 038401, filed June 18, 2020, which is incorporated herein by reference in its entirety.

[0051] The buttons 400 and 500 may be preferred for their location on the bone close to the patient's skin. Portions of the buttons 400, 500 protrude from the bone surface where they can be easily palpated, and these portions are configured with a low profile, tapered profile to reduce palpability. For example, in an ACL repair, the buttons 400 and 500 may engage the tibial side of the repair. The buttons 400, 500 define a dome-shaped top surface with a tapered perimeter edge to maintain a low profile. The buttons 400, 500 define a maximum dome thickness T1 that protrudes above the bone outer surface, and this maximum dome thickness T1 is minimized to reduce palpability. The circular buttons provide improved stress distribution near the bone-button interface, which allows the circular buttons to be thinner (T1) compared to, for example, the oval buttons 100 and 200.

[0052] The button 400 includes a post 410 (FIG. 4D) concentric with the dome portion 420 and extending from a bottom surface 422 of the dome portion 420. The bottom surface 422 may define a flat plane for engaging an outer bone surface. The dome portion 420 may include an annular planar surface 421 located parallel to the bottom surface 422. The dome portion 420 may also include a recess 430 for receiving the flexible strand 30 therein such that the flexible strand 30 is at least partially located within the recess 430, thereby reducing tactility of the flexible strand 30. The recess 430 is disposed toward the center of the dome portion 420 and includes a plurality of openings 440a, 440b, 440c, 440d therethrough that provide a passageway for inserting at least one flexible strand 30 therethrough. The button 400 includes four apertures 440a, 440b, 440c, 440d, each defining a hole surrounded by 360 degrees. Each aperture 440a, 440b, 440c, 440d may have the same diameter. The boundaries of all apertures 440a, 440b, 440c, 440d may be disposed generally within the recess 430. The apertures 440a, 440b, 440c, 440d may extend through the post 410 and have an aperture exit at the bottom surface 412 of the post 410. All four apertures 440a, 440b, 440c, 440d may be generally enclosed within the post 410. The apertures 440a, 440b, 440c, 440d may be equally spaced apart from one another. The openings 440a, 440b, 440c, 440d may be arranged in a generally square or rectangular configuration, with each opening defining a vertex of the array. The openings 440a, 440b, 440c, 440d may define a first pair 440a, 440d and a second pair 440b, 440c, each pair defining an end of a strand channel 442a, 442b therebetween. The strand channels 442a, 442b extend below the bottom surface 432 of the recess 430. The strand channels 442a, 442b at least partially capture a portion of the flexible strand 30 therein.The strand channels 442a, 442b define a pulley surface along which the flexible strand 30 may slide, thereby shortening the flexible strand in an adjustable loop configuration. Each of the strand channels 442a, 442b may define a convex curved surface along the length of the strand channel 442a, 442b that corresponds to the curvature of the strand loop (as seen most clearly in FIGS. 4B and 6B).

[0053] The recess 430 defines a perimeter 434 that may be circular and concentric with the dome perimeter. The perimeter 434 may be intersected by a third pair of openings 445a, 445b that extend through and along the outer perimeter of the post 410. Each opening 445a, 445b thus has a first axial length that is completely enclosed and defines a 360 degree enclosed hole generally formed by the dome portion 420. The openings 445a, 445b also include a second axial length extending from and continuous with the first axial length, the second axial length being not completely enclosed and defining an axial channel (shown as 446a) that is enclosed by the post 410 as seen most clearly in FIG. 4D. The first opening 445a of the third pair of openings is disposed between and radially spaced apart from the first pair 440a, 440d. The second opening 445b of the third pair of openings is disposed between and radially spaced apart from the second pair 440b, 440c. The third pair of openings 445a, 445b may be equal in diameter to each other or may both be larger in diameter compared to the openings 440a, 440b, 440c, 440d. The button 400 is configured to be preassembled and prepared for use with a flexible strand structure.

[0054] 5A, 5B, 5C, 5D, 5E, and 5F illustrate another embodiment of a button 500 that may have a circular or slightly elliptical dome 520 and a post 510 extending from the dome 520. The button 500 may be a non-passing button and may include radially slotted openings 540 / 543 for receiving the flexible strands therethrough and thus coupling to the flexible strand structure during the procedure. Similar to the button 400, the button 500 includes a concave central portion 530 for receiving the flexible strands therein to reduce tactility. The button 500 is similar to the button 400 except where noted. For example, the button 500 includes four channels or pulley faces 542a, 542b, 542c, and 542d. All of the channels or pulley faces 542a, 542b, 542c, 542d may be perpendicular to one another and form a square or rectangle surrounding the central concave post 532. Having four channels 542a, 542b, 542c, 542d provides the user with greater versatility in assembling the flexible strand structure. The concave post 532 may define a top surface 533 that is planar and recessed below the top surface 524 of the dome portion 520.

[0055] Button 500 includes a plurality of openings, designated slotted openings 540, which extend radially from the ends of the channels or pulley faces (542a, 542b, 542c, 542d) to and including the outer periphery of dome portion 520. Openings 540 define dock portions 541 into which flexible strands (30) are received, with tapered openings 543 extending radially therefrom. Tapered openings 543 may extend linearly to a larger opening at the dome periphery. Dock portions 541 extend vertically through the thickness of dome portion 520 and at least partially through the thickness of post 510. The dock portion 541 may extend through or interrupt the circumferential outer surface of the post 510, as seen most clearly in FIGS. 5B and 5E. The post 510 may be configured to fit within the bone tunnel and may be a close or sliding fit against the bone tunnel. The outermost opening 545 defines a pair of openings that may define an aperture encompassed 360 degrees and may be larger in diameter than the dock portion 541. The button 500 may be provided in a variety of sizes. In some larger button sizes, the post 510 may have a larger diameter or width and the outermost opening 545 may intersect the post 510. In exemplary smaller button sizes, the post 510 may be spaced generally inwardly from the outermost hole 545, such that the post 510 and the hole 545 do not intersect.

[0056] 6A and 6B illustrate a system including a button 400 and a flexible strand 630. The flexible strand 630 may be prepared for assembly to the button 400 and may include at least one locking passage 638 along the flexible strand 630. FIG. 6B shows two looped ends 620 extending through two pairs of openings 440a, 440b, 440c, 440d, each of which includes a single length of the strand 630 therethrough. Under tension, the loop 620 is received within a corresponding channel 442a, 442b, which may be contoured to define a convex curved surface for engaging the loop 620. Rims 625a, 625b may extend through a third pair of openings 445a, 445b. Tension on the rims 625a, 625b may slide the loop 620 through the corresponding channel and may shorten the overall length of the loop. Stated another way, tension on the rims 625a, 625b may pull the locking passage 638 towards the button 400.

[0057] In a manner similar to that shown in Figures 6A and 6B, the button 500 may be prepared operatively coupled to an adjustable loop formed by a flexible strand 630 in a manner similar to that shown in Figures 6A and 6B. In all internal techniques, the surgeon may remove or disassemble at least one of the loops 620 from the button 500 via the slot 540. The button 500 may be completely removed from the flexible strand 630, and at least one of the loops 620 and the rim 625a may be passed through the joint and then reassembled (via a pulley) to the button 500 to re-form a fully assembled loop.

[0058] Adjustable Loop Embodiments 7 illustrates an adjustable loop structure 700 that may include two locking passages 710a, 710b and may be assembled or partially assembled to an anchor such as a cortical button 750. The adjustable loop structure 700 may be formed from a flexible strand 30. The adjustable loop structure 700 may be pre-assembled to at least one side of the button 750, which collectively defines an adjustable suspension fixation system 706. The adjustable loop structure 700 may be formed from a single length of the flexible strand 30. Button 750 may be any button disclosed herein or may be other cortical buttons known in the art, such as, for example, the buttons disclosed in commonly assigned PCT patent application PCT / US20 / 038401, filed June 18, 2020, or the buttons disclosed in commonly assigned U.S. Pat. No. 10,383,617, both of which are incorporated by reference in their entireties herein.

[0059] The adjustable loop structure 700 may define a portion of an adjustable suspension fixation system 706 for ligament reconstruction or repair. During tissue repair, the saddle end 704 may be coupled to a body, which may be at least one of a tissue component or a surgical component, such as, but not limited to, a ligament or a graft, and the surgical component may be a tissue anchor or another flexible strand. For example, the adjustable suspension fixation system 706 may connect a first bone to a second bone and may have another tissue anchor (not shown here) operably coupled to the saddle end 704. The body may be coupled to loop the saddle end 704 between two locking passages 710a, 710b.

[0060] The adjustable loop structure 700 may be formed by a flexible strand 30 of braided suture that is braided to define an elongated passage and is hollow. A first end 702 of the adjustable loop structure 700 may be assembled to a button 750 and an opposing saddle end 704 may be attached to a body as defined herein. The adjustable loop structure 700 includes two locking passages 710a, 710b spaced apart from the saddle end 704. Although the two locking passages 710a, 710b may provide a similar knotless locking strength (capable of withstanding similar physiological cycle loads) as compared to at least the structure 32 shown in FIG. 3A, which includes a single locking passage 38, the two locking passages, i.e., a split locking passage, may provide several advantages. For example, this configuration of locking passages 710a, 710b may allow the loop circumference of the structure 700 to be shortened using less force or tension on the ends 705a, 705b as compared to a structure with a single locking passage. This is a result of the locking passages 710a, 710b being substantially straight (not curved or bent) and substantially parallel to the shortening force direction (F) on the ends 705a, 705b. In contrast, the locking passages 38 are curved to loop around the ends of the structure. During shortening, the strands 30 slide through the corresponding locking passages. By maintaining a straight locking passage, the strands 30 can slide in a straight line, reducing pinching of the strands due to kinking or bending along the locking passage. Additionally, a saddle end 704 that does not have a locking passage may be easier to couple to a body. The inventors have found that the inherent increased outer diameter of the locking passage may add greater force and / or tissue tearing upon threading through the Body (as defined herein). A larger tunnel opening size may be required, for example through the tissue anchor, to accommodate the locking passage. In the case of soft tissue grafts, a larger needle and / or greater force may be required to thread the locking passage through the soft tissue.

[0061] The inventors have also found that the separation length (SL) or linear distance along the strand 30 between the two locking passages 710a, 710b preferably has an upper limit. When shortening the adjustable loop structure 706, it should be considered that the shortest length to which the loop structure can be shortened or the shortened minimum loop length is limited by the fixed length portion of the adjustable loop structure. These include at least the length of the two passages 710a, 710b and the separation length SL between the two passages 710a, 710b. Depending on the length of the tissue or graft or the anatomical structure of the repair, a large shortening may be preferred. Depending on the length of the tissue or graft or the anatomical structure of the repair, a short final shortened length may be preferred. Thus, the shorter the two locking cradles 710a, 710b and the separation length SL, the shorter the adjustable loop structure can be shortened by shortening. A shorter length and separation length SL of the locking passages 710a, 170b may provide an adjustable loop structure that accommodates a wider range of graft or tissue configurations. However, the locking passages 710a, 710b require a minimum length to securely tighten and lock the adjustable loop 706 without knots. Thus, the locking passages 710a, 710b define a non-adjustable length for the adjustable loop structure 700 while providing sufficient locking force on the adjustable suture loop 700 to withstand physiological loads. This length may depend on the material and properties of the flexible strand. In some exemplary embodiments, each locking passage 710a, 710b may be 0.5 inches to 1.5 inches (12.7 mm to 38.1 mm) long, and more preferably, may be approximately 0.75 inches (19.05 mm) long.

[0062] The spacing SL is also preferably short so as not to add unnecessary length to the minimum shortened loop length of the adjustable suture loop 700. The separation length SL is preferably long enough to separate the two locking passages 710a, 710b so as to reduce the shortening force F of the adjustable loop. The separation length SL between the two locking passages, as measured linearly along the strand 30 between the two locking passages 710a, 710b (see FIG. 8A), may be between 0.10 inches and 0.5 inches (2.54 mm and 12.7 mm), and in some procedures may be about 0.25 inches (6.35 mm).

[0063] 8A, 8B, and 8C illustrate steps for forming the structure 700. Beginning with FIG. 8A, a length portion of the flexible strand 30 is shown. The locations of the locking passages 710a, 710b are shown as enlarged or expanded portions for clarity of illustration. However, as provided, these locations may be similar in diameter and shape to the remaining length of the strand 30, and the act of spicing the strand 30 to extend it through itself may expand that portion of the strand 30. A snare loop (not shown) may extend along the passages 710a, 710b. An expansion means (not shown) may first extend through the passage locations.

[0064] 8B, the end 705b may extend into and along the strand 30 at the lock passage location 710b, and may extend out of the passage 710b by a length (approximately SL) at the lock passage location 710a and then extend into and along the strand 30. This forms a first eye splice loop 708b and a rim 705b. The length SL between the two lock passages 710a, 710b may be selected depending on the procedure or application. For example, if the saddle end 704 is configured to couple to a graft, the saddle length SL may be long enough to surround the width of the graft with the lock passages 710a, 710b positioned along the sides of the graft. As a second example, if the saddle end 704 is configured to couple to a tissue anchor, the length SL may be long enough to place the locking passages 710a, 710b on the outside of the tissue anchor and couple to the anchor, depending on the configuration of the anchor. In forming this first eye splice loop 708b, the loop may be threaded through an opening in the button, such as openings 110a, 110b in FIG. 1A. Thus, the first eye splice loop 708b may be directly coupled to the anchor 750 of the button, thereby assembling the button to the structure 700. As shown, the eye splice loop 708b is short for ease of illustration, but the length of the loop 708b may be any length.

[0065] 8C illustrates the formation of the second eye splice loop 708a. The rim end 705a may first extend into and along the strand 30 at the lock passage 710a, thereby forming the second eye splice loop 708b. The rim end 705a may extend a length along the saddle end 704 at the lock passage 710b, and then extend into and along the strand 30. The second eye splice loop 708a may also be threaded through an opening in a button, such as button 400, thereby assembling both loops 708a, 708b to the button. In other embodiments, at least one of the loops 708a, 708b may define a free looped end and may be looped over and through a slotted opening in the button during the procedure. The button 100, 200, or 500 exhibits a slotted opening that allows selective assembly of at least one of the eye splice loops 708a, 708b from the button. In other examples, at least one of the loops and limbs (708a, 708b, 705a, 705b) may be operatively coupled to a threading member, such as a shaft, rod, or needle (at least the exemplary passing structure 300 shown in FIG. 3A). The threading member may be configured to insert the loops and / or limbs of the structure 700 through a body, such as, for example, tissue, a graft, or a tissue anchor.

[0066] In this structure 700, each lock passage 710a, 710b includes two lengths of strand 30 that extend through each lock passage 710a, 710b. The two lengths of strand 30 cross over each other to lead out from opposite ends of each lock passage 710a, 710b. In other embodiments, each limb may extend through only one lock passage 710a, 710b. For example, limb 705b may extend through passage 710b only to form an eye splice loop 708a. The distance between the two discrete lock passages 710a, 710b may be sufficient to suspend an implant over, extend through a thickness of tissue, or extend through an anchor. The saddle end 704 may include three strand lengths of strand 30, two of which are slidable and one single strand that is stationary or fixed (non-slidable) and extends directly from and is continuously braided to both locking passages 710a, 710b.

[0067] 9A illustrates another adjustable loop structure 900 that may form multiple adjustable loops and may include two locking passages 910a, 910b. The adjustable loop structure 900 may define an adjustable suspension fixation device for ligament reconstruction or repair. In another example, the structure 800 may define an adjustable attachment means between a first bone and a second bone and may have a tissue anchor operably coupled to a portion of the structure 900 (not shown here).

[0068] The adjustable loop structure 900 may be formed by a braided suture that may be hollow to define a longitudinal passage therealong. Two locking passages 910a, 910b are formed by splicing the suture through itself to form a knotless locking mechanism under tension and to prevent the loop from expanding. The adjustable loop structure defines a first end 902 that may be assembled to a button 950 and an opposing saddle end 904. The adjustable loop structure 900, similar to structure 700, may have a locking force that reduces the loop shortening force.

[0069] The steps for forming the structure 900 may start with a strand 30 similar to that shown in FIG. 8A with a similar location and concept of locking passage. However, compared to FIG. 8B, the loop is formed differently. As shown in FIG. 9B, forming the adjustable structure 900 may include extending the end 905b through an opening in a button 950 (shown in FIG. 9A), then extending through the strand 30 at a location first identified as 910a, preferably on the side adjacent to the end 905a, and then leading out of the passage 910a adjacent to the saddle 904. The end 905b then extends along the saddle 904 for a length portion, and then extends along the strand 30 at the lock passage location 910b. This forms a first loop 908b and a rim 905b. In forming this loop 908b, the loop may be threaded through an opening in the button, such as the openings 110a, 110b in FIG. 1A. Another example of a button is disclosed in commonly-owned U.S. Patent No. 10,383,617, which is incorporated herein by reference in its entirety. Each opening preferably provides passage for one length of suture therethrough, which allows the button to be assembled to the structure 900. A second loop 908a may be formed in a manner similar to the first loop 908b and is shown in FIG. 9C. The rim end 905a extends through the strand 30 at lock passage 910b, then across the saddle 904, and then along the strand 30 at lock passage 710a.

[0070] FIG. 10 illustrates another exemplary structure 1000 that may incorporate a button 1050 and may include four locking passages 1010a, 1010b, 1010c, 1010d.

[0071] In some embodiments, the adjustable loop structure 700 may be prepared in a fully assembled configuration (also referred to as a closed loop configuration) assembled to a button 750. Unlike the structure shown in Figures 3A, 3B, 3C, and 3D, both loops 708a, 708b may be pre-assembled to the button 750. The button may be rotated in four 360 degrees ( ° ) so that the loops 708a, 708b cannot be disassembled without disassembling the adjustable loop. In some embodiments, when prepared in a closed loop configuration, the adjustable loop structure 700 may include a pass-through structure 1450 coupled to the saddle end 704, as shown in FIG. 14. The pass-through structure 1450 is configured to pull the adjustable loop structure 700 through the tissue or graft.

[0072] The passing structure 1450 may include a loop 1455 formed from a flexible strand, such as a wire or suture. The loop 1455 may be coupled to a threading member 1460, which may have a fixed length (non-adjustable). The threading member 1460 may be a stiff needle that pierces the tissue or graft. The threading member 1460 may be configured to pass through an opening in another tissue anchor (not shown) or through a prepared tunnel through bone. The threading member 1460 may be configured to pierce the tissue or graft and may be configured to pull the loop 1455 and further pull the saddle end 704 of the adjustable loop structure 700 through the loop 1455.

[0073] The loop 1455 may originate from a length of suture or wire with two ends crimped or crimped to the threading member 1460 to form the loop 1455. The loop 1455 may be formed from a flexible strand different from the flexible strand 30 or may be formed from a flexible strand formed separately from the flexible strand 30. The passing structure 1450 may be coupled to the three strand lengths of the saddle end 704 by a composite loop. The composite loop may be configured to pull the three strand lengths sequentially through tissue. Pulling the strand lengths of the saddle end 704 sequentially may reduce tissue damage or deformation and may reduce the force required to pull the saddle end 704 through the tissue or graft. The passing structure 1450 may couple the saddle end 704 to the tissue or graft. The composite loop may be configured to limit sliding of the pass-through structure 1450 along the adjustable loop structure 700. The composite loop may help control the three strand lengths as they slide relative to one another and may help keep the three strand lengths in close proximity, as described further herein.

[0074] The loop 1455 may form a composite loop around the saddle end, such as a figure-of-eight loop as partially illustrated in FIG. 15. FIG. 15 illustrates a first lock passage 710a having three strand lengths extending therefrom. Strand length 730a defines a static strand in that it is directly connected to and extends from both lock passages 710a, 710b. When the adjustable loop structure 700 is shortened, strand length 730a does not slide. Strand length 730a may be continuously braided with respect to lock passages 710a, 710b and therefore does not extend through or slide through lock passages 710a, 710b. The strand lengths 730b, 730c are dynamic strands, and each strand 730b, 730c is continuous with respect to a limb 705a, 705b. Pulling on the limbs 705a, 705b causes the dynamic strand lengths 730b, 730c to slide through the passages 710a, 710b, thereby shortening the circumference of the adjustable loop.

[0075] The loop 1455 may form a first loop 1455a in a figure-of-eight loop around the static strand 730a, and a second loop 1455b in a figure-of-eight loop may wrap around both dynamic strands 730b, 730c. The figure-of-eight configuration may limit the sliding of the pass-through structure 1450 along and around the adjustable loop structure 700. Off-center sliding may need to be corrected by the user during stitching. The first loop 1455a in the figure-of-eight is limited to sliding only along the static strand 730a, and the range of sliding is constrained by the locking passages 710a, 710b. Limiting the sliding may avoid asymmetry when the adjustable loop structure 700 is threaded through a tissue or graft. The figure-of-eight loop configuration is configured to maintain the pass-through structure 1450 between the two locking passages 710a, 710b. Without the formation of the figure-eight loop, the loop 1455 may slide over one of the locking passages 710a, 710b and pull that locking passage first into and through the graft or tissue. As explained above, this may increase the force required to couple the adjustable loop structure 700 to the tissue graft. Additionally, if the loop 1455 were wrapped around only the static strand length 730a rather than a figure-eight loop, the dynamic strand lengths 730b, 730c may lean too far back as they pass through the tissue / graft, causing confusion during stitching and uneven adjustment of the structure 700. The figure-eight loop may pass the dynamic strand lengths 730b, 730c through the graft first, followed by the static strand length 730a, followed by the two locking passages 710a, 710b. The second loop 1455b is configured to hold the two dynamic strand lengths in close proximity as the saddle end 704 is passed through the tissue / graft, which may reduce confusion when stitching through the tissue or graft.The loop 1455 is coupled to the adjustable loop structure 700 in a manner that maintains a substantially central position of the pass structure 1450 along the adjustable suture loop 700 (limiting sliding of the pass structure 1450 along the saddle portion 704) while allowing the dynamic strand lengths 730b, 730c to slide without inhibiting shortening of the adjustable loop structure 700. The pass structure 1455 is coupled to the adjustable loop structure 700 to maintain the three strand lengths 730a, 730b, 730c further aligned with one another for effective passing through tissue.

[0076] In another configuration, the loop 1455 may form a composite loop in the form of a cargo tag loop around all three strands 730a, 730b, 730c. However, this may tighten around the moving (dynamic) strands 730b, 730c, resulting in an increased loop shortening force. A further embodiment is shown in Figures 16A and 16B, where the loop 1455 forms a composite loop in the form of a split cargo tag loop including a first loop 1455aa around the static strand 730a. A second loop 1455bb is split to loop around both sides of the dynamic strands 730b, 730c (as seen most clearly in Figure 16B). However, this loop requires a more complicated assembly.

[0077] Method for attaching an adjustable loop structure A method for attaching an adjustable loop structure 1700 to an implant 1650 is illustrated in Figures 17A, 17B, 17C, 17D, 17E, 17F, 17G, 17H, 17I, and 17J. The adjustable loop structure 1700 may be similar to the adjustable loop structures (32, 700, 900, 1000) disclosed herein and may be coupled to a pass-through structure 1750 at a link end 1704 of the adjustable loop structure 1700. The pass-through structure may be coupled to the link end 1704 using a composite loop as disclosed herein. For example, the adjustable loop structure may be structure 700 coupled to a pass-through structure 1450 at a saddle end 704 using a figure-eight loop. However, the method is not limited to structure 700 and structure 1450. The disclosed method is to bond an adjustable loop structure 1700 to a graft 1650 such that the final stitched graft includes both the adjustable loop structure 1700 and the flexible loop 1755 of the pass-through structure 1750 stitched therethrough, the flexible loop 1755 being bonded to the adjustable loop structure 1700 but formed separately from the adjustable loop structure 1700. In the final stitched graft, the flexible loop 1755 may define an axially overlapping stitch relative to the stitch of the adjustable loop structure. 17A, 17B, 17C, 17D, 17E, 17F, 17G, 17H, 17I, and 17J show simplified configurations of adjustable loop structure 1700 that omit components such as, but not limited to, locking passages (such as, but not limited to, locking passages 710a, 710b), individual adjustable loops (such as, but not limited to, loops 708a, 708b), and linking ends 1704 (such as, but not limited to, saddle ends 704). These details have been omitted from the drawings to simplify understanding of the drawings, and thus the method.Additionally, the method may couple any adjustable loop structure disclosed herein or known in the art, such as those having different locking passages and different adjustable loop configurations, to the graft in this manner.

[0078] Beginning with FIG. 17A, the method may include preparing and / or obtaining a graft 1650. The graft 1650 may be an elongate body defining a top surface 1655, a bottom surface 1675, and two opposing ends 1660, 1670. One of the opposing ends (1670) may be clamped to stabilize the graft 1650 during stitching and may thus be defined as the clamped end 1670. The other of the opposing ends may be a free end 1660. The free end 1660 may be inserted first into a prepared tissue tunnel and may be directly bonded to both the adjustable loop structure and the pass-through structure loop. The free end 1660 may be tapered or bullet-shaped using a scalpel or scissors to facilitate threading through a prepared bone tunnel. The graft 1650 may be a single solid body, typically harvested from a quadriceps tendon. The graft 1650 may include the ends of thin bundles. The graft 1650 may be prepared as multiple long strands, such as is typical when harvested from the hamstring. The graft 1650 may be folded back on itself to form the target thickness of the graft 1650.

[0079] 17B, ​​which shows a side view of the implant 1650, an attachment method may include forming and / or providing an adjustable loop structure 1700 that may be assembled at one end to a cortical button 1715 and at the other end (hereinafter, connecting end 1704) to a flexible loop 1755 of a pass-through structure. The flexible loop 1755 may be operatively coupled to a threading member 1760, such as a needle, which together define a pass-through configuration 1750. The threading member 1760 may pierce the top surface 1655 of the implant at a first location (1) and pull the flexible loop 1755 from the top surface 1655 of the implant through the thickness of the implant 1650 to the bottom outer surface 1675, thereby defining a first pass-through through the implant 1650. The first location (1) may be approximately 1.5 cm to 2 cm from the end of the free end 1660. In some exemplary methods, the flexible loop 1755 may form a composite loop and may be coupled to the strands (730a, 730b, 730c) along a link end 1704, which may be similar to the saddle end 704. The composite loop, not shown in Figures 17B, 17C, 17D, 17E, 17F, 17G, 17H, 17I, and 17J, but visible in at least Figure 15, may be configured to stagger the introduction point of the strands (730a, 730b, 730c) through the graft 1650 during this first pass. The composite loop may also maintain the position of the flexible loop within the target zone along the adjustable loop structure 1700. The first pass may be completed when the pass structure 1750 is pulled completely through the implant 1650 until the entire pass structure 1750 is routed outside the implant 1650 and the adjustable loop structure 1700 extends through the implant 1650 from both the top surface 1655 and the bottom surface 1675 (FIG. 17C). With the first pass completed, the cortical button 1715 is positioned adjacent the free end 1660 and the top surface 1655, and the link end 1704 is positioned adjacent the bottom surface 1675 (FIG. 17C). This may also preferably position the locking passageway, which is exterior to the implant 1650, adjacent the bottom surface 1675.The adjustable loop structure 1700 may include two limbs 1705a, 1705b that are wrapped around a portable card or tool 1725 for its management. The first pass may extend through the implant 1650 at an angle that is not oblique to the longitudinal axis (YY), and thus is neither parallel nor perpendicular to the longitudinal axis (YY) of the implant 1650. The angle may be between 30 degrees and 60 degrees to the longitudinal axis. The first pass may extend along the longitudinal axis and may cross the longitudinal axis. The first pass, and all subsequent passes, may extend through the midline of the implant 1650 as far as possible, given the nature of the soft tissue implant.

[0080] The link ends 1704 of the adjustable loop configuration may then be unfolded to wrap around both outer surfaces of the implant 1650, and the free ends 1660, button 1715, and card or tool 1725 may be inverted against the top surface 1655 (FIG. 17D). This may position the link ends 1704 between the clamped ends 1670 and the first position (1). The adjustable loop structure 1700 may then be shortened via tension on the limbs 1705a, 1705b (which may be bonded to the card or tool 1725). The adjustable loop structure 1700 may then be shortened such that the link ends 1704 are wrapped circumferentially around the outer surfaces of the implant 1650 (FIG. 17E) and such that the button 1715 is adjacent the free ends 1660. Upon everting the connection end 1704, the flexible loop 1755 of the pass-through structure 1750 may be maintained through the connection end 1704 and between any locking passages via a composite loop, such as a figure-of-eight loop. The adjustable loop structure 1700 may be shortened by pulling a flexible strand through any locking passage of the adjustable loop structure 1700 such that the locking passage wraps circumferentially around the exterior surface of the graft 1650 (FIG. 17E). By shortening the structure 1700, the locking passage may be disposed substantially outside the graft and not inside the graft, and the locking passage may be tightened to prevent loop shortening.

[0081] 17F, the threading member 1760 may again pass (second pass) from the top surface 1655 to the bottom surface 1675 of the graft at a second location (2) (FIG. 17F) directly adjacent to the link end 1704. This locks the position of the link end 1704 along the graft 1650 and prevents the link end 1704 from sliding along the graft 1650. The second location (2) may be approximately coincident with the link end 1704 or may be between the clamped end 1670 and the first location (1). The adjustable loop structure 1700 is now fixedly attached to the graft 1650. The second pass may be perpendicular to the longitudinal axis (YY) of the graft and may define the furthest pass from the free end 1660. At the end of the second pass, a portion of the flexible loop 1755 may extend through the graft 1650. At the end of the second pass (FIG. 17G), a first loop 1755 a of the composite loops of the flexible loop 1755 may be retained on the top surface 1655 , while a second loop 1755 b may extend through the implant 1650 .

[0082] The flexible loop 1755 may now form a running whipstitch that moves progressively along the graft 1650 toward the free end 1660, preferably including at least two whipstitch passes through the graft 1650 (the third and fourth passes in the attachment method). The running whipstitch forms a plurality of axially spaced circumferential turns around the graft free end 1660. By applying tension to the plurality of axially spaced circumferential turns, the graft free end 1660 may be formed into a more cylindrical shape for easier passage through a prepared bone tunnel. By applying tension to the whipstitches, the graft free end 1660 may be further tapered for easier passage through a prepared bone tunnel. This running whipstitch may include at least two passes and acts to mitigate tearing of the attachment portion (the adjustable loop structure 1700 and the flexible loop 1755 cheese-wiring from the graft). The whipstitch runs progressively towards the free end 1660. The whipstitch may be formed by looping the flexible loop 1755 (which may be the second loop 1755b) from the bottom surface 1675 and around from the end 1660, which may place the threading member 1760 on the top surface (FIGS. 17H and 17I). The threading member 1760 may then pass again from the top surface 1655 to the bottom surface 1675. This may be position (3) between the free end 1660 and position (1). This allows the flexible loop 1755 (1755b) to be wrapped circumferentially around the implant 1650, over and across the adjustable loop 1700 which is wrapped around the outer surface and connecting end 1704 of the implant.

[0083] The steps shown in Figures 17H and 17I may be repeated to form a second whipstitch of the running whipstitch as shown in Figure 17J. The threading member 1760 may be placed on the top surface 1655 by wrapping the flexible loop 1755 around the graft 1650 and over the free end 1660. The threading member 1760 may then pierce the graft at a location between position (4) and the free end 1660 and may penetrate from the top surface 1655 to the bottom surface 1675. This may be repeated until the whipstitch reaches the terminal end 1661 of the free end 1660. The loop 1755 may then be knotted and tightened to further tape the tapered free end 1660. The threading member 1760 may then be removed, leaving the cut loop 1755' available (Figure 17J).

[0084] The graft 1650 coupled to the adjustable loop structure 1700 and to the cut loop 1755' (cut from the threading member 1760) may then be threaded through a prepared bone tunnel (not shown). The cut loop 1755' (FIG. 17J) may be of sufficient length to couple to a tool for pulling the graft 1650 into and along the prepared bone tunnel. Thus, the cut loop 1755', as prepared or prepared, has sufficient length to form at least two whipstitch passes through the graft, leaving sufficient length to be pulled along the prepared bone tunnel. Pulling the cut loop 1755' is preferred over pulling the adjustable structure 1700 to avoid the free end 1660 of the graft folding over itself as it slides through the prepared bone tunnel. By simply pulling the adjustable structure 1700, a crease adjacent the second position (2) may be formed.

[0085] Turning now to a more specific example, the attachment method may include forming or providing an adjustable loop structure 700 having a cortical button 750 assembled at one end and coupled to a pass-through structure 1450 at a saddle end 704. A needle 1460 may pierce a top surface 1655 of the implant at a first location (1) and may pull a loop 1455 of the pass-through structure 1450 from the top surface 1655 of the implant through the thickness of the implant 1650 to a bottom outer surface 1675, thereby defining a first pass-through. The first location may be approximately 1.5 cm to 2 cm from a distal end 1661 of the free end 1660. In some exemplary methods, the flexible loop 1455 may form a composite loop and may couple multiple strands (730a, 730b, 730c) along the saddle end 704. The composite loop may be configured to stagger the introduction points of the strands (730a, 730b, 730c) through the implant 1650 during this first pass. The composite loop may be a figure-of-eight loop, where the first loop 1455a is looped around the static strand 730a and the second loop 1455b is looped around the strands 730b, 730c. The first pass may be completed when the pass structure 1450 is fully pulled through the implant 1650 until the entire pass structure 1450 is brought out of the implant 1650 and the adjustable loop structure 700 extends through the implant 1650 from both the top surface 1655 and the bottom surface 1675. Upon completion of the first pass, the cortical button 750 is positioned adjacent the top surface 1655 and the saddle end 704 is positioned adjacent the bottom surface 1675. The adjustable loop structure 700 may include two limbs (705a, 705b) that wrap around a portable card or tool 1725 for its management. The first pass may extend through the implant 1655 at an oblique angle relative to the longitudinal axis (LL) of the implant 1650. The angle may be between 30 degrees and 60 degrees relative to the longitudinal axis. The first pass may extend along the longitudinal axis and may intersect with the longitudinal axis. The first pass may be oriented substantially along the midline of the implant 1650 as much as possible given the nature of the soft tissue implant.

[0086] The saddle end 704 may then be unfolded to wrap around both sides of the implant 1650, and the free end 1660, button 750, and card or tool 1725 may be inverted against the top surface 1655. This may position the saddle end 704 between the clamped end and the first location (1) on the top surface 1655. The adjustable loop structure 700 may then be shortened via tension on the rims 705a, 705b (which may be bonded to the card or tool 1725). The adjustable loop structure 700 may be shortened such that the saddle end 704 is wrapped circumferentially around the implant 1650 and the button 750 is adjacent the free end 1660. When the saddle end 704 is inverted, the pass-through structure 1450 may be maintained between the locking passages (710a, 710b) through the saddle end 704 via a composite loop, such as a figure-of-eight loop.

[0087] The needle 1460 may pass again (second pass) from the top surface 1655 to the bottom surface 1675 of the implant at a second location (2) directly adjacent to the saddle end 704. This locks the position of the saddle end 704 along the implant 1650 and prevents the saddle end 704 from sliding along the implant 1650. The second location (2) may be approximately coincident with the saddle end 704 and may be between the clamped end 1670 and the first insertion location (1). The adjustable loop structure 700 is now fixedly attached to the implant 1650. The second pass may be approximately perpendicular to the longitudinal axis of the implant and may define the furthest pass from the free end 1660. At the end of the second pass, a portion of the flexible loop 1455 may extend through the implant 1650. At the end of the second pass, a first loop 1455 a of the composite loops of the flexible loop 1455 may be retained on the top surface 1655 , while a second loop 1455 b may extend through the implant 1650 .

[0088] The flexible loop 1455 may now form a running whipstitch that stitches progressively toward the free end 1660, preferably including at least two whipstitch passes through the graft 1650 (the third and fourth passes in the attachment method). The running whipstitch forms a plurality of axially spaced circumferential turns around the graft free end 1660. By applying tension to the plurality of axially spaced circumferential turns, the graft free end 1660 may be formed into a more cylindrical shape for easier passage through a prepared bone tunnel. By applying tension to the whipstitches, the graft free end 1660 may be further tapered for easier passage through a prepared bone tunnel. The running whipstitch may include at least two passes and acts to mitigate tearing of the attachment portion (cheese-wiring of the adjustable loop structure 700 and flexible loop 1455 from the graft). The whipstitch runs progressively toward the free end 1660. The whipstitch may be formed by looping the second loop 1455b from the bottom surface 1675 and around the end 1660 of the graft, which may place the needle 1460 on the top surface. The needle 1460 then passes from the top surface 1655 to the bottom surface 1675. This may be position (3) between the free end 1660 and the insertion position (1). This may cause the second loop 1455b to wrap circumferentially around the graft 1650, over and across the saddle end 704 of the adjustable loop. This may cause the second loop 1455b to wrap circumferentially around the graft 1650, over and across the locking passages 710a, 710b, which may no longer be adjustable when tension is applied to the second loop.

[0089] A second whipstitch may be formed by looping the second loop 1455b from the bottom surface 1675 and again from the end 1660, which may place the needle 1460 on the top surface. The needle 1460 may then pass again from the top surface 1655 to the bottom surface 1675. This may be a position between the free end 1660 and the insertion position (3). This may be repeated until the whipstitch reaches the end of the free end 1660. The second loop 1455b may then be tied tightly with a knot 1810, which may further tape the tapered free end 1660. The needle 1460 may then be removed, leaving the length of the second loop 1455b available (and possibly no longer a loop). The graft 1650 coupled to the adjustable loop structure 700 and to the second loop 1455b' (cut from the needle 1460) may then be threaded through a prepared bone tunnel (not shown).

[0090] FIG 18A illustrates a plan view of the adjustable loop structure 700 stitched through the graft 1650 after a first pass and before a second pass, similar to the configuration shown in FIG 17E. FIG 18B illustrates a plan view of the adjustable loop structure 700 and flexible loop 1455 stitched through the graft 1650 in the final stitched configuration. FIG 18B also illustrates the circumferential wrapping and tapering of the free end 1660. A knot 1855 is shown in the second loop 1455b with the cut second loop 1455b' extending therefrom.

[0091] Shortening Bar 11A, 11B, 11C, 11D, 11E, 12A, 12B, 12C, 13A, 13B, 13C, and 13D illustrate various features and associated methods of use of the shortening bar 1100. The shortening bar 1100 may serve multiple functions during tissue repair. The shortening bar 1100 may be assembled to an adjustable suspension fixation system and may be used as a handle or tool to apply tension to adjustable loops of the fixation system to position the implant at a target location. The shortening bar 1100 may also be prepared or ready with a suspension fixation system pre-assembled and therefore may be equivalently referred to as a fixation system storage tool.

[0092] Although a suspension fixation system such as the system 280 shown in FIG. 3A includes multiple loops of flexible strands 30, which may be difficult to track and may result in strand entanglement or errors when coupled to a graft if prepared in a loose configuration. The shortening bar 1100 may include retention containment means, including cavities, slots, cleats, channels, and spools, disposed along the shortening bar 1100 to accommodate or retain portions of the suspension fixation system. Other exemplary fixation systems that may be assembled to the shortening bar 1100 are disclosed herein and in commonly-owned PCT Patent Application No. PCT / US20 / 038401, filed June 18, 2020, entitled "METHODS AND DEVICES FOR TISSUE GRAFT FIXATION," which is commonly-owned and incorporated herein by reference in its entirety.

[0093] Such storage means may hold and manage the components of the suspension fixation system such that they are on the exterior surface of the bar 1100 and may be selectively removed from the bar 1100 in stages according to the operational stage of the tissue repair. Thus, the shortening bar 1100 may not only store the suspension fixation system, but may also configure the suspension fixation system to guide its staged removal according to the preferred stage of the procedure.

[0094] More specifically, the storage means may arrange the components of the suspension fixation system, which may include the adjustable loop structure (32), the pass-through structure (300) and the tissue anchors (100, 200), around the shortening bar 1100 in a staged manner to improve management of the suspension fixation system during tissue repair and to limit entanglement and disarray. With reference to Figures 3A, 3B, 3C, 3D and 3E, the storage means may arrange the adjustable loop structure 32, the pass-through structure 300 and the tissue anchors 100, 200 around the shortening bar 1100 in a manner that allows the pass-through structure 300 to be removed first, and furthermore, the pass-through structure 300 is pre-assembled to the free rim 33b and to the free adjustable loop 35b. The free rim 33b and the free adjustable loop 35b may then be removed from the bar 1100. When the pass-through structure 300, free rim 33b, and free adjustable loop 35b are coupled to the implant (FIG. 3A), the remainder of the suspension fixation system 280 may remain held by the bar 1100.

[0095] Additionally, the shortening bar 1100 may act as a tool to guide the closure of an open adjustable loop structure, such as the suspension fastening system 280. For example, the anchors (100, 200) may be prepared stored inside the bar 1100 in an orientation that exposes the slotted openings 120a, 120b (FIGS. 11C, 11D, and 11E). The slotted openings 120a, 120b may be aligned with guide surfaces of the shortening bar 1100 to align and guide the free adjustable loops 35b into the slotted openings 120a, 120b.

[0096] Additionally, the shortening bar 1100 may act as a handle when shortening the adjustable loop structure 32, thereby reducing the force applied to the surgeon's hand. The shortening bar 1100 may include means for operatively coupling to, for example, the looped rim ends 33a, 33b of the adjustable loop structure 32 to place the suspension fixation system 280 in a shortened configuration. The bar 1100 may then be swung and rotated while applying tension to the ends 33a, 33b, thereby reducing the size of the adjustable loop structure, thereby pulling the tissue, graft, or tissue anchor towards the tissue anchors (100, 200).

[0097] Thus, the shortening bar 1100 is a multi-function handle body configured to house a suspension fixation system that may include an adjustable loop structure, a tissue anchor, and / or a pass-through structure. The shortening bar 1100 may also provide a means to guide the assembly of the open loop adjustable structure to the tissue anchor. The shortening bar 1100 may be assembled to the suspension fixation system and prepared for staging removal of the system components according to tissue repair. The shortening bar 1100 may also be reassembled to the adjustable loop structure in a different configuration than the pre-assembled configuration to shorten / adjust the adjustable loop structure.

[0098] 11A, 11B, 11C, 11D, and 11E illustrate various features of the shortening bar 1100 with the suspension fixation system removed. Starting with FIGS. 11A and 11B, the shortening bar 1100 may generally be a single body and may be sized to fit in a surgeon's hand and be comfortable when applying tension to the adjustable loop structure to shorten it. The shortening bar 1100 may define an elongated body defining a longitudinal axis XX and an elliptical or oval cross-section. Along a bottom surface 1117, the bar 1100 may have a larger, more bulbous cross-section configured to fit within the curled fingers of a user. The bottom surface 1117 of the bar may also define an arcuate or convex curved surface 1110 such that the handle 1100 is curved along the longitudinal axis XX with the handle 1100 having its thickest cross-section near the midline MM of the handle 1100. The elongated convex curved surface 1110 and the bulbous bottom surface 1117 are shaped together to rest within the surgeon's finger when applying tension to the adjustable loop structure.

[0099] The bar 1100 has an inner length 1111 with circumferential spools 1113a, 1113b at either end. The bar 1100 includes a first lateral end 1114 extending from the spool 1113a having a first lateral end surface 1124 that may be planar. An opposite second lateral end 1116 extends from the spool 1113b. Each spool may be intersected by a notch 1123a, 1123b (one each). Each notch 1123a, 1123b may be curved and may be "L" shaped or inverted "L" shaped. Each notch 1123a, 1123b extends through the thickness of the bar 1100, as shown most clearly in FIG. 11E. The bar end 1114 may be different from the bar end 1116. The bar end 1114 may extend further along the longitudinal axis XX from the inner portion 1111. Thus, the bar 1100 may be an asymmetric body with respect to a plane along the midline MM. The bar end 1114 is sized to include a slot 1150 for receiving a portion of a tissue anchor. The bar end 1114 includes a channel 1155 extending from the slot 1150 for receiving a portion of a flexible strand coupled to the anchor.

[0100] The bar 1100 may define a number of circumferentially extending ribs 1112 that may add structural integrity to the bar 1100, accommodate manufacturing processes, and reduce material usage. At least some of the ribs 1112 may be discontinuous, such as the reliefs 1120, the channels 1130, and the retention channels 1140, that define gaps along the inner length 1111. These gaps may provide at least a portion of the storage means for portions of the suspension and fastening system that include the adjustable loop structures and the pass-through structures, as disclosed in more detail below.

[0101] 11C, 11D, and 11E illustrate various views of a bar 1100 with an exemplary button assembled thereto. FIG. 11C illustrates the back of the bar 1100, which may not have a retention slot or channel along the central portion 1111. The slot 1150 is configured to receive a portion of a button, such as button 100, 200. FIG. 11D illustrates the button 100, 200 received within the slot 1150. The channel 1155 is continuous with and extends from the slot 1150 and is also continuous with the spool 1113a, such that a portion of an adjustable loop structure (shown in subsequent figures) coupled to the button may extend from within the slot 1150, along the channel 1155, into and around the spool 1113a (FIG. 12C).

[0102] The slot 1150 may receive the button 100, exposing a portion of it including the lateral openings 121a, 121b, as seen most clearly in FIG. 11E. The plane 1124 may be oriented at a non-orthogonal angle to the longitudinal axis XX and may provide a guide surface when assembling the free adjustable loop end 35b of the open adjustable loop structure to the cortical button (a small portion of the free adjustable loop end 35b is shown adjacent the plane 1124). Thus, the free adjustable loop end 35b may be slid along the plane 1124 (see arrows) to thread the adjustable loop end 35b through the lateral slots 121a, 121b and into the slotted openings 120a, 120b, thereby closing the open adjustable loop structure 32 (FIGS. 3C and 3D). This is preferably done after threading the free loop end 35b through the implant, as disclosed herein.

[0103] FIG. 12A illustrates a suspension system 280, which includes a button 100 (shown in a simpler form) and an adjustable loop structure 32. To understand the assembly of the suspension system 280 to the shortening bar 1100, FIG. 12A illustrates a virtual division of the suspension system 280 into portions 1200a and 1200b. As shown, portion 1200a may include a pass-through structure 300, (threading member 305 and pass-through loop 310), a free adjustable loop end 35b, a free loop end 33b, and a locking passage 38. Portion 1200a may also include a portion of the flexible strand 30 that forms part of the assembled loop end 35a that extends directly between the locking passage 38 and the anchor 100. Portion 1200a may also include all of the strand 30 that extends directly between the anchor 100 and the passage 38. Thus, it may include a strand length portion of first looped end 33a and rim 35b that is positioned directly between button 100 and locking passageway 38. As shown, portion 1200b may include anchor 100 assembled to assembled looped end 35a and to looped end 33a.

[0104] Figures 12B and 12C (in combination) illustrate an embodiment in which the bar 1100 and the suspension system are prepared or facilitated in a pre-assembled configuration. In this example, the suspension system 280 is assembled to the bar 1100, see Figures 3A, 3B, 3C, 3D, 3E and 12A. However, other suspension systems may be assembled based on the same idea. Both Figures 12B and 12C should be seen in combination. In other words, both parts 1200a and 1200b may be assembled to the shortened bar 1100 as presented. Figure 12B illustrates only the assembly of part 1200b, while the rest of the system 280 (part 1200a) is shown assembled in Figure 12C. Part 1200a is not shown in Figure 12B for clarity of understanding. Similarly, in Fig. 12C, only portion 1200a is shown, portion 1200b has been omitted from the figure for ease of illustration only. As packaged, bar 1100 is pre-assembled to both portions 1200a and 1200b, and both Figs. 12B and 12C should be referenced in combination to see the pre-assembled configuration.

[0105] Starting with FIG. 12B, the front of the bar 1100 is shown, with the front half of the end 1114 removed to improve understanding of the routing of the strands. The suspension anchor 280 may be prepared in a pre-assembled configuration with a tissue anchor, such as a button 100, nested within a slot 1150. This is also shown at least in FIGS. 11C, 11D, and 11E. The portion 1200b including the looped end 33a may be pushed into the end 1114 and extend along the channel 1155, across the spool 1113a, into the channel 1130, along the channel 1130, and towards the spool 1113b. The looped end 33a is then wrapped around the outermost circumferential surface of the spool 1113b multiple times and then threaded through the cleat 1133b, thereby securing it in place and preventing the looped end 33a from unwinding. The channel 1130 may be defined by interrupting the circumferential rib 1112 around the bar 1100. The channel 1130 may extend parallel to the longitudinal axis XX. The channel 1130 may have openings at both spools 1113a and 1113b, such that the looped end 33a is substantially forced into the interior of the channel 1155 and the channel 1130 in the assembled configuration. The spools 1113a and 1113b may extend from and be continuous with the ends of the channel 1130.

[0106] FIG. 12C illustrates the routing of portion 1200a. Again, FIG. 12C is illustrated with the front half of end 1114 removed to improve understanding of the strand routing. Multiple lengths of flexible strand 30 may extend from anchor 100 along channel 1155 and may wrap around spool 1113a. Locking passage 38, adjustable looped end 35b, and looped end 35b may all wrap around the outermost circumference of spool 1113a (shown in simplified form in the figures for ease of illustration). In addition, flexible loop 310 may also wrap around spool 1113a. Threading member 305 may extend along retention channel 1140. Retention channel 1140 is defined by interrupting circumferential rib 1112, which interruption defines the width of the retention channel. The retaining channel may loosely accommodate the threading member 305, with the exception of the most central end of the retaining channel 1140, defined by the ends of the circumferential ribs forming the narrowed width 1141, which is spaced apart to pinch the tip 305a of the threading member. The retaining channel 1140 may be continuous with the spool 1113a. The threading member 305 may be oriented parallel to the longitudinal axis XX and may be positively retained at the end 1141. The threading member may be a tube, a needle, or a thickened section of flexible material. The channel 1140 may be continuous with the relief or cavity 1120. The tip 305a of the threading member may extend into the relief 1120. The relief 1120 may be deeper than the channel 1140 (seen most clearly in FIG. 11E) to allow a user to place a finger or tool within the relief 1120 and to grasp the tip 305a of the threading member.The tip 305a of the threading member may be accessible from or may extend into the relief 1120, which defines a cavity within the shortening bar 1100 that allows a surgeon to access the threading member 305 and to remove the threading member 305 from the shortening bar 1100.

[0107] Thus, the tissue repair method may begin with preparing a bar 1100 pre-assembled with a fastening system 280 including both portions 1200a and 1200b, as shown in combination in Figures 12B and 12C. The surgeon may first remove portion 1200a. This may involve first removing threading member 305 from channel 1140 by placing a finger or tool within relief 1120 and engaging tip 305a of threading member 305. After removal, a portion of adjustable loop structure 280 may be unwound from spool 1113a. This may involve unwinding flexible loop 310, adjustable free looped end 35b, looped end 33b, and at least one locking passage 38 from spool 1113a. With portion 1200b still assembled to bar 1100, threading member 305 may be inserted through the body (tissue / graft or tissue anchor) to couple suspension fixation system 280 to the body. When inserting threading member 305 through the body, cortical button (100, 200) may remain within slot 1150. When inserting threading member 305 through the body, looped end 33a may remain wrapped around spool 1113b. Inserting threading member 305 may include inserting threading member 305 through bone hole 6a by first pulling looped end 33b through hole 6a and then pulling adjustable loop 35b through bone hole 6a.

[0108] After being coupled to the body, the bar 1100 may also function as a tool to facilitate coupling of the free adjustable looped end 33b and the free looped end 35b to the button 100. After the suspension fastening system 280 is coupled to the body, the threading member 310 may be inserted through an opening (135b) in the button 100 located adjacent the face 1124 of the bar 1100 to pull the looped end 33b therethrough, with the button 100 held within the bar slot 1150. As shown in at least FIGS. 11C and 11D, the button 100 is oriented by the slot 1150 to expose the lateral slots 121a, 121b and the opening 135b. The lateral slots 121a, 121b may be aligned with the plane 1124. Thus, end 1114 and slot 1150 are deep enough to accommodate button 100 in this orientation while aligning lateral slots 121a, 121b with plane 1124. Free looped end 35b may slidingly engage surface 1124 and may be pulled toward slotted openings 121a, 121b, causing adjustable loop 35b to pass over top surface 108 of button 100 and into slotted openings 121a, 121b, as shown in FIG. 11E. Surface 1124 may conform to a portion of lateral slots 121a, 121b.

[0109] Continuing with the exemplary method, the entire suspension fixation structure 280 may at this point be removed from the shortening bar 1100, including removing the portion 1200b, and then reassembled in a shortened configuration, in which the shortening bar 1100 may be a tool to apply tension to the system 280 and to shorten the adjustable loop structure 32. This tension may also lock any locking passages of the system 280 without knotting.

[0110] For assembly in the shortened configuration, the looped ends 33a, 33b may be disposed around the corresponding segment of the spool 1113a, 1113b by sliding each one along and into the notches 1123a, 1123b. The notches 1123a, 1123b define a shortened circumference for the outermost spool 1113a, 1113b, and have a secondary surface or penetration through which the looped ends 33a, 33b may be disposed, as shown most clearly in FIGS. 13A and 13B. The looped ends 33a, 33b may extend a significant distance from the button 100, which may be cumbersome. The act of shortening the system 280 may further increase this distance. The bar 1100 may preferably first be rotationally driven about its longitudinal axis (shown as step 1 in FIG. 13D ) to shorten the length of the ends 33a, 33b, and subsequently and in execution, to shorten the adjustable loop structure. The shortening of the adjustable loop structure 32 and the rotationally driving of the bar 1100 may be performed sequentially and iteratively. For example, the bar 1100 may first be rotationally driven to wind a portion of the ends 33a, 33b around the spools 1113a, 1113b, and then tension may be applied (shown by arrow step 2) to shorten the size of the adjustable loop (lengthening the ends 33a, 33b). The bar 1100 may then be rotationally driven again to further wind the ends 33a, 33b around the corresponding spools 1113a, 1113b, thereby shortening the distance between the bar 1100 and the button 100.

[0111] Shown in Figures 13B and 13C is a cross-section of spool 1113a, showing outermost circumferential surface 1313a and second surface 1323a defined by notch 1123a (only one spool is shown, but the spools may be similar). Spool 1113b may have the same cross-section. Second surface 1323a may define a plane 1313a across shortening bar 1100. Second surface 1323a may define a "shortcut" configured to prevent looped ends 33a, 33b from slipping around spool 1113a when the bar is driven in rotation (step 1). Each looped end 33a, 33b may be formed with a spice or knot at point "P". The second surface 1323a may define a corner or discontinuity sufficient to limit the looped end from rotating around the spool circumference 1313a, such that the looped end 33a may preferentially fold back on itself (as shown in FIG. 13C) without slipping when the bar 1100 is driven in rotation (step 1). Each notch 1123a, 1123b is configured to position the looped end (33a, 33b) within a segment of the corresponding spool 1113a, 1113b to prevent the looped end 33a, 33b from slipping or sliding when the looped end 33a, 33b is wound around the corresponding spool 1113a, 1113b. The notches (1123a, 1123b) are configured to form a fold in the looped end when the bar 1100 is driven in rotation about the longitudinal axis XX.

[0112] Those skilled in the art will appreciate that the present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The above examples should therefore be considered in all respects as illustrative and not limiting on the disclosure described herein. The scope of the present disclosure is thus indicated by the appended claims, rather than by the above description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims

1. A cortical button (100, 400, 500, 750) configured to pass through a bone tunnel (14) in an elongate orientation and subsequently be flipped to a deployed configuration, an oval body having a length greater than its width and a longitudinal axis (LL); the width extends from a first side wall to a second side wall of the body, the first side wall and the second side wall extending along the longitudinal axis between a first end and a second end, the body also having a bottom surface (107) configured to engage an outer bone surface when the cortical button is in the deployed configuration; an oval body having a pair of slotted openings (120a, 120b) extending through the entire thickness of said body and for receiving loops of flexible strands (30) therethrough; a rib (140, 240) extending from the bottom surface of the oval body and disposed between the pair of slotted openings, the rib being coaxial with the pair of slotted openings along the longitudinal axis.

2. 2. The cortical button of claim 1, further comprising a pair of enclosed openings (110a, 110b) adjacent said pair of slotted openings, said rib being disposed between said pair of enclosed openings and coaxial with said pair of enclosed openings along said longitudinal axis.

3. 3. The cortical button of claim 2, further comprising a first end opening disposed between said pair of slotted openings and said first end, and a second end opening disposed between said pair of enclosed openings and said second end.

4. The cortical button of claim 3 , wherein said first end opening and said second end opening are axially spaced from said rib.

5. The cortical button of claim 1 , wherein the rib is an oval solid body.

6. 2. The cortical button of claim 1, wherein said rib is an oval body having a longitudinal axis aligned with and parallel to said longitudinal axis of said cortical button.

7. 2. The cortical button of claim 1, wherein each of said pair of slotted openings defines an interior surface extending through a thickness of said cortical button and extending directly from a side of said rib.

8. 2. The cortical button of claim 1, wherein each of the pair of slotted openings defines a lateral opening through one of the first side wall or the second side wall, and wherein the rib is configured to compensate for a reduction in structural integrity of the cortical button, the reduction in structural integrity being a result of the lateral opening.

9. 2. The cortical button of claim 1, wherein the rib extends vertically from the bottom surface of the oval body less than 2 mm.

10. 2. The cortical button of claim 1, wherein said rib extends from said bottom surface of said oval body a distance less than a thickness of said body.

11. The cortical button of claim 1, wherein the width of the body defines a minimum diameter of a bone tunnel through which the cortical button may pass, and the ribs are configured to increase the structural integrity of the cortical button while preserving the minimum diameter.

12. 12. The cortical button of claim 11, wherein each of the pair of slotted openings defines a lateral opening through one of the first side wall or the second side wall, and the rib is coaxial along the longitudinal axis with the lateral opening.

13. 12. The cortical button of claim 11, wherein each of the pair of slotted openings extends through a thickness of the cortical button and defines an inner surface that is continuous with an outer surface of the rib.

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