Methods and devices for tissue graft fixation

Abstract

Methods and apparatus for tissue graft fixation include fixation devices that are attached to adjustable fixation loops of sutures without damaging the graft or requiring additional materials for repair. Other fixation devices may be attached to independent adjustable suture systems. The adjustable fixation loops minimize slippage / peristalsis of the sutures within the loop.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 862,807, filed June 18, 2019; U.S. Provisional Application No. 62 / 901,463, filed September 17, 2019; U.S. Provisional Application No. 62 / 933,695, filed November 11, 2019; U.S. Provisional Application No. 62 / 978401, filed February 19, 2020; U.S. Provisional Application No. 62 / 978,425, also filed February 19, 2020; and U.S. Provisional Application No. 63 / 036,570, filed June 9, 2020; all of which are entitled “Methods and Devices for Tissue Graft Fixation” and are incorporated herein by reference in their entirety.

[0003] This application also claims U.S. Provisional Application No. 62 / 869,593, filed July 2, 2019, entitled “Adjustable ACL Fixation Device,” which is incorporated herein by reference in its entirety.

[0004] This application also incorporates, by reference, the commonly owned U.S. Patent No. 10,383,617, which is incorporated herein by reference in its entirety. Technical Field

[0005] This disclosure relates to methods and apparatus for fixing tissue grafts in surgical repair. Background Technology

[0006] Tortured and irreparable soft tissue (such as ligaments and tendons) is typically replaced arthroscopically with tissue grafts. Currently, for soft tissue repairs where surgeons wish to use adjustable suspension fixation, one of two methods must be employed. If the tendon graft is not long enough to cover the closed loop of the adjustable fixation device, the end of the graft must typically be secured to the closed loop via lockstitch, which can damage the graft and may be difficult to form on such a small piece of tissue. In the other method, suture bands or similar materials are used to attach the ring of the adjustable fixation device through holes drilled in the bone block, requiring additional materials to complete the repair. Another problem encountered with adjustable fixation rings is that slippage or peristalsis of the sutures within the ring is more common than with non-adjustable rings. Furthermore, graft fixation devices are primarily designed to support or attach soft tissue grafts attached to bone blocks. In contrast, grafts with bone blocks are typically secured to bone tunnels using interference screws.

[0007] Adjustable fixation devices have become increasingly popular because they minimize fixation length calculations and allow grafts to be positioned at the bottom of the tunnel. Furthermore, femoral and tibial tunnels used for ACL reconstruction have become shorter over the past decade. These shorter tunnels are a preferred, more horizontal byproduct of the preferred femoral and tibial tunnels, which can improve post-graft function. Shorter tunnels mean shorter tunnel lengths available for suture loops, thus requiring adjustable suture loops of minimum length are preferred. Adjustable suture loops typically require significant pulling force to reduce their size, which can sometimes injure surgeons or damage their gloves. Some attempted solutions include multiple wrappings of suture around instruments (e.g., forceps) or the use of reinforced gloves, but these have not adequately met the industry's needs. Therefore, a means is needed to achieve the required force to reduce the size of adjustable suture structures in a safe and reliable manner. Summary of the Invention

[0008] This article describes various improvements to methods and devices for securing tissue grafts using adjustable fixation rings. Such improvements include examples of fixation devices that attach to an adjustable fixation ring of sutures without damaging the graft or requiring additional materials for repair. Other improvements include suture ring / fixation device structures designed to minimize suture slippage / peristalsis within the ring. Further improvements include spiral needles for suturing tissue grafts designed to minimize suture inward growth obstruction. Other improvements include fixation devices that can be used with grafts attached to bone blocks, such as patellar tendon or quadriceps tendon grafts. Still further improvements include fixation devices that can be attached to a separate adjustable suture system.

[0009] For example, a first embodiment may disclose a fastening device, which may be a leather button and may include two bodies; a first body having a first recess defined in a sidewall between a first end and a second end, and a second body having a second recess defined in a sidewall between a first end and a second end, wherein the first and second bodies are detachably connectable in the same plane, such that a first end of the second body can be inserted into the first recess, and a second end of the first body can be inserted into the second recess. The first and second bodies may be mirror images of each other. Both the first and second bodies are configured to be assembled with a portion of an adjustable suture structure. At least one of the bodies is configured to allow a portion of the adjustable suture structure to pass through tissue before being attached to the other body. A suture holder of the adjustable suture structure may be disposed between the first and second bodies. Both the first and second bodies define a longitudinal axis extending between their respective first and second ends, and wherein, when attached, the two bodies partially overlap axially and partially extend axially away from each other and thus do not overlap axially. The first body can be assembled with the first ring of the adjustable suture structure and the second body can be assembled with the second ring of the adjustable suture structure. When connected, the first ring can be disposed within the recess of the second body and the second ring can be disposed within the recess of the first body.

[0010] In a further exemplary embodiment, a fixation device may be disclosed, comprising a first body having a first end and a second end. The first body may define a maximum fixation device footprint. The first body may include a groove formed through the upper surface of the body and transverse to the longitudinal axis of the body, closer to the first end. The groove may define an aperture through the lower surface of the body. The device may also include a second body having a plurality of apertures and configured to extend through the apertures in a first orientation and then nested within the groove in a second orientation. The first body may be operatively coupled to a first loop of an adjustable suture structure. The first body may include a pair of apertures adjacent to the groove for operative coupling to the first loop. The second body may be operatively coupled to a second loop of the adjustable suture structure. The second body may have a width extending through the first body from a first transverse side to a second transverse side. When operatively coupled, the upper surfaces of the first and second bodies may be flush. The second body is configured to allow the second loop of the adjustable suture structure to pass through tissue before coupling to another body. A suture holder of the adjustable suture structure may be disposed between the first and second bodies.

[0011] In a further exemplary embodiment, a fixation device may be disclosed, comprising a body having a first groove and a second groove formed through the body and extending along a longitudinal axis of the body. The body also includes a plurality of openings defining a path between sidewalls of the body, the openings communicating with the first groove and the second groove. All of the plurality of openings may define a path oriented transversely to the longitudinal axis of the body. The fixation device may further include a pin for insertion through the plurality of openings. The pin may bifurcate the first groove and the second groove. The pin may be configured to selectively and operably engage with a loop of an adjustable suture structure. The pin may be configured to selectively and operably engage with a first loop of an adjustable suture structure within the first groove and a second loop of an adjustable suture structure within the second groove. A method of repairing tissue may include engaging a first loop of an adjustable suture structure to the fixation device by partially inserting a pin of the fixation device through the first groove and inserting a second loop of the adjustable suture structure through the tissue. The second loop may then be inserted through the second groove, and the pin may be advanced through the second groove and through the second loop to assemble the second loop with the fixation device.

[0012] Further exemplary embodiments disclosed herein may include a fastening device comprising a first body having a first end defining a triangular cavity formed in an upper surface of the first body. The cavity also includes a hole extending from the bottom of the cavity and through a bottom surface of the first body. The first body further includes a plurality of holes through its entire thickness for engaging the first end of a suture. The device also includes a second body defining a plurality of slots and configured to nest within the triangular cavity of the first body. When disposed within the cavity, the plurality of slots may be surrounded. When nested, the plurality of slots may engage a peripheral surface of the cavity. After the suture has extended through the hole extending from the cavity, the plurality of slots may engage a second end of the suture. The first and second bodies cooperate to engage the second end of the suture and prevent the second end from disengaging from the second body.

[0013] Further exemplary embodiments disclosed herein include a fastening device having a pivoting member comprising a body having a first sidewall and a second sidewall defining a longitudinal groove. The body also includes a plurality of grooves perpendicular to the longitudinal groove, the grooves being configured to engage a first end of a suture. The body further includes a plurality of holes for engaging a second end of the suture and a closing member configured to pivot relative to the second sidewall within the longitudinal groove between an open position and a closed position to engage the suture.

[0014] Further exemplary embodiments disclosed herein include a fixation device having a first slot and a second slot formed through a first side of a body, and a third slot and a fourth slot formed through a second opposing side of the body. The body is configured to receive a first side of an adjustable suture loop structure through the first and third slots; and wherein the first and third slots include a tortuous path to retain the first side of the suture loop structure. The body is configured to receive a second side of the adjustable suture loop structure through the second and fourth slots. The body may include at least a pair of holes through the body, the holes being arranged internally relative to the slots. The pair of holes may be operatively coupled to the adjustable suture structure. A method of tissue repair using the fixation device may include extending a first or second side of the adjustable suture loop through the tissue to place a suture holder of the adjustable suture loop within the tissue. The first side may then be coupled to the first and third slots. In some exemplary methods, the first side may be coupled before extending the second side of the adjustable suture loop through the tissue. When assembled to the fixation device, the slots are configured to form a tortuous path for the adjustable suture structure.

[0015] This document discloses an embodiment of a fixation device, which includes a tubular cylindrical body and a hollow suture extending through an internal channel of the body. The fixation device also includes a plug configured to be inserted into and pushed through the hollow suture, and fixed within the internal channel of the body to prevent the suture from sliding relative to the body.

[0016] Another exemplary embodiment disclosed herein includes a fixation device operatively coupled to an adjustable suture structure having at least one contraction portion or longitudinal channel. This structural portion may be disposed adjacent to the bottom surface of the fixation device. A contraction member is configured to apply 360-degree compression to at least one suture loop extending through the contraction member.

[0017] Further exemplary embodiments disclosed herein include a fastening device comprising an anchor body having a plurality of holes and a suture thread passing through the plurality of holes, such that a first ring and a second ring extend from the bottom surface of the anchor body, while a first free end and a second free end extend from the top surface of the anchor body. Each of the first ring and the second ring extends through a bracket region and exits from the same side of the bracket region, and a connecting member connects a portion of the first ring and the second ring extending from the same side of the bracket region.

[0018] An exemplary method for attaching a graft to a fastener is disclosed and may include inserting a spiral needle coupled to a suture into the graft, passing the needle and suture through the graft along a first suture path, passing the needle and suture through an adjustable suture loop of a fastener, reinserting the needle into the graft, and passing the needle and suture through the graft along a second suture path.

[0019] Further exemplary embodiments disclosed herein include a fixation member and an adjustable suture loop attached to the fixation member. The adjustable suture loop includes a bracket portion and an implant coupled to the bracket region, the implant being configured to engage the outer surface of a bone block pre-attached to soft tissue.

[0020] An exemplary method for attaching a fixation device / suture loop structure to a graft is disclosed and may include inserting a needle into the proximal end of the graft and exiting through the top surface of the graft; surrounding the end of the graft such that the needle and the bracket are positioned below the bottom surface of the graft; inserting the needle from the bottom surface of the graft to the top surface at a second exit point distal to the first exit point to pull the bracket above the top surface of the graft; and attaching reinforcing material to the graft at least between the first and second exit points of the needle such that the needle passes through the reinforcing material.

[0021] Further exemplary embodiments are disclosed herein and include a fixation system for suspending a bone-tendon graft within a bone tunnel, the bone-tendon graft comprising a bone block. The fixation system includes a fixation device, a continuous suture loop, and an adjustable suture loop. The adjustable suture loop is operatively coupled to the fixation device, thereby providing a connection between the fixation device and the continuous loop. The adjustable loop is operatively coupled to the continuous loop at a loop intersection point. The continuous loop has a length configured to extend through a channel in the bone block and along the outer surface of the bone block, such that the loop intersection point is positioned at a target location axially spaced along the outer surface and from a first proximal end of the bone block adjacent to the fixation device. In some embodiments, the continuous loop may include means for holding the loop intersection point at the target location. In some embodiments, the means may include a luggage tag loop with an adjustable loop. In some embodiments, the means may include a knot at a first end of the continuous loop. In some embodiments, the means may include a button operatively coupled to the first end of the continuous loop. In some embodiments, the adjustable loop may include at least two adjustable loops continuously wrapped around at least one of the adjustable loops to form a luggage tag loop and hold the loop intersection point at the target location. In some embodiments, the adjustable portion may include a bracket operably coupled to a continuous ring via a luggage tag ring.

[0022] An exemplary embodiment of a fixation system for suspending a bone-tendon graft within a bone tunnel is disclosed, the bone-tendon graft comprising a bone block. The fixation system includes a fixation device, a continuous ring, and an adjustable ring; the adjustable ring is operatively coupled to the fixation device and to the continuous ring. The adjustable ring is operatively coupled to the continuous ring at a ring intersection; wherein the continuous ring has a length configured to extend through a channel in the bone block and along the outer surface of the bone block, such that the ring intersection is located at a target position axially spaced from a first end of the bone block adjacent to the fixation device.

[0023] An exemplary method for securing soft tissue to bone is disclosed, comprising preparing a tunnel along the longitudinal axis of a bone graft. A fixation structure, including a retaining button, an adjustable suture loop, and a continuous suture loop, can then be attached to the bone graft. The two suture loops form independent sutures. The attachment involves first extending a first end of the continuous suture loop through the entire tunnel, and then passing the retaining button through the first end to form a luggage tag loop that passes through and surrounds the bone graft; both the continuous loop and the adjustable suture loop form part of the luggage tag loop.

[0024] This document discloses a further exemplary fixation system for surgical implantation, comprising a first flexible member having a first free end, a second free end, and a first body extending between the first and second free ends of the first flexible member. The first body defines a first longitudinal channel portion in the first flexible member, the first flexible member forming an adjustable loop by passing the first free end through the first longitudinal channel portion. This embodiment also includes a second flexible member defining a continuous loop and coupled to the first flexible member; wherein the first and second flexible members are formed as independent components. A fixing button anchor is directly coupled to the first flexible member, the arrangement being configured such that the adjustable loop of the first flexible member defines a connection between the anchor and the second flexible member. The first flexible member defines a first loop end and a second loop end at an opposite end of the first loop end, the second flexible member being coupled to the first loop end. The anchor is coupled to the second loop end. The fixation system also includes a retaining button slidably coupled to at least one of the first or second flexible member to restrict migration of the continuous loop into a prepared bone block tunnel. In some exemplary embodiments, the second flexible member has a length configured to form part of a ring surrounding and passing through the bone block, with the first flexible member completing the ring. In some exemplary embodiments, the length of the second flexible member is limited to form an incomplete ring surrounding the bone block, such that the first flexible member completes the ring and the intersection between the first and second flexible members places a longitudinal channel portion on the outer surface of the bone block spaced between its distal and proximal ends.

[0025] This document also discloses an exemplary method for fixing soft tissue to bone, comprising preparing a tunnel through a bone block of a graft having a longitudinal axis and a transverse axis, and the tunnel being oriented at an angle between the longitudinal and transverse axes. The tunnel defines a first opening through the cortical outer surface of the bone block and a second opening through the lower cancellous outer surface of the bone block between its distal and proximal ends. The method further includes extending an adjustable suture loop operatively coupled to a bone fixation device through the angular bone tunnel and then extending it at a tendon / bone interface opposite the first opening; thereby attaching the suture loop to the bone block. The adjustable suture loop may include a suture holder, and wherein, after the suture loop has been extended at the tendon / bone interface, the adjustable loop may be shortened to pull the bone fixation device to the bone block. The method may further include forming bilateral grooves around the lateral surfaces of the bone block and extending the suture loop at the tendon / bone interface to position the loop within the bilateral grooves.

[0026] Further exemplary embodiments disclosed herein include a graft suspension device comprising an elongated body. The elongated body may include a first end, a second end, and a longitudinal axis extending therebetween; a first sidewall extending along the longitudinal axis between the first and second ends; and a second sidewall extending along the longitudinal axis between the first and second ends opposite to the first sidewall. The elongated body also includes at least a first hole and a second hole defined by the body adjacent to a midpoint of the body defined by the first and second ends; a first groove formed by one of the first or second sidewalls such that the first groove is adjacent to the first hole; and a second groove formed by one of the first or second sidewalls such that the second groove is adjacent to the second hole. At least the first hole and the second hole are pre-assembled to a first ring of an adjustable suture loop. The first and second grooves are configured to receive a second ring of the adjustable suture loop. In some embodiments, the adjustable suture loop includes a bracket disposed between the first and second rings. The second ring may define a provided free end. In some exemplary embodiments, the free end is configured to pull the bracket into or through the transplanted tissue rather than to support it and then wrap around the first and second grooves to attach to the elongated body. In some exemplary embodiments, the bracket includes a longitudinal channel portion through which the ends of the first and second suture limbs extend, and wherein the elongated body also includes a third and a fourth hole respectively disposed adjacent to the first and second ends, the third and fourth holes being configured to receive the first and second limbs therethrough.

[0027] An exemplary method for attaching an adjustable suture loop structure to a graft may include placing a reinforcing device around the proximal end of the graft, including a bottom surface, an end surface, and a top surface surrounding the proximal end of the graft. A needle is coupled to a bracket of the adjustable suture loop structure and inserted through the reinforcing device into the proximal end of the graft and exiting through the top surface of the graft and through the reinforcing device, thereby defining a first exit point. The bracket is then wrapped around the end of the graft such that the needle and the bracket are positioned below the bottom surface of the graft. In some embodiments, the needle is inserted from the bottom surface of the graft to the top surface at a second exit point distal to the first exit point to pull the bracket above the top surface of the graft. In some exemplary methods, the needle is coupled to the bracket via a flexible member having a tapered member disposed coaxially thereon. The tapered member defines a smaller opening end adjacent to the needle and a larger opening end therein receiving a portion of the bracket. The needle is inserted through the reinforcing device and the graft, thereby pulling the tapered member through the reinforcing device and the graft. In some exemplary embodiments, the reinforcing device is selected from flat braided sutures, braided caps, or rigid implants. In some exemplary embodiments, the reinforcing device includes a pre-formed hole for receiving a needle therethrough.

[0028] Some exemplary embodiments disclosed herein may include an adjustable fixation system for suspending a graft within a bone tunnel. The system may include a suspension device comprising a fixation device and an adjustable suture structure operatively coupled to the fixation device. The adjustable suture structure has a first limb, a second limb, and a bifurcation therebetween. In some embodiments, the adjustable suture structure may include at least two adjustable loops. In some embodiments, the bifurcation may connect to or support the graft. In some embodiments, the bifurcation defines two longitudinal channels of the adjustable suture structure. In some embodiments, the bifurcation is continuous with the first and second limbs and formed during the weaving of the suture structure. In some embodiments, both the first and second limbs include a braided core, thereby defining the length of the bifurcation therebetween, the length of the bifurcation defining two parallel longitudinal channels. In some embodiments, the first longitudinal channel of the bifurcation is configured to receive one of the first or second limbs therethrough and form a first adjustable suture loop, and the second longitudinal channel of the bifurcation is configured to receive the other of the first or second limbs therethrough and form a second adjustable suture loop. In some embodiments, both the first and second limbs include an outer wall having a first plurality of braided strands and a core having a second plurality of braided strands. Each longitudinal channel may include at least one strand from the first plurality of braided strands and at least one strand from the second plurality of braided strands. In some embodiments, the first plurality of braided strands and the second plurality of braided strands are equally separated between the longitudinal channels.

[0029] In another embodiment of the adjustable tissue fixation system disclosed herein, the system includes a tissue anchor and a flexible member coupled to the tissue anchor. The flexible member has a first free end, a second free end, and a body extending between the first and second free ends of the flexible member, the body defining a first longitudinal channel portion and a second longitudinal channel portion within the flexible member. The first and second longitudinal channel portions are parallel to each other. The flexible member forms a first adjustable ring by passing the first free end through the first longitudinal channel portion. The flexible member forms a second adjustable ring by passing the second free end through the second longitudinal channel portion. In some embodiments, tension on the first free end is configured to reduce the length of the first adjustable ring or reduce the diameter of the first longitudinal channel portion to selectively limit further adjustment of the length of the first adjustable ring. In some embodiments, tension on the second free end is configured to reduce the length of the second adjustable ring or reduce the diameter of the second longitudinal channel portion to selectively limit further adjustment of the length of the second adjustable ring. In some embodiments, the first end passes through the first longitudinal channel portion in a first direction and the second free end passes through the second longitudinal channel portion in a direction opposite to the first direction. In some embodiments, the first longitudinal channel and the second longitudinal channel are formed by a single suture structure continuously woven to form a length including the first longitudinal channel and the second longitudinal channel. In some embodiments, the first longitudinal channel and the second longitudinal channel are configured to support tissue to be fixed within the bone tunnel.

[0030] An exemplary method for securing soft tissue to bone is also disclosed, comprising attaching the soft tissue to a bracket of an adjustable suture loop structure. The bracket has two parallel longitudinal channels of a bifurcated length of the adjustable suture loop structure. The method further includes extending the adjustable loop suture structure, operatively attached to a bone fixation device, through a bone tunnel. A first end of the adjustable suture loop structure is pulled to slide the first end through the first of the two parallel longitudinal channels and pull the soft tissue into the bone tunnel. The first end of the adjustable suture loop structure can also be pulled to tighten the first of the two parallel longitudinal channels around a first free end. The method may further include pulling a second end of the adjustable suture loop structure to slide the second end through the second of two parallel cores and pull the soft tissue into the bone tunnel. Pulling the second end of the adjustable suture loop structure can also tighten the second of the two parallel cores around a second free end. The method may further include operatively attaching a button anchor of the adjustable suture loop structure to the bone.

[0031] This document discloses another exemplary embodiment including a suture tensioning device defining a rod-shaped handle having a longitudinal axis and two side ends. A groove extends along a portion between the side ends of the handle, defining an elongated opening along a first outer surface of the handle. The groove has a bottom surface extending along the handle, defining an innermost surface of the groove. At least one notch extends radially from the groove, having a first end at the first outer surface and an opposing inner end radially offset from the bottom surface of the groove. The groove may be configured to receive a suture of a certain length, and the at least one notch may be configured to retain a connecting device associated with the suture of said length therein, and to limit lateral sliding of the suture along the groove. The at least one notch includes a plurality of notches axially spaced along a middle portion of the groove. The groove may terminate at a first end and a second end, each end of the groove being continuous with a groove and spaced apart from the two side ends. The groove may extend from the groove through the handle to a second outer surface opposite the first outer surface. The at least one notch may have a cross-sectional dimension larger than the corresponding cross-sectional dimension of the groove. The groove may be sized to prevent the connecting device associated with the suture from engaging the bottom surface of the groove. At least one notch may be sized to receive a connecting device associated with a suture and to retain the connecting device within the at least one notch during use. At least one notch may be sized to receive a connecting device associated with a suture, and a groove may be sized to receive a suture of the length extending from the connecting device, such that the length of suture is positioned inside the connecting device. A suture tensioning device may be configured to receive a suture loop formed by two suture tails joined by the connecting device, the groove may be configured to receive two suture tails, and at least one notch may be configured to engage the connecting device.

[0032] In a further embodiment, a suture loop reduction device is disclosed, comprising a handle having a double-sided groove extending from a first outer surface of the handle to a second outer surface of the handle. The first and second outer surfaces are on opposite sides of the handle. The device further includes a groove extending between and continuous with the double-sided groove, wherein a suture loop is received through the double-sided groove and enters the groove. The handle also includes at least one notch for receiving a knot or splice of the suture loop, the at least one notch extending from an inner surface of the groove to the second outer surface. In some embodiments, the groove has a bottom surface extending along the handle, defining an innermost surface of the groove. In some embodiments, the at least one notch has an axis arranged transversely to the longitudinal axis of the handle. In some embodiments, the innermost end of the at least one notch is offset from the bottom surface of the groove. In some embodiments, the at least one notch is a plurality of notches axially spaced along a middle portion of the groove. In some embodiments, the cross-section of the at least one notch is larger than the cross-section of the groove, such that the cross-section of the groove impedes the entry of a knot or splice. In some embodiments, the suture loop is part of an adjustable fixing structure, and wherein tension is applied to the suture loop to reduce the suture loop of the adjustable fixing structure.

[0033] This document also discloses a method for reducing the circumference of an adjustable suture structure. The method includes placing a first suture tail and a second suture tail of the adjustable suture structure within an elongated groove of a tensioning handle, and placing a connecting device for the first and second tails within a notch extending from the groove, thereby restricting the suture tails from sliding along the groove. The method further includes reciprocatingly rocking the tensioning handle to apply alternating tension between the first and second tails, thereby reducing the circumference of the adjustable suture structure. In some exemplary methods, the suture joint is held within the notch while the tensioning handle is rocked.

[0034] This document also discloses another method for reducing the circumference of an adjustable suture structure, the method comprising placing a first side of the adjustable suture structure in a first groove via a tensioning handle and placing a second side of the adjustable suture structure in a second groove via the tensioning handle; a first opening and a second opening are provided adjacent to the end of the tensioning handle. The tensioning handle is then rocked back and forth to apply alternating tension between the first and second sides, thereby reducing the circumference of the adjustable suture structure. In some exemplary methods, a connecting device for the adjustable suture structure may be present, which may be placed within a notch in the tensioning handle to restrict the sliding of the adjustable suture structure along a tension bar during rocking. In some exemplary methods, the adjustable suture structure is operatively coupled to a fixation device and is also configured to be coupled to a graft, wherein rocking the tensioning handle pulls the graft toward the fixation device. The first and second sides may define a first loop and a second loop, and placing the first side in the first groove includes wrapping the first loop around the tensioning handle and through the first groove, and placing the second side in the second groove includes wrapping the second loop around the tensioning handle and through the second groove.

[0035] This document discloses a tissue repair system comprising an open-loop adjustable fixation structure having a first end assembled with a leather button and a second end defining a free end. The system also includes a needle system comprising needles operatively coupled to a first loop and a second loop extending from the needles of different lengths. Both the first and second loops can be directly coupled to the needles. The first loop may be longer than the second loop. The first and second loops can be formed independently and include means for easily distinguishing them from each other, including different surface markings, stitch weaves, shapes, sizes, or colors. The first loop at the second end of the structure can be coupled to the first loop of the needle system. The second loop at the second end of the structure can be coupled to the second loop of the needle system.

[0036] These and other features and advantages will become apparent from reading the following detailed description and viewing the accompanying drawings. It should be understood that the foregoing general description and the following detailed description are illustrative only and not intended to limit the claimed aspects. Attached Figure Description

[0037] This disclosure will be more fully understood by referring to the following detailed description in conjunction with the accompanying drawings, wherein:

[0038] Figure 1A and 1B A first example of a fixation device of the present disclosure for use with an adjustable fixation suture structure is shown;

[0039] Figure 2A-2C A second example of the fixing device of this disclosure is shown;

[0040] Figure 3Aand 3B A third example of the fixing device of this disclosure is shown;

[0041] Figure 4A and 4B A fourth example of the fixation device with an open-loop adjustable suture structure of the present disclosure is shown;

[0042] Figure 5A-5G A fifth example of the fixation device with an open-loop adjustable suture structure and its method of use are shown in this disclosure;

[0043] Figure 6A -C illustrates a sixth example and method of use of the fixation device with an open-loop adjustable suture structure disclosed herein;

[0044] Figures 7A-7D A seventh example of the fixation device with an open-loop adjustable suture structure of the present disclosure and its method of use are shown;

[0045] Figures 8A-8C An eighth example of a fixation device with an open-loop adjustable suture structure according to the present disclosure is shown;

[0046] Figure 8D The present disclosure illustrates a method for forming a suture structure, the suture structure being at least Figure 1A , 1B An open-loop structure used together with the fixing devices of 2A-2C, 3A, 3B, 4A, 4B, 5A-5G, 6A-6C, 7A-7D, 8A-8C and 12A-12D;

[0047] Figure 9A-9G A ninth example of the fixing device of this disclosure is shown;

[0048] Figure 10A-10I An example of the device / suture loop structure of this disclosure for minimizing suture slippage / peristalsis is shown;

[0049] Figure 11A and 11C A known fixing device in the art is shown;

[0050] Figure 11B and 11D -11G shows a tenth example of a fixation device according to the present disclosure having an open-loop adjustable suture structure having two connected tension suture ends;

[0051] Figure 11H-11V It shows the use of Figure 11A Example of a fixing device in a G-shaped device / suture loop structure;

[0052] Figure 12A-12DEleventh example of the fixation device with an open-loop adjustable suture structure of the present disclosure is shown;

[0053] Figures 13A-13F An example of a spiral needle used for suturing tissue grafts according to this disclosure is shown;

[0054] Figure 13G -J shows the operation Figures 13A-13F Example of a fastener for a spiral needle;

[0055] Figure 14A -K illustrates an example of a device for attaching a fixation device to a graft comprising bone blocks, according to at least some embodiments;

[0056] Figure 15A-15N 15P-15R illustrates examples of systems and related methods for directly attaching a device / suture loop structure to a graft or bone block according to at least some embodiments;

[0057] Figure 16A , 16B 16C schematically illustrates an isometric view of an adjustable structure for fixing a graft with bone blocks within a bone tunnel, according to at least some embodiments;

[0058] Figure 17A and 17B The adjustable structure for adjusting between extending and shortening the ring length is schematically shown separately;

[0059] Figures 18A-18D A method for connecting adjustable structures via longitudinal bone block channels according to at least some embodiments is illustrated schematically;

[0060] Figure 19A An adjustable structure according to at least some embodiments is shown;

[0061] Figure 19B An adjustable structure for attachment to a bone block is shown according to at least some embodiments;

[0062] Figure 20A-20D Alternative embodiments of an adjustable structure coupled to a bone block, according to at least some of the embodiments, are schematically shown;

[0063] Figure 21 The diagram schematically illustrates alternative systems and methods for attaching an adjustable fixation structure to a bone block including a retaining button, according to at least some embodiments.

[0064] Figure 22 Alternative methods for attaching an adjustable fixation structure to a bone block are illustrated schematically according to at least some embodiments;

[0065] Figures 23A-23CAlternative embodiments of an adjustable structure coupled to a bone block, according to at least some of the embodiments, are schematically shown;

[0066] Figure 24 An adjustable fixing structure according to at least some embodiments is schematically shown;

[0067] Figure 25A and 25B The routes of the first adjustable loop and the two adjustable loops are schematically shown respectively;

[0068] Figure 26A The diagram schematically illustrates routing a first adjustable loop by providing a first loose end 2430 along longitudinal channel 2418', according to at least some embodiments.

[0069] Figure 26B and 26C Exemplary cross-sections along the non-forked length and the forked length, respectively, are schematically shown according to at least some embodiments;

[0070] Figures 27A-27C Various views of embodiments of a tension bar according to at least some of the embodiments are schematically shown;

[0071] Figure 27D A cross-section along the longitudinal axis of the handle is schematically shown;

[0072] Figure 27E schematically shown Figure 27D An isometric view of the cross-section shown.

[0073] Figure 28A and 28B Corresponding end views of the cross section and cross section of a tension bar according to at least some embodiments are shown respectively;

[0074] Figure 29A and 29B Corresponding end views of the cross section and cross section of a tension bar according to at least some embodiments are shown respectively;

[0075] Figure 30 An exemplary adjustable fixing structure having an operatively connected tension bar is schematically shown according to at least some embodiments;

[0076] Figure 31A and 31B A method of using a tension bar with an adjustable fixing structure is shown according to at least some embodiments;

[0077] Figure 32A This illustrates a double-ring needle system with knots.

[0078] Figure 32BA needle system comprising two loops is shown according to at least some embodiments;

[0079] Figure 32C An open-loop fixing structure operatively coupled to a needle system according to at least some embodiments is shown;

[0080] Figure 32D An alternative needle system comprising two loops is shown according to at least some embodiments;

[0081] Figure 32E An alternative needle system comprising two loops is shown according to at least some embodiments;

[0082] Figure 32F An alternative needle system comprising two loops is shown according to at least some embodiments;

[0083] Figures 33A-33C Alternative open-loop constructions with bypass rings according to at least some embodiments are shown;

[0084] Figures 34A-34B This illustrates a method for attaching an open-loop fixation structure to tissue;

[0085] Figures 35A-35C A low-profile shinbone button according to at least some embodiments is shown;

[0086] Figures 36A-36C An alternative low-profile shin button according to at least some embodiments is shown;

[0087] Figures 37A-37B An alternative low-profile shin button according to at least some embodiments is shown;

[0088] Figure 37C An open-loop fixation structure for assembly to a low-profile tibial button is shown according to at least some embodiments;

[0089] Figure 38 An open-loop construction assembly tool according to at least some embodiments is shown;

[0090] Figures 39A-39D Various views of the assembly tool according to at least some embodiments are shown;

[0091] Figure 40A-40F The use according to at least some embodiments is shown. Figure 38 and Figures 39A-39D Methods for repairing tissues using open-loop fixation structures and assembly tools; and

[0092] Figure 41 Alternative assembly tools according to at least some embodiments are shown. Detailed Implementation

[0093] In the following description, similar parts have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate the examples clearly and concisely, the figures may not necessarily be drawn to scale, and some features may be shown in a slightly schematic manner. Features described and / or shown with respect to one example may be used in the same or similar manner in one or more other examples and / or combined with or in place of features of other examples.

[0094] As used in the specification and claims, for the purposes of describing and defining the invention, the terms “about” and “approximately” are used to indicate the inherent uncertainty attributable to any quantitative comparison, value, measurement, or other representation. The terms “about” and “approximately” are also used herein to indicate the extent to which a quantitative representation may differ from the stated reference without causing a change in the essential function of the subject matter under discussion. The forms “comprising,” “including,” and / or each” are open-ended and include the listed portions and may include additional portions not listed. “And / or” is open-ended and includes one or more listed portions and combinations of listed portions. The use of the terms “up,” “down,” “up,” etc., is intended only to help clearly describe this disclosure and is not intended to limit the structure, positioning, and / or operation of this disclosure in any way.

[0095] Now for reference Figure 1A A first example of a detachable two-part suspension fixation device 100 for soft tissue repair is shown in an exploded view. The device 100 includes a first elongated, substantially flat body 102 and a second elongated, substantially flat body 104. The first body 102 and the second body 104 may be made of a biocompatible material, such as titanium or polyetheretherketone (PEEK). The first body 102 has a first end 102a and a second end 102b. A recess 102c is formed in the sidewall of the body 102 between the first end 102a and the second end 102b. Similarly, the second body 104 has a first end 104a and a second end 104b. A recess 104c is formed in the sidewall of the body 104 between the first end 104a and the second end 104b. The first body 102 is pre-assembled to a first side 106a of an adjustable fixation ring 106 through a first plurality of holes 108 defined in the second end 102b. The second body 104 is pre-assembled to the second side 106b of the adjustable retaining ring 106 through a second plurality of holes 110 defined in the first end 104a, forming an open-loop configuration. As will be disclosed in more detail later, the bracket portion 106c is disposed between the two sides 106a and 106b and spaced apart from the first and second bodies.

[0096] During the repair process, the graft (not shown) can be attached to or suspended on the adjustable fixation ring 106 to be pulled into the bone tunnel. More specifically, the graft can be wrapped around the bracket 106c. The first body 102 and the second body 104 are detachably connectable in the same plane, whereby the first end 104a of the second body 104 can be inserted into the recess 102c of the first body 102, and the second end 102b of the first body 102 can be inserted into the second recess 104c of the second body 104, forming a closed-loop structure. Figure 1B In this manner, the first body 102 can be fed through a hole formed in the bone or soft tissue to place the bracket 106c within the bone or soft tissue. The first body 102 can then be coupled to the second body 104 before the repair is completed in a normal manner for suspension fixation. The adjustable fixation ring 106 can be formed in at least the manner shown in 8D. However, other adjustable rings can be formed, wherein the ring includes means for adjusting the ring, the means including a sleeve portion defining a hollow length therethrough through which the length of the adjustable ring can be received. Exemplary adjustable rings also include, for example Figures 16A-16C As shown in the figure, the open-loop configuration of the adjustable fixation ring 106 advantageously allows the second side 106b of the fixation ring 106 to shuttle through the tissue graft or bone block before being assembled into the device 100. As shown, each body 102 and 104 is approximately a mirror image of each other and forms the left and right sides of the fixation body.

[0097] Turn now Figure 2AA second example of a detachable two-part suspension fixation device 200 for soft tissue repair is shown in an exploded view. The device 200 includes a first elongated, substantially flat body 202 and a second elongated, substantially flat body 204. The first body 202 has a first end 202a and a second end 202b. A recess 202c is formed in the sidewall of the body 202 between the first end 202a and the second end 202b. A rib 212 extends along the inner surface of the recess 202c and along the outer surface of the second end 202b. The second body 204 has a first end 204a and a second end 204b. A recess 204c is formed in the sidewall of the body 204 between the first end 204a and the second end 204b. A groove 214 extends along the inner surface of the recess 204c and along the outer surface of the first end 204a. The first body 202 is pre-assembled to a first side 206a of an adjustable retaining ring 206 through a first plurality of holes 208 defined in the second end 202b. The second body 204 is pre-assembled to the second side 206b of the adjustable retaining ring 206 through a second plurality of holes 210 defined in the first end 204a, forming an open-loop structure. The first body 202 and the second body 204 are detachably connected in the same plane, whereby the first end 204a of the second body 204 can be inserted into the recess 202c of the first body 202, and the second end 202b of the first body 202 can be inserted into the second recess 204c of the second body 204, forming a closed-loop structure. Figure 2B In this manner, the first body 202 can be fed through a hole formed in the bone or soft tissue and reattached to the second body 204 before the repair is completed in the normal manner for suspension fixation. The adjustable fixation ring 206 can be... Figure 8D The configuration is as shown. The open-loop construction of the adjustable fixation ring 206 advantageously allows the second side 206b of the fixation ring 206 to shuttle through the tissue graft or bone block before being assembled into the device 200.

[0098] The two locking mechanisms of device 200 are in Figure 2C The details are shown in more detail below. A first locking mechanism may include a rib 212 of the first body 202 that can be inserted into a groove 214 of the second body, such that the first body 202 and the second body 204 can be locked together for easier passage during repair to reduce the likelihood of separation. An additional locking mechanism may include a first mating shape between a first end 204a of the second body 204 and a recess 202c of the first body 202, and a second mating shape between a second end 202b of the first body 202 and a second recess 204c of the second body 204. The first and second mating shapes prevent separation of the anchor bodies 202, 204. Additionally, for final fixation, each body 202, 204 may extend across a cortical tunnel to increase strength.

[0099] Turn now Figure 3AAnother example of a detachable two-part suspension fixation device 300 for soft tissue repair is shown in an exploded view. The device 300 includes a first elongated, generally flat body 302 and a second, smaller body 304. The first body 302 has a first end 302a and a second end 302b. A groove 302c is formed through the upper surface of the body 302 transverse to the longitudinal axis L of the body 302 and closer to the first end 302a. The groove 302c includes an opening 312 in the lower surface of the body 302. The first body 302 is pre-assembled to a first side 306a of an adjustable retaining ring 306 via a plurality of first holes 308 disposed on either side of the longitudinal axis and facing the second end 302b relative to the groove 302c. The second body 304 is pre-assembled to a second side 306b of the adjustable retaining ring 306 via a plurality of second holes 310 defined in the body 304, forming an open-loop configuration. The open-loop construction of the adjustable fixation ring 306 advantageously allows the second side 306b and free end 306c of the fixation ring 306 to shuttle through the tissue graft or bone block before assembly into the device 300. The pores in the bone block or soft tissue can advantageously be smaller than those described above. Figure 1A and 2A The anchor body passes through a hole in the desired bone block or soft tissue.

[0100] like Figure 3B As shown, the first body 302 and the second body 304 are detachably connectable, whereby the second body 304 can be inserted upward through the opening 312 and secured into the groove 302c of the first body 302 to form a closed-loop structure. The second body 304 is held in place by an adjustable retaining ring 306, which will always be under tension after implantation, thereby holding the second body 304 in place. In this way, the second body 304 can be passed through or sutured to a small hole and then assembled into the larger first body 302 to form a closed-loop structure. Before completing the repair in the normal manner for suspension fixation, the second body 304 can be fed through a hole formed in the bone or soft tissue and connected back to the first body 302. The adjustable retaining ring 306 can be... Figure 8D It is formed in the manner shown. The tension on the ends 306c and 306d can reduce the adjustable fixation ring and pull the transplanted tissue toward the body 302 and 304.

[0101] Turn now Figure 4AThis illustration shows another example of a detachable two-part suspension fixation device 400 for soft tissue repair. The device 400 includes an elongated, generally flattened body 402 and an insertable pin 404. The body 402 has a first end 402a and a second end 402b. Two parallel grooves 402c, 402d are formed at the center of the body 402, extending along the longitudinal axis L of the body 402. The sidewalls of the grooves 402c, 402d include openings 412 defining a path P extending transversely to the longitudinal axis L through the body 402. The pin 404 is inserted through the opening 412 in the groove 402d and pre-assembled to a first side 406a of an adjustable fixation ring 406, forming an open-loop configuration. The open-loop configuration of the adjustable fixation ring 406 advantageously allows the second side 406b and the free end 406c of the fixation ring 406 to shuttle through tissue grafts or bone blocks before assembly into the device 400. The pores in bone or soft tissue can be advantageously smaller than those described above. Figure 1A and 2A The anchoring solid passes through a hole in the desired bone or soft tissue. The second side 406b of the adjustable retaining ring 406 can be inserted upwards through the slot 402c. (As...) Figure 4B As shown, pin 404 can then be inserted through opening 412 in slot 402c to engage with the second side 406b of adjustable retaining ring 406, forming a closed-loop configuration. In this way, the second side 406b of adjustable retaining ring 406 can pass through or be sutured to a small hole and then assembled into the larger body 402 to form a closed-loop configuration. The second side 406b can be fed through a hole formed in the bone or soft tissue and engaged back into the body 402 before the repair is completed in the normal manner for suspension fixation. Adjustable retaining ring 406 can be... Figure 8D It is formed in the manner shown.

[0102] Turn now Figure 5A and 5B Another example of a detachable two-part suspension fixation device 500 for soft tissue repair is shown in an exploded view. Figure 5A In this configuration, device 500 and adjustable retaining ring 506 form an open-loop structure. For example... Figure 5B As shown, the device 500 includes a first elongated, generally flat body 502 and a second, triangular body 504. The first body 502 has a first end 502a and a second end 502b. A triangular groove 502c is formed through the upper surface of the body 502 closer to the first end 502a. The groove 502c includes an opening 512 in the lower surface of the body 502. The second body 504 includes a plurality of grooves 510 defined by the body 504. Figure 5CAs shown, the first body 502 is pre-assembled to the first side 506a of the adjustable fixation ring 506 via a plurality of closed holes 508 defined in the second end 502b. The second end 506b and the free end 506c can be fixed around a soft tissue graft or a bone block of transplanted tissue. The second end 506b and the free end 506c of the adjustable fixation ring 506 can then be inserted upwardly through the opening 512 and by inserting the strands of the ring 506 through the slot 510 ( Figure 5D The second body 504 can be connected via multiple slots 510.

[0103] like Figure 5E As shown, the first body 502 and the second body 504 are detachably connectable, whereby the second body 504 can be secured into the groove 502c of the first body 502 to form a closed-loop structure. An assembly jig (not shown) facilitates the handling of the second body 504, i.e., holding the second body 504, passing it through a suture, and placing the second body 504 into the groove 502c of the first body 502. In this way, the second body 504 can be passed through or sutured to a small hole and then assembled into the larger first body 502 to form a closed-loop structure. The repair can then be completed in the normal manner for suspension fixation without adding any significant time to the repair. The hole in the bone or soft tissue can advantageously be smaller than described above. Figure 1A and 2A The anchor body passes through a hole in the desired bone block or soft tissue. Figure 5F and 5G Perspective and top views of the assembly device 500 without the adjustable retaining ring 506 are shown respectively.

[0104] Open-loop adjustable structures such as structures 406 and 506 define a free end. Unlike the double-ring, adjustable-ring structure disclosed in U.S. Patent No. 10,383,617, which is commonly owned and incorporated herein by reference in its entirety, this open-loop adjustable structure forms a first ring constrained to a first end of a bracket and a second ring constrained to a second end. Figure 8DThe configuration shown allows a first ring to be attached, for example, to a fixing anchor and a second ring to define a provided free end, which is then placed through, for example, a hole in the transplanted tissue to subsequently pull the bracket into the transplanted tissue hole. In contrast, since each ring described in U.S. Patent No. 10,383,617 extends from both ends of the bracket, pulling one of the rings in this configuration would appear to pull both ends of the bracket into the tissue hole, and at most wed the bracket end into the tissue hole. This does not address the need to form an adjustable suture structure connected through the tissue hole. The adjustable fixing rings 5-6 form two adjustable rings, one retaining on a first side of the single suture bracket and the other retaining on the opposite side of the single suture bracket. In some embodiments, the bracket 520 may be a sleeve element separate from the length of the suture. However, preferably, the bracket 520 defines a certain length of braided suture with a hollow core, which is continuously braided with the remainder of the suture and thus with the adjustable suture loops. In other words, the bracket 520 and the strands 522 and 524 of the suture are a single element. The first strand 522 preferably extends from and is continuously woven with the first end of the bracket 520, and the second strand 524 preferably extends from and is continuously woven with the opposite end or second end of the bracket 520. In other words, the first strand 522 of the suture forms a first side 506a of the adjustable retaining loop 506, and the second strand 524 of the suture forms a second side 506b of the adjustable retaining loop 506. The open-loop construction of the adjustable retaining loop 506 advantageously allows the second side 506b of the retaining loop 506 to be without a retaining button, thus allowing it to shuttle through the tissue graft or bone block before assembly into the device 500. The first strand 522 extends from the first end of the bracket and may form a first loop or ring, then extends along the hollow core of the bracket 520, then through the suture weave of that length at the first end of the bracket, and then exits between the suture weaves of that length. A second thread 524 extends from the second end of the bracket 520 and can form a second loop on the second side 506b, then extends along the hollow core of the bracket 520 through the braid of the suture thread at the second end of the bracket 520 for that length, and then exits at the first end of the bracket between the braids of the suture thread for that length. Some exemplary fastening devices include a groove configured to selectively receive a loop end or ring from a free end of the adjustable suture structure.

[0105] Turn now Figure 6AThis illustration shows another example of a suspension and fixation device 600 for soft tissue repair. The device 600 includes an elongated, generally flat body 602. The body 602 has a first end 602a and a second end 602b. Two closed holes 608 are formed at the center of the body 602 adjacent to a first side 602c of the body 602. Two slots 610 are formed at the center of the body 602 adjacent to a second side 602d of the body 602. The two slots 610 may be directly opposite the two closed holes 608. The two closed holes and the two slots may be positioned near the midpoint between the first ends 602a and 602b. The first of the two holes may be adjacent to and directly opposite the first of the two slots. The second of the two holes may be adjacent to and directly opposite the second of the two slots. The two closed holes 608 may be positioned on a first side of the longitudinal axis L of the body, while the two slots may be positioned on opposite sides of the longitudinal axis L. Both the slots 610 and the holes 608 may define a maximum diameter that is equivalent to each other. The body also defines a top surface 602e and a lower surface 602f. The lower surface defines the cortical layer therein, which is configured to join the bone. The body 602 is pre-assembled to a first side 606a of an adjustable retaining ring 606 through closed holes 608, forming an open-loop configuration. The first side 606a includes a ring portion that, during the construction of the adjustable structure 606, passes through both closed holes 608 before passing through the bracket portion 606d. At least in Figure 8D The construction of the adjustable ring is shown in more detail below. The open-loop construction of the adjustable retaining ring 606 advantageously allows the second side 606b and the free limb 606c of the retaining ring 606 to first shuttle through the tissue graft or bone block before being assembled into the device 600. The holes in the bone block or soft tissue can advantageously be smaller than those described above. Figure 1A and 2A The anchoring solid passes through a hole in the desired bone or soft tissue. For example... Figure 6B As shown, the second side 606b of the adjustable retaining ring 606 can be connected to the slot 610 by first placing the loop of the ring 606b directly adjacent to the top surface 606e of the body and inserting the strand of the ring 606b into the slot provided on the second side 602d of the slot 610 to form a closed-loop structure. The top surface 602e of the body may include a shaped recess 602g, which is recessed below the surface 606e and connects the two slots 610 parallel to the longitudinal axis. The recess 602g is configured to nest the loop of the ring 606b and reduce the suture loop protruding from the body surface 602e. The slot 610 includes a narrow entrance at the slot on the second surface 606d to prevent the ring 606b from accidentally slipping out of the slot 610. The bone hole is also preferably sized such that the width of the body 602 (from the first side 602c to 602d) is greater than the formed bone hole. Therefore, once the lower surface 602f engages with the bone, the slot 610 is partially closed, causing the second side ring 606b to be trapped within the slot 610. Figure 6CThe main body 602, detached from the adjustable retaining ring 606, is shown. The adjustable retaining ring 606 can be... Figure 8D It is formed in the manner shown.

[0106] The body 602 also includes at least two additional holes 612 that may be located on the longitudinal axis L of the body. Each hole 612 may be located on either side of hole 608 and may be of equal size. Holes 612 are configured to receive free limbs, such as limb 606c, therethrough. Holes 612 may be circular and have a diameter or cross-section larger than slot 610 or hole 608. In some embodiments, holes 612 may be oval. The opening size of holes 612 is generally maximized to facilitate the passage of suture limbs while maintaining the structural integrity of the body 602. Figure 39B In an alternative embodiment of the anchor 602 shown, the hole 612 may have a larger oval hole 612, as previously described.

[0107] Turn now Figure 7A Another example of a suspension fixation device 700 for soft tissue repair is shown. The device 700 includes an elongated, generally flat body 702. The body 702 has a first end 702a and a second end 702b. Two closed holes 708 are formed at the center of the body 702 adjacent to a first side 702c of the body 702. Two slots 710 are formed at the center of the body 702 adjacent to a second side 702d of the body 702. A groove 714 is formed in the second side 702d of the body 702 adjacent to the slots 710. A pin 712 is hingedly attached to the first end 702a of the body 702. The body 702 is pre-assembled through the closed holes 708 to the first side 706a of an adjustable fixation ring 706, forming an open-loop configuration. The open-loop configuration of the adjustable fixation ring 706 advantageously allows the second side 706b and the free end 706c of the fixation ring 706 to shuttle through tissue grafts or bone blocks before assembly into the device 700. The pores in bone or soft tissue can be advantageously smaller than those described above. Figure 1A and 2A The anchor body passes through a hole in the desired bone block or soft tissue.

[0108] like Figure 7B As shown, the second side 706b of the adjustable retaining ring 706 can be connected to the slot 710 by inserting the strands of the ring 706 into the slot 710 to form a closed-loop structure. The pin 712 can be used as a "safety pin" ( Figure 7C The pin 712 is inserted into the groove 714 to ensure that the second side 706b of the adjustable retaining ring 706 does not migrate from the device 700 during use. The pin 712 also provides greater structural strength to the grooved side of the body 702. Figure 7D The main body 702, detached from the adjustable retaining ring 706, is shown. The adjustable retaining ring 706 can be formed in the manner shown in FIG. 5H.

[0109] Turn now Figure 8A This illustration shows another example of a suspension fixation device 800 for soft tissue repair. The fixation device 800 can be used with an open-loop adjustable suture structure, which is described in more detail below. The device 800 includes an elongated, generally flat body 802. The body 802 has a first end 802a and a second end 802b. Two closed holes 808 are defined throughout the entire thickness of the flat body 802 and at the center of the body 802. A first slot 810a is formed between the closed hole 808 and the first end 802a via a first side 802c of the body 802. A second slot 810b is formed between the closed hole 808 and the second end 802b via the first side 802c of the body 802. A third slot 810c is formed between the closed hole 808 and the first end 802a via a second side 802d of the body 802. A fourth slot 810d is formed between the closed hole 808 and the second end 802b via the second side 802d of the body 802. All slots 810a, b, c, and d may define the same shape as each other. All slots may have a more inward opening defining a first maximum size for housing a portion of the adjustable suture structure and an inlet portion for receiving the adjustable suture structure therethrough to allow the adjustable suture structure into the inward opening, which is smaller than the inward opening to reduce accidental escape of the adjustable suture structure. Figure 8B and 8C As shown, the body 802 can reach the first side 806a of the open-loop adjustable suture structure 806 during surgery via slots 810a, 810c. This embodiment allows the surgeon to assemble the entire adjustable loop structure 806, for example, during surgery. Slots 810a, b, c, and d are characterized by a “zigzag path” to retain the first side 806a and the second side 806b of the suture structure 806 after engagement. Furthermore, a closed hole 808 can receive finger rings 830a, 830b therethrough, and tension on finger rings 803a and 803b can reduce the adjustable suture loop and pull the graft toward the body 802. Finger rings 803a and 803b can then be connected by a knot 832 on the top surface of the body 802. Finger rings 830a, 830b allow tensioning of the suture structure 806.

[0110] Figure 8DThe steps for forming an open-loop adjustable suture structure 806 (also shown as at least structures 106, 206, 306, 3206) are illustrated. The suture structure 806 includes a bracket 820, a first strand 822 (which may include a ring 830a) of the suture forming a first side 806a of the suture structure 806, and a second strand 824 (including a ring 830b) of the suture forming a second side 806b of the suture structure 806. The bracket 820 is shown having a larger cross-section than the strands 822 and 824. During weaving, the bracket 802 and the strands 822 and 824 can all define similar cross-sections of the hollow core suture. The bracket can be expanded during processing to increase the cross-section. The bracket 820 can expand simply because the strands 822 and 824 are passed through it during the construction of the adjustable loop structure described herein. The first strand 822 of the suture, the bracket 820, and the second strand 824 of the suture can be a single, continuously braided flexible material. The open-loop construction of the suture structure 806 advantageously allows the second side 806b of the suture structure 806 to shuttle through the tissue graft or bone block before assembly to the body, such as at least bodies 102, 202, 302, 402, 502, 602, and 802. This allows the length of the bracket 820 to be positioned through the transplanted tissue or bone block. The traction ends 830a and 830b can reduce sides 806a and 806b, thereby forming an adjustable loop structure.

[0111] Turn now Figure 9A Another example of a dual-body suspension fixation device 900 for soft tissue repair is shown. Device 900 includes a tubular cylindrical body 902 and a tubular cylindrical plug 904. The outer surface of plug 904 may include multiple retaining features, such as annular ribs 938, as shown. Body 902 has a first portion 902a and a second portion 902b. The outer diameter of the first portion 902a is selected to be larger than the outer diameter of the second portion 902b. The inner diameter of body 902 is selected to receive a hollow suture 940 therethrough, such as... Figure 9B As shown. Figure 9C As shown, the plug 904 can be inserted into the hollow suture 940 and can be pushed through the suture 940 toward the inner diameter of the body 902. Figure 9D As shown, the plug 904 can then be locked within the inner diameter of the body 902 to prevent the suture 940 from sliding relative to the body 902. During repair, the hollow suture 940 can “form a luggage tag” around the bone block / soft tissue and pass through a bone tunnel. The body 902 can then be positioned around the hollow suture 940 and pushed downward toward the cortical bone surface. The plug 904 is then inserted into the hollow suture 940 to lock the suture 940 in place. Figure 9E and 9F Cross-sectional and perspective views of the assembly device 900 without the hollow suture 940 are shown respectively. Figure 9G This is a detailed view of the 904 plug.

[0112] Figure 10A -I illustrates a suture loop / fixation device construction 1001 designed to minimize slippage / peristalsis by incorporating a "Chinese finger cot" concept to provide suture sheath compression at 360° around a single suture extending within the cot. Compared to a bracket-type structure that receives two sutures, this concept is configured to receive only a single suture, thereby reducing slippage / peristalsis by providing 360° compression around the single suture on the tendon and cot elongation. For example, Figure 10A A single-loop adjustable suture loop 1006 is shown, which is dead-end in the fixation device 1000, and wherein the suture loop 1006 extends within the sleeve 1050 under high sleeve tension and high adjustable suture tension. Figure 10B A single-loop adjustable suture loop 1006 is shown, which has a dead end via a loop on a fixing device 1000. Figure 10C A single-loop adjustable suture loop 1006 is shown, wherein a sleeve 1050 is formed above the device 1000 under high sleeve tension and high adjustable suture tension. For these examples, half of the applied tension will result in similar retention of the suture through the sleeve 1050.

[0113] Figure 10D A double-ring adjustable suture loop 1006 is shown, comprising two loops 1050a, b formed below device 1000 under partial loop tension (T / 4) and partially adjustable suture tension (T / 4), such that the two suture loops receive complete 360° suture compression. Optionally, a limiting member 1052 (i.e., a knot / bead or expanded loop segment) may be included to eliminate tethered sutures, such as... Figure 10E (or in) Figure 10D The position “a” in the text is shown. Figure 10F A quadruple-loop adjustable suture loop 1006 is shown, comprising two loops 1050a (1050b not shown) formed below the device 1000 under partial loop tension (T / 8) and partial adjustable suture tension (T / 8), such that the four suture loops receive full 360° suture compression, with both loops adjustable together. Figure 10G Alternate passage through device 1000 is shown for two of the four suture loops (mirror loops omitted for clarity). Figure 10H and 10I The use of Sheath 1050 with full 360° suture compression under high sheath tension (T / 2) and low adjustable suture tension (T / 3 or T / 4) is shown. Figure 10HThe twisted suture is shown. It is further anticipated that by increasing the friction between sutures, the 1050 sleeve will exhibit less suture slippage / creep. This can be achieved by adding a certain amount of co-woven material (i.e., a material with higher friction) to the suture weave or by manipulating the suture texture.

[0114] Figure 11A A device / suture loop structure 1101 is shown, including a fixation device 1100 and an adjustable suture loop 1106, wherein the adjustable suture loop uses two connected tension sutures 1102 instead of two separate tension sutures. The device in 11A is disclosed in commonly owned U.S. Patent No. 10,383,617, which is incorporated herein by reference in its entirety. Figure 11B A device / suture loop structure 1151 is shown, including a fixation device 1150 and an adjustable suture loop 1156, wherein the adjustable suture loop uses two connected tension sutures 1152 instead of two separate tension sutures. Although Figure 11A The structure shown requires separating tissue 1160 to attach the bracket to the tissue, but a structure similar to structure 1151 allows the free end of the suture structure to be inserted through tissue 1160. In other words, instead of using a continuous circular loop without openings to allow the adjustable suture loop 1106 to be placed through tissue 1160... Figure 11A One of the loops of the adjustable suture loop 1106 can be unfolded and passed through tissue 1160, and then attached to the fixation device 1150. Figure 11B ).exist Figure 11C In the example of (and 11A), the adjustable suture loop 1106 consists of a series of suture loops, each loop passing through the 12 o'clock position (vertical dotted line) and then continuing around to the bracket 1120. In order to pass the adjustable suture loop 1106 through the tissue and back to the device 1150, the suture cannot pass through the 12 o'clock position. Instead, the suture will still make a 180° turn on the same side from which they originated and then continue through the bracket 1120 in the opposite direction to the device 1150, as... Figure 11D As shown in the diagram. It is worth noting that the two free ends 1156c, 1156d of the adjustable suture loop 1156 cannot be joined because free end 1156c needs to pass through the tissue. To join the two free ends 1156c, d, both need to be located away from the bracket 1120 on the same side of the device 1150, as shown in the diagram. Figure 11EAs shown in the example. In this example, this will be achieved by adding a “redirection” loop 1192 to the adjustable suture loop 1106. While this will eliminate the need for one of the free ends 1156a, b to pass through the tissue, it may still be necessary for both loops to pass through the tissue and then attach to the device 1150. It may be necessary to have more holes in the device 1150, thus making the device 1150 larger, as well as additional sutures passing through the bracket 1120. Figure 11F The preferred embodiment shown would require only one ring 1156a attached to the device 1150, thus allowing for a smaller device 1150 while still retaining the suture features of a connection. In the example, this can be achieved by moving a "redirection" turn 1192 from the device 1150 to the suture adjacent to the bracket 1120. In the example, the redirection turn 1192 would include a bypass ring 1193 attached to the suture, connecting to the suture, or a rigid pulley. Alternatively, as... Figure 11G As shown, the final redirection path can be outside the bracket 1120. The second redirection turn 1192' can help control the path.

[0115] Turn now Figure 11H -V shows a further example of device 1150 used in the above-described device / suture loop structure 1156. The example of device 1150 is substantially similar to devices 600 and 700, except as described below. Figure 11H In the example of device 1150 shown in -J, the transverse pin 1154 can be securely held to the body 1152 of device 1150 and springs up in a plane perpendicular to the load. The linear member 1194 can bend beyond the center, thereby preventing the transverse pin 1154 from detaching from device 1150. The end of the linear member 1194 will also bottom out within the body 1152, thereby providing closure via forced bending. Figure 11K In a further example of the device 1150 shown in Figures -M, the transverse pin 1155 can be securely held to the body 1152 of the device 1150 and open in a plane parallel to the load. In a further example of the device 1150 shown in Figures 13N-P, the retaining pin 1198 can be held securely in the body 1152 of the device 1150 while allowing longitudinal sliding between the "load" and "locked" positions. A pawl will ensure that the retaining pin 1198 does not prematurely reopen. In the "load" position ( Figure 11N The retracted retaining pin 1198 will allow the suture to enter the internal "pulley" hole 1160 from the outside of the body 1152. When in the "locked" position... Figure 11O When the retaining pin 1194 is engaged, it will increase the rigidity of the body 1152. The retaining pin 1198 will not encounter a relatively high suture load, but will require a relatively low force to hold the suture in the "pulley" hole 1160. Figure 11P This is a cross-sectional view of device 1150. Figure 11QIn the alternative example shown, the hole 1158 of the adjustable suture loop (not shown) can communicate with the pulley hole 1110.

[0116] exist Figure 11R and 11S In a further exemplary embodiment of the illustrated device 1150, the linear member 1194 can be held within the body 1152 of the device 1300 while allowing vertical sliding between a "loaded" and a "locked" position. In the "loaded" position ( Figure 11R The retracted linear component 1194 slides to the "locked position" ( Figure 11S This allows the suture to enter the internal "pulley" hole 1160 from the outside of the body 1152. The suture member 1194 will not encounter a relatively high suture load, but rather requires a relatively low force to hold the suture in its "pulley" hole 1160. Flipping the suture will form a loop around the two transverse members 1199a, 1199b of the suture member 1194. The suture member 1194 may include a spring latch 1196, thus ensuring that it will not open once closed. Figure 11T In the example of the device shown in -V, the linear member 1194 can remain held within the body 1152 of the device 1150 while allowing bending in a plane parallel to the force between the "load" and "locked" positions. In the "load" position ( Figure 11T The threaded part 1194 will allow the stitching to enter the internal "pulley" hole 1160 from the outside of the body 1152, and then snap back to the locked position. Figure 11U The linear element 1194 does not encounter a relatively high suture load, but rather requires a relatively low force to hold the suture in its "pulley" hole 1160. The key to generating the spring force is the offset O between the pivot axes of the linear element 1194, such as... Figure 11V As shown in the image.

[0117] Turn now Figure 12A This illustration shows another example of a suspension and fixation device 1200 for soft tissue repair. The device 1200 includes an elongated, generally flat body 1202. The body 1202 has a first end 1202a and a second end 1202b, and a longitudinal axis extending therebetween. Two closed holes 1208 are formed adjacent to a first side 1202c and a second side 1202d of the body 1202, respectively, and closer to the first end 1202a. The two closed holes are formed on opposite sides of the longitudinal axis and are directly opposite each other. The first and second of two slots 1210 are formed adjacent to the first side 1202c and the second side 1202d of the body 1202, respectively, and closer to the second end 1202b. Figure 12BAs shown, the body 1202 is pre-assembled to the first side 1206a of the adjustable fixation ring 1206 through a closed hole 1208, forming an open-loop configuration. The open-loop configuration of the adjustable fixation ring 1206 advantageously allows the second side 1206b and free end 1206c of the fixation ring 1206 to shuttle through a tissue graft or bone block, and then wrap around the body 1200 to position the second side 1206b through two slots 1220. During assembly, the sides 1206a and 1206b are oriented to intersect the longitudinal axis of the body 1202. The holes in the bone block or soft tissue can advantageously be smaller than those described above. Figure 1A and 2A The anchoring solid passes through a hole in the desired bone or soft tissue. For example... Figure 12C As shown, the second side 1206b of the adjustable retaining ring 1206 can then be connected to the slot 1210 by inserting the strands of the ring 1206 through the slot of the slot 1210 to form a closed-loop structure. Figure 12D The "V"-shaped groove opening 1211 at hole 1210 ensures that the second side 1206b of the adjustable retaining ring 1206 does not migrate from the device 1200 during use. Both the groove 1210 and the hole 1208 can define a maximum diameter equivalent to each other. The body 1202 also defines a top surface 1202e and a lower surface 1202f. The lower surface defines the cortical layer to which it is constructed as a bone graft. Figure 12C and Figure 40C As shown, the second side 1206b of the adjustable retaining ring 1206 can be connected to the slot 1210 by first placing a loop of the ring 1206b around the end of the body (e.g., end 1202b) and directly adjacent to the top surface 1206e of the body, and pulling the strand of the ring 1206b through the slot 1210. One slot is configured to pass through the first side 1202c of the body 1202, and the other slot passes through the second side 1202d of the body 1202 to form a closed-loop structure. Similar to... Figures 6A-6C In the illustrated embodiment, the top surface 602e of the main body may include a shaped recess recessed below the surface 1206e and connected to two slots 1210. This recess may be perpendicular to the longitudinal axis. The adjustable retaining ring 606 can be... Figure 8D It is formed in the manner shown.

[0118] Figure 13A -F indicates a spiral needle for lock-lock suture tissue grafts, designed to minimize suture ingrowth obstruction. Figure 13A A graft 1360 and a fixation device 1300 are shown, wherein a suture 1362 is inserted into the graft 1360. Figure 13AThe diagram shows two spirals 1364a and 1364b to illustrate the suture path. However, in practice, only one needle 1364 can be used for two passes, and needle 1364 is not retained in the graft 1360. The two suture paths are shown as interlaced, concentric, and entirely within the graft 1360. Advantageously, needle 1364 is completely below the surface of the graft 1360, which eliminates the graft-to-bone inward growth obstruction caused by suture 1362. Furthermore, even when the core of the graft 1360 is compressed under tension, contact between the graft 1360 and the tunnel wall can be maintained. Figure 13B As shown, spiral 1364a represents one pass, while spiral 1364b represents another pass. The same needle 1364 is used for both passes, but with the axial offset being half the pitch length for each pass. This prevents the paths from intersecting and thus minimizes the possibility of the sharp needle 1364 piercing the previously placed suture. Figure 13C In the diagram, segments 1366a, 1366b, 1366c, and 1366d show some of the infinite number of compressed lines between the two helices 1364a and 1364b. All segments 1366a, 1366b, 1366c, and 1366d pass directly through the centerline extending along axis A. (As shown...) Figure 13D As shown in the example using a needle 1364 with both ends sharpened, the needle 1364 with suture 1362 passes through the fixation device 1300 toward the end of the graft 1360 and then away from the end of the graft 1360. Figure 13E A knot 1368 is shown in the suture 1362 at the point of lowest tension. In other examples not shown, two needles 1364 may be used. Figure 13F An additional example of needle 1364 is shown, wherein the axes of spirals 1364a and 1353b are not collinear. In this example, the path of suture 1362 can still be entirely within graft 1360 or at least partially outside graft 1360. Alternatively, spirals with opposite rotational winding directions can be used. Figure 13G As shown in Figure -J, movement of the spiral needle 1364 can be accomplished via a retainer 1370, which includes a base 1372, a graft compressor 1374 for compressing the graft 1360 within the base 1372, and a needle driver 1376 bonded to match the spiral of the needle 1364. This allows the spiral 1634 to be advanced in both directions through the tissue and through loops of an adjustable suture structure.

[0119] Figure 14A-C illustrates a first example of a device for attaching a fixation device 1400 to a graft 1460 (e.g., a patellar tendon or quadriceps tendon graft) attached to a bone block 1480. The fixation device can be any adjustable suture fixation device, such as those disclosed in at least Structures 600, 1200, 1650, and 1680, or those disclosed in commonly owned U.S. Patent No. 10,383,617, which is incorporated herein by reference in its entirety. Figure 14A As shown, a small hole 1482 (e.g., 2.4 mm) is initially drilled longitudinally through the bone block 1480. An adjustable retaining ring 1406 passes through the hole 1482 and a device including a transverse pin implant 1484 that connects the ring 1406 to the bone passes laterally through the ring 1406, thereby acting as a pulley against the cortex of the bone block 1480. In some exemplary suture structures with a bracket, for example... Figure 8D and Figure 11A In the illustrated embodiment, the bracket portion may enclose a device for connecting the ring, such as a transverse pin implant 1484. The implant 1484 may include a recess or channel circumferentially disposed around the implant to receive and retain the ring 1406 therein. The bottom surface of the tissue graft 1460 intersects the bone block 1480 at different heights. Therefore, various techniques can be used to place the implant 1484. For example, as... Figure 14B As shown, graft 1460 can be tilted upwards and implant 1484 can be positioned below graft 1460. Alternatively, as Figure 14C As shown, the implant 1484 can be introduced through the slit 1486 in the graft 1460. Additionally, as... Figure 14I As shown, a retainer 1485 can be used to minimize movement of the implant 1484 relative to the bone block 1480. The retainer 1485 may include sutures or other materials that can wrap around the outer portion of the bone block 1480. Alternatively, as... Figure 14J As shown, the intermediate tension member 1487 can be positioned within the longitudinal hole connecting the implant 1484 and the adjustable fixation ring 1406.

[0120] Another example of a device for attaching the fixation device 1400 to the graft 1460 attached to the bone block 1480 is shown in Figure 14D and 14EThe device, as shown, includes an implant 1484 configured to engage the top outer surface of a bone block 1480. Similarly, device 1400 may include any adjustable ring fixation device, such as at least structure 600, structure 1200, structure 1650, and structure 1680, or the structure disclosed in the commonly owned U.S. Patent No. 10,383,617. Two small holes (e.g., 2.0 mm) may be drilled through the bone block 1480, which may be perpendicular to the longitudinal axis of the bone block 1480. The two small holes may be axially spaced from each other and located on an axis parallel to the longitudinal axis. A small area of ​​soft tissue may be removed around these holes down to the bone 1480. The implant 1484 may include two posts 1492 or cotter pins configured to be inserted into the two small holes and securely engage the implant 1484 to the bone block 1480. An adjustable fixation ring 1406 may pass around a portion of the implant 1484, thereby acting as a pulley against the cortex of the bone block 1480. The bracket portion of ring 1406 may extend around the end of implant 1484 furthest from the anchoring portion of device 1400. Implant 1484 may include a shelf or top surface configured to hold ring 1406 on the implant and prevent ring 1406 from slipping off. The implant 1484 is sized to fit within bone tunnel 1488. Figure 14E )Inside.

[0121] like Figure 14F As shown, the implant 1484 has a cross-section including two posts 1492 and may include a lift-off feature 1490 (e.g., a screw, clip, etc.) to prevent lift-off of the implant 1484 before the graft 1460 is placed within the restrained bone tunnel. The lift-off clip 1490 may engage the bottom surface or the opposite surface of the bone block. In the example, the implant 1484 may be used with a conventional trapezoidal cross-section bone block 1480. Figure 14G As shown, implant 1484 can be further made symmetrical to minimize misalignment. An adjustable retention ring 1406 can be held against implant 1484 via a clip (not shown) to prevent premature slippage before tensioning. The implant can be in the form of a bridge with two posts to minimize soft tissue removal. Figure 14G There are only two points around the pillar shown. Figure 14H In other examples shown, the adjustable fixation ring 1406 can be positioned around the opposing posts to reduce tissue removal and prevent premature slippage from the ring 1406. Preferably, it has two fixation points with the bone block to reduce the likelihood of implant 1484 lifting or bending. Alternatively, as... Figure 14KAs shown, the holes within the bone block 1480 may not be orthogonal to the longitudinal axis of the bone block to address tension on the posts of the implant. To reduce the overall profile of the implant, the bridging portion 1484c may be angled relative to the upper surface of the bone block; such that a first end 1484a of the implant 1484 can be recessed into the bone block, and a second end 1484b may include space for the receiving ring 1406. The legs or posts of 1492 may define a rectangular cross-section of the implant 1484 to improve fixation between the implant 1484 and the circular (drilled) holes in the graft 1460.

[0122] Figure 15A-15R An example is shown of a method for directly attaching the fixation device / suture loop structure 1501 of this disclosure to the graft 1560 (or bone block, as further described below) without separating the graft 1560. At least in Figure 11A The text describes separate transplantation. Figure 15A-15R A system for improving the fixation between the fixation structure 1501 and the graft is also shown, which may include improving the penetration... Figure 15A-15R The fixation method is shown. Fixation structure 1501 can be any adjustable suture fixation device, such as those disclosed in at least Structures 600, 1200, 1650, and 1680, or those disclosed in commonly owned U.S. Patent No. 10,383,617, which is incorporated herein by reference in its entirety. Figure 15A As shown, the threading suture 1561, connected to the needle 1564, is loosely attached to the bracket 1520 of the device / suture loop structure 1501, which may be an adjustable suture loop structure. The needle 1564 can be inserted into the first end 1560a of the graft 1560 and exit through the top surface 1560c of the graft 1560 to pull the bracket 1520 through the graft 1560, causing the bracket 1520 to leave the top surface 1560c of the graft 1560. Figure 15B , 15C ).like Figure 15D As shown, the bracket 1520 then wraps around either the first end 1560a or the second end 1560b of the graft 1560, such that the bracket 1520 is positioned below the bottom surface 1560d of the graft 1560. Figure 15E As shown, the needle 1564 is then inserted from the bottom surface 1560d of the graft 1560 to the top surface 1560c to pull the bracket 1520 above the top surface 1560c of the graft 1560. Figure 15F This step creates a "V" shaped needle mark 1565 in graft 1560. (See example...) Figure 15GAs shown, by again wrapping the bracket 1520 around the first or second end 1560a or 1560b of the graft 1560 and repeating the above steps, additional "herringbone" stitches 1565 can be formed in the graft 1560. It is noteworthy that, in order to prevent unraveling, the position of the bracket 1520 after the last stitch must be chosen on the side of the graft 1560 opposite to the position where the needle 1564 last left the graft 1560 (e.g., as shown). Figure 15G (as shown in the image).

[0123] exist Figure 15H In the alternative example shown, the continuous loop of suture 1562 can be incorporated into the device / suture loop structure 1501 and in accordance with the above description regarding Figure 15A-15G The same method described is used to pass the graft 1560 or bone block (not shown). Figure 15L In a further alternative example shown, the second adjustable ring 1590 may be incorporated into the suture loop structure 1501, and the second adjustable ring is attached to the graft 1560 (or bone block) or, as described above regarding Figure 15A As stated in -G. Figure 15M In another alternative example shown, the continuous loop 1562 can be connected to the suture loop structure 1501 via a luggage tag 1502. The suture holder of the suture loop structure 1501 can form part of the connection with the continuous loop 1562. Figure 15I In another further example shown, to minimize the resistance of pulling the bracket 1520 through the graft 1560, a tapered member 1563 that can be attached to the needle 1564 can be used to gradually increase the graft hole diameter and minimize the chance of the bracket 1520 getting stuck on the graft 1560. The bracket 1520 can form a ring through the hole in the tapered member 1563. Preferably, the tapered member 1563 is made of a flexible material. Figure 15N In the alternative embodiment shown, a tapered member 1563 having a smaller opening end adjacent to needle 1564 can extend from needle 1564 to the larger opening end. The larger opening can be sized to temporarily close part of the bracket 1520 and facilitate the passage of the bracket through the graft. The bracket 1520 can be temporarily folded to form a loop to fit within the larger opening. The larger opening can be sized to form an interference fit with the bracket 1520 to help hold the bracket within the larger opening during graft passage suturing. The tapered member 1663 can slide along the thread-through suture 1561 without needle 1564.

[0124] exist Figure 15J In other examples shown, the above attachment method can also be applied to attach the fixation device 1501 to the bone block 1580 through the oblique hole 1584 in the bone block 1580. Figure 15J The oblique hole in the bone block begins at the first end 1580a and may include the surface of cancellous bone. Alternatively, as Figure 15K As shown, the oblique hole 1584 can start from the cortical side surface 1580b to pass through the cortex of the bone block 1580.

[0125] The system may also include reinforcement devices to reduce the detachment of flexible components, such as the adjustable suture structure 1501 described herein, from the graft. Figure 15P , 15Q As shown in 15R. Prioritize strengthening at least two opposing sides of the graft. (As illustrated in 15R) Figure 15P As shown, a single-length suture band or flat braid 1550 can extend along the top side of the graft 1560c, around the end surface 1560a, and along the bottom surface 1560d of the graft. Figure 15Q Alternatively, an alternative reinforcement device may include a braided cap 1551, which may include a shaped braided element through which holes 1551a and 1551b are pre-formed. Holes 1551a and 1551b are configured to receive an adjustable suture structure, such as structure 1501, through which. Holes 1551a and 1551b may be positioned relative to the braided cap to guide a needle 1564 through the insertion position of the graft 1560. Figure 15RIn this embodiment, alternative reinforcement devices may include an implant 1591 formed of, for example, a more rigid material. This embodiment may include a plurality of holes pre-formed therein, including at least holes 1591a, 1591b, 1591c, and 1591d. Holes 1591a, 1591b, 1591c, and 1591d are configured to receive an adjustable suture structure, such as structure 1501, therein. More specifically, the holes may be configured to receive a holder 1520 for needles and suture structure 1501 therein. Holes 1591a, 1591b, 1591c, and 1591d may be positioned relative to implant 1591 to guide needle 1564 through an insertion site of graft 1560. Implant 1591 may also include a hole 1592 orthogonally oriented relative to holes 1591a, 1591b, 1591c, and 1591d to receive needle 1564 therein. The method of attaching the adjustable suture structure 1501 to the graft may therefore include placing a reinforcing device, such as a band 1550, a cap 1551, or an implant 1591, around the end portion of the graft 1560 to arrange the reinforcing device along the top and bottom surfaces of the graft, and may also place a portion of the reinforcing device along the end surface. The method can then continue by inserting a needle 1564 into the top or end surface (1560c or 1560a) of the graft, including through the reinforcing device, then through the thickness of the graft, then through the bottom surface 1560c of the graft 1560, and out again through the reinforcing device. This pulls the support 1520 through the graft 1560 and through at least two portions of the reinforcing device. Alternatively, the needle 1564 may enter the graft from the bottom surface 1560d and exit from the top surface 1560c. The support 1520 may then pass around the graft and then the needle 1564 may pass through the graft again, which may include making the needle 1564 pass through the reinforcing device again while entering and exiting the graft 1560. The reinforcing device may include a pre-drilled hole through which the needle 1564 passes.

[0126] Additional embodiments relate to adjustable suspension fixation structures configured to attach to bone blocks and are shown in Figures 16-23. Some of these embodiments include attaching the adjustable suspension fixation device to a loop or ring knot, alternatively referred to as a luggage tag loop. A loop knot is formed by extending a first end of a continuous loop (strap) through a channel in the bone block and around the outer surface of the bone block, and then extending the fixation device and a portion of the adjustable loop through the first end of the continuous loop, with the adjustable loop operatively attached to the continuous loop. A knot is now formed around and through the bone block. In this preferred embodiment, the knot or luggage tag loop comprises a continuous loop and an adjustable loop. This loop connection provides a robust and adjustable cortical fixation, increases maximum bone-to-bone ingrown growth, and minimizes variations in surgical workflow. Because the structure is adjustable and the bone block can be directly pulled to the fixation button, the need for accurate measurement of graft and bone tunnel length is now reduced. Furthermore, as explained in more detail later, by placing the adjustable loop at least partially along the length of the bone block, it is easier to shorten the adjustable loop so that the bone block can be directly adjacent to or even adjacent to the button fixation device.

[0127] Advantageously, this connection can now allow for the placement of sutures associated with continuous and adjustable suture loops along the outer surface of the bone block where bone-to-bone inward growth is not desired. Typically, the cortical surface of the bone block is shaped to be spaced apart from the femoral tunnel walls, a space that reduces the likelihood of bone-to-bone inward growth. As shown in the various figures of this application, a bone block, such as a portion of the patella, typically includes a first outer surface of the patella, comprising cortical bone and possibly a thin covering of soft tissue such as tendon tissue. However, other outer surfaces of the bone block may include cancellous patellar tissue. Exposed cancellous bone is more likely to promote bone-to-bone growth. Therefore, by maintaining suture loops along the cortical bone surface of the bone block, thus eliminating any suture loops on the cancellous bone surface, it is conceivable that the arrangement of these suture loops can minimize the influence on bone-to-bone inward growth.

[0128] This article also discloses alternative adjustable structures and associated attachment methods, including an alternative adjustable ring operably coupled to a button-type fixation device; a continuous ring operably coupled to the adjustable ring; and a continuous ring short enough that it positions the intersection of the adjustable ring and the continuous ring along the length of the bone block.

[0129] The first embodiment of the fixed structure 1600 is in Figure 16AAs shown in the diagram. Structure 1600 includes a fixed button 1625, an adjustable ring 1620 including a bracket 1630, and a continuous ring 1640. The fixed button 1625 and the adjustable ring 1620 may be similar to the Ultrabutton manufactured by Smithand Nephew and disclosed in at least the commonly assigned U.S. Patent 10,383,617, the entire disclosure of which is incorporated herein by reference. The continuous ring 1640 may be formed into a loop by the adjustable ring 1620 and may preferably engage the bracket 1630, defining a first continuous ring end 1646. The continuous ring 1640 is preferably not directly coupled to the fixed button 1625. In alternative embodiments, for example Figure 16B In the illustrated structure, structure 1650 may include an alternative adjustable ring structure having a connecting end 1666 and a sleeve portion 1665. In further alternative embodiments, for example... Figure 16C In the illustrated structure, structure 1680 may include an alternative adjustable ring structure, forming two rings 1670a and 1670b connected at sleeve portions 1675a and 1675b. In all embodiments, a second fixed and continuous ring 1640 is operatively coupled to adjustable rings 1620, 1660, and 1670. The continuous ring 1640 can be formed into a ring via the adjustable structure, can extend through the lumen of the adjustable structure, or can be attached to the adjustable rings (1620, 1660, or 1670) in a tag-like manner. Adjustable structures 1620, 1660, and 1670, as well as the continuous ring 1640, can all be formed independently, thus being independent flexible members, such as sutures, and can be operatively coupled or can be coupled during surgical procedures. Each individual suture (1620, 1640, 1660, and 1670) can be similar or unique in size and material. For example, adjustable suture loops can be formed from a more lubricated suture material for better sliding and adjustment of loop length.

[0130] Adjustable ring structure, for example Figure 16A , 16B Those described in 16C, including suture loop structures, tend to limit how short the final loop can be. For example, as... Figure 17A and 17B As shown, the adjustable ring with bracket portion 1630 can be shortened to a length of approximately 10 mm, at which point the diameter of bracket 1630 and the stiffness of the three suture lengths limit any further significant shortening. As a further example, Figure 16B and 16CThe embodiments shown also illustrate sleeves or eyelet connectors (1665, 1675) similar to those with a single suture passing through it, which can limit the final minimum loop length. Because the bone tunnel length becomes shorter during ACL reconstruction, the tunnel length available for long suture loops is smaller. This disclosure describes a method for attaching an adjustable suture loop structure that reduces the effective length between the fixation button and the graft.

[0131] exist Figures 18A-18D An exemplary method for attaching structures such as structures 1600, 1650, or 1680 to a bone block is illustrated. First, a suture threader 1810 can pass through a longitudinal channel 1865 of the bone block 1860 and then through a tendon 1870. The longitudinal channel 1865 can be drilled and its diameter can be between 2-3 mm. The first end 1645 of a continuous loop 1640 can then pass through the suture threader end 1815, possibly using a third suture 1825. The suture threader 1810 can then pull the first end 1645 through the tendon 1870 and then out along the channel 1865. A fastening button 1625 can then pass through the first end 1645 to form a loop or luggage tag ring around the bone block 1860, such as... Figure 18B , 18C As shown in various views in 18D. The luggage tag ring surrounding the bone block includes a continuous ring 1640 and an adjustable ring 1620.

[0132] Figure 19A and 19B Structures 1620 or 1660, connecting to bone block 1860 before and after it, are schematically shown respectively. Figure 19BAs best shown, bone block 1860 includes an outer cortical layer 1861 only on its apical side, as this bone block is typically the apical portion of a bone such as the patella. The apical / cortical layer may also be covered with a thin layer of soft tissue, such as connective tissue and tendons 1862. The underside and other lateral sides of bone block 1860 define exposed cancellous bone 1863. The joining method involves extending sutures along the outer surface of the bone block, which preferably includes the apical surface and thereby joins the cortical bone and tendons while avoiding the cancellous bone surface. Avoiding covering or obstructing the outer surface of the cancellous bone is preferred. As previously mentioned, this apical surface is least likely to integrate with the femoral tunnel, therefore it is expected that the suture loops (1620, 1660, 1640) will not inhibit bone-to-bone inward growth. The intersection or transition from ring 1640 to the adjustable ring (1620, 1660, or 1670) is preferably positioned along the length (L) of the bone block 1860, and preferably closer to the tendon attachment end 1865 of the bone block 1860. A typical bone block is 2-3 cm long and approximately 6-11 mm thick. The continuous ring 1640 can therefore be approximately 3-5 cm long and preferably less than or equal to twice the length L of the bone block 1860, allowing the continuous ring 1640 to wrap around the bone block, forming a luggage tag and positioning the intersection with the adjustable ring along the length L of the bone block on the outer cortical surface. This allows for a reduction in the length of the adjustable ring, enabling the retaining button 1625 to be less than a few millimeters from the bone block end 1866, while the intersection between the two rings is further away from the retaining button 1625 interval.

[0133] Figures 20A-20C This refers to a similar method of connecting the adjustable structure to the bone block using an alternative adjustable ring structure. For example... Figure 20A A structure 1650 is shown attached to the bone block 1860, wherein the sleeve portion 1665 is limited to the minimum ring length available during adjustment. The intersection 2010 is maintained along the length L of the bone block 1860 and includes a connection 1666 of the adjustable structure 1660 and a continuous ring end. Figure 20B An alternative adjustable ring structure 2050 is shown, which includes a luggage tag portion 2060 and a sleeve 2005 providing adjustability. As a further example, Figure 20C The structure 1680, which is attached to bone block 1860, is shown, wherein sleeve portions 1675a and 1675b limit the minimum loop length available during adjustment. Crosspoint 2010 includes two suture loops and is held along the length L of bone block 1860. Figure 20D An alternative method for operatively connecting an adjustable ring structure to a second ring is illustrated. An exemplary adjustable ring structure 1620 can be connected to a continuous ring 1640 at an intersection. Any adjustable ring structure disclosed herein can be connected similarly.

[0134] In other embodiments, the method may not include, for example... Figures 18A-18DLuggage tags are formed on the adjustable rings shown in 19A, 19B, and 20A-20C. In these alternative embodiments, the continuous ring end 1645 may include a limiting element operatively coupled to end 1645 to prevent the continuous ring 1645 from being pulled through the tunnel passage 1865. Alternatively, the limiting element may be a knot (not shown) in end 1645, the width or diameter of which is greater than the bone hole opening 1866. The surgeon may form the knot (not shown) after end 1645 has been passed through the bone passage. This option allows the intersection between the two rings to be more freely associated with the bone block, which may not be preferred because additional suture management may be required when inserting structure 1600 and inserting it along the tibial and femoral tunnels. Alternatively, limiting button 2180 may engage an adjustable ring such as ring 1620 and be selectively coupled to end 1645 after end 1645 has been passed through the bone block passage. The limiting button 2180 is configured to prevent the end 1645 of the continuous ring from migrating into the bone block channel and to keep the adjustable ring closer to the outer surface of the bone block when tension is applied to the structure. In this embodiment, the continuous ring can be larger than... Figures 18A-18D The continuous rings described in 19A, 19B, and 20A-20C are short because they do not wrap around the adjustable ring. For example, a typical bone block is 6-11 mm long. The continuous ring 1640, using a limiting button, can therefore be approximately 2-4 cm long and preferably less than twice the length of the bone block 1860 to be positioned along the outer cortical surface of the bone block and at the intersection with the adjustable ring along the length L.

[0135] Further embodiments and methods of connecting to bone block 1860 are described in Figure 22 As shown in A and 23A-23C. For example, this embodiment may include adjustable fixing structures 1620, 1660, or 1670. In this embodiment, a second ring, such as ring 1640, may not be used. In this embodiment, the bracket portion 1630 can pass through... Figure 15J Or a similar angular channel 2222 as described in 15K. The bracket portion may initially pass through the top cortical surface 1861 to add structure to the entry point 2220 of the channel 2222. An entry through the cancellous bone surface may not provide sufficient structural stiffness and may allow suture combout of the bone block 1860. A pair of bilateral circumferential grooves 2224 may extend at an angle from the first channel 2222 to receive a portion of the bracket 1630. The grooves 2224 allow the bracket 1630 or the adjustable ring 1620 to sink below the outer surface of the block, thereby allowing the bone block 1860 to be more closely juxtaposed to the bone tunnel through the tibia or femur. The grooves 2224 may be axially continuous and may intersect the channel opening on the lower surface 1863 and extend at an angle across the width of the bone block 1860. The grooves 2224 may pass through the cortical bone on the tendon side of the bone block, thereby creating a structure more resistant to suture combout.

[0136] It may include needles (at least in Figure 15A The guiding suture (shown in the diagram) can be loosely attached to the bracket 1630 of the device / suture loop structure 1620. The guiding suture can be inserted into the first end 2220 of a pre-formed bone block channel 2222 within the bone block 1860, the channel extending at an angle of 20-60 degrees relative to the longitudinal axis of the bone block 60. The channel 2222 can extend from the top cortical outer surface and exit through the lower cancellous bone surface 1863 of the bone block 1860. The bracket 1630 can be pulled or passed through the channel 2222 of the bone block 1860, causing the bracket 1630 to exit from the surface 1863 of the bone block 1860. Figure 22 As shown, the bracket 1630 is then wrapped around the tendon / bone interface and placed within the groove 2224. The tension on structure 1600 now applies compression to the tendon / bone interface 1862. This is preferable to, for example, a bracket wrapped around surface 1864, which could be used to cut the tendon / bone interface 1862. The large radius of curvature around the bone block at the bracket 1630 minimizes kinking of the bracket, thereby minimizing internal suture friction within the system and allowing for easier reduction of the length of the adjustable ring 1640. As previously described, this embodiment also places the adjustable ring along the bone block, with its end longer than the bone block, so that the retaining button 1625 can be directly adjacent to the bone block when reducing the length of the adjustable ring.

[0137] Figures 23A-23C It shows the relationship with Figure 22 Various alternative embodiments of adjustable structures that are directly attached to bone blocks in a manner similar to that described in the text. For example, such as... Figure 23A As shown, an adjustable ring structure such as structure 1650 can extend through the angular channel 2222 and surround the top surface of the bone / tendon interface 1862, and connector 1666 can compress the tendon to the bone. Alternatively, bilateral grooves (not shown) can be formed in the bone block 1860 and connector 1866 can be located within the grooves. Figure 23B As a further example shown, an adjustable ring structure, such as structure 2050, can extend through the angular channel 2222 and surround the top surface of the bone / tendon interface 1862 and enter the groove 2224 formed in the bone block 1860. Figure 23C As shown in a further example, an adjustable ring structure such as structure 1670 may extend through the angular channel 2222 and surround the top surface of the bone / tendon interface 1862 and may be located within a prefabricated groove 2224.

[0138] Figure 24 An alternative embodiment of an adjustable fixing device including a forked or split bracket 2420 is shown. (See reference...) Figure 24An example of a graft suspension device 2410 of this disclosure is shown. The graft suspension device 2410 includes strands of suture 2422 having a first loop 2412 and a second loop 2414 (collectively referred to as suspension loops 2424) suspended from an anchor 2416. The suture 2422 is formed of a braided material with braided threads that together can form a non-hollow tubular material. In some embodiments, some sutures 2422 may be hollow or coreless. The suture 2422 may be made of a suitable biocompatible material, which may be a bioabsorbable material or a non-absorbable permanent material. The strands of the suture 2422 may be about 46 inches in length. The anchor 2416 may be a conventional construction for fixation to the exterior of bone, such as a cortical button. The anchor (or cortical button) 2416 may be about 10 mm to about 15 mm in length and about 2 mm to about 5 mm in width. As further described below, the graft suspension device 2410 may include a bifurcated bracket 2420 substantially located midway along the length of the suture 2422. In other embodiments, the graft suspension device 2410 may be configured to separate from a single suture into a plurality of longitudinal channels, including two, three, four, or five longitudinal channels substantially located midway along the length of the suture 2422. As further described below, the bifurcated bracket 2420 defines two parallel braided coreless longitudinal channels 2418' and 2418' at the end of the suspension ring 2424 relative to the anchor 2416.

[0139] Also Figure 24As shown, anchor 2416 may include multiple holes, up to eight holes, extending through them and facilitating the passage of suture 2422. The outer and intermediate holes 2401, 2402, 2407, and 2408 are aligned with each other along the longitudinal axis of anchor 2416. The central holes 2403, 2404, 2405, and 2406 are formed in two pairs symmetrically offset from the longitudinal axis but aligned with each other transversely to the longitudinal axis. The two pairs of central holes 2403, 2404, 2405, and 2406 are designed to receive suture loops 2412 and 2414 passing through them. The intermediate hole pair 2402 and 2407 are designed to receive the two ends 2430 and 2432 of the suture, respectively. The outer hole pair 2401 and 2408 are designed to assist in placing anchor 2416 on the lateral side of bone using anterior and posterior sutures passing through holes 2401 and 2408 (not shown). As further described below, the first and second rings 2412, 2414 are shown passing through central holes 2403, 2404, 2405, and 2406. The loose ends 2430, 2432 of the suture 2422 are shown passing through two separate longitudinal channels or bifurcated sleeve portions 2418' and 2418" to complete the suspension ring 2424. In addition to bifurcation, this insertion of the loose ends 2430, 2432 has the effect of widening the bifurcated sleeve portions 2418' and 2418" relative to the remainder of the suspension ring 2424. The loose ends 2430, 2432 are then shown passing through a pair of intermediate holes 2402, 2407. In some embodiments, the loose ends 2430 and 2432 may then be joined together to form a single tail 2434. Advantageously, routing the suture 2422 through multiple holes keeps the individual strands of the suture 2422 separate, making them less likely to bunch or tangle. The single tail 2434 can be further adapted to form a ring 2436 to provide a device whereby the surgeon can adjust the distance between the bifurcated brackets 2418' and 2418" and the anchor 2416, and / or shorten the length of the suspension ring 2424, before or during surgery. Advantageously, the ring 2436 can be used with only one hand.

[0140] The bifurcation portion 2418 forms an integral part of the first and second rings 2412, 2414. First and second eyelets 2438, 2440 may be formed at a spaced interval in the first longitudinal channel 2418' of the bifurcation portion 2418, through which a loose end 2430 may pass, as further described below. This disclosure contemplates that the first and second eyelets 2438, 2440 need not be pre-formed in the bifurcation portion 2418 if the loose ends 2430, 2432 can pass through the gap between adjacent threads of the braided stitch 2422. In alternative embodiments, the first and second eyelets 2438 and 2440 may be pre-formed or provided in the first and / or second limbs, adjacent but not necessarily within the bifurcation portion itself. Therefore, the exemplary loose end may extend into and along a limb that is at least partially continuous with the bifurcation portion 2418, such that the exemplary loose end extends along one of the limb and the bifurcation longitudinal channel 2418' or 2418'". The exemplary loose end may also remain within the seam and extend into another limb adjacent to the other side of the bifurcation portion 2418, then exit between the weaves or through pre-drilled eyelets.

[0141] The length of the bifurcation 2418 can vary, but it can be long enough to accommodate the ligament-fixed graft suspended thereon, and short enough to facilitate effective adjustment of the suspension ring 2424. The distance between the pre-drilled eyelets or the outlet and inlet positions at the loose ends of the braids can vary, but is selected to be long enough to accommodate the ligament-fixed graft suspended thereon, and short enough to facilitate effective adjustment of the suspension ring 2424.

[0142] For clarity, Figure 25A This is a schematic diagram illustrating an embodiment where only the first ring's routing is shown. For clarity, the second ring is omitted and... Figure 25B Added to illustrate a preferred embodiment. Now refer to Figure 25AThe formation of the first ring 2412 includes a loose end 2430 extending from the first end of the bifurcated bracket portion 2420 through a pair of central holes 2403 and 2405 of the anchor 2416 from its underside to its top side. More specifically, the loose end portion 2430a passes through the central hole 2403 and then loops back through the hole 2405 adjacent to the hole 2403 it has already passed through. Specifically, the loose end portion 2430b passes through the hole 2405 from the top side to the underside of the anchor 2416. Thereafter, the loose end portion 2430b passes through the first longitudinal channel 2418' of the bracket portion 2420' between the braids, entering the hole 2440 and exiting the hole 2438. At this stage, the loose end portion 2430c passes through the intermediate hole 2402 from the underside to the top side of the anchor, i.e., the loose end portion 2430c passes through the hole 2402. The bifurcated bracket portion 2420 defines two longitudinal channels or sleeves 2418' and 2418', which are parallel to each other and woven together at either end into a single stitch. Figure 25A In the diagram, the suture end 2432a is shown as extending from the bifurcation portion 2420.

[0143] Now for reference Figure 25B The second ring 2414 (in addition to the first ring 2412) includes a loose end 2432 extending from the second end of the bifurcation bracket portion 2420 through a pair of center holes 2404 and 2406 in the anchor 2416 from its underside to its top side. More specifically, the loose end portion 2432a first passes through the center hole 2406 and then loops back through the hole 2404 adjacent to the hole 2406 it has already passed through. Specifically, the loose end portion 2432b passes through the hole 2404 from the top side to the underside of the anchor 2416. Subsequently, the loose end portion 2432b passes through the second longitudinal channel 2418” of the bracket portion 2420 into the hole 2442 and exit the hole 2444. At this stage, the loose end portion 2432c passes through the intermediate hole 2407 from the underside to the top side of the anchor, i.e., the loose end portion 2432c passes through the hole 2407. Both loose end portions 2430 and 2432 extend through separate sleeves formed by the bifurcation portion 2420, intersecting each other in opposite directions.

[0144] Figure 26AThis is an alternative view illustrating an example where the bifurcation portion 2420 and the free end 2430 pass through the core or longitudinal channel of the first coreless longitudinal channel 2418' into the opening 2438 and then out through the opening 2440. The free end 2432 passes through 2418" in a similar manner (not shown). In some embodiments, the two free ends pass through in opposite directions. In some embodiments, the two free ends pass through along their respective cores at different lengths. In some embodiments, the two free ends enter along their respective longitudinal channels at an offset position along the bracket portion 2420. In some embodiments, the two longitudinal channels 2418' and 2418" are equal in diameter to each other.

[0145] Using current technology, sutures can be continuously braided to branch off at certain lengths and then rejoined. Furthermore, sutures can be continuously braided to create multiple longitudinal channels, including more than two channels. In some embodiments, each longitudinal channel can have a different diameter. For example, the first longitudinal channel can have a larger diameter, allowing the loose end to slide through more easily and thus reducing the suture loop more readily. The second leg can have a smaller diameter, which allows for a more secure lock with the free end passing through it and provides a tighter lock to the suture structure.

[0146] In use, each longitudinal channel 2418' and 2418" can be configured such that tension can generate a Chinese finger lock and selectively reduce the core diameter. Once the soft tissue is in the target position, this Chinese finger lock, once activated, prevents the free ends passing through it from slipping. In some examples, the tissue in the target position applies counter-tension on the adjustable ring, thus contributing to the activation tension and generating automatic locking. In other words, once the soft tissue reaches the target position, the soft tissue can automatically resist further repositioning, providing a counter-force to reduce the inner diameter of the longitudinal channel, preventing the suture from slipping further through the bifurcation bracket and thereby reducing the ring, thus locking the soft tissue in the target position. Compared to a single suture through which multiple free ends are received, as described in U.S. Application 2017 / 0231752, which is incorporated herein by reference in its entirety, through multiple free ends having circumferential closures, each free end having its own dedicated longitudinal channel, the frictional force at each free end can be higher. This increased friction can reduce the likelihood of suture loop loosening, thereby mitigating tissue displacement. Now the friction is circumferential at each free end.

[0147] The cross-section of each loose end or limb is schematically shown in Figure 26BThe diagram shows cross-sections of a first plurality of braids and a second plurality of braids (2650 and 2660, respectively). The first plurality of braids 2650 define the outer wall or sheath of the braided suture. The second plurality of braids 2660, shown in shaded form for clarity, may constitute the core portion of the braided suture. The tension on the suture 2422 tends to be unevenly distributed overall; most of it is occupied by the braids in the core segment 2660. Therefore, the inventors envision that the suture can preferably be branched by continuous braiding to divide the suture into at least two longitudinal channels that substantially uniformly separate the braids from the first and second plurality of braids 2650 and 2660 between the two channels, such as... Figure 26C As shown in the diagram. This allows for a more even distribution of tension between the overall suture and the separate channels; resulting in a more uniform distribution of the structure's operation, allowing all longitudinal channels to be evenly locked around the suture passing through them. Figure 26C The diagram shows two longitudinal channels through which no sutures pass. In other words, when each channel of the bifurcation or separation section comprises a mixture of braids of a generally uniform distribution between the first and second plurality of braids 2650 and 2660, both loops 2412 and 2414 can reduce the loop size more uniformly and tighten and lock more uniformly around the sutures passing through them.

[0148] In alternative embodiments, each longitudinal channel 2418' and 2418'" may include a non-uniform distribution of first and second plurality of knitted fabrics. For example, if the inventors wish to provide two longitudinal channels with different functions, the first longitudinal channel 2418' may be formed entirely or substantially from knitted fabrics from the first plurality, while the second longitudinal channel may be formed entirely or substantially from knitted fabrics from the second plurality. Thus, each longitudinal channel may be characterized by a potentially non-uniform distribution of tension. This may tend to cause one longitudinal channel to lock more preferentially around the suture along which it is positioned than the other, while the second longitudinal channel may more preferentially allow the suture to slide.

[0149] The exemplary suture 2422 may include a total of 8-64 braids, which may be evenly distributed between each separate longitudinal channel, for example, 32 braids divided into two channels, each channel having 16 braids. In some alternative embodiments, each longitudinal channel 2418', 2418" may have a different number of braids to provide an alternative function for each channel. For example, one channel may have 22 braids while another channel may have 10. For example, one channel may be more tightly or preferentially locked than another channel, while the other channel may preferentially allow the suture to slide through it.

[0150] Figures 27A-27CAn example of a tension bar 2700 for, for example, anterior cruciate ligament (ACL) surgery is shown. The tension bar 2700 can be used to attach to at least two suture tails 2750, which can be joined together by a connecting device 2755 to form a suture reduction loop. The tension bar 2700 can be used to apply tension to at least one of the suture tails 2750. The connecting device can include any means for joining multiple suture tails together and can include, for example, eyelet connectors, loops, buttons, or knots. Alternatively, the connecting device can include a connecting device on each suture tail such that each suture tail terminates with, for example, a dedicated knot, loop, and loop or button. For example, each suture tail 2750 can terminate with a knot (not shown) that individually engages the suture bar 2700, so each suture tail may not be joined to form a reduction loop. For example, in Figure 8D In the suture structure shown in 32C, the tension bar can be configured to be connected via exemplary clip 2780 (in... Figure 27B and 27C (As shown in the diagram) Receives the suture loop end. In one embodiment, tension bar 2700 is configured to engage suture tail 2750 and connecting device (2755) to limit slippage of suture 2750 relative to suture bar 2700 and help tension the adjustable suture structure associated with suture tail 2750. Alternatively, lateral clip 2780 may receive finger rings 830a, 830b therein to wrap ring 830a around the first clip 2780 and ring 830b around the other clip 2780. The suture structure, more specifically the suture tail or loop, can be operatively coupled to an adjustable tissue fixation system, such as those disclosed herein, wherein tensioning the suture tail or loop reduces the adjustable loop of the adjustable suture loop structure, thereby adjusting the tissue fixation structure.

[0151] Tension bar 2700 may define a generally tubular or rod-shaped body member having a plurality of slots, recesses, clips, and notches arranged to selectively receive suture tails 2750 or loops 830, which are operatively coupled to an adjustable suture fixation structure, such as those previously described herein. Tension bar 2700 may define a one-piece or integral single-shot molded plastic component. Bar 2700 is configured to receive suture tails 2750 or loops 830a, 830b and distribute the load on the surgeon's fingers when tightening / pulling the suture. Bar 2700 may include at least one notch or device for receiving and engaging a connecting device such as a button, collar, knot, or eyelet. The notch may be centrally located along bar 2700. Bar 2700 may include at least two notches for receiving and engaging first and second connecting devices associated with the ends of first and second suture tails, respectively.

[0152] Figure 27AA view of the rod 2700 is shown, with a suture tail 2750 operably connected to the rod. The suture tail 2750 forms a loop using a connecting device 2755 as a grommet connector. An exemplary end forming a single tail can be similar to... Figure 24 The single tail 2434 is shown. The adjustable suture fixation system can be any adjustable suture structure described to date, such as those disclosed in Figures 5H, 8D, 24 and 16A-16C.

[0153] The tension bar 2700 includes a lower side surface 2720, an upper side surface 2730, and two lateral end surfaces 2740. The lower side surface 2720 may define a curved surface for nesting within the user's hand and better distributing load on the user's fingers. The lower side surface 2720 faces an adjustable suture structure. The lower side surface 2720 may include two grooves 2725, each groove receiving a suture tail 2750 of a certain length therein to guide the suture tail into a groove. The tension bar 2700 has a total length L that approximates the width of the surgeon's hand. The tension bar 2700 may define a middle working portion L spaced apart from the two lateral ends 2740. m It receives and engages the suture tail 2750. This can create a mechanical advantage in cases where some of the surgeon's fingers are laterally positioned in the suture groove 2727, which occurs when the lever 2700 is cranked, as described below. The groove 2725 can define the intermediate working portion L. m The outer periphery of the rod 2700. A groove 2725 may extend from the top surface 2702 of the rod 2700 toward the central axis XX and may be continuous with the recess 2760. The groove 2725 may have a constant width “W” on the lower side surface 2720 and may extend at an angle such that the closed end 2726 of each groove 2725 is farther from the nearest side end 2740 than the open end 2727. A portion along each groove 2725 may include a ramp 2726, which locally reduces the width “W” to better hold the suture tail 2750 therein and reduce the likelihood of the tension rod 2700 falling to the floor. The ramp 2726 may be closer to the closed end 2728 than the open end 2727. The ramp 2826 may be approximately one suture tail diameter or width from the closed end 2728. The ramp 2826 may define the closed portion of the groove 2725 continuous with the recess 2760. Each groove 2725 can extend from the lower surface 2720 to the upper surface 2730 and can be continuous with the groove 2760 along the upper surface 2730. In an alternative embodiment, the intermediate working portion L m The total length L of the rod 2700 can be approximately the same. In this case, the slot 2725 will be absent and the stitching 2750 will be away from the side end 2740. In an alternative embodiment, the rod 2700 may include an additional clip 2780 relative to the middle portion L. mLaterally positioned for receiving rings 830a and 830b therethrough.

[0154] Figure 27C A rod 2700 is shown, having modified side ends 2740 to allow a single-action mold-making process via an exposed cavity 2701 at each end. This can make the device more cost-effective and require less material. The device can be disposable, made of plastic, and supplied aseptically. Alternatively, the device can be used as a durable or reusable device and can be formed from materials that have been resterilized using existing sterilization methods. For example, a reusable tension rod can be made of stainless steel.

[0155] like Figure 27A and 27C As shown, each groove 2725 extends to and includes an upper side surface 2730 and may include a curved surface 2728 curving toward the center 1705 of the rod. The center is approximately equidistant between the two side ends 2740. Each groove 2725 and the curved surface 2728 are configured to guide the suture tail 2750 into the groove 2760. Figure 27A and 27C As can also be seen, at least one notch 2770 extends radially from the groove 2760 for receiving a connecting device, such as a knot, button, collar, or eyelet associated with the suture tail 2750. At least one notch has a larger cross-section to receive and engage the connecting device 2755, which typically has a larger cross-section than the suture tail 2750.

[0156] Figure 27D The longitudinal cross-section of rod 2700 shows a lower surface 2720 having a groove 2725 passing through it. At least a portion of the groove bottom surface 2765 is shown as continuous with the groove 2725 and laterally or radially spaced from the opening 2770. The groove bottom surface 2765 may extend at a non-zero angle relative to the longitudinal axis of rod 2700, defining a apex in the middle of the rod, approximately equidistant from both ends 2740. Clamp 2780 from... Figure 27D The text is omitted for simplification. Figure 27E An isometric view of the continuous groove 2725 and the bottom surface 2765 of the recess is shown.

[0157] Figure 28A and 28BA first cross-section of the rod 2700 is shown, extending through the center of the notch 2770. A groove 2760 extends parallel to the longitudinal axis of the rod and defines a bottom surface 2765 spaced inwardly relative to the notch surface 2771. The groove 2760 is sized to receive the tail of the suture but prevents the connecting device 2755 from entering. The groove 2760 is sized to prevent the connecting device 2755 from entering the innermost portion of the groove 2760 and to place the connecting device within one of the notches 2770. In the intermediate portion L between the two grooves 2725... m The diagram illustrates multiple axially spaced notches 2770. In some embodiments, a single notch may be located at the center 2705, equidistant from the two side ends 2740. The width of the notch 2770 is configured to receive and engage a connecting device to restrict movement of the suture tail 2750 along the tension bar 2700. At least one notch 2770 defines two angled channels 2771a and 2771b extending from both sides of the notch. Channels 2771a and 2771b may be mirror images of each other. In some embodiments, a single channel, such as channel 2771a, is sufficient.

[0158] Figure 29A and 29B A second cross-section of the rod 2700 is shown, offset from the first cross-section and extending through a rib 2778 that separates two tandemly arranged notches 2770. The rib 2778 may include a chamfer 2779. The ribs 2778 are axially spaced, defining notches 2770 to allow a connecting device 2755 to be located within the notch 2770, while the suture tail 2750 is disposed more inwardly along a groove 2760. Since the lengths of each suture tail may be unequal, depending on the construction of the suture structure and the location of the connecting device 2755, multiple notches 2770 may be preferred to accommodate some asymmetry between the suture tails. In an alternative embodiment where each suture tail terminates with its own connecting device, a first connecting device on the first suture tail may engage a first notch, and a second connecting device on the second suture tail may engage a second notch.

[0159] Figure 30 An adjustable fixing structure 2800 operably connected to a tension bar 2700 is shown. A grommets are shown as connecting devices 2755 to join two suture tails 2750 together, the grommets being located within a notch 2770.

[0160] Figure 31A and 31BThis describes a method for implanting a tissue graft 3124 within the knee 3150 during anterior cruciate ligament (ACL) repair and reconstruction surgery. A drilling procedure is performed to create one or more bone tunnels, such as an appropriately sized tibial tunnel 3118 extending through the tibia 3116 and a femoral tunnel 3122 extending through the femur 3120. Surgical structures include the tissue graft 3124 and suture structures 3127 (e.g., [missing information]). Figure 24 Rings 2412 and 2414 in the middle, or Figure 8D (as shown in the ring structure) and graft attachment device 3114.

[0161] In use Figure 30 In the first example of the fixation device shown, after the attachment device 3114 has been placed on the outer surface of the femur, or before the attachment device 3114 has passed through tunnels 3118, 3122, the suture tail 2750 can be coupled to the tension bar 2700. Each suture tail 2750 can be configured to connect to form a loop, which is formed using a connecting device 2755. Each suture tail 2750 can extend through a separate groove 2725 via the tension bar 2700, with the length of each suture tail 2750 positioned along the groove, and the connecting device positioned along the groove 2760 within the notch 2770. The surgeon can then apply tension to the suture tail 2750 by pulling the tension bar 2700 to pull the suture, graft attachment device, and tissue graft through the bone tunnel. For example, a surgeon can pull tension bar 2700 to pull suture tail 2750 and loop 3127 through tibial tunnel 3118 and femoral tunnel 3122, thereby positioning tissue graft 3124 within femoral tunnel 3122 and tibial tunnel 3118. Pulling tension bar 2700 prevents suture tail 2750 from slipping along tension bar 2700 because connecting device 2755 is located within notch 2770. Tension bar 2700 can be rocked, pulling the first tail of suture tail 2750 in alternating rocking motions, then pulling the other, as... Figure 31B As shown in the diagram. This allows the increased tension to be isolated and concentrated at the first tail, followed by the other. This applies greater tension to a single length of suture, making it easier to overcome friction from suture structures (e.g., bracket 2420), and thus providing a means to more easily reduce suture loops.

[0162] In the second example using a fixation device that includes a suture structure, such as Figure 8DAs shown, after the attachment device 3114 has been placed on the outer surface of the femur or before the attachment device 3114 has passed through tunnels 3118, 3122, suture loops 830a, 830b can be coupled to the tension bar 2700. In this example, for example, at least one of the suture loops 830b may first pass through the graft tissue or bone block before being coupled to or passing through the hole in the fixation device 3114, as disclosed herein. Each suture loop 830a, 830b can form a loop around the bar 2700 and enter into its own clip 2780. The tension bar 2700 can be rocked to, as Figure 31B A similar manner, as shown, involves pulling the first loop 830a in an alternating rocking motion, followed by the other. This allows the increased tension to be isolated and concentrated at the first tail, followed by the other. This applies greater tension to individual loops, making it easier to overcome friction from suture structures (e.g., bracket 820), thus providing a means to more easily reduce the size of the suture loops.

[0163] Many embodiments have been described. However, it should be understood that various modifications can be made. For example, although tension bar 2700 is shown for use with the knee joint, it can be used in other areas of the body, such as the hip or shoulder joint, and its size can be adjusted accordingly. Tension bar can be made of many different materials, such as stainless steel, aluminum, PEEK, polycarbonate, acetal, etc., and can be used disposable or multiple times. Although tension bar 2700 has been described as being used by hand, it is conceivable that tension bar 2700 can be used with another instrument or can be connected to a pulling or winding device. Tension bar can be operatively coupled to the working head of a robotic arm. Therefore, other embodiments are within the scope of the following claims.

[0164] exist Figure 32B-32F The invention discloses a method for passing multiple sutures or suture loops through a target tissue with minimal friction / resistance and damage to the target tissue. For example, this involves connecting multiple suture loops and / or adjusting the suture length (e.g., at least) via grafts. Figure 8D The ring structure shown in 806 may be necessary. For example, the graft may include a bone block or a quadriceps tendon (QT). Figure 32B-32F The paper discloses a method for threading multiple sutures in a single needle pass, thereby reducing the number of suture threading actions and thus reducing graft preparation time in surgery.

[0165] Threading multiple suture loops around a suture threader (such as a needle) and inserting each suture simultaneously creates additional friction / resistance when passing through the tissue. Threading multiple suture loops through the tissue one at a time multiplies the number of sutures to be threaded. Another option is to knot the looped sutures to form two tandem loops (…). Figure 32AThe first suture can be attached to the first of two tandem loops, and the second suture can pass through the second of two tandem loops. When passing the needle through the tissue, the two sutures can be pulled through the tissue in stages. However, adding knots creates additional resistance when passing through the tissue and requires greater force. Transplanted tissue is typically about 10 mm wide and 5 mm thick and can be very slippery. Therefore, handling such small and slippery tissue can be difficult, and threading multiple sutures, which involves large, transient variations in cross-sectional shape, such as the form of knots, or the number of sutures, is cumbersome, time-consuming, and can damage the transplanted tissue. Therefore, there is a need to provide a means of passing multiple sutures through the tissue with minimal friction / resistance and / or unnecessary tissue damage.

[0166] Referring now to the preceding figures, which disclose open-loop suspension fixation structures, such as at least structures 106, 206, and 806. These structures provide a free end that can pass through the transplanted tissue before being directly assembled to a leather button (e.g., button 1202). Figure 32C An open-loop structure 3206, at least similar to structure 1205, is shown, and its formation method is at least in Figure 8D The structure 3206 may include an anchor or leather button 3220, a pre-assembled end 3230, and a free end 3240. As described in at least 11B and 34A, the free end 3240 may pass through and connect to the transplanted tissue. The free end 3240 includes a loop end 3244 and a finger ring end 3246 of an adjustable ring 3242. The finger ring end 3246 and the loop end 3244 may be offset from each other because the loop end 3244 is configured to connect around the button 3220, while the finger ring end 3246 is configured to pass through a hole in the button 3220 and extend away from the button 3220, thereby providing a means of adjusting the structure 3206. The proposed method discloses a needle insertion system having means for staged insertion of the two rings (3244 and 3246) with reduced force for a single needle insertion through the transplanted tissue. The proposed method includes a needle insertion system that avoids knots. Figure 32A As shown, the knot can increase the penetrating force through the tissue. The disclosed needle penetrating system may include a double-loop needle system.

[0167] Figure 32B A first embodiment of a double-loop needle system 3250 is shown, which allows flexible material of multiple lengths to pass through target tissue, such as transplanted tissue, while minimizing the volume of flexible material passed each time. System 3250 includes two flexible material loops of offset or different lengths, a first shorter loop 3252 and a second longer loop 3254, both directly coupled to a needle 3255. The loop material can be any flexible material suitable for coupling in surgical procedures, such as suture strands, monofilaments, or fine threads. Loops 3252 and 3254 can have different colors or markings for suture management. The difference in loop lengths is determined based on the construction of loops 3252 and 3254.

[0168] Exemplary usage methods in Figure 32C The diagram shows that the first ring 3252 can be connected to the ring end 3246 and the second ring 3254 can be connected to the ring end 3244. As shown, structure 3206 is initially in an open-loop configuration. The needle 3255 can pass through the transplanted tissue to pull both ends 3244 and 3246 through the transplanted tissue, first pulling end 3246, then pulling end 3244 to pass through in stages and reduce the penetration resistance through the tissue. The sleeve or bracket 3205 can now extend through the transplanted tissue and the ring end 3244 can be connected to the anchor 3220 to change structure 3206 into a closed configuration. The needle system 3250 can be disconnected from the ring end 3244 before connecting the ring end 3244, while the needle system 3250 remains connected to end 3246. The needle 3255 can then extend through the leather button 3220 to pull the ring end 3246 through the hole in the leather button 3220 before disconnecting the needle system 3250 from the ring end 3246. The tension on the ring end 3246 can be reduced in a manner similar to that described in at least U.S. Patent No. 10,383,617 and disclosed herein in the preceding figures. The needle system 3250 can be disconnected via cutting loops 3254 and 3252. By offsetting the loops and without adding any knots, the threading pull is less (easier), saving OR time and potential graft damage.

[0169] Figure 32D A second embodiment of the double-loop needle system 3260 is presented. The system 3260 may include a flexible member 3262 attached to a needle 3255 and two axially spaced loops 3264 and 3266 extending along the single flexible member. The flexible member 3262 may be formed of knitting yarn, and the loops 3264 and 3266 may be formed by changing the knitting pattern during manufacturing to form a fork (i.e., the yarn of the suture may be knitted in different patterns from single strand to fork, then back to single strand and then back to fork). Thus, the first loop 3264 may be operatively coupled to, for example, loop 3244, while the second loop 3266 may be operatively coupled to the finger loop end 3246.

[0170] Therefore, an exemplary method of use may include providing an adjustable ring fastening structure 3206 with an open ring configuration, which can be assembled with a double-ring needle system 3260. A first ring 3264 may be configured to attach to a ring end 3244 and a second ring 3266 may be configured to attach to the ring 3246. A needle 3255 may pass through the transplanted tissue to pull the ends 3244 and 3246 one after another through the transplanted tissue. This allows the sleeve or bracket 3205 to be placed through the transplanted tissue before attaching the ring end 3244 to the anchor 3220. The needle system 3260 may be disconnected from the ends 3244 and 3246 by cutting the two rings 3264 and 3266. The needle system may first disconnect from the ring end 3244 and the ring end 3244 may be assembled to a leather button 3220, while the ring end 3246 remains attached to the double-ring needle system 3260. The needle 3255 may be used to extend the ring 3246 through a hole 3220 in the leather button. The tension on the ring end 3246 can be reduced in a manner similar to that described in at least U.S. Patent No. 10,383,617, as disclosed herein.

[0171] Figure 32E Another embodiment of the double-loop needle system 3270 is presented. One end of the suture is attached to the needle 3255, and the other end may include two eyelet connectors or finger cots 3271 and 3273, with two loops 3272 and 3274 alternating between them. This structure can be formed using a single flexible member extending from the needle 3255 to form a first loop 3272, and then defining the length of a first finger cot 3271 by extending itself. The suture then leaves the finger cot 3271 for a short length and then returns to extend along the core of the flexible member for a length defining a second finger cot 3274. A low-profile knot 3275 can be formed using intertwine adjacent to the second loop 3274 to prevent the suture from slipping along itself. The intertwine can be similar to that disclosed in at least U.S. Patent No. 10,383,617, which is co-owned and incorporated herein by reference.

[0172] Therefore, exemplary usage methods may include providing an adjustable ring fixation structure, such as exemplary structure 3206 which can be assembled with the double-ring needle system 3270. A second ring 3274 may be configured to attach to the ring end 3246, and a first ring 3272 may be configured to attach to the ring end 3244. A needle 3255 may pass through the transplanted tissue to pull the ends 3244 and 3246 through the transplanted tissue. This allows the sleeve 3205 to be placed through the transplanted tissue before the ring end 3244 is directly attached to the anchor 3220. The needle system 3270 can be disconnected from the ends 3244 and 3246 by cutting the two rings 3272 and 3274. The first ring 3272 may initially detach from the second ring but remain attached until the end 3244 is attached to the anchor 3220. Tension on the ring end 3246 can be reduced as disclosed herein with the adjustable suture structure 3206. The needle system 3250 may have a straight needle 3255 or a curved needle.

[0173] Figures 33A-33C An alternative embodiment of the open-loop adjustable suture structure is shown, which allows the flexible member to be passed through the transplanted tissue in stages using a bypass ring 3310. Similar to... Figure 32B -F, the adjustable fixing structure 3300 can be an open-loop adjustable structure having a free end 3340, including a finger loop end 3346 and a ring end 3344. The free end also includes a bypass ring 3310. The bypass ring 3310 can be formed during the weaving or manufacturing of the flexible member 3305 and can be a forked portion, in which some yarns are short-distance woven to form two separate lengths of flexible material before being woven together. Alternatively, the bypass ring 3310 can be formed using an eyelet joint or finger loop, or by intertwine as described herein. Reference will now be made to... Figure 33B An exemplary method for forming the finger ring end 3346 and the ring 3310 is described. The end of the flexible member 3305 may be formed into a ring to form the finger ring end 3346, and then extended along the hollow core of the flexible member 3305 to form an eyelet connector 3311. The end of the flexible member may then exit the hollow core and pass through the ring end 3344, and re-enter the hollow core at point P to form a bypass ring 3310. The end of the flexible member may then be twisted together near point P to hold it in place, or, for example, secured in place using an adhesive. The bypass ring 3310 is preferably marked for easy identification by the surgeon and may be, for example, a different color or shape from the rest of the flexible member 3305. The system 3300 may be configured to be operatively coupled to the needle system 3350 using a single ring 3252 of flexible material. The single ring 3252 may be formed as a suture strand, monofilament, or thread. The ring 3252 may have a different color than the flexible member 3305 and the bypass ring 3310 for use in suture management.

[0174] An exemplary method of use may include passing the free end 3340 of the open-loop adjustable fixation structure 3300 through the transplanted tissue. The free end includes a finger loop end 3346 directly coupled to the needle system 3350. The free end 3340 also includes a loop end 3344 operatively coupled to a bypass ring 3310 of the structure. The structure 3300 may initially be in an open-loop configuration, defining the finger loop end 3346 and the loop end 3344, with a second end 3330 operatively coupled to a leather button 3335. A needle 3255 may pass through the transplanted tissue to pull both ends 3344 and 3346 through the transplanted tissue until the support 3355 extends through the transplanted tissue. The bypass ring 3310 may then be cut to release the loop end 3344. The bypass ring 3310 is easily identifiable and distinguished from the rest of the flexible material so that only the bypass ring is cut. This can be achieved, for example, by marking, shaping, or coloring. The loop end 3344 can then be attached to the anchor 3220 to change the structure 3300 into a closed configuration. The needle system 3350 can remain attached to the finger ring end 3346 while attaching the loop end 3344. The needle 3255 can then extend through a hole in the leather button 3220 to pull the finger ring end 3346 through the hole before disconnecting the needle system 3350 from the finger ring end 3346. The tension on the finger ring end 3346 can be reduced in a manner similar to that described at least in U.S. Patent No. 10,383,617. The needle system 3350 can be disconnected by cutting the loop 3254.

[0175] Figure 33C It shows the relationship with Figure 33A and 33B The illustrated embodiment is similar to other embodiments, except that it discloses an adjustable fixation structure 3350 having two free ends 3360a and 3360b. This can be referred to as a symmetrical open-loop construction. At least one of the free ends (shown as 3360b) can be coupled to the needle system 3350. Both free ends 3360a and 3350b can include bypass loops 3310a and 3310b. This system allows the surgeon to selectively engage a leather button, such as button 800, and prevents the loop ends from accidentally pulling out of the support 3355, as this would damage the structure.

[0176] The number of loops can exceed two, and each design requires a different offset length. The needle can be straight or curved. Figure 32F The material of the ring can be suture thread (the size depends on design requirements, but generally the thinner the better without compromising strength), monofilament, or even metal wire.

[0177] Sometimes adjustable suture structures are attached to the graft by forming herringbone stitches within the graft, such as... Figure 15C-15GAs shown in the diagram. This may require the use of connecting tape or sutures, and may be difficult to pull multiple suture loops through the graft. Alternatively, the graft can be divided into two “legs” approximately two-thirds of its length along its longitudinal axis and passed through a closed, adjustable loop structure, such as the structure disclosed in at least U.S. Patent No. 10,383,617. In this option, the legs are re-sutured together to secure the loops within the graft. This method is time-consuming in the operating room and may compromise the integrity of the graft. Furthermore, the sutures used to re-suture the legs together increase the graft volume. Therefore, there is a need for adjustable suture structures that are directly attached to the transplanted tissue without the need for tape or sutures, while simultaneously pulling multiple suture loops through or separating the graft.

[0178] Therefore, this paper discloses a method using an open-loop adjustable fixing structure (e.g., at least in this paper...). Figures 1A-8D and Figure 32C The method involves forming a single free end of the structure (disclosed in the text) through a stitch in the tissue. This allows the ring of the fixation structure to be directly attached to the transplanted tissue without the need for connecting bands or sutures; it can improve the integrity of the graft; it can reduce graft preparation time in OR; and it is versatile, applicable to both soft and hard tissues (patellar grafts, or QTs with bone blocks) and different types of grafts for ACL reconstruction or ACL repair or other ligament reconstruction surgeries.

[0179] The open-loop structure can be similar to the structure disclosed herein, including at least structure 3206 and including structures that can be used, for example... Figure 32B-32F The disclosed double-needle system pulls the free end 3240 of the transplanted tissue through the suture threader. A suture threader, such as threader 3250, can be used to guide the free end of the open loop structure (which may include a ring end 3246 and a loop end 3244) along... Figure 34A and 34B The path shown traverses the soft tissue graft. Final support location 3205 is... Figure 34A As shown in the image. Figure 34BThe steps of passing the free end 3240 through the graft tissue 10 to form a needle mark through the graft 10 are shown. The graft defines an anterior surface 11, a top surface 12, a bottom surface 13, a first lateral surface 14, and a second lateral surface 15. To pass the free end of the loop through the soft tissue, a loop needle or suture threader can be used. As shown in step 1, the free end 3240 may pass from the anterior surface 11 to the top surface 12, and then around the first lateral surface 14 (step 2) before passing from the bottom surface 13 to the top surface 12 (step 3). Steps 2 and 3 may be repeated. The end 3240 may pass around the bottom surface of the graft to the second lateral surface 15, enter the top surface 12, and exit from the bottom surface 13 of the graft (step 6). Starting from the bottom surface 13, the end 3240 may pass around the second lateral surface, then enter the top surface 12, and exit the anterior surface 11 (steps 7 and 8). The end 3240 is pulled through the graft 10 and preferably a bracket 3205 is placed around the two side surfaces 14 and 15 and the lower surface 13, along the graft 10 and spaced apart from the front 11.

[0180] The suture entry and exit points are designed on the front 11 of the graft 10 to avoid accumulation during graft passage through the tunnel. Because the entry and exit points are separate, a more uniform stress distribution through the graft 10 will be provided (it can be uniformly 1 / 3, 1 / 3, 1 / 3, or any other way, such as 1 / 4, 1 / 2, 1 / 4, etc.). Although in Figure 34A and 34B The diagram shows two passes, but the number of suture rows is flexible and can be selected by the surgeon. Allowing the free end 3240 to pass through the graft 10 can form any number of suture patterns / techniques, including but not limited to Krackow, whip stitch, baseball stitch, etc. The exit and entry points can be on different surfaces to form different stitches through the graft.

[0181] Turn now Figures 35A-35C This paper discloses button-type anchors that can be operatively attached to suspension fixation structures, such as those disclosed herein, to secure the reconstructed tibial side. This is closer to the patient's skin, an area with less inherent muscle, fat, and connective tissue, and is more likely to be noticed by the patient. Some attempted solutions have tried to use screw-type anchors placed within a prepared tibial tunnel to secure the tibial side, but this has not adequately addressed the need to adjust tension on the graft tissue. Some attempted solutions have tried to secure the tibial side with button-type anchors with thin, square or rectangular cross-sectional profiles, but this has not adequately addressed the need to provide an inaccessible button. Therefore, a minimally contoured device for securing the graft to the tibial cortex is needed to improve tactile sensation.

[0182] Figure 35A and 35BVarious views of a low-profile button-type anchor 3500 that can attach a flexible member of a fixed structure to the tibial cortex are shown. A head portion 3520 is configured to protrude from the cortical surface for positioning, while a body portion 3530 can extend into the tibial tunnel. The head portion is configured with a low profile, including a dome or rounded dome surface 3510 to reduce tactile feedback to the patient. The anchor 3500 may define a circular cross-section to increase the contact surface with the cortical tibia, thereby improving stress distribution around the anchor. This allows for a reduced thickness (T) of the head 3520 (see Figure 36c) and therefore the low-profile head 3520, reducing tactile feedback to the patient to achieve the same mechanical strength. Furthermore, the dome-shaped profile (or any gradient of the profile) on the top helps to provide a smoother tactile feel. Other shapes may include an oval or rounded rectangle.

[0183] The cavity 3540 at the center of the anchor 3500 button is configured to accommodate any knot formed by the flexible member structure. This preferably holds the knot below the top surface 3510 to reduce tactile feedback to the patient. The body portion 3530 may be tapered, allowing the anchor 3500 to press-fit into the tibial tunnel and improving fixation.

[0184] Anchor 3500 includes a plurality of radially oriented grooves 3505a, 3505b, 3505c, and 3505d extending through both a head 3520 and a body 3530. Grooves 3505a, 3505b, 3505c, and 3505d are configured to receive a flexible member of a fixed structure therethrough. Grooves 3505a, 3505b, 3505c, and 3505d are tapered, having a maximum opening at the outermost peripheral edge of the head 3520 and narrowing as each groove extends inward. The narrowing profile 3507 along each groove 3505 also helps retain the flexible member within the inner end of the groove. Grooves 3505a, 3505b, 3505c, and 3505d are generally configured to guide the flexible member into the inner end of the groove and help retain the flexible member therein. These flexible members can be used for suture loop reduction. Grooves 3505a, 3505b, 3505c, and 3505d all terminate at and intersect with recesses 3506a or 3506b, such as... Figure 35C As best shown. Both grooves 3505a and 3505d terminate at the end of recess 3506a. Recess 3506a extends between the ends of grooves 3505a and 3505d. Recess 3506a is continuous with and below the bottom of cavity 3540. Recess 3506a is configured to receive a flexible member therein. For example, a ring of the flexible member may extend through the two grooves 3505a and 3505d and be nested within recess 3506d.

[0185] Figures 36A-36CAn alternative embodiment 3600 is shown with at least two holes 3610 extending through both the head 3620 and the body 3630. The ends of the flexible members may extend along the tibial tunnel and then through at least one of the two holes 3610. Tension applied to the ends of these flexible members may reduce the adjustable structure or apply tension to the graft. At least two holes 3610 are provided on either side of the recesses 3606a and 3606b and may be located on a line passing through the center of the anchor 3600. Figures 37A-37C An alternative embodiment 3700 with asymmetrical slots and holes is shown. The button 1600 includes two slots 3505b and 3505c. The anchor 3700 includes at least four holes 3710a, 3710b, 3710c, and 3710d. All holes and slots extend through both the head 3720 and the body 3730. Figure 37C As shown, the ends and rings of the flexible member can pass through some of these holes 3710a, 3710b, 3710c, and 3710d. In this embodiment, the flexible member of the adjustable fixation structure can be configured to pre-assemble into the button 3700 and may include a ring pre-assembled through holes 3710c and 3710d. Similar to the open-loop adjustable structure described herein, the free end 3750 can pass through the transplanted tissue before extending along grooves 3505b and 3505c. Once assembled with the button 3700, the ring end 3750 can be positioned within the recess 3506b. The button is configured to engage the tibial cortical end of the prepared ACL tunnel.

[0186] For example, when using open-loop adjustable fixation structures (such as Structure 106 or 3206), suture and anchor management during surgery requires different and more complex operations compared to closed-loop adjustable fixation structures. For instance, anchors are small and may be difficult to see, or even more difficult to use, especially when wearing wet / greasy gloves and lacking specialized support instruments. Furthermore, the multiple lengths and loops of sutures can be difficult to track, and unintentionally cutting the wrong suture can damage the entire structure. Therefore, this paper discloses a means of managing this structure to improve surgical efficiency and avoid costly errors. In addition, the tool or clamp is designed to provide tactile feedback when mating suture loops and implantation hole slots, thereby reducing the need for visualization of small mating features.

[0187] exist Figure 38A management and assembly tool for an open-loop adjustable fixation structure is disclosed, pre-loaded with button implants (anchors) and flexible members. The assembly tool provides a means of suture management and facilitates simpler assembly of the anchors and sutures by allowing the user to safely manipulate the micro-implant while manipulating the suture into the corresponding feature on the implant. This document discloses an adjustable suture structure management and assembly tool with means that securely holds the anchor to allow for precise manipulation of the suture on the anchor without concern about it falling off / removing. The tool can be configured to have buttons / sutures packaged and pre-assembled thereon, allowing for out-of-the-box use without assembling the anchor into the fixation member and subsequently assembling the suture onto it.

[0188] Figure 38 An overall view of the assembly tool 3800 is shown. Assembled thereon are an exemplary anchor (button implant) 3220 and an adjustable ring structure, which may include a bracket portion 3205, an exemplary open-loop adjustable suture structure 3206, and an exemplary two-needle system similar to system 3250. The assembly tool 3800 may be a cubic shape with a manipulable profile, but other shapes are contemplated for easy insertion into the surgeon's hand. The assembly tool may include means for clamping or attaching to a positioning arm or surgical drape of a patient (not shown). The assembly tool 3800 may include a channel 3803 for nesting a length of flexible member of the exemplary adjustable suture structure 3206. At least in Figure 39A As best seen, channel 3803 extends inward at its transition point to groove 3805, which conforms to the shape of anchor 3220, to nest and retain the leather button or anchor 3220. Tension on the seam structure along channel 3803 will not release anchor 3220. Anchor 3220 can be nested and orthogonal to the longitudinal axis of the groove. Groove 3805 can be configured to nest anchor 3220 within the groove so that it stands upright within groove 3805 and protrudes slightly beyond top surface 3807. At least as Figure 39B As shown, the depth of groove 3805 preferably places anchor grooves 3855a and 3855b above surface 3807. Groove 3855 is configured to receive the free end of the suture structure (e.g., free end 3240), as disclosed herein. Grooves 3855a and 3855b can be similar to at least Figure 12B The groove 1210 is shown. A portion of the grooves 3855a and 3855b may be flush with the surface 3807. When this feature is provided, the user is able to align the ring (e.g., ring 3244) with the surface 3807 of the assembly tool 3800 and simply pull the structure 3206 to engage the ring 3244 within the retaining grooves 3855a and 3855b, instead of having to visualize the grooves 3855a and 3855b and attempt to align the suture loop while applying tension. Figure 39BA hole 3856 for receiving the end of the ring through it is also shown.

[0189] Figure 39C The illustration shows a channel 3803 and an exemplary adjustable suture structure 3206 extending therefrom. For example, structure 3206 may include... Figure 12B The first pre-assembled side is similar to side 1206a shown in the diagram. The portion of the open-loop adjustable suture structure 3206 not attached to the anchor 3220 can be freely manipulated outside the tool 3800 to allow assembly to BTB grafts or QT tissue. Figure 39D The underside of tool 3800 is shown, including a suture management spool 3825. From the bottom of groove 3805 is a through-hole (not shown) extending to a depth through assembly block 3800 (not shown). This through-hole allows a first suture, which is attached to anchor 3850, to pass through assembly clamp 3800 and be tightly wound around the spool feature 3825 on the bottom of assembly tool 3800. By winding the suture and subsequently clamping it within spool feature 3825, button 3850 is secured in groove 3805 to allow manipulation of structure 3806 around button 3850 without worrying about button 3850 being removed from tool 3800.

[0190] Figure 40A-40F An exemplary method is shown for attaching an open-loop adjustable structure, such as structure 3206, to a transplanted tissue, such as tissue 25, using assembly tool 3800. Other structures described throughout this disclosure can be assembled to tool 3800 in a similar manner. Figure 40a illustrates step 1, allowing the free end 3240 of the open-loop adjustable structure 3860 to pass through the transplanted tissue 25. This tissue may include tunnels of bone. Passage can be achieved, for example, using a double-ring suture system 3250. A bracket 3205 may be placed within the tissue 25. Figure 40B The next step is shown, which includes disengaging the suture loop 3244 of the free end 3240 from the threading system 3250. This may include cutting a second suture segment through the threading system 3250. Figure 40C The diagram shows the released suture loop being placed flush against the face 3807 of the assembly tool and pulled around the anchor 3850 in the direction of the suture channel 3803 to engage with the button 3220. The suture loop 3244 can extend through and into the slots 3855a and 3855b of the anchor 3850. Figure 40D The steps are shown to pass the needle of the needle system 3250 through the hole 3856 of, for example, the anchor 3220 and pull the ring through. Figure 40E The ring is shown being removed from system 3250 by cutting through the first suture segment of system 3250. Figure 40FThe sutures are shown being unwound and then unrolled one at a time, starting with the first length suture 3845 and then the second length suture 3847. Once sutures 3845 and 3847 have been unrolled, the assembly tool can be flipped over and the tension on the second suture 3847 can be removed from the tool from structure 3206. The free end 3240 is now assembled with anchor 3220 and the bracket 3205 extends through the transplanted tissue 25.

[0191] Figure 41 An alternative embodiment of the tool assembly 4100 is shown, which includes an additional suture management channel 4110 with a mistake-proof design to ensure the correct sequence of operations. Once the suture is wrapped around the oval base, it is lifted and secured within the clip 4120. After securing the suture, the suture threading device is woven through the hole in the button implant and snapped onto the circular exterior of the clip feature, ensuring that the ring is threaded through the button implant using the suture threader before being released from the clip and unwound from the base. Furthermore, the concept is illustrated with numbers corresponding to the technical steps that assist the user in assembling the suture to the button implant.

[0192] Those skilled in the art will recognize that this disclosure may be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the foregoing examples are to be considered illustrative in all respects and not limiting of the disclosure described herein. The scope of this disclosure is thus indicated by the appended claims rather than by the foregoing description, and therefore all variations in the meaning and scope of the equivalents of the claims are intended to be included therein.

Claims

1. A graft suspension device comprising: an elongate body having a first end, a second end, and a longitudinal axis extending therebetween, a first sidewall extending along the longitudinal axis between the first end and the second end, and a second sidewall opposite the first sidewall extending along the longitudinal axis between the first end and the second end; wherein the elongate body further comprises: at least a first aperture and a second aperture defined through the body proximate a midpoint of the body defined by the first end and the second end; a first slot extending through the body and further through one of the first sidewall or the second sidewall such that the first slot is proximate the first aperture; a second slot formed through the body and further through one of the first sidewall or the second sidewall such that the second slot is proximate the second aperture; and an adjustable suture loop, wherein the at least first aperture and second aperture are pre-assembled to a first loop of the adjustable suture loop; and wherein the first slot and the second slot are configured to receive a second loop of the adjustable suture loop.

2. The graft suspension device of claim 1, wherein the adjustable suture loop includes a carrier spacing the first loop from the second loop.

3. The graft suspension device of claim 2, wherein the second loop defines a free end configured to draw the carrier through a graft tissue and then loop around the elongate body and into the first slot and the second slot to couple the free end, and thereby the graft tissue, to the elongate body.

4. The graft suspension device of claim 2, wherein the carrier includes a longitudinal channel portion through which ends of first and second suture limbs of the adjustable suture loop extend, and wherein the elongate body further comprises third and fourth apertures disposed proximate the first end and the second end, respectively, configured to receive the first and second suture limbs therethrough.

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