Dynamic ligamentous attachment implant system and method

Abstract

An implant system for dynamic stabilization of a syndesmotic joint. The system includes a soft bone anchor, a dynamic bone anchor, and a tether coupled to and extending between the soft bone anchor and the dynamic bone anchor. First and second retention portions of the tether are knotlessly coupled to the dynamic bone anchor, and an intermediate portion of the tether extending between the first and second retention portions passes through the soft bone anchor. An inner portion of the intermediate portion extends to and is elastically coupled to the dynamic bone anchor. The system further includes an insertion and tensioning instrument, the soft bone anchor being removably held on a free end of the first portion of the instrument, and the dynamic bone anchor being removably held on at least one of the first and second portions of the base.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 483,091, filed February 3, 2023, entitled "Dynamic Ligamentosynthesis Implant System and Method," and U.S. Provisional Patent Application No. 63 / 622,967, filed January 19, 2024, entitled "Dynamic Ligamentosynthesis Implant System and Method," the disclosures of which are incorporated herein by reference in their entireties.

[0002] The present disclosure relates generally to orthopedic surgery related to dynamic stabilization of bone and / or tissue. More particularly, but not exclusively, the present disclosure relates to implant devices, systems, and methods for achieving dynamic stabilization of syndesmotic joints. [Background technology]

[0003] A syndesmotic joint is a fibrous joint in which two bones are connected by a strong ligament or membrane. The distal tibiofibular joint, located between the fibula and tibia, is formed by three major ligaments: the anterior inferior tibiofibular ligament (AITFL), the posterior inferior tibiofibular ligament (PITFL), and the interosseous tibiofibular ligament (ITFL). A fourth ligament, the inferior transverse tibiofibular ligament, coincides with the PITFL but is sometimes considered a separate ligament. Although technically, the syndesmotic joint is a joint, most literature describes syndesmotic injuries as affecting the syndesmotic ligaments.

[0004] Syndesmotic injuries most typically occur in the distal tibiofibular syndesmotic ligament and are caused by trauma (such as, but not limited to, sports injuries). Syndesmotic injuries can occur as pure ligament injuries or in combination with fractures, in which the syndesmotic ligament is torn, separated, or damaged.

[0005] The current standard of care for syndesmotic injuries involves rigid fixation with screws or suture / tether-based full-width restraint (stabilization) of the syndesmotic joint. Rigid screw fixation is easy to implant and stabilizes the joint, but does not allow for any of the normal physiological motion. This results in limited patient range of motion and unpredictable screw failure locations, which can lead to damage to existing bone and / or patient pain.

[0006] Currently available suture / tether syndesmosis stabilization / constraint implant systems allow for limited joint movement but fail to mimic the intact ligamentous structure of the syndesmosis in terms of attachment location and distance between the articular bones (e.g., tibia and fibula). These current stabilization / suture-based syndesmosis implants typically involve drilling the entire articular bone (e.g., for the distal tibiofibular syndesmosis, drilling the fibula and tibia from lateral to medial), placing a first component of the implant on a first bone surface (e.g., the lateral surface of the fibula), placing a second component on a second bone surface (e.g., the medial surface of the tibia), and extending sutures or other elastic / resilient tethers between them.

[0007] However, current tether restraints inevitably have reduced structural strength due to the through-holes created by the implant surgical procedure and are unable to completely fill or enclose holes that are only partially filled by the through-extending sutures / tethers. Furthermore, these current tether restraints span the entire width of the syndesmotic joint and therefore utilize relatively long sutures / tethers.

[0008] Therefore, there is a need for new and improved dynamic syndesmosis stabilization devices, systems, and methods to overcome the above-mentioned shortcomings of currently available solutions for addressing syndesmosis injuries. Summary of the Invention

[0009] The present disclosure relates to ligamentous attachment implants, systems, and methods for use in dynamic stabilization of syndesmotic joints (i.e., constrained, controlled movement and / or force in a joint). While the implants, systems, and methods disclosed herein (and described in detail below) are particularly advantageous for use in the distal tibiofibular ligamentous attachment and dynamic stabilization of the distal tibiofibular ligamentous attachment, the implants and methods can be configured and utilized for use in any joint, particularly any syndesmotic joint. Dynamically stabilizing syndesmotic implants, systems, and methods offer the advantage of relatively short suture / tether lengths that do not completely penetrate the bone of the syndesmotic joint. For example, with respect to dynamic stabilization of the distal tibiofibular ligamentous attachment, the dynamically stabilizing syndesmotic implants, systems, and methods are advantageously configured so that the implant does not extend into the medial portion of the tibia. Therefore, the sutures / tethers of the dynamically stabilizing syndesmotic implants, systems, and methods are advantageously more resistant to elongation, both from a strength / load perspective and a time perspective.

[0010] Dynamically stabilizing ligamentous attachment implants, systems, and methods also minimize the amount of bone removal (e.g., bone drilling) of the bone at the ligamentous attachment joint for through-holes to accommodate the sutures / tethers of the system. For example, with respect to dynamic stabilization of the distal tibiofibular attachment, dynamically stabilizing ligamentous attachment implants, systems, and methods advantageously limit the amount of bone removal from the tibia. Thus, the sutures / tethers of the dynamically stabilizing ligamentous attachment implants, systems, and methods advantageously minimize the number of bone openings and the total amount of bone removal / disturbance that may not be completely filled / obturated by the sutures / tethers of the implants, systems, and methods.

[0011] In one aspect, the present disclosure provides an implant system for dynamic stabilization of a syndesmotic joint, comprising: a soft bone anchor; a dynamic bone anchor; and a tether coupled to and extending between the soft bone anchor and the dynamic bone anchor. First and second retaining portions of the tether are knotlessly coupled to the dynamic bone anchor, and an intermediate portion of the tether extending between the first and second retaining portions passes through the soft bone anchor. An inner portion of the intermediate portion extends to and is elastically coupled to the dynamic bone anchor.

[0012] In some embodiments, the soft anchor is configured to deform to a compact, expanded shape due to tension in the intermediate portion of the tether. In some embodiments, the soft anchor is configured as a suture anchor. In some embodiments, the dynamic bone anchor comprises a head portion at one end and a body portion at an opposing end, the head portion and the body portion being cannulated.

[0013] In some embodiments, the first and second retention portions pass through cannulations in the head and body portions and exit through openings in the head portion. In some such embodiments, the dynamic bone anchor further comprises an elastic bumper and a movable tether post within the cannulation in the body portion. In some such embodiments, the elastic bumper and tether post are cannulated, and the first and second retention portions pass through the cannulations in the elastic bumper and tether post. In some such embodiments, the elastic bumper is held between the end of the body portion and the tether post. In some such embodiments, an inner portion of the intermediate portion extends around a portion of the tether post and passes through the cannulation in the elastic bumper. In some such embodiments, an inner portion of the intermediate portion of the tether forms a loop extending from the soft bone anchor.

[0014] In some embodiments, the first retention portion extends through the cannulation in the head portion, exits the first opening in the head portion, over a portion of the outer top side, down to the second opening in the head portion, into the cannulation, and back up through the fourth opening in the head portion. In some such embodiments, the second retention portion extends through the cannulation in the head portion, exits the second opening in the head portion, over a portion of the outer top side, down to the first opening in the head portion, into the cannulation, and back up through the third opening in the head portion. In some such embodiments, the portions of the first retention portion and the second retention portion that extend over the portion of the outer top side form first and second retention loops, respectively, that are located beyond the outer top side of the head portion. In some such embodiments, the portions of the first retention portion and the second retention portion that extend from the fourth opening and the third opening pass under at least one of the first retention loop and the second retention loop, respectively.

[0015] In some embodiments, the first and second openings open to respective lateral sides of the head portion, and in some such embodiments, the third and fourth openings are bounded by the top side of the head portion.

[0016] In some embodiments, the enlarged upper portion of the head portion has a rectangular cross-sectional shape, hi some such embodiments, the enlarged upper portion of the head portion comprises first and second lateral side portions that extend laterally beyond the base portion of the head portion and have tapered lower surfaces, and third and fourth lateral side portions that extend between the first and second sides and do not extend laterally beyond the base portion.

[0017] In some embodiments, the tether is a suture.

[0018] In some such embodiments, the system further comprises an insertion and tensioning instrument, wherein the soft bone anchor is removably retained on a free end of the first portion of the instrument, and the dynamic bone anchor is removably retained on at least one of the first portion and the second portion of the instrument.

[0019] In some embodiments, the first portion is removably coupled to the second portion, hi some such embodiments, the first portion is removably coupled to the second portion via a laterally disposed dovetail coupling arrangement.

[0020] In some embodiments, the first portion comprises a base portion detachably coupled to a distal portion of the second portion and a longitudinally elongated inserter portion extending longitudinally from the base portion to a free end. In some such embodiments, the free end of the inserter portion is forked. In some such embodiments, the forked free end of the inserter portion comprises a pair of tines with a base retaining portion extending therebetween, and a pair of grooves extending longitudinally proximally from the base retaining portion of the forked free end. In some such embodiments, an end of the soft bone anchor extends over the grooves, and an inner portion of the soft bone anchor extends over the base retaining portion between the pair of tines. In some such embodiments, an intermediate portion of the tether extends longitudinally from the soft bone anchor at the free end of the inserter portion along the inserter portion to the dynamic bone anchor.

[0021] In some embodiments, the head portion of the dynamic bone anchor is retained in a recess in the distal portion of the second portion. In some such embodiments, when the first portion is removably coupled to the second portion, the base portion of the first portion extends partially over the recess on the distal portion of the second portion, and when the first portion is removably coupled to the second portion to removably retain the dynamic bone anchor on the instrument, at least a portion of the head portion is disposed between the recess and the base portion.

[0022] In some embodiments, the second portion of the instrument comprises a main housing portion and a tensioning handle portion manually movably coupled to the main housing. In some such embodiments, the first and second retention portions of the tether are removably retained in the tensioning handle portion, and when the dynamic bone anchor is pulled relative to the instrument, rotation of the tensioning handle portion relative to the main housing portion pulls the tether through the dynamic bone anchor and the soft bone anchor, shortening the length of and / or tensioning an intermediate portion extending between the dynamic bone anchor and the soft bone anchor. In some such embodiments, the first and second retention portions of the tether are removably retained in the tensioning handle portion, and rotation of the tensioning handle portion relative to the main housing portion pulls the tether through the main housing portion, pulling the dynamic bone anchor relative to the instrument.

[0023] In some embodiments, the tensioning handle portion is longitudinally slidably coupled to the main housing portion, and longitudinal movement of the tensioning handle portion in a first direction extending away from the distal end portion of the second portion of the instrument pulls the tether through the main housing portion and tensions the dynamic bone anchor relative to the distal end portion.

[0024] In some embodiments, the tensioning handle portion is longitudinally slidably coupled to the main housing portion, such that when the dynamic bone anchor is pulled relative to the distal portion, longitudinal movement of the tensioning handle portion in a first longitudinal direction extending away from the distal portion of the second portion of the instrument pulls the tether through the dynamic bone anchor and the soft bone anchor, shortening the length of and / or tensioning an intermediate portion extending between the dynamic bone anchor and the soft bone anchor. In some such embodiments, the second portion of the instrument further comprises at least one ratchet member having at least one tooth and coupled to the main housing portion, the at least one ratchet member being resiliently biased against the externally threaded shaft portion of the tensioning handle portion, such that the tensioning handle portion is rotatably coupled to and longitudinally slidably coupled to the main housing portion. In some such embodiments, the at least one ratchet member prevents the tensioning handle portion from slidably moving longitudinally relative to the main housing portion along a second longitudinal direction opposite the first longitudinal direction.

[0025] In some such embodiments, the first and second retaining portions of the tether comprise opposing ends of the tether, hi some such embodiments, the first and second retaining portions of the tether each extend through the head portion of the dynamic bone anchor and beyond the outer upper portion of the head portion.

[0026] In some embodiments, the first retaining portion of the tether forms a first loop portion extending from the head portion of the dynamic bone anchor past the outer upper portion of the head portion and a first end extending from the head portion past the outer upper portion, and the second retaining portion of the tether forms a second loop portion extending from the head portion past the outer upper portion and a second end extending from the head portion past the outer upper portion. In some such embodiments, the first end of the first retaining portion of the tether extends over the outer upper portion through the first and second loop portions, and the second end of the first retaining portion of the tether extends over the outer upper portion through the first and second loop portions, knotlessly coupling the first and second retaining portions to the dynamic bone anchor. In some such embodiments, a first retention portion of the tether extends from the internal passageway in the head portion through a first opening in the head portion, over a portion of the outer top, through a second opening in the head portion, and back into the internal passageway to form a first loop portion; the first retention portion of the tether extends from the second opening through the internal passageway, past the outer top, and through a third opening in the head portion to form a first end; in some such embodiments, a second retention portion of the tether extends from the internal passageway through the second opening in the head portion, over a portion of the outer top, and back into the internal passageway through the first opening in the head portion to form a second loop portion; and the second retention portion of the tether extends from the first opening through the internal passageway, past the outer top, and through a fourth opening in the head portion to form a second end.

[0027] In some embodiments, the first and second loop portions extend through a tip portion of the second portion, through a portion of the main housing portion, and to the carrier portion of the tensioning handle portion, where the first and second loop portions are removably coupled to the carrier portion. In some such embodiments, movement of the tensioning handle portion relative to the main housing portion in a first direction away from the tip portion results in movement of the carrier portion in a first direction away from the tip portion, whereby the first and second loop portions are pulled through the main housing portion and the head portion of the dynamic bone anchor relative to the tip portion. In some such embodiments, movement of the tensioning handle portion relative to the main housing portion in a first direction away from the tip portion results in movement of the carrier portion in a first direction away from the tip portion, whereby when the dynamic bone anchor is pulled relative to the tip portion, the first and second loop portions expand, pulling the tether through the dynamic bone anchor and the soft bone anchor, shortening the length of and / or tensioning an intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

[0028] In some embodiments, the carrier portion includes a sleeve portion within the main housing portion having at least one opening and a post portion within the main housing portion having at least one post extending in a first direction away from the tip portion, the sleeve portion and the post portion being biased in a first relative configuration, with the at least one post extending through the at least one opening and past the engagement side of the sleeve portion. In some such embodiments, the first loop portion and the second loop portion extend around the at least one post and over the engagement side of the sleeve portion. In some such embodiments, the carrier portion further includes a release member exposed at a rear end of the tension handle portion and extending to the post portion, the tension handle portion being configured such that movement of the release member in a second direction opposite the first direction moves the post portion in the second direction relative to the sleeve portion such that the at least one post is positioned under the engagement side of the sleeve portion to release the first loop portion and the second loop portion from the at least one post.

[0029] In some embodiments, the first and second retention portions are coupled to a tensioning handle portion, and the instrument is configured such that movement of the tensioning handle portion relative to the main housing portion tensions the first and second retention portions. In some such embodiments, the instrument is configured such that tensioning the first and second retention portions via the tensioning handle portion pulls the head portion of the dynamic bone anchor against the distal portion of the second portion, tensioning the tether via the dynamic bone anchor and the soft bone anchor, shortening the length of and tensioning an intermediate portion extending between the dynamic bone anchor and the soft bone anchor. In some such embodiments, the distal portion of the second portion comprises a tip member longitudinally movably coupled to a front portion of the main housing portion, and the second portion further comprises an elastic member configured to elastically resist movement of the tip portion relative to the main housing portion toward the rear portion of the main housing portion when the dynamic bone anchor contacts the tip portion and the first and second retention portions are tensioned by the tensioning handle portion. In some such embodiments, the second portion further comprises a tension indicator longitudinally movably coupled to the main housing portion, the tension indicator including an indicator portion visually exposed and having a visual indication adjacent a reference portion of the main housing portion, the tension indicator mating with the tip member such that resiliently resisted movement of the tip portion toward its rear relative to the main housing portion causes the visual indication to move longitudinally relative to the reference portion to provide a visual indication of the tension in the first retention portion and the second retention portion, thereby providing a visual indication of the tension in an intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

[0030] In some embodiments, the second portion further comprises a tension indicator longitudinally movably coupled to the main housing portion, the tension indicator including an indicator portion visually exposed and having a visual indication adjacent a reference portion of the main housing portion, wherein tension in the first retention portion and the second retention portion exceeding a threshold causes the visual indication to move longitudinally relative to the reference portion to provide a visual indication of the tension in the first retention portion and the second retention portion, thereby providing a visual indication of the tension in an intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

[0031] In some such embodiments, the first and second loop portions of the first and second retention portions, respectively, are coupled to the tensioning handle portion, and the instrument is configured such that movement of the tensioning handle portion relative to the main housing portion tensions the first and second retention portions. In some such embodiments, the first and second ends of the first and second retention portions, respectively, are fixed to the instrument. In some such embodiments, the first and second ends are fixed to the instrument within the main housing portion and are not fixed to the tensioning handle portion.

[0032] In some embodiments, the rearward end of the tension handle portion comprises a handle knob portion having a ring portion.

[0033] In one aspect, the present disclosure provides a method for dynamically stabilizing a distal tibiofibular joint. The method includes obtaining any one of the implant systems described above and implanting a soft bone anchor through the lateral fibula into a cavity in the lateral cortex of the fibula, with an intermediate portion extending between the lateral fibula and the lateral cortex. The method also includes tensioning the first and second retention portions to at least partially retract the dynamic bone anchor into the lateral cortex and induce tension in the intermediate portion extending between the dynamic and soft bone anchors, thereby inducing tension across the distal tibiofibular joint.

[0034] In some such embodiments, implanting the soft bone anchor through the lateral fibula and into the lateral cortical cavity comprises implanting the soft bone anchor through the lateral fibula and into the lateral cortical cavity via manual manipulation of any one of the insertion and tensioning instruments described above.

[0035] In some such embodiments, the method includes implanting the soft bone anchor through the lateral fibula into the lateral cortical cavity, followed by detaching the first portion from the second portion of the device and separating the first portion from the soft bone anchor.

[0036] In some such embodiments, applying tension to the first and second retention portions includes manually moving a tension handle portion and a main housing portion of any one of the insertion and tension adjustment instruments described above relative to one another.

[0037] In some embodiments, applying tension to the first and second retention portions moves a visual indicator of the instrument relative to a reference portion of the instrument to provide a visual indication of the tension in the first and second retention portions, thereby providing a visual indication of the tension in the intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

[0038] These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of the various aspects of the disclosure taken in conjunction with the accompanying drawings.

[0039] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description, serve to explain the principles of the present disclosure. It is emphasized that, according to standard industry practice, various features have not been drawn to scale. In fact, dimensions of various features may be arbitrarily increased or decreased for clarity of discussion. The drawings are for the purpose of illustrating preferred embodiments and are not to be construed as limiting the disclosure. [Brief explanation of the drawings]

[0040] [Figure 1] FIG. 1 is a perspective view of an exemplary dynamic joint stabilization implant system according to one aspect of the present disclosure; [Figure 2] FIG. 2 is another side perspective view of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 3] FIG. 2 is a top view of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 4] FIG. 2 is a side view of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 5] FIG. 2 is another perspective view of the implant system of FIG. 1 with a pair of suture loops of the system in an expanded position, according to one embodiment of the present disclosure. [Figure 6] FIG. 2 is a side cross-sectional exploded view of a portion of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 7] FIG. 2 is a perspective cross-sectional view of an anchor portion of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 8] FIG. 2 is an exploded perspective view of an anchor portion of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 9] FIG. 2 is a side exploded view of a portion of the anchor portion of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 10] FIG. 2 is a side cross-sectional view of a portion of the anchor portion of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 11] FIG. 2 is a perspective view of a head portion of the anchor portion of the implant system of FIG. 1 according to one embodiment of the present disclosure; [Figure 12]FIG. 2 is another perspective view of the head portion of the anchor portion of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 13] 2 is a side exploded view of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 14] 14 is a cross-sectional side exploded view of the implant system of FIG. 1 shown in FIG. 13 according to one embodiment of the present disclosure. [Figure 15] 14 is a cross-sectional view of the head portion of the anchor portion of the implant system of FIG. 13; [Figure 16] 14 is another cross-sectional view of the head portion of the anchor portion of the implant system of FIG. 13; [Figure 17] FIG. 2 is a side view of the implant system of FIG. 1 with a pair of suture loops of the system in an expanded position, according to one embodiment of the present disclosure. [Figure 18] 18 is a cross-sectional view of the suture loop portion of the anchor portion of the implant system of FIG. 1 shown in FIG. 17; [Figure 19] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 20] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 21] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 22] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 23] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 24] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 25] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 26] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 27] FIG. 2 is a perspective view of an insertion and tensioning tool for implanting and utilizing the implant system of FIG. 1; [Figure 28] Perspective view showing the distal tibiofibular syndesmosis dynamically stabilized via an implant [Figure 29] FIG. 1 is a perspective view of another exemplary dynamic joint stabilization implant system with a pair of suture loops of a suture portion of the implant system in a collapsed position, according to one aspect of the present disclosure; [Figure 30] FIG. 30 is another perspective view of the implant system of FIG. 29 according to one embodiment of the present disclosure. [Figure 31] FIG. 30 is a top view of the implant system of FIG. 29, according to one embodiment of the present disclosure. [Figure 32] FIG. 30 is a side view of the implant system of FIG. 29 according to an embodiment of the present disclosure. [Figure 33] 2 is an end view of the implant system of FIG. 1 according to one embodiment of the present disclosure. [Figure 34] 30 is a perspective cross-sectional view of the anchor portion of the implant system of FIG. 29 according to one embodiment of the present disclosure; [Figure 35] FIG. 30 is an end perspective view showing the anchor portion of the implant system of FIG. 29 with its head portion partially visible, according to one embodiment of the present disclosure; [Figure 36] FIG. 30 is a side perspective view showing the anchor portion of the implant system of FIG. 29 with a head portion thereof partially visible, according to one embodiment of the present disclosure; [Figure 37] 30 shows another end perspective view of the anchor portion of the implant system of FIG. 29 according to one embodiment of the present disclosure; [Figure 38] FIG. 30 is an end view of the anchor portion of the implant system of FIG. 29 without the suture portion of the implant system, according to one embodiment of the present disclosure. [Figure 39] FIG. 30 is another perspective view of the implant system of FIG. 29, with a pair of suture loops of the suture portion of the implant system in an expanded pre-loaded position, according to one embodiment of the present disclosure. [Figure 40]Perspective view showing an insertion and tension adjustment instrument for another exemplary implant system for implanting and using the implant systems of FIGS. 29 to 39 [Figure 41] Another perspective view showing the insertion and tension adjustment instrument of FIG. 40 [Figure 42] Exploded perspective view showing a part of the insertion and tension adjustment instrument of FIG. 40 [Figure 43] Exploded perspective view showing another part of the insertion and tension adjustment instrument of FIG. 40 [Figure 44] Exploded perspective view showing another part of the insertion and tension adjustment instrument of FIG. 40 [Figure 45] Exploded perspective view showing another part of the insertion and tension adjustment instrument of FIG. 40 [Figure 46] Perspective view showing the implant systems of FIGS. 29 to 39 mounted on the insertion and tension adjustment instrument of FIG. 40 [Figure 47] Another perspective view showing the implant systems of FIGS. 29 to 39 mounted on the insertion and tension adjustment instrument of FIG. 40 [Figure 48] Perspective view showing the first part and the second part of the insertion and tension adjustment instrument of FIG. 40 [Figure 49] Another perspective view showing the first part and the second part of the insertion and tension adjustment instrument of FIG. 40 [Figure 50] Perspective view showing the first part of the insertion and tension adjustment instrument of FIG. 40 [Figure 51] Perspective view showing the front part of the second part of the insertion and tension adjustment instrument of FIG. 40 [Figure 52] Perspective view showing a state where a part of the housing of the implant systems of FIGS. 29 to 39 mounted on the second part of the insertion and tension adjustment instrument of FIG. 40 is removed [Figure 53] Top view showing a state where a part of the housing of the implant systems of FIGS. 29 to 39 mounted on the second part of the insertion and tension adjustment instrument of FIG. 40 is removed [Figure 54]40. FIG. 41 is a top view of the implant system of FIGS. 29-39 attached to the second portion of the insertion and tensioning instrument with a portion of the housing removed and a tension handle portion thereof in a first operating position. [Figure 55] 40. A perspective view of the implant system of FIGS. 29-39 attached to the second portion of the insertion and tensioning instrument with a portion of the housing removed and a tensioning handle portion in a first operating position. [Figure 56] 41 is a top view of the tension handle portion of the implant system of FIGS. 29-39 attached to the second portion of the insertion and tensioning instrument of FIG. 40 in a first operating position; [Figure 57] FIG. 41 is a top view of the implant system of FIGS. 29-39 attached to a second portion of the insertion and tensioning tool of FIG. 40 with the tension handle portion in a second actuation position applying a greater tension to the implant system than in the first actuation position of the insertion and tensioning tool and exceeding a predetermined threshold. [Figure 58] FIG. 41 is a top view of the implant system of FIGS. 29-39 attached to a second portion of the insertion and tensioning instrument of FIG. 40 with a portion of the housing removed and the tensioning handle portion in a second actuated position, applying a tension above a predetermined threshold. [Figure 59] 40. FIG. 41 is a perspective view of the implant system of FIGS. 29-39 attached to a second portion of the insertion and tensioning instrument of FIG. 40 with a portion of the housing removed and the tensioning handle portion in a second, actuated position, applying a tension above a predetermined threshold. [Figure 60] 40. FIG. 41 is a perspective view of the implant system of FIGS. 29-39 separated from the second portion of the insertion and tensioning instrument of FIG. 40 with a portion of the housing removed. [Figure 61] FIG. 41 is a top cross-sectional view of the rear of the second portion of the insertion and tensioning tool of FIG. 40 with a portion of the housing removed; [Figure 62] FIG. 41 is a top view of the rear of the second portion of the insertion and tensioning tool of FIG. 40 with a portion of the housing removed to reveal the threaded shaft portion; DETAILED DESCRIPTION OF THE INVENTION

[0041] Generally, disclosed herein are devices and systems for achieving bone stabilization. Additionally, methods of using the devices and systems for achieving ligament fixation are described.

[0042] In this detailed description and the claims that follow, the terms proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior, and inferior are defined according to standard usage to designate specific portions or locations of a bone or implant, following reference terms that indicate the relative placement or orientation of natural bone. For example, "proximal" refers to the portion of the device or implant closest to the body, and "distal" refers to the portion of the device or implant farthest from the body. As terms relating to direction, "anterior" means toward the front of the body, "posterior" means toward the back of the body, "medial" means toward the midline of the body, "lateral" means toward the side of the body or away from the midline of the body, "superior" means above another object or structure, and "infrior" means toward below another object or structure.

[0043] Similarly, positions or orientations may be used herein with reference to anatomical structures or surfaces. For example, as current implants, devices, instruments, and methods are described herein with reference to use with the ankle / leg bones, the bones of the foot, ankle, and lower leg may be used to describe the surfaces, positions, directions, or orientations of the implants, devices, instruments, and methods. Furthermore, the implants, devices, instruments, and methods disclosed herein, as well as their aspects, components, features, etc., are described with respect to one side of the body for purposes of brevity. However, because the human body is relatively symmetrical or mirror-like about a line of symmetry (the midline), it is expressly contemplated that the implants, devices, instruments, and methods described and / or illustrated herein, as well as their aspects, components, features, etc., may be changed, varied, modified, reconfigured, or otherwise altered for use with or in association with another side of the body for the same or similar purposes without departing from the spirit and scope of the present disclosure. For example, implants, devices, instruments, and methods, and aspects, components, features, etc., described herein with respect to the right leg can be mirrored to function similarly in the left leg. Additionally, while the implants, devices, instruments, and methods, and aspects, components, features, etc., disclosed herein are described with respect to the leg for purposes of brevity, it will be understood that the implants, devices, instruments, and methods can also be used in other bones of the body having similar structures.

[0044] Referring to the drawings, wherein like reference numerals are used throughout the several views to indicate like or similar components, and with particular reference to Figures 1-17, an implant system 100 is illustrated. The implant system 100 can be configured, for example, to post-operatively heal syndesmotic ligaments and / or stabilize a syndesmotic joint, including, but not limited to, the distal tibiofibular syndesmotic joint. The implant system 100 can be configured to selectively restrict movement (e.g., in any direction) between two or more syndesmotic bones to heal one or more syndesmotic bones and / or stabilize a syndesmotic joint extending therebetween. The implant system 100 allows only a limited amount of relative movement / motion between the bones in which it is implanted or placed, and such relative movement / motion and / or forces acting between the bones are controlled (e.g., resisted / inhibited and / or encouraged / enhanced).

[0045] The components and portions of the implant system 100 can be formed from, for example, titanium, stainless steel, polymers, polyesters, polypropylene, ultra-high molecular weight polyethylene (UHMWPE), thermoplastics (e.g., thermoplastic urethanes), bio-resorbable materials, or any other biocompatible materials, such that the implant system 100 is configured to be implanted in a mammalian patient, such as a human patient.

[0046] As shown in FIGS. 1-18 , implant system 100 enables dynamic stabilization / fixation of a joint between two bones (either naturally distinct bones or bone portions / fragments), such as bones at a syndesmotic joint (e.g., the distal fibula and tibia at the distal tibiofibular syndesmotic joint). Implant system 100 is configured to provide dynamic stabilization through limited and / or controlled relative movement between the bones. The region of allowed, limited, and controlled movement provided by implant system 100 can be located in the space or gap between adjacent bones or bone segments (e.g., the syndesmotic joint / space between the distal fibula and distal tibia).

[0047] As shown in FIGS. 1-18 , the implant system 100 includes a flexible suture or tether 150 extending from and through a portion of the dynamic bone anchor 110 as a restraining and / or tensioning member. As shown in FIGS. 1-18 , an inner portion of the tether 150 extending from the dynamic bone anchor 110 passes through or is otherwise coupled to the bone anchor 130. The dynamic bone anchor 110 and the bone anchor 130 are configured to couple to and be at least partially implanted into a first bone and a second bone, respectively, such as bones of a syndesmotic joint (e.g., the distal fibula and tibia, respectively, of the distal tibiofibular syndesmotic joint). The tether 150 passes between and is coupled to the dynamic bone anchor 110 and the bone anchor 130.

[0048] The bone anchor 130 may be coupled to an intermediate loop portion 156 of a tether 150 extending from the dynamic bone anchor 110. The inner loop portion 158 of the intermediate loop portion 156 and the first and second retention portions 152, 154 of the tether 150 are knotlessly coupled to the dynamic bone anchor 110 to prevent the tether 150 from moving through the dynamic bone anchor 110 in a direction that would expand the loop portion, as will be further described below. As will also be described below, the inner portion 158 of the intermediate loop portion 156 of the tether 150 is held to the dynamic bone anchor 110 via an elastic or resilient member that dynamically controls the movement of the inner portion in a direction that would expand the intermediate loop portion 156. In this way, the implant system 100 provides dynamic stabilization of a joint between a first bone and a second bone.

[0049] 1-18 , the intermediate loop portion 156 of the tether 150 can pass through the soft bone anchor 130 multiple times. For example, a first loop portion 162 of the intermediate loop portion 156 extending from a first retaining portion 152 (within the bone anchor 130) can extend through a portion of the soft bone anchor 130 to the inner loop portion 158, and a second loop portion 164 of the intermediate loop portion 156 extending from a second retaining portion 154 (within the bone anchor 130) can extend through a second portion of the soft bone anchor 130 to the inner loop portion 158. The first and second portions of the soft bone anchor 130 can be substantially the same portion of the soft bone anchor 130, or the portions can overlap longitudinally / axially or can be spaced apart from one another.

[0050] In some embodiments, the first loop portion 162 and the second loop portion 164 of the intermediate loop portion 156 of the tether 150 may extend in different longitudinal / axial directions through the soft bone anchor 130 to the inner loop portion 158. For example, as shown in FIGS. 1-18 , the first loop portion 162 may extend from the first retaining portion 152 to a first longitudinal / axial portion of the soft bone anchor 130, through the soft bone anchor 130, and to a second longitudinal / axial portion of the soft bone anchor 130. The second loop portion 164 may extend from the second retaining portion 154 to a third longitudinal / axial portion of the soft bone anchor 130 that is proximal to the second longitudinal / axial portion and distal to the first longitudinal / axial portion, and through the soft bone anchor 130 to a fourth longitudinal / axial portion of the soft bone anchor 130 that is proximal to the first longitudinal / axial portion and distal to the second longitudinal / axial portion. In this manner, the first loop portion 162 and the second loop portion 164 may overlap to extend longitudinally / axially within the soft bone anchor 130.

[0051] In some embodiments, the first and fourth portions of the soft bone anchor 130 are proximal to a first longitudinal / axial end of the soft anchor 130 and distal to a second longitudinal / axial end of the soft anchor 130. The second and third portions of the soft bone anchor 130 are proximal to the second longitudinal / axial end and distal to the first longitudinal / axial end. In some embodiments, the first and fourth portions of the soft anchor 130 are the same portion of the soft anchor 130 or are substantially adjacent to each other. The second and third portions of the soft anchor 130 are the same portion of the soft anchor 130 or are substantially adjacent to each other. As will be further described below, the inner loop portion 158 extending between the first loop portion and the second loop portion 162 may extend over / through / loop the tether post 120 that extends to the dynamic bone anchor 110 and is movably held within a cavity / lumen / cannulation in the anchor body 112 of the dynamic bone anchor 110. Movement of the tether post 120 within the anchor body 112 lengthens or shortens the size / length of the intermediate loop portion 156, thereby adjusting the distance between the soft bone anchor 130 and the dynamic bone anchor 110. Note that the tether 150 may be slidably coupled to / through the soft bone anchor 130, allowing the soft bone anchor 130 to slide along the intermediate loop portion 156 of the tether 150 as the soft bone anchor 130 is adjusted in size / length.

[0052] Tether 150 can be configured to mimic the function, location, and / or length of, for example, an interosseous ligament. Tether 150 can be a thin, long, and substantially freely manually manipulated flexible structure or configuration, such as a suture, strand, cable, or string-like configuration. Tether 150 can be, for example, a biomedical suture or tether (e.g., a stranded cerclage cable) or similar construct. In some embodiments, tether 150 can be formed of, for example, polymer, polyester, polypropylene, or UHMWPE suture, strands or filaments, braids thereof, or similar materials known to those skilled in the art, as known to those skilled in the art. Tether 150 can be, for example, a suture (e.g., a braided suture), such as a single cross-sectional strand of suture or multiple loops of suture. For example, tether 150 may be a co-braid suture of UHMWPE and polypropylene.

[0053] The soft deformable anchor 130 may be solid or porous. For example, the soft deformable anchor 130 may be molded using a solid material. As another example, the soft deformable anchor 130 may be woven from one or more threads, fibers, or filaments. In some embodiments, the soft deformable anchor 130 may be formed by one or more machining, additive manufacturing, and / or extrusion processes. The soft deformable anchor 130 may be a unitary structure or may be formed from multiple members or portions (and / or materials). The soft deformable anchor 130 may be formed or constructed from any biocompatible material. For example, the soft deformable anchor 130 may be formed or constructed from polyester, polyethylene (e.g., ultra-high molecular weight polyethylene), polypropylene, nylon (e.g., polyamide), silk, polyglycolic acid (PGA), polydioxanone (PDO), polylactic acid (PLA), polylactic-co-glycolic acid (PLGA), stainless steel, or a combination thereof. In one example, the soft deformable anchor 130 is made of polyester.

[0054] Tether 150 may or may not be resiliently axially / longitudinally stretchable or deformable. In some embodiments, tether 150 may have one or more openings or gaps along its length configured to allow another tether or suture (or the like) to pass therethrough. In this manner, tether 150 functions as a tether or suture passer to pass another tether or suture to and / or through at least a portion of implant system 100.

[0055] As described above, the intermediate or inner loop portion 158 of the tether 150 extends through the bone anchor 130. As shown in FIGS. 1-18 , in the illustrated embodiment, the bone anchor 130 is a soft, deformable bone anchor, such as an all-soft suture anchor (ASA). For example, the bone anchor 130 may be a tube, sleeve, or tape made (e.g., woven) of suture or tether material, into which the tether 150 is woven. In other embodiments, the tube, sleeve, or tape may be solid and / or formed of a resilient material, such as an elastomer.

[0056] The soft deformable anchor 130 may be elongated along its longitudinal direction in a neutral state. In some embodiments, the soft deformable anchor 130 may define a longitudinal length in the range of 5 mm to 35 mm. The soft deformable anchor 130 may have a larger size proportion than the tether 150. For example, the width or diameter of the soft deformable anchor 130 may be larger than the width or diameter of the tether 150.

[0057] In some embodiments, the soft deformable anchor 130 may be formed with an annular sidewall defining an inner cavity and first and second longitudinal ends. This may result in the soft deformable anchor 130 being hollow. The size of the inner cavity may be larger than the tether 150 so that the tether 150 can pass through the inner cavity. The inner cavity may extend through the soft deformable anchor 130, and the inner cavity may be open or accessible at one or both of the longitudinal ends. Alternatively, the longitudinal ends may be closed or sealed. In some embodiments, the soft deformable anchor 130 may not define an inner cavity or may not include an inner cavity.

[0058] The soft deformable anchor 130 is flexible, collapsible, deformable, bendable, stretchable, or otherwise repositionable in its overall shape. In its natural, neutral, or undeformed state, the soft deformable anchor 130 may extend substantially linearly or generally arcuately along its longitudinal axis, as shown in FIGS. 1-18 . The soft deformable anchor 130 is configured such that tension on a portion of the suture extending from the soft deformable anchor 130 in a lateral direction angled from the longitudinal axis (e.g., substantially perpendicular from the outer surface of the anchor 130) causes the soft deformable anchor 130 to deform into a curved, folded, compressed, or “bunched” shape, as shown in FIG. 28 . The tether 150 can extend one or more times through a side or portion of the soft deformable anchor 130, which, when tensioned laterally (at least generally), causes the anchor 130 to deform into tightly undulating, arced, folded, "C" or "U" and / or "V" shapes, as shown in Figure 28. For example, in the deployed or neutral state, the anchor 130 can be bent and / or pulled (e.g., via the tether 150) to assume a sharply arched U or V shape (e.g., defined by a relatively small radius), as shown in Figures 19, 20, and 23. As shown in FIG. 28, the tether 150 can be tensioned laterally, causing the tether 150 to deform, compress, or pull together the sides or portions of the soft deformable anchor 130, causing the deformable anchor 130, or portions thereof, to bunch, roll, or otherwise be more closely spaced in a sharply arched shape, defining a larger width, lateral / cross-sectional dimension, or other size.In this manner, the soft deformable bone anchor 130 is inserted into an appropriately sized / shaped hole, tunnel, or cavity in bone, and is configured such that when the suture portion extending from the anchor 130 is tensioned / pulled in at least a general lateral direction, the anchor 130 tightens and expands in at least one dimension, compressing the anchor 130 against the side walls of the bone hole / cavity and forming a dense "ball" that is forced into the hole / tunnel / cavity and thereby secured therein. As described further below, in some exemplary methods, a hole / tunnel / cavity can be formed in the distal tibia (which may be formed by drilling a hole in the distal tibia) for dynamic stabilization of the distal tibiofibular ligament. This allows the anchor 130 to be a tibial anchor. It should be noted that the configuration of anchor 130 allows anchor 130 to be placed in a bone hole / tunnel / cavity of substantially smaller diameter (e.g., 1-3 mm), thereby allowing bone preservation, e.g., greater bone preservation.

[0059] As described above and shown in FIGS. 1-18 , the implant system 100 includes a dynamic bone anchor 110 having an inner loop portion 158 of an intermediate loop portion 156 and first and second retention portions 152, 154 of a flexible suture or tether 150 extending therefrom. As also shown in FIGS. 1-18 , an inner portion of the tether 150 extending from the dynamic bone anchor 110 passes through or is otherwise coupled to the bone anchor 130. Also, as described above, the dynamic bone anchor 110 is configured to couple to and be at least partially implanted within a second bone, such as a bone of a syndesmotic joint (e.g., the distal fibula of a distal tibiofibular syndesmotic joint), with the tether 150 extending between and coupled to the dynamic bone anchor 110 and the bone anchor 130.

[0060] 1-18 , in some embodiments, the dynamic bone anchor 110 includes an anchor body 112 and a head portion 114. The anchor body 112 may be disposed at and / or define a first longitudinal / axial end or end portion 111 of the bone anchor 110. The head portion 114 may be disposed at and / or define a second longitudinal / axial end or end portion 113 of the bone anchor 110. In some embodiments, the dynamic bone anchor 110 may be substantially or generally cylindrical overall.

[0061] As shown in Figures 6, 7, 10, and 14, anchor body 112 can include an inner cavity / lumen / cannulation / opening extending longitudinally / axially therethrough. The inner cavity of anchor body 112 opens to first end 111 of bone anchor 110 through tether opening 115 in end wall 116 of anchor body 112. Tether opening 115 is configured to allow inner loop portion 158 of intermediate loop portion 156 and first retention portion 152 and second retention portion 154 of tether 150 to extend therethrough, as shown in Figures 6, 7, 10, and 14.

[0062] As shown in FIGS. 6-10, 13, and 14, the anchor body 112 includes a resiliently / elastically deformable bumper 118 and a tether post 120 movably housed within the internal cavity of the bumper 118, since the bumper 118 is larger than the tether opening 115. The tether post 120 is movable at least axially / longitudinally within the internal cavity of the anchor body 112. The bumper 118 is compressible and extensible at least axially / longitudinally within the internal cavity of the anchor body 112. As such, as the bumper 118 compresses and expands in the axial / longitudinal direction, at least a portion of the bumper 118 moves axially / longitudinally within the internal cavity, and therefore the bumper 118 is considered to be movable at least axially / longitudinally within the internal cavity. The bumper 118 and / or the tether post 120 may be rotatably held within the internal cavity of the anchor body 112.

[0063] The bumper 118 is axially / longitudinally disposed and sandwiched between the end wall 116 of the anchor body 112 and the tether post 120, and is therefore axially / longitudinally compressible and extensible therebetween. The tether post 120 may abut an axial / longitudinal end of the bumper 118, and the other axial / longitudinal end of the bumper 118 may abut the end wall 116. As shown in FIGS. 6-10, 13, and 14, the bumper 118 may have a cavity / lumen / cannulation / opening extending therethrough. The cannulation of the bumper 118 is configured to allow the intermediate loop portion 156 and the first and second retention portions 152 and 154 of the tether 150 to extend axially / longitudinally therethrough to and pass through the tether post 120.

[0064] In some embodiments, bumper 118 may be a resilient or elastic spring-like member. Bumper 118 may be composed of one or more resiliently deformable members or materials. For example, bumper 118 may be one or more springs (e.g., Belleville or coil springs) or resiliently compressible disks or tubes, or combinations thereof. For example, bumper 118 may include a resiliently compressible disk (e.g., an elastomeric, polymeric, polyurethane, or polyethylene disk, etc.), a tube (e.g., a polyurethane tube), or a coil spring. In some embodiments, bumper 118 comprises at least one urethane tube or similar member, such as at least one polycarbonate urethane (PCU) tube or similar member, or at least one thermoplastic polyurethane (TPU) tube or similar member.

[0065] Bumper 118 is configured to resiliently deform to tension inner loop portion 158 of tether 150 pulling anchor portion 130 and dynamic anchor 110 together, and / or to allow a limited degree of relative movement between anchor portion 130 and dynamic anchor 110. As explained further below, tether post 120 can be variably forced axially / longitudinal toward end wall 116 of anchor body 112 via tension in inner loop portion 158 of mid-loop portion 156 of tether 150, variably compressing bumper 118 between tether post 120 and end wall 116 of anchor body 112.

[0066] 6-10, 13, and 14, tether post 120 may have a cavity / lumen / cannulation / opening extending longitudinally / axially therethrough. The cannulation in tether post 120 is configured to allow first retention portion 152 and second retention portion 154 of tether 150 to extend axially / longitudinal therethrough, through / passing bumper 118, and to intermediate loop portion 156.

[0067] 1-18 , head portion 114 may be configured to mate with anchor body 112 (or they may be unitary) and include a longitudinally / axially extending cavity / lumen / cannulation / opening that allows first and second retention portions 152, 154 of tether 150 to extend therethrough. The cannulation in head portion 114 is configured to allow first and second retention portions 152, 154 to hold, couple, affix, etc. to head portion 114 and each other, preventing first and second retention portions 152, 154 from sliding or otherwise moving back through dynamic anchor 110 and extending / expanding intermediate loop portion 156 of tether 150, and thereby inner loop portion 158, and the distance between dynamic anchor 110 and soft anchor 130.

[0068] As shown in FIGS. 11-16 , head portion 114 can include multiple openings in communication with the cannulation and is configured to allow first and second retention portions 152, 154 to extend through and around a portion of head portion 114. In some such embodiments, first and second retention portions 152, 154 extend through and around a portion of head portion 114 in a knotless arrangement that secures or fixes first and second retention portions 152, 154. For example, as shown in FIGS. 15-18 , head portion 114 can include first, second, third, and fourth openings 160, 161, 162, and 163. In the illustrated exemplary embodiment, first retaining portion 152 of tether 150 extends from a cannulation in head portion 114 through first opening 160, over the top of head portion 114, down to second opening 161, and back up through fourth opening 163, as shown in Figures 15-18. Similarly, second retaining portion 154 of tether 150 extends from a cannulation in head portion 114 through second opening 161, over the top of head portion 114, down to first opening 160, and back up through third opening 162, as shown in Figures 15-18. As a result, the paths of first retaining portion 152 and second retaining portion 154 form adjustment loops 152A and 154A, respectively, above the top of head portion 114. 15-18, the ends of first and second retention portions 152, 154 can pass under one or both of adjustment loops 152A, 154A. In this manner, when tether 150 is tensioned, adjustment loops 152A, 154A are pulled down and up toward the top side of head portion 114, compressing against the ends of first and second retention portions 152, 154, and securing tether 150 without the use of knots.

[0069] The back or underside of the head portion 114 of the dynamic anchor 110 may be configured to mate with a bone and / or bone plate. For example, as shown in FIGS. 1-18 , the head portion 114 has a backside taper configured to engage with a countersunk aperture in the bone and / or bone plate. In some other embodiments, the back or underside of the head portion 114 may include threads configured to engage with a threaded opening in the bone and / or bone plate, for example. The outer surface of the anchor body 112 may likewise be substantially smooth or threaded, for example.

[0070] As shown in FIGS. 19-27, the stabilization system 100 can be coupled to an insertion or implantation instrument 200 configured for use in implanting the stabilization system 100. As shown in FIGS. 19-23, the dynamic anchor 210 can be removably received within a cavity in a first insertion portion 212 of the instrument 200, and the soft anchor 130 can be removably coupled on / over a bifurcated free end 210 of the first insertion portion 212. The soft anchor 130 can be removably held to the bifurcated free end 210 by tension in a tether 150, which can be removably coupled to a second portion 213 of the instrument 200, as described further below. As shown in FIGS. 19-23, the bifurcated free end 210 of the first insertion portion 212 has a base portion extending therebetween with a pair of tines, and a pair of grooves extending proximally from the base portion of the bifurcated free end. The soft anchor 130 is held on the bifurcated free end 210 with the end of the soft anchor 130 extending over or into the pair of grooves and the inner portion of the soft anchor 130 extending beyond the base portion between the pair of tines.

[0071] The instrument can be utilized to introduce the soft anchor 130 into a cavity or hole in a first bone (e.g., the lateral cortex of the tibia) through a second bone (e.g., the fibula). After insertion, the instrument can be pulled pack to apply tension to the mid-loop portion 156, deforming the soft anchor 130 and securing it to the bone. After such securing, the first portion 212 can be detached or separated from the second portion 213 to expose the dynamic anchor 110, as shown in FIGS. 26 and 27.

[0072] As shown in FIGS. 22-25, the second portion 213 can include a proximal tensioning handle 216 and a main housing 214. The tensioning handle 216 can be removably and rotatably coupled within a cavity in the main housing 214, and the adjustment loops 152A, 154A can be wrapped around or otherwise releasably coupled thereto, as shown in FIG. 25. The tensioning handle 216 and main housing 214 can be configured so that the tensioning handle 216 rotates in only one direction, such that rotation of the tensioning handle 216 tensions the adjustment loops 152A, 154A and shortens the intermediate loop portion 156, bringing the dynamic anchor 110 into contact with the second bone. The tensioning handle 216 can be further rotated, ultimately applying a desired level of tension across the joint between the first and second bones.

[0073] After tension is applied, second portion 213 can be configured such that tensioning handle 216 can be detached or separated from main housing 214, thereby releasing adjustment loops 152A, 154A. Note that the static friction of portions of tether 150 on itself and on components of system 100 is high enough to maintain tension and prevent adjustment loops 152A, 154A from sliding back into head portion 114. As shown in FIGS. 22 and 23 , the ends of first and second retention portions 152, 154 are coupled, housed, and maintained within / on main housing 213. Thus, after tension is applied and tensioning handle 216 is detached, main housing 213 can be pulled back to tension the ends of first and second retention portions 152, 154, causing adjustment loops 152A, 154A to retract above head portion 114 and secure tether 150 (without knots) as described above. The first and second retaining portions 152, 154 can then be cut near the head portion 114 to completely remove the system from the instrument 200.

[0074] As shown in FIG. 28 , system 100 can be used with bone plate 190 and bone screws 192 to stabilize the distal tibiofibular ligament. As shown in FIG. 28 , the bone plate can be coupled to fibula 180, with screws 192 in fibula 180 extending through openings 191. One or more dynamic anchors 110 can be inserted into fibula 180 through openings 191. In some embodiments, soft anchors 130 are implanted in tibia 182, and tethers 150 can span the joint space to dynamically stabilize the joint. In some embodiments, system 100 can be implemented in combination with a bone plate the same as or similar to bone plate 190 and one or more other implants having dynamic properties and configured to be at least partially implanted in at least one of the tibia and / or fibula.

[0075] Another exemplary stabilization implant system 300 is shown in Figures 29-39. The stabilization implant system 300 of Figures 29-39 is substantially similar to the stabilization implant system 300 described above with respect to Figures 1-18, and accordingly, like reference numerals preceded by a "3" as opposed to a "1" are used to indicate like components, aspects, features, portions, members, functions, etc., the above descriptions of which likewise apply and may not be repeated below for purposes of brevity and / or clarity.

[0076] The implant system 300 can be configured to, for example, post-operatively heal syndesmotic joints and / or stabilize syndesmotic joints, including but not limited to, the distal tibiofibular syndesmotic joint. The implant system 300 can be configured to selectively limit movement (e.g., in all directions) between two or more syndesmotic bones to heal and / or stabilize syndesmotic joints relative to one or more syndesmotic bones extending therebetween. The implant system 300 allows only a limited amount of relative movement between the bones into which it is implanted or placed, and such relative movement and / or forces acting between the bones are controlled (e.g., resisted / restricted and / or facilitated / enhanced).

[0077] The components and portions of the implant system 300 can be formed from, for example, titanium, stainless steel, polymer, polyester, polypropylene, UHMWPE, thermoplastic (e.g., thermoplastic urethane), bioabsorbable material, or any other biocompatible material such that the implant system 300 is configured to be implanted into a mammalian patient, such as a human patient.

[0078] As shown in FIGS. 29-39 , implant system 300 allows for dynamic stabilization / fixation of a joint between two bones (either naturally distinct bones or portions / fragments of bones), such as bones at a syndesmotic joint (e.g., the distal fibula and tibia at the distal tibiofibular syndesmotic joint). Implant system 300 is configured to provide dynamic stabilization through limited and / or controlled relative movement between the bones. The region of allowed, limited, and controlled movement provided by implant system 300 can be located in the space or gap between adjacent bones or bone segments (e.g., the syndesmotic joint / space between the distal fibula and distal tibia).

[0079] As shown in Figures 29-37 and 39, implant system 300 includes a flexible suture or tether 350 as a constraint and / or tension member extending through and from a portion of dynamic bone anchor 310. As also shown in Figures 29-37 and 39, an inner portion 356 of tether 350 extending from dynamic bone anchor 310 passes through or is otherwise coupled to bone anchor 330. Dynamic bone anchor 310 and bone anchor 330 are configured to be coupled to and at least partially implanted within first and second bones, respectively, such as bones of a syndesmotic joint (e.g., the distal fibula and tibia, respectively, of a distal tibiofibular syndesmotic joint), with tether 350 extending between and coupled to dynamic bone anchor 310 and bone anchor 330.

[0080] The bone anchor 330 may be coupled to an intermediate loop portion 356 of a tether 350 extending from the dynamic bone anchor 310, and an inner loop portion 358 of the intermediate loop portion 356 may be coupled to first and second retention portions 352, 354 of the tether 350 that are knotlessly coupled to the dynamic bone anchor 310 (this prevents the tether 350 from moving in a direction that would expand the intermediate loop portion 356 through the dynamic bone anchor 310, as described further below). As described below, the inner portion 358 of the intermediate loop portion 356 of the tether 350 is held to the dynamic bone anchor 310 via a resilient or elastic member that provides dynamic controlled translation between the dynamic bone anchor 310 and the bone anchor 330. In this way, the implant system 300 provides dynamic stabilization of a joint between a first bone and a second bone.

[0081] 29-31 , 33 , and 39 , the intermediate loop portion 356 of the tether 350 can pass through the soft bone anchor 330 multiple times. For example, a first loop portion of the intermediate loop portion 356 extending from the first retaining portion 352 (in the dynamic bone anchor 310) can extend through a portion of the soft bone anchor 330 to the inner loop portion 358, and a second loop portion of the intermediate loop portion 356 extending from the second retaining portion 354 (in the dynamic bone anchor 310) can extend through a second portion of the soft bone anchor 330 to the inner loop portion 358. The first and second portions of the soft bone anchor 330 can be substantially the same portion of the soft bone anchor 330, or the first and second portions can be longitudinally / axially overlapping or spaced apart from one another.

[0082] In some embodiments, the first and second loop portions of the intermediate loop portion 356 of the tether 350 may extend in different longitudinal / axial directions through the soft bone anchor 330 to the inner loop portion 358. For example, as shown in FIGS. 29-31 , 33 , and 39 , the first loop portion may extend from the first retaining portion 352 to a first longitudinal / axial portion of the soft bone anchor 330, through the soft bone anchor 330 to a second longitudinal / axial portion of the soft bone anchor 330, and the second loop portion may extend from the second retaining portion 354 to a third longitudinal / axial portion of the soft bone anchor 330 that is proximal to the second longitudinal / axial portion and distal from the first longitudinal / axial portion, and through the soft bone anchor 330 to a fourth longitudinal / axial portion of the soft bone anchor 330 that is proximal to the first longitudinal / axial portion and distal from the second longitudinal / axial portion. In this manner, the first loop portion and the second loop portion may overlap to extend longitudinally / axially within the soft bone anchor 330 (e.g., within its interior longitudinal and / or elongated passage or cavity).

[0083] In some embodiments, the first and fourth portions of the soft bone anchor 330 are proximal to a first longitudinal / axial end of the soft anchor 330 and distal to a second longitudinal / axial end of the soft anchor 330, and the second and third portions of the soft bone anchor 330 are proximal to the second longitudinal / axial end and distal to the first longitudinal / axial end. In some embodiments, the first and fourth portions of the soft anchor 330 are on the same portion of the soft anchor 330 or are positioned substantially adjacent to each other, and the second and third portions of the soft anchor 330 are on the same portion of the soft anchor 330 or are positioned substantially adjacent to each other. As explained further below, an inner loop portion 358 extending between the first and second loop portions extends into the dynamic bone anchor 310 and can extend / be looped over / through a tether post 320 that is movably and elastically held within a cavity / lumen / cannulation in the anchor body 312 of the dynamic bone anchor 310. Movement of the tether post 320 within the anchor body 312 lengthens or shortens the size / length of the intermediate loop portion 356, adjusting the distance between the soft bone anchor 330 and the dynamic bone anchor 310 (as the tether 150 slides within the soft bone anchor 330). Note that the tether 350 is slidably coupled to / through the soft bone anchor 330, thereby allowing the soft bone anchor 330 to slide along the intermediate loop portion 356 of the tether 350 as it is adjusted in size / length.

[0084] The tether 350 can be configured to mimic, for example, the function, location, and / or length of an interosseous ligament. The tether 350 can be a thin, long, substantially freely manually flexible configuration or structure, such as a suture, strand, cable, or cord-like configuration. The tether 350 can be, for example, a biomedical suture or tether (e.g., a braided cerclage cable), or similar construct. In some embodiments, the tether 350 can be formed of, for example, a polymeric, polyester, polypropylene, or UHMWPE suture, strand, or filament, a braid thereof, or similar material known to those skilled in the art. The tether 350 can also be a suture (e.g., a braided suture), such as, for example, a single cross-sectional strand of suture or multiple loops of suture. For example, the tether 350 can be a co-braided suture of UHMWPE and polypropylene.

[0085] The soft deformable anchor 330 may be solid or porous. For example, the soft deformable anchor 330 may be molded using a solid material. As another example, the soft deformable anchor 330 may be woven from one or more threads, fibers, or filaments. In some embodiments, the soft deformable anchor 330 may be formed by one or more machining, additive manufacturing, and / or extrusion processes. The soft deformable anchor 330 may be a unitary structure or may be formed from multiple members or sections (and / or materials). The soft deformable anchor 330 may be formed or constructed from any biocompatible material. For example, the soft deformable anchor 330 may be formed or constructed from polyester, polyethylene (e.g., ultra-high molecular weight polyethylene), polypropylene, nylon (e.g., polyamide), silk, polyglycolic acid (PGA), polydioxanone (PDO), polylactic acid (PLA), polylactic-co-glycolic acid (PLGA), stainless steel, or a combination thereof. In one example, the soft deformable anchor 330 is made of polyester.

[0086] Tether 350 may or may not be resiliently axially / longitudinally stretchable or deformable. In some embodiments, tether 350 may have one or more openings or gaps along its length configured to allow another tether or suture (or the like) to pass therethrough. In this manner, tether 350 functions as a tether or suture passer, passing another tether or suture to and / or through at least a portion of implant system 300.

[0087] As described above, a portion of the intermediate or inner loop portion 358 of the tether 350 extends within the bone anchor 330. The bone anchor 330 may be a soft, deformable bone anchor, such as an all-soft suture anchor (ASA). For example, the bone anchor 330 may be a tube, sleeve, or tape made (e.g., woven) of suture or tether material, into which the tether 350 is woven. In other embodiments, the tube, sleeve, or tape may be solid and / or formed of a resilient material, such as an elastomer.

[0088] The soft deformable anchor 330 may be longitudinally elongated in a neutral state. In some embodiments, the soft deformable anchor 330 may define a longitudinal length in the range of 5 mm to 35 mm. The soft deformable anchor 330 may have a larger size ratio than the tether 350. For example, the width or diameter of the soft deformable anchor 330 may be larger than the width or diameter of the tether 350.

[0089] In some embodiments, the soft deformable anchor 330 may be formed with an annular sidewall defining an inner cavity and first and second longitudinal ends. This may result in the soft deformable anchor 330 being hollow. The size of the inner cavity may be larger than the tether 350 so that the tether 350 can pass through the inner cavity. The inner cavity may extend through the soft deformable anchor 330, and the inner cavity may be open or accessible at one or both of the longitudinal ends. Alternatively, the longitudinal ends may be closed or sealed. In some embodiments, the soft deformable anchor 330 may not define an inner cavity or may not include an inner cavity.

[0090] The soft deformable anchor 330 is flexible, collapsible, deformable, bendable, stretchable, or otherwise repositionable in its overall shape. As shown in FIGS. 29-33 and 39 , in its natural, neutral, or undeformed state, the soft deformable bone anchor 330 may extend substantially linearly or generally arcuately along its longitudinal axis. The soft deformable bone anchor 330 is configured such that tension on a portion of the suture extending from the soft deformable anchor 330 in a lateral direction angled from the longitudinal direction (e.g., substantially perpendicular from the outer surface of the anchor 330) causes the soft deformable anchor 330 to deform into a curved, folded, compressed, or “bunched” shape, as described above for anchor 130.

[0091] The tether 350 (e.g., its intermediate loop portion 356, including its inner loop portion 358) can extend one or more times through the sides or portions of the soft deformable anchor 330, which, when tensioned laterally (at least generally), causes the anchor 330 to deform into tightly curved, arced, folded, "C" or "U" and / or "V" shapes. For example, in the deployed or neutral state, the anchor 330 can be bent and / or pulled (e.g., via the tether 350) to assume a sharply arced U- or V-shape (e.g., defined by a relatively small radius). Tether 350 (e.g., intermediate loop portion 356 including its inner loop portion 358) can be tensioned laterally, such that tether 350 deforms, compresses, or pulls together the sides or portions of soft deformable anchor 330, causing deformable anchor 330, or portions thereof, to bunch, roll, or otherwise closely space in a sharply arched shape to define a larger width, lateral / cross-sectional dimension, or other size. In this manner, the soft deformable bone anchor 330 is inserted into an appropriately sized / shaped hole, tunnel, or cavity in bone, and is configured such that when the suture portion extending from the anchor 330 (e.g., its intermediate loop portion 356, including its inner loop portion 358) is tensioned / pulled at least generally laterally, the anchor 330 tightens and expands in at least one dimension, compressing the anchor 330 against the sidewalls of the bone hole / cavity and forming a dense "ball" that is forced into and secured within the hole / tunnel / cavity. As described further below, in some exemplary methods, a hole / tunnel / cavity can be formed in the distal tibia (which may be formed by drilling a hole in the distal tibia) for dynamic stabilization of the distal tibiofibular ligament. This allows the anchor 330 to be a tibial anchor. It should be noted that the configuration of anchor 330 allows anchor 330 to be placed in a bone hole / tunnel / cavity of substantially smaller diameter (e.g., 1-3 mm), thereby allowing bone preservation, e.g., greater bone preservation.

[0092] As described above and shown in Figures 29-39, implant system 300 includes dynamic bone anchor 310. An inner loop portion 358 of an intermediate loop portion 356 (of flexible suture or tether 350), and first and second retaining portions 352, 354 extending to intermediate loop portion 356, extend to / through dynamic bone anchor 310. As described above, intermediate loop portion 356 extending from dynamic bone anchor 310 passes through or couples with bone anchor 330. As described above, the dynamic bone anchor 310 is configured to couple to a second bone, such as a bone of a ligamentous joint (e.g., the distal end of the fibula of the distal tibiofibular ligamentous joint), and to be at least partially implanted within the second bone, and the tether 350 (first retaining portion 352 and second retaining portion 354 and intermediate loop portion 356 (including inner loop portion 358)) extends between the dynamic bone anchor 310 and the bone anchor 330 and couples to the dynamic bone anchor 310 and the bone anchor 330.

[0093] 29-39 , in some embodiments, the dynamic bone anchor 310 includes an anchor body 312 and a head portion 314. The anchor body 312 may be disposed at and / or define a first longitudinal / axial end or end of the bone anchor 310. The head portion 314 may be disposed at and / or define a second longitudinal / axial end or end of the bone anchor 310. In some embodiments, the dynamic bone anchor 310 may be substantially or generally cylindrical overall.

[0094] As shown in Figures 30, 33-35, 37, and 38, anchor body 312 can include an inner cavity / lumen / cannulation / opening extending longitudinally / axially therethrough. The inner cavity of anchor body 312 can open to a first end of bone anchor 310 through tether opening 315 in end wall 316 of anchor body 312. Tether opening 315 is configured to allow inner loop portion 358 of intermediate loop portion 356 and first and second retention portions 352, 354 of tether 350 to extend therethrough, as shown in Figures 30 and 34.

[0095] As shown in FIG. 34 , the anchor body 312 includes a resiliently / elastically deformable bumper 318 and a tether post 320 movably housed within the internal cavity of the anchor body 312, since the bumper 318 is larger than the tether opening 315. The tether post 320 is movable at least axially / longitudinal within the internal cavity of the anchor body 312. The resilient member or bumper 318 is resiliently compressible and / or extensible at least axially / longitudinal within the internal cavity of the anchor body 312. Thus, as the bumper 318 compresses / shortens and expands axially / longitudinal, at least a portion of the bumper 318 moves axially / longitudinal within the internal cavity. The bumper 318 and / or the tether post 320 may also be rotatably retained within the internal cavity of the anchor body 312.

[0096] The bumper 318 is axially / longitudinally disposed and sandwiched between the end wall 316 of the anchor body 312 and the tether post 320, and is therefore resiliently / elastically compressible and / or extensible in the axial / longitudinal direction therebetween. The tether post 320 may abut an axial / longitudinal end of the bumper 318, and the other axial / longitudinal end of the bumper 318 may abut the end wall 316. As shown in FIG. 34 , the bumper 318 may have a cavity / lumen / cannulation / opening extending therethrough in the longitudinal direction. The cannulation of the bumper 318 is configured to allow the intermediate loop portion 356 and the first and second retention portions 352 and 354 of the tether 350, respectively, to extend axially / longitudinally therethrough, to extend to and through the tether post 320.

[0097] In some embodiments, the bumper 318 may be a resilient or elastic spring-like member. The bumper 318 may be composed of one or more resiliently deformable members or materials. For example, the bumper 318 may be one or more springs (e.g., Belleville or coil springs) or resiliently compressible disks or tubes, or combinations thereof. For example, the bumper 318 may include a resiliently compressible disk (e.g., an elastomeric, polymeric, polyurethane, polyethylene disk, etc.), a tube (e.g., a polyurethane tube), or a coil spring. In some embodiments, the bumper 318 comprises at least one urethane tube or similar member, such as at least one polycarbonate urethane (PCU) tube or similar member, or at least one thermoplastic polyurethane (TPU) tube or similar member.

[0098] Bumper 318 is configured to resiliently deform to tension inner loop portion 358 of tether 350, pulling anchor portion 330 and dynamic anchor 310 together, and / or to allow a limited degree of relative movement between anchor portion 330 and dynamic anchor 310. Tether post 320 can be variably biased axially / longitudinal toward end wall 316 of anchor body 312 via tension in inner loop portion 358 of mid-loop portion 356 of tether 350, variably compressing bumper 318 between tether post 320 and end wall 316 of anchor body 312.

[0099] As shown in FIG. 34 , the tether post 320 may have a cavity / lumen / cannulation / opening extending longitudinally / axially therethrough. The cannulation of the tether post 320 is configured to allow the first and second retention portions 352, 354 of the tether 350 to extend axially / longitudinally therethrough, through / passing the bumper 318, and to the intermediate loop portion 356. The cannulation of the tether post 320 also allows the inner loop portion 358 to extend partially therethrough and beyond the post portion of the tether post 320. This allows the intermediate loop portion 356 to be looped over the post portion of the tether post 320, which can prevent the inner loop portion 358 from migrating or otherwise becoming detached from the dynamic anchor 310 when tension is applied.

[0100] 29-39 , head portion 314 may be configured to mate with anchor body 312 (or they may be unitary) and include a longitudinally / axially extending cavity / lumen / cannulation / opening that allows first and second retention portions 352, 354 of tether 350 to extend therethrough. The cannulation in head portion 314 is configured to allow first and second retention portions 352, 354 to hold, couple, affix, etc. to head portion 314 and each other, preventing first and second retention portions 352, 354 from sliding or otherwise moving back through dynamic anchor 310 and extending / expanding intermediate loop portion 356 of tether 350, and thus inner loop portion 358, and the distance between dynamic anchor 310 and soft anchor 330.

[0101] As shown in FIGS. 33-38 , head portion 314 can include multiple openings in communication with the cannulation and is configured to allow first and second retention portions 352, 354 to extend through and around a portion of head portion 314. In some such embodiments, first and second retention portions 352, 354 extend through and around a portion of head portion 314 in a knotless arrangement that adjustably secures or fixes first and second retention portions 352, 354. For example, as shown in FIGS. 33-38 , head portion 314 can include first opening 360, second opening 361, third opening 362, and fourth opening 363. In the illustrated exemplary embodiment, first retaining portion 352 of tether 350 extends from the cannulation in head portion 314 through first opening 360, over the top of head portion 314, down to second opening 361, and back up through third opening 362, as shown in Figures 33-38. Similarly, second retaining portion 354 of tether 350 extends from the cannulation in head portion 314 through second opening 361, over the top of head portion 314, down to first opening 360, and back up through fourth opening 363, as shown in Figures 33-38. Thus, the paths of first retaining portion 352 and second retaining portion 354 form adjustment loops 352A and 354A, respectively, above the top of head portion 314. 33-38, the ends of first and second retention portions 352, 354 can pass under one or both of adjustment loops 352A, 354A. In this manner, when tether 350 is tensioned, adjustment loops 352A, 354A are pulled down and up toward the top side of head portion 314, compressing against the ends of first and second retention portions 352, 354, and securing tether 350 without the use of knots.

[0102] Thus, first retaining portion 352 and second retaining portion 354 can each extend through head portion 314 and pass through its outer top one or more times (e.g., twice). As described above, first retaining portion 352 and second retaining portion 354 of tether 350 comprise opposing ends of tether 350. Thus, first retaining portion 352 extends from head portion 314 through its outer top to form first loop portion 352A, with a first end of first retaining portion 352 extending from head portion 314 through its outer top (from third opening 362). Similarly, second retaining portion 354 extends from head portion 314 through its outer top to form second loop portion 354A, with a second end of second retaining portion 354 extending from head portion 314 through its outer top (from fourth opening 363). As described above, the first end of first retaining portion 352 extends over the outer upper portion and through first loop portion 352A and second loop portion 354A, and the second end of first retaining portion 354 extends over the outer upper portion and through first loop portion 352A and second loop portion 354A, adjustably and knotlessly coupling first retaining portion 352 and second retaining portion 354 to head portion 314 of dynamic bone anchor 310.

[0103] 33-38, first opening 360 and second opening 361 may open to each of the side surfaces of head portion 314. In contrast, as also shown, third opening 362 and fourth opening 363 may not be exposed at the side surfaces of head portion 314, but rather may comprise openings on the upper side of head portion 314 formed in the top surface portion of head portion 314.

[0104] The underside or underside of the head portion 314 of the dynamic anchor 310 may be configured to mate with a bone and / or bone plate. For example, as shown in FIGS. 33-39 , the head portion 314 may include an underside or backside taper configured to engage, for example, with a countersunk aperture in the bone and / or bone plate. In some other embodiments, the underside or underside of the head portion 314 may include threads configured to engage, for example, with a threaded opening in the bone and / or bone plate. The outer surface of the anchor body 312 may likewise be configured to be substantially smooth or threaded, for example.

[0105] As shown in FIGS. 33-39 , the enlarged upper portion of the head portion 314 can have an oval cross-sectional shape, which allows it to seat obliquely on the bone and / or bone plate without a significantly raised portion of the head portion 314. The enlarged upper portion of the head portion 314 can compress first and second side portions 372, 374 that extend laterally beyond the base portion of the head portion 314. The side portions 372, 374 can have tapered undersurfaces. The third and fourth side portions of the head portion 314 can extend between the first and second side portions 372, 374. The third and fourth side portions do not have to extend laterally through the base portion and may include at least a portion of the third and fourth openings 362, 363, as shown in FIGS. 33-39 .

[0106] Another exemplary implant insertion and tensioning instrument 400 is shown in Figures 40-62. The insertion and tensioning instrument 400 of Figures 40-62 is similar to the insertion and tensioning instrument 200 described above with respect to Figures 19-27, and accordingly, like reference numerals preceded by a "4" as opposed to a "2" are used to indicate like components, aspects, features, parts, members, functions, etc., and the above descriptions directed thereto equally apply and may not be repeated hereinafter for purposes of brevity and / or clarity.

[0107] The implant insertion and tensioning instrument 400 is configured to implant, reduce, and tension a stabilized implant system described herein, such as the above-described stabilized implant system 100 or stabilized implant system 300. For purposes of illustration and / or explanation, in the case of Figures 29-39, the implant insertion and tensioning instrument 400 is shown and described herein as being used with stabilized implant system 300. However, it is specifically contemplated that stabilized implant system 100, or another stabilized implant system similar to systems 100 and 300, may likewise be employed.

[0108] The implant insertion and tensioning instrument 400 is configured to implant, reduce, and tension the stabilizing implant system 300 across a joint between two bones (either naturally distinct bones or bone portions / fragments), such as the bones (i.e., syndesmotic bones) of a syndesmotic joint (e.g., the distal fibula and tibia of a distal tibiofibular syndesmotic joint), such that the implant system 300 provides dynamic stabilization through limited and / or controlled relative movement between the syndesmotic bones (and thereby repair one or more syndesmotic joints extending therebetween, treat the syndesmotic joint, and / or stabilize the syndesmotic joint). The implant insertion and tensioning instrument 400 and the stabilizing implant system 300 (and / or another stabilizing implant system) can cooperate to form a system, such as an implant system for dynamic stabilization of a syndesmotic joint.

[0109] As shown in Figures 40, 41, and 46-62, the device 400 includes a first portion 412 that is removably coupled to a second portion 413. The first portion 412 may extend longitudinally from a front or distal end of the second portion 413, and the first portion 412 and the second portion 413 may be longitudinally fixed when removably coupled. As described further below, the first portion 412 and the second portion 413 may be configured to be separated by relative lateral movement therebetween along at least a first lateral direction.

[0110] As shown in Figures 46 and 47 and further described herein, the soft bone anchor 330 may be removably retained on the free end 410 of the first portion 412 of the device 400, and the dynamic bone anchor 310 may be removably retained on at least one of the first portion 412 and the second portion 413 of the device 400.

[0111] 40-43 and 46-50, first portion 412 may be or form a soft bone anchor inserter or inserter portion configured to removably hold soft bone anchor 330 and pass / implant soft bone anchor 330 through, into, and / or onto one or more bones or bone cavities. For example, as described herein, first portion 412 can be configured to hold soft bone anchor 330 thereon and insert / pass soft bone anchor 330 into a hole / tunnel extending through at least a portion of two or more bones (e.g., the distal tibia and fibula) and implant soft bone anchor 330 onto or against the outer surface of one of the bones (e.g., the tibia). After implantation of the soft bone anchor 330 , the soft bone anchor 330 can be detached / removed from the first portion 412 , and the first portion 412 can be detached from the second portion 413 .

[0112] As shown in Figures 40-43 and 46-50, the first part 412 may include a base portion 420 that removably couples to a distal portion of the second part 413, and a longitudinally elongated inserter portion 422 that extends longitudinally from the base portion to its free end 410. The inserter portion 422 may be configured as a rigid, elongated rod or like member that can be inserted into and extend into / through one or more bone holes, such as drill holes.

[0113] 40-43 and 46-50, the free end 410 of the inserter portion 422 may be forked. For example, the free end 410 of the insertion portion 422 may have a pair of longitudinally extending (e.g., elongated) tines and a base retainer extending therebetween. In some embodiments, the free end 410 may also include a pair of grooves extending longitudinally proximally from the base retainer toward the base portion 420.

[0114] 46 and 47 , in a pre-installed, pre-configured, and / or loaded state / arrangement / configuration of the implant system comprising the instrument 400 and implant 300, the soft anchor 130 is removably retained or coupled to / on the bifurcated free end 210 of the first insertion portion 212. The soft anchor 130 may be removably retained to the bifurcated free end 210 via tension on the tether 150, which may be removably coupled to the second portion 213 of the instrument 200, as described further below. The soft anchor 130 is retained on the bifurcated free end 210, with an end of the soft anchor 130 extending beyond or into the pair of grooves and an inner portion of the soft anchor 130 extending beyond the base portion between the pair of tines.

[0115] The instrument 400, and in particular the first portion 412, can be utilized to introduce the soft anchor 330 into a cavity or hole in a first bone (e.g., the lateral cortex of the tibia) through a second bone (e.g., the fibula). After insertion, the instrument 400 can be pulled back to tension the mid-loop portion 356, deforming the soft anchor 330 and securing it to / on the bone, and detaching the soft anchor 330 from the end 410 of the first portion 412. After such implantation, the first portion 412 can be removed or decoupled from the second portion 413, which also exposes or releases the dynamic anchor 410, as shown in FIGS. 51-59.

[0116] As shown in FIGS. 50 and 51 , the first portion 412 can be removably coupled to the second portion 413 via a laterally disposed dovetail coupling arrangement. For example, as shown in FIGS. 50 and 51 , an inner side of the base portion 420 of the first portion 412 can include a recess or tenon 424 configured to mate with a corresponding / matingly shaped protrusion or tenon 428 on a side of the tip portion 429 of the second portion 413 (or vice versa). The protrusion 428 can extend from a longitudinal end or wall of the tip portion 429. The recess 424 and protrusion 428 can be flared or widened longitudinally away from the tip portion 429, such that the first portion 412 and the second portion 413 are secured together longitudinally but can be disassembled or separated by relative lateral movement therebetween.

[0117] The soft anchor 330 may be removably held at the bifurcated free end 410 by tension on a tether 350 (e.g., intermediate portion 356), which may be removably coupled to the second portion 413 of the instrument 400, as further described below. This allows the intermediate portion 356 of the tether 350 to extend longitudinally from the soft bone anchor 330 at the free end 410 of the inserter portion 422 along the inserter portion 422 to the dynamic bone anchor 310. As shown in FIGS. 46 and 47, in the pre-installed, pre-configured, and / or loaded state / position / configuration of the implant system, the dynamic bone anchor 310 may be held in a recess or groove 425 in the leading tip portion of the second portion 413. For example, the head portion 314 of the dynamic bone anchor 310 may be positioned in or against the recess or groove 425 in the tip member 427 of the second portion 413, as shown in FIGS. 46-49 and 51. Thus, the recess 425 can be shaped and otherwise configured to receive at least a portion of the head portion 314 of the dynamic bone anchor 310 therein.

[0118] The dynamic bone anchor 310 can be retained within the recess or groove 425 of the second portion 413 by tension in the tether 350 and / or the first portion 412 (when the first portion 412 is coupled to the second portion 413). As shown in FIGS. 46-50 , the medial side portion 423 of the base portion 420 of the first portion 412 can extend partially laterally to (but longitudinally spaced from) the recess 425 and end of the tip member 427 of the second portion 413 when the first portion 413 is removably coupled to the second portion 413. The medial side portion 423 of the base portion 420 can partially cover the recess 425 and end of the tip member 427 and include a recessed or shaped surface configured to potentially engage a portion of the dynamic bone anchor 310. In this manner, the medial side portion 423 of the base portion 420 and the recess 425 and end of the tip member 427 can form a cavity, pocket, or opening that holds, accommodates, or captures a portion of the dynamic bone anchor 310, such as its head portion 314, to removably retain the dynamic bone anchor 310 to the instrument 400 (when the first portion 413 is removably coupled to the second portion 413). In some embodiments, a portion of the medial side portion 423 can be configured to engage or abut a portion of the anchor body 312 of the dynamic bone anchor 310.

[0119] As shown in Figures 40-49 and 51-60, the second portion 413 of the instrument 400 further includes a main housing portion 430 and a tensioning handle assembly or portion 432 manually movably coupled to the main housing 430. The main housing 430 may define an interior cavity in which other components of the instrument 400, such as some of the components of the tensioning handle portion 432, are housed. The main housing 430 may be longitudinally elongated, with the tip member 427 located at the front end and the tensioning handle portion 432 extending beyond the rear / aft end of the main housing 430. The main housing 430 may be shaped and sized to be manually engaged and manipulated.

[0120] The portion of tensioning handle portion 432 that extends beyond the rear / rear end of main housing 430 may form or include handle knob portion 434 having ring member or portion 433. Handle knob portion 434 may be shaped and sized to be manually engaged and manipulated. For example, as described further herein, main housing 430 and tensioning handle portion 432 can be manually moved longitudinally relative to each other, and tensioning handle portion 432 can be rotated about its axis within main housing 430 via handle knob portion 434. This shortens intermediate portion 356 of tether 350, bringing anchors 330, 310 closer together (and into contact with bone and / or tissue), applying tension to intermediate portion 356 and stabilizing the joint.

[0121] As shown in FIGS. 40-49 and 51-60 , the tensioning handle portion 432 includes a rear handle knob portion 434 and a longitudinally elongated external threaded shaft portion 436 extending longitudinally forward from the tensioning handle portion 432. The threaded shaft portion 436 extends longitudinally forward through a rear opening in the main housing 430 and within an internal cavity of the main housing 430. The handle knob portion 434 is secured to the threaded shaft portion 436 such that rotation (e.g., manual rotation) of the handle knob portion 434 relative to the main housing 430 (about its longitudinal axis and / or about the longitudinal axis of the threaded shaft portion 436) effects rotation of the threaded shaft portion 436 relative to (and at least partially within) the main housing 430.

[0122] The tensioning handle portion 432 may further include a longitudinally elongated release member or rod 437 having a rearward engagement end 438 (which may be shaped or configured as a button or actuator) and a forward end, as shown in FIGS. 40-49 and 51-60. The release member or rod 437 is rigid and extends through the cannulation, the handle knob portion 434, and a through-hole / opening or cavity in the longitudinally elongated threaded shaft portion 436, with the rearward engagement end 438 at or proximal to and exposed within the ring portion 433. The release member 437 is longitudinally movably retained within the cannulation in the handle knob portion 434 and the longitudinally elongated threaded shaft portion 436. In some embodiments, the release member or rod 437 is resiliently biased via a resilient member (e.g., a spring) (not shown), such that the rear engagement end 438 is normally biased to protrude from the rear surface of the handle knob portion 434 and is manually accessible, such as by being exposed within the ring portion 433, to allow the release member 437 to be moved longitudinally forward (toward the tip portion 429).

[0123] As shown in FIGS. 40-49 and 51-60, tensioning handle portion 432 may also include a carrier portion at a longitudinal forward end of tensioning handle portion 432 within an internal cavity of main housing 430. The carrier portion and internal cavity of main housing 430 may be configured such that the carrier portion can translate / move or slide longitudinally within tensioning handle portion 432 but is prevented from rotating (e.g., rotating about a longitudinal axis, such as the longitudinal axis of main housing 430 and / or threaded shaft portion 436).

[0124] The carrier portion of the tensioning handle portion 432 may include a sleeve portion 440 including at least one longitudinal opening 441 and a post portion 442 including at least one post 443 extending longitudinally rearward (away from the distal end portion 429 of the instrument 400), as shown in FIG. 43. As shown in FIGS. 52-55 and 58-60, the sleeve portion 440 of the carrier portion is rotatably coupled to and longitudinally fixed to the forward longitudinal end of the threaded shaft portion 436. In this manner, longitudinal movement of the threaded shaft portion 436 effects longitudinal movement of the sleeve portion 440, but rotation of the threaded shaft portion 436 does not cause the sleeve portion 440 to rotate within the interior cavity of the main housing 430.

[0125] 52-55 and 58-60, post portion 442 of the carrier portion is coupled to a longitudinally forward end of release member 437. As such, longitudinal movement of release member 437 effects longitudinal movement of post portion 442 within the interior cavity of main housing 430. In this manner, when a user manually longitudinally moves release member 437 forward (relative to tip portion 429) via its engagement end 438, post portion 442 moves longitudinally forward relative to sleeve portion 440 (and, e.g., threaded shaft portion 436 and main housing 430).

[0126] As shown in Figures 52-55 and 58-60, the sleeve portion 440 and the post portion 442 are movably assembled / arranged / coupled together such that at least one post 443 of the post portion 442 extends into at least one opening 441 in the post portion 442. As shown in Figures 52-55, 58, and 59, the post portion 442 is resiliently biased longitudinally forward into a first relative longitudinal configuration, such as via a resilient member (e.g., a spring) (not shown). The sleeve portion 440 and the post portion 442 are configured such that, in the first relative configuration, the at least one post 443 of the post portion 442 extends through the at least one opening 441 and past a rear engagement side or side / face 444 of the sleeve portion 440. However, longitudinal forward movement of the release member 437 (e.g., via the engagement end 438) can reposition the sleeve portion 440 and the post portion 442 to a second relative longitudinal arrangement, thereby urging the post portion 442 longitudinally forward relative to the sleeve portion 440 so that the tip / end of at least one post 443 is located below / beneath the engagement side 444 of the sleeve portion 440, as shown in FIG. 60.

[0127] It should be noted that the carrier portion as a whole is longitudinally fixed to the threaded shaft portion 436. That is, other than relative movement between the post portion 442 and the sleeve portion 440 when biased from a first relative longitudinal configuration to a second relative longitudinal configuration, the post portion 442 and the sleeve portion 440 (and release member 437) are longitudinally fixed or coupled at the forward end of the threaded shaft portion 436, such that rearward longitudinal movement of the threaded shaft portion 436 relative to the main housing portion 430 effects rearward longitudinal movement of the carrier portion (i.e., the post portion 442 and the sleeve portion 440) relative to (within) the main housing portion 430.

[0128] 42-45, 52, 61, and 62, the threaded shaft portion 436 is threadably coupled to the main housing 430, such that rotation of the threaded shaft portion 436 about its longitudinal axis relative to the main housing 430 causes the threaded shaft portion 436 to move longitudinally either inward or outward (depending on the direction of rotation) of the main housing 430. In this manner, the threaded shaft portion 436 can be rotated relative to the main housing 430 (such as via the rear handle knob portion 434) in a first rotational direction, causing the threaded shaft portion 436 to become less nested and move longitudinally rearward relative to the main housing 430 (and / or the main housing 430 to move longitudinally forward relative to the threaded shaft portion 436).

[0129] In some embodiments, the threaded shaft portion 436 is threadably coupled to the main housing 430 via internal threads or protrusions (e.g., teeth) of the main housing 430, such as within an internal cavity thereof. As shown in FIGS. 42-45, 52, 61, and 62, in some embodiments, the threaded shaft portion 436 is threadably coupled to the main housing 430 via at least one ratchet member 446 that couples to the main housing portion 430. The at least one ratchet member 446 may include threads or protrusions that mate with the external threads of the threaded shaft portion 436 to form a threaded connection. In some such embodiments, as shown in FIGS. 61 and 62, the at least one ratchet member 446 is configured to be resiliently biased (e.g., via a resilient member such as a spring (not shown)) against the external threaded shaft portion 436, such that the threaded shaft portion 436 is rotatably coupled to the main housing portion 430 and slidably coupled longitudinally rearwardly. At least one ratchet member 446 may be configured, via its configuration and / or range of movement, etc., to provide longitudinal rearward movement of the threaded shaft portion 436 relative to the main housing portion 430, but to prevent longitudinal forward movement of the threaded shaft portion 436 relative to the main housing portion 430.

[0130] As shown in Figures 46, 47, 52-55, 58 and 59, in the pre-installed / installed, pre-configured / configured, and / or loaded state / arrangement / configuration of the implant system, the first and second retaining portions 354 of the retaining portion 352 of the tether 350 extend through the opening 426 in the tip member 427, through at least a portion of the main housing portion 430, and are retained, secured, or otherwise coupled (e.g., detachably or securely) to the tensioning handle assembly 432. Longitudinal movement of the tensioning handle portion 432 relative to the main housing portion 430 in a first longitudinal direction extending away from the tip portion 429 (e.g., via the rear handle knob portion 434 and / or the threaded shaft portion 436) pulls the first and second holding portions 352, 354 through the instrument 400, pulling the head portion 314 of the dynamic bone anchor 310 against the tip portion 427 / 429 of the instrument 400, and once / if the dynamic bone anchor 310 is positioned against the tip portion 427 / 429, pulling the tether 350 through the dynamic bone anchor 310 and the soft bone anchor 330, shortening the length of and / or tensioning the intermediate portion 356 extending between the dynamic bone anchor 310 and the soft bone anchor 330.

[0131] In some embodiments, the first retaining portion 352 and the second retaining portion 354 of the tether 350 are retained, secured, or otherwise coupled (e.g., removably or fixedly) to a carrier portion of the tension handle assembly 432. Longitudinal movement of the carrier portion relative to the first longitudinal main housing portion 430 extending away from the tip portion 429 (such as via the rear handle knob portion 434 and / or the threaded shaft portion 436) pulls the first and second holding portions 352, 354 through the instrument 400, pulling the head portion 314 of the dynamic bone anchor 310 against the tip portion 427 / 429 of the instrument 400, and once / when the dynamic bone anchor 310 is positioned against the tip portion 427 / 429, pulling the tether 350 through the dynamic bone anchor 310 and the soft bone anchor 330, shortening the length of and / or applying tension to the intermediate portion 356 extending between the dynamic bone anchor 310 and the soft bone anchor 330.

[0132] In some embodiments, the first retaining portion 352 and the second retaining portion 354 of the tether 350 are retained, secured, or otherwise coupled (e.g., detachably or fixedly) to the post portion 442 of the carrier portion (e.g., to / with at least one post 443). Longitudinal movement of the post portion 442 relative to the main housing portion 430 in a first longitudinal direction extending away from the tip portion 429 (e.g., via the rear handle knob portion 434 and / or the threaded shaft portion 436) pulls the first and second retention portions 352, 354 through the instrument 400, pulls the head portion 314 of the dynamic bone anchor 310 against the tip portion 427 / 429 of the instrument 400, and pulls the tether 350 through the dynamic bone anchor 310 and the soft bone anchor 330 once the dynamic bone anchor 310 is positioned against the tip portion 427 / 429, shortening the length of and / or applying tension to the intermediate portion 356 extending between the dynamic bone anchor 310 and the soft bone anchor 330.

[0133] 52-55, 58, and 59, in some embodiments, the first and second loop portions 352A, 354A of the first and second retention portions 352, 354 of the tether 350 may be retained, fixed, or otherwise coupled, such as removably retained, fixed, or otherwise coupled, to the tensioning handle assembly 432. For example, in some embodiments, the first and second loop portions 352A, 354A may be retained, fixed, or otherwise coupled, such as removably retained, fixed, or otherwise coupled, to a carrier portion of the tensioning handle assembly 432. In some such embodiments, the first and second loop portions 352A, 354A may be retained, fixed, or otherwise coupled, such as removably retained, fixed, or otherwise coupled, to a post portion 442 of the carrier portion. For example, in some embodiments, the first loop portion 352A and the second loop portion 354A can be looped over at least one post 443 of the post portion 442 of the carrier portion (i.e., at least one post 443 extends into the interior of the respective loop) and can extend over the engagement side 444 of the sleeve portion 440, as shown in Figures 52-55, 58 and 59.

[0134] As described above, in embodiments in which the first loop portion 352A and the second loop portion 354A couple to at least one post 443 of the post portion 442 of the carrier portion, the first loop portion 352A and the second loop portion 354A may be released or decoupled from the post portion 442 by longitudinally forward movement of the release member 437 (e.g., via the engagement end 438), as shown in FIG. 60 . A user can longitudinally forward move the release member 437 toward the tip portion 427 / 429, such as by depressing the engagement end 438, as shown in FIG. 60 , urging the post portion 442 longitudinally forward against the sleeve portion 440 so that the tip / end of the at least one post 443 is positioned below / below the engagement side 444 of the sleeve portion 440. In such an arrangement, the first loop portion 352A and the second loop portion 354A are no longer looped over / around the at least one post 443 and can move freely from the carrier portion. Once released from at least one post 443, tensioning / pulling the free ends of the first and second retaining portions 352, 354 longitudinally forward (e.g., by pulling / moving the device 400 longitudinally rearward) can cause the first and second loop portions 352A, 354A to move longitudinally forward, reducing the size / length of the first and second loop portions 352A, 354A until they contract and / or clamp onto the ends of the first and second retaining portions 352, 354 and above the head portion 314 of the dynamic bone anchor 310.

[0135] In some embodiments, as shown in Figures 52-55, 58 and 59, first loop portion 352A and second loop portion 354A can extend through passage 426 in tip member 427, through a portion of the internal cavity of main housing portion 430 (which can include extending through one or more passages, cannulations, or openings in the tension indicator assembly or portion), to tension handle assembly 432, e.g., to carrier portion, e.g., to post portion 442, e.g., around at least one post 443 of post portion 442, and over engagement side 444 of sleeve portion 440.

[0136] In some embodiments, ends of first and second holding portions 352, 354 can be retained, secured, or otherwise coupled (removably or fixedly) to a portion of instrument 400, as shown in FIGS. 52-55, 58, and 59. In some such embodiments, portions of first and second holding portions 352, 354 may not be coupled to tension handle portion 432, as shown in FIGS. 52-55, 58, and 59. For example, in some embodiments, ends of first and second holding portions 352, 354 can be retained, secured, or otherwise coupled directly or indirectly to main housing portion 430, such as within an interior cavity of main housing portion 430, as shown in FIGS. 52-55, 58, and 59. In some such embodiments, the ends of the first and second retaining portions 352, 354 can be coupled (removably or fixedly) to a portion of a tension indicator assembly or portion, as shown in FIGS. 52-55, 58, and 59. In some other embodiments, the ends of the first and second retaining portions 352, 354 can be coupled (removably or fixedly) to a tension handle assembly 432, e.g., a carrier portion, e.g., post portion 442 and / or sleeve portion 440. In some embodiments, the first and second ends of the first and second retaining portions 352, 354 can extend through the passageway 426 of the tip member 427 and through a portion of the internal cavity of the main housing portion 430 (which can include extending through one or more passageways, cannulations, or openings in the tension indicator assembly or portion), as shown in FIGS. 52-55, 58, and 59.

[0137] Thus, the instrument 400 is configured to tension (longitudinally rearwardly) the first and second retention portions 352, 354 by longitudinally moving the tensioning handle portion 432 (e.g., at least the carrier portion and / or post portion 442 thereof) relative to the main housing portion 430. Longitudinal rearward movement of the tensioning handle portion 432 relative to the main housing portion 430 pulls the tether 350 through the instrument 400 (e.g., the tip member 427 and the main housing portion 430), pulling and seating the dynamic bone anchor 310 (such as its head portion 314) relative to the instrument 400 (e.g., against the forward tip of the tip member 427 (when not already seated / held thereon)), as shown in Figures 52-55, 58, and 59. Additionally, when the dynamic bone anchor 310 is seated / held against the tip portion 427 / 429 (e.g., the forward tip of the tip member 427) of the instrument 400, rearward longitudinal movement of the tension handle portion 432 relative to the main housing portion 432 draws / pulls / moves the tether 350 through the dynamic bone anchor 310 and the soft bone anchor 330, shortening the length of the mid-loop portion 356, thereby drawing the dynamic bone anchor 310 and the soft bone anchor 330 closer together (which may seat the dynamic bone anchor 310 and / or the soft bone anchor 330 against the bone and / or bone plate or other hardware attached to the bone and / or displace the bone) and / or tension the mid-loop portion 356 extending between the dynamic bone anchor 310 and the soft bone anchor 330 (resulting in compression or restriction of the joint between the bones).Longitudinal movement of tension handle portion 432 relative to main housing portion 430 in a first longitudinal direction extending away from tip portion 429 (e.g., via rear handle knob portion 434 and / or threaded shaft portion 436) pulls first loop portion 352A and second loop portion 354A through instrument 400, pulling head portion 314 of dynamic bone anchor 310 against tip portions 427 / 429 of instrument 400, and thereby Once the anchor 310 is positioned relative to the tip portion 427 / 429, pulling the tether 350 through the dynamic bone anchor 310 and the soft bone anchor 330 expands the first loop portion 352A and the second loop portion 354A, shortening the length of the intermediate portion 356 extending between the dynamic bone anchor 310 and the soft bone anchor 330 and / or applying tension to the intermediate portion 356, as shown in Figures 52-55, 58 and 59.

[0138] As described above in this specification, the tension handle portion 432 (e.g., at least the carrier portion and / or post portion 442 thereof) can be moved longitudinally rearward relative to the main housing portion 430, thereby manually sliding the threaded shaft portion 436 longitudinally (e.g., manually pulling the rear handle knob portion 434 longitudinally) and / or manually rotating the threaded shaft portion 436 in a first rotational direction (e.g., by rotating the rear handle knob portion 434), thereby threadably moving / translating the tension handle portion 432 longitudinally rearward relative to the main housing portion 430.

[0139] It should be noted that due to the nature / configuration of implant system 300, tension applied to intermediate loop portion 356 of tether 350 between dynamic bone anchor 310 and soft bone anchor 330 is maintained after first retaining portion 352 and second retaining portion 354 are detached or released from device 400 (e.g., from post portion 442) and before first loop portion 352A and second loop portion 354A are contracted and / or tightened onto the ends of first and second retaining portions 352 and second retaining portions 354 and above head portion 314. For example, the tether 350 experiences a significant amount of friction against itself and the soft bone anchor 330 as it extends therethrough (several times), and against itself and the components of the dynamic bone anchor 310 (e.g., anchor body 312, deformable bumper 318, tether post 320, and head portion 314) as it extends through its cannulations and passageways (several times). Such friction is at least sufficient to prevent the tether 350 from slipping through the soft bone anchor 330 and / or dynamic bone anchor 310, thereby expanding the intermediate loop portion 356 between the soft bone anchor 330 and the dynamic bone anchor 310 and thereby losing / reducing its tension.

[0140] As shown in Figures 40-43, 45-48, and 52-59, the device 400 can include a tension indicator feature, as described above. The tension indicator feature provides a user with a visual indication of whether or not a threshold amount of tension has been applied to the tether 350 (mid-loop portion 356) between the soft bone anchor 330 and the dynamic bone anchor 310 via the device 400 (and indicates the extent to which the tension exceeds the threshold). The tension indicator feature can include a tension indicator assembly mating with the main housing portion 430 and the dynamic bone anchor 310 and a reference portion of the main housing portion 430, as shown in Figures 41, 42, 43, 45, 52-55, 58, and 59. The tension indicator feature can be configured to utilize tension applied to the first and second retention portions 352, 354 of the dynamic bone anchor 310 to create tension in the mid-loop portion 356 and provide a visual indication.

[0141] As shown in Figures 41, 42, 43, 45, 52-55, 58, and 59, the tension indicator assembly may include a tip member 427, a resilient / elastic member (e.g., a spring or bumper) 488, and an indicator body 480. The indicator body 480 may include an indicator portion 484 having a visual indication 485 and a body member or portion 482. As also shown in Figures 41, 42, 43, 45, 52-55, 58, and 59, the front portion of the main housing portion 430 may include an interior indicator cavity or recess 486 extending laterally and longitudinally between the front and rear walls or dividers.

[0142] 41 , 42 , 43 , 45 , 52-55 , 58 and 59 , the tip member 427 extends into the indicator cavity 486, and the resilient member 488 is longitudinally disposed between the rear wall of the indicator cavity 486 and the tip member 427. The resilient member 488 biases or positions the tip member 427 longitudinally forward relative to the front wall of the indicator cavity 486. This allows the tip member 427 to be longitudinally movably coupled within the main housing portion 430 (within the indicator cavity 486), and the resilient member 488 resists movement of the tip member 427 rearward relative to the main housing portion when the dynamic bone anchor 310 contacts the tip / end of the tip member 427 and the first and second retaining portions 352, 354 are tensioned by the tensioning handle portion 432.

[0143] The body member or portion 482 of the indicator body 480 can extend longitudinally through at least a portion of the resilient member 488 and can be adjacent to or coupled to the tip member 427. Rearward longitudinal movement of the tip member 427 thereby causes rearward longitudinal movement of the indicator body 480. As shown in FIGS. 41 , 42 , 43 , 45 , 52-55 , 58 and 59 , in some embodiments, the body member or portion 482 of the indicator body 480 can comprise a tube or similar member defining an internal passageway and extending longitudinally through at least a portion of the resilient member 488. The first and second retention portions 352, 354 (e.g., the ends of the first and second retention portions 352, 354 and / or the intermediate loop portions 352A, 354A of the first and second retention portions 352, 354) can extend longitudinally from the head portion 314 of the dynamic bone anchor 310 into the tension handle portion 432 / interior cavity of the instrument 400 by extending longitudinally through the passage 426 of the tip member 427 and the interior passage of the body member or portion 482 of the indicator body 480, as shown in Figures 41, 42, 43, 45, 52-55, 58 and 59.

[0144] 52-55, 58, and 59, the ends of the first and second retention portions 352, 354 of the tether 350 may be coupled (e.g., fixedly coupled) to a tension indicator assembly, such as the indicator body 480. Thus, when the first and second retention portions 352, 354 of the tether 350 are tensioned, thereby applying tension to the intermediate loop portion 356 between the soft bone anchor 330 and the dynamic bone anchor 310, the tension in the ends of the first and second retention portions 352, 354 causes the indicator body 480 to be pulled / tensioned longitudinally forward, e.g., against the front wall of the indicator cavity 486.

[0145] As shown in Figures 40-43, 45-48 and 52-59, indicator portion 484 having visual indicia 485 of indicator body 480 may be positioned within the inner cavity of tension handle portion 432 / instrument 400, directly beneath / below the outer wall of tension handle portion 432. As also shown in Figures 40-43, 45-48 and 52-59, tension handle portion 432 includes an indicator window 490 (e.g., an opening aligned with indicator portion 484) having at least one visual reference portion or indicia 492 through which indicator portion 484 having visual indicia 485 of indicator body 480 is exposed.

[0146] The tension indicator feature is configured such that when the head portion 314 of the dynamic bone anchor 310 is held / adjacent / abuts against the tip / end of the tip member 427 and tension is applied to the intermediate loop portion 356 between the soft bone anchor 330 and the dynamic bone anchor 310 via tension in the first and second retaining portions 352, 354 (e.g., the ends of the first and second retaining portions 352, 354 and / or the intermediate loop portions 352A, 354A of the first and second retaining portions 352, 354), the tip portion 427 is pulled / tensioned longitudinally backward relative to the elastic member 488. If such tension is below the strength / resilience / spring constant of the elastic member 488, the tip portion 427, and thus the indicator body 480 (having the indicator portion 484 / visual indication 485) will not move longitudinally rearward, and the visual indication 485 will be positioned longitudinally forward within the indicator window 490 relative to at least one visual reference portion or indication 492, as shown in Figures 52-56.

[0147] However, if the longitudinal rearward pulling force applied to the tip portion 427 via the dynamic bone anchor 310 by the first and second retaining portions 352 and 354 (e.g., the ends of the first and second retaining portions 352 and 354 and / or the intermediate loop portions 352A, 354A of the first and second retaining portions 352 and 354) is greater than the strength / resilience / spring constant of the elastic member 488, the tip portion 427, and thus the indicator body 480 (having the indicator portion 484 / visual indication 485) will move longitudinally rearward, and the visual indication 485 will move longitudinally forward relative to at least one visual reference portion or indication 492 within the indicator window 490, as shown in Figures 57-59. The strength / resilience / spring constant of the elastic member 488 and / or indicator window 490 and at least one visual reference portion or indicia 492 can thereby be configured or selected to correlate to a particular tension threshold (or force range threshold). The particular strength / resilience / spring constant of the elastic member 488 (and / or the position of the indicator window 490 and at least one visual reference portion or indicia 492) thereby serves as a tension threshold. Above this tension threshold, tension must be applied to the intermediate loop portion 356 between the soft bone anchor 330 and the dynamic bone anchor 310 via tension in the first and second retention portions 352, 354 (e.g., the ends of the first and second retention portions 352, 354 and / or the intermediate loop portions 352A, 354A of the first and second retention portions 352, 354). This causes the visual representation 485 to move relative to the indicator window 490 and relative to at least one visual reference portion or representation 492, thus providing the user with an indication of the tension being applied to the intermediate loop portion 356 (and thereby, e.g., across the joint).

[0148] To dynamically stabilize the distal tibiofibular joint, the implant system 100 or 300 can be implanted across the joint using the instrument 400. For example, referring to the implant system 300 for illustrative purposes only, the implant system 300 can be loaded / held / configured in the instrument 400. A soft bone anchor 330 can be held in the bifurcated free end 410 of the first portion 412 of the instrument 400, and the head portion 314 of the dynamic bone anchor 410 can be held in a recess / cavity formed by the recess 425 of the tip member 427 and the medial side portion 423 of the base portion 420 of the first portion 412. The first and second retaining portions 352, 354 (e.g., the ends of the first and second retaining portions 352, 354 and / or the intermediate loop portions 352A, 354A of the first and second retaining portions 352, 354) extend into the instrument 400 through the passage 426 of the tip member 427 and the passage of the indicator body 480.

[0149] Ends of first and second retaining portions 352, 354 are secured to instrument 400, such as indicator body 480. First and second intermediate loop portions 352A, 354A extend within main housing portion 430 to and are removably coupled to carrier portion 440. First intermediate loop portion 352A is looped over first post 443 of post portion 442 and extends on / over engagement surface 444 of sleeve portion 440. Second intermediate loop portion 354A is looped over second post 443 of post portion 442 and extends on / over engagement surface 444 of sleeve portion 440. The first and second retaining portions 352, 354, and potentially the intermediate loop portion 356 may be under some tension to relatively securely hold the soft bone anchor 330 on the bifurcated free end 410 and the head portion 314 of the dynamic bone anchor 410 on the recess 425 of the tip member 427.

[0150] With the implant system 300 attached and held in the instrument 400, the instrument 400 can be manually manipulated / steered to introduce the soft bone anchor 330 into a hole (e.g., a drilled hole) in the fibula, pass through it, and ultimately be placed into a hole in the adjacent tibia or pass through the outer surface of the tibia.

[0151] After the soft bone anchor 330 is inserted into / on the tibia at the desired location, the instrument can be manually pulled backward / rearward in the direction opposite to the direction of insertion, such as by manually grasping the distal portion 429 of the instrument 4000 and pulling backward / rearward. Such a backward / rearward force / movement causes the soft bone anchor 330 to deform to an enlarged size and be securely held in / on the tibia. A backward / rearward force / movement can also detach / disconnect the soft bone anchor 330 from the bifurcated free end 410.

[0152] Once the soft bone anchor 330 is securely implanted, the first portion 412 of the device 400 can be detached from the second portion 113. For example, the second portion 113 can be manually moved / slid laterally relative to the first portion (toward the exposed internal tether 350), releasing the second portion 113 from the first portion 112 and exposing the dynamic bone anchor 310. Once severed, the first portion 112 can be removed from the patient (e.g., from the fibula) by pulling it directly back from the limb.

[0153] After the first portion 112 is decoupled from the second portion 113 and the first portion 112 is removed from the patient, the instrument 400 can be used to implant the dynamic bone anchor 310 into the fibula. For example, while maintaining tension on the dynamic bone anchor 310 from the intermediate loop portion 356 by pulling / holding the loop / ring 433 of the handle knob portion 434 of the tension handle portion 432 backward / rearward, a user can manually slidably push / move the main housing portion 430 longitudinally forward relative to the tension handle portion 432 toward the fibula to advance the dynamic bone anchor 310 toward the fibula. Once the dynamic bone anchor 310 approaches the fibula (which may include a bone plate coupled to the fibula), the anchor body 312 of the dynamic bone anchor 310 can be inserted into a hole in the fibula and / or bone plate, and the dynamic bone anchor 310 can be slidably advanced further longitudinally until the head portion 314 seats against the fibula and / or bone plate.

[0154] With the dynamic bone anchor 310 seated against the fibula and / or bone plate, the tension handle portion 432 can be manually rotated (e.g., via the loop / ring 433 of the handle knob portion 434) in a first rotational direction (e.g., clockwise or counterclockwise) relative to the tension handle portion 432 to fine-tune the size / length of the intermediate loop portion 356 and adjust the distance between the soft bone anchor 330 and the dynamic bone anchor 310, thereby adjusting the position of the dynamic bone anchor 310 relative to the fibula / bone plate and / or applying a specific amount of tension to the intermediate loop portion 356 (thereby across the joint between the tibia and fibula). For example, the tension handle portion 432 can be adjusted longitudinally (slidably and / or rotatably) relative to the main housing portion 430 until the tension applied to the intermediate loop portion 356 (and thereby across the joint between the tibia and fibula) via the first retaining portion 352 and the second retaining portion 354 reaches a tension threshold of the tension indicator function, causing the tension indicator function to indicate that a proper or appropriate level of tension is present.

[0155] After the dynamic bone anchor 310 is seated and tension in the intermediate loop portion 356 is set, a user can actuate the release member 437 by depressing the rear engagement end 438 of the release member 437, releasing the first and second intermediate loop portions 352A, 354A from the posts 443 of the carrier portion post portion 442. With the first and second intermediate loop portions 352A, 354A released, the user can pull the device 400 away from the limb, extending the ends of the first and second retaining portions 352, 354 and retracting the first and second intermediate loop portions 352A, 354A over the ends of the first and second retaining portions 352, 354 and the head portion 314 of the dynamic bone anchor 310. Once the first and second intermediate loop portions 352A, 354A are shortened onto the ends of the first and second retaining portions 352, 354 and the head portion 314 of the dynamic bone anchor 310, the first and second retaining portions 352, 354 can be manually pulled / tensioned in opposing directions (e.g., approximately aligned with the axis of the fibula) to securely couple the first and second retaining portions 352, 354 to the head portion 314 of the dynamic bone anchor 310. If desired, the first and second retaining portions 352, 354 may or may not be tied (e.g., via one or more surgical knots). Any excess lengths of the first and second retaining portions 352, 354 may eventually be trimmed from the construct.

[0156] As those skilled in the art will recognize based on the teachings herein, numerous changes and modifications can be made to the above-described and other embodiments of the present disclosure without departing from the scope of the present disclosure. Moreover, the implants and systems may include more or fewer components or features than the embodiments described and illustrated herein. Therefore, this detailed description of the presently preferred embodiments should be interpreted as illustrative, rather than limiting, of the present disclosure.

[0157] Similarly, positions or orientations may be used herein with reference to anatomical structures or surfaces. Furthermore, for purposes of brevity, implants, systems, devices, instruments, and methods, as well as aspects, components, features, etc., that may be disclosed herein, are described with respect to one side of the body. However, because the human body is relatively symmetrical or mirrored about a line of symmetry (the midline), it is expressly contemplated that the implants, systems, devices, instruments, and methods, as well as aspects, components, features, etc., described and / or illustrated herein may be altered, varied, modified, reconfigured, or otherwise modified for use with or in association with another side of the body for the same or similar purposes without departing from the spirit and scope of the present invention. For example, implants, devices, systems, instruments, and methods, as well as aspects, components, features, etc., described herein with respect to a right syndesmotic joint (right ankle / leg) may be mirrored or otherwise reconfigured to function similarly with a left syndesmotic joint (left ankle / leg), if necessary or desirable. Additionally, although the implants, systems, devices, instruments, and methods, and aspects, components, features, etc., disclosed herein are described with respect to the distal tibiofibular ligament syndesmosis, it should be understood that the implants, systems, devices, instruments, and methods may be used with other bones of the body having similar structures.

[0158] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Furthermore, the terms "comprise" (and all forms of "comprise," such as "comprises" and "comprising"), "have" (and all forms of "have," such as "has" and "having"), "include" (and all forms of "include," such as "includes" and "including"), and "contain" (and all forms of "contain," such as "contains" and "containing") will be further understood to be open-ended linking verbs. Consequently, a method or apparatus that "comprises," "has," "includes," or "contains" one or more steps or elements has those one or more steps or elements, but is not limited to having only those one or more steps or elements. Similarly, a method step or apparatus element that "comprises," "has," "includes," or "contains" one or more features has those one or more features, but is not limited to having only those one or more features. Furthermore, an apparatus or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways not recited.

[0159] This disclosure has been described with reference to preferred embodiments. It will be understood that the architectural and operational embodiments described herein are illustrative of multiple possible arrangements for providing the same general features, characteristics, and general system operation. Modifications and changes may occur to others upon reading and understanding the foregoing detailed description. It is intended that this disclosure be construed to include all such modifications and changes.

Claims

1. 1. An implant system for dynamic stabilization of a syndesmotic joint, comprising: Soft bone anchors and Dynamic bone anchors and a tether coupled to the soft bone anchor and the dynamic bone anchor and extending between the soft bone anchor and the dynamic bone anchor; Equipped with a first retention portion and a second retention portion of the tether are knotlessly coupled to the dynamic bone anchor, and an intermediate portion of the tether extending between the first retention portion and the second retention portion passes through the soft bone anchor; an inner portion of the intermediate portion extending to and elastically coupling to the dynamic bone anchor; Implant system.

2. the soft anchor is configured to deform to a compact expanded shape under tension in the intermediate portion of the tether. The system of claim 1 .

3. The soft anchor is configured as a suture anchor.

3. The system according to claim 1 or 2.

4. the dynamic bone anchor comprises a head portion at one end and a body portion at an opposing end, the head portion and the body portion being cannulated; A system according to any one of claims 1 to 3.

5. the first and second holding portions pass through cannulations in the head portion and the body portion and exit through openings in the head portion; The system of claim 4.

6. the dynamic bone anchor comprises a resilient bumper and a movable tether post within a cannulation in the head portion; The system of claim 5.

7. the elastic bumper and the tether post are cannulated, and the first retention portion and the second retention portion pass through the cannulations of the elastic bumper and the tether post. The system of claim 6.

8. The resilient bumper is held between an end of the body portion and the tether post. The system of claim 7.

9. the inner portion of the intermediate section extends around a portion of the tether post and through the cannulation in the elastic bumper. The system of claim 8.

10. the inner portion of the intermediate portion of the tether forms a loop extending from the soft bone anchor. The system of claim 9.

11. the first retaining portion extends through a cannulation in the head portion, out a first opening in the head portion, over a portion of the outer top, down to a second opening in the head portion and into the cannulation therein, and back up through a fourth opening in the head portion; 11. A system according to any one of claims 5 to 10.

12. the second holding portion extends through the cannulation in the head portion, out the second opening in the head portion, over a portion of the outer top portion, down to the first opening in the head portion and into its cannulation, and back up through a third opening in the head portion; The system of claim 11.

13. the portions of the first and second retention portions extending over a portion of the outer top form first and second retention loops located beyond the outer top of the head portion; The system of claim 12.

14. a portion of the first holding portion extending from the fourth opening and a portion of the second holding portion extending from the third opening pass under at least one of the first holding loop and the second holding loop, respectively; The system of claim 13.

15. the first opening and the second opening open to respective sides of the head portion; 15. A system according to any one of claims 11 to 14.

16. the third opening and the fourth opening are surrounded by an upper side of the head portion at an upper side of the head portion; The system of claim 15.

17. the enlarged upper portion of the head portion has a rectangular cross-sectional shape; 17. A system according to any one of claims 5 to 16.

18. the enlarged upper portion of the head portion includes first and second lateral sides having tapered lower surfaces extending laterally beyond the base portion of the head portion, and third and fourth lateral sides extending between the first and second lateral sides and not extending laterally beyond the base portion; 20. The system of claim 17.

19. the tether is a suture; 19. A system according to any one of claims 1 to 18.

20. Further, an insertion and tensioning tool is provided; the soft bone anchor is removably retained at a free end of the first portion of the instrument; the dynamic bone anchor is removably retained on at least one of the first and second portions of the device; 20. A system according to any one of claims 1 to 19.

21. the first portion removably couples to the second portion; 21. The system of claim 20.

22. the first portion removably couples to the second portion via a laterally disposed dovetail coupling arrangement; 22. The system of claim 21.

23. the first portion comprises a base portion removably coupled to a distal end portion of the second portion, and a longitudinally elongated inserter portion extending longitudinally from the base portion to the free end.

23. A system according to any one of claims 20 to 22.

24. the free end of the inserter portion is bifurcated; 24. The system of claim 23.

25. the bifurcated free end of the inserter portion includes a pair of tines and a base retaining portion extending therebetween, and a pair of grooves extending longitudinally proximally from the base retaining portion of the bifurcated free end.

25. The system of claim 24.

26. an end of the soft bone anchor extends over the groove and an inner portion of the soft bone anchor extends over the base retaining portion between the pair of tines; 26. The system of claim 25.

27. the intermediate portion of the tether extends longitudinally from the soft bone anchor at the free end of the inserter portion along the inserter portion to the dynamic bone anchor; 27. The system of claim 26.

28. The head portion of the dynamic bone anchor is held in a recess in the distal end portion of the second portion.

28. A system according to any one of claims 20 to 27.

29. a base portion of the first portion extending partially over a recess in a tip portion of the second portion when the first portion is removably coupled to the second portion; at least a portion of the head portion is disposed between the recess and the base portion when the first portion is removably coupled to the second portion to removably retain the dynamic bone anchor on the device.

29. The system of claim 28.

30. The second portion of the instrument comprises a main housing portion and a tensioning handle portion manually movably coupled to the main housing portion.

30. A system according to any one of claims 20 to 29.

31. the first and second retention portions of the tether are removably retained on the tension handle portion, and when the dynamic bone anchor is pulled relative to the instrument, rotation of the tension handle portion relative to the main housing portion pulls the tether through the dynamic bone anchor and the soft bone anchor, shortening the length of and / or tensioning the intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

31. The system of claim 30.

32. the first retention portion and the second retention portion of the tether are removably retained in the tensioning handle portion, and rotation of the tensioning handle portion relative to the main housing portion pulls the tether through the main housing portion and tensions the dynamic bone anchor relative to the device.

32. A system according to claim 30 or 31.

33. the tensioning handle portion is longitudinally slidably coupled to the main housing portion, and longitudinal movement of the tensioning handle portion in a first direction extending away from the distal end of the second portion of the instrument tensions the tether through the main housing portion and tensions the dynamic bone anchor relative to the distal end.

33. A system according to any one of claims 30 to 32.

34. the tensioning handle portion is longitudinally slidably coupled to the main housing portion, and longitudinal movement of the tensioning handle portion in a first longitudinal direction extending away from a distal portion of the second portion of the instrument pulls the tether through the dynamic bone anchor and the soft bone anchor when the dynamic bone anchor is pulled relative to the distal portion, thereby shortening a length of and / or tensioning the intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

34. A system according to any one of claims 30 to 33.

35. the second portion of the instrument further comprises at least one ratchet member having at least one tooth and coupled to the main housing portion; the at least one ratchet member is resiliently biased against an externally threaded shaft portion of the tensioning handle portion, the tensioning handle portion being rotatably coupled to the main housing portion and longitudinally slidably coupled to the main housing portion; 35. A system according to claim 33 or 34.

36. the at least one ratchet member prevents the tension handle portion from slidably moving relative to the main housing portion along a second longitudinal direction opposite the first longitudinal direction.

36. The system of claim 35.

37. the first retention portion and the second retention portion of the tether comprising opposing ends of the tether; 37. A system according to any one of claims 30 to 36.

38. the first retention portion and the second retention portion of the tether each extend through a head portion of the dynamic bone anchor and beyond an upper outer portion of the head portion; 38. A system according to any one of claims 30 to 37.

39. the first retention portion of the tether forms a first loop portion extending from a head portion of the dynamic bone anchor beyond an upper lateral surface of the head portion, and a first end portion extending from the head portion beyond the upper lateral surface of the head portion; the second retention portion of the tether forms a second loop portion extending from the head portion beyond the outer top and a second end portion extending from the head portion beyond the outer top.

39. A system according to any one of claims 30 to 38.

40. the first end of the first retention portion of the tether extends over the outer upper portion and through the first loop portion and the second loop portion, and the second end of the first retention portion of the tether extends over the outer upper portion and through the first loop portion and the second loop portion to knotlessly couple the first retention portion and the second retention portion to the dynamic bone anchor; 40. The system of claim 39.

41. the first retention portion of the tether extends from the interior passageway of the head portion through a first opening in the head portion, over a portion of the outer upper portion, and back to the interior passageway through a second opening in the head portion to form the first loop portion; the first retention portion of the tether extends from the second opening through the interior passage, past the outer top portion, and through a third opening in the head portion to form the first end; 41. A system according to claim 39 or 40.

42. the second retention portion of the tether extends from the interior passageway through the second opening in the head portion, over a portion of the outer top portion, back to the interior passageway through the first opening in the head portion, and forms the second loop portion; the first retention portion of the tether extends from the first opening through the interior passage, past the outer top portion, and through a fourth opening in the head portion to form the second end.

42. The system of claim 41.

43. the first loop portion and the second loop portion extend through a distal end portion of the second portion, through a portion of the main housing portion, and to a carrier portion of the tension handle portion; the first loop portion and the second loop portion removably couple to the carrier portion.

43. A system according to any one of claims 39 to 42.

44. movement of the tension handle portion relative to the main housing portion in a first direction extending away from the tip portion causes movement of the carrier portion in the first direction extending away from the tip portion, pulling the first loop portion and the second loop portion through the main housing portion and the head portion of the dynamic bone anchor relative to the tip portion; 44. The system of claim 43.

45. movement of the tension handle portion relative to the main housing portion in a first direction extending away from the tip portion causes movement of the carrier portion in a first direction extending away from the tip portion such that when the dynamic bone anchor is pulled relative to the tip portion, the first loop portion and the second loop portion expand, pulling the tether through the dynamic bone anchor and the soft bone anchor and shortening the length of and / or tensioning the intermediate portion extending between the dynamic bone anchor and the soft bone anchor; 45. The system of claim 44.

46. the carrier portion comprises a sleeve portion within the main housing portion having at least one opening, and a post portion within the main housing portion having at least one post extending in a first direction away from the tip portion; the sleeve portion and the post portion are biased in a first relative configuration, and the at least one post extends through the at least one opening and past the mating side of the sleeve; 46. ​​A system according to any one of claims 43 to 45.

47. the first loop portion and the second loop portion extend around the at least one post and over the engagement side of the sleeve portion; 47. The system of claim 46.

48. the carrier portion further comprises a release member exposed at a rear end of the tension handle portion and extending to the post portion; the tension handle portion is configured such that movement of the release member in a second direction opposite the first direction causes the post portion to move relative to the sleeve portion in the second direction such that the at least one post is positioned under the engagement side of the sleeve portion to release the first loop portion and the second loop portion from the at least one post.

48. The system of claim 47.

49. the first retaining portion and the second retaining portion are coupled to the tension handle portion; the device is configured such that movement of the tension handle portion relative to the main housing portion applies tension to the first and second retention portions.

49. A system according to any one of claims 30 to 48.

50. the instrument is configured such that tensioning the first and second holding portions via the tension handle portion pulls the head portion of the dynamic bone anchor against the distal portion of the second portion, pulling the tether through the dynamic bone anchor and the soft bone anchor to shorten the length of and tension the intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

50. The system of claim 49.

51. the distal end portion of the second section includes a distal end member longitudinally movably coupled to a front portion of the main housing section; the second portion further comprising a resilient member configured to resiliently resist movement of the tip portion relative to the main housing portion toward a rear of the main housing portion when the dynamic bone anchor contacts the tip portion and the first and second retention portions are tensioned by the tension handle portion.

51. The system of claim 50.

52. the second portion further comprises a tension indicator longitudinally movably coupled to the main housing portion, the tension indicator comprising an indicator portion having a visually exposed visual indicia adjacent a reference portion of the main housing portion; the tension indicator engages a tip member and provides a visual indication of tension in the first retention portion and the second retention portion by resiliently resisted movement of the tip portion relative to the main housing toward the rear of the main housing, thereby providing a visual indication of tension in the intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

52. The system of claim 51.

53. the second portion further comprises a tension indicator longitudinally movably coupled to the main housing portion, the tension indicator comprising an indicator portion having a visually exposed visual indicia adjacent a reference portion of the main housing portion; tension in the first and second retention portions exceeding a threshold causes the visual indication to move longitudinally relative to the reference portion to provide a visual indication of the tension in the first and second retention portions, thereby providing a visual indication of the tension in the intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

50. The system of claim 49.

54. a first loop portion and a second loop portion of the first holding portion and the second holding portion, respectively, coupled to the tension handle portion; wherein movement of the tension handle portion relative to the main housing portion applies tension to the first and second holding portions.

54. A system according to any one of claims 30 to 53.

55. a first end and a second end of the first and second holding portions, respectively, secured to the instrument; 55. The system of claim 54.

56. The first and second ends of the first and second holding portions, respectively, are secured to the instrument within the main housing portion and are not secured to the tension handle portion.

56. The system of claim 55.

57. a rearward end of the tension handle portion comprising a handle knob portion having a ring portion; 57. A system according to any one of claims 30 to 56.

58. 1. A method of dynamically stabilizing a distal tibiofibular joint, comprising: Obtaining an implant system according to any one of claims 1 to 57; implanting the soft bone anchor through the lateral fibula and into the lateral cortical cavity such that the intermediate portion extends between the lateral fibula and the lateral cortex; applying tension to the first and second retention portions to draw the dynamic bone anchor at least partially into the lateral cortex and induce tension in the intermediate portion extending between the dynamic bone anchor and the soft bone anchor, thereby inducing tension across the tibiofibular joint; Including, method.

59. Obtaining an implant system according to any one of claims 1 to 57 comprises obtaining an implant system according to any one of claims 20 to 57; Implanting the soft bone anchor through the lateral fibula and into the lateral cortical cavity includes implanting the soft bone anchor through the lateral fibula and into the lateral cortical cavity via manual manipulation of the insertion and tensioning instrument.

59. The method of claim 58.

60. and further comprising, after implanting the soft bone anchor through the lateral fibula and into the lateral cortical cavity, removing the first portion from the second portion of the device and separating the first portion from the soft bone anchor.

60. The method of claim 59.

61. Obtaining an implant system according to any one of claims 20 to 57 comprises obtaining an implant system according to any one of claims 30 to 57; applying tension to the first and second holding portions includes manually moving the tension handle portion and the main housing portion relative to one another.

61. The method of claim 59 or 60.

62. applying tension to the first and second retention portions includes moving a visual representation of the instrument relative to a reference portion of the instrument to provide a visual representation of the tension in the first and second retention portions, thereby providing a visual representation of the tension in the intermediate portion extending between the dynamic bone anchor and the soft bone anchor.

62. The method of any one of claims 58 to 61.

Images