System for embedding suture buttons

Abstract

To provide a suture button system for fixing a syndesmotic injury.SOLUTION: A suture button system comprises a flexible fixation implant and an inserter device used to deploy the implant across bones. The flexible fixation implant comprises a flexible connector and two suture buttons which interface with a bone surface or a bone plate or a bone washer. The flexible connector comprises a plurality of suture strands. The buttons have a feature part which allows them to interface with an instrument used to deploy the implant across the two bones. The inserter device is configured to interface with the flexible fixation implant and to position the flexible fixation implant across bones through a pre-drilled bone tunnel. The inserter device may comprise a cannulated insertion rod and a handle.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to the field of surgery, and more particularly to systems, devices and methods for bone fracture stabilization and fixation. [Background technology]

[0002] The ankle joint is made up of three bones: the tibia and fibula of the lower leg, and the talus of the foot. The tibia is the medial or inside bone of the ankle, and the fibula runs parallel to the tibia and makes up the lateral or outside bone of the ankle. One common ankle injury is a tear of the syndesmosis. An ankle syndesmosis is a tear of the tough fibrous ligaments that hold the fibula and tibia together near the ankle joint. When a syndesmosis is torn, the ankle joint becomes unstable and surgery is usually required.

[0003] Fixation methodology for ankle syndesmosis tears has advanced with the use of flexible suture-button devices to stabilize the distal tibiofibular joint. However, the current techniques used to achieve fixation have several drawbacks. Current techniques require incisions on both sides of the ankle and drilling holes completely through both the fibula and tibia. Furthermore, sutures must be manually held under tension while they are manually tied to complete fixation. This process often results in undesirable suture loosening, thereby reducing the degree of fixation that can be achieved. Furthermore, multiple knots may be required to tie the sutures, which often can cause soft tissue damage.

[0004] It would therefore be desirable to have a system, device, and method for use in fixation of syndesmosis injuries of the ankle that is robust and strong, while minimizing or eliminating the number and size of knots formed by the surgeon. It would also be desirable to provide a system, device, and method in which the system requires minimal number of components to attach the suture button to the bone and draw the tissue to the bone. There is also a need for a suture button, and a method of positioning such a button, that minimizes the surgical trauma associated with implanting a button of a certain size. Summary of the Invention

[0005] The present disclosure provides a suture button system that includes an implantable, flexible fixation construct that interfaces with an implant delivery instrument that is intended to improve ease of insertion and positioning of the construct. In particular, the suture button system is designed to provide flexible fixation to the ankle following syndesmosis rupture to allow healing of damaged ligaments and soft tissues. The primary objectives of the suture button system are (1) to aid in anatomical reduction to improve clinical outcomes, (2) to reduce soft tissue damage associated with open surgery, and (3) to simplify intraoperative procedures.

[0006] In one embodiment of the present disclosure, the suture button system comprises a flexible fixation implant and an inserter device used to deploy the implant across the bone. A flexible fixation implant according to the present disclosure typically includes a flexible connector and two suture buttons or suture anchors that interface with a bone surface or a bone plate or bone washer. The flexible connector includes multiple suture strands of braided suture, wire, spring, or other elastic material. The button or anchor typically has features that allow it to interface with an instrument used to deploy the implant across two bones. The inserter device is configured to interface with the implant and position the implant across the bone through a pre-drilled bone tunnel. The inserter device may include a cannulated insertion rod and a handle.

[0007] In a further non-limiting embodiment of the above-described system, the flexible fixation implant includes a medial button and an lateral button intended to be positioned on the medial side of the tibia and the lateral side of the fibula. In various embodiments, the medial button is generally oblong in shape configured to pass through a drilled hole and be deployed on the medial side of the tibia, and the lateral button is circular in shape configured to be positioned on the lateral side of the fibula or to interface with a fibula plate or washer.

[0008] In a further non-limiting embodiment of any of the above systems, the flexible connector includes a plurality of suture strands that are looped through the inner button and the outer button. In another embodiment, the suture strands are threaded through at least one hole in both the inner button and the outer button. In another embodiment, the flexible connector has at least one free end that extends through the outer button.

[0009] In a further non-limiting embodiment of the above system, the flexible connector includes two self-intersecting loop assemblies, one positioned through the inner button and the other positioned between the inner and outer buttons, formed by threading one section of the suture strand through another section of the suture strand such that the self-intersecting loop assembly contracts against the section of the suture strand through which it is threaded when the free end of the suture strand is tightened.

[0010] In a further non-limiting embodiment of the above system, one free end of the suture strand is secured to the inner button by a sturdy fastener that prevents pull-out, by forming a knot, by attaching the free end to the inner button, or by other fastening means, and the opposite end of the suture strand is threaded through the outer button and back through the inner button and looped.

[0011] In a further non-limiting embodiment of the above-described system, the flexible suture connector includes a suture passageway formed by loosening the braid of a portion of the suture strand and splicing another portion of the suture strand through the loosened portion of the suture strand.

[0012] According to one embodiment, the present disclosure provides a method for positioning a flexible fixation implant across bone comprising drilling a bone tunnel through from a lateral side of the fibula to a medial side of the tibia, providing a flexible fixation implant including an inner button, an outer button, and a flexible connector extending between the buttons, providing an inserter device having a cannulated insertion rod extending from a handle of the inserter device, attaching the inner button to the insertion rod of the inserter device, inserting the inner button through the bone tunnel until the inner button exits the medial side of the tibia, removing the inner button from the cannulated insertion rod of the inserter device, positioning the inner button so that it sits flat against the medial side of the tibia, withdrawing the inserter rod of the inserter device from the bone tunnel, and positioning the outer button on the lateral side of the fibula by applying tension to the flexible connector.

[0013] In a further non-limiting embodiment of the above method, attaching the inner button to the insertion rod of the inserter device includes inserting a tab of the inner button into the cannulated insertion rod of the inserter device and pulling the suture strand toward the handle of the inserter device.

[0014] In a further non-limiting embodiment of the above method, removing the inner button from the cannulated insertion rod of the inserter device comprises retracting the cannulated rod away from the inner button by means disposed on the handle.

[0015] In a further non-limiting embodiment of the above method, the flexible connector includes a plurality of suture strands that are looped through the inner button and the outer button. In another embodiment, the suture strands are threaded through at least one aperture in both the inner button and the outer button. In another embodiment, the flexible connector has at least one free end that extends through the outer button.

[0016] In a further non-limiting embodiment of the above method, positioning the internal button includes applying tension to at least one free end of the suture strand until the internal button device pivots from one position generally parallel to the tunnel to another position generally transverse to the tunnel.

[0017] According to one embodiment, the present disclosure provides an inserter device for positioning a flexible fixation implant. An exemplary inserter device of the present disclosure includes a cannulated insertion rod fixedly attached to a handle that contains structure for disengaging an internal button at the distal tip of the cannulated rod.

[0018] In a further non-limiting embodiment of the above-described device, the inner oblong button is secured to the cannulated rod via insertion of a tab located at one end of the inner button into the distal tip of the cannulated rod, the tab of the inner button working with tension in a suture looped between the inner button and an outer button positioned on the handle to secure the inner button to the distal tip of the cannulated rod.

[0019] In a further non-limiting embodiment of the above device, the inserter device may include a handle having a safety tap to prevent accidental button deployment. The safety tap may be located on a retraction trigger located on the handle. Once the safety tap is removed, the retraction trigger can be operated to retract the cannulated rod away from the inner button.

[0020] In a further non-limiting embodiment of the above-mentioned device, the inserter device of the present disclosure may include a tensioning handle configured to tension the outer button. The tensioning handle includes a removable proximal portion having two anchor points and a distal housing for receiving the outer button. Each anchor point is located on an opposite side of the proximal portion of the handle. The surgeon can deploy the tensioning handle by rotating the proximal portion of the handle a quarter turn counterclockwise and then lifting it from the distal housing. The proximal portion of the handle can then be separated into two halves, each held with two hands, to provide tension to the outer button.

[0021] In a further non-limiting embodiment of the above-mentioned device, the inserter device of the present disclosure may include a tensioning handle. The tensioning handle includes a removable proximal portion and a fixed distal portion. The removable proximal portion is coupled to the fixed distal portion by a mating groove and a friction fit, and the removable proximal portion can be separated from the fixed distal portion by rotating the proximal and distal portions of the handle in opposite directions. In one embodiment, the removable proximal portion can be separated from the fixed distal portion to retract the inner rod.

[0022] In view of the above, other aspects, features, details, utilities, and advantages of the disclosed embodiments will become apparent from the following description and claims, as well as the accompanying drawings. [Brief description of the drawings]

[0023] The following detailed description and examples are provided for the purpose of illustrating some, but not necessarily all, examples or embodiments of the present disclosure in a non-exhaustive manner and are not intended to limit the scope of the present disclosure in any way.

[0024] [Figure 1]1 shows a schematic diagram of a suture button implant positioned across the fibula and tibia at the lower tibiofibular joint. [Figure 2A] 2A and 2B show schematic perspective and side views of a round outer button according to the present disclosure. [Figure 2B] 2A and 2B show schematic perspective and side views of a round outer button according to the present disclosure. [Figure 3A] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 3B] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 3C] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 3D] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 3E] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 3F] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 3G] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 3H] 13 shows an alternative design for a round outer button according to the present disclosure. [Figure 4A] 4A and 4B show schematic perspective and top views of a horizontally elongated inner button according to the present disclosure. [Figure 4B] 4A and 4B show schematic perspective and top views of a horizontally elongated inner button according to the present disclosure. [Figure 5A] 13 shows an alternative design for a landscape inward button according to the present disclosure. [Figure 5B] 13 shows an alternative design for a landscape inward button according to the present disclosure. [Figure 6A] 1 illustrates an exemplary suture button assembly having a splice according to the present disclosure. [Figure 6B] 1 illustrates an exemplary suture button assembly having a splice according to the present disclosure. [Figure 7A]1 illustrates an alternative embodiment of a sewing button braided assembly according to the present disclosure. [Figure 7B] 1 illustrates an alternative embodiment of a sewing button braided assembly according to the present disclosure. [Figure 8] 1 illustrates one embodiment of a single splice suture braid assembly according to the present disclosure. [Figure 9] 1 illustrates one embodiment of a single-sided double splice braid assembly according to the present disclosure. [Figure 10] 1 illustrates one embodiment of a suturing assembly according to the present disclosure. [Figure 11] 1 illustrates one embodiment of a suturing assembly according to the present disclosure. [Figure 12] 13 shows an inwardly elongated button secured to a cannulated rod extending from the handle of an inserter device according to the present disclosure. [Figure 13A] A cross-sectional view of the stationary inner rod extending through the outer cannulated rod of the handle is shown. [Figure 13B] A cross-sectional view of the stationary inner rod extending through the outer cannulated rod of the handle is shown. [Figure 14A] The tension in the sutures is shown to prevent the horizontal button from popping out of the medial insertion rod. [Figure 14B] The tension in the sutures is shown to prevent the horizontal button from popping out of the medial insertion rod. [Figure 14C] The tension in the sutures is shown to prevent the horizontal button from popping out of the medial insertion rod. [Figure 15A] 13A-13C illustrate method steps for uncoupling an elongated button by retracting a cannulated rod away from the button using a pullback trigger on the inserter handle of an inserter device according to the present disclosure. [Figure 15B] 13A-13C illustrate method steps for uncoupling an elongated button by retracting a cannulated rod away from the button using a pullback trigger on the inserter handle of an inserter device according to the present disclosure. [Figure 15C]13A-13C illustrate method steps for uncoupling an elongated button by retracting a cannulated rod away from the button using a pullback trigger on the inserter handle of an inserter device according to the present disclosure. [Figure 16A] 13 illustrates method steps for tensioning an outer button with an integrated tensioning handle according to the present disclosure. [Figure 16B] 13 illustrates method steps for tensioning an outer button with an integrated tensioning handle according to the present disclosure. [Figure 16C] 13 illustrates method steps for tensioning an outer button with an integrated tensioning handle according to the present disclosure. [Figure 17A] 1 illustrates an embodiment of a self-drilling inserter according to the present disclosure. [Figure 17B] 1 illustrates an embodiment of a self-drilling inserter according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] It is to be understood that the disclosure is not limited to the particular devices, methods, protocols, and systems described herein, as such may vary. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the disclosure, which is defined only by the claims.

[0026] The terms used herein are for the purpose of describing particular embodiments only and are 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 unless the context clearly indicates otherwise. It will be further understood that as used herein, the terms "comprises" and / or "comprising" specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0027] The following detailed description and the accompanying drawings to which it refers are intended to illustrate some, but not necessarily all, examples or embodiments of the present disclosure. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The contents of this detailed description and the accompanying drawings are not intended to limit the scope of the present disclosure in any manner.

[0028] The present disclosure is directed to systems, devices, and methods for deploying a flexible fixation implant across two bones. For purposes of illustration, several exemplary embodiments are described in detail herein. The described systems, devices, and methods can also be utilized in other contexts.

[0029] In one embodiment of the present disclosure, a suture button system comprises a flexible fixation implant and an inserter device that is used to deploy the implant across two bones. Flexible fixation implants according to the present disclosure typically include a flexible connector and two suture buttons or suture anchors that interface with a bone surface or a bone plate or bone washer.

[0030] FIG. 1 shows a schematic diagram of a suture button implant positioned across the fibula and tibia at the lower tibiofibular joint. As shown in FIG. 1, flexible implant buttons 110, 120 are intended to be located on the medial side of the tibia and the lateral side of the fibula. As a result, the medial button 110 and the lateral button 120 often have different geometric shapes, since the medial button needs to be able to be deployed through a drilled hole to the medial side of the tibia, while the lateral button needs to be able to be independently located on the lateral side of the fibula or to interface with a fibula plate or washer. In various embodiments, the medial button generally has an oblong configuration with two openings and rounded edges, and the lateral button has a circular configuration.

[0031] 2A and 2B show schematic perspective (FIG. 2A) and side (FIG. 2B) views of a round outer button according to the present disclosure. The outer button 200 has a standard circular shape to allow compatibility with ankle plates and two-hole washers, and incorporates a chamfered outer edge 210 to reduce soft tissue irritation. This is especially important with respect to the outer side of the fibula where the button is placed, as the bone surface is in close proximity to the skin with a very limited amount of soft tissue between them. The central core 220 of the button is thicker to retain strength. The button also features three holes (230, 240, and 250) that allow for routing and rerouting of suture braids to increase suture strength and prevent suture slippage.

[0032] 3A-3H show alternative designs for the outer button. FIG. 3A shows a basic rounded outer button 300 design with four openings (310, 311, 312, 313) evenly spaced in a circular pattern. FIG. 3B shows an outer button 301 designed with a central core 320 that is thicker than a peripheral edge 330 that has additional surface area to better distribute load across the bone surface. FIG. 3C shows an outer button 302 with a crown 340 located in the center of one side of the outer button. This design is configured to improve interfacing with various washers and plate holes. FIG. 3D shows an outer button 303 with an additional vertical opening 350 located in the center of one side of the outer button to provide additional area for suture passage. FIG. 3E shows an outer button 304 with a closure hook 360 located on one side of the outer button for self-locking. 3F, 3G, and 3H show other outer buttons (305, 306, and 307, respectively).

[0033] 4A and 4B show schematic perspective (FIG. 4A) and top (FIG. 4B) views of a horizontal inner button according to the present disclosure. In one embodiment, the inner button 400 features a standard horizontal shape to allow passage through a bone tunnel. Additionally, the inner button features rounded edges 410 at each corner of the horizontal button to prevent irritation to soft tissue. In another embodiment, the inner button 400 has a rectangular tab 420 at one end that allows the button to mate with an insertion rod of an inserter device and provides controlled rotation and deployment on the medial side of the tibia. The inner button can have two openings (430, 440) disposed substantially around the longitudinal midline of the inner button that allow flexible material, including suture strands, to pass through or be threaded through the openings to form the flexible, adjustable, self-tightening suture connector of the present disclosure.

[0034] Figures 5A and 5B show alternative designs for the internal button. Figure 5A shows an elongated button 500 with ridges 510 on either side to provide additional traction when placed against bone. Figure 5B shows an elongated button 501 with a pointed surface 520 with a bladed edge 530, which can be used instead for self-drilling, thus eliminating the need for pre-drilling.

[0035] In one embodiment of the present disclosure, the flexible connector includes a plurality of suture strands that are looped through the inner and outer buttons. In another embodiment, the suture strands are threaded through at least one opening in both the inner and outer buttons. In another embodiment, the flexible connector has at least one free end that extends through the outer button. The flexible connector of the present disclosure allows the surgeon to apply and maintain tension by simply pulling on the free end and without forming a knot.

[0036] FIG. 6A shows a flexible connector 600 with one exemplary suture assembly. In accordance with the present disclosure, the flexible connector is constructed of ultra-high molecular weight polyethylene (UHMWPE) assembled in a braided fashion. The design features an asymmetric, knotless tensioning technique in which one self-crossing "splice" 610 is positioned between an inner button 630 and an outer button 640. The splice is created by threading one section of the suture strand inside another section of the braided suture strand, so that the outer suture section essentially forms a tunnel for the section of suture that is threaded within. After a distance, called the "splice length," the inner suture exits the splice. More specifically, the front and rear ends of the suture braid are threaded through the splice as the braid is routed and rerouted between the inner and outer buttons. When the free ends of the suture are pulled tight, the splice contracts against the inner section suture that is threaded through it, creating enough friction to allow for a knotless design. Figure 6A shows a symmetrical three-hole button, while Figure 6B shows an oblong three-hole button design.

[0037] 7A and 7B show alternative embodiments of flexible connectors. FIG. 7A shows flexible connector 700, which features a tensioned knotted free end. One free end 710 of the suture is secured to a first anchor 720 by a rigid stop to prevent pull-out, including forming a knot, or by attaching the free end to the anchor itself, or by other fastening means. The opposite end 730 passes through a second anchor 740 and then back through the first anchor 720, where it is looped. FIG. 7B shows an embodiment of flexible connector 701, which features a tensioned knotless free end. After exiting the first anchor 750, the free end 760 is threaded through a suture passage 770. A suture passage is defined as a portion of the suture body that allows the suture to pass through itself. This can be accomplished by loosely braiding only this section, or simply by requiring a loose braid over the entire suture body. When the anchor is placed under tension, the suture body, including the suture passage, is placed under tension and contracts as the suture is passed through. This creates a self-tightening effect that prevents the assembly from undoing once assembled. After the free end has been threaded through the suture passage, it is threaded back through the second anchor (outer button) 780.

[0038] FIG. 8 shows one embodiment of a flexible connector 800 featuring a single splice suture braid assembly. The suture assembly is constructed of ultra-high molecular weight polyethylene (UHMWPE) assembled in a braided fashion. The design features a self-crossing "splice" to allow for knot-free tensioning. The splice 810 is created by threading one end of the suture inside another section of braided suture, so that the outer suture section essentially forms a tunnel for the section of suture being threaded through. After a distance, called the "splice length," the inner suture exits the splice. More specifically, the front and back ends of the suture braid are threaded through the splice as the braid is routed and rerouted through the inner and outer buttons. When the free end of the suture is pulled tight, the splice contracts against the inner section of suture that is threaded through it, creating enough friction to allow for a knot-free design.

[0039] FIG. 9 shows one embodiment of a flexible connector 900 featuring a one-sided double splice braid assembly. The suture assembly is constructed of ultra-high molecular weight polyethylene (UHMWPE) assembled in a braided fashion. The design features a knotless tensioning technique with two self-crossing "splices" (910, 920) positioned together on either side between the inner and outer buttons. While the braid is routed and rerouted between the inner and outer buttons, the back end of the suture braid is threaded through the first splice and the front end is routed from the second splice through the inner button and then through the outer button. When the free ends of the sutures are tightened, the splices contract against the sutures of the inner section that are threaded through them, creating enough friction to allow for a knotless design.

[0040] 10 shows another embodiment of a flexible connector 1000. In this suture assembly, the sutures can be threaded through anchors (1010, 1020) and looped in parallel in exactly the same fashion to create a construct with twice the tensile strength. The free ends of the suture strands can be attached to the openings in the round button.

[0041] 11 shows another embodiment of a flexible connector 1100. This suturing assembly uses an anchor 1110 having a vertical opening 1120 centrally located on one side. The suture can be looped in the exact same manner through the vertical opening in parallel with horizontal openings spaced apart in a circular pattern within the anchor to create a construct with twice the tensile strength. The free ends of the suture passages can be attached to the openings in the round button.

[0042] There are several methods and devices that a surgeon may use when deploying a suture button implant across a bone.

[0043] K-wire placement utilizes incisions on both the lateral and medial sides of the ankle. After drilling a bone tunnel through the lateral fibula, syndesmotic joint, and distal medial tibia, the k-wire is threaded through the bone tunnel and exits the skin of the medial ankle. The k-wire has openings at the posterior end that pull two sutures. The shorter, tight suture pulls the anterior end of the horizontal button through the bone tunnel. Once the horizontal button is pulled to its position on the medial side of the tibia, the longer, loose suture is pulled. Tension is maintained on the posterior suture that connects to the round button until the horizontal button reaches its final position. This helps maintain the longitudinal orientation of the horizontal button through the bone tunnel. Pulling the longer anterior suture allows the horizontal button to rest against the bone surface by flipping it perpendicular to the bone tunnel. The round button can then be tensioned all the way to the outer bone surface, allowing the entire construct to hold the syndesmotic joint in place.

[0044] The button / drill bit combination placement places the suture button construct completely from the lateral side of the ankle. This can be accomplished using a horizontal button with a self-drilling surface. The button is rotated in a drilling fashion on the end of the insertion rod with a removable quick connect handle. The drilling button / rod can be advanced under power using the quick connect interface. The sutures are protected during drilling by being inside the cannula of the insertion rod. Once the horizontal drill / button is advanced through the medial tibia, the outer sleeve of the rod can be rotated to unlatch the horizontal button / drill bit while simultaneously aligning the longitudinal grooves in the insertion rod so that the sutures exit into the bone tunnel as the rod is retracted. The horizontal button can be manipulated through the skin so that in its final position it is oriented flat against the bone.

[0045] Placement of the inserter utilizes a single incision on the lateral side of the ankle. The inserter device is used to insert and position the flexible fixation implant. The inserter device includes a cannulated insertion rod fixedly attached to a handle, which is envisioned to house a structure for disengaging a medial button at the distal tip of the cannulated rod. After drilling bone tunnels through the lateral fibula, the syndesmotic joint, and the distal medial tibia, the insertion rod with the medial button attached is inserted through the bone tunnel. The inserter handle has the ability to disengage the medial button from the insertion rod, allowing it to be positioned on the medial side of the tibia. This eliminates the need for a medial incision to position the medial button. The implant is then disengaged from the inserter, and final tightening is performed, either by hand or by tensioning handle.

[0046] During deployment, as shown in Figure 12, a rectangular tab on one end of the inner oblong button is attached to a cannulated rod 1210 extending from the handle of the inserter device. A suture strand 1220 is routed between the inner button and an outer round button positioned on the handle. The tab on the inner button, in cooperation with tension in the suture, keeps the button positioned on the cannulated rod and prevents the button from falling off.

[0047] In some embodiments, as shown in Figure 13, an inner rod 1310 extends through an outer cannulated rod 1320 in the handle. The inner rod 1310 is stationary and acts as a stop, pushing out a button when the cannulated rod is retracted.

[0048] As shown in Fig. 14A, tension in the suture 1410 keeps the horizontal button in close contact with the outer cannulated rod 1420, preventing it from falling off. A rectangular entrance 1430 (Fig. 14B) in the cannulated rod 1420 receives a tab on the inner horizontal button 1440, thereby keeping the button rotationally constrained on the cannulated rod. Once the horizontal button is in the desired position inside the bone tunnel, it is deployed by retracting the outer cannulated rod by actuation on the handle. Both the cannulated rod and the button are retracted until the button is pushed out by the inner stationary rod (Fig. 14C).

[0049] With reference to FIG. 15A, the inserter device 1500 may include a handle 1510 having a safety tap 1520 to prevent accidental button deployment. The safety tap may be located on a retraction trigger 1530 located on the handle. Once the inner button 1540 is in the desired position on the inner side of the bone tunnel, the surgeon may remove the safety tab from the handle, which prevents accidental button deployment. With reference to FIG. 15B, once the safety tap 1520 is removed, the button 1540 may be deployed by pulling the retraction trigger 1530 on the inserter handle to retract the cannulated rod 1550 away from the button 1540. With reference to FIG. 15C, as the cannulated rod 1550 is retracted, a stationary inner rod extending through the cannulated rod 1560 acts as a stop against the tab 1570 of the button 1540. Once the cannulated rod 1550 is retracted past the tip of the inner rod 1560, the button 1540 is pushed out and deployed from the cannulated rod 1550. The released inner button 1540 sits flat against the tibia on the inner side of the bone tunnel and the round button is free to be tensioned from the outer side using the knotless tensioning mechanism.

[0050] 16A-16C, the inserter device 1600 may include a tensioning handle 1610 used to tension the outer button. The tensioning handle 1610 includes a removable proximal portion 1620 with two anchor points 1630 and a distal housing 1640 for receiving the outer button. The two anchor points 1630 are located on opposite sides of the proximal portion of the handle. Once the inner button is deployed, the surgeon can deploy the tensioning handle by turning the proximal portion of the handle a quarter turn counterclockwise (FIG. 16A) and then lifting the proximal portion 1620 off the distal housing 1640 (FIG. 16B). The proximal portion 1620 of the handle can then be separated into two halves (1621, 1622) and held with both hands to provide tension to the outer button (FIG. 16C). The proximal portion of the handle features an anchor point for wrapping excess suture around and securing in place with an O-ring. The integrated tensioning handle configuration of the present disclosure is highly advantageous in that (1) the handle helps prevent injury to the surgeon's fingers and hands, which can result in lacerations when manually tightening the suture, (2) the surgeon is more likely to use the integrated tensioning handle than not, thereby reducing the occurrence of injury, (3) procedure time is reduced, as the surgeon does not need to require a separate instrument to tension and then spend time wrapping or clamping the suture, and (4) there are fewer components to unpack or keep track of, thereby reducing the chance of dropping or wasting time searching for components during transport. This also simplifies packaging.

[0051] 17A and 17B show an embodiment of a self-drilling inserter. The self-drilling inserter 1700 is for use with a self-drilling inner button as described in FIG. 5B. The button is rotated in a drilling fashion at the distal end of the insertion rod 1710 using the removable quick connect handle 1720 (FIG. 17A). The drilling button 1730 / rod 1710 can be advanced under power using the quick connect interface. The sutures are protected during drilling by being inside the cannula of the insertion rod. Once the horizontal self-drilling button 1730 has been advanced through the medial tibia, the outer sleeve 1711 of the rod 1710 can be rotated to unlatch the horizontal button while simultaneously aligning the longitudinal groove in the insertion rod so that the sutures exit into the bone tunnel as the rod is retracted (FIG. 17B). The horizontal button can be manipulated through the skin so that in its final position it is oriented flat against the bone.

[0052] It is intended that all matter contained in the above description or shown in the accompanying drawings be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the disclosure as defined in the appended claims.

[0053] A first aspect of the present disclosure is a method for fixating a syndesmosis injury, comprising drilling a bone tunnel penetrating from a lateral side of the fibula to a medial side of the tibia; providing a flexible fixation implant including a first suture button, a second suture button, and a flexible suture connector extending with a plurality of suture strands looped through the first suture button and the second suture button; providing an inserter device, the inserter device having a cannulated insertion rod extending from a handle of the inserter device; attaching the first suture button to the insertion rod of the inserter device; and inserting the first suture button into the inserter device. inserting the first suture button through the bone tunnel until the first suture button exits the medial side of the tibia; removing the first suture button from the insertion rod of the inserter device; positioning the first suture button so that it sits flat against the medial side of the tibia; withdrawing the insertion rod of the inserter device from the bone tunnel; positioning the second suture button on the lateral side of the fibula by applying tension to the flexible suture connector; and tying a knot on a free end of the flexible suture connector to secure the second suture button against the lateral side of the fibula.

[0054] A second aspect of the present disclosure may be a method according to the first aspect, further comprising inserting a tab of the first suture button into the cannulated insertion rod of the inserter device and pulling the suture strand towards the handle of the inserter device.

[0055] A third aspect of the present disclosure may be a method as described in Aspect 1, further comprising retracting the cannulated rod away from the first suture button by means disposed on the handle.

[0056] A fourth aspect of the present disclosure may be a method according to the first aspect, wherein the first sewing button has two openings and the second sewing button has at least three openings.

[0057] A fifth aspect of the present disclosure may be the method of the fourth aspect, wherein the suture strand is threaded through at least one opening in both the inner button and the outer button.

[0058] A sixth aspect of the present disclosure may be the method of the fourth aspect, wherein the flexible connector has at least one free end extending through the outer button.

[0059] A seventh aspect of the present disclosure may be a method as described in Aspect 6, further comprising applying tension to at least one free end of the suture strand until the first suture button pivots from one position generally parallel to the bone tunnel to another position generally transverse to the bone tunnel.

Claims

1. 1. A suture button system for providing flexible fixation to an ankle following a syndesmotic tear, comprising: a flexible fixation implant; an inserter device for positioning the flexible fixation implant across a bone; The flexible fixation implant comprises: a first suture button configured to be positioned at the second location, the first suture button having a sharp self-drilling surface at one end for drilling a bone tunnel extending from a first location on a first bone to a second location on a second bone and a tab at the other end configured to mate with the inserter device during drilling of the bone tunnel; a second suture button configured to be positioned at the first location; and a flexible suture connector connected to the first suture button and the second suture button; the flexible suture connector includes a suture strand; at least one free end of the suture strand is received through an opening in the second suture button, the free end being tensionable to shorten a length of the flexible suture connector between the first suture button and the second suture button; The suture button system, wherein the inserter device is configured to simultaneously drill the bone tunnel and insert the first suture button through the bone tunnel.

2. The system of claim 1 , wherein the first suture button has an elongated configuration with two openings and rounded edges.

3. The system of claim 2 , wherein the first sewing button has ridges on either side of the first sewing button.

4. The system of claim 1 , wherein the second suture button has a circular configuration with three openings.

5. The system of claim 4 , wherein the second sewing button further comprises a beveled periphery.

6. The system of claim 4 , wherein the second sewing button further comprises a central core portion that is thicker than a peripheral portion.

7. The system of claim 4 , wherein the second suture button further comprises a crown portion centrally disposed on one side of the second suture button.

8. 2. The system of claim 1, wherein the flexible suture connector includes a self-intersecting loop assembly positioned between the first suture button and the second suture button, the self-intersecting loop assembly being formed by threading one section of the suture strand through another section of the suture strand, the self-intersecting loop assembly contracting against the section of the suture strand through which it is threaded when the free end of the suture strand is tightened.

9. one free end of the suture strand is secured to the first suture button; The system of claim 1 , wherein the other free end of the suture strand is looped through the second suture button and back through the first suture button.

10. 2. The system of claim 1, wherein the flexible suture connector includes a suture passageway formed by loosening the braid of a portion of the suture strand and passing another portion of the suture strand through the loosened portion of the suture strand.

Images