Self-flushing side drain anchor and anchor drive

Abstract

The invention relates to a self-flushing type side discharge driver. The driver includes a handle assembly including an impingement surface and a retention splint, a suture splint, and a handle body. The handle body is rotatable relative to the suture splint. The driver also includes a driver tube assembly and an anchor assembly extending from the suture splint. The anchor assembly includes a proximal screw and a distal anchor having a self-piercing tip. The anchor assembly is connected to the driver tube assembly. In a pre-deployed configuration, the screw and the anchor are spaced along the driver tube assembly, and in a post-deployed configuration, the screw abuts or engages the anchor. The rotation of the handle relative to the suture splint moves the screw from the pre-deployed configuration to the post-deployed configuration.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of June 2, 2021, national application number 202180039752.7 (PCT application number PCT / US2021 / 035450), and name “Self-flushing side-discharge anchor and anchor drive”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 033,541, filed on June 2, 2020, and entitled “SelfPunching Lateral RowKnotless Anchor,” U.S. Provisional Patent Application No. 63 / 033,545, filed on June 2, 2020, and entitled “Internally Fixated Self-Punching Knotless Bone Anchor,” and U.S. Provisional Patent Application No. 63 / 112,389, filed on November 11, 2020, and entitled “SelfPunching Lateral Row Assembly and Operation,” the entireties of which are incorporated herein by reference. Background Art 1. Technical Field

[0004] The present invention relates to a surgical anchor and anchor driver / deployment device, and more particularly to a self-flushing anchor and driver.

[0005] 2. Related technical description

[0006] Self-piercing bone anchors are commonly used in arthroscopic shoulder repairs because they do not require a pre-punched guide hole for implantation. This allows the clinician to avoid the potential difficulty and hassle of trying to re-identify a pre-punched osteotomy in order to insert the anchor, which can be difficult if there is residual soft tissue at the implant site. Self-piercing also eliminates the implant error of not implanting the bone anchor along the same longitudinal axis as the guide hole, which can lead to misalignment and anchor breakage. Most self-piercing bone anchors on the market are variations of PEEK or a bioresorbable screw that clamps the suture to the surrounding bone. However, if the bone quality is poor, as it often is, the screw cannot find enough support in the bone and the implant cannot adequately hold the suture, or the anchor may even pull out.

[0007] Therefore, there is a need for a suture anchor that allows the suture retaining feature to move internally within the anchor so that the grip on the suture is strong and consistent regardless of bone quality.

[0008] As used herein, the term "suture" may be any type of filamentous material, such as a biocompatible or bioabsorbable filament, ribbon, strip, woven or nonwoven material.

[0009] Related Art Section Disclaimer Description: With respect to specific patents / publications / products described above in the Related Art section or discussed elsewhere in this disclosure, such discussion should not be considered an admission that the discussed patents / publications / products are prior art for patent law purposes. For example, some or all of the discussed patents / publications / products may not be sufficiently early in time, may not reflect subject matter that was developed early enough in time, and / or may not be sufficient to achieve prior art equivalents for patent law purposes. With respect to specific patents / publications / products described above in this Related Art section and / or discussed throughout this application, their descriptions / disclosures are incorporated herein by reference in their respective entireties. Summary of the Invention

[0010] Embodiments of the present invention are directed to an anchor assembly, a self-piercing side-displacement driver, and a self-piercing side-displacement driver kit. An anchor assembly embodiment includes an anchor having a proximal end, a distal self-piercing tip, and one or more holes extending through the proximal end. The assembly also includes a first suture hole extending through the anchor between the proximal end and the distal self-piercing tip, and a screw configured to engage or abut the proximal end of the anchor.

[0011] An embodiment of the self-piercing side-discharge driver includes a handle assembly, which includes an impact surface and a retaining splint, a suture splint and a handle body. The handle body can rotate relative to the suture splint. The driver also includes a driver tube assembly and an anchor assembly extending from the suture splint. The anchor assembly includes a proximal screw and a distal anchor with a self-piercing tip. The anchor assembly is connected to the driver tube assembly. In the pre-expansion configuration, the screw and the anchor are separated along the driver tube assembly, and in the post-expansion configuration, the screw abuts or engages the anchor (or can be at least partially positioned in or above the anchor) (or can still be just separated from the anchor at a distance, the distance being less than the spacing between the proximal screw and the distal anchor in the pre-expansion position). The rotation of the handle moves the screw from the pre-expansion configuration to the post-expansion configuration.

[0012] An embodiment of a self-piercing side-discharge driver kit includes a driver and a suture loader. The driver includes a handle assembly, which includes an impact surface and a retaining splint, a suture splint, and a handle body. The handle body is rotatable relative to the suture splint. The driver also includes a driver tube assembly and an anchor assembly extending from the suture splint. The anchor assembly includes a proximal screw and a distal anchor with a self-piercing tip. The anchor assembly is connected to the driver tube assembly. The driver also includes a suture passage hole extending through the anchor. In the pre-deployment configuration, the screw and the anchor are spaced apart along the driver tube assembly, and in the post-deployment configuration, the screw abuts or engages the anchor. The rotation of the handle moves the screw from the pre-deployment configuration to the post-deployment configuration. The suture loader is configured to removably extend through the suture passage hole.

[0013] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The present invention will be more fully understood and appreciated by reading the following detailed description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject matter and, therefore, should not be considered limiting of its scope, as the disclosed subject matter may admit to other equally effective embodiments. Reference will now be made briefly to the accompanying drawings, in which:

[0015] Figure 1A is a front view of a self-flushing side-discharge drive according to an embodiment;

[0016] Figure 1B is a perspective view of a distal end portion of a driver according to an embodiment;

[0017] Figure 2 is a front view of a self-flushing side-discharge drive kit according to an embodiment;

[0018] Figure 3 is a cross-sectional elevation view of a driver according to an embodiment;

[0019] Figure 4A is a front view of an inner driver tube of a driver tube assembly according to an embodiment;

[0020] Figure 4B is a front view of an inner driver tube connected to a strike surface and a retention cleat according to an embodiment;

[0021] Figure 4C is a front view of an outer driver tube above an inner driver tube according to an embodiment;

[0022] Figure 5A is a front view of a molded half-body member of a handle body according to an embodiment;

[0023] Figure 5B are perspective and front views of a suture splint and a stabilizing yoke according to an embodiment;

[0024] Figure 5C is a front view of an impact surface and retention cleat, a stabilizing yoke, and a stitching cleat connected within a molded body half according to an embodiment;

[0025] Figure 5D is a front view of a handle assembly according to an embodiment;

[0026] Figure 6A is a front view of an actuator (with anchor assembly omitted) in a pre-deployment configuration according to an embodiment;

[0027] Figure 6B is a close-up elevational view of the distal end of the anchor and inner driver tube according to an embodiment;

[0028] Figure 7A is a cross-sectional elevational view of a driver in a pre-deployment configuration according to an embodiment;

[0029] Figure 7B is a top view of an anchor according to an embodiment;

[0030] Figure 8A is a front view of a self-flushing side-discharge driver kit according to an embodiment;

[0031] Figure 8B is a close-up elevational view of a distal end of a driver and a suture loader according to an embodiment;

[0032] Figure 8C is a perspective view of a distal end of a driver and a suture loader according to an embodiment;

[0033] Figure 9A is a front view of a driver in a pre-deployment configuration according to an embodiment;

[0034] Figure 9B is a front view of a driver in a deployed configuration according to an embodiment;

[0035] Figure 9C is a close-up elevational view of an anchor assembly in a deployed configuration according to an embodiment;

[0036] Figure 9D is a close-up side view of an anchor assembly in a deployed configuration according to an embodiment;

[0037] Figure 10A is a front view of a self-flushing side-discharge drive according to an alternative embodiment;

[0038] Figure 10B is a side view of a driver according to an alternative embodiment;

[0039] Figure 10C is a close-up elevational view of a distal end of a driver according to an alternative embodiment;

[0040] Figure 10D is a cross-sectional elevational view of a distal end portion of a driver according to an alternative embodiment;

[0041] Figure 11 is a front view of a deployment mechanism, a torsion mechanism, a trigger mechanism, a driver tube assembly, and an actuator connected within a molded body half according to an embodiment;

[0042] Figure 12A is a close-up elevational view of the external threads of a screw according to an alternative embodiment;

[0043] Figure 12B is a close-up front view of an external thread with a standard thread form;

[0044] Figure 13A is a close-up elevational view of an anchor assembly with a locking suture according to an alternative embodiment;

[0045] Figure 13B is a close-up and interior elevational view of an anchor assembly with a locking suture according to an alternative embodiment;

[0046] Figure 14A is a close-up elevational view of an anchor assembly with a locking suture according to another alternative embodiment;

[0047] Figure 14B is a close-up rear view of an anchor assembly according to another alternative embodiment;

[0048] Figure 14C is a close-up and cross-sectional elevational view of an anchor assembly according to another alternative embodiment;

[0049] Figure 14D is a close-up elevational view of internal and external threads of an anchor assembly according to another alternative embodiment;

[0050] Figure 14E is a close-up elevational view of an anchor assembly according to yet another alternative embodiment;

[0051] Figure 14F is a close-up cross-sectional elevational view of an anchor assembly according to yet another alternative embodiment;

[0052] Figure 14G is a close-up rear view of an anchor assembly with a locking suture according to yet another alternative embodiment;

[0053] Figure 14His a close-up cross-sectional rear view of an anchor assembly according to yet another alternative embodiment;

[0054] Figure 15A is a close-up elevational view of an anchor assembly in a pre-deployment configuration according to an alternative embodiment;

[0055] Figure 15B is a close-up cross-sectional elevational view of an anchor assembly in a pre-deployment configuration according to an alternative embodiment;

[0056] Figure 15C is a close-up cross-sectional elevational view of the anchor assembly during deployment according to an alternative embodiment;

[0057] Figure 15D is a close-up cross-sectional elevational view of an anchor assembly in a deployed configuration according to an alternative embodiment;

[0058] Figure 16A is a perspective view of a driver according to another alternative embodiment;

[0059] Figure 16B is a close-up perspective view of a distal end of a driver according to another alternative embodiment;

[0060] Figure 16C is a perspective view of a driver in a pre-deployment configuration at a desired surgical location according to an embodiment;

[0061] Figure 16D is a perspective view of a driver during deployment according to an embodiment;

[0062] Figure 16E is a perspective view of a driver in a deployed configuration according to an embodiment;

[0063] Figure 17A is a perspective view of an anchor according to an alternative embodiment;

[0064] Figure 17B is a top view of an anchor according to an alternative embodiment;

[0065] Figure 17C is a side view of an anchor according to an alternative embodiment; and

[0066] Figure 17D is a cross-sectional elevational view of an anchor according to an alternative embodiment. DETAILED DESCRIPTION

[0067] The various aspects of the present invention and its specific features, advantages and details are explained more fully below with reference to the non-limiting examples shown in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the present invention in detail. However, it should be understood that the detailed description and specific non-limiting examples, while indicating various aspects of the present invention, are given by way of illustration only and are not given by way of limitation. In light of this disclosure, various substitutions, modifications, additions and / or arrangements within the spirit and / or scope of the basic concepts of the present invention will be apparent to those skilled in the art.

[0068] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, Figure 1A 1 is a front view of a self-flushing side-discharge driver (hereinafter referred to as "driver") 10 in its assembled state, according to an embodiment. Driver 10 includes a proximal handle assembly 100 extending to a driver tube assembly 200. Driver tube assembly 200 extends to an anchor assembly 300 at distal end 12 of driver 10. Portions of anchor assembly 300 may be made from one or more of the following compositions / materials: PEEK, fiberglass, and a polymer such as PLA, PGA, or PCL; however, anchor assembly 300 may be made from metal or another polymer that is strong enough to flush a guide hole into bone. For example, an all-PEEK solution may be more biocompatible than a solution that leaves metallic components in the patient's body.

[0069] Now refer to Figure 1B , shows a perspective view of the distal end 12 of the driver 10 according to an embodiment. As previously mentioned, the distal end 12 includes an anchor assembly 300. The anchor assembly 300 is connected to the driver tube assembly 200 and includes an anchor 302 having a distally positioned self-piercing tip 304. The anchor assembly 300 also includes a screw 306 connected to the driver tube assembly 200 (positioned proximally relative to the anchor 302). The distal self-piercing tip can be made of the same or different material as the proximal non-self-piercing portion of the anchor 302 (e.g., see the previous paragraph). Part or all of the anchor can be made of the same and / or different material as compared to the screw 306. In Figure 1A to Figure 1B In the pre-deployment configuration shown in , screw 306 and anchor 302 are spaced apart from one another along driver tube assembly 200 .

[0070] Temporarily go to Figure 2 , which is a front view of a self-flushing side-discharge drive kit (hereinafter referred to as "kit") 400. Kit 400 includes Figure 1A and Figure 1B The driver 10 and the suture loader 402 are shown below. Figures 8A to 8C Suture loader 402 is described in detail.

[0071] Now refer to Figure 3, which is a cross-sectional front view of the driver 10 according to the embodiment. Figure 3 1 shows the connections of the components of the driver 10. The driver tube assembly 200 extends through the handle assembly 100 and is connected to the anchor assembly 300. Aspects of the handle assembly 100 and the driver tube assembly 200 are shown in FIG. Figures 4A to 4C The driver tube assembly 200 includes an inner driver tube 202. The inner driver tube 202 is hollow. At the distal end 204 of the inner driver tube 202, there is an indicator 206. Figures 4A to 4C In FIG. 2 , indicator 206 extends through inner driver tube 202, ie, perpendicular to a central axis yy extending through inner driver tube 202. In use, indicator 206 allows a user to see when driver 10 has reached a desired depth at a desired surgical site.

[0072] like Figure 4B As shown in FIG, handle assembly 100 includes an impact surface and retention cleat 102 connected to a proximal end 208 of an inner driver tube 202. Figure 3 The proximal end 208 of the inner driver tube 202 is shown extending through the impact surface and the channel 104 in the retaining cleat 102. Figure 4C As shown in FIG, the driver tube assembly 200 further includes a concentric hexagonal (but not limited to being so shaped) outer driver tube 210. The outer driver tube 210 is hollow to accommodate the inner driver tube 202 therein. The outer driver tube 210 has a proximal hexagonal feature 212 and a distal hexagonal feature 214. Figure 4C In the pre-deployment configuration, the distal hexagonal feature 214 is proximal relative to the indicator 206. The proximal hexagonal feature 212 can mate with a complementary feature in the handle (see Figure 5C ), so that when the handle is rotated, the outer driver tube can rotate with it and assist in driving the screw 306 (which mates with the distal hexagonal feature 214) into the bone hole formed by the anchor 302 (as described below).

[0073] Now refer to 5A to 5D , shows various views of the handle assembly 100 of the driver 10 according to an embodiment. In the depicted embodiment, the handle assembly 100 is composed of a handle body 105 formed from two molded half-body pieces 106. Note that although Figure 5A Only one of the body halves 106 is shown in FIG, but the other body half 106 is a compatible mirror image version.

[0074] Figure 5BThe suture splint 108 and the stabilizing yoke 110 of the handle assembly 100 are shown. The stabilizing yoke 110 is tubular and has a proximal ring 112 and a distal ring 114 connected by two rods 116. The proximal ring 112 and the distal ring 114 each have an opening 118. Figure 5B As shown in FIG, the opening 118 in the proximal ring 112 extends therein in an opposite direction from the opening 118 in the distal ring 114. The suture cleat 108 is generally T-shaped having a cleat portion 120 with a connecting rod 122 extending proximally therefrom. The cleat portion 120 has one or more channels 124 extending partially therethrough. Figure 5B In the embodiment shown in FIG, there are eight channels 124 arranged such that four channels 124 are opposite and aligned with the remaining four channels 124 in pairs.

[0075] Figure 5C The suture cleat 108, stabilizing yoke 110, and impact surface and retaining cleat 102 are shown connected within the handle body 105 of the handle assembly 100. As shown, the opening 118 ( Figure 5B ) receives and connects to the proximal end 126 of the connecting rod 122 of the suture clamp 108. The opening 118 ( Figure 5B ) receives and connects to the distal end 128 of the impact surface and retention splint 102. The suture splint 108, the stabilizing yoke 110, and the impact surface and retention splint 102 are placed within one of the molded half-body members 106 of the handle body 105. Figure 5D As shown in the figure, the remaining molded half-body piece 106 of the handle body 105 is attached to the first molded half-body piece 106, thereby forming a closed handle body 105. The handle body 105 and the attached driver tube 210 are movable relative to the suture cleat 108, the stabilizing yoke 110, and the impact surface and retention cleat 102. When the handle 105 is moved in the distal direction (downward with the outer driver tube 210 as shown in the figure and described below), the suture cleat 108, the stabilizing yoke 110, and the impact surface and retention cleat 102 move in opposite directions from the space inside the handle 105. Figure 9A The pre-deployed position and configuration shown in FIG is slid to Figure 9B The deployed position and configuration shown in .

[0076] In the pre-deployment configuration, screw 306 is added to the driver tube assembly 200, as shown. Figure 1A to Figure 1B Specifically, Figure 6A As shown in FIG, the screw 306 is cannulated and has an internal hexagonal shape that matches the distal hexagonal feature 214 ( Figure 4C) and slides onto the distal hexagonal feature, which helps deploy the screw 306 into the bone hole formed by the anchor 302, as described below (as the outer tube rotates with the rotation of the handle, the outer tube rotates the screw over the inner driver tube and drives the screw into the bone hole formed by the anchor 302). In the pre-deployment configuration shown, the screw 306 is proximal relative to the indicator 206 of the inner driver tube 202. Figure 6B As shown in FIG, inner driver tube 202 is connected to anchor 302 having distal self-piercing tip 304. Inner driver tube 202 is secured to anchor assembly 300 using retention suture 500 (which can be pulled out and discarded after anchor assembly 300 is inserted).

[0077] Now refer to Figure 7A , shows a cross-sectional elevational view of the actuator 10 in a pre-deployment configuration according to an embodiment. As described above, the retention suture 500 connects the anchor 302 to the actuator tube assembly 200. Figure 7A , a retention suture 500 extends from the anchor 302 through the hollow inner driver tube 202, through the suture cleat 108, and through the stabilization yoke 110. The retention suture 500 then extends from the stabilization yoke 110, through the impact surface and the channel 104 in the retention cleat 102. To maintain tension to keep the anchor 302 connected to the inner driver tube 202, the retention suture 500 is wedged or otherwise secured around the impact surface and the retention cleat 102, as shown. Figure 7A In the depicted embodiment, the retention suture 500 is wrapped around the diameter of the impact surface and the retention splint 102.

[0078] Go to Figure 7B , shows a top view of the anchor 302 looking in the distal direction through the screw 306 in accordance with an embodiment. The screw 306 includes a hexagonal receiving feature 308 in its proximal end 310 that is sized and configured to engage the distal hexagonal feature 214 of the outer driver tube 210. The proximal end of the anchor 302 includes a recessed area having a surface 312 (which may be circular) that is sized and configured to receive the inner driver tube 202 (the diameter of the inner tube 202 may be smaller than the diameter of the recessed area). The surface 312 extends in a plane perpendicular to the longitudinal axis of the anchor 302 and includes one or more holes 314 to secure the retaining suture 500 (in alternative embodiments, the surface having one or more holes may be positioned at the very proximal end of the anchor 302, which may not include a recessed area). Specifically, at Figure 7BIn the embodiment shown in FIG, the surface 312 includes two holes 314 that receive retention sutures 500 to secure the anchor 302 to the impact surface and the retention splint 102. In use, the retention suture 500 is passed through one of the holes 314 and then through the other hole 314, and the free end of the retention suture 500 is wedged at the impact surface and the retention splint 102, as shown in FIG. Figure 7A As shown in .

[0079] Now refer to Figure 8A , shows a front view of a kit 400 according to an embodiment. The kit 400 includes a driver 10 having a suture loader 402 connected to or otherwise engaged with the distal end 12 of the driver 10. Figure 8B and Figure 8C , a suture loader 402 is shown having a rectangular body 404 with an eyelet 406 extending therefrom. The eyelet 406 may be constructed of a flexible material such as nitinol, or other suitable material as will be appreciated by one of ordinary skill in the art. In the depicted embodiment, the eyelet 406 is diamond-shaped when expanded and is connected to the rectangular body 402 by a straight portion 408. The rectangular body 404 further has a molded portion 410 extending therefrom. Figure 8C , the molded portion 410 has a channel 412 extending therethrough that is sized and configured to accommodate the inner driver tube 202. When the eyelet 406 extends through the suture pass hole 316 in the anchor 302, the channel 412 in the molded portion 410 receives the inner driver tube 202, as shown in FIG. Figure 8B Inner driver tube 202 may be positioned within channel 412 , or molded portion 410 may form a snap fit around inner driver tube 202 .

[0080] Go to Figure 9A , showing a front view of the driver 10 in a pre-deployment configuration according to an embodiment. In the pre-deployment configuration, the suture loader 402 ( Figures 8A to 8C ) is used to load a locking suture (not shown) onto the anchor 302. As will be understood by one of ordinary skill in the art in conjunction with a review of this disclosure, the locking suture can be attached to the end of the soft tissue used in the repair procedure. To load the locking suture onto the anchor 302, the eyelet 406 of the suture loader 402 is first passed through the suture passing hole 316 in the anchor 302. The free end of the locking suture is passed through the eyelet 406, and the eyelet 406 is then passed back through the suture passing hole 316 in the anchor 302, thereby threading the locking suture through the anchor 302. The suture loader 402 is then removed, leaving the locking suture extending through the anchor 302, as will be understood by one of ordinary skill in the art in conjunction with a review of this disclosure.

[0081] Thereafter, the self-piercing tip 304 is positioned at a desired surgical location adjacent the soft tissue requiring repair, not shown (as will be appreciated by one of ordinary skill in the art in conjunction with a review of this disclosure; see generally for a similar series of illustrative steps in conjunction with bone hole formation and insertion with reference to alternative embodiments described herein). Figures 16C to 16E ). A locking suture (not shown) connected to the soft tissue is then secured to the suture clamp 108. Specifically, the locking suture is wound through the channel 124 in the suture clamp 108 to maintain tension in the locking suture. When the self-piercing tip 304 is aligned at the desired surgical location, the locking suture secured around the suture clamp 108 can be adjusted and re-secured at any time to maintain appropriate tension in the locking suture.

[0082] After the self-piercing tip 304 is in the desired surgical position, the anchor 302 is inserted into the bone (not shown) using the self-piercing tip 304 by hammering the impact surface and holding splint 102. The impact surface and holding splint 102 are hammered until the indicator 206 on the inner driver tube 202 is below the bone surface. Thus, in practice, the user continues hammering the impact surface and holding splint 102 until the indicator 206 is no longer visible.

[0083] Once the indicator 206 is below the bone surface, the screw 306 is inserted. To insert the screw 306, the user holds the suture clamp 108 steadily and rotates the handle body 105 clockwise. The handle body 105 is rotated until the screw 306 is fully inserted, as shown in FIG. Figure 9B 306 is shown in its position relative to the device itself. When the screw 306 is fully inserted, it abuts or engages the proximal end 310 of the anchor 302. Combining the flushing and implantation of the anchor 302 reduces surgical time and eliminates some of the hassles that the clinician faces when using an anchor that must be pre-punched with a guide hole. Figure 9C A close-up front view of the screw 306 and anchor 302 is shown in a deployed configuration according to an embodiment. As shown, the screw 306 attached to the outer driver tube 210 is connected to or engaged with the anchor 302, as shown in FIG. Figure 9C After the screw 306 is inserted, the driver tube assembly 200 and the suture 500 can be removed from the surgical site, leaving the screw 306 and the anchor 302 behind. Figure 9D , the screw 306 may further include one or more vents 318 extending at least partially therethrough. The vents 318 are bone marrow vents that allow bone marrow to grow into the screw 306 and engage the screw.

[0084] Now refer to 10A to 13B , showing multiple views of alternative embodiments of the driver 10 . Figure 10AA front view of a driver 10 according to an alternative embodiment is shown. Driver 10 includes a proximal handle assembly 100 extending to a driver tube assembly 200. Driver tube assembly 200 extends to an anchor assembly 300 at the distal end 12 of driver 10. Handle assembly 100 includes a handle body 105 having a deployment mechanism 130 extending therefrom. Deployment mechanism 130 is at least partially rotatable relative to handle body 105. Figure 10B In the side view of the driver 10 shown in FIG, the handle assembly 100 additionally includes a torque mechanism 132.

[0085] Go to Figure 10C and Figure 10D , showing a close-up elevational view and a cross-sectional elevational view of the distal end 12 of the driver 10 according to an alternative embodiment. Figure 10C As shown in FIG, anchor assembly 300 is connected to driver tube assembly 200. Anchor assembly 300 includes screw 306 and anchor 302. In use, both anchor 302 and screw 306 will be implanted in a patient's body. Figure 10D The driver tube assembly 200 is clearly shown to include a hollow inner driver tube 202 positioned within a hollow outer driver tube 210. Screws 306 are attached to the inner driver tube 202. Figure 10D As shown in FIG, the actuator 216 extends through the inner driver tube 202, the screw 306, and the anchor assembly 300. In the depicted embodiment, the actuator 216 is a rod having a self-piercing tip 304. Figure 10C and Figure 10D As shown in FIG, a self-piercing tip 304 extends distally from the anchor 302. The anchor 302 includes an internal thread 320 configured to mate with an external thread 322 of the screw 306, as shown in FIG. Figure 10D As shown in .

[0086] like Figure 10C As shown in FIG, the anchor 302 further includes one or more wing features 324 formed by strategic cutouts or channels in the proximal end 310 of the anchor 302. The wing features 324 are designed to expand and deploy into the surrounding bone as the proximal end 326 of the screw 306 is advanced via the torque mechanism 132. Thus, the anchor 302 is the primary retaining feature of the implant in the bone. The deployment of the wing features 324 increases the overall outer dimensions of the anchor 302, making it larger than the osteotomy into which it is implanted, thereby stabilizing the anchor 302 in the bone and preventing pullout.

[0087] refer to Figure 11 , shows a close-up front view of the handle assembly 100 (one molded half body 106) of the driver 10 according to an alternative embodiment. As shown, the handle body 105 is composed of two molded half body pieces 106 (note that Figure 11 Only one molded half body is shown. Figure 11 As shown in FIG, an outer driver tube 210 having an inner driver tube 202 extending at least partially therein is placed within one of the molded half-body members 106. The outer driver tube 210 protects the inner driver tube 202 and the actuator 216 during implantation and protects them from surrounding tissue. The inner driver tube 202 is connected to a torque mechanism 132, and the torque mechanism 132 is rotatable. Therefore, when the torque mechanism 132 is rotated, the inner driver tube 202 also rotates, thereby rotating the connected screw 306. The torque mechanism 132 is also a screw feature. The torque mechanism 132 can be a single-lead, double-lead, or quad-lead screw feature. The torque mechanism 132 rotates to deploy the screw 306 into the anchor 302.

[0088] Still refer to Figure 11 , the actuator 216 extends through the torsion mechanism 132 and the trigger mechanism 134. The trigger mechanism 134 is connected to or selectively engaged with the deployment mechanism 130. The trigger mechanism 134 is used to pull the actuator 216 and deploy the anchor 302. In use, when the deployment mechanism 130 is engaged (i.e., rotated toward the handle body 105), the trigger mechanism 134 is engaged and pulls the actuator 216 proximally. Figure 11 As shown in FIG, the actuator 216 extends from the handle body 105. Figure 11 , the portion of the actuator 216 extending from the handle body 105 is circular or disc-shaped and acts as a striking surface for hammering. The actuator 216 drives the anchor 302 into the bone and maintains the connection of the anchor 302 to the handle assembly 100. The handle assembly 100 further includes one or more suture splints 108. In the depicted embodiment, the handle body 105 includes two splints 108 formed in the molded half-body member 106 and extending proximally. During use of the torque mechanism 132, the suture splints 108 maintain their position to provide consistent, proper tension and placement of the locking suture.

[0089] The structure of the anchor assembly 300 maximizes the internal suture retention force. The external threads 322 (i.e., male thread form) of the screw 306 are smaller in size than the internal threads 320 (i.e., female thread form) of the anchor 302 to allow space for the locking suture to be compressed between the external threads 322 and the internal threads 320. The thread forms for both the external threads 322 and the internal threads 320 have Figure 12A The wide circular profile 323A shown in FIG, rather than Figure 12B The more compact triangular profile 323B with a standard thread form is shown in FIG. In use, the locking suture is in tension on the opening of the internal thread 320. Compared to a standard thread form ( Figure 12B ) with a narrower, more pointed opening and a wider, more rounded profile ( Figure 12A) requires less force to compress the locking suture into the wider and more rounded internal threads 320 ( Figure 12A ). The standard thread form requires too much force to compress the locking suture therein, and the locking suture may resist compression and resist advancement of the screw 306. In contrast, Figure 12B Compared with the standard thread form in Figure 12A The rounded thread form shown in has a larger pitch, more consistent thread-to-thread spacing for forming a uniform distribution of the reaction force generated by compression of the locking suture, and has a larger cross-sectional area to resist deformation.

[0090] like Figure 13A and Figure 13B As shown in FIG, to use the driver 10, the user first loads it with a locking suture 600. As described in conjunction with the first embodiment described herein, the locking suture 600 connected to the soft tissue to be repaired is passed through the anchor 302. The locking suture 600 may include two pre-loaded suture pull tabs 602 having nitinol wire. To load, the locking suture 600 is passed through the distal suture passing hole 328, which extends through the anchor 302, as shown in FIG. Figure 13A and Figure 13B The locking suture 600 is passed through the proximal suture hole 330, which extends through the anchor 302, also as shown. Figure 13A and Figure 13B . The holes 328, 330 are sized and configured so that the anchor 302 can hold a total of six (6) locking suture limbs, with each pull tab 602 holding a maximum of three (3) limbs of locking suture. As described above, the holes 328, 330 are also offset to maximize the amount of material of the anchor 302 that is pulled by the locking suture 600 to maximize the internal compressive force.

[0091] After this, the user inserts the driver 10 into the desired surgical position through the cannula or through the patient's soft tissue. Subsequently, the user uses a mallet to drive the driver 10 into the bone. Specifically, the user can strike the portion of the actuator 216 that extends proximally from the handle body 105. Hammer the actuator 216 until it reaches the indicated laser mark (e.g., on the inner driver tube 202) at a depth of at least 2 mm below the bone surface. Subsequently, the user tensions the anchor 302 relative to the repaired tissue by pulling the locking suture 600. After reaching the desired tension, the locking suture 600 is wedged into the suture splint 108 of the handle body 105.

[0092] To lock the locking suture 600 in place within the anchor 302, the user rotates the torque mechanism 132, thereby rotating the attached screw 306 into the anchor 302 and trapping the locking suture 600 between the screw 306 and the anchor 302. This process also deploys the wing features 324. In other words, as the screw 306 moves distally within the anchor 302, the screw 306 forces the wing features 324 outward. Once the screw 306 is fully inserted into the anchor 302, the user deploys the anchor 302 and removes the anchor 302 from the handle assembly 100. The user deploys and removes the anchor 302 by pressing the deployment mechanism 130 toward the handle body 105. Depressing the deployment mechanism 130 pulls the actuator 216 proximally, which in turn pulls the anchor 302 toward the driver tube assembly 200 until the force strips the plastic left-handed internal threads 336 ( Figure 10D ) and unfold the anchor 302.

[0093] Now refer to 14A to 14D , various views of an alternative embodiment of an anchor assembly 300 are shown. 14A to 14D The anchor assembly 300 shown in FIG is similar in function to 13A to 13B The anchor assembly shown in . 14A to 14D The anchor assembly 300 in FIG. 3 includes a screw 306 and an anchor 302. The anchor assembly 300 is configured to be hammered into a desired surgical location. The screw 306 has a relatively wide circular outer thread 322 configured to mate with the relatively wide circular inner thread 320 of the anchor 302 ( Figure 14D ).like Figures 14B to 14C As shown in FIG, in the depicted embodiment, the anchor 302 includes external threads 325. The anchor 302 further includes wing features 324 that are configured to pop outward or move (5.46 mm) when the screw 306 is rotated distally into the anchor 302. In addition, the anchor 302 includes a distal suture hole 328 that is offset from the proximal suture hole 330, as described above with reference to FIG. 13A to 13B As described above, each distal suture hole receives at least three (3) locking sutures 600. As described above, the anchor 302 also includes a plastic left-handed internal thread 336 ( Figure 14C ) to expand anchor 302.

[0094] Now refer to Figures 14E to 14H , various views of another alternative embodiment of an anchor assembly 300 are shown. Figures 14E to 14HThe anchor assembly 300 in FIG. 1 uses a "pull" deployment. The anchor assembly 300 includes a tubular "punch portion" 306 (instead of a screw) and an anchor 302. The punch portion 306 includes distal suture through holes 328 that are sized and configured to accommodate four (4) branches of a locking suture 600 passed therethrough. This differs from the previous embodiment in that the punch portion 306 has distal suture through holes 328 instead of the anchor 302. During deployment, the punch portion 306 is guided into the anchor 302 and the locking suture 600 is compressed between the punch portion 306 and the anchor 302. As shown, the punch portion 306 includes some external threads 322 that assist in compressing the locking suture 600 against the anchor 302. Anchor 302 additionally includes wing features 324, which, as described above, deform or extend outward (5.46 mm) to lock anchor 302 in place within the bone.

[0095] Go to 15A to 15D , showing various views of yet another alternative embodiment of an anchor assembly 300. The anchor assembly 300 includes an anchor assembly 302 and a punched portion 306 (again, rather than a screw). The punched portion 306 is configured to be inserted into the anchor 302. The punched portion 306 includes a proximal end 326 that is wider than a distal end 332. The proximal end 326 includes a proximal suture hole 330 that is configured to receive a locking suture (not shown) therethrough. The distal end 332 of the punched portion 306 includes wing features 324 that expand or move outward within the anchor 302. When the anchor assembly 300 is deployed, as shown FIG. 15C to FIG. 15D , the stamped portion 306 extends into the anchor 302 until the wing features 324 engage the locking features 334 within the anchor 302. When the stamped portion 306 is fully deployed within the anchor 302, the proximal end 326 of the stamped portion 306 can cause the proximal end 310 of the anchor 302 to radially expand.

[0096] Now refer to 16A to 16E , various views of another alternative embodiment of the driver 10 are shown. Figure 16A , driver 10 includes a proximal handle assembly 100 that extends to a driver tube assembly 200. Driver tube assembly 200 extends to an anchor assembly 300 at the distal end 12 of driver 10. Anchor assembly 300 is preferably made of PEEK; however, anchor assembly 300 may be made of metal or another polymer that is strong enough to punch a guide hole into bone.

[0097] The handle assembly 100 includes a proximal rotatable knob 136 connected to the handle body 105. The handle body 105 includes a cleat 108 extending therefrom and configured to assist in tensioning the suture. The driver tube assembly 200 includes an inner driver tube 202 and an outer driver tube 210. The outer driver tube 210 is hollow and has the inner driver tube 202 extending therein. The inner driver tube 202 is connected to the anchor assembly 300, as described in detail below. The inner driver tube 202 can be fixedly connected to the knob 136 and the outer driver tube 210 can be fixedly connected to the handle body 105, or vice versa, depending on which portion of the instrument is driving which portion of the anchor assembly (as will be understood by one of ordinary skill in the art in conjunction with a review of this disclosure).

[0098] Figure 16B A close-up perspective view of the distal end 12 of the driver 10 is shown. As previously mentioned, the distal end 12 includes an anchor assembly 300. The anchor assembly 300 is connected to the driver tube assembly 200 and includes a screw 306 and an anchor 302 having a self-piercing tip 304. The anchor 302 includes a broaching feature 338 extending around and along the length of the anchor 302, which helps minimize stress cracking when the self-piercing tip 304 is impacted into the bone. The distal end 204 of the inner driver tube 202 includes a suture hole 316 extending therethrough.

[0099] like Figure 16A As shown in FIG, screw 306 of anchor assembly 300 is connected to driver tube assembly 200. Specifically, screw 306 is connected to outer driver tube 210. Screw 306 is located proximally relative to anchor 302 and suture pass-through hole 316. In the pre-deployment configuration ( Figure 16A ), screw 306 and anchor 302 are spaced apart along driver tube assembly 200 with suture pass-through hole 316 located therebetween.

[0100] Figure 16C A perspective view of the driver 10 is shown in its pre-deployment configuration. In use, a locking suture 600 connected to the soft tissue to be repaired is passed through the suture hole 316 in the inner driver tube 202. Figure 16C , the locking suture 600 is then tensioned and wrapped around, or otherwise connected to, the splint 108 of the handle body 105. Once tensioned, the self-piercing tip 304 of the anchor 302 is aligned at the desired surgical location. Note that the locking suture 600 can be re-tensioned and re-wedge at any time to ensure that the locking suture 600 remains under proper tension.

[0101] Afterwards, in Figure 16D In the embodiment of the present invention, the knob 136 of the handle assembly 100 is hammered or otherwise struck to drive the self-piercing tip 304 into the bone. This is done until the screw 306 contacts the bone surface, as shown in FIG. Figure 16D From there, the user grasps the knob 136 and rotates the handle body 105 relative to the knob (or vice versa in alternative embodiments, depending on which tubes 202, 210 are connected to the knob 136 and which tubes are connected to the handle body 105). Figure 16E As shown in FIG, rotating the handle body 105 distally toward the desired surgical location inserts the screw 306 into the bone. Because the screw 306 is connected to the outer driver tube 210, which is connected to the handle body 105, the screw 306 rotates when the handle body 105 is rotated. The screw 306 locks the locking suture 600 to the bone. The locking suture 600 also becomes locked between the screw 306 and the anchor 302.

[0102] Now refer to 17A to 17D , showing various views of alternative embodiments of anchor 302. Figure 17B In a top view of FIG, anchor 302 includes a proximal end 310 having two holes 314 extending therethrough. The two holes 314 are sized and configured to receive retention sutures 500 ( Figure 6B ), which retains the anchor 302 on the driver tube assembly 200 or handle assembly 100, as described above with reference to Figure 17B As described. Figure 17C As shown in FIG, anchor 302 further includes a suture hole 316 configured to receive a locking suture connected to the soft tissue to be repaired. Figure 17D Anchor 302 is shown including a wider proximal end 310 compared to a distal end 340. The wider proximal end 310 allows anchor 302 to grasp bone and lock into the guide hole.

[0103] It should be understood that the values ​​used above are merely representative values ​​and that other values ​​may be consistent with the spirit and intent of the present disclosure.

[0104] Although several invention embodiments have been described and shown herein with reference to specific exemplary embodiments, a person of ordinary skill in the art will readily conceive of various other devices and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the invention embodiments described herein (and those skilled in the art will understand that various details can be changed therein without departing from the spirit and scope of the invention as defined by the claims supported by the written description and the drawings). More generally, those skilled in the art will readily understand that all parameters, dimensions, materials and configurations described herein are exemplary, and that actual parameters, dimensions, materials and / or configurations will depend on one or more specific applications for which the teachings of the present invention are used. Using only routine experimentation, those skilled in the art will recognize or be able to ascertain many equivalents to the specific invention embodiments described herein. Therefore, it should be understood that the foregoing embodiments are presented by way of example only, and within the scope of the appended claims and their equivalents, and that embodiments of the present invention may be practiced in a manner different from that specifically described and claimed. In addition, where exemplary embodiments are described with reference to a particular number of elements, it will be understood that the exemplary embodiments can be practiced with fewer or more than the particular number of elements.

[0105] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0106] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0107] Unless otherwise indicated herein or clearly contradicted by context, the use of the terms "a," "an," and "the," and similar referents in the context of describing the present invention (especially in the context of the following claims) should be understood to cover both the singular and the plural. The terms "comprising," "having," "including," and "containing" should be understood as open-ended terms (i.e., meaning "including, but not limited to"), unless otherwise indicated herein or clearly contradicted by context. The term "connected" should be understood to mean partially or completely contained within, attached to, or joined together, even if not directly attached to something intervening.

[0108] As used herein in the specification and claims, the phrase "at least one" in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but does not necessarily include at least one element of each element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. This definition also allows that elements other than the elements specifically identified in the list of elements to which the phrase "at least one" refers may optionally be present, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B," or equivalently, "at least one of A and / or B") may refer to at least one, optionally including more than one A, without B (and optionally including elements other than B), in one embodiment; to at least one, optionally including more than one B, without A (and optionally including elements other than A), in another embodiment; to at least one, optionally including more than one A, and at least one, optionally including more than one B (and optionally including other elements), in yet another embodiment; etc.

[0109] It should also be understood that in any method claimed herein that includes more than one step or action, the order of the steps or actions of the method is not necessarily limited to the order in which the steps or actions of the method are recited unless explicitly indicated to the contrary.

[0110] As used herein throughout the specification and claims, approximating language may be applied to modify any quantitative representation that is permissible for variation without resulting in a change in the basic function to which it relates. Accordingly, values ​​modified by terms such as "about" and "substantially" are not limited to the precise value specified. In at least some instances, approximating language may correspond to the precision of an instrument used to measure the value. Herein and throughout the specification and claims, range limitations may be combined and / or interchanged; unless context or language indicates otherwise, such ranges are identified and include all subranges contained therein.

[0111] Recitation of ranges of values ​​herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein.

[0112] Unless otherwise indicated herein or otherwise clearly contradicted by context, all methods described herein can be performed in any suitable order. Unless otherwise required, the use of any and all examples or exemplary language (e.g., "such as") provided herein is intended solely to better illustrate embodiments of the invention and does not impose a limitation on the scope of the invention.

[0113] No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0114] In the claims and in the foregoing description, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "maintaining," "consisting of," and the like are to be understood as open-ended, i.e., meaning including, but not limited to, including. Only the transitional phrases "consisting of" and "consisting essentially of" are to be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0115] It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the present invention. It is not intended to limit the present invention to the specific forms disclosed, but on the contrary, it is intended to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the present invention as defined by the appended claims. Therefore, the present invention is intended to cover modifications and variations of the present invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. A self-flushing side-discharge drive, comprising: a handle assembly comprising an impact surface and a retaining cleat, a suture cleat, and a handle body rotatable relative to the suture cleat; a driver tube assembly extending from the suture cleat; an anchor assembly comprising a proximal screw and a distal anchor having a distal self-piercing tip, the anchor assembly coupled to the driver tube assembly; wherein in a pre-deployment configuration, the proximal screw and the distal anchor are spaced apart along the driver tube assembly, and in a post-deployment configuration, a distal portion of the proximal screw abuts or engages the distal anchor; and wherein the rotation of the handle body moves the screw from the pre-deployment configuration to the post-deployment configuration.

2. The driver of claim 1, wherein the driver tube assembly comprises a hollow hexagonal outer driver tube having an inner driver tube extending therethrough.

3. The driver of claim 2, further comprising an indicator extending through the inner driver tube.

4. The driver of claim 3, wherein in the pre-deployment configuration, the indicator is positioned between the screw and the anchor.

5. The driver of claim 1 further comprising a retention suture connecting the distal anchor to the impact surface and the retention splint.

6. The driver of claim 2, wherein the inner driver is connected to the impact surface and the retaining cleat.

7. The driver of claim 2, wherein the suture cleat is connected to the hexagonal outer driver tube.

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