Self-piercing side-discharging anchor and anchor driver

Abstract

A self-inserting side-loading driver. The driver includes a handle assembly that includes an impact surface and retaining splints, suture splints, and a handle body. The handle body is rotatable relative to the suture splints. The driver further includes a driver tube assembly and an anchor assembly extending from the suture splints. The anchor assembly includes a proximal screw and a distal anchor having a self-inserting tip. The anchor assembly is connected to the driver tube assembly. In a pre-deployment configuration, the screw and the anchor are spaced along the driver tube assembly, and in a post-deployment configuration, the screw abuts or engages the anchor. The rotation of the handle relative to the suture splints moves the screw from the pre-deployment configuration to the post-deployment configuration.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 033,541, filed on June 2, 2020, and titled "Self Punching Lateral Row Knotless Anchor", U.S. Provisional Patent Application No. 63 / 033,545, filed on June 2, 2020, and titled "Internally Fixated Self - Punching Knotless Bone Anchor", and U.S. Provisional Patent Application No. 63 / 112,389, filed on November 11, 2020, and titled "Self Punching Lateral Row Assembly and Operation", the entire disclosures of which are incorporated herein by reference. Background of the Invention 1. Field of the Technology

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

[0005] 2. Description of Related Technologies

[0006] Self - punching bone anchors are commonly used in arthroscopic shoulder repairs because they do not require pre - punched guide holes to be implanted. This spares the clinician the potential difficulty and hassle of trying to relocate a pre - punched osteotomy for anchor insertion, which can be difficult if there is residual soft tissue at the implant site. Self - punching also eliminates the implantation error of not implanting the bone anchor along the same longitudinal axis as the guide hole, which can lead to malposition and bone anchor breakage. Most self - punching bone anchors on the market are variants of PEEK or absorbable biocompatible screws that clamp sutures to the surrounding bone. However, if the bone quality is poor, as is often the case, the screw cannot find sufficient support in the bone, and the implant cannot adequately hold the suture, or the anchor may even pull out.

[0007] Accordingly, there is a need for a suture anchor that allows the suture retention feature to move internally within the anchor, such that the clamping of the suture is always strong and consistent regardless of bone quality.

[0008] As used herein, the term "suture" can be any type of filamentous material, such as biocompatible or bioabsorbable filaments, ribbons, strips, woven or non - woven materials.

[0009] Disclaimer for the Related Art Section: With respect to the specific patents / published works / products described in the related art section above or elsewhere in this disclosure, such discussions should not be taken as an admission that the patents / published works / products discussed are prior art for the purposes of patent law. For example, some or all of the patents / published works / products discussed may not be early enough in time, may not reflect subject matter developed early enough in time, and / or may not be sufficient to constitute prior art for the purposes of patent law. With respect to the specific patents / published works / products described in this related art section above and / or discussed throughout the application, their descriptions / disclosures are hereby incorporated by reference in their entireties. Summary of the Invention

[0010] Embodiments of the present invention are directed to an anchor assembly, a self-piercing side discharge driver, and a self-piercing side discharge driver kit. Embodiments of the anchor assembly include an anchor having a proximal end, a distal self-piercing tip, and one or more holes extending through the proximal end. The assembly further includes: a first suture passage 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] Embodiments of the self-piercing side discharge driver include a handle assembly including an impact surface and retaining jaws, suture jaws, and a handle body. The handle body is rotatable relative to the suture jaws. The driver further includes a driver tube assembly and an anchor assembly extending from the suture jaws. 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-deployment configuration, the screw and the anchor are spaced along the driver tube assembly, and in a post-deployment configuration, the screw abuts or engages the anchor (or may be at least partially positioned within or above the anchor) (or may still be exactly spaced from the anchor by a distance less than the spacing between the proximal screw and the distal anchor in the pre-deployment position). Rotation of the handle moves the screw from the pre-deployment configuration to the post-deployment configuration.

[0012] An embodiment of a self-piercing side-loading driver kit includes a driver and a suture loader. The driver includes a handle assembly that 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 having 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 a pre-deployment configuration, the screw and the anchor are spaced apart along the driver tube assembly, and in a post-deployment configuration, the screw abuts or engages the anchor. 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 become apparent and be 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 drawings illustrate only typical embodiments of the disclosed subject matter and should not be considered limiting of its scope as the disclosed subject matter may admit to other equivalent embodiments. Now briefly referring to the drawings, wherein:

[0015] Figure 1A is a front view of a self-piercing side-loading driver according to an embodiment;

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

[0017] Figure 2 is a front view of a self-piercing side-loading driver kit according to an embodiment;

[0018] Figure 3 is a cross-sectional front 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 an impact surface and a retaining splint 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 a retaining splint, a stabilizing yoke, and a suture splint connected within a molded half-body member 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 a driver (with the anchor assembly omitted) in a pre-deployment configuration according to an embodiment;

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

[0028] Figure 7A is a cross-sectional front 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-piercing side-discharge driver kit according to an embodiment;

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

[0032] Figure 8C is a perspective view of the 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 post-deployment configuration according to an embodiment;

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

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

[0037] Figure 10A is a front view of a self-piercing side-discharge driver 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 front view of the distal end of a driver according to an alternative embodiment;

[0040] Figure 10D is a cross-sectional front view of the distal end 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 half-body member according to an embodiment;

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

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

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

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

[0046] Figure 14A is a close-up front view of an anchor assembly having 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 front view of an anchor assembly according to another alternative embodiment;

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

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

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

[0052] Figure 14G is a close-up rear view of an anchor assembly having 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 front view of an anchor assembly in a pre-deployment configuration according to an alternative embodiment;

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

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

[0057] Figure 15D is a close-up cross-sectional front view of an anchor assembly in a post-deployment 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 the 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 post-deployment 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 front view of an anchor according to an alternative embodiment. Detailed Description

[0067] Aspects of the present invention and its specific features, advantages, and details are more fully explained 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 the specific non-limiting examples, while indicating aspects of the present invention, are given by way of illustration only and not by way of limitation. Various substitutions, modifications, additions, and / or arrangements within the spirit and / or scope of the basic concepts of the present disclosure will be apparent to those skilled in the art.

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

[0069] Referring now to Figure 1B , a perspective view of the distal end 12 of the driver 10 according to an embodiment 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 an anchor 302 having a self-piercing tip 304 positioned distally. The anchor assembly 300 also includes a screw 306 (positioned proximally relative to the anchor 302) that is connected to the driver tube assembly 200. The distal self-piercing tip may be made of the same or different material as the proximal non-self-piercing portion of the anchor 302 (see, for example, the previous paragraph). Portions or the whole of the anchor may be made of the same and / or different materials compared to the screw 306. In the Figures 1A to 1B pre-deployment configuration shown, the screw 306 and the anchor 302 are spaced apart from each other along the driver tube assembly 200.

[0070] Turning temporarily to Figure 2 , this is a front view of a self-piercing side-discharge driver kit (hereinafter referred to as the "kit") 400. The kit 400 includes Figure 1A and Figure 1B a driver 10 and a suture loader 402. The suture loader 402 is described in detail below with reference to Figures 8A to 8C .

[0071] Referring now to Figure 3, This is a cross-sectional front view of the driver 10 according to an embodiment. Figure 3 The connection of the components of the driver 10 is shown. 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 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. In Figures 4A to 4C , the indicator 206 extends through the inner driver tube 202, that is, perpendicular to the central axis y-y extending through the inner driver tube 202. In use, the indicator 206 allows the user to see when the driver 10 has reached the desired depth at the desired surgical position.

[0072] As Figure 4B shown, the handle assembly 100 includes an impact surface and a retaining splint 102 connected to the proximal end 208 of the inner driver tube 202. Figure 3 The proximal end 208 of the inner driver tube 202 extending through the channel 104 in the impact surface and the retaining splint 102 is shown. As Figure 4C shown, the driver tube assembly 200 further includes a concentric hexagonal (but not limited to being shaped like this) 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. In Figure 4C , in the pre-deployment configuration, the distal hexagonal feature 214 is proximal to the indicator 206. The proximal hexagonal feature 212 can match the 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 matches the distal hexagonal feature 214) into the bone hole formed by the anchor 302 (as described below).

[0073] Now referring to Figures 5A to 5D , various views of the handle assembly 100 of the driver 10 according to an embodiment are shown. In the depicted embodiment, the handle assembly 100 is constituted by a handle body 105, which is formed by two molded half-body parts 106. Note that although Figure 5A only one of the half-body parts 106 in the half-body parts 106 is shown, the other half-body part 106 is a compatible mirror image version.

[0074] Figure 5BShows the suture splint 108 and the stabilizing yoke 110 of the handle assembly 100. 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. As Figure 5B shown, the opening 118 in the proximal ring 112 extends therein in a direction opposite to the opening 118 in the distal ring 114. The suture splint 108 is generally T-shaped and has a splint portion 120 that has a connecting rod 122 extending proximally from the splint portion. The splint portion 120 has one or more channels 124 extending therethrough partially. In Figure 5B the embodiment shown, there are eight channels 124 that are arranged such that four channels 124 are paired and opposite and aligned with the remaining four channels 124.

[0075] Figure 5C Shows the suture splint 108, the stabilizing yoke 110, and the impact surface and retention splint 102 connected within the handle body 105 of the handle assembly 100. As shown, the opening 118 in the distal ring 114 ( Figure 5B ) receives and connects to the proximal end 126 of the connecting rod 122 of the suture splint 108. The opening 118 in the proximal ring 112 ( 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. As Figure 5D shown, the remaining molded half-body member 106 of the handle body 105 is attached to the first molded half-body member 106, thereby forming the enclosed handle body 105. The handle body 105 and the attached drive tube 210 are movable relative to the suture splint 108, the stabilizing yoke 110, and the impact surface and retention splint 102. When the handle 105 is moved in the distal direction (as shown in the figure and described below, downward together with the outer drive tube 210), the suture splint 108, the stabilizing yoke 110, and the impact surface and retention splint 102 slide within the space inside the handle 105 in the opposite direction from Figure 9A the pre-deployment position and configuration shown in Figure 9B to the post-deployment position and configuration shown in

[0076] In the pre-deployment configuration, the screw 306 is added to the drive tube assembly 200, as Figures 1A to 1B shown. Specifically, as Figure 6A shown, the screw 306 is hollow and has an internal hexagonal shape that matches the distal hexagonal feature 214 of the outer drive tube 210 ( Figure 4C), and slide onto the distal hexagonal feature, which helps deploy the screw 306 into the bone hole formed by the anchor 302, as described below (when the outer tube rotates with the rotation of the handle, the outer tube causes the screw to rotate above the inner drive 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 to the indicator 206 of the inner drive tube 202. As Figure 6B shown, the inner drive tube 202 is connected to an anchor 302 having a distal self-drilling tip 304. The inner drive tube 202 is secured to the anchor assembly 300 using a retention suture 500 (which can be pulled out and discarded after the anchor assembly 300 is inserted).

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

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

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

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

[0081] Thereafter, the self-inserting tip 304 is positioned at the desired surgical location near the soft tissue to be repaired, not shown (as would be understood by one of ordinary skill in the art in light of a review of the present disclosure; with reference to the alternative embodiments described herein, for a series of similar exemplary steps involving bone hole formation and insertion, generally see Figures 16C to 16E ). Subsequently, a locking suture (not shown) attached to the soft tissue is secured to the suture splint 108. Specifically, the locking suture is wound through the channel 124 in the suture splint 108 to maintain tension in the locking suture. When the self-inserting tip 304 is aligned at the desired surgical location, the locking suture secured around the suture splint 108 can be adjusted and re-secured at any time to maintain proper tension in the locking suture.

[0082] After the self-inserting tip 304 is in the desired surgical location, the mallet impact surface and the holding splint 102 are struck, thereby inserting the anchor 302 into the bone (not shown) using the self-inserting tip 304. The mallet impact surface and the holding splint 102 are struck until the indicator 206 on the inner drive tube 202 is below the bone surface. Thus, in effect, the user continues to strike the mallet impact surface and the 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 firmly holds the suture splint 108 and rotates the handle body 105 in a clockwise direction. The handle body 105 is rotated until the screw 306 is fully inserted, as Figure 9B shown in relation to the position of the device itself. When the screw 306 is fully inserted, it abuts or engages the proximal end 310 of the anchor 302. Combining the ramming and implantation of the anchor 302 reduces the surgical time and eliminates some of the complications faced by clinicians when using an anchor that must be pre-rammed with a pilot hole. Figure 9C A close-up front view of the screw 306 and the anchor 302 in the deployed configuration according to an embodiment is shown. As shown, the screw 306 attached to the outer drive tube 210 is connected to or engages the anchor 302, as Figure 9C shown. After the screw 306 is inserted, the drive tube assembly 200 and the suture 500 can be removed from the surgical location, leaving the screw 306 and the anchor 302. In the Figure 9D close-up side view shown, the screw 306 may additionally include one or more vent holes 318 extending at least partially therethrough. The vent holes 318 are bone marrow vent holes that allow bone marrow to grow into and engage the screw 306.

[0084] Now referring to Figures 10A to 13B , multiple views of an alternative embodiment of the driver 10 are shown. Figure 10AShows a front view of the driver 10 according to an alternative embodiment. The driver 10 includes a proximal handle assembly 100 that extends into a driver tube assembly 200. The driver tube assembly 200 extends to an anchor assembly 300 at the distal end 12 of the driver 10. The handle assembly 100 includes a handle body 105 that has a deployment mechanism 130 extending therefrom. The deployment mechanism 130 is at least partially rotatable relative to the handle body 105. In Figure 10B the side view of the driver 10 shown, the handle assembly 100 further includes a torsion mechanism 132.

[0085] Turning to Figure 10C and Figure 10D , shows a close-up front view and a cross-sectional front view of the distal end 12 of the driver 10 according to an alternative embodiment. As Figure 10C shown, the anchor assembly 300 is connected to the driver tube assembly 200. The anchor assembly 300 includes a screw 306 and an anchor 302. In use, both the anchor 302 and the screw 306 will be implanted into the patient's body. Figure 10D It is clearly shown that the driver tube assembly 200 includes a hollow inner driver tube 202 located within a hollow outer driver tube 210. The screw 306 is connected to the inner driver tube 202. Also as Figure 10D shown, an 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 with a self-drilling tip 304. As Figure 10C and Figure 10D shown, the self-drilling tip 304 extends distally from the anchor 302. The anchor 302 includes an internal thread 320 that is configured to mate with the external thread 322 of the screw 306, as Figure 10D shown.

[0086] As Figure 10C shown, the anchor 302 further includes one or more wing features 324 that are formed by strategic cuts 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 when the proximal end 326 of the screw 306 is advanced via the torsion mechanism 132. Thus, the anchor 302 is the primary retention feature implanted in the bone. The deployment of the wing features 324 increases the overall outer dimension of the anchor 302 such that it is larger than the osteotomy into which it is implanted, thereby stabilizing the anchor 302 in the bone and preventing pull-out.

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

[0088] Still referring 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 engages 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. As Figure 11 shown, the actuator 216 extends from the handle body 105. In Figure 11 , the portion of the actuator 216 that extends from the handle body 105 is circular or disk-shaped and serves as an impact surface for malleting. 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 clamps 108. In the depicted embodiment, the handle body 105 includes two clamps 108 formed in the molded half-body members 106 and extending proximally. During use of the torsion mechanism 132, the suture clamps 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 holding force. The outer threads 322 (i.e., in male thread form) of the screw 306 are smaller in size compared to the inner threads 320 (i.e., in female thread form) of the anchor 302 to allow space for the locking suture to be compressed between the outer threads 322 and the inner threads 320. The thread form for both the outer threads 322 and the inner threads 320 has Figure 12A the wide circular profile 323A as shown, rather than Figure 12B the more compact triangular profile 323B with a standard thread form as shown. In use, the locking suture is in tension over the opening of the inner threads 320. Compared to the narrower and sharper opening with a standard thread form ( Figure 12B ), the wider, more circular profile ( Figure 12A)Less force is required to compress the locking suture into the wider and more circular internal thread 320( Figure 12A ) than is required for a standard thread form. The standard thread form requires too much force to compress the locking suture therein, and the locking suture may resist compression and resist the advancement of the screw 306. In contrast, compared to the standard thread form in Figure 12B , the circular thread form shown in Figure 12A has a greater pitch, a more consistent line-to-line spacing for a uniform distribution of the reaction forces generated by compression for forming the locking suture, and a greater cross-sectional area to resist deformation.

[0090] As shown in Figure 13A and Figure 13B , to use the driver 10, the user first loads the locking suture 600 therein. As described in connection with the first embodiment described herein, the locking suture 600 connected to the soft tissue to be repaired passes through the anchor 302. The locking suture 600 may include two pre-loaded suture pull tabs 602 having nitinol wires. For loading, the locking suture 600 passes through the distal suture through-hole 328, which extends through the anchor 302, as shown in Figure 13A and Figure 13B . The locking suture 600 passes through the proximal suture through-hole 330, which also extends through the anchor 302, as shown in Figure 13A and Figure 13B . The holes 328, 330 are sized and configured such that the anchor 302 can hold a total of six (6) locking suture branches, with each pull tab 602 holding a maximum of three (3) branches of the locking suture. As described above, the holes 328, 330 are also offset to maximize the amount of material of the anchor 302 pulled by the locking suture 600 to maximize the internal compression force.

[0091] Thereafter, the user inserts the driver 10 into the desired surgical location through a cannula or through the patient's soft tissue. Subsequently, the user drives the driver 10 into the bone with a mallet. Specifically, the user can strike the portion of the actuator 216 that extends proximally from the handle body 105. The actuator 216 is struck 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 repair tissue by pulling on the locking suture 600. After the desired tension is achieved, 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 twisting mechanism 132, thereby rotating the attached screw 306 into the anchor 302 and capturing the locking suture 600 between the screw 306 and the anchor 302. This process also deploys the wing feature 324. In other words, as the screw 306 moves distally within the anchor 302, the screw 306 forces the wing feature 324 outward. Once the screw 306 is fully inserted into the anchor 302, the user deploys the anchor 302 and detaches the anchor 302 from the handle assembly 100. The user deploys and detaches the anchor 302 by pressing the deployment mechanism 130 toward the handle body 105. Pressing 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 of the anchor 302( Figure 10D ) and deploys the anchor 302.

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

[0094] Now referring to Figures 14E to 14H , various views of another alternative embodiment of the anchor assembly 300 are shown. Figures 14E to 14HThe anchor assembly 300 therein uses a "pull" type of deployment. The anchor assembly 300 includes a tubular "stamping portion" 306 (instead of a screw) and an anchor 302. The stamping portion 306 includes a distal suture passage hole 328 that is sized and configured to receive four (4) branches of the locking suture 600 that passes therethrough. This is different from the previous embodiments in that the stamping portion 306 has the distal suture passage hole 328 instead of the anchor 302. During deployment, the stamping portion 306 is guided into the anchor 302, and the locking suture 600 is compressed between the stamping portion 306 and the anchor 302. As shown, the stamping portion 306 includes some external threads 322 that assist in compressing the locking suture 600 against the anchor 302. The anchor 302 further includes wing features 324 that, as described above, deform or extend outwardly (5.46 mm) to lock the anchor 302 in place within the bone.

[0095] Go to Figures 15A to 15D , which shows various views of yet another alternative embodiment of the anchor assembly 300. The anchor assembly 300 includes the anchor assembly 300 and a stamping portion 306 (again instead of a screw). The stamping portion 306 is configured to be inserted into the anchor 302. The stamping portion 306 includes a proximal end 326 that is wider than the distal end 332. The proximal end 326 includes a proximal suture passage hole 330 that is configured to receive a locking suture (not shown) that passes therethrough. The distal end 332 of the perforated portion 306 includes wing features 324 that expand or move outwardly within the anchor 302. When the anchor assembly 300 is deployed, as Figures 15C to 15D shown therein, the stamping portion 306 extends into the anchor 302 until the wing features 324 engage the locking features 334 within the anchor 302. When the stamping portion 306 is fully deployed within the anchor 302, the proximal end 326 of the stamping portion 306 may cause the proximal end 310 of the anchor 302 to expand radially.

[0096] Now refer to Figures 16A to 16E , which shows various views of another alternative embodiment of the driver 10. As depicted in the perspective view in Figure 16A , the driver 10 includes a proximal handle assembly 100 that extends into the driver tube assembly 200. The driver tube assembly 200 extends to the anchor assembly 300 at the distal end 12 of the driver 10. The anchor assembly 300 is preferably made of PEEK; however, the anchor assembly 300 may be made of metal or another polymer that is strong enough to punch a guide hole into the bone.

[0097] The handle assembly 100 includes a proximally rotatable knob 136 connected to the handle body 105. The handle body 105 includes splints 108 extending therefrom and configured to assist in tensioning sutures. The drive tube assembly 200 includes an inner drive tube 202 and an outer drive tube 210. The outer drive tube 210 is hollow, and the inner drive tube 202 extends therein. The inner drive tube 202 is connected to the anchor assembly 300, as described in detail below. The inner drive tube 202 is fixedly connected to the knob 136, and the outer drive tube 210 is fixedly connected to the handle body 105, or vice versa, depending on which part of the instrument is driving which part of the anchor assembly (as would be understood by one of ordinary skill in the art in light of a review of the present 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 the anchor assembly 300. The anchor assembly 300 is connected to the drive 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 that extends around and along the length of the anchor 302 and that helps to minimize stress cracking when the self-piercing tip 304 is impacted into bone. The distal end 204 of the inner drive tube 202 includes a suture passage hole 316 extending therethrough.

[0099] As Figure 16A shown, the screw 306 of the anchor assembly 300 is connected to the drive tube assembly 200. Specifically, the screw 306 is connected to the outer drive tube 210. The screw 306 is proximal to the anchor 302 and the suture passage hole 316. In the pre-deployment configuration ( Figure 16A ), the screw 306 and the anchor 302 are spaced apart along the drive tube assembly 200, and the suture passage hole 316 is therebetween.

[0100] Figure 16C A perspective view of the driver 10 in the pre-deployment configuration is shown. In use, a locking suture 600 connected to soft tissue to be repaired is passed through the suture passage hole 316 in the inner drive tube 202. As Figure 16C shown, the locking suture 600 is then tensioned and wrapped, or otherwise connected to the splints 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 wedged again at any time to ensure that the locking suture 600 remains under proper tension.

[0101] Thereafter, in Figure 16D the knob 136 of the handle assembly 100 is malleted or otherwise struck to drive the self-piercing tip 304 into the bone. This is done until the screw 306 contacts the bone surface, asFigure 16D as shown therein. From there, the user grasps the knob 136 and rotates the handle body 105 relative to the knob (or vice versa in an alternative embodiment, depending on which tube 202, 210 is connected to the knob 136 and which tube is connected to the handle body 105). As Figure 16E shown therein, rotating the handle body 105 distally toward the desired surgical location inserts the screw 306 into the bone. Since the screw 306 is connected to the outer drive tube 210, which is connected to the handle body 105, the screw 306 rotates when the handle body 105 rotates. 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 referring to Figures 17A to 17D , various views of an alternative embodiment of the anchor 302 are shown. In Figure 17B 's top view, the anchor 302 includes a proximal end 310 having two holes 314 extending therethrough. The two holes 314 are sized and configured to receive the retention suture 500( Figure 6B ), which holds the anchor 302 on the drive tube assembly 200 or the handle assembly 100, as described above with reference to Figure 7B . As Figure 17C shown therein, the anchor 302 also includes a suture passage hole 316, which is configured to receive the locking suture connected to the soft tissue to be repaired. Figure 17D shows that the anchor 302 includes a proximal end 310 that is wider than the distal end 340. The wider proximal end 310 allows the anchor 302 to grip and lock the bone into the guide hole.

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

[0104] Although several inventive embodiments have been described and illustrated herein with reference to specific exemplary embodiments, those of ordinary skill in the art will readily envision 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 inventive embodiments described herein (and those skilled in the art will understand that various changes in details can be made therein without departing from the spirit and scope of the invention as defined by the claims that can be supported by the written description and the drawings). More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary, and the actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications for which the teachings of the invention are directed. Using only routine experimentation, those skilled in the art will recognize or be able to ascertain many equivalent forms of the specific inventive embodiments described herein. Accordingly, it should be understood that the foregoing embodiments are presented by way of example only and are within the scope of the appended claims and their equivalents, and that the inventive embodiments can be practiced in a manner different from that specifically described and claimed. Additionally, in instances where an exemplary embodiment is described with reference to a specific number of elements, it will be understood that the exemplary embodiment can be practiced with fewer or more than the specific number of elements.

[0105] All references cited herein (including publications, patent applications, and patents) 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 defined and used herein should be understood to be controlling 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 terms "a" and "the" and similar referents used in the context of describing the invention (especially in the context of the following claims) should be understood to cover both the singular and the plural. Unless otherwise noted, the terms "comprising," "having," "including," and "containing" should be understood to be open-ended terms (i.e., meaning "including but not limited to"). The term "connected" should be understood to mean partly or wholly contained within, attached to, or joined together, even if not directly attached where there is some intervening element.

[0108] As used herein in the specification and claims, the phrase "at least one" referring to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one element of each specifically listed element in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows that elements other than those specifically identified within the list of elements referred to by the phrase "at least one" may optionally exist, 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, in one embodiment, refer to at least one, optionally including more than one A, without B (and optionally including elements other than B); in another embodiment, refer to at least one, optionally including more than one B, without A (and optionally including elements other than A); in yet another embodiment, refer 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); and so on.

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

[0110] As used herein throughout the specification and claims, approximate language may apply to modify any quantitative representation that admits of variation without resulting in a change in the basic function associated therewith. Thus, values modified by terms such as "about" and "substantially" are not limited to the precise values specified. In at least some instances, the approximate language may correspond to the precision of the instrument used to measure the value. In this document and throughout the specification and claims, range limitations may be combined and / or interchanged; unless the context or language indicates otherwise, such ranges are identified and include all the subranges contained therein.

[0111] Unless otherwise indicated herein, the recitation of a range of values herein is merely intended to be a shorthand method of referring individually to each separate value falling within the range, and each separate value is incorporated into the specification as if it were recited herein individually.

[0112] Unless otherwise indicated herein or otherwise clearly contradicted by the context, all methods described herein may 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 merely intended 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 that any non-claimed element is essential to the practice of the invention.

[0114] In the claims, as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "consisting of," and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases as set forth, respectively, in Section 2111.03 of the United States Patent and Trademark Office's Manual of Patent Examining Procedure.

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

Claims

1. An anchor assembly, the anchor assembly comprising: A distal anchor extending along a longitudinal axis and having a proximal end and a distal self-piercing tip; At least a first hole extending through the proximal end of the distal anchor in a direction substantially parallel to the longitudinal axis; A first suture passage hole extending through the distal anchor at an angle to the longitudinal axis and located between the proximal end and the distal self-piercing tip; And A proximal screw configured to engage or abut the proximal end of the distal anchor, Wherein the proximal end of the distal anchor includes a groove having a surface positioned therein that extends in a plane substantially perpendicular to the longitudinal axis, and wherein the at least first hole is positioned through the surface.

2. The assembly of claim 1, the assembly further comprising one or more ventilation holes extending at least partially through the proximal screw.

3. The assembly of claim 1, wherein a second hole is positioned through the surface.

4. The assembly of claim 1, wherein at least the distal end of the proximal screw is configured to fit within the groove in the proximal end of the distal anchor.

5. The assembly of claim 2, wherein the distal anchor includes an internal thread configured to mate with an external thread of the proximal screw.

6. The assembly of claim 1, the assembly further comprising a second suture passage hole extending through the distal anchor between the proximal end and the distal self-piercing tip.

7. The assembly of claim 6, wherein the first suture passage hole is offset from the second suture passage hole.

8. The assembly of claim 1, wherein the proximal end of the distal anchor includes one or more wing features.

9. The assembly of claim 1, wherein the proximal screw and the distal anchor are made of different materials.

10. The assembly of claim 1, wherein the proximal end and the distal self-piercing tip of the distal anchor are made of different materials.

Images