Patent Description:
The present invention relates to a surgical anchor and anchor driver/deployment device and, more particularly, to a self-punching anchor and driver.

Self-punching bone anchors are commonly used in arthroscopic shoulder repairs because they do not require a pre-punched pilot hole to be implanted. This lets the clinician avoid the potential hardship and hassle of trying to re-find the pre-punched osteotomy in order to insert the anchor, which can be difficult if there is residual soft tissue in the implantation site. Self-punching also removes the implantation error of not implanting the bone anchor along the same longitudinal axis as the pilot hole, which can lead to misalignment and bone anchor fracture. Most of the self-punching bone anchors on the market are variations of a PEEK or resorbable biomaterial screw that pinches the suture to the surrounding bone. However, if the bone quality is poor, and often times it is, the screw cannot find enough purchase in the bone and the implant cannot sufficiently retain the suture or the anchor may even pull out.

Therefore, there is a need for a suture anchor that shifts the suture retention feature internally within the anchor so there is always a strong and consistent pinching of the suture, regardless of bone quality.

The term "suture" as used herein may be any type of filamentous material such as a biocompatible or bioabsorbable filament, ribbon, tape, woven or non-woven material.

Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as 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 developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes.

<CIT> discloses an anchor assembly with the features in the preamble of present claim <NUM>. Other conventional anchors are described in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

The scope of protection is defined in the appended claims. Embodiments of the present invention are directed to an anchor assembly, self-punching lateral row driver, and self-punching lateral row driver kit. An embodiment of the anchor assembly includes an anchor having a proximal end, a distal self-punching tip, and one or more apertures extending through the proximal end. The assembly also includes a first suture passing aperture extending through the anchor between the proximal end and the distal self-punching tip and a screw configured to engage or abut the proximal end of the anchor.

An embodiment of the self-punching lateral row driver includes a handle assembly including a strike surface and retention cleat, a suture cleat, and a handle body. The handle body is rotatable relative to the suture cleat. The driver also includes a driver tube assembly extending from the suture cleat and an anchor assembly. The anchor assembly includes a proximal screw and a distal anchor with a self-punching 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 (or can be positioned at least partially within, or over) the anchor (or can still be spaced from the anchor, just at a distance that is less than the spacing between he proximal screw and the distal anchor in the pre-deployment position). The rotation of the handle moves the screw from the pre-deployment configuration to the post-deployment configuration.

An embodiment of the self-punching lateral row driver kit includes a driver and a suture loader. The driver includes a handle assembly including a strike surface and retention cleat, a suture cleat, and a handle body. The handle body is rotatable relative to the suture cleat. The driver also includes a driver tube assembly extending from the suture cleat and an anchor assembly. The anchor assembly includes a proximal screw and a distal anchor with a self-punching tip. The anchor assembly is connected to the driver tube assembly. The driver also includes a suture passing aperture extending through the anchor. 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 moves the screw from the pre-deployment configuration to the post-deployment configuration. The suture loader is configured to removably extend through the suture passing aperture.

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 are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments. Reference is now made briefly to the accompanying drawings, in which:.

Aspects of the present invention and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the invention, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and/or arrangements, within the scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.

Referring now to the figures, wherein like reference numerals refer to like parts throughout, <FIG> is a front view of self-punching lateral row driver (hereafter "driver") <NUM> in its assembled state, according to an embodiment. The driver <NUM> comprises a proximal handle assembly <NUM> extending to a driver tube assembly <NUM>. The driver tube assembly <NUM> extends to an anchor assembly <NUM> at a distal end <NUM> of the driver <NUM>. Portions of the anchor assembly <NUM> can be made from one or more of the following compositions/materials PEEK, glass fiber and a polymer such as PLA, PGA or PCL; however, the anchor assembly <NUM> can be made of metal or another polymer strong enough to punch a pilot hole into bone. Having an all-PEEK solution, for example, can be more biocompatible than a solution with metal components left in the patient.

Referring now to <FIG>, there is shown a perspective view of the distal end <NUM> of the driver <NUM>, according to an embodiment. As previously mentioned, the distal end <NUM> comprises the anchor assembly <NUM>. The anchor assembly <NUM> is connected to the driver tube assembly <NUM> and comprises an anchor <NUM> with a distally positioned self-punching tip <NUM>. The anchor assembly <NUM> also comprises a screw <NUM> (proximally positioned with respect to the anchor <NUM>) connected to the driver tube assembly <NUM>. The distal self-punching tip can be made from a material (see, e.g., previous paragraph) that is the same as or different from the proximal non-self-punching portion of the anchor <NUM>. Portions of or the anchor as a whole can be made from the same and/or different material as compared to the screw <NUM>. In the pre-deployment configuration shown in <FIG>, the screw <NUM> and the anchor <NUM> are spaced apart from each other along the driver tube assembly <NUM>.

Turning briefly to <FIG>, there is a front view of a self-punching lateral row driver kit (hereafter "kit") <NUM>. The kit <NUM> includes the driver <NUM> of <FIG> and <FIG> and a suture loader <NUM>. The suture loader <NUM> is described in detail below with reference to <FIG>.

Referring now to <FIG>, there is a sectioned front view of the driver <NUM>, according to an embodiment. <FIG> shows the connections of the components of the driver <NUM>. The driver tube assembly <NUM> extends through the handle assembly <NUM> and connects to the anchor assembly <NUM>. Aspects of the handle assembly <NUM> and driver tube assembly <NUM> are shown in <FIG>. The driver tube assembly <NUM> comprises an inner driver tube <NUM>. The inner driver tube <NUM> is cannulated. At a distal end <NUM> of the inner driver tube <NUM>, there is an indicator <NUM>. In <FIG>, the indicator <NUM> extends across the inner driver tube <NUM>, i.e., perpendicular to the central axis y - y extending through the inner driver tube <NUM>. In use, the indicator <NUM> allows the user to see when the driver <NUM> has reached the desired depth at the desired surgical location.

As shown in <FIG>, the handle assembly <NUM> comprises a strike surface and retention cleat <NUM> connected to a proximal end <NUM> of the inner driver tube <NUM>. <FIG> shows the proximal end <NUM> of the inner driver tube <NUM> extending through a channel <NUM> in the strike surface and retention cleat <NUM>. The driver tube assembly <NUM> additionally includes a concentric hex (but is not limited to being so shaped) outer driver tube <NUM>, as shown in <FIG>. The outer driver tube <NUM> is cannulated to accommodate the inner driver tube <NUM> therein. The outer driver tube <NUM> has a proximal hex feature <NUM> and a distal hex feature <NUM>. In <FIG>, the distal hex feature <NUM> is proximal relative to the indicator <NUM> in the pre-deployment configuration. The proximal hex feature <NUM> can mate with a complimentary feature in the handle (see <FIG>), so that when the handle is turned the outer driver tube can turn with it and assist with driving the screw <NUM> (which mates with the distal hex feature <NUM>) into a bone hole formed by the anchor <NUM> (as described below).

Referring now to <FIG>, there are shown various views of the handle assembly <NUM> of the driver <NUM>, according to an embodiment. In the depicted embodiment, the handle assembly <NUM> is composed of a handle body <NUM> formed by two molded half body pieces <NUM>. Note, although only one of the half pieces <NUM> is shown in <FIG>, the other half body piece <NUM> is a compatible mirrored version.

<FIG> shows a suture cleat <NUM> and a stabilizing yolk <NUM> of the handle assembly <NUM>. The stabilizing yolk <NUM> is tubular with a proximal ring <NUM> and a distal ring <NUM> connected by two rods <NUM>. The proximal and distal rings <NUM>, <NUM> each have openings <NUM>. The opening <NUM> in the proximal ring <NUM> extends therein in an opposite direction as the opening <NUM> in the distal ring <NUM>, as shown in <FIG>. The suture cleat <NUM> is generally T-shaped having a cleat portion <NUM> with a connecting rod <NUM> extending proximally therefrom. The cleat portion <NUM> has one or more channels <NUM> extending partially therethrough. In the embodiment shown in <FIG>, there are eight channels <NUM> arranged such that four channels <NUM> oppose and are aligned with the remaining four channels <NUM> in pairs.

<FIG> shows the suture cleat <NUM>, the stabilizing yolk <NUM>, and the strike surface and retention cleat <NUM> connected within the handle body <NUM> of the handle assembly <NUM>. As shown, the opening <NUM> in the distal ring <NUM> (<FIG>) receives and connects to a proximal end <NUM> of the connecting rod <NUM> of the suture cleat <NUM>. The opening <NUM> (<FIG>) in the proximal ring <NUM> receives and connects to a distal end <NUM> of the strike surface and retention cleat <NUM>. The suture cleat <NUM>, the stabilizing yolk <NUM>, and the strike surface and retention cleat <NUM> are placed within one of the molded half body pieces <NUM> of the handle body <NUM>. As shown in <FIG>, the remaining molded half body piece <NUM> of the handle body <NUM> is attached to first molded half body piece <NUM>, creating the enclosed handle body <NUM>. The handle body <NUM> and the attached driver tube <NUM> can move with respect to the suture cleat <NUM>, the stabilizing yolk <NUM>, and the strike surface and retention cleat <NUM>. When the handle <NUM> moves in a distal direction (downward, as shown in the drawings and described below, with the outer driver tube <NUM>), the suture cleat <NUM>, the stabilizing yolk <NUM>, and the strike surface and retention cleat <NUM> slide in the opposite direction within a space in the interior of the handle <NUM> from a pre-deployment position and configuration shown in <FIG> to a post-deployment position and configuration shown in <FIG>.

In the pre-deployment configuration, the screw <NUM> is added to the driver tube assembly <NUM>, as shown in <FIG>. Specifically, as shown in <FIG>, the screw <NUM> is cannulated, has an internal hex shape that mates and slides onto the distal hex feature <NUM> (<FIG>) of the outer driver tube <NUM>, which aids in deployment of the screw <NUM> into the bone hole created by the anchor <NUM> as described below (when the outer tube rotates per rotation of the handle, the outer tube rotates screw over the inner driver tube and drives the screw into the bone hole formed by the anchor <NUM>). In the pre-deployment configuration shown, the screw <NUM> is proximal relative to the indicator <NUM> of the inner driver tube <NUM>. The inner driver tube <NUM> connects to the anchor <NUM> having the distal self-punching tip <NUM>, as shown in <FIG>. The inner driver tube <NUM> is secured to the anchor assembly <NUM> with a retention suture <NUM> (which can be pulled out and discarded post-insertion of anchor assembly <NUM>).

Referring now to <FIG>, there is shown a sectioned front view of the driver <NUM> in the pre-deployment configuration, according to an embodiment. As recited above, retention suture <NUM> connects the anchor <NUM> to the driver tube assembly <NUM>. In <FIG>, the retention suture <NUM> extends from the anchor <NUM> through the cannulated inner driver tube <NUM>, through the suture cleat <NUM>, and through the stabilizing yolk <NUM>. The retention suture <NUM> then extends from the stabilizing yolk <NUM>, through the channel <NUM> in the strike surface and retention cleat <NUM>. To maintain the tension keeping the anchor <NUM> connected to the inner driver tube <NUM>, the retention suture <NUM> is cleated or otherwise secured around the strike surface and retention cleat <NUM>, as shown in <FIG>. In the depicted embodiment, the retention suture <NUM> is wrapped around a diameter of the strike surface and retention cleat <NUM>.

Turning to <FIG>, there is shown a top view of the anchor <NUM> looking through the screw <NUM> in a distal direction, according to an embodiment. The screw <NUM> comprises a hex receiving feature <NUM> in its proximal end <NUM> that is sized and configured to engage the distal hex feature <NUM> of the outer driver tube <NUM>. The proximal end of the anchor <NUM> comprises a recessed area with a surface <NUM> (which can be circular) sized and configured to receive the inner driver tube <NUM> (the inner tube <NUM> can have a diameter that is less than the diameter of the recessed area). The surface <NUM> extends in a plane perpendicular to the longitudinal axis of the anchor <NUM>, which comprises at least two apertures <NUM> to secure the retention suture <NUM> (in an alternative embodiments not forming part of the invention, the surface with the at least two apertures can be positioned at the very proximal end of the anchor <NUM>, which can include no recessed area). Specifically, in the embodiment shown in <FIG>, the surface <NUM> comprises two apertures <NUM> that receive the retention suture <NUM> to secure the anchor <NUM> to the strike surface and retention cleat <NUM>. In use, the retention suture <NUM> is passed through one of the apertures <NUM> and then the other aperture <NUM>, and the free ends of the retention suture <NUM> are cleated at the strike surface and retention cleat <NUM>, as shown in <FIG>.

Referring now to <FIG>, there is shown a front view of the kit <NUM>, according to an embodiment. The kit <NUM> includes the driver <NUM> with the suture loader <NUM> connected to or otherwise engaged with the distal end <NUM> of the driver <NUM>. In <FIG> and <FIG>, the suture loader <NUM> is shown having a rectangular body <NUM> with an eyelet <NUM> extending therefrom. The eyelet <NUM> can be composed of flexible material, such as nitinol, or other suitable material as should be understood by a person of ordinary skill in the art. In the depicted embodiment, the eyelet <NUM> is a diamond-shaped when expanded and connects to the rectangular body <NUM> by a straight portion <NUM>. The rectangular body <NUM> additionally has a molded portion <NUM> extending therefrom. As shown in <FIG>, the molded portion <NUM> has a channel <NUM> extending therethrough that is sized and configured to accommodate the inner driver tube <NUM>. When the eyelet <NUM> extends through a suture passing aperture <NUM> in the anchor <NUM>, the channel <NUM> in the molded portion <NUM> receives the inner driver tube <NUM>, as shown in <FIG>. The inner driver tube <NUM> may rest within the channel <NUM> or the molded portion <NUM> may form a snap fit around the inner driver tube <NUM>.

Turning to <FIG>, there is shown a front view of the driver <NUM> in the pre-deployment configuration, according to an embodiment. In the pre-deployment configuration, the suture loader <NUM> (<FIG>) is used to load locking suture (not shown) onto the anchor <NUM>. As should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure, the locking suture can be connected at an end to soft tissue that is used in part of a repair procedure. To load the locking suture on the anchor <NUM>, the eyelet <NUM> of the suture loader <NUM> is first passed through the suture passing aperture <NUM> in the anchor <NUM>. A free end of the locking suture is threaded through the eyelet <NUM> and the eyelet <NUM> is then passed back through the suture passing aperture <NUM> in the anchor <NUM>, threading the locking suture through the anchor <NUM>. The suture loader <NUM> is then removed, leaving the locking suture extending through the anchor <NUM>, as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure.

Thereafter, the self-punching tip <NUM> is positioned at the desired surgical location near the soft tissue in need of repair, not shown (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure; see generally <FIG> for a similar illustrative example series of steps in conjunction with bone hole formation and insertion with respect to an alternative embodiment described herein). The locking suture (not shown) connected to soft tissue is then secured to the suture cleat <NUM>. Specifically, the locking suture is wrapped through the channels <NUM> in the suture cleat <NUM> to maintain the tension in the locking suture. The locking suture secured around the suture cleat <NUM> can be adjusted and re-secured at any time as the self-punching tip <NUM> is aligned at the desired surgical location to maintain proper tension in the locking suture.

After the self-punching tip <NUM> is at the desired surgical location, the strike surface and retention cleat <NUM> is malleted, using the self-punching tip <NUM> to insert the anchor <NUM> into the bone (not shown). The strike surface and retention cleat <NUM> is malleted until the indicator <NUM> on the inner driver tube <NUM> is below the bone surface. Thus, practically, the user continues to mallet the strike surface and retention cleat <NUM> until the indicator <NUM> is no longer visible.

Once the indicator <NUM> is below the bone surface, the screw <NUM> is inserted. To insert the screw <NUM>, the user holds the suture cleat <NUM> steady and rotates the handle body <NUM> clockwise. The handle body <NUM> is rotated until the screw <NUM> is fully inserted, as positionally shown with respect to the device itself in <FIG>. When the screw <NUM> is fully inserted, it abuts or engages the proximal end <NUM> of the anchor <NUM>. Coupling the punching and implantation of the anchor <NUM> reduces the time of surgery and removes some of the hassles clinicians face when using an anchor that must have a pilot hole pre-punched. <FIG> shows a close-up, front view of the screw <NUM> and the anchor <NUM> in the post-deployment configuration, according to an embodiment. As shown, the screw <NUM>, attached to the outer driver tube <NUM>, is connected to or engages the anchor <NUM>, as shown in <FIG>. After the screw <NUM> is inserted, the driver tube assembly <NUM> and suture <NUM> can be removed from the surgical location, leaving the screw <NUM> and the anchor <NUM>. In the close-up, side view shown in <FIG>, the screw <NUM> can additionally comprise one or more vents <NUM> extending at least partially therethrough. The vents <NUM> are bone marrow vents that allow bone marrow to grow into and engage the screw <NUM>.

Referring now to <FIG>, there are shown multiple views of an alternative embodiment of the driver <NUM>. <FIG> shows a front view of the driver <NUM>, according to an alternative embodiment. The driver <NUM> comprises a proximal handle assembly <NUM> extending to a driver tube assembly <NUM>. The driver tube assembly <NUM> extends to an anchor assembly <NUM> at a distal end <NUM> of the driver <NUM>. The handle assembly <NUM> comprises a handle body <NUM> with a deployment mechanism <NUM> extending therefrom. The deployment mechanism <NUM> is at least partially rotatable relative to the handle body <NUM>. In the side view of the driver <NUM> shown in <FIG>, the handle assembly <NUM> additionally comprises a torsional mechanism <NUM>.

Turning to <FIG> and <FIG>, there is shown a close-up, front view and a sectioned front view of the distal end <NUM> of the driver <NUM>, according to an alternative embodiment. As shown in <FIG>, the anchor assembly <NUM> is connected to the driver tube assembly <NUM>. The anchor assembly <NUM> comprises a screw <NUM> and an anchor <NUM>. In use, both the anchor <NUM> and the screw <NUM> will be implanted into the body of the patient. <FIG> shows clearly that the driver tube assembly <NUM> comprises a cannulated inner driver tube <NUM> within a cannulated outer driver tube <NUM>. The screw <NUM> is connected to the inner driver tube <NUM>. As also shown in <FIG>, an actuator <NUM> extends through the inner driver tube <NUM>, screw <NUM>, and anchor assembly <NUM>. In the depicted embodiment, the actuator <NUM> is a rod with a self-punching tip <NUM>. As shown in <FIG> and <FIG>, the self-punching tip <NUM> extends out distally from the anchor <NUM>. The anchor <NUM> comprises internal threads <NUM> that are configured to mate with external threads <NUM> of the screw <NUM>, as shown in <FIG>.

As shown in <FIG>, the anchor <NUM> additionally comprises one or more wing features <NUM> created by strategic cuts or channels in a proximal end <NUM> of the anchor <NUM>. The wing features <NUM> are designed to expand and deploy into the surrounding bone as a proximal end <NUM> of the screw <NUM> is advanced via the torsional mechanism <NUM>. Thus, the anchor <NUM> is the main retention feature implanted into the bone. The deploying the of the wing features <NUM> increases the overall outer dimensions of the anchor <NUM>, making it larger than the osteotomy in which it was implanted, stabilizing the anchor <NUM> into the bone and resisting pullout.

Referring to <FIG>, there is shown a close-up, front view of the handle assembly <NUM> (one molded half body piece <NUM>) of the driver <NUM>, according to an alternative embodiment. As shown, the handle body <NUM> is composed of two molded half body pieces <NUM> (note, only one is shown in <FIG>). As shown in <FIG>, the outer driver tube <NUM> with the inner driver tube <NUM> extending at least partially therein is placed within one of the molded half body pieces <NUM>. The outer driver tube <NUM> protects the inner driver tube <NUM> and the actuator <NUM> during implantation and shield them from the surrounding tissue. The inner driver tube <NUM> is connected to the torsional mechanism <NUM> and the torsional mechanism <NUM> is rotatable. Therefore, when the torsional mechanism <NUM> is rotated, the inner driver tube <NUM> rotates as well, rotating the connected screw <NUM>. The torsional mechanism <NUM> is also a screw feature. The torsional mechanism <NUM> can be a single, dual, or quad lead screw feature. The torsional mechanism <NUM> is rotated to deploy the screw <NUM> into the anchor <NUM>.

Still referring to <FIG>, the actuator <NUM> extends through the torsional mechanism <NUM> and a trigger mechanism <NUM>. The trigger mechanism <NUM> is connected to or selectively engages the deployment mechanism <NUM>. The trigger mechanism <NUM> is used to pull the actuator <NUM> and deploy the anchor <NUM>. In use, when the deployment mechanism <NUM> is engaged (i.e., rotated toward the handle body <NUM>), the trigger mechanism <NUM> is engaged and pulls the actuator <NUM> proximally. As shown in <FIG>, the actuator <NUM> extends out of the handle body <NUM>. The portion of the actuator <NUM> that extends out of the handle body <NUM> is circular or disk-shaped in <FIG> and functions as a striking surface for malleting. The actuator <NUM> drives the anchor <NUM> into the bone and retains the anchor <NUM> connection to the handle assembly <NUM>. The handle assembly <NUM> additionally includes one or more suture cleats <NUM>. In the depicted embodiment, the handle body <NUM> includes two cleats <NUM> formed in the molded half body piece <NUM> and extending proximally. The suture cleat <NUM> maintains its position to provide consistent, proper tension and placement of locking suture during the use of the torsional mechanism <NUM>.

The structure of the anchor assembly <NUM> maximizes internal suture retention. External threads <NUM> (i.e., male threadform) of the screw <NUM> are undersized compared to internal threads <NUM> (i.e., female threadform) of the anchor <NUM> to allow room for the locking suture to be compressed between the external threads <NUM> and the internal threads <NUM>. The threadform used for both the external threads <NUM> and the internal threads <NUM> has a wide, rounded profile 323A shown in <FIG> instead of a tighter, triangular profile 323B of a standard threadform shown in <FIG>. In use, the locking suture is in tension across the opening of the internal threads <NUM>. The wide, rounder profile (<FIG>) requires less force to compress the locking suture into the wider and rounder internal threads <NUM> (<FIG>) than the narrower and sharper opening of the standard threadform (<FIG>). The standard threadform requires too much force to compress the locking suture therein, and the locking suture may resist the compression and resist the advancement of the screw <NUM>. The rounded threadform shown in <FIG>, instead, has a larger pitch, more consistent line-to-line spacing for creating an even spread of the reaction forces of the locking suture from compression, and a larger cross-sectional area to resist deformation as compared to the standard threadform in <FIG>.

To use the driver <NUM>, the user first loads it with locking suture <NUM>, as shown in <FIG> and <FIG>. As described in conjunction with the first embodiment described herein, locking suture <NUM> connected to the soft tissue to be repaired is threaded through the anchor <NUM>. The locking suture <NUM> may comprise two pre-loaded suture pull tabs <NUM> with nitinol wire. For loading, the locking suture <NUM> is passed in through a distal suture passing aperture <NUM> that extends through the anchor <NUM>, as shown in <FIG> and <FIG>. The locking suture <NUM> is passed out through a proximal suture passing aperture <NUM> that extends through the anchor <NUM>, as also shown in <FIG> and <FIG>. The apertures <NUM>, <NUM> are sized and configured such that the anchor <NUM> can hold a total of six (<NUM>) limbs of locking suture, with each pull tab <NUM> holding a maximum of three (<NUM>) limbs of locking suture. The apertures <NUM>, <NUM> are also offset to maximize the amount of material of the anchor <NUM> that the locking suture <NUM> pulls against to maximize the internal compression force, as described above.

Thereafter, the user inserts the driver <NUM> through a cannula or through the soft tissue of the patient to the desired surgical location. Then, the user punches the driver <NUM> into the bone with a mallet. In particular, the user can strike the portion of the actuator <NUM> that extends out proximally from the handle body <NUM>. The actuator <NUM> is malleted until it reaches an indicated laser mark (e.g., on the inner driver tube <NUM>) to a depth of at least <NUM> below the surface of the bone. The user then tensions the anchor <NUM> relative to the repair tissue by pulling on the locking suture <NUM>. The locking suture <NUM> is cleated to the suture cleat <NUM> of the handle body <NUM> after the desired tension is reached.

To lock the locking suture <NUM> in place within the anchor <NUM>, the user rotates the torsional mechanism <NUM>, thereby rotating the connected screw <NUM> into the anchor <NUM> and trapping the locking suture <NUM> between the screw <NUM> and the anchor <NUM>. This process also deploys the wing features <NUM>. In other words, as the screw <NUM> moves distally within the anchor <NUM>, the screw <NUM> forces the wing features <NUM> outward. Once the screw <NUM> is completely inserted within the anchor <NUM>, the user deploys the anchor <NUM> and detach the anchor <NUM> from the handle assembly <NUM>. The user deploys and detaches the anchor <NUM> by depressing the deployment mechanism <NUM> toward the handle body <NUM>. Depressing the deployment mechanism <NUM> pulls the actuator <NUM> proximally, which, in turn, pulls the anchor <NUM> against the driver tube assembly <NUM> until the force strips the plastic, left-handed internal threads <NUM> (<FIG>) of the anchor <NUM> and deploys the anchor <NUM>.

Referring now to <FIG>, there are shown various views of an alternative embodiment of the anchor assembly <NUM>. The anchor assembly <NUM> shown in <FIG> is similar in function to that shown in <FIG>. The anchor assembly <NUM> in <FIG> comprises a screw <NUM> and an anchor <NUM>. The anchor assembly <NUM> is configured to be malleted into the desired surgical location. The screw <NUM> has wider, rounded external threads <NUM> that are configured to mate with wider, rounded internal threads <NUM> of the anchor <NUM> (<FIG>). As shown in <FIG>, the anchor <NUM> comprises external threads <NUM> in the depicted embodiment. The anchor <NUM> additionally comprises wing features <NUM> that are configured to pop or move outward (<NUM>) when the screw <NUM> is rotated distally into the anchor <NUM>. Furthermore, the anchor <NUM> comprises a distal suture passing aperture <NUM> that is offset from a proximal suture passing aperture <NUM>, as described above with reference to <FIG>, which each accommodate at least three (<NUM>) threads of locking suture <NUM>. The anchor <NUM> also comprises plastic, left-handed internal threads <NUM> (<FIG>) to deploy the anchor <NUM>, as described above.

Referring now to <FIG>, there are shown various views of another alternative embodiment of the anchor assembly <NUM>. The anchor assembly <NUM> in <FIG> uses a "pull" style deployment. The anchor assembly <NUM> comprises a tubular "punch portion" <NUM> (instead of a screw) and an anchor <NUM>. The punch portion <NUM> comprises distal suture passing apertures <NUM> that are sized and configured to accommodate four (<NUM>) limbs of locking suture <NUM> therethrough. This differs from the previous embodiments in that the punch portion <NUM> has the distal suture passing apertures <NUM> instead of the anchor <NUM>. During deployment, the punch portion <NUM> is guided into the anchor <NUM> and the locking suture <NUM> is compressed between the punch portion <NUM> and the anchor <NUM>. As shown, the punch portion <NUM> comprises some external threads <NUM> that assist in compressing the locking suture <NUM> against the anchor <NUM>. The anchor <NUM> additionally comprises wing features <NUM>, as described above, that deform or extend outward (<NUM>) to lock the anchor <NUM> in place within the bone.

Turning to <FIG>, there are shown various views of yet another alternative embodiment of the anchor assembly <NUM>. The anchor assembly <NUM> comprises an anchor assembly <NUM> and a punch portion <NUM> (again, instead of a screw). The punch portion <NUM> is configured to be inserted into the anchor <NUM>. The punch portion <NUM> comprises a proximal end <NUM> that is wider than a distal end <NUM>. The proximal end <NUM> comprises proximal suture passing apertures <NUM> configured to receive locking suture (not shown) therethrough. The distal end <NUM> of the punch portion <NUM> comprises wing features <NUM> that expand or move outward within the anchor <NUM>. As the anchor assembly <NUM> is deployed, as shown in <FIG>, the punch portion <NUM> extends into the anchor <NUM> until the wing features <NUM> engage a locking feature <NUM> within the anchor <NUM>. The proximal end <NUM> of the punch portion <NUM> may cause a proximal end <NUM> of the anchor <NUM> to expand radially when the punch portion <NUM> is fully deployed within the anchor <NUM>.

Referring now to <FIG>, there are show various views of another alternative embodiment of the driver <NUM>. As depicted in the perspective view in <FIG>, the driver <NUM> comprises a proximal handle assembly <NUM> extending to a driver tube assembly <NUM>. The driver tube assembly <NUM> extends to an anchor assembly <NUM> at a distal end <NUM> of the driver <NUM>. The anchor assembly <NUM> is preferably made of PEEK; however, the anchor assembly <NUM> can be made of metal or another polymer strong enough to punch a pilot hole into bone.

The handle assembly <NUM> comprises a proximal, rotatable knob <NUM> connected to a handle body <NUM>. The handle body <NUM> comprises a cleat <NUM> extending therefrom and configured to assist in tensioning suture. The driver tube assembly <NUM> includes an inner driver tube <NUM> and an outer driver tube <NUM>. The outer driver tube <NUM> is cannulated and the inner driver tube <NUM> extends therein. The inner driver tube <NUM> is connected to the anchor assembly <NUM>, as described in detail below. The inner driver tube <NUM> can be fixedly connected to knob <NUM> and the outer driver tube <NUM> can be fixedly connected to the handle body <NUM> or vice versa, depending on which portion of the instrument is driving which portion of the anchor assembly (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

<FIG> shows a close-up, perspective view of the distal end <NUM> of the driver <NUM>. As previously mentioned, the distal end <NUM> comprises the anchor assembly <NUM>. The anchor assembly <NUM> is connected to the driver tube assembly <NUM> and comprises a screw <NUM> and an anchor <NUM> with a self-punching tip <NUM>. The anchor <NUM> comprises a broaching feature <NUM> extending around and along the length of the anchor <NUM> that aids in minimizing stress cracking when impacting the self-punching tip <NUM> into bone. A distal end <NUM> of the inner driver tube <NUM> comprises a suture passing aperture <NUM> extending therethrough.

As shown in <FIG>, the screw <NUM> of the anchor assembly <NUM> is connected to the driver tube assembly <NUM>. Specifically, the screw <NUM> is connected to the outer driver tube <NUM>. The screw <NUM> is proximal relative to the anchor <NUM> and the suture passing aperture <NUM>. In a pre-deployment configuration (<FIG>), the screw <NUM> and the anchor <NUM> are spaced along the driver tube assembly <NUM> with the suture passing aperture <NUM> therebetween.

<FIG> shows a perspective view of the driver <NUM> in the pre-deployment configuration. In use, locking suture <NUM> connected to the soft tissue in need of repair is threaded through the suture passing aperture <NUM> in the inner driver tube <NUM>. The locking suture <NUM> is then tensioned and wrapped around or otherwise connected to the cleat <NUM> of the handle body <NUM>, as shown in <FIG>. Once tensioned, the self-punching tip <NUM> of the anchor <NUM> is aligned at the desired surgical location. Note, the locking suture <NUM> can be retensioned and cleated again at any time to ensure that the locking suture <NUM> remains under proper tension.

Thereafter, in <FIG>, the knob <NUM> of the handle assembly <NUM> is malleted or otherwise impacted to punch the self-punching tip <NUM> into the bone. This is done until the screw <NUM> comes in contact with the bone surface, as shown in <FIG>. From there, the user holds the knob <NUM> and rotates the handle body <NUM> relative thereto (or vice versa in an alternative embodiment, depending on which tube <NUM>, <NUM> is connected to the knob <NUM> and which is connected to the handle body <NUM>). Rotating the handle body <NUM> distally toward the desired surgical location inserts the screw <NUM> into the bone, as shown in <FIG>. Because the screw <NUM> is connected to the outer driver tube <NUM>, which is connected to the handle body <NUM>, when the handle body <NUM> is rotated, the screw <NUM> rotates as well. The screw <NUM> locks the locking suture <NUM> against the bone. The locking suture <NUM> also becomes locked between the screw <NUM> and the anchor <NUM>.

Referring now to <FIG>, there are shown various views of an alternative embodiment of the anchor <NUM>. In the top view in <FIG>, the anchor <NUM> comprises a proximal end <NUM> with two apertures <NUM> extending therethrough. The two apertures <NUM> are sized and configured to receive a retention suture <NUM> (<FIG>) that holds the anchor <NUM> to a driver tube assembly <NUM> or handle assembly <NUM>, as described above with reference to <FIG>. The anchor <NUM> also includes a suture passing aperture <NUM> that is configured to receive locking suture that is connected to the soft tissue to be repaired, as shown in FIG. 7D shows that the anchor <NUM> comprises a wider proximal end <NUM> as compared to a distal end <NUM>. The wider proximal end <NUM> allows the anchor <NUM> to grasp the bone and lock into the pilot hole.

It should be understood that the values used above are only representative values, and other values may be in keeping with the spirit and intention of this disclosure.

While several inventive embodiments have been described and illustrated herein with reference to certain exemplary embodiments, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein (and it will be understood by one skilled in the art that various changes in detail may be effected therein without departing from the scope of the invention as defined by claims that can be supported by the written description and drawings). More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; inventive embodiments may be practiced otherwise than as specifically described and claimed. Further, where exemplary embodiments are described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements.

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

The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The term "connected" is to be construed as partly or wholly contained within, attached to, or joined together, even if not directly attached to where there is something intervening.

Accordingly, a value modified by a term or terms, such as "about" and "substantially", are not to be limited to the precise value specified. Here and throughout the specification and claims, range limitations may be combined and/or interchanged; such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise.

The 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.

The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate embodiments of the invention and does not impose a limitation on the scope of the invention unless otherwise claimed.

Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section <NUM>.

Claim 1:
An anchor assembly (<NUM>), comprising:
a distal anchor (<NUM>) extending along a longitudinal axis and having a proximal end (<NUM>) and a distal self-punching tip (<NUM>);
at least a first aperture (<NUM>) extending through the proximal end (<NUM>) of the distal anchor (<NUM>) in a direction substantially parallel to the longitudinal axis;
a first suture passing aperture (<NUM>, <NUM>) extending through the distal anchor (<NUM>) at an angle to the longitudinal axis and between the proximal end (<NUM>) and the distal self-punching tip (<NUM>); and
a proximal screw (<NUM>) configured to engage or abut the proximal end (<NUM>) of the distal anchor (<NUM>),
characterized in that the proximal end (<NUM>) of the distal anchor (<NUM>) includes a recess with a surface (<NUM>) positioned therein extending in a plane substantially perpendicular to the longitudinal axis, wherein the at least first aperture (<NUM>) and a second aperture (<NUM>) are positioned through the surface (<NUM>).