Bunion Correction Systems and Methods

Abstract

To provide a bunion correction implant system for correcting a bunion formed at a joint between a metatarsal and a big toe.SOLUTION: An implant nail includes a first fastener and a second fastener, the implant nail having a body, the body having a head, an anchor, a neck, and a second opening. The head includes: a first end of the head including a first shoulder and a second shoulder; a second end of the head; and a first opening extending through the head, the first opening extending along a second axis of the head. The heat extends between a first end part of the head and a second end part of the head along a first axis of the head. The neck extends between the head and the anchor. The anchor and the neck extend along an implant axis. The second opening extends through the neck or the head and extends along a third axis of the head.SELECTED DRAWING: Figure 25

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is related to U.S. Patent Application No. 16 / 033,086, entitled "BUNION CORRECTION SYSTEM AND METHOD," the entire disclosure of which is hereby incorporated by reference for all purposes as if fully set forth herein in all respects contained therein. This application claims the benefit of U.S. Patent Application No. 62 / 883,819, entitled "BUNION CORRECTION SYSTEM AND METHOD," filed August 7, 2019, which is hereby incorporated by reference in its entirety.

[0002] (Field) The present invention relates to surgical treatments for foot deformities. More particularly, the present invention relates to implants, instrumentation, and methods for minimally invasive bunion correction. [Background technology]

[0003] (background) A bunion is typically a progressive disorder that begins with a tilt of the big toe, which can gradually change the angle of the bone and produce a characteristic bulge on the medial side of the metatarsal near the proximal phalanx's articulation with the metatarsal. Specifically, a bunion is a protuberance consisting of bone and sometimes an inflamed bursa. Hallux valgus is a condition in which the big toe deviates from its normal position toward the second toe.

[0004] Bunion correction or repair is a common surgical procedure, with over 100,000 surgeries performed annually in the United States. Many surgical procedures for bunion repair are invasive and painful, requiring multi-inch incisions and lengthy recovery periods of up to 10-12 weeks. Minimally invasive surgery has been practiced in orthopedic surgery for decades. However, creating bone cuts is performed using drilling instruments and drill bits inserted invisibly through small incisions. This surgical method leads to potential adjacent soft tissue damage and irreproducible results between patients. The disclosure contained herein seeks to rectify this problem by providing a simple implant insertion technique, as well as instrumented techniques and guidance to provide reproducibility and limit damage to tissue.

[0005] Disclosed herein are implants and methods for bunion repair that can be performed as minimally invasive procedures, thus reducing discomfort, scarring, and recovery time compared to more invasive bunion correction procedures. Summary of the Invention [Problem to be solved by the invention]

[0006] The various systems and methods of the present invention have been developed in response to this state of the art, and particularly in response to problems and needs in the art that have not yet been fully addressed by currently available techniques. The systems and methods of the present invention may provide techniques for bunion correction that result in streamlined procedures, more rapid recovery, reduced scarring, and reduced discomfort during healing. [Means for solving the problem]

[0007] To achieve the foregoing, in accordance with the invention as embodied and broadly described herein, one aspect of the present disclosure provides a method for treating a bunion formed at the joint between the metatarsal and the big toe. A first method for correcting a tarsal flexion is described. An incision is made along the lateral side of a metatarsal. A target location is selected on the metatarsal. The metatarsal is resected at the target location into a first metatarsal portion and a separate second metatarsal portion. The first metatarsal portion has a distal-facing surface created by the resection. A pocket instrument is inserted into the first metatarsal portion at the distal-facing surface to create a pocket within the first metatarsal portion at the distal-facing surface. An implant is implanted into the pocket of the first metatarsal portion through the incision, the implant having a monolithic body with a head and an anchor.

[0008] In another aspect of the first method, the pocket extends through the distally facing surface into the intramedullary canal of the first metatarsal portion.

[0009] In another aspect of the first method, at least one k-wire is inserted through the distal facing surface into the first metatarsal portion, the first k-wire directing a first instrument into the first metatarsal portion to create a pocket.

[0010] In another aspect of the first method, the first pocket device is a broach.

[0011] In another aspect of the first method, a broach includes a handle aligned along a first axis, an insert portion having a plurality of teeth aligned along a second axis, and an offset portion between the handle and the insert portion such that the first axis is angled relative to the second axis.

[0012] In another aspect of the first method, an implant head is attached to the first metatarsal portion.

[0013] In another aspect of the first method, attaching the implant head to the first metatarsal portion includes inserting a screw through an opening in the implant head and into the first metatarsal portion.

[0014] In another aspect of the first method, the implant head is attached to the second metatarsal portion.

[0015] In another aspect of the first method, a length of suture is secured to the big toe, the suture is tensioned to realign the big toe with the first metatarsal portion, and the length of suture is attached to the head of the implant.

[0016] In another aspect of the first method, the second metatarsal portion is translated to expose a distally facing surface on the first metatarsal portion.

[0017] Another aspect of the present disclosure is a second method for correcting a bunion. An incision is made along the lateral side of a metatarsal. A target location is selected on the metatarsal. The metatarsal is resected into a first metatarsal portion and a separate second metatarsal portion, the first metatarsal portion having a distal-facing surface created by the resection. An implant is implanted into the first metatarsal portion through the incision. The implant has a monolithic body with a head and an anchor, the anchor extending along the implant axis. The implant head is first attached to the first metatarsal portion at the distal-facing surface, and the implant head is then attached to the second metatarsal portion.

[0018] In another aspect of the second method, an implant head is attached to the first metatarsal portion and includes inserting a first screw through a first opening in the implant head and into a distally facing surface of the first metatarsal portion.

[0019] In another aspect of the second method, the first opening is aligned along a first axis at a first angle relative to the implant axis.

[0020] In another aspect of the second method, the first angle is less than approximately 45°.

[0021] In another aspect of the second method, attaching the implant head to the second metatarsal portion includes inserting a second screw through a second opening in the implant head and into the second metatarsal portion.

[0022] In another aspect of the second method, the second aperture is aligned along a second axis at a second angle relative to the implant axis, the second angle being greater than the first angle.

[0023] In another aspect of the second method, the second angle is greater than 60°.

[0024] In another aspect of the second method, the second metatarsal portion is translated to expose a distally facing surface on the first metatarsal portion, and a pocket is created in the first metatarsal portion at the distally facing surface, the pocket extending through the distally facing surface into the intramedullary canal of the first metatarsal portion.

[0025] In another aspect of the second method, a pocket instrument is inserted and guided by at least one k-wire into the first metatarsal portion at the distally facing surface to create a pocket.

[0026] In another aspect of the second method, a length of suture is secured to the big toe, the suture is tensioned to realign the big toe with the first metatarsal portion, and the length of suture is attached to the implant.

[0027] Another aspect of the present disclosure is a third method for correcting a bunion. An incision is made along the lateral side of a metatarsal. A first k-wire is introduced into the metatarsal at a selected target location through the incision. The metatarsal is resected at the selected target location into a first metatarsal portion and a separate second metatarsal portion. The first metatarsal portion has a distal-facing surface created by the resection. A second k-wire is inserted into the first metatarsal portion at the distal-facing surface. A pocket instrument is inserted into the first metatarsal portion at the distal-facing surface guided by the second k-wire to create a pocket within the first metatarsal portion at the distal-facing surface. An implant is inserted into the first metatarsal portion through the incision, the implant having a monolithic body with a head and an anchor, the anchor extending along the implant axis. An implant head is attached to the first metatarsal portion at the distal-facing surface, attaching the implant head to the second metatarsal portion.

[0028] In another aspect of the third method, attaching the implant head to the first metatarsal portion includes inserting a first screw through a first opening in the implant head and into a distally facing surface of the first metatarsal portion, and attaching the implant head to the second metatarsal portion includes inserting a second screw through a second opening in the implant head and into the second metatarsal portion.

[0029] In another aspect of the third method, the second metatarsal portion is translated to expose a distally facing surface on the first metatarsal portion, and a pocket is created in the first metatarsal portion at the distally facing surface, the pocket extending through the distally facing surface into the intramedullary canal of the first metatarsal portion.

[0030] These and other features and advantages of the present invention will become more apparent from the following description and appended claims. These will become entirely apparent or may be learned by practice of the invention as described hereinafter. [Brief explanation of the drawings]

[0031] Exemplary embodiments of the present invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which it is understood that these drawings depict exemplary embodiments only and therefore should not be considered limiting of the scope of the invention, and that exemplary embodiments of the present invention will be described with additional specificity and detail through the use of the accompanying drawings.

[0032] [Figure 1A] FIG. 1A is a perspective view of a bunion correction implant with nails and fasteners according to one embodiment of the present invention. [Figure 1B] FIG. 1B is an exploded view of the implant.

[0033] [Figure 2] FIG. 2 is a perspective view of a partial skeleton of a foot with the implant of FIG. 1A implanted in the first metatarsal bone.

[0034] [Figure 3A] FIG. 3A is a medial view of the nail of FIG. 1A. [Figure 3B] FIG. 3B is a side view of the nail of FIG. 1A.

[0035] [Figure 4] FIG. 4 is a perspective view of a foot skeleton with a k-wire inserted into a metatarsal bone and a first guide portion mounted on the k-wire, the first guide portion having a plurality of guide holes.

[0036] [Figure 5] FIG. 5 is a perspective view of the foot skeleton, k-wires, and guides of FIG. 4 with additional k-wires inserted into the metatarsals.

[0037] [Figure 6] FIG. 6 is a perspective view of the foot skeleton, k-wire, and first guide of FIG. 5 with a trocar extending through one of the guide holes to create a hole in the metatarsal.

[0038] [Figure 7] FIG. 7 is a perspective view of the foot skeleton and k-wire of FIG. 5 with a second guide mounted on the k-wire.

[0039] [Figure 8] FIG. 8 is a perspective view of the foot skeleton, k-wire, and second guide of FIG. 7 with a broach extending through the guide slot and cutting an osteotomy within the metatarsal, separating the metatarsal into a proximal metatarsal portion and a distal metatarsal portion.

[0040] [Figure 9] FIG. 9 is a perspective view of the foot skeleton of FIG. 8 with the distal metatarsal portion shifted laterally relative to the proximal metatarsal portion.

[0041] [Figure 10] 10 is a perspective view of the foot skeleton of FIG. 9 with the nail of FIG. 1 mounted on an implant inserter and implanted into the proximal metatarsal portion.

[0042] [Figure 11A] FIG. 11A is a medial view of the foot with the nail of FIG. 1 implanted within the proximal metatarsal portion and a needle and suture inserted into the foot through an incision at the site of the implant and exiting from a first location on the big toe at the proximal phalanx. [Figure 11B] FIG. 11B is a medial view of the foot of FIG. 11A with a first stitch being made at a first location on the big toe. [Figure 11C] FIG. 11C is a medial view of the foot of FIG. 11B with the needle emerging at a second location on the big toe. [Figure 11D] FIG. 11D is a medial view of the foot of FIG. 11C with a second stitch being made at a second location on the big toe. [Figure 11E] FIG. 11E is a medial view of the leg of FIG. 11D with the suture routed through the implant bore and the needle and suture emerging through the incision and showing the route of the suture.

[0043] [Figure 12] FIG. 12 is a perspective view of the foot skeleton of FIG. 10 showing the sutures and fasteners directed toward the nail opening.

[0044] [Figure 13A] 13A is a perspective view of the first guide portion of FIG. 5. FIG. [Figure 13B] 13B is an inside view of the first guide portion of FIG. [Figure 13C] 13C is a side view of the first guide portion of FIG. 5. FIG. [Figure 13D] 13D is a top view of the first guide of FIG. [Figure 13E] FIG. 13E is a distal view of the trocar of FIG. 6 extending through the distal end of the metatarsal, the first guide portion, and another of the guide holes with dotted lines indicating the trajectories of the guide holes.

[0045] [Figure 14A] 14A is an inner perspective view of the second guide portion of FIG. 7. FIG. [Figure 14B] 14B is an inside view of the second guide portion of FIG. [Figure 14C] 14C is a side view of the second guide portion of FIG. [Figure 14D] 14D is a side perspective view of the second guide portion of FIG. 7. FIG. [Figure 14E] FIG. 14E is an inside view of another embodiment of the second guide.

[0046] [Figure 15] FIG. 15 is a perspective view of the broach of FIG.

[0047] [Figure 16] 16 is a perspective view of the implant inserter of FIG. 10. FIG.

[0048] [Figure 17] FIG. 17 is a perspective view of the foot skeleton of FIG. 9 showing the insertion of k-wires into the proximal metatarsal portion.

[0049] [Figure 18] 18 is a perspective view of the foot skeleton of FIG. 17 showing a pocket instrument for forming a pocket inserted into the proximal metatarsal portion, as guided by a k-wire.

[0050] [Figure 19] FIG. 19 is a side view of the pocket device shown in FIG.

[0051] [Figure 20] FIG. 20 is a bottom view of the pocket device shown in FIG.

[0052] [Figure 21] FIG. 21 is a perspective view of another bunion correction implant.

[0053] [Figure 22] FIG. 22 is an exploded view of the implant of FIG.

[0054] [Figure 23] FIG. 23 is a medial view of the nail of the implant of FIG.

[0055] [Figure 24] FIG. 24 is a side view of the nail of FIG.

[0056] [Figure 25] FIG. 25 is a cross-sectional view of the implant of FIG.

[0057] [Figure 26] FIG. 26 is a medial view of the nail of another implant system.

[0058] [Figure 27] FIG. 27 is a side view of the nail of FIG.

[0059] [Figure 28] FIG. 28 is a top view of the nail of FIG.

[0060] [Figure 29] FIG. 29 is a cross-sectional view of the implant of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0061] (Detailed explanation) Exemplary embodiments of the present invention will be best understood by reference to the drawings, in which like parts are designated with like numerals throughout. It will be readily understood that the components of the invention, as generally described herein and illustrated in the figures, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of device, system, and method embodiments, as represented in Figures 1A-25, is not intended to limit the scope of the invention, as claimed, but is merely representative of exemplary embodiments of the invention.

[0062] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components can be functionally coupled to one another without being in direct contact with one another. The term "abutting" refers to items that are in direct physical contact with one another, although the items may not necessarily be attached together. The phrase "fluid communication" refers to two features that are connected such that fluid in one feature can pass into the other feature.

[0063] Directional and / or relational terms, such as, but not limited to, left, right, upper, lower, top, bottom, vertical, horizontal, medial, and lateral, are relative to one another and depend on the specific orientation of the applicable element or article, and thus are used to aid in the description of the various embodiments and appended claims herein and are not intended to be necessarily limiting. Standard medical terminology may be used to describe human anatomical structures or the relationship of objects to human anatomical structures. For example, "proximal" refers to an object or anatomical element that is closer to the center of the body, while "distal" refers to an object or anatomical element that is farther away from the center of the body.

[0064] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0065] 1A, a bunion correction implant system 100 according to one embodiment of the present invention includes a nail 102 and a fastener 104. As seen in FIG. 2, the nail 102 may be implanted so as to extend longitudinally within the proximal portion 2a of the resected metatarsal 2, and a fastener 104 may be inserted through a portion of the nail and secure it to the distal portion 2b of the metatarsal 2. The bunion correction implant system 100 may further include a suture that may be routed through the medial capsule of the metatarsophalangeal (MTP) joint, secured within the soft tissue of the big toe, tensioned, realigning the position of the proximal phalanx 4 relative to the metatarsal, and secured to the nail.

[0066] 1A-B and 3A-C, the implant nail 102 is a monolithic body extending from a first end 106, which may be a distal end, to a second end 108, which may be a proximal end. The nail 102 may be generally rectangular in cross section and has an inner side 110, which may be an outer side, an outer side 112, which may be an inner side, an upper side 114, and a lower side 116. The nail 102 includes a head 120, an anchor 122, and a neck 124 extending between the head 120 and the anchor 122.

[0067] 3B and 3C, the nail anchor 122 and neck 124 extend along the longitudinal axis 105, with the nail head 120 extending distally away from the neck 124 at an angle. The nail head extends along a head first axis 107 between a head first end 126 and a head second end 128. In the depicted embodiment, the angle α between the head first axis 107 and the longitudinal axis 105 is 15°, and the angle β between the neck outer surface and the head outer surface is 165°. In other embodiments of the invention, the angle α may be in the range of 0° to 25°. At least in the depicted embodiment, the nail 102 and assembled implant 100 are symmetrical with respect to the longitudinal axis 105 and with respect to the head first axis 107.

[0068] The nail head 120 includes an opening 130 centered on a head second axis 109 that is perpendicular to the head first axis 107. The head second axis may extend generally in a medial-lateral direction (ML) during implantation. In the depicted embodiment, the opening 130 extends between the head lateral side 115 and the head medial side 113 and includes threads 132 for engagement with the fastener 104, although additional embodiments may lack threads. A concave edge 134 surrounds the opening 130. The head second end 128 is wider than the neck 124 in the vertical dimension and includes a first shoulder 140 and a second shoulder 142 that project upward and downward, respectively, away from the neck 124 at the intersection of the neck and head. The first shoulder 140 includes a first proximal shoulder surface 141, and the second shoulder 142 includes a second proximal shoulder surface 143. The proximal shoulder surfaces 141, 143 face proximally, away from the head 120, and are perpendicular to the upper and lower sides 114, 116 of the neck. The head 120 may further include a transverse bore 148 extending along a head third axis 111 that is perpendicular to the head first axis 107 and the head second axis 109. The head third axis 111 may extend generally in the superior-inferior (SI) direction upon implantation. In the depicted embodiment, the thickness of the head 120 between its medial side 113 and lateral side 115 increases between the head first end 126 and the head second end 128 such that the thickest portions of the head are at the shoulders 140, 142.

[0069] A neck 124 extends between and connects the head 120 and the anchor 122. The thickness of the neck 124 between the medial side 110 and the lateral side 112 can vary depending on the desired degree of metatarsal shift. In at least the depicted embodiment, the thickness of the neck is tapered between the head 120 and the anchor 122. The width of the neck 124 between the upper side 114 and the lower side 116 can also vary. The length of the nail between the first and second ends 106, 108 can vary, as can the relative lengths of the head, neck, and / or anchor portions. The anchor 122 is coaxial with the neck 124 and extends from the neck to the second end of the nail. The thickness of the anchor between the medial side 110 and the lateral side 112 and the width of the neck 124 between the upper side 114 and the lower side 116 can also vary. Both the width of the anchor and the neck are tapered toward the second end of the nail, which can facilitate easy insertion of the nail into the bone. The second end of the anchor can be rounded, as in the embodiment depicted in FIGS. 1A and 1B, or in other embodiments, it can be pointed, flat, serrated, or another shape. The anchor 122 includes multiple bone-engaging features 144, which can be shaped as teeth, scallops, serrated edges, or other shapes to facilitate engagement within the bone. For example, the scallops 146 in the depicted embodiment provide surface irregularities that resist nail backout. In the embodiment shown, the neck and anchor are without openings, while other embodiments may include openings for supplemental fixation or instrument connection.

[0070] Fastener 104 includes a fastener head 150, a fastener shaft 152, and a tip 154. Head 150 includes threads 156 for locking engagement with threads 132 in nail head 120; other embodiments may lack threads 156. Shaft 152 includes threads 158 for engagement within bone. Head 150 may include drive features 157 for engagement with a driver. In the depicted embodiment, fastener 104 is a locking screw-type fastener; in other embodiments, the fastener may be locking or non-locking, and may be multi-axially adjustable or non-multi-axially adjustable.

[0071] The nails 102 and fasteners 104 may comprise titanium, stainless steel, polyetheretherketone (PEEK), nitinol, and / or other rigid biocompatible materials, or combinations thereof. The sutures are non-absorbable sutures, although other embodiments may include absorbable sutures.

[0072] 4-16, a method for correcting a bunion includes one or more of the following steps: Although the steps are described in one order, in other embodiments of the method, one or more of the steps may be repeated, omitted, or performed in a different order.

[0073] A small incision is made in the affected metatarsal medial to the bunion. Preferably, the incision is 0.5 inches or less in length. Referring to FIG. 4, a first k-wire 159 is introduced through the incision into the metatarsal at the selected target location. A first guide block 164 is mounted on the k-wire 159 and advanced toward the metatarsal 2. Referring to FIG. 5, second and third k-wires 160, 162 are introduced through the guide block 164 into the metatarsal on either side of the selected target location. The second k-wire 160 is positioned in the proximal metatarsal portion 2a, and the third k-wire 162 is introduced into the distal metatarsal portion 2b. The first k-wire 159 is removed from the metatarsal.

[0074] As shown in Figures 13A-E, the first guide block 164 extends between a first or outer side 166 and a second or inner side 168. First and second guide portions 170, 172 protrude upward and downward, respectively. A series of guide holes 174 extend through the guide block, each defining a track 175, and the series of guide holes 174 converge to a common point, as seen in Figure 13E. The guide holes 174 and their tracks 175 are coplanar and define a cutout plane when the first guide block 164 is mounted over the k-wires 160, 162. A pair of mounting holes 176, 178 are sized to slide over the k-wires. First and second mounting supports 180, 182 extend inward from the guide block 164 and are separated by a gap 184. The mounting supports 180, 182 include slots 186, 188 for guiding and supporting the k-wires and, once mounted, prevent rotation of the guide block 164. The inner side 168 of the guide block 164 may be convexly curved, as shown.

[0075] Referring to Figures 6 and 13E, a first guide block 164 is mounted on a k-wire. After abutting the metatarsal 2, a trocar 192, reamer, or other instrument is introduced through one of the guide holes 174 and inserted into the metatarsal 2, creating holes through the metatarsal along the trajectory of the guide holes. Trocars 192 may then be inserted through additional guide holes 174 and through the metatarsal. This step creates a linear series of openings through the bone at targeted locations, weakening the bone in preparation for a subsequent osteotomy to resect the head of the metatarsal. After the desired number of openings have been created, the first guide block 164 is withdrawn from the k-wire.

[0076] Referring to FIG. 7, a second guide block 200 is introduced over the k-wires 160, 162. As shown in FIGS. 14A-D, the second guide block 200 extends between a first or outer side 202 and a second or inner side 204. First and second guide portions 206, 208 protrude upward and downward, respectively. A notched slot 210 extends through the guide block 200 and opens on the outer and inner sides 202, 204, with mounting holes 212, 214 extending between the inner and outer sides for mounting the block onto the k-wires. The guide block 200 may be curved as shown, with the inner side 204 of the guide block 200 being convexly curved and the outer side 202 being concave. At least the concave outer surface may allow the guide portions to closely fit against the targeted location. When the second guide block 200 is mounted on the k-wires 160, 162, the medial plane of the opening defined by the notch slots 210 is coplanar or at least parallel to the notch plane defined by the guide holes 174 and tracks 175 of the first guide block and the series of openings created in the bone in the previous steps.

[0077] 14E illustrates an alternative embodiment of a second guide block 200a similar to the second guide block 200 with the differences described below. The second guide block 200a can extend between a first or inner side (204a) and an outer side (not shown). The outer side can be concave, and the inner side 204a can be convex. A cutout slot 210a extends through the guide block 200a. The cutout slot 210a can include a first concave channel 210b on a first side of the cutout slot 210a and / or a second concave channel 210c on a second side of the cutout slot 210a. The channels 210b, 210c can form an opening for receiving a k-wire (e.g., a first k-wire 159). First and second guide portions 206a, 208a protrude upward and downward from the cutout slot 210a. Mounting holes 212a, 214a extend between the medial and lateral sides. The second guide block 200a can first be mounted onto a k-wire through the channels 210b, 210c and advanced toward the metatarsal 2 (see FIG. 4). Second and third k-wires 160, 162 can then be introduced into the metatarsal 2 through the mounting holes 212a, 214a. The first k-wire 159 can then be removed from the metatarsal 2.

[0078] 8 and 15 , a broach 220 is used to create an osteotomy in a metatarsal 2, resecting the metatarsal into a first or proximal metatarsal portion 2a and a second or distal metatarsal portion 2b. The broach 220 includes a handle portion 222, a shaft portion 224, and an insert portion 226 with a cutting tip 228 and cutting edges 230, 232. The cutting edges and tip may be beveled, sharpened, serrated, and / or otherwise configured to cut through bone. The insert portion 226 of the broach is forced outward into the bone through the notched slot 210 to create the osteotomy. The shaft portion 224 may serve as a stop to limit the outward insertion of the insert portion through the notched slot. In other embodiments of the method, instead of or in combination with the broach 220, a saw, blade, chisel, osteotome, curette, pick, file, or other instrument, or combination thereof, may be used to perform the osteotomy. Once the osteotomy step is complete, the second guide block 200 is removed from the k-wire. A cutting instrument, such as those listed above, can then be forced outwardly through the notched slot 210a of the second guide block 200a and into the bone to create an osteotomy.

[0079] Referring to FIG. 9 , a separate distal metatarsal bone portion 2b is now translated outward relative to the proximal metatarsal bone portion 2a. A generally flat distal-facing surface 2c on the proximal metatarsal bone portion 2a is exposed, and a nail 102 is embedded into this surface. The distal-facing surface 2c of the proximal metatarsal bone portion 2a and the medial-facing surface 2d of the distal metatarsal bone portion 2b may be referred to as abutment surfaces. The degree of offset of the distal metatarsal bone portions may vary, but is sufficient to allow embedding of the nail 102 into the distal-facing surface 2c such that the nail head 120 does not protrude medially beyond the medial-lateral surface of the proximal metatarsal bone portion 2a after embedding. The k-wires 160, 162 may be removed before or after shifting the distal metatarsal bone portion relative to the proximal metatarsal bone portion.

[0080] 10 and 16, the nail 102 is inserted through the incision and anchored into the prepared proximal metatarsal portion 2a. Prior to implantation, a suture 250 may be introduced and extend through the lateral bore 148. An implant inserter, such as inserter 240, may be employed to implant the nail 102 into the bone. The inserter 240 includes a handle portion 242, a shaft portion 244, and an implant-engaging end 246. Threads 248 may be formed on the implant-engaging end 246 and cooperate with 132 to removably attach the nail 102 to the inserter 240. The inserter 240 is moved to insert the anchor 122 and neck 124 proximally into the distal-facing surface 2c and into the intramedullary canal of the metatarsal, leaving the head 120 distal to the proximal metatarsal portion 2a. If needed, the inserter 240 can be tapped to drive the nail 102 into position within the proximal metatarsal portion 2 a. The nail 102 is positioned so that the proximal surfaces 141, 143 of the shoulders 140, 142 abut the prepared distal-facing surfaces 2 c of the metatarsals and the lateral nail head 115 is directly adjacent the medial surface 2 d of the distal metatarsal portion 2 b. Once the nail 102 is properly placed in the desired location, the inserter 240 can be rotated to disengage it from the implanted nail 102.

[0081] 11A-11F and 12, a suture 250 may be engaged with the implant 100 and secured to the soft tissue of the big toe 6 to change the alignment of the phalanx 4 relative to the metatarsal 2 and correct hallux valgus. As shown in FIG. 11A, a needle 260 carrying the suture 250 is introduced through the incision 5, enters the medial capsule, and emerges at a first location 6a on the epidermis of the big toe. The suture includes a first end 252 and a second end 254. As shown in FIG. 11B, the needle re-enters the skin at location 6a and creates a first stitch 256 in the soft tissue surrounding the phalanx 4. Continuing with FIG. 11C, the needle 260 and suture 250 emerge at a second location 6b on the epidermis of the big toe. Referring to FIG. 11D, the needle 260 and suture 250 re-enter the big toe at location 6b, creating a second stitch 258 in the soft tissue of the big toe 6. As shown in FIG. 11E, the second end 252 of the needle and suture emerges through the incision 5. The suture 250 is tensioned, changing the alignment of the phalanx 4 relative to the metatarsal 2 and providing tension along the medial side of the phalanx, correcting the hallux valgus. The nail shoulders 140, 142 abutting against the proximal metatarsal portion 2a act as buttress brackets to assist in tensioning and alignment correction. The tensioned suture 250 is attached to the nail 102, and one or both of the first and second ends 252, 254 pass through the lateral bore 148. A first end 252 of the suture may pass through the transverse bore 148 from the underside 116 to the top side 114 of the nail 102, and a knot 262 may be tied at the top side of the bore 148 to maintain tension and correction of the suture. The knot 262 may be wider than the diameter of the transverse bore 148 so that the knot cannot pass through the bore. After tying the knot, the remaining free suture ends 252, 254 may be trimmed. As seen in FIGS. 11E and 12, the suture 250 may follow a three-sided path from the implant 100 to the first and second stitches in the big toe and back to the implant 100.

[0082] 12 and 2, the screw tip 154 ​​and shaft 152 are inserted through the nail opening 130, securing the nail head 120 to the distal metatarsal portion 2b. As the shaft threads 158 engage into the bone, the lateral side 115 of the nail head 120 is forced against the medial surface 2d of the distal metatarsal portion 2b. The screw head threads 156 engage the nail opening threads 132, locking the screw 104 to the nail 102. The incision 5 is closed. Following incision closure, a suture 250 is secured to the big toe, remaining attached to the implant 100.

[0083] 17-18 illustrate an optional additional step in the insertion process for the bunion correction implant system 100 into a patient's foot, as shown and described in FIGS. 1-16 and the accompanying text. FIG. 17 illustrates the separate distal metatarsal portion 2b and proximal metatarsal portion 2a prior to insertion of the nail 102 into the proximal metatarsal portion 2a. The distal metatarsal portion 2b can include a medial-facing surface 2d. The proximal metatarsal portion 2a can include a distal-facing surface 2c. A k-wire 360 ​​can be inserted into the proximal metatarsal portion 2a. The k-wire 360 ​​can be inserted through the distal-facing surface 2c. The k-wire 360 ​​can include an end 362. The end 362 can include a sharp point. The end 362 can be inserted into the intramedullary portion of the metatarsal bone 2. The k-wire 360 ​​can be inserted into the proximal metatarsal portion 2a after the distal metatarsal portion 2b has been shifted relative to the proximal metatarsal portion 2a (e.g., to expose the distal facing surface 2c).

[0084] The k-wire 360 ​​can be inserted at an angle corresponding to the desired positioning of the implant 100 within the proximal metatarsal portion 2 a. The entry point and / or entry angle of the k-wire 360 ​​into the distal facing surface 2 c can determine the amount of offset between the distal metatarsal portion 2 b and the proximal metatarsal portion 2 a. The k-wire 360 ​​can therefore be used to estimate the final positioning of the distal metatarsal portion 2 b and the proximal metatarsal portion 2 a. If the k-wire 360 ​​is inserted in an undesirable position, it can be easily removed and repositioned within the proximal metatarsal portion 2 a. The k-wire 360 ​​can be used as a guide for the pocket instrument 320. As shown in FIG. 18 , the pocket instrument 320 can be used to remove bone material from the proximal metatarsal portion 2 a and form a pocket 380 for the nail 102. The nail 102 of the implant 100 can be inserted into the proximal metatarsal portion 2a (e.g., pocket 380) using the steps and / or instruments described above in Figure 10 and in the accompanying text. The nail head 120 can be aligned with and attached to the medial-facing surface 2d of the distal metatarsal portion 2b.

[0085] As further shown in FIGS. 19-20 , the pocket device 320 can include a handle 322. The pocket device 320 can include an insert portion 326. The handle 322 can be generally aligned along a first axis 323. The insert portion 326 can be generally aligned along a second axis 327. In one implementation, the first and second axes 323, 327 are parallel, although this is not required. The insert portion 326 can be connected to the handle 322 by an offset neck 324. The offset neck 324 can space the handle portion 322 from the insert portion 326.

[0086] The insert portion 326 can be a broach, punch, or non-rotary cutting instrument. The insert portion 326 can include one or more cutting edges 330. The cutting edges 330 can be used to remove material from the proximal metatarsal portion 2a and form the pocket 380. Alternatively, the insert portion 326 can be smooth. The insert portion 326 can include a tip 328. The insert portion 326 can be smooth or cut. The pocket 380, whether or not including the stub 330, can be used to create a trial pocket for the nail 102. The shape of the pocket 380 can correspond to the shape of the nail 102 (e.g., the insert portion 326) of the implant 100. The insert portion 326 can include an outer side 312 and an inner side 310. The insert portion 326 can include an upper side 314 and a lower side 316. The insert portion 326 can have a non-cylindrical cross-sectional shape (e.g., rectangular as shown). The non-cylindrical cross-sectional shape can improve stability of the nail 102 within the pocket 380. The pocket 380 (and / or the insert portion 326) can be smaller than the nail 102 in one or more dimensions and / or along one or more sides. After insertion, the nail 102 can be in an interference fit within the pocket 380 (e.g., engaged with one or more opposing sides of the pocket 380). In some implementations, the opening 380 and the insert portion 326 can be sized to the dimensions of the nail 102 .

[0087] The insert portion 326 can include a channel 340. The channel 340 can extend along a second axis 327 of the insert portion 326. The channel 340 can include a proximal opening 342 and a distal opening 344. The proximal opening 342 can be adjacent to the offset neck portion 324. The distal opening 344 can be adjacent to the tip 328.

[0088] During use to form the pocket 380, the insert portion 326 of the pocket instrument 320 can be guided along the k-wire 360 ​​into the proximal metatarsal portion 2a. The offset neck 324 can space the handle portion 322 from the k-wire 360, improving the ergonomics of the pocket instrument 320. The k-wire 360 ​​can be received within the channel 340. The pocket instrument 320 can be slid into the proximal metatarsal portion 2a along the length of the k-wire 360. The pocket instrument 320 can be moved in one or more sawing strokes or impacts (e.g., from a hammer striking the pocket instrument 320) to form the pocket 380. After forming the pocket 380, the k-wire 360 ​​and insert portion 326 can be removed from the proximal metatarsal portion 2a. The implant system 100 can be installed within the pocket 380 as described above.

[0089] 21-25 , a bunion correction implant system 400 according to another embodiment of the present invention includes a nail 402, a first fastener 404a, and a second fastener 404b. The nail 402 can be implanted to extend longitudinally within the proximal metatarsal portion 2a of the resected metatarsal bone 2. The first fastener 404a can be inserted through a first portion of the nail 402 and secure it to the distal metatarsal portion 2b of the metatarsal bone 2. The second fastener 404b can be inserted through a second portion of the nail 402 and secure it to the proximal metatarsal portion 2a of the metatarsal bone 2. The implant system 400 may further include sutures that may be routed through the medial capsule of the MTP joint and secured within the soft tissue of the big toe, tensioned, realigned relative to the metatarsal, and / or secured to a nail, as described above in connection with FIGS. 1-20 and the description of the ankle.

[0090] The implant nail 402 can be a monolithic body extending from a first end 406, which can be a distal end, to a second end 408, which can be a proximal end. The nail 402 can be generally rectangular in cross section. The nail 402 can have an inner side 410, which can be an outer side, an outer side 412, which can be an inner side, an upper side 414, and / or a lower side 416. The nail 402 can include a head 420. The head 420 can be on the first end 406. The nail 402 can include an anchor 422. The anchor 422 can be on the second end 408. The nail 402 can include a neck 424. The neck 424 can extend between the head 420 and the anchor 422.

[0091] The nail anchor 422 and neck 424 can extend along the implant axis 405. The nail head 420 can extend distally away from the neck 424 at an angle α. The nail head 420 can extend along a head first axis 407 between a head first end 426 and a head second end 428. The angle α between the neck outer surface and the head outer surface can be approximately 25°. In other implementations of the invention, the angle α can be in the range of 0° to 90°. Desirably, the angle α can be in the range of 0° to 60°. Desirably, the angle α can be in the range of 15° to 60°. In at least the depicted embodiment, the nail 402 and assembled implant 400 are symmetrical about the implant axis 405 and about the head first axis 407.

[0092] The nail head 420 includes a first opening 430a. The first opening 430a can be centered within the nail head 420. The first opening 430a can extend along a head second axis 410a. The head second axis 410a can be at an angle A1 relative to the implant axis 405. The angle A1 can be approximately 0° to 135°. Desirably, the angle A1 can be in the range of 30° to 60°. The head second axis 410a can extend in a generally medial-lateral (ML) direction upon implantation. The first opening 430a can extend between the head lateral side 415 and the head medial side 413. The first opening 430a can include threads 432a for engagement with the first fastener 404a. Other implementations may lack threads. A concave edge 434a can surround the first opening 430. The second axis 410a of the head can be at an angle γ with respect to the first axis 407 of the head. The angle γ can be approximately 90°. Desirably, the angle γ can be in the range of 45° to 135°.

[0093] The nail 402 can include a second opening 430b. The second opening 430b can be on the nail head 420 and / or the neck 424. The second opening 430b can be centered about a head third axis 410b. The second opening 430b can extend between the head lateral side 415 and the head medial side 413. The head third axis 410b can be at an angle A2 relative to the implant axis 405. The angle A2 can be less than approximately 45°. Desirably, the angle A2 can be in the range of 0° to 90°. Desirably, the angle A2 can be in the range of 30° to 60°. The second opening 430b can include a concave edge 434b. In some implementations, the second opening 430b can include threads (not shown) for engagement with the second fastener 404b.

[0094] The head second end 428 can be wider than the neck 424 in the vertical dimension. The head second end 428 can include a first shoulder 440 and a second shoulder 442. The shoulders 440, 442 can project upward and downward, respectively, away from the neck 424 at the intersection of the neck 424 and the head 420. The first shoulder 440 can include a first proximal shoulder surface 441. The second shoulder 442 can include a second proximal shoulder surface 443. The proximal shoulder surfaces 441, 443 can face proximally, away from the head 420. The proximal shoulder surfaces 441, 443 can be perpendicular to the upper and lower sides 414, 416 of the neck.

[0095] The head 420 can include a lateral bore 448. The lateral bore 448 can extend along a head fourth axis 411 that is perpendicular to the head first axis 407 and the head second axis 410a. The head fourth axis 411 can extend generally in the superior-inferior (SI) direction when implanted. The thickness of the head 420 between the medial side 413 and the lateral side 415 can increase between the head first end 426 and the head second end 428 such that the thickest portion of the head 420 is at shoulders 440, 442. The increased thickness of the head 420 between the medial side 413 and the lateral side 415 can extend further outward relative to the medial axis of the proximal metatarsal portion 2a. The head 420 can be shifted when necessary. The lateral bore 448 can extend through the thickest portion of the head 420.

[0096] The neck 424 can extend between and connect the head 420 and the anchor 422. The thickness of the neck 424 between the medial side 410 and the lateral side 412 can vary depending on the desired degree of metatarsal shift. The thickness of the neck can be tapered between the head 420 and the anchor 422. The width of the neck 424 between the upper side 414 and the lower side 416 can also vary. The length of the nail 402 between the first and second ends 406, 408 can vary, such that the relative lengths of the head, neck, and / or anchor portions can vary. The anchor 422 can be coaxial with the neck 424. The anchor 422 can extend from the neck 424 to the second end 408 of the nail 402. Both the thickness of the anchor 422 between the medial side 410 and the lateral side 412 and the width of the anchor 422 between the upper side 414 and the lower side 416 can be tapered toward the second end 408 of the nail. This can facilitate easy insertion of the nail 402 into the metatarsal 2.

[0097] The anchor 422 can be rounded, pointed, flat, serrated, or another shape at its second end 408. The anchor 422 can include a plurality of bone-engaging features 444, which can be shaped like teeth, scallops, serrated edges, or other shapes to promote engagement within the bone. The neck 424 and anchor 422 can be free of or include openings for secondary fixation or instrument connection.

[0098] Fastener 404a can include a fastener head 450a, a drive feature 459a, a fastener shaft 452a, a tip 454a, threads 456a (e.g., opening 430a) for locking engagement with threads in nail head 420, and / or threads 458a for engagement within bone. Fastener 404b can include a fastener head 450b, a drive feature 459b, a fastener shaft 452b, a tip 454b, and / or threads 458b for engagement within bone. Fasteners 404a / 404b can be locking screw-type fasteners; in other embodiments, fasteners 404a / 404b can be locking or non-locking, and can be multi-axially adjustable or non-multi-axially adjustable. The nails 402 and fasteners 404a / 404b may comprise titanium, stainless steel, PEEK, nitinol, and / or other rigid biocompatible materials, or combinations thereof.

[0099] Implant system 400 can be used in the insertion process into a patient's foot as shown and described in FIGS. 1-20 and the accompanying text in place of implant system 100. Implant system 400 can require the following additional steps to anchor nail 402 into the prepared proximal metatarsal portion 2 a.

[0100] An implant inserter, such as inserter 240, can be employed to implant nail 402 into proximal metatarsal portion 2a. Implant engaging end 246 can cooperate with openings 430a and / or 430b or otherwise with nail 402. Implant engaging end 246 can include threads 248 that can engage with nail threads 432a (or the nail threads in second opening 430b) and removably attach nail 402 to inserter 240. Inserter 240 is moved to insert anchor 422 and neck 424 proximally into distal-facing surface 2c and into the intramedullary canal of metatarsal 2. Desirably, engaging end 246 can cooperate with opening 430b, which can more closely align inserter 240 with anchor 422 and neck 424. Thus, the inserter 240 can be used to apply force more directly into the proximal metatarsal portion 2a as the anchor 422 and neck are inserted.

[0101] The head 420 can be left distal to the proximal metatarsal portion 2a. If so, the inserter 240 can be tapped to drive the nail 402 into position within the proximal metatarsal portion 2 a. The nail 402 can be positioned so that the proximal surfaces 441, 443 of the shoulders 440, 442 abut the distally facing surface 2 c of the metatarsal. The lateral nail head 415 can be directly adjacent to the medial surface 2 d of the distal metatarsal portion 2 b. Once the nail 402 is in the desired location, the inserter 240 can be rotated to disengage it from the implanted nail 402.

[0102] A fastener 404b can fasten the nail 402 to the proximal metatarsal portion 2a. A driver (e.g., a screwdriver) can be employed to embed the fastener 404b. The driver can be coupled to a drive feature 459b. The tip 454b and shaft 452b can be inserted into the second opening 430b. The fastener 404b can be rotated to engage the threads 458b with the proximal metatarsal portion 2a. Installing the fastener 404b can advantageously fix the position of the nail 402 relative to the metatarsal 2. Thus, the suturing step and alignment of the distal metatarsal portion 2b to the nail 402, as shown in FIGS. 11A-12 and described in the accompanying description, can be performed more accurately.

[0103] 26-29, a bunion correction implant system 500 according to another embodiment of the present invention includes a nail 502. The implant system 500 can be used in place of the implant system 400 during the insertion process into the patient's foot as shown and described above. The nail 502 can be implanted to extend longitudinally into the proximal metatarsal portion 2a of the resected metatarsal 2. The nail 502 can be secured with fasteners in a manner similar to the fasteners 404a, 404b described above.

[0104] The implant nail 502 can be a monolithic body extending from a first end 506, which can be a distal end, to a second end 508, which can be a proximal end. The nail 502 can have an inner side 510, which can be an outer side, an outer side 512, which can be an inner side, an upper side 514, and / or a lower side 516. The nail 502 can include a head 520. The head 520 can be on the first end 506. The nail 502 can include an anchor 522. The anchor 522 can be on the second end 508. The nail 502 can include a neck 524. The neck 524 can extend between the head 520 and the anchor 522.

[0105] The nail anchor 522 and neck 524 can extend along the implant axis 505. The nail head 520 can extend distally away from the neck 524 at an angle α1 along the head axis 507. The angle α1 between the neck outer surface (long axis 505) and the head outer surface (along the head axis 507) can be approximately 25°. In other implementations of the invention, the angle α1 can be in the range of 0° to 90°. Desirably, the angle α1 can be in the range of 0° to 60°. Desirably, the angle α1 can be in the range of 15° to 60°. In at least the depicted embodiment, the nail 502 and assembled implant 500 are symmetrical about the implant axis 505.

[0106] The nail head 520 includes a first opening 530a and a second opening 530b. The first and second head openings 530a, 530b can extend along respective first and second axes 510a, 510b. The first axis 510a can be at an angle B1 relative to the implant axis 505. The second axis 510b can be at an angle B2 relative to the implant axis 505. The angles B1 and B2 can be equal, but this is not required. The angles B1, B2 can be in the range of approximately 0° to 135°. Desirably, the angles B1, B2 can be in the range of 30° to 90°. The axes 510a, 510b can extend generally in the medial-lateral (ML) direction when implanted. The first and second openings 530a, 530b can extend between the outer head and the inner head. The first and second openings 530a, 530b can include threads 532a, 532b for engagement with a fastener. Other implementations may lack threads. A concave edge can surround each of the first and second openings 530a, 530b. The first and / or second axis 510a, 510b can be perpendicular to the axis 507.

[0107] The nail 502 can include a third opening 530c. The third opening 530c can be on the nail head 520 and / or the neck 522. The third opening 530c can be centered about a third axis 510c. The third opening 530c can extend between the lateral head and the medial head. The third axis 510c of the head can be at an angle B3 relative to the implant axis 505. The angle B3 can be less than approximately 45°. Desirably, the angle B3 can be in the range of 0° to 90°. Desirably, the angle B3 can be in the range of 30° to 60°. The third opening 530c can include a concave or upwardly tapered edge. In some implementations, the third opening 530c can include threads (not shown) for engagement with a fastener.

[0108] The neck 524 can extend between and connect the head 520 and the anchor 522. The neck 524 and / or the anchor 522 can be generally rectangular in cross section. The anchor 522 can extend from the neck 524 to the second end 508 of the nail 502. Both the thickness of the anchor 522 between the medial side 510 and the lateral side 512 and the width of the anchor 522 between the superior side 514 and the inferior side 516 can taper toward the second end 508 of the nail. This can facilitate easy insertion of the nail 502 into the metatarsal 2. The head 520 can include a lateral bore 548. The lateral bore 548 can extend generally in the superior-inferior direction (SI) when implanted.

[0109] Anchor 522 can be rounded, pointed, flat, serrated, or another shape at its second end 508. Anchor 522 can include a plurality of bone-engaging features 544, which can be shaped like teeth, scallops, serrated edges, or other shapes to promote engagement within bone. Neck 524 and anchor 522 can be free of or include openings for secondary fixation or instrument connection.

[0110] Any method disclosed herein includes one or more steps or actions for implementing the described method. Method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified.

[0111] References throughout this specification to "an embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the recited phrases or variations thereof, as listed throughout this specification, do not necessarily all refer to the same embodiment.

[0112] Similarly, in the above description of embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure. This method of disclosure, however, should not be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in combinations of less than all features of any single foregoing disclosed embodiment. Thus, the claims following this detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment. The present disclosure includes all permutations of independent claims and their dependent claims.

[0113] The recitation of the term "first" with respect to a feature or element in a claim does not necessarily imply the presence of a second or additional such feature or element. Elements recited in a "means-and-function" format are intended to be construed in accordance with 35 U.S.C. Section 112, sixth paragraph. It will be apparent to those skilled in the art that changes may be made to the details of the embodiments described above without departing from the underlying principles of the invention.

[0114] While specific embodiments and applications of the present invention have been illustrated and described, it should be understood that the invention is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations, which will be apparent to those skilled in the art, can be made in the arrangement, operation, and details of the methods and systems of the present invention disclosed herein without departing from the spirit and scope of the invention.

[0115] The terms "approximately," "about," and "substantially," as used herein, refer to an amount close to a stated amount that still performs a desired function or achieves a desired result. For example, in some embodiments, as the context may dictate, the terms "approximately," "about," and "substantially" may refer to an amount within less than 10% of or equal to a stated amount. The term "generally," as used herein, primarily refers to a value, amount, or characteristic that includes or tends to approach a particular value, amount, or characteristic. By way of example, in certain embodiments, as the context may dictate, the term "substantially parallel" can refer to a deviation from being strictly parallel by an angle less than or equal to 20 degrees. A given range includes the endpoints.

Claims

1. A bunion correction implant system (400) for correcting a bunion formed at the joint between the metatarsal (2) and the big toe (6), comprising: The system includes an implant nail (402), a first fastener (404a), and a second fastener (404b); The implant nail has a body, the body has a head (420), an anchor (422), a neck (424), and a second opening (430b), the body being insertable into the metatarsal; the head comprises a head first end (428) including a first shoulder and a second shoulder, a head second end (426), and a first opening (430a) extending through the head, the first opening (430a) extending along a head second axis (410a); the head extends along a head first axis (407) between the head first end and the head second end; the neck extends between the head and the anchor, the anchor and the neck extending along an implant axis (405); the second opening extends through the neck or the head and along a third axis (410b) of the head; the first fastener is configured to be received within the first opening; the second fastener is configured to be received within the second opening; the implant axis forms a first angle (α) with a first axis of the head, the first angle being less than 90°; the implant axis forms a second angle (A2) with the third axis of the head, the second angle being in the range of 30° to 60°; the head includes a transverse bore (448) extending along a fourth axis of the head, the fourth axis of the head being perpendicular to the first axis of the head and the fourth axis of the head being perpendicular to the second axis of the head; a suture is inserted into the lateral bore and secured to the big toe, thereby adjusting the position of the big toe relative to the metatarsal; When the first fastener is received in the first opening and the second fastener is received in the second opening, the lateral bore is not blocked by the first fastener and the second fastener, and the suture can be inserted into the lateral bore.

2. The system of claim 1 , wherein the first angle is in the range of 15° to 60°.

3. The system of claim 1 , wherein the second axis of the head is perpendicular to the first axis of the head.

4. 2. The system of claim 1, wherein the first shoulder has a first proximal shoulder surface (441) and the second shoulder has a second proximal shoulder surface (443), the first proximal shoulder surface and the second proximal shoulder surface extending perpendicular to respective opposing sides (414, 416) of the neck.

5. A system according to claim 1; A pocket instrument (320) including a handle (322) and an insertion portion (326) having a channel (340), the channel configured to receive a k-wire (360), and the insertion portion configured to be guided along the k-wire.

6. The kit of claim 5 , wherein the insert portion is configured to form a pocket in bone for receiving the implant nail.

7. 2. The system of claim 1, wherein the implant nail extends from a first end (406) to a second end (408), the head is at the first end of the implant nail, and the anchor is at the second end of the implant nail.

8. 2. The system of claim 1, wherein the head comprises a head first side (413) and a head second side (415) opposite the head first side, the first opening extending between the head first side and the head second side, and the second opening extending between the head first side and the head second side.

9. The head portion has a head first side portion (413) and a head second side portion (415) opposite to the head first side portion, The head has a head thickness between the first head side and the second head side.

10. The system of claim 1, wherein the head thickness is tapered such that the head thickness at a first end of the head is greater than the head thickness at a second end of the head.

10. the first fastener includes a first fastener head (450a), a first fastener drive feature (459a), a first fastener shaft (452a), a first fastener tip (454a), and first fastener threads (456a, 458a); 2. The system of claim 1, wherein the second fastener includes a second fastener head (450b), a second fastener drive feature (459b), a second fastener shaft (452b), a second fastener tip (454b), and second fastener threads (456b, 458b).

11. The system described in claim 1, wherein the thickness of the head is tapered so that the thickness of the head at a first end of the head is greater than the thickness of the head at a second end of the head, and the lateral bore is located near the first end of the head.

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