Bunion correction system and method

Abstract

A minimally invasive method for correcting bunions includes performing an osteotomy to divide the metatarsal bone into first and second portions, forming a depression in the first portion to insert a pin in the depression, securing sutures to the joint capsule, tightening the sutures to align the big toe with the metatarsal bone, attaching the sutures to the pin, and fastening the pin to the second portion. The pin includes an anchoring portion for anchoring in the first portion, a head for attaching to the second portion, a channel for attaching the sutures, a first hole for fastening the head to the first portion, and a second hole for fastening the head to the second portion.

Description

[0001] Cross-references to related applications

[0002] This application relates to U.S. Patent Application US16 / 033,086, entitled "Bunny Bunny Correction System and Method". Therefore, the entire disclosure of that application is as fully set forth herein as is included in this specification, and all contents contained therein are incorporated herein by reference for all purposes. This application claims the benefit of U.S. Patent Application US62 / 883,819, filed August 7, 2019, entitled "Bunny Bunny Correction System and Method", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to the surgical treatment of foot deformities. More specifically, this invention relates to implants, devices, and methods for minimally invasive correction of bunions. Background Technology

[0004] Bunions are a progressive condition that typically begins with the tilting of the big toe, which can gradually alter the angle of the bones and create a characteristic bulge on the medial side of the metatarsal bone near the junction of the metatarsal and proximal phalanges. Specifically, a bunion is a bony protrusion, sometimes an inflamed sac. Hallux valgus is a condition where the big toe deviates from its normal position towards the second toe.

[0005] Bunion correction or repair is a common surgical procedure, with over 100,000 performed annually in the United States. Many surgeries for bunion repair are invasive and painful, requiring several inches of incision and a long recovery period of 10–12 weeks. Minimally invasive surgery has been practiced in orthopedic surgery for decades. However, the bone cut has been created by blindly inserting burrs and drills through small incisions. This surgical approach itself leads to potential damage to adjacent soft tissues and non-reproducible results between patients. The disclosure contained herein attempts to address this problem by providing instrumentation techniques and guides to offer repeatability and limit tissue damage while providing a simple implant insertion technique.

[0006] This article discloses an implant and method for the repair of bunions, which can be performed as a minimally invasive procedure. Therefore, compared with more invasive bunion correction surgery, the implant and method disclosed herein can reduce discomfort, reduce scarring and shorten recovery time. Summary of the Invention

[0007] The various systems and methods of the present invention were developed in response to the current state of the prior art, and in particular to problems and needs that are not yet fully resolved by currently available technologies. The systems and methods of the present invention can provide techniques for the correction of bunions that result in simplified procedures, faster recovery, reduced scarring, and reduced discomfort during the healing process.

[0008] To achieve the above objectives and according to the invention as specifically implemented and extensively described herein, one aspect of the invention is a first method for correcting bunions formed at the joint between the metatarsal and the big toe. An incision is made along one side of the metatarsal. A target location is selected on the metatarsal. The metatarsal is resected at the target location to form a first metatarsal portion and a separate second metatarsal portion. The first metatarsal portion has a distally facing surface formed by the resection. A cavitation-forming instrument is inserted into the first metatarsal portion at the distally facing surface to form a cavity in the first metatarsal portion at the distally facing surface. An implant having an integral body with a head and an anchoring portion is inserted through the incision into the cavity of the first metatarsal portion.

[0009] In another aspect of the first method, the recess extends through the distally facing surface into the intramedullary canal of the first metatarsal portion.

[0010] In another aspect of the first method, at least one Kirschner wire is inserted into the first metatarsal portion through the distally facing surface. The first Kirschner wire guides the first instrument into the first metatarsal portion to form a cavity.

[0011] In another aspect of the first method, the first cavity-forming tool is a pull cutter.

[0012] In another aspect of the first method, the broach includes a handle disposed along a first axis, an insertion portion having a plurality of teeth disposed along a second axis, and an offset portion located between the handle and the insertion portion such that the first axis is angled relative to the second axis.

[0013] In another aspect of the first method, the implant head is attached to the first metatarsal portion.

[0014] In another aspect of the first method, attaching the implant head to the first metatarsal portion includes passing a screw through a hole in the implant head and inserting it into the first metatarsal portion.

[0015] In another aspect of the first method, the implant head is attached to the second metatarsal portion.

[0016] In another aspect of the first method, a suture is secured to the big toe, the suture is tightened to realign the big toe relative to the first metatarsal portion, and the suture is attached to the head of the implant.

[0017] In another aspect of the first method, the second metatarsal portion is translated to expose the distally facing surface on the first metatarsal portion.

[0018] Another aspect of the invention is a second method for correcting bunions. An incision is made along one side of the metatarsal bone. A target location is selected on the metatarsal bone. The metatarsal bone is resected to form a first metatarsal portion and a separate second metatarsal portion, the first metatarsal portion having a distally facing surface created by the resection. An implant is inserted into the first metatarsal portion through the incision. The implant has an integral body with a head and an anchoring portion extending along the implant axis. First, the implant head is attached to the first metatarsal portion at the distally facing surface; and then, the implant head is attached to the second metatarsal portion.

[0019] In another aspect of the second method, attaching the implant head to the first metatarsal portion includes inserting a first screw through a first hole in the implant head and into the distally facing surface of the first metatarsal portion.

[0020] In another aspect of the second method, the first hole is disposed along a first axis, which forms a first angle with respect to the axis of the implant.

[0021] In another aspect of the second method, the first angle is less than approximately 45°.

[0022] In another aspect of the second method, attaching the implant head to the second metatarsal portion includes inserting a second screw through a second hole in the implant head and into the second metatarsal portion.

[0023] In another aspect of the second method, the second hole is disposed along a second axis, which forms a second angle with respect to the implant axis, the second angle being greater than the first angle.

[0024] In another aspect of the second method, the second angle is greater than 60°.

[0025] In another aspect of the second method, the second metatarsal portion is translated to expose a distally facing surface on the first metatarsal portion. A recess is formed in the first metatarsal portion on the distally facing surface, and this recess extends through the distally facing surface into the intramedullary canal of the first metatarsal portion.

[0026] In another aspect of the second method, a cavitation-forming device is inserted into and guided into the first metatarsal portion at the distal surface using at least one Kirschner wire to form a cavitation.

[0027] In another aspect of the second method, a suture is secured to the big toe, the suture is tightened to realign the big toe relative to the first metatarsal portion, and the suture is attached to the implant.

[0028] Another aspect of the invention is a third method for correcting bunions. An incision is made along one side of the metatarsal bone. A first Kirschner wire is inserted through the incision and into the metatarsal bone at a selected target location. The metatarsal bone is resected at the selected target location to form a first metatarsal portion and a separate second metatarsal portion. The first metatarsal portion has a distally facing surface formed by the resection. A second Kirschner wire is inserted into the first metatarsal portion at the distally facing surface. Guided by the second Kirschner wire, a cavitation-forming instrument is inserted into the first metatarsal portion at the distally facing surface to form a cavitation in the first metatarsal portion. An implant having an integral body with a head and an anchoring portion extending along the implant axis is inserted into the first metatarsal portion through the incision. The implant head is attached to the first metatarsal portion on the distally facing surface, and the implant head is attached to the second metatarsal portion.

[0029] In another aspect of the third method, attaching the implant head to the first metatarsal portion includes inserting a first screw through a first hole in the implant head and into the 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 hole in the implant head and into the second metatarsal portion.

[0030] In another aspect of the third method, the second metatarsal portion is translated to expose the distally facing surface on the first metatarsal portion; and a recess is formed at the distally facing surface in the first metatarsal portion, wherein the recess extends through the distally facing surface into the intramedullary canal of the first metatarsal portion.

[0031] These and other features and advantages of the invention will become more apparent from the following description and appended claims, or may be learned by the practice of the invention as described below. Attached Figure Description

[0032] Exemplary embodiments of the invention will become more apparent from the following description taken in conjunction with the accompanying drawings and the appended claims. It should be understood that these drawings depict only exemplary embodiments and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described with additional specificity and detail using the drawings, in which:

[0033] Figure 1A This is a perspective view of a bunion correction implant including nails and fasteners according to an embodiment of the present invention; Figure 1B It is an exploded view of the implant;

[0034] Figure 2 This is a perspective view of a portion of the foot's skeleton. Figure 1A The implant is inserted into the first metatarsal bone;

[0035] Figure 3A yes Figure 1A A view of the inside of the nail's foot; Figure 3B yes Figure 1A A view of the outside of the nail's foot; Figure 3C yes Figure 1A A view of the nail;

[0036] Figure 4 It is a perspective view of the foot bones, in which Kirschner wires are inserted into the metatarsals, and a first guide block is mounted on the Kirschner wires, the first guide block having multiple guide holes;

[0037] Figure 5 yes Figure 4 A perspective view of the foot bones, Kirschner wires, and guide blocks, with additional Kirschner wires inserted into the metatarsals;

[0038] Figure 6 for Figure 5 The diagram shows a perspective view of the foot bones, Kirschner wires, and a first guide block, with the cannula extending through one of the guide holes to form a hole in the metatarsal bone.

[0039] Figure 7 for Figure 5 A perspective view of the foot bones and Kirschner wires, with the second guide block mounted on the Kirschner wires;

[0040] Figure 8 for Figure 7 A perspective view of the foot bones, Kirschner wires, and a second guide block, in which a puller extends through the guide suture to perform osteotomy in the metatarsals and separate the metatarsals into proximal and distal metatarsal portions;

[0041] Figure 9 for Figure 8 A perspective view of the foot bones shown, in which the distal metatarsal portion moves laterally relative to the proximal metatarsal portion;

[0042] Figure 10 for Figure 9 A perspective view of the foot bones shown in Figure 1, wherein the nail shown in Figure 1 is mounted on an implant inserter and implanted into the proximal metatarsal portion;

[0043] Figure 11AThis is a medial view of the foot, where the nail in Figure 1 is implanted in the proximal metatarsal portion, and the needle and suture are inserted into the foot through the incision at the implantation site and emerge at the first position in the proximal phalanx of the big toe. Figure 11B yes Figure 11A A medial view of the foot, wherein a first trace is formed at a first position of the big toe; Figure 11C yes Figure 11B A view of the inner side of the foot, with the needle emerging at the second position of the big toe; Figure 11D yes Figure 11C A medial view of the foot, wherein a second trace is formed at the second position of the big toe; Figure 11E yes Figure 11D The inner side view of the foot shows the sutures being guided through the implant hole, and the needle and sutures coming out through the incision, with the path of the sutures shown.

[0044] Figure 12 for Figure 10 The perspective view of the foot bones shown illustrates the sutures and fasteners with openings for the pins.

[0045] Figure 13A for Figure 5 Perspective view of the first guide block shown; Figure 13B yes Figure 5 Medial view of the first guide block of the foot; Figure 13C yes Figure 5 Lateral view of the first guide block of the foot; Figure 13D yes Figure 5 Top view of the first guide block; Figure 13E It extends through another guide hole Figure 6 The cannula, the first guide block, and the distal view of the metatarsal bone are shown, with dashed lines indicating the trajectory of multiple guide holes.

[0046] Figure 14A for Figure 7 The second guide block is shown as a perspective view of the foot's inner side. Figure 14B yes Figure 7 The medial view of the second guide block; Figure 14C yes Figure 7 A side view of the second guide block; Figure 14D yes Figure 7 lateral perspective view of the second guide block; Figure 14E This is a medial view of the foot of another embodiment of the second guide block;

[0047] Figure 15 for Figure 8 Perspective view of the broach shown;

[0048] Figure 16 for Figure 10 A perspective view of the implant inserter shown;

[0049] Figure 17 for Figure 9 The perspective view of the foot bones shown illustrates the insertion of a Kirschner wire into the proximal metatarsal portion;

[0050] Figure 18 for Figure 17 The perspective view of the foot bones shown illustrates a cavitation-forming device for forming a cavitation cavity, which is inserted into the proximal metatarsal portion under the guidance of a Kirschner wire.

[0051] Figure 19 for Figure 18 Side view of the cavity-forming device shown;

[0052] Figure 20 for Figure 18 A bottom view of the cavity-forming device shown;

[0053] Figure 21 A perspective view of another orthopedic implant for bunions;

[0054] Figure 22 for Figure 21 An exploded view of the implant shown;

[0055] Figure 23 for Figure 21 Medial view of the nail in the implant shown;

[0056] Figure 24 for Figure 23 The outer side view of the foot of the nail shown;

[0057] Figure 25 for Figure 21 A cross-sectional view of the implant shown;

[0058] Figure 26 Medial view of the foot for a nail from another implantation system;

[0059] Figure 27 for Figure 26 The outer side view of the foot of the nail shown;

[0060] Figure 28 for Figure 26 Top view of the nail shown;

[0061] Figure 29 for Figure 26 A cross-sectional view of the implant shown. Detailed Implementation

[0062] Exemplary embodiments of the invention can be better understood by referring to the accompanying drawings, in which like parts are denoted by like reference numerals throughout. It will be readily understood that the parts of the invention as generally described and shown in the accompanying drawings can be arranged and designed in a variety of different configurations. Therefore, the following descriptions of... Figures 1A to 25 The more detailed description of the embodiments of the devices, systems and methods shown is not intended to limit the scope of the claimed invention, but is merely representative of exemplary embodiments of the invention.

[0063] The phrases “connected to,” “linked to,” and “connected to / communicate with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be functionally connected to each other, even if they are not in direct contact. The terms “adjacent to / abutting” refer to items that are in direct physical contact with each other, although these items are not necessarily connected. The phrase “fluid connectivity” refers to two structural features connected such that fluid within one structural feature can enter the other.

[0064] For example, but not limited to, directional and / or relational terms such as left, right, up, down, top, bottom, vertical, horizontal, middle / center, and lateral are relative to each other, depend on the specific orientation of the applicable element or article, are therefore used to aid in describing the various embodiments in this specification and the appended claims, and are not necessarily intended to be limiting. Standard medical terminology may be used to describe human anatomy, or the relationship of an object to human anatomy. For example, proximal refers to an object or anatomical component closer to the center of the body, while distal refers to an object or anatomical component further away from the center of the body.

[0065] The term “exemplary” as used herein means “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as being more preferred or advantageous than other embodiments. Although various aspects of embodiments are presented in the accompanying drawings, the drawings are not necessarily drawn to scale unless specifically indicated otherwise.

[0066] refer to Figure 1A A bunion correction implant system 100 according to an embodiment of the present invention includes a nail 102 and a fastener 104. Figure 2 As shown, the nail 102 can be implanted to extend longitudinally into the proximal portion 2a of the resected metatarsal 2, and a fastener 104 is inserted through a portion of the nail to secure it to the distal portion 2b of the metatarsal 2. The bunion correction implant system 100 may also include a suture that can be guided through the medial capsule of the metatarsophalangeal (MTP) joint, secured in the soft tissue of the big toe, tightened to realign the proximal phalanx 4 relative to the metatarsal, and secured to the nail.

[0067] refer to Figure 1A-1B and Figures 3A-3CThe implanted nail 102 is a single-piece body extending from a first end 106 (which may be distal) to a second end 108 (which may be proximal). The cross-section of the nail 102 may be generally rectangular, having a medial foot side 110 (which may be lateral), a lateral foot side 112 (which may be medial), a superior side 114, and a inferior side 116. The nail 102 includes a head 120, an anchoring portion 122, and a neck 124 extending between the head 120 and the anchoring portion 122.

[0068] Special Reference Figure 3B and 3C The anchoring portion 122 and neck 124 of the nail extend along the longitudinal axis 105, and the head 120 of the nail extends distally away from the neck 124 at an angle. The head of the nail extends along a first head axis 107 between a first head end 126 and a second head end 128. In the illustrated embodiment, the angle α between the first head axis 107 and the longitudinal axis 105 is 15°, wherein the angle β between the lateral surface of the neck and the lateral surface of the head is 165°. In other embodiments of the invention, the angle α may be in the range of 0° to 25°. At least in the illustrated embodiment, the nail 102 and the assembled implant 100 are bilaterally symmetrical about the longitudinal axis 105 and about the first head axis 107.

[0069] The head 120 of the stud includes an opening 130 centered on a second head axis 109, which is perpendicular to a first head axis 107. The second head axis may extend generally in a medial-lateral (ML) direction after implantation. In the illustrated embodiment, the opening 130 extends between a lateral head side 115 and a medial head side 113 and includes threads 132 for engagement with a fastener 104, but in other embodiments, threads may be absent. A concave lip 134 surrounds the opening 130. In vertical dimensions, a second head end 128 is wider than a neck 124 and includes a first shoulder 140 and a second shoulder 142, which project upwards and downwards, respectively, at the junction of the neck and head in a direction away from the neck 124. 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 neck surfaces 114 and 116. The head 120 may also include a transverse aperture 148 extending along a third head axis 111 perpendicular to the first and second head axes 107 and 109. The third head axis 111 may extend generally up-down (SI) after implantation. In the illustrated embodiment, the thickness of the head 120 between its medial foot surface 113 and lateral foot surface 115 increases from the first head end 126 to the second head end 128, such that the thickest portion of the head is at the shoulders 140, 142.

[0070] A neck 124 extends between a head 120 and an anchor portion 122, connecting the head 120 and the anchor portion 122. The thickness of the neck 124 between the medial side 110 and the lateral side 112 of the foot can vary depending on the desired degree of metatarsal movement. At least in the illustrated embodiment, the neck thickness gradually decreases from the head 120 to the anchor portion 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 portion. The anchor portion 122 is coaxial with the neck 124 and extends from the neck to the second end 108 of the nail. The thickness of the anchor portion between the medial side 110 and the lateral side 112 of the foot, and the width of the anchor portion between the upper side 114 and the lower side 116, can gradually decrease towards the second end of the nail, thereby facilitating easy insertion of the nail into the bone. The second end of the anchoring part can be round, such as... Figure 1A and 1BThe illustrated embodiment is shown; in other embodiments, it can be pointed, flat, serrated, or other shapes. The anchoring portion 122 includes a plurality of bone-engaging features 144, the shapes of which can be defined as toothed, fan-shaped, serrated, or other shapes to facilitate engagement within the bone. For example, the fan-shaped feature 146 in the illustrated embodiment provides surface irregularity to prevent pin retraction. In the illustrated embodiment, the neck and anchoring portion have no openings; other embodiments may include openings for assisting fixation or appliance connection.

[0071] Fastener 104 includes a fastener head 150, a fastener shaft 152, and a tip 154. The head 150 includes threads 156 for locking engagement with threads 132 in the head 120 of a nail; other embodiments may omit threads 156. The shaft 152 includes threads 158 for engagement in bone. The head 150 may include a drive feature structure 157 for engagement with a driver. In the illustrated embodiment, fastener 104 is a locking screw type fastener; in other embodiments, the fastener may be locking or unlocking, and may be multi-axis adjustable or non-multi-axis adjustable.

[0072] The nail 102 and fastener 104 may comprise titanium, stainless steel, polyetheretherketone (PEEK), nitinol, and / or other rigid biocompatible materials, or combinations thereof. The suture is non-absorbable, but other embodiments may include reabsorbable sutures.

[0073] refer to Figure 4-16 The method for correcting bunions includes one or more of the following steps. Although these steps are described in sequence, in other embodiments of the method, one or more steps may be repeated, omitted, or performed in a different order.

[0074] Make a small incision in the affected metatarsal bone on the medial side of the foot for hallux bursitis. Preferably, the incision is 0.5 inches long or shorter. (Reference) Figure 4 The first Kirschner wire 159 is inserted into the metatarsal bone at the selected target location via an incision. A first guide block 164 is mounted on the Kirschner wire 159 and pushed towards the metatarsal bone 2. (Reference) Figure 5 The second and third Kirschner wires 160 and 162 are introduced into the metatarsus through the guide block 164 on both sides of the selected target location. The second Kirschner wire 160 is located in the proximal metatarsal portion 2a, and the third Kirschner wire 162 is introduced into the distal metatarsal portion 2b. The first Kirschner wire 159 is removed from the metatarsus.

[0075] like Figure 13AAs shown in Figure -E, the first guide block 164 extends between the first side or lateral side of the foot 166 and the second side or medial side of the foot 168. The first and second guide portions 170 and 172 project upwards and downwards, respectively. A series of guide holes 174 extend through the guide block, each guide hole defining a trajectory 175, as shown... Figure 13E As shown, these tracks converge at a common point. When the first guide block 164 is mounted on the Kirschner wires 160, 162, the guide holes 174 and their tracks 175 are coplanar, thus defining a cutting plane. A pair of mounting holes 176, 178 are sized to allow sliding on the Kirschner wires. First and second mounting supports 180, 182 extend from the guide block 164 toward the foot, and are spaced apart by a gap 184. The mounting supports 180, 182 include grooves 186, 188 for guiding and supporting the Kirschner wires, and prevent the guide block 164 from rotating after it is mounted. The foot-side surface 168 of the guide block 164 may be convex and curved as shown.

[0076] refer to Figure 6 and 13E After the first guide block 164 is mounted on the Kirschner wire and abuts against the metatarsal 2, a cannula 192, a bone reamer, or other instrument is guided through one of the guide holes 174 and inserted into the metatarsal 2 to create holes through the metatarsal along the trajectory of the guide holes. The cannula 192 can then be inserted through more guide holes 174 and through the metatarsal. This step creates a series of linear openings through the bone at the target location, weakening the bone at that location and preparing for a subsequent osteotomy to remove the metatarsal head. After the required number of openings have been formed, the first guide block 164 is removed from the Kirschner wire.

[0077] refer to Figure 7 The second guide block 200 is guided onto Kirschner wires 160 and 162. For example... Figure 14AAs shown in Figure -D, the second guide block 200 extends between the first side or lateral side 202 and the second side or medial side 204. The first and second guide portions 206 and 208 project upwards and downwards, respectively. A cut slit 210 extends through the guide block 200, opening on the lateral side 202 and the medial side 204. Mounting holes 212 and 214 extend between the medial and lateral sides for mounting the guide block onto Kirschner wires. The guide block 200 can be bent as shown, with the medial side 204 of the guide block 200 convexly bent and the lateral side 202 concavely bent. At least the concave lateral side allows the guide block to fit snugly against the target location. When the second guide block 200 is mounted on the Kirschner wires 160, 162, the intermediate plane of the opening defined by the cutting slit 210 is coplanar or at least parallel to the cutting plane defined by the first guide block guide hole 174 and the track 175, and is coplanar or at least parallel to a series of openings formed in the bone in the previous step.

[0078] Figure 14E An alternative embodiment of the second guide block 200a is shown, which is similar to the second guide block 200 but has the following differences. The second guide block 200a may extend between a first side or medial side of the foot (204a) and a lateral side of the foot (not shown). The lateral side of the foot may be concave, and the medial side of the foot 204a may be convex. A cutting slit 210a extends through the guide block 200a. The cutting slit 210a may include a first concave channel 210b on the first side of the cutting slit 210a and / or a second concave channel 210c on the second side of the cutting slit 210a. Channels 210b, 210c may form holes for receiving Kirschner wires (e.g., the first Kirschner wire 159). First and second guide portions 206a, 208a project upward and downward from the cutting slit 210a. Mounting holes 212a, 214a extend between the medial side of the foot and the lateral side of the foot. The second guide block 200a can first be installed on the Kirschner wire through channels 210b and 210c, and then pushed toward the metatarsal bone 2 (see Figure 4 Then, the second and third Kirschner wires 160 and 162 can be inserted into the metatarsal 2 through mounting holes 212a and 214a. The first Kirschner wire 159 can then be removed from the metatarsal 2.

[0079] refer to Figure 8 and Figure 15A broach 220 is used to perform osteotomy on the metatarsal 2, removing the metatarsal bone to form 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 insertion portion 226 having a cutting tip 228 and cutting blades 230, 232. The cutting blades and tip may be angled, sharp, serrated, and / or otherwise configured to cut bone. The broach insertion portion 226 is pushed laterally through the cutting slit 210 and into the bone to perform osteotomy. The shaft portion 224 may act as a stop to limit the insertion portion's lateral insertion through the cutting slit. In other embodiments of the method, instead of or in combination with the broach 220, a saw, blade, chisel, bone chisel, scraper, pick, file, or other instrument, or combinations thereof, may be used to perform osteotomy. Once the osteotomy step is complete, the second guide block 200 is removed from the Kirschner wire. Similarly, a cutting instrument (such as those listed above) can be pushed outward toward the foot through the cutting slit 210a of the second guide block 200a and into the bone to perform the osteotomy.

[0080] refer to Figure 9 The now separated distal metatarsal portion 2b is translated laterally relative to the proximal metatarsal portion 2a. A generally flat, distally facing surface 2c on the proximal metatarsal portion 2a is exposed, and the pin 102 is inserted into this distally facing surface. The distally facing surface 2c of the proximal metatarsal portion 2a and the medial facing surface 2d of the distal metatarsal portion 2b can be referred to as adjacent surfaces. The degree of offset of the distal metatarsal portion can vary, but should be sufficient to allow the pin 102 to be inserted into the distally facing surface 2c such that the head 120 of the pin does not protrude medially beyond the lateral medial surface of the proximal metatarsal portion 2a after insertion. Kirschner wires 160, 162 can be removed before or after the distal metatarsal portion is displaced relative to the proximal metatarsal portion.

[0081] refer to Figure 10 and 16The nail 102 is inserted through the incision and anchored in the prepared proximal metatarsal portion 2a. Prior to implantation, a suture 250 can be introduced to extend through the transverse hole 148. The nail 102 can be implanted into the bone using an implant inserter such as inserter 240. Inserter 240 includes a handle portion 242, a shaft portion 244, and an implant engagement end 246. Threads 248 are formed on the implant engagement end 246, which can mate with the threads 132 of the nail to removably attach the nail 102 to inserter 240. Inserter 240 is moved to insert the anchor portion 122 and neck 124 proximally into the distally facing surface 2c of the metatarsal and the intramedullary canal, distancing the head 120 away from the proximal metatarsal portion 2a. If necessary, inserter 240 can be tapped to drive the nail 102 into position within the proximal metatarsal portion 2a. The nail 102 is positioned such that the proximal surfaces 141, 143 of the shoulder portions 140, 142 abut against the prepared distally facing surface 2c of the metatarsal, and the lateral aspect 115 of the nail head is adjacent to the medial surface 2d of the distal metatarsal portion 2b. When the nail 102 is correctly positioned as desired, the inserter 240 can be rotated to disengage it from the implanted nail 102.

[0082] refer to Figure 11A-11E and Figure 12 The suture 250 can be joined with the implant 100 and fixed 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. Figure 11A As shown, a needle 260 carrying suture 250 is introduced through incision 5, enters the medial bursa of the foot, and exits at a first position 6a on the skin of the big toe. The suture includes a first end 252 and a second end 254. Figure 11B As shown, the needle re-enters the skin at position 6a, creating the first needle mark 256 in the soft tissue surrounding the phalanx 4. Continue to... Figure 11C Needle 260 and suture 250 emerge at the second position 6b on the skin of the big toe. (Reference) Figure 11D The needle 260 and suture 250 re-enter the big toe at position 6b, forming a second stitch 258 in the soft tissue of the big toe 6. (See below) Figure 11EAs shown, the needle and the second end 252 of the suture emerge through the incision 5. The suture 250 is tightened to alter the alignment of the phalanx 4 relative to the metatarsal 2, thereby providing tension along the medial side of the foot along the phalanx and correcting hallux valgus. The nail shoulders 140, 142 abutting the lateral metatarsal portion 2a act as supports to support tension and alignment correction. The tensioned suture 250 is attached to the nail 102, wherein one or both of the first and second ends 252, 254 pass through the transverse hole 148. The first end 252 of the suture can pass through the transverse hole 148 from the lower side 116 of the nail 102 to the upper side 114, and can be knotted 262 on the upper side of the hole 148 to maintain the tension and correction of the suture. The knot 262 can be wider than the diameter of the transverse hole 148, such that the knot cannot pass through the hole. After knotting, the remaining free ends 252, 254 of the suture can be trimmed off. Figure 11E and 12 As shown, the suture 250 can follow the first and second stitches from the implant 100 to the big toe, and then return to the three-sided path of the implant 100.

[0083] See Figure 12 and Figure 2 The screw tip 154 ​​and shaft 152 are inserted through the opening 130 of the screw to secure the head 120 of the screw to the distal metatarsal portion 2b. As the thread 158 of the shaft engages in the bone, the lateral aspect 115 of the head 120 of the screw is pushed against the medial surface 2d of the distal metatarsal portion 2b. The screw head thread 156 engages with the screw opening thread 132 to lock the screw 104 onto the nail 102. The incision 5 is closed. After the incision is closed, the suture 250 remains fixed to the big toe and attached to the implant 100.

[0084] Figure 17-18 Optional additional steps during the insertion of the bunion correction implant system 100 into a patient's foot are shown in Figures 1-16 and the accompanying text. Figure 17 The diagram shows the separated distal metatarsal portion 2b and proximal metatarsal portion 2a before the pin 102 is inserted into the proximal metatarsal portion 2a. The distal metatarsal portion 2b may include a surface 2d facing the medial side of the foot. The proximal metatarsal portion 2a may include a surface 2c facing the distal side. A Kirschner wire 360 ​​may be inserted into the proximal metatarsal portion 2a. The Kirschner wire 360 ​​may be inserted through the surface 2c facing the distal side. The Kirschner wire 360 ​​may include a tip 362. The tip 362 may include a pointed portion. The tip 362 may be inserted into the intramedullary portion of the metatarsal 2. The Kirschner wire 360 ​​may be inserted into the proximal metatarsal portion 2a after the distal metatarsal portion 2b has been displaced relative to the proximal metatarsal portion 2a (e.g., exposing the surface 2c facing the distal side).

[0085] The Kirschner wire 360 ​​can be inserted at an angle corresponding to the desired positioning of the implant 100 within the proximal metatarsal portion 2a. The entry point and / or entry angle of the Kirschner wire 360 ​​into the distally facing surface 2c can determine the amount of offset between the distal metatarsal portion 2b and the proximal metatarsal portion 2a. The Kirschner wire 360 ​​can be used accordingly to estimate the final positioning of the distal metatarsal portion 2b and the proximal metatarsal portion 2a. If the Kirschner wire 360 ​​is inserted in an undesirable position, it can be easily removed and repositioned within the proximal metatarsal portion 2a. The Kirschner wire 360 ​​can be used as a guide for the cavity-forming device 320. Figure 18 As shown, the recess-forming device 320 can be used to remove bone material from the proximal metatarsal portion 2a to form a recess 380 for the nail 102. The nail 102 of the implant 100 can be used as described above. Figure 10 The steps and / or tools described in the accompanying text are inserted into the proximal metatarsal portion 2a (e.g., into the recess 380). The head 120 of the nail may be aligned with and attached to the medial surface 2d of the distal metatarsal portion 2b.

[0086] like Figures 19-20 As shown, the cavity-forming device 320 may include a handle 322. The cavity-forming device 320 may include an insertion portion 326. The handle 322 may be positioned generally along a first axis 323. The insertion portion 326 may be positioned generally along a second axis 327. In one embodiment, the first and second axes 323, 327 are parallel, but this is not necessary. The insertion portion 326 may be connected to the handle 322 via an offset neck 324. The offset neck 324 may space the handle portion 322 from the insertion portion 326.

[0087] The insertion portion 326 may be a broach, punch, or non-rotational cutting tool. The insertion portion 326 may include one or more cutting blades 330. The cutting blades 330 may be used to remove material from the proximal metatarsal portion 2a to form a cavity 380. Alternatively, the insertion portion 326 may be smooth. The insertion portion 326 may include a tip 328. Whether the insertion portion 326 is smooth or includes cutting blades 330, it can be used to create a test cavity for the nail 102. The shape of the cavity 380 may correspond to the shape of the nail 102 of the implant 100 (e.g., the insertion portion 326). The insertion portion 326 may include a lateral foot surface 312 and a medial foot surface 310. The insertion portion 326 may include a superior surface 314 and a inferior surface 316. The cross-sectional shape of the insertion portion 326 may be non-cylindrical / non-circular (e.g., rectangular as shown). A non-circular cross-sectional shape may enhance the stability of the nail 102 within the cavity 380. The recess 380 (and / or insertion portion 326) may be smaller than the pin 102 in one or more dimensions and / or along one or more sides. After insertion, the pin 102 may be in a press-fit state within the recess 380 (e.g., engaging with one or more opposite sides of the recess 380). In some embodiments, the dimensions of the recess 380 and the insertion portion 326 may be set to be equal to the dimensions of the pin 102.

[0088] The insertion portion 326 may include a channel 340. The channel 340 may extend along a second axis 327 of the insertion portion 326. The channel 340 may include a proximal opening 342 and a distal opening 344. The proximal opening 342 may be adjacent to the offset neck 324. The distal opening 344 may be adjacent to the tip 328.

[0089] When forming a cavity 380, the insertion portion 326 of the cavity forming device 320 can be guided along the Kirschner wire 360 ​​into the proximal metatarsal portion 2a. An offset neck 324 can space the handle portion 322 from the Kirschner wire 360 ​​to improve the ergonomics of the cavity forming device 320. The Kirschner wire 360 ​​can be received within the channel 340. The cavity forming device 320 can slide along the length of the Kirschner wire 360 ​​into the proximal metatarsal portion 2a. The cavity forming device 320 can be moved with one or more sawing strokes or impacts (e.g., by hammering the cavity forming device 320) to form the cavity 380. After forming the cavity 380, the Kirschner wire 360 ​​and the insertion portion 326 can be removed from the proximal metatarsal portion 2a. As described above, the implantation system 100 can be installed within the cavity 380.

[0090] refer to Figure 21-25According to another embodiment of the present invention, a bunion correction implant system 400 includes a nail 402, a first fastener 404a, and a second fastener 404b. The nail 402 can be implanted to extend longitudinally into the proximal metatarsal portion 2a of the resected metatarsal 2. The first fastener 404a can be inserted through the first portion of the nail 402 to secure it to the distal metatarsal portion 2b of the metatarsal 2. The second fastener 404b can be inserted through the second portion of the nail 402 to secure it to the proximal metatarsal portion 2a of the metatarsal 2. The implant system 400 may also include a suture that can pass through the medial bursa of the MTP joint, be secured in the soft tissue of the big toe, be tightened to realign the proximal phalanx 4 relative to the metatarsal, and / or be secured to the nail, as described above with respect to Figures 1-20 and the accompanying description.

[0091] The implanted staple 402 may be a single, integral body extending from a first end 406 (which may be distal) to a second end 408 (which may be proximal). The cross-section of the staple 402 may be generally rectangular. The staple 402 may have a medial foot side 410 (which may be lateral), a lateral foot side 412 (which may be medial), a superior side 414, and / or a inferior side 416. The staple 402 may include a head 420. The head 420 may be on the first end 406. The staple 402 may include an anchoring portion 422. The anchoring portion 422 may be on the second end 408. The staple 402 may include a neck 424. The neck 424 may extend between the head 420 and the anchoring portion 422.

[0092] Anchoring portion 422 and neck 424 may extend along implant axis 405. Head 420 of the nail may extend distally away from neck 424 at an angle α. Head 420 of the nail may extend along first head axis 407 between first head end 426 and second head end 428. Angle α between the lateral foot surface of the neck and the lateral foot surface of the head may be approximately 25°. In other embodiments of the invention, angle α may be in the range of 0° to 90°. Ideally, angle α may be in the range of 0° to 60°. Ideally, angle α may be in the range of 15° to 60°. At least in the described embodiments, nail 402 and assembled implant 400 are bilaterally symmetrical about implant axis 405 and about first head axis 407.

[0093] The head 420 of the stud includes a first opening 430a. The first opening 430a may be located at the center of the head 420. The first opening 430a may extend along a second axis 410a of the head. The second axis 410a of the head may form an angle A1 with respect to the implant axis 405. Angle A1 may be in the range of about 0° to 135°. Ideally, angle A1 may be in the range of 30° to 60°. After implantation, the second axis 410a of the head may extend generally medial-lateral (ML) foot-to-foot. The first opening 430a may extend between the lateral foot side 415 and the medial foot side 413 of the head. The first opening 430a may include threads 432a for engagement with a first fastener 404a. Other implementations may not include threads. A concave lip 434a may surround the first opening 430. The second axis 410a of the head may form an angle γ with respect to the first axis 407 of the head. Angle γ may be about 90°. Ideally, the angle γ can be in the range of 45° to 135°.

[0094] The stud 402 may include a second opening 430b. The second opening 430b may be on the head 420 and / or neck 424 of the stud. The second opening 430b may be centered on a third axis 410b of the head. The second opening 430b may extend between the lateral foot side 415 and the medial foot side 413 of the head. The third axis 410b of the head may form an angle A2 with the implant axis 405. Angle A2 may be less than about 45°. Ideally, angle A2 may be in the range of 0° to 90°. Ideally, angle A2 may be in the range of 30° to 60°. The second opening 430b may include a concave lip 434b. In some embodiments, the second opening 430b may include threads (not shown) for engagement with a second fastener 404b.

[0095] In terms of vertical dimensions, the second end portion 428 of the head may be wider than the neck 424. The second end portion 428 of the head may include a first shoulder 440 and a second shoulder 442. Shoulders 440 and 442 may project upward and downward, respectively, at the junction of the neck 424 and the head 420 in a direction away from the neck 424. The first shoulder 440 may include a first proximal shoulder surface 441. The second shoulder 442 may include a second proximal shoulder surface 443. The proximal shoulder surfaces 441 and 443 may be proximal to the side opposite to the ground of the head 420. The proximal shoulder surfaces 441 and 443 may be perpendicular to the upper surface 414 and the lower surface 416 of the neck.

[0096] The head 420 may include a transverse aperture 448. The transverse aperture 448 may extend along a fourth axis 411 of the head, perpendicular to the first axis 407 and the second axis 410a of the head. After implantation, the fourth axis 411 of the head may extend generally up-down (SI). The thickness of the head 420 between the medial side 413 and the lateral side 415 of the foot may increase from the first end 426 to the second end 428 of the head, such that the thickest portion of the head 420 is at the shoulder 440, 442. This increased thickness of the head 420 between the medial side 413 and the lateral side 415 of the foot allows for further lateral movement of the head 420 relative to the midline of the proximal metatarsal portion 2a. The transverse aperture 448 may extend through the thickest portion of the head 420.

[0097] A neck 424 may extend between a head 420 and an anchor portion 422, connecting the head 420 and the anchor portion 422. The thickness of the neck 424 between the medial side 410 and the lateral side 412 of the foot may vary depending on the desired degree of metatarsal displacement. The neck thickness may gradually decrease from the head 420 to the anchor portion 422. The width of the neck 424 between the superior side 414 and the inferior side 416 may also vary. The length of the nail 402 between the first and second ends 406, 408 may vary, as may the relative lengths of the head, neck, and / or anchor portion. The anchor portion 422 may be coaxial with the neck 424. The anchor portion 422 may extend from the neck 424 to the second end 408 of the nail 402. The thickness of the anchor portion 422 between the medial side 410 and the lateral side 412 of the foot, and the width of the anchor portion 422 between the superior side 414 and the inferior side 416, may gradually decrease toward the second end 408 of the nail. This can help to easily insert nail 402 into metatarsal bone 2.

[0098] The anchoring portion 422 at the second end 408 can be circular, pointed, flat, serrated, or other shapes. The anchoring portion 422 may include multiple bone-joining features 444, which may be shaped as toothed, fan-shaped, serrated, or other shapes to facilitate engagement within the bone. The neck 424 and the anchoring portion 422 may or may include openings for auxiliary fixation or device connection.

[0099] Fastener 404a may include a fastener head 450a, a drive feature structure 459a, a fastener shaft 452a, a tip 454a, a thread 456a for locking engagement with a thread (e.g., an opening 430a) in the head 420 of the nail, and / or a thread 458a for engagement in bone. Fastener 404b may include a fastener head 450b, a drive feature structure 459b, a fastener shaft 452b, a tip 454b, and / or a thread 458b for engagement in bone. Fasteners 404a / 404b may be locking screw-type fasteners; in other embodiments, fasteners 404a / 404b may be locking or unlocking, and may be multi-axis adjustable or non-multi-axis adjustable. Nail 402 and fasteners 404a / 404b may include titanium, stainless steel, PEEK, nitinol and / or other rigid biocompatible materials, or combinations thereof.

[0100] The implantation system 400 can be used in place of the implantation system 100 as shown in Figures 1-20 and the accompanying text, for insertion into the patient's foot during insertion. The implantation system 400 may require the following further steps to anchor the nail 402 into the prepared proximal metatarsal portion 2a.

[0101] An implant inserter, such as inserter 240, can be used to insert the nail 402 into the proximal metatarsal portion 2a. The implant engagement end 246 can mate with openings 430a and / or 430b, or otherwise mate with the nail 402. The implant engagement end 246 may include threads 248 that can engage with the threads 432a of the nail (or the nail threads in the second opening 430b) to removably attach the nail 402 to the inserter 240. The inserter 240 is moved to insert the anchor portion 422 and the neck 424 proximally into the distally facing surface 2c and the intramedullary canal of the metatarsal 2. Ideally, the engagement end 246 can mate with the opening 430b, which allows for a tighter alignment of the inserter 240 with the anchor portion 422 and the neck 424. Therefore, when the anchor portion 422 and the neck are inserted, the inserter 240 can be used to apply force more directly to the proximal metatarsal portion 2a.

[0102] The head 420 may remain distal to the proximal metatarsal portion 2a. If desired, the inserter 240 may be tapped to drive the nail 402 into position within the proximal metatarsal portion 2a. The nail 402 may be positioned such that the proximal surfaces 441, 443 of the shoulders 440, 442 abut against the distal metatarsal surface 2c. The lateral aspect 415 of the nail head may be abutted against the medial surface 2d of the distal metatarsal portion 2b. As the nail 402 is in the desired position, the inserter 240 may be rotated to disengage it from the implanted nail 402.

[0103] Fastener 404b secures nail 402 to the proximal metatarsal portion 2a. Fastener 404b can be inserted using an actuator (e.g., a screwdriver). The actuator can be engaged with drive feature structure 459b. Tip 454b and shaft 452b can be inserted into second opening 430b. Fastener 404b can be rotated to engage thread 458b with the proximal metatarsal portion 2a. Installation of fastener 404b advantageously secures the position of nail 402 relative to the metatarsal 2. Thus, as... Figure 11A-12 The suturing steps shown and described in the accompanying description, and the alignment of the distal metatarsal portion 2b relative to the nail 402, can be performed more precisely.

[0104] refer to Figure 26-29 According to another embodiment of the present invention, a bunion correction implant system 500 includes a nail 502. The implant system 500 can be used in place of the implant system 400 as described above and inserted into the patient's foot during insertion. 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.

[0105] The implanted staple 502 may be a single, integral body extending from a first end 506 (which may be distal) to a second end 508 (which may be proximal). The staple 502 may have a medial foot side 510 (which may be lateral), a lateral foot side 512 (which may be medial), a superior side 514, and / or a inferior side 516. The staple 502 may include a head 520. The head 520 may be on the first end 506. The staple 502 may include an anchoring portion 522. The anchoring portion 522 may be on the second end 508. The staple 502 may include a neck 524. The neck 524 may extend between the head 520 and the anchoring portion 522.

[0106] Anchoring portion 522 and neck 524 may extend along implant axis 505. Head 520 of the nail may extend distally away from neck 524 along head axis 507 at an angle α1. The angle α1 between the lateral foot surface of the neck (along axis 505) and the lateral foot surface of the head (along head axis 507) may be approximately 25°. In other embodiments of the invention, angle α1 may be in the range of 0° to 90°. Ideally, angle α1 may be in the range of 0° to 60°. Ideally, angle α1 may be in the range of 15° to 60°. At least in the illustrated embodiment, nail 502 and assembled implant 500 are bilaterally symmetrical with respect to implant axis 505.

[0107] The head 520 of the nail includes a first opening 530a and a second opening 530b. The first and second openings 530a and 530b of the head may extend along first and second axes 510a and 510b, respectively. The first axis 510a may form an angle B1 with the implant axis 505. The second axis 510b may form an angle B2 with the implant axis 505. Angles B1 and B2 may be equal, but this is not required. Angles B1 and B2 may be in the range of about 0° to 135°. Ideally, angles B1 and B2 may be in the range of 30° to 90°. After implantation, axes 510a and 510b may extend generally medial-lateral (ML) foot-to-foot. The first and second openings 530a and 530b may extend between the lateral and medial sides of the head. The first and second openings 530a and 530b may include threads 532a and 532b for engagement with fasteners. Other implementations may not have threads. The concave lip may surround the corresponding first and second openings 530a, 530b. The first and / or second axes 510a, 510b may be perpendicular to axis 507.

[0108] The stud 502 may include a third opening 530c. The third opening 530c may be on the head 520 of the stud and / or on the neck 522. The third opening 530c may be centered on a third axis 510c. The third opening 530c may extend between the lateral and medial sides of the head. The third axis 510c of the head may form an angle B3 with the implant axis 505. Angle B3 may be less than about 45°. Ideally, angle B3 may be in the range of 0° to 90°. Ideally, angle B3 may be in the range of 30° to 60°. The third opening 530c may include a concave or tapered upper lip. In some embodiments, the third opening 530c may include threads (not shown) for engagement with a fastener.

[0109] A neck 524 may extend between the head 520 and the anchor portion 522, connecting the head 520 and the anchor portion 522. The cross-section of the neck 524 and / or the anchor portion 522 may be generally rectangular. The anchor portion 522 may extend from the neck 524 to the second end 508 of the nail 502. The thickness of the anchor portion 522 between the medial side 510 and the lateral side 512 of the foot, and the width of the anchor portion 522 between the upper side 514 and the lower side 516, may gradually decrease towards the second end 508 of the nail, which may facilitate easy insertion of the nail 502 into the metatarsal 2. The head 520 may include a transverse hole 548. After implantation, the transverse hole 548 may extend generally up-down (SI).

[0110] The anchoring portion 522 at the second end 508 can be circular, pointed, flat, serrated, or other shapes. The anchoring portion 522 may include multiple bone-jointing features 544, the shapes of which may be toothed, fan-shaped, serrated, or other shapes to facilitate engagement within the bone. The neck 524 and the anchoring portion 522 may or may include openings for auxiliary fixation or device connection.

[0111] Any method disclosed herein includes one or more steps or actions for performing the method. Method steps and / or actions may be interchangeable. In other words, the order and / or use of a particular step and / or action may be modified unless the correct operation of the embodiment requires a specific order of steps or actions.

[0112] Throughout this specification, the terms "an embodiment" or "this embodiment / described embodiment" refer to a particular feature, structure, or characteristic described in connection with that embodiment, which is included in at least one embodiment. Therefore, not all phrases or variations thereof referenced throughout this specification necessarily refer to the same embodiment.

[0113] Similarly, it should be understood that in the above description of embodiments, various features are sometimes combined in a single embodiment, figure, or description therein for the purpose of simplifying the disclosure. However, this method of disclosure should not be construed as reflecting an intention in any claim to require more features than those expressly recited in the claim. Rather, as reflected in the following claims, aspects of the invention lie in a combination of fewer than any single foregoing disclosed embodiment. Therefore, the claims following this detailed description are thus expressly incorporated into this detailed description, each claim being a separate embodiment in itself. This disclosure includes all permutations of the independent claims and their dependent claims.

[0114] The use of the term "first" in the claims relating to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements described in the form of means plus function are intended to be interpreted according to paragraph 2 of 35 U.S.C. § 112. It will be apparent to those skilled in the art that changes may be made to the details of the above embodiments without departing from the fundamental principles of the invention.

[0115] While specific embodiments and applications of the invention have been described and illustrated, it should be understood that the invention is not limited to the exact configurations and components disclosed herein. Various modifications, alterations, and variations that will be apparent to those skilled in the art can be made to the arrangement, operation, and details of the methods and systems disclosed herein without departing from the spirit and scope of the invention.

[0116] The terms “approximately,” “about,” and “substantially / roughly” as used herein refer to quantities that are close to the stated quantity and still achieve the desired function or result. For example, in some examples, as the context suggests, the terms “approximately,” “about,” and “substantially / roughly” may refer to quantities within a range of less than or equal to 10% of the stated quantity. The term “generally / typically” as used herein represents a value, quantity, or characteristic that primarily includes or tends to include a particular value, quantity, or characteristic. As an example, in some embodiments, as the context may indicate, the term “roughly parallel” may refer to something that deviates from exact parallelism by less than or equal to 20 degrees. All ranges include endpoint values.

Claims

1. A bunion correction implant system (400) for correcting bunions formed at the joint between the metatarsal (2) and the big toe (6), comprising: An implantable staple (402) with a one-piece body, comprising: Head (420), the head comprising: The first end of the head (426); The second end of the head (428) includes a first shoulder and a second shoulder; A transverse hole (448) extending along the fourth axis of the head, wherein a first end of the suture can pass through the transverse hole from the underside of the implant to the upper side of the implant, and can be knotted on the upper side of the transverse hole to maintain suture tension and correction; and A first opening (430a) extends through the head, the first opening extending along the second axis (410a) of the head; The head extends along the first axis (407) between the first end of the head and the second end of the head; The fourth axis of the head is perpendicular to the first axis of the head, and the fourth axis of the head is perpendicular to the second axis of the head; Anchorage (422); and A neck (424) extending between the head and the anchor portion, the anchor portion and the neck extending along the implant axis (405); A second opening (430b) extends through the neck and / or the head, the second opening extending along a third axis (410b) of the head; A first fastener (404a) configured to be received within the first opening; and The second fastener (404b) is configured to be received within the second opening; The implant axis forms a first angle (α) with the first axis of the head, and the first angle is less than 90°; The implant axis forms a second angle (A2) with the third axis of the head, the second angle being between 30° and 60°.

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

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

4. The bunion correction implant system according to claim 1, wherein the first shoulder includes a first proximal shoulder surface (441), wherein the second shoulder includes a second proximal shoulder surface (443), the first proximal shoulder surface and the second proximal shoulder surface extending at right angles to the corresponding opposite sides (414, 416) of the neck.

5. A bunion correction kit, comprising: The bunion correction implant system according to claim 1, and A recess-forming device (320) includes a handle (322) and an insertion portion (326) with a channel (340) configured to receive a Kirschner wire (360) and the insertion portion configured to guide along the Kirschner wire.

6. The bunion correction kit of claim 5, wherein the insertion portion is configured to create a recess (380) in the bone for receiving the implanted pin.

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