Bunion correction system and method

Abstract

A minimally invasive method of correcting hallux valgus includes performing a resection to divide the metatarsal bone into first and second portions, implanting a nail in the second portion, and securing the nail to the first portion using a k-wire and a cannulated screw inserted through an opening in the nail head.

Description

Technical Field

[0001] The present invention relates to the surgical treatment of foot deformities. More specifically, the present invention relates to implants, instruments, and methods for minimally invasive hallux valgus correction.

Background Art

[0002] Hallux valgus is a progressive disorder that typically begins with the inclination of the big toe, gradually changing the angle of the bone and sometimes causing a characteristic swelling on the inner side of the metatarsal bone near the joint between the metatarsal bone and the proximal phalanx. Specifically, hallux valgus is a bony prominence and sometimes an inflamed bursa. Hallux valgus is a condition where the big toe is displaced from its normal position towards the direction of the second toe.

[0003] The correction or repair of hallux valgus is a common surgical procedure, with 100,000 surgeries being performed annually in the United States. Many surgical procedures for hallux valgus repair are invasive and painful, require an incision of several inches, and a long recovery period of up to 10 to 12 weeks. Minimally invasive surgery has been performed in orthopedic surgery for decades. However, the formation of osteotomies has been performed using bars and drill bits blindly inserted through small incisions. This surgical method results in potential damage to adjacent soft tissues and non-reproducible results for each patient. The disclosure included herein attempts to improve this problem by providing techniques and guides with devices for providing reproducibility and limiting damage to tissues, along with simple implant insertion techniques.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Disclosed herein are implants and methods for hallux valgus repair that can be performed as minimally invasive techniques and thus reduce discomfort, scarring, and recovery time compared to more invasive hallux valgus correction techniques.

Means for Solving the Problems

[0005] The various systems and methods of the present invention have been developed in accordance with the current state of the art, and in particular in accordance with problems and needs in the art that have not been fully solved by the currently available art. The systems and methods of the present invention can provide techniques for correcting hallux valgus that result in streamlined treatment, faster recovery, reduced scarring, and reduced discomfort during healing.

[0006] To achieve the above, according to the present invention as embodied and broadly described herein, one aspect of the present disclosure is a first method for correcting hallux valgus formed at the joint between the metatarsal bone and the big toe. An incision is made along the lateral portion of the metatarsal bone. A target site is selected on the metatarsal bone. The metatarsal bone is excised at the target site into a first metatarsal portion and a separate second metatarsal portion. The first metatarsal portion has a distally facing surface formed by the excision. A pocket device is inserted into the first metatarsal portion on the distally facing surface, forming a pocket in the first metatarsal portion on the distally facing surface. An implant is inserted into the pocket of the first metatarsal portion through the incision, and the implant has a monolithic body with a head and an anchor.

[0007] In another aspect of the first method, the pocket extends through the distally facing surface into the intramedullary cavity of the first metatarsal portion.

[0008] In another aspect of the first method, at least one k-wire is inserted through the distally facing surface into the first metatarsal portion. The first k-wire guides the first instrument into the first metatarsal portion, forming a pocket.

[0009] In another aspect of the first method, the first pocket device is a brooch.

[0010] In another aspect of the first method, the broach includes a handle aligned along a first axis, an insertion portion having a plurality of teeth aligned along a second axis, and an offset portion between the handle and the insertion portion such that the first axis is at an angle with respect to the second axis.

[0011] In another aspect of the first method, the implant head is attached to a first metatarsal portion.

[0012] In another aspect of the first method, the implant head attached to the first metatarsal portion includes inserting a screw into the first metatarsal portion through an opening in the implant head.

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

[0014] In another aspect of the first method, a suture of a certain length is fixed to the big toe, tension is applied to the suture to realign the big toe with respect to the first metatarsal portion, and a suture of a certain length is attached to the implant head.

[0015] In another aspect of the first method, the second metatarsal portion is translated such that it exposes the distal surface of the first metatarsal portion.

[0016] Another aspect of the present disclosure is a second method for correcting hallux valgus. The incision is made along the lateral aspect of the metatarsal bone. The target site is selected on the metatarsal bone. The metatarsal bone is excised into a first metatarsal portion and a separate second metatarsal portion, the first metatarsal portion having a distally facing surface formed by the excision. The implant is embedded in 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 on its distally facing surface, and then the implant head is attached to the second metatarsal portion.

[0017] In another aspect of the second method, the implant head is attached to a first metatarsal portion, and a first screw is inserted through a first opening of the implant head into the distally facing surface of the first metatarsal portion.

[0018] In another aspect of the second method, the first opening is aligned along the first axis at a first angle with respect to the implant axis.

[0019] In another aspect of the second method, the first angle is less than approximately 45°.

[0020] 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 into the second metatarsal portion.

[0021] In another aspect of the second method, the second opening is aligned along the second axis at a second angle with respect to the implant axis, the second angle being greater than the first angle.

[0022] In another aspect of the second method, the second angle is greater than 60°.

[0023] In another embodiment of the second method, the second metatarsal portion is translated to expose the distally facing surface of the first metatarsal portion. A pocket is formed in the first metatarsal portion on the distally facing surface, and the pocket extends through the distally facing surface into the medullary cavity of the first metatarsal portion.

[0024] 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 on its distally facing surface to form a pocket.

[0025] In another aspect of the second method, a suture of a certain length is fixed to the big toe, tension is applied to the suture to realign the big toe with respect to the first metatarsal portion, and a suture of a certain length is attached to the implant.

[0026] Another aspect of the present disclosure is a third method for correcting hallux valgus. An incision is made along the side of the midfoot bone. A first k-wire is introduced through the incision into the midfoot bone at a selected target location. The midfoot bone is excised at the selected target location into a first midfoot bone portion and a separate second midfoot bone portion. The first midfoot bone portion has a distally facing surface formed by the excision. A second k-wire is inserted into the first midfoot bone portion at the distally facing surface. A pocket instrument is guided by the second k-wire and inserted into the first midfoot bone portion at the distally facing surface to form a pocket in the first midfoot bone portion at the distally facing surface. An implant is inserted through the incision into the first midfoot bone portion. The implant has a monolithic body with a head and an anchor, and the anchor extends along the implant axis. The implant head is attached to the first midfoot bone portion at the distally facing surface, and the implant head is attached to the second midfoot bone portion.

[0027] In another aspect of the third method, attaching the implant head to the first midfoot bone portion includes inserting a first screw through a first opening of the implant head into the distally facing surface of the first midfoot bone portion, and attaching the implant head to the second midfoot bone portion includes inserting a second screw through a second opening of the implant head into the second midfoot bone portion.

[0028] In another aspect of the third method, the second midfoot bone portion is translated to expose the distally facing surface on the first midfoot bone portion, a pocket is formed within the first midfoot bone portion at the distally facing surface, and the pocket extends into the medullary cavity of the first midfoot bone portion through the distally facing surface.

[0029] These and other features and advantages of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention set forth hereinafter.

Brief Description of the Drawings

[0030] Exemplary embodiments of the present invention will become more fully apparent from the following description and the appended claims in conjunction with the accompanying drawings. Understanding that these drawings depict only exemplary embodiments and should not be considered to limit the scope of the present invention, exemplary embodiments of the present invention will be described with further specificities and details through the use of the accompanying drawings. [Figure 1A] This is a perspective view of a bunion correction implant comprising a nail and a fastener, according to one embodiment of the present invention. [Figure 1B] This is an exploded view of an implant. [Figure 2] Figure 1A is a perspective view of a partial skeletal structure of the foot with the implant embedded in the first metatarsal bone. [Figure 3A] Figure 1A is an inside view of the nail. [Figure 3B] Figure 1A is a side view of the nail. [Figure 3C] Figure 1A is a top view of the nail. [Figure 4] This is a perspective view of a foot skeleton, which has a k-wire inserted into the metatarsal bone and a first guide attached to the k-wire, the first guide having a plurality of guide holes. [Figure 5] Figure 4 is a perspective view of the foot skeleton, k-wire, and guide, with an additional k-wire inserted into the metatarsal bone. [Figure 6] Figure 5 is a perspective view of the foot skeleton, k-wire, and the first guide, in which the trocar extends through one of the guide holes to form a hole in the metatarsal bone. [Figure 7] Figure 5 is a perspective view of the foot skeleton and k-wire, with the second guide attached to the k-wire. [Figure 8] Figure 7 is a perspective view of the foot skeleton, k-wire, and second guide, in which a broach extends through the guide slot to perform an osteotomy on the metatarsal bone, separating the metatarsal bone into a proximal metatarsal portion and a distal metatarsal portion. [Figure 9] Figure 8 is a perspective view of the foot skeleton, where the distal metatarsal portion is shifted laterally relative to the proximal metatarsal portion. [Figure 10] Figure 9 is a perspective view of the foot skeleton, and the nails in Figures 1A and 1B are attached to implant inserters and embedded in the proximal metatarsal region. [Figure 11A] Figures 1A and 1B show the medial view of the leg, with the nail embedded in the proximal metatarsal region, and the needle and suture inserted into the foot through an incision at the implant site, emerging at the first position above the big toe on the proximal phalanx. [Figure 11B] Figure 11A shows the inner side of the foot, where the first stitch is formed at the first position on the big toe. [Figure 11C] Figure 11B shows the inner side of the foot, with the needle emerging from the second position of the big toe. [Figure 11D] Figure 11C shows the inner side of the foot, where the second stitch is formed in the second position above the big toe. [Figure 11E] Figure 11D shows the medial side of the foot, where the suture is passed through the implant bore, and the needle and suture emerge from the incision, indicating the path of the suture. [Figure 12] Figure 10 is a perspective view of the foot skeleton, showing the sutures and fasteners directed towards the nail opening. [Figure 13A] Figure 5 is a perspective view of the first guide. [Figure 13B] This is an inside view of the first guide in Figure 5. [Figure 13C] This is a side view of the first guide in Figure 5. [Figure 13D] This is a top view of the first guide in Figure 5. [Figure 13E] This is a distal view of the distal end of the metatarsal bone, the first guide, and the trocar in Figure 6 extending through another guide hole, with the dotted lines indicating the trajectories of the multiple guide holes. [Figure 14A] This is an inside perspective view of the second guide in Figure 7. [Figure 14B] This is an inside view of the second guide in Figure 7. [Figure 14C] This is a side view of the second guide in Figure 7. [Figure 14D] Figure 7 is a side view of the second guide. [Figure 14E] This is an inside diagram of another embodiment of the second guide. [Figure 15] Figure 8 is a perspective view of the brooch. [Figure 16] Figure 10 is a perspective view of the implant inserter. [Figure 17] Figure 9 is a perspective view of the foot skeleton, showing the insertion of the k-wire into the proximal metatarsal region. [Figure 18] Figure 17 is a perspective view of the foot skeleton, showing that a pocket device for forming a pocket is inserted into the proximal metatarsal bone, guided by a k-wire. [Figure 19] Figure 18 is a side view of the pocket device shown. [Figure 20] Figure 18 is a bottom view of the pocket device shown. [Figure 21] This is a perspective view of another bunion correction implant. [Figure 22] Figure 21 is an exploded view of the implant. [Figure 23] Figure 21 is an internal view of the implant nail. [Figure 24] Figure 23 is a side view of the nail. [Figure 25] Figure 21 is a cross-sectional view of the implant. [Figure 26] This is an internal view of a nail in a different implant system. [Figure 27] Figure 26 is a side view of the nail. [Figure 28] Figure 26 is a top view of the nail. [Figure 29] Figure 26 is a cross-sectional view of the implant. [Figure 30] This is a perspective view of the foot skeleton showing the insertion of a bone alignment correction implant into the proximal resected metatarsal portion. [Figure 31] This shows the insertion of a K-wire into the metatarsal portion of the distal resection. [Figure 32] This demonstrates the removal of material from within the distal metatarsal portion using a cannula-like instrument. [Figure 33]This shows the insertion of a screw with a cannula into the distally excised metatarsal portion for securing the implant. [Modes for carrying out the invention]

[0031] Exemplary embodiments of the present invention will be best understood by reference to the drawings, where similar parts are designated by the same numbering throughout. It will be readily apparent that the components of the present invention can be arranged and designed in a wide variety of different configurations, as generally described herein and illustrated in the figures. Accordingly, the following more detailed description of embodiments of apparatus, systems, and methods shown in Figures 1A to 25 is not intended to limit the scope of the present invention as described in the claims, but merely to be representative examples of exemplary embodiments of the present invention.

[0032] The phrases “connected,” “joined,” and “communicate” 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 coupled to one another even if they are not in direct contact with each other. The term “contacting” refers to items that are in direct physical contact with each other, but the items are not necessarily attached to each other. The phrase “fluid communication” refers to two feature parts that are connected in such a way that fluid in one feature part can enter the other feature part.

[0033] Without limitation, directional and / or relational terms such as left, right, up, down, upper, bottom, vertical, horizontal, inside, and outside are relative to each other, depend on the specific orientation of the applicable element or article, and are therefore used to aid in the description of the various embodiments in this specification and the appended claims, and are not necessarily intended to be construed as limiting. Standard medical terminology may be used to describe human anatomical structures or the relationship of an object to human anatomical structures. For example, proximal refers to an object or anatomical element closer to the center of the body, and distal refers to an object or anatomical element further from the center of the body.

[0034] The term “exemplary” in this specification means “serving as an example, case, or illustration.” Any embodiment described as “exemplary” in this specification should not necessarily be construed as being preferable or advantageous to other embodiments. Various aspects of the embodiments are presented in the drawings, which are not necessarily drawn to a certain scale unless otherwise indicated.

[0035] Referring to Figure 1A, a hallux valgus correction implant system 100 according to one embodiment of the present invention includes a nail 102 and a fastener 104. As shown in Figure 2, the nail 102 may be embedded so as to extend longitudinally into the proximal portion 2a of the excised metatarsal bone 2, and the fastener 104 may be inserted through a portion of the nail to fix the nail to the distal portion 2b of the metatarsal bone 2. The hallux valgus correction implant system 100 may further include a suture, which may be fed through the medial capsule of the metatarsophalangeal (MTP) joint, fixed to the soft tissue of the big toe, pulled to realign the position of the proximal phalanx 4 relative to the metatarsal bone, and fixed to the nail.

[0036] Referring to Figures 1A-1B and 3A-3C, the implant nail 102 is a monolithic body extending from a first end 106, which may be the distal end, to a second end 108, which may be the proximal end. The nail 102 may have a substantially rectangular cross-section and has an inner side 110, which may be the outer side, an outer side 112, 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.

[0037] Referring particularly to Figures 3B and 3C, the nail anchor 122 and neck 124 extend along the longitudinal axis 105, and the nail head 120 extends distally from the neck 124 at a predetermined angle. The nail head extends along the first axis 107 of the head between the first end 126 and the second end 128 of the head. In the embodiments described, the angle α between the first axis 107 of the head and the longitudinal axis 105 is 15°, and the angle β between the outer surface of the neck and the outer surface of the head is 165°. In other embodiments of the present invention, the angle α may be in the range of 0° to 25°. In at least the embodiments described, the nail 102 and the assembled implant 100 are symmetrical with respect to the longitudinal axis 105 and the first axis 107 of the head.

[0038] The nail head 120 includes an opening 130 centered on a second head axis 109 perpendicular to a first head axis 107. The second head axis may extend medially-laterally (ML) when embedded. In the described embodiment, the opening 130 extends between the outer head 115 and the inner head 113 and includes threads 132 for engaging with the fastener 104, although additional embodiments may not have threads. A concave lip 134 surrounds the opening 130. The second head end 128 is wider than the neck 124 in vertical dimensions and includes a first shoulder 140 and a second shoulder 142, the shoulders 140 and 142 projecting upward and downward away from the neck 124 at the intersection of the neck and head, respectively. 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 and 143 face proximal to the head 120 and are perpendicular to the upper and lower sides 114 and 116 of the neck. The head 120 may further include a lateral bore 148 extending along a third head axis 111 perpendicular to the first head axis 107 and the second head axis 109. The third head axis 111 may extend superiorly-inferiorly (SI) when embedded. In the embodiment described, the thickness of the head 120 between the inner 113 and the outer 115 increases between the first end 126 and the second end 128 of the head, so that the thickest part of the head is at the shoulders 140, 142.

[0039] The neck 124 extends between the head 120 and the anchor 122, connecting the head 120 to the anchor 122. The thickness of the neck 124 between the medial 110 and the lateral 112 can vary depending on the desired degree of metatarsal shift. In at least the embodiments described, the thickness of the neck is tapered between the head 120 and the anchor 122. The width of the neck 124 between the upper 114 and the lower 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 122 is coaxial with the neck 124 and extends from the neck to the second end 108 of the nail. Both the thickness of the anchor between the medial 110 and the lateral 112, and the width of the anchor between the upper 114 and the lower 116, can be tapered towards the second end of the nail, facilitating easy insertion of the nail into the bone. The second end of the anchor may be rounded, as in the embodiments depicted in Figures 1A and 1B. In other embodiments, it may be pointed, flat, serrated, or another shape. The anchor 122 includes a plurality of bone engagement features 144, which may be shaped as teeth, scallops, serrations, or other shapes to facilitate engagement within the bone. For example, the scallop 146 in the depicted embodiment provides surface irregularity to resist nail recession. In the illustrated embodiment, the neck and anchor have no openings. Other embodiments may include openings for auxiliary fastening or device connection.

[0040] The fastener 104 includes a fastener head 150, a fastener shaft 152, and a tip 154. The head 150 includes a thread 156 for locking engagement with the thread 132 in the nail head 120. Other embodiments may not have the thread 156. The shaft 152 includes a thread 158 for engagement in the bone. The head 150 may include a drive feature 157 for engagement with a driver. In the embodiment described, the fastener 104 is a locking screw type fastener. In other embodiments, the fastener may be locking or non-locking, and may be multi-axis adjustable or non-multi-axis adjustable.

[0041] The nails 102 and fasteners 104 may comprise titanium, stainless steel, polyether ether ketone (PEEK), nitinol, and / or other rigid biocompatible materials, or combinations thereof. The sutures are non-absorbable sutures, although other embodiments may include absorbable sutures.

[0042] Referring to Figures 4 to 16, a method for correcting hallux valgus includes one or more of the following steps. The steps are described in a certain order, but in other embodiments of this method, one or more of the steps may be repeated, omitted, or performed in a different order.

[0043] A small incision is made in the affected metatarsal bone on the medial side of the hallux valgus. Preferably, the incision is 0.5 inches or less in length. Referring to Figure 4, the first k-wire 159 is introduced through the incision to a selected target location within the metatarsal bone. The first guide block 164 is attached to the k-wire 159 and biased toward the metatarsal bone 2. Referring to Figure 5, the second and third k-wires 160 and 162 are introduced through the guide block 164 into the metatarsal bone on either side of the selected target location. The second k-wire 160 is located in the proximal metatarsal portion 2a, and the third k-wire 162 is introduced in the distal metatarsal portion 2b. The first k-wire 159 is removed from the metatarsal bone.

[0044] As shown in Figures 13A to 13E, the first guide block 164 extends between the first side or outer 166 and the second side or inner 168. The first and second guide portions 170 and 172 project upward and downward, respectively. A series of guide holes 174 extend through the guide block, each defining a track 175 that converges to a common point, as seen in Figure 13E. The guide holes 174 and their tracks 175 are coplanar and define a cross-section when the first guide block 164 is mounted on the k-wires 160 and 162. A pair of mounting holes 176 and 178 are sized to slide on the k-wires. The first and second mounting supports 180 and 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-wire and, when mounted, prevent rotation of the guide block 164. The inner surface 168 of the guide block 164 may be curved convexly as shown.

[0045] Referring to Figures 6 and 13E, the first guide block 164 is attached to the k-wire and, after contact with the metatarsal bone 2, a trocar 192, reamer, or other instrument is introduced through one of the guide holes 174 and inserted into the metatarsal bone 2, forming a hole in the metatarsal bone 2 along the trajectory of the guide hole. The trocar 192 may then be inserted through more guide holes 174 and through the metatarsal bone. This step forms a series of linear openings that penetrate the bone at the target location, weakening the bone at that location in preparation for a subsequent osteotomy of the metatarsal head. After the desired number of openings have been formed, the first guide block 164 is withdrawn from the k-wire.

[0046] Referring to Figure 7, the second guide block 200 is introduced onto the k-wires 160 and 162. As shown in Figures 14A to 14D, the second guide block 200 extends between the first side or outer 202 and the second side or inner 204. The first and second guide portions 206 and 208 project upward and downward, respectively. A cutting slot 210 extends through the guide block 200 and opens on the outer and inner sides 202 and 204, and mounting holes 212 and 214 extend between the inner and outer sides for mounting the block onto the k-wire. The guide block 200 may be curved as shown, with the inner side 204 of the guide block 200 being convex and the outer side 202 being concave. At least the concave outer surface may allow the guide to fit closely to the target position. When the second guide block 200 is attached to the k-wires 160 and 162, the central plane of the opening defined by the cutting slot 210 is coplanar or at least parallel to the cutting plane defined by the first guide block guide hole 174 and start 175, and a series of openings have been formed in the bone in the previous step.

[0047] Figure 14E shows an alternative embodiment of a second guide block 200a similar to the second guide block 200, having the differences described below. The second guide block 200a may extend between a first side or inner side (204a) and an outer side (not shown). The outer side may be concave, and the inner side 204a may be concave. The cutting slot 210a extends through the guide block 200a. The cutting slot 210a may include a first concave channel 210b on the first side of the cutting slot 210a and / or a second concave channel 210c on the second side of the cutting slot 210a. The channels 210b, 210c may form an opening for receiving a k-wire (e.g., the first k-wire 159). The first and second guide portions 206a, 208a project upward and downward from the cutting slot 210a. Mounting holes 212a and 214a extend between the medial and lateral sides. The second guide block 200a can be first attached to the k-wire through channels 210b and 210c and biased toward the metatarsal bone 2 (see Figure 4). The second and third k-wires 160 and 162 can then be introduced into the metatarsal bone 2 through mounting holes 212a and 214a. The first k-wire 159 can then be removed from the metatarsal bone 2.

[0048] Referring to Figures 8 and 15, a broach 220 is used to perform an osteotomy on the metatarsal bone 2, which is resected 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 insertion portion 226 having 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 bone. The broach insertion portion 226 is biased laterally into the bone through the cutting slot 210 to perform the osteotomy. The shaft portion 224 may act as a stopper to limit the lateral insertion of the insertion portion through the cutting slot. In other embodiments of this method, a saw, blade, chisel, bone knife, scraper, pick, file, or other instrument, or a combination thereof, may be used instead of or in combination with the broach 220 to perform the osteotomy. Once the osteotomy step is complete, the second guide block 200 is removed from the k-wire. Similarly, cutting instruments such as those listed above can be laterally biased into the bone through the cutting slot 210a of the second guide block 200a to perform the osteotomy.

[0049] Referring to Figure 9, a new, separate distal metatarsal portion 2b is translated laterally relative to the proximal metatarsal portion 2a. The substantially flat distal surface 2c of the proximal metatarsal portion 2a is exposed, and the nail 102 is embedded within this surface. The distal surface 2c of the proximal metatarsal portion 2a and the medial surface 2d of the distal metatarsal portion 2b can be referred to as the contact surface. The degree of offset of the distal metatarsal portion may vary, but is sufficient to allow the embedding of the nail 102 into the distal surface 2c, so that the nail head 120 does not protrude medially beyond the medial lateral surface of the proximal metatarsal portion 2a after embedding. The k-wires 160 and 162 can be removed before or after the shift of the distal metatarsal portion relative to the proximal metatarsal portion.

[0050] Referring to Figures 10 and 16, the nail 102 is inserted through the incision and fixed to the prepared proximal metatarsal portion 2a. Prior to implantation, sutures 250 may be introduced to extend through the transverse bore 148. An implant inserter, such as inserter 240, may be used to implant the nail 102 into the bone. Inserter 240 comprises a handle portion 242, a shaft portion 244, and an implant engagement end 246. Threads 248 are formed on the implant engagement end 246, and these threads 248 may cooperate with nail threads 132 to removably attach the nail 102 to the inserter 240. To insert the anchor 122 and neck 124 into the distally facing surface 2c and the metatarsomal medullary lumen, the inserter 240 is moved, leaving the head 120 distal to the proximal metatarsal portion 2a. If necessary, the inserter 240 may be struck to drive the nail 102 into a predetermined position within the proximal metatarsal portion 2a. The nail 102 is positioned such that the proximal surfaces 141, 143 of the shoulders 140, 142 abut against the prepared distal surface 2c of the metatarsal, and the lateral nail head 115 is immediately adjacent to the medial surface 2d of the distal metatarsal portion 2b. Once the nail 102 is properly seated in the desired position, the inserter 240 may be rotated to disengage it from the embedded nail 102.

[0051] Referring to Figures 11A-11F and Figure 12, the suture 250 can be engaged with the implant 100 and fixed to the soft tissue of the big toe 6, altering the alignment of the metatarsal bones 2 and the phalanges 4 for correcting hallux valgus. As shown in Figure 11A, the needle 260 with the suture 250 is introduced through the incision 5, enters the medial capsule, and emerges at a first position 6a on the epidermis of the big toe. The suture includes a first end 252 and a second end 254. As shown in Figure 11B, the needle re-enters the skin at position 6a, forming a first stitch 256 in the soft tissue surrounding the phalanges 4. Continuing in Figure 11C, the needle 260 and suture 250 emerge at a second position 6b on the epidermis of the big toe. Referring to 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. As shown in Figure 11E, the second end 252 of the needle and suture emerges through the incision 5. The suture 250 is tensioned to alter the alignment of the phalanges 4 relative to the metatarsals 2, providing tension along the medial side of the phalanges and correcting hallux valgus. Nail shoulders 140, 142 abutting the proximal metatarsal portion 2a act as buttresses to support the tension and alignment correction. The tensioned suture 250 is attached to the nail 102, with one or both of the first and second ends 252, 254 passing through the transverse bore 148. The first end 252 of the suture can pass through the transverse bore 148 from the lower side 116 to the upper side 114 of the nail 102, and a knot can be tied on the upper side of the bore 148 to maintain suture tension and correction. The knot may be wider than the diameter of the transverse bore 148 so that the knot cannot pass through the bore. After tying, the remaining free ends 252, 254 of the suture can be excised. As shown in Figures 11E and 12, the suture 250 can follow a three-way path from the implant 100 to the first and second stitches in the big toe and back to the implant 100.

[0052] Referring to Figures 12 and 2, the screw tip 154 ​​and shaft 152 are inserted through the nail opening 130 to fix the nail head 120 to the distal metatarsal portion 2b. When the shaft threads 158 engage with the bone, the outer side 115 of the nail head 120 is biased toward the medial surface 2d of the distal metatarsal portion 2b. To lock the screw 104 into the nail 102, the screw head threads 156 engage with the nail opening threads 132. The incision 5 is closed. After the incision is closed, the suture 250 is fixed to the big toe and remains attached to the implant 100.

[0053] Figures 17-18 show optional additional steps in the insertion process for the hallux valgus correction implant system 100 into the patient's foot, as shown and described in Figures 1-16 and the accompanying documentation. Figure 17 shows the separate distal metatarsal portion 2b and proximal metatarsal portion 2a before insertion of the nail 102 into the proximal metatarsal portion 2a. The distal metatarsal portion 2b may include a medially facing surface 2d. The proximal metatarsal portion 2a may include a distally facing surface 2c. The k-wire 360 ​​can be inserted into the proximal metatarsal portion 2a. The k-wire 360 ​​can be inserted through the distally facing surface 2c. The k-wire 360 ​​may include an end 362. The end 362 may include a sharp tip. The end 362 can be inserted into the intramedullary portion of the metatarsal bone 2. After the distal metatarsal portion 2b is shifted relative to the proximal metatarsal portion 2a (for example, to expose the distal surface 2c), the k-wire 360 ​​can be inserted into the proximal metatarsal portion 2a.

[0054] The k-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 k-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. Thus, the k-wire 360 ​​can be used to estimate the final positioning of the distal metatarsal portion 2b and the proximal metatarsal portion 2a. If the k-wire 360 ​​is inserted in an undesirable position, the k-wire can be easily removed and repositioned within the proximal metatarsal portion 2a. The k-wire 360 ​​can be used as a guide for the pocket instrument 320. As shown in Figure 18, the pocket instrument 320 can be used to remove bone material from the proximal metatarsal portion 2a to form a pocket 380 for the nail 102. Using the steps and / or tools described above in Figure 10 and the accompanying documentation, the nail 102 of the implant 100 can be inserted into the proximal metatarsal portion 2a (e.g., pocket 380). The nail head 120 can be aligned with and attached to the medial-facing surface 2d of the distal metatarsal portion 2b.

[0055] As further shown in Figures 19-20, the pocket device 320 may include a handle 322. The pocket device 320 may also include an insertion portion 326. The handle 322 can be substantially aligned along a first axis 323. The insertion portion 326 can be substantially aligned along a second axis 327. In one configuration, the first and second axes 323 and 327 are parallel, but this is not mandatory. The insertion portion 326 can be connected to the handle 322 by an offset neck 324. The offset neck 324 can separate the handle portion 322 from the insertion portion 326.

[0056] The insertion portion 326 may be a broach, punch, or non-rotating cutting instrument. The insertion portion 326 may include one or more cutting edges 330. The cutting edges 330 can be used to remove material from the proximal metatarsal portion 2a to form a pocket 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 edges 330, it can be used to form a trial pocket for the nail 102. The shape of the pocket 380 may correspond to the shape of the nail 102 in the implant 100 (e.g., the insertion portion 326). The insertion portion 326 may include an outer 312 and an inner 310. The insertion portion 326 may include an upper 314 and a lower 316. The insertion portion 326 may have a non-cylindrical cross-sectional shape (e.g., rectangular as shown). The non-cylindrical cross-sectional shape can enhance the stability of the nail 102 within the pocket 380. The pocket 380 (and / or insertion 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 press-fitted within the pocket 380 (e.g., engaged with one or more opposing sides of the pocket 380). In some implementations, the opening 380 and insertion portion 326 can be sized to match the dimensions of the nail 102.

[0057] The insertion portion 326 may include a channel 340. The channel 340 may extend along the 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 portion 324. The distal opening 344 may be adjacent to the tip 328.

[0058] In use for forming a pocket 380, the insertion portion 326 of the pocket instrument 320 can be guided into the proximal metatarsal portion 2a along the k-wire 360. The offset neck 324 can separate the handle portion 322 from the k-wire 360 ​​to improve the ergonomics of the pocket instrument 320. The k-wire 360 ​​can be housed within the channel 340. The pocket instrument 320 can slide 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 insertion portion 326 can be removed from the proximal metatarsal portion 2a. The implant system 100 can be placed in the pocket 380 as described above.

[0059] Referring to Figures 21 to 25, a bunion correction implant system 400 according to another embodiment of the invention includes a nail 402, a first fastener 404a, and a second fastener 404b. The nail 402 can be embedded so as to extend longitudinally into the proximal metatarsal portion 2a of the excised metatarsal bone 2. The first fastener 404a can be inserted through the first portion of the nail 402 and fixed to the distal metatarsal portion 2b of the metatarsal bone 2. The second fastener 404b can be inserted through the second portion of the nail 402 and fixed to the proximal metatarsal portion 2a of the metatarsal bone 2. As described above with respect to Figures 1 to 20 and the accompanying description, the implant system 400 may further include sutures which are passed through the medial capsule of the MTP joint, fixed in the soft tissue of the big toe, tensioned to realign the position of the proximal phalanx 4 relative to the metatarsal bones, and / or fixed to nails.

[0060] The implant nail 402 may be a monolithic body extending from a first end 406, which may be the distal end, to a second end 408, which may be the proximal end. The nail 402 may have a substantially rectangular cross-section. The nail 402 may have an inner end 410, which may be the outer end, an outer end 412, an upper end 414, and / or a lower end 416. The nail 402 may include a head 420. The head 420 may be located at one of the first ends 406. The nail 402 may include an anchor 422. The anchor 422 may be located at the second end 408. The nail 402 may include a neck 424. The neck 424 may extend between the head 420 and the anchor 422.

[0061] The nail anchor 422 and neck 424 may extend along the implant axis 405. The nail head 420 may extend distally from the neck 424 at an angle α. The nail head 420 may extend along the first axis 407 of the head between the first end 426 of the head and the second end 428 of the head. The angle α between the outer surface of the neck and the outer surface of the head may be approximately 25°. In other implementations of the present invention, the angle α may be in the range of 0° to 90°. Preferably, the angle α may be in the range of 0° to 60°. Preferably, the angle α may be in the range of 15° to 60°. In at least the embodiments described, the nail 402 and the assembled implant 400 are symmetrical with respect to the implant axis 405 and the first axis 407 of the head.

[0062] The nail head 420 includes a first opening 430a. The first opening 430a may be centered in the nail head 420. The first opening 430a may extend along the second shaft 410a of the head. The second shaft 410a of the head may be at an angle A1 with respect to the implant shaft 405. The angle A1 may be approximately 0° to 135°. Preferably, the angle A1 may be in the range of 30° to 60°. The second shaft 410a of the head may extend approximately inward-outward (ML) when embedded. The first opening 430 may extend between the outer part 415 and the inner part 413 of the head. The first opening 430 may include threads 432a for engaging with the first fastener 404a. Other mounting configurations may not have threads. A concave lip 434a may surround the first opening 430. The second shaft 410a of the head can be at an angle γ with respect to the first shaft 407 of the head. The angle γ can be approximately 90°. Preferably, the angle γ can be in the range of 45° to 135°.

[0063] The nail 402 may include a second opening 430b. The second opening 430b may be located on the nail head 420 and / or neck 424. The second opening 430b may be centered on the third shaft 410b of the head. The second opening 430b may extend between the outer 415 and inner 413 of the head. The third shaft 410b of the head may be at an angle A2 with respect to the implant shaft 405. The angle A2 may be less than approximately 45°. Preferably, the angle A2 may be in the range of 0° to 90°. Preferably, the angle A2 may be in the range of 30° to 60°. The second opening 430b may include a concave lip 434b. In some implementations, the second opening 430b may include threads (not shown) for engaging with a second fastener 404b.

[0064] The second end 428 of the head can be wider than the neck 424 in terms of vertical dimension. The second end 428 of the head can include a first shoulder 440 and a second shoulder 442. The shoulders 440 and 442 can project upward and downward, respectively, 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 and 443 can face proximal to the head 420. The proximal shoulder surfaces 441 and 443 can be perpendicular to the upper and lower parts 414 and 416 of the neck.

[0065] The head 420 may include a transverse bore 448. The transverse bore 448 may extend along a fourth head axis 411 perpendicular to the first head axis 407 and the second head axis 410a. The fourth head axis 411 may extend substantially superior-inferior (SI) at implantation. The thickness of the head 420 between the medial 413 and the lateral 415 may increase between the first head end 426 and the second head end 428, thereby causing the thickest part of the head 420 to be in the shoulders 440, 442. The greater thickness of the head 420 between the medial 413 and the lateral 415 may further shift the head 420 laterally relative to the medial axis of the proximal metatarsal portion 2a. The transverse bore 448 may extend through the thickest part of the head 420.

[0066] The neck 424 can extend between the head 420 and the anchor 422, and can connect the head 420 to the anchor 422. The thickness of the neck 424 between the medial and lateral 410, 412 can vary depending on the desired degree of metatarsal shift. The thickness of the neck can taper between the head 420 and the anchor 422. The width of the neck 424 between the upper 414 and the lower 416 can also vary. The length of the nail 402 between the first and second ends 406, 408 can vary, as can the relative lengths of the head, neck and / or anchor portion. 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 and lateral 410, 412, and the width of the anchor 422 between the upper 414 and the lower 416 can taper toward the second end 408 of the nail. This can facilitate the easy insertion of the nail 402 into the metatarsal bone 2.

[0067] The anchor 422 at the second end 408 may be rounded, pointed, flat, serrated, or of another shape. The anchor 422 may include a plurality of bone engagement features 444, which may be shaped as teeth, scallops, serrations, or other shapes to facilitate engagement within the bone. The neck 424 and anchor 422 may or may not have openings for auxiliary fixation or device connection.

[0068] The fastener 404a may include a fastener head 450a, a drive feature 459a, a fastener shaft 452a, a tip 454a, a thread 456a (e.g., an opening 430a) for locking engagement with the threads in the nail head 420, and / or a thread 458a for engaging with bone. The fastener 404b may include a fastener head 450b, a drive feature 459b, a fastener shaft 452b, a tip 454b, and / or a thread 458b for engaging with bone. The fasteners 404a / 404b may be locking screw-type fasteners. In other implementations, the fasteners 404a / 404b may be locking or non-locking, and may be multi-axis adjustable or non-multi-axis adjustable. The nail 402 and fasteners 404a / 404b may comprise titanium, stainless steel, PEEK, nitinol, and / or other rigid biocompatible materials, or combinations thereof.

[0069] The implant system 400 can be used in place of the implant system 100 in the insertion process into the patient's foot, as illustrated and described in Figures 1 to 20 and the accompanying documentation. The implant system 400 may require the following further steps to fix the nail 402 into the prepared proximal metatarsal portion 2a.

[0070] An implant inserter, such as inserter 240, may be used to implant a nail 402 into the proximal metatarsal portion 2a. The implant engagement end 246 can cooperate with the openings 430a and / or 430b or otherwise with the nail 402. The implant engagement end 246 may include a thread 248 that can engage with the nail thread 432a (or the nail thread in the second opening 430b) to removably attach the nail 402 to the inserter 240. The inserter 240 is moved to insert the anchor 422 and neck 424 into the proximal, distally facing surface 2c and into the medullary lumen of the metatarsal 2. Preferably, the engagement end 246 can cooperate with the opening 430b, which allows the inserter 240 to be more closely aligned with the anchor 422 and neck 424. Therefore, inserter 240 can be used to apply force more directly to the proximal metatarsal portion 2a when the anchor 422 and neck are inserted.

[0071] The head 420 can be left distal to the proximal metatarsal portion 2a. If necessary, the inserter 240 can be struck to drive the nail 402 into place in the proximal metatarsal portion 2a. The nail 402 can be positioned so that the proximal surfaces 441, 443 of the shoulders 440, 442 abut against the distal surface 2c of the metatarsal bone. The lateral side 415 of the nail head can be immediately adjacent to the medial surface 2d of the distal metatarsal portion 2b. Once the nail 402 is seated in the desired position, the inserter 240 can be rotated to remove it from the embedded nail 402.

[0072] The fastener 404b can fix the nail 402 to the proximal metatarsal portion 2a. A screwdriver (e.g., a screwdriver) can be used to insert the fastener 404b. The screwdriver can be coupled with the 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. The installation of the fastener 404b advantageously allows for the fixation of the position of the nail 402 relative to the metatarsal 2. Thus, the suturing steps and the alignment of the distal metatarsal portion 2b relative to the nail 402, as shown in Figures 11A to 12 and described in the attached description, can be performed more accurately.

[0073] Referring to Figures 26-29, 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 in the process of insertion into the patient's foot, as illustrated and described above. The nail 502 can be embedded so as to extend longitudinally into the proximal metatarsal portion 2a of the excised metatarsal bone 2. The nail 502 can be secured by fasteners in a manner similar to the fasteners 404a, 404b described above.

[0074] The implant nail 502 may be a monolithic body extending from a first end 506, which may be the distal end, to a second end 508, which may be the proximal end. The nail 502 may have an inner end 510, which may be the outer end, an outer end 512, an upper end 514, and / or a lower end 516. The nail 502 may include a head 520. The head 520 may be located at one of the first ends 506. The nail 502 may include an anchor 522. The anchor 522 may be located at the second end 508. The nail 502 may include a neck 524. The neck 524 may extend between the head 520 and the anchor 522.

[0075] The nail anchor 522 and neck 524 may extend along the implant axis 505. The nail head 520 may extend distally along the head axis 507 away from the neck 524 at an angle α1. The angle α1 between the outer surface of the neck (along the axis 505) and the outer surface of the head (along the head axis 507) may be approximately 25°. In other implementations of the present invention, the angle α1 may be in the range of 0° to 90°. Preferably, the angle α1 may be in the range of 0° to 60°. Preferably, the angle α1 may be in the range of 15° to 60°. In at least the embodiments described, the nail 502 and the assembled implant 500 are symmetrical with respect to the implant axis 505.

[0076] The nail head 520 includes a first opening 530a and a second opening 530b. The first and second head openings 530a and 530b may extend along the first and second axes 510a and 510b, respectively. The first axis 510a may be at angle B1 with respect to the implant axis 505. The second axis 510b may be at angle B2 with respect to the implant axis 505. Angle B1 and B2 may be equal, but this is not required. Angle B1 and B2 may be approximately 0° to 135°. Preferably, angles B1 and B2 may be in the range of 30° to 90°. The axes 510a and 501b may extend approximately inward-outward (ML) when implanted. The first and second openings 530a and 530b may extend between the outer and inner sides of the head. The first and second openings 530a, 530b may include threads 532a, 532b for engaging with fasteners. Other mounting configurations may not have threads. A concave lip may surround the respective first and second openings 530a, 530b. The first and / or second shafts 510a, 510b may be perpendicular to the shaft 507.

[0077] The nail 502 may include a third opening 530c. The third opening 530c may be located on the nail head 520 and / or neck 522. The third opening 530c may be centered on the third shaft 510c. The third opening 530c may extend between the outside and inside of the head. The head third shaft 510c may be at an angle B3 with respect to the implant shaft 505. The angle B3 may be less than approximately 45°. Preferably, the angle B3 may be in the range of 0° to 90°. Preferably, the angle B3 may be in the range of 30° to 60°. The third opening 530c may include a concave or tapered lip. In some implementations, the third opening 530c may include threads (not shown) for engaging with a fastener.

[0078] The neck 524 may extend between the head 520 and the anchor 522, allowing the head 520 to connect to the anchor 522. The neck 524 and / or anchor 522 may have a substantially rectangular cross-section. The anchor 522 may extend from the neck 524 to the second end 508 of the nail 502. Both the thickness of the anchor 522 between the medial and lateral sides 510, 512, and the width of the anchor 522 between the upper side 514 and the lower side 516, may taper towards the second end 508 of the nail. This can facilitate the easy insertion of the nail 502 into the metatarsal bone 2. The head 520 may include a lateral bore 548. The lateral bore 548 may extend substantially superior-inferior (SI) when implanted.

[0079] The anchor 522 at the second end 508 may be rounded, pointed, flat, serrated, or of another shape. The anchor 522 may include a plurality of bone engagement features 544, which may be shaped as teeth, scallops, serrations, or other shapes to facilitate engagement within the bone. The neck 524 and anchor 522 may or may not have openings for auxiliary fixation or device connection.

[0080] Figures 30–33 show another embodiment of the installation method for a hallux valgus correction implant system 400, which includes a nail 402 for adjusting the alignment between a pair of bones (for example, to correct hallux valgus formed between metatarsal 2 and proximal phalanx 4). The metatarsal 2 can be divided into a proximal portion 2a and a distal portion 2b by excision (for example, as described above in relation to the method shown in Figures 4–8). The excision can form a distally facing surface 2c on the proximal portion 2a. The anchor portion 422 of the nail 402 can be inserted into the medullary lumen of the proximal portion 2a of the metatarsal 2, leaving the head 420 distal to the distally facing surface 2c. The anchor portion 422 can be inserted so that the head 420 is in contact with the distally facing surface 2c. The head 420 can be aligned with the distal portion 2b. Optionally, a pocket can be formed in the intramedullary lumen of the proximal portion 2a using the pocket instrument 320 to assist in the insertion of the anchor portion 422.

[0081] Optionally, the inserter 240 can be attached to the head 420 of the nail 402. The inserter 240 can assist in positioning the anchor portion 422 within the proximal portion 2a. The inserter 240 may include threads that engage with the threads of the first opening 430a. Once the nail 402 is properly seated in the desired position, the inserter 240 can be rotated to disengage it from the embedded nail 402 (e.g., disengage from the threads). Once embedded, one or more fasteners (e.g., fastener 404a) can be inserted into the nail 402 to secure it within the proximal portion 2a. Alternatively, the steps illustrated and described in relation to Figures 30-33 may be used in conjunction with any of the implant systems and insertion steps described herein.

[0082] Alignment between a pair of bones (e.g., proximal phalanx 4 and metatarsal 2) can be fully or partially corrected by adjustment between the alignment of the distal portion 2b and the proximal portion 2a. The distal portion 2b can be connected to the head 420 of a nail 402 to fix the corrected position of the bone. Generally, the fastener 619 can be inserted into the distal portion 2b through the first opening 430a of the head 420.

[0083] However, one aspect of this disclosure is the recognition of the difficult step of seating the fastener through the nail 402 and into the distal portion 2b while the distal portion 2b and the proximal phalanx 4 are in the correct adjusted position. To assist in achieving the correct adjusted position, a k-wire 614 can be inserted into the distal portion 2, for example, on the underside or medially, as shown in Figure 31. The distal portion 2b can be controlled to rotate (frontal) during the positioning of the distal portion 2b relative to the nail head 420. The k-wire 614 can be used to align the distal portion 2b to the corrected configuration relative to the nail 402 and the proximal portion 2a. In the correct adjusted position, a position on the distal portion with its center in the opening 430a can be identified and / or marked. A k-wire 618 can be inserted into the distal portion 2b through the first opening 430a. In the correct adjusted position, the k-wire 618 can be inserted into the distal portion 2b at the center of the opening 430a. Alternatively, the k-wire 618 can be inserted into the distal portion 2b before the alignment between the proximal portion 2a and the distal portion 2b is adjusted to the correct, adjusted position. Preferably, the k-wires 614 and / or 618 can be used to align the distal portion 2b with the nail head 420 and the proximal portion 2a. In the corrected configuration, the k-wire 618 can be centered within the first opening 430a.

[0084] As shown in Figure 32, a cannula-like instrument 615, such as a drill or reamer as shown in Figure 32, or a conventional drill, can be used to pre-perforate a cavity in the distal portion 2b to receive a fastener 619 (such as a bone screw). The cannula-like instrument 615 can be aligned with the distal portion 2b by sliding it along the k-wire 618. The k-wires 614 and / or 618 can help the surgeon maintain a corrected and aligned state between the distal portion 2b and the proximal portion 2a while using the cannula-like instrument 615 to form a properly aligned pocket. By using the k-wires 618, the properly aligned pocket can have little to no error (e.g., due to undesirable movement of the distal portion 2b).

[0085] The fastener 619 can be cannula-shaped. The fastener 619 can be inserted by sliding it along the k-wire 618 (for example, using a cannula-shaped driver). The fastener 619 can be inserted using a cannula-shaped driver 620. The k-wires 614 and 618 can assist the surgeon in maintaining the corrected and aligned state between the distal portion 2b and the proximal portion 2a during insertion of the fastener 619 to fix the corrected and aligned state. By using the k-wire 618, the insertion of the fastener 619 can be performed with little to no error.

[0086] After inserting the fastener 619, the k-wire 618 can be removed, leaving the fastener 619 in place. The second fastener can be inserted into the proximal portion 2b through the second opening 430b via the nail 402. Optionally, final alignment adjustments can be made using sutures through the implant bore 448, as described above.

[0087] A kit for correcting hallux valgus formed at the joint between the metatarsal bone and the big toe, the kit may include the following features: nails 402, k wires 614, 618, inserter 240, cannula-like device 615, and one or more fasteners for fixing the nails to the bone portion. Any of nails 102, 402, or 502 may be used. The nails may include an anchor portion and a head portion. The head portion may include a first opening and / or a second opening (e.g., 530a, 530b) including female threads. The neck portion between the head portion and the anchor portion may include a third opening (e.g., 530c, 430b). The cannula-like bone screw 619 may include a head and a threaded shaft. The inserter 240 may include a handle 242 and an engaging end 246 configured to screw-engage with the female threads of the first opening 430a. The anchor portion is configured to be inserted into the first bone fragment, the head portion is configured to be aligned with the second bone fragment, the first k-wire is configured to be inserted into the second bone fragment through a first opening, and the cannula-shaped bone screw is configured to be inserted on the first k-wire and advanced into the second bone fragment to fix the second bone fragment to the nail. The second k-wire is configured to be inserted into the second bone fragment. The second fastener is configured to be inserted into the second bone fragment through a second opening in the head portion of the nail. The cannula-shaped reamer is configured to be inserted on the first k-wire and to form a pocket in the second bone fragment for receiving the cannula-shaped bone screw. The head portion of the nail may include a shoulder. The nail may include a neck portion between the head portion and the anchor portion. The neck portion may include a third opening configured to be aligned with the first bone fragment.

[0088] Any method disclosed herein includes one or more steps or actions for carrying out the described method. The method steps and / or actions are interchangeable with each other. In other words, the order and / or use of specific steps and / or actions can be modified unless a specific sequence of steps or actions is required for the proper operation of the embodiment.

[0089] Throughout this specification, any reference to “an embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment. Therefore, not all cited phrases or variations thereof listed throughout this specification necessarily refer to the same embodiment.

[0090] Similarly, in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure. However, the method of this disclosure should not be interpreted as reflecting an intention that no claim requires more features than those expressly described in that claim. Rather, as reflected in the following claims, embodiments of the invention consist of fewer combinations of features than all the features of any single aforementioned disclosed embodiment combined. Accordingly, the claims following this detailed description are expressly incorporated into this detailed description, and each claim stands independently as a separate embodiment. This disclosure includes all substitutions of independent claims and their dependent claims.

[0091] The use of the term “first” in the claims with respect to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements enumerated in means-plus-function form are intended to be interpreted in accordance with 35 United States Code § 112, paragraph 6. It will be apparent to those skilled in the art that modifications can be made to the details of the embodiments described above without departing from the basic principles of the present invention.

[0092] While specific embodiments and applications of the present invention are illustrated and described, it should be understood that the present invention is not limited to the exact configurations and components disclosed herein. Without departing from the spirit and scope of the present invention, various modifications, variations, and changes can be made to the arrangement, operation, and details of the methods and systems of the present invention disclosed herein, which will be apparent to those skilled in the art.

[0093] As used herein, the terms “approximately,” “about,” and “substantially” refer to quantities close to the stated quantity that still perform the desired function or achieve the desired result. For example, in some embodiments, where the context may indicate, the terms “approximately,” “about,” and “substantially” may refer to quantities within a range of 10% or less of the stated quantity. As used herein, the term “approximately” refers to a value, quantity, or characteristic that primarily comprises or tends toward a particular value, quantity, or characteristic. For example, in certain embodiments, where the context may indicate, the term “approximately parallel” may refer to a range that is 20 degrees or less away from exactly parallel. All ranges include endpoints.

[0094] [Implementation Method] (1) A method for correcting hallux valgus formed at the joint between the metatarsal bone and the big toe, To form an incision along the lateral portion of the metatarsal bone, The metatarsal bone is excised into a first metatarsal portion and a separate second metatarsal portion, wherein the first metatarsal portion has a distal surface formed by the excision. The implant is embedded through the incision into the distal surface of the first metatarsal portion, wherein the implant comprises a monolithic body having a head and an anchor. To adjust the alignment between the first metatarsal portion and the second metatarsal portion, Aligning the first opening of the head of the implant with the second metatarsal portion, A method comprising inserting a k-wire through the first opening into the second metatarsal portion. (2) The method according to Embodiment 1, further comprising sliding a cannula-shaped screw on the k-wire and inserting the cannula-shaped screw into the second metatarsal portion through the first opening. (3) The method of Embodiment 2, further comprising pre-drilling a cavity in the second metatarsal portion, wherein the cavity is configured to receive the cannula-shaped screw. (4) The method according to embodiment 3, wherein the cavity is formed using a cannula-like instrument aligned along the k-wire. (5) The method according to Embodiment 1, wherein attaching the implant head to the first metatarsal portion includes inserting a second screw into the first metatarsal portion through a second opening of the implant head.

[0095] (6) The method according to Embodiment 1, further comprising fixing a suture of a certain length to the big toe, tensing the suture to realign the big toe with respect to the first metatarsal portion, and attaching the suture of a certain length to the implant head. (7) The method according to Embodiment 1, further comprising translating the second metatarsal portion to expose the distal surface on the first metatarsal portion. (8) The method according to Embodiment 1, wherein the insertion of the k wire into the second metatarsal portion is performed in a state in which the joint is corrected and aligned. (9) The method according to embodiment 8, wherein the k-wire is inserted at a position centered with respect to the opening. (10) The method according to Embodiment 1, wherein the k-wire is configured to control the movement of the second metatarsal portion in the frontal plane.

[0096] (11) A kit for correcting hallux valgus formed at the joint between the metatarsal bone and the big toe, It is a nail, The anchor part, A nail comprising a head portion including a first opening containing female threads, A cannula-shaped bone screw, The head and, A cannula-shaped bone screw comprising a threaded shaft, It is an inserter, The handlebars and An inserter comprising: a threaded end configured to screw-engage with the female threads of the first opening; A first k-wire and a, A kit comprising: an anchor portion configured to be inserted into a first bone fragment; a head portion configured to be aligned with a second bone fragment; a first k-wire configured to be inserted into the second bone fragment through a first opening; and a cannula-shaped bone screw configured to be inserted onto the first k-wire and advanced into the second bone fragment in order to fix the second bone fragment to the nail. (12) The kit according to embodiment 11, further comprising a second k-wire configured to be inserted into the second bone fragment. (13) The kit according to embodiment 11, further comprising a second fastener configured to be inserted into the second bone fragment through a second opening in the head portion. (14) The kit according to embodiment 11, further comprising a cannula-like instrument configured to be inserted onto the first k-wire to form a pocket in the second bone fragment for receiving the cannula-like bone screw. (15) The kit according to embodiment 11, wherein the head portion of the nail is provided with a shoulder.

[0097] (16) The kit according to embodiment 11, wherein the nail has a neck portion between the head portion and the anchor portion, and the neck portion has a second opening configured to be aligned with the first bone piece.

Claims

1. A kit for correcting hallux valgus, located between the metatarsal bone and the proximal phalanx. An implant nail having a thumb side and a little finger side, The anchor part, An implant nail comprising: a head portion including a first opening containing female threads, wherein the first opening extends between the thumb side and the little finger side; A cannula-shaped bone screw, The head and, A cannula-shaped bone screw comprising a threaded shaft, It is an inserter, The handlebars and An inserter comprising: a threaded end configured to screw-engage with the female threads of the first opening; A first k-wire and a, The kit is configured such that the anchor portion is embedded so as to extend longitudinally from the excised distal metatarsal portion into the proximal metatarsal portion, the head portion is configured to be aligned with the big toe side surface of the distal metatarsal portion, the first k-wire is configured to be inserted into the distal metatarsal portion through the first opening, and the cannula-shaped bone screw is configured to be inserted onto the first k-wire and advanced into the distal metatarsal portion in order to fix the distal metatarsal portion to the nail.

2. The kit according to claim 1, further comprising a second k-wire configured to be inserted into the distal metatarsal portion from the plantar side.

3. The kit according to claim 1, further comprising a second fastener configured to be inserted into the distal metatarsal portion through a second opening in the head portion.

4. The kit according to claim 1, further comprising a cannula-like device configured to be inserted onto the first k-wire to form a pocket in the distal metatarsal portion for receiving the cannula-like bone screw.

5. The kit according to claim 1, wherein the head portion of the implant nail is provided with a shoulder.

6. The kit according to claim 1, wherein the implant nail has a neck portion between the head portion and the anchor portion, and the neck portion is configured to be aligned with the distal metatarsal portion.

Images