Systems, implants and related methods for bunion correction

Abstract

Implants, systems and related methods for correcting bunions are disclosed. The implants, systems and methods include a first bunion implant plate configured to couple to a first respective metatarsal bone, and a second bunion implant plate configured to couple to a second respective metatarsal bone that is adjacent to the first metatarsal bone. The implants, systems and methods further include a flexible tether extending between the first and second bunion implant plates that allows motion between the first and second bunion implant plates but for movement of the first and second bunion implant plates away from each other. The tether draws the first and second metatarsal bones together to decrease an angle formed between therebetween, and maintains such angle while allowing other movement therebetween. The first and second implants include smooth passageway that accommodate the tether. The first and second implants are configured for optimal anatomical engagement and long lifespan.

Description

[0001] SYSTEMS, IMPLANTS AND RELATED METHODS FOR BUNION CORRECTION

[0002] CROSS-REFERENCE TO RELATED APPLICATION

[0003]

[0001] This application / patent perfects and claims priority benefit of U.S. Provisional Application No. 63 / 676,898 filed on July 29, 2024, entitled Systems, Implants and Related Methods for Bunion Correction, which is hereby incorporated herein by reference in its entirety.

[0004] FIELD OF THE DISCLOSURE

[0005]

[0002] Aspects herein relate to surgical implants for the correction of bunions. Methods of correcting bunions using a surgical implant are also described herein.

[0006] BACKGROUND

[0007]

[0003] Hallux abducto valgus is a particular type of deformity of the foot which is more commonly referred to as a bunion. Hallux valgus is a condition or deformity in which the first metatarsal (commonly referred to as the big toe) points toward the second metatarsal or second toe, resulting in a protrusion or bony bump at the metatarsophalangeal (MTP) joint at the base of the first metatarsal. A bunion exists when the intramedullary (IM) angle between the first metatarsal and second metatarsal is greater than about 9 degrees.

[0008]

[0004] Other types of bunions (bunions involving other bones than the first metatarsal) exist. For example, a Tailor’s bunion (sometimes referred to as a bunionette) is a similar condition or deformity to hallux valgus in which the fifth metatarsal or fifth toe (commonly referred to as the pinky toe) is angled toward the fourth metatarsal or fourth toe, resulting in a protrusion at the MTP joint at the base of the fifth metatarsal.

[0009]

[0005] Current non-surgical treatment of bunions include externally applied devices such as orthotics, bunion pads, arch supports, and braces. Unfortunately, these treatments are typically ineffective. Current surgical procedures that correct bunions include arthroplasty, osteotomy, and arthrodesis. Conventional implantable devices for the treatment of bunions include an artificial joint that replaces all or part of the MTP joint and a suture-button construct that passes through and between the respective metatarsal bones to laterally tension the metatarsal bones together. These current surgical procedures and devices for treating bunions thereby all require or involve cutting (osteotomy) and / or drilling through the respective bone(s).

[0006] Bunion correction devices / implants and related methods that do not require bone cutting and / or bone drilling are therefore desirable. Bunion correction devices / implants and related methods that include fewer potential complications as compared to current bunion treatments are also desirable. Further, bunion correction devices / implants and related methods that utilize a simplified surgical procedure are also desirable. Still further, bunion correction devices / implants and related methods that allow for improved patient recovery times and / or address a larger number of patients and / or bunions, as compared to current bunion correction devices / implants and related methods, are desirable.

[0010]

[0007] While certain aspects of conventional technologies have been discussed to facilitate disclosure of Applicant’s inventions, the Applicant in no way disclaims these technical aspects, and it is contemplated that their inventions may encompass one or more conventional technical aspects.

[0011]

[0008] In this specification, where a document, act or item of knowledge is referred to or discussed, the reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was, at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.

[0012] SUMMARY

[0013]

[0009] Briefly, the present disclosure satisfies the need for surgical bunion treatments that are not significantly invasive, do not include numerous potential complications, and involve relatively short recovery periods.

[0014]

[0010] The Applicant has found that the use of conventional bunion-correction implants gives rise to a high incidence of complications, including loosening of knots, stress fractures, stress risers, and recurrence of bunions, such as hallux valgus and / or tailor's bunions. Further, many conventional bunion-correction constructs invasively pass through the metatarsal bones, which may contribute to these complications. The Applicant has also appreciated that such complications (and / or other potential complications) may be reduced with the use of a less invasive construct, such as an implant that does not pass through the metatarsal bones (e.g., does not include holes drilled across one or more metatarsal bones) and does not utilize an osteotomy. As a result, the Applicant has determined that current surgical bunion treatments unnecessarily involve lengthy recovery periods, which may discourage many potential patients from treatment. [Oil] Accordingly, the bunion correction systems, implants and related methods disclosed herein do not require holes to be formed through one or more metatarsal bones, nor require an osteotomy, while allow limited controlled movement of metatarsal bones to aid in recovery and anatomical positioning, movement and load balancing. The bunion correction systems, implants and related methods disclosed herein also provide minimally invasive bunion correction with small, anatomically contoured implants that only require a single small incision (e.g., 25mm or less) for implantation. The implants partially wrap around metatarsal bones which they are sized and shaped to engage with, positioned primarily on only the dorsal side thereof, and are affixed to the metatarsal bones with small countersunk dorsal screws, thereby enabling a less invasive and more comfortable construct, for example.

[0015]

[0012] In one aspect, the present disclosure provides an implant system for correcting a bunion comprising: a first bunion implant plate; a second bunion implant plate; and a flexible tether. The first bunion implant plate comprises a first medial portion, a first dorsal portion and a first lateral portion that cooperatively form a first outer side and a concave first bone engagement inner side that is configured to couple over a medial side, a dorsal side and a lateral side, respectively, of a first respective metatarsal bone. The second bunion implant plate comprises a second medial portion, a second dorsal portion and a second lateral portion that cooperatively form a second outer side and a concave second bone engagement inner side that is configured to couple over a medial side, a dorsal side and a lateral side, respectively, of a second respective metatarsal bone. The flexible tether extends between the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate that allows motion between the first and second bunion implant plates but prevents relative movement of the first and second bunion implant plates away from each other such that a maximum distance therebetween is maintained.

[0016]

[0013] In some embodiments, the first respective metatarsal bone is a first metatarsal bone or a second metatarsal bone, and the second respective metatarsal bone is the other of the first metatarsal bone or the second metatarsal bone. In some embodiments, the first respective metatarsal bone is a first metatarsal bone, and the second respective metatarsal bone is a second metatarsal bone.

[0017]

[0014] In some embodiments, the first bone engagement inner side is anatomically shaped such that it corresponds to the shape of a corresponding outer surface portion of the first respective metatarsal bone. In some such embodiments, the second bone engagement inner side is anatomically shaped such that it corresponds to the shape of a corresponding outer surface portion of the second respective metatarsal bone.

[0015] In some embodiments, the length of the flexible tether extending between the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate is configured to decrease an intermetatarsal angle formed between the first and second respective metatarsal bones and prevent the intermetatarsal angle from increasing above a maximum intermetatarsal angle. In some embodiments, the first bone engagement inner side is concave in the dorsal -plantar direction as it extends in the medial- lateral direction, and wherein the second bone engagement inner side is concave in the dorsal-plantar direction as it extends in the medial-lateral direction.

[0018]

[0016] In some embodiments, the first bone engagement inner side defines a first maximum width in the medial-lateral direction between the first medial and lateral portions, and the second bone engagement inner side defines a second maximum width in the medial-lateral direction between the second medial and lateral portions that is less than the first maximum width. In some such embodiments, the first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof at a distal side of the first bunion implant plate that is larger than at a proximal side of the first bunion implant plate. In some embodiments, the first bone engagement inner side tapers inwardly in width in the medial-lateral direction between the first medial and lateral portions as it extends in a proximal-to-distal direction.

[0019]

[0017] In some embodiments, the first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof that tapers inwardly as it extends distally from proximal sides of the first medial and lateral portions to an intermediate portion of the first bone engagement inner side in the proximal-distal direction. In some such embodiments, the first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof that tapers inwardly as it extends proximally from distal sides of the first medial and lateral portions to the intermediate portion of the first bone engagement inner side in the proximal -distal direction. In some such embodiments, the first medial portion of the first bunion implant plate extends further in the plantar direction than the first lateral portion of the first bunion implant plate.

[0020]

[0018] In some embodiments, at least a tip portion of the first bone engagement inner side defined by the first medial portion of the first bunion implant plate extends medially and dorsally. In some such embodiments, the at least a tip portion of the first bone engagement inner side defined by the first lateral portion of the first bunion implant plate extends laterally and dorsally.

[0019] In some embodiments, at least a tip portion of the first bone engagement inner side defined by the first medial portion of the first bunion implant plate is medially-laterally convex along the proximal -distal direction. In some such embodiments, the at least a tip portion of the first bone engagement inner side defined by the first lateral portion of the first bunion implant plate is medially-laterally convex along the proximal -distal direction. In some embodiments, a portion of the first bone engagement inner side defined by the dorsal portion of the first bunion implant plate extends dorsally as it extends distally.

[0021]

[0020] In some embodiments, the second lateral portion of the second bunion implant plate comprises a pair of proximal and distal wing portions that extend proximally and distally, respectively, from a middle portion of the second lateral portion past proximal and distal sides of the middle portion and of the second dorsal portion. In some such embodiments, the proximal and distal wing portions comprise notches adjacent to the middle portion. In some such embodiments, the notches extend from a dorsal side of the proximal and distal wing portions toward a plantar side of the proximal and distal wing portions. In some such embodiments, portions of the first bone engagement inner side defined by the proximal and distal wing portions extend laterally as they extend medially and laterally, respectively, from the middle portion. In some such embodiments, the portions of the first bone engagement inner side defined by the proximal and distal wing portions are curved laterally as they extend proximally and distally, respectively, from the middle portion to proximal and distal tip portions, respectively, thereof. In some embodiments, a portion of the first bone engagement inner side defined by the middle portion and the proximal and distal wing portions is medially-laterally convex along the proximal -distal direction.

[0022]

[0021] In some embodiments, the second dorsal portion of the second bunion implant plate comprises a pair apertures extending from the second outer side to the second bone engagement inner side that are proximally-distally spaced. In some such embodiments, the pair of apertures are substantially aligned with each other in the medial-lateral direction. In some such embodiments, the pair of apertures are angled in a medial-to-lateral direction as they extend from the second outer side to the second bone engagement inner side. In some such embodiments, the pair of apertures are substantially aligned in the proximal -distal direction with a pair of openings of a passageway at the second medial portion through which the tether passes. In some such embodiments, the pair of apertures comprise a countersink at the second outer side.

[0023]

[0022] In some embodiments, the first dorsal portion of the first bunion implant plate comprises a plurality of apertures extending from the first outer side to the first bone engagement inner side, the plurality of apertures comprising at least one of a pair of proximally-distally spaced apertures and a pair of medially-laterally spaced apertures. In some such embodiments, the dorsal portion of the first bunion implant plate comprises the pair of medially-laterally spaced apertures and the pair of proximally-distally spaced apertures. In some such embodiments, the pair of proximally-distally spaced apertures are substantially aligned with each other in the medial-lateral direction. In some such embodiments, the pair of proximally-distally spaced apertures are substantially aligned in the proximal-distal direction with a pair of openings of a passageway at the second medial portion through which the tether passes. In some such embodiments, the plurality of apertures comprise the pair of proximally-distally spaced apertures, and wherein the pair of proximally-distally spaced apertures are angled medially as they extends from the first outer side to the first bone engagement inner side. In some such embodiments, the plurality of apertures comprise the pair of medially-laterally spaced apertures, and wherein a medial aperture of the medially-laterally spaced apertures is angled laterally as extends from the first outer side to the first bone engagement inner side, and a lateral aperture of the medially- laterally spaced apertures is angled medially as extends from the first outer side to the first bone engagement inner side. In some such embodiments, the plurality of apertures comprise a countersink at the first outer side.

[0024]

[0023] In some embodiments, the first medial portion, the first dorsal portion and the first lateral portion of the first bunion implant plate are integral, and wherein the second medial portion, the second dorsal portion and the second lateral portion of the second bunion implant plate are integral. In some embodiments, at least one of the first bunion implant plate and the second bunion implant plate is an additively manufactured implant plate.

[0025]

[0024] In some embodiments, the first lateral portion of the first bunion implant plate comprises a first passageway through which the tether passes. In some such embodiments, the first passageway extends between proximally-distally spaced openings that face laterally, wherein the first passageway extends in a medial-lateral and proximal-distal arcuate pathway between the proximally-distally spaced openings, and wherein the first passageway comprises substantially smooth internal surfaces. In some such embodiments, the edges of the openings are arcuately convex. In some other such embodiments, the openings are positioned at the lateral-most portion of the first bunion implant plate. In some other such embodiments, the first outer side at the first lateral portion of the first bunion implant plate comprises at least one laterally-extending boss that extends about both of the openings or each of the openings. In some such embodiments, a thickness of the first bunion implant plate between the first outer and inner sides at the at least one laterally-extending boss is greater than at a thickness of the first bunion implant plate between the first outer and inner sides at at least one of the first medial portion spaced from the at least one boss, the first dorsal portion and the first lateral portion. In some such embodiments, the first outer side at the first lateral portion of the first bunion implant plate comprises a dorsally-plantarly extending rib portion that defines a thickness between the first outer and inner sides that is greater than at thicknesses of portions of the first medial portion that are adjacent to the rib portion. In some such embodiments, the rib portion is substantially aligned medially-laterally between the openings. In some embodiments, the first passageway is defined by the second medial portion of the second bunion implant plate.

[0026]

[0025] In some embodiments, the first passageway is defined by a first passageway component that is separate and distinct from first bunion implant plate. In some such embodiments, the first lateral portion of the first bunion implant plate defines the passageway extending between proximally-distally spaced openings, and wherein the first passageway component extends within the passageway. In some such embodiments, the first passageway component is a tube member with ends that arcuately flare outwardly. In some such embodiments, the first passageway of the first passageway component is exposed at the first bone engagement inner side of the first bunion implant plate.

[0027]

[0026] In some embodiments, the first passageway component is a first insert component that is mated with the first lateral portion of the first bunion implant plate. In some such embodiments, the first insert component is a machined component. In some other such embodiments, the first lateral portion of the first bunion implant plate comprises a first insert aperture, and wherein the first insert member extends within the first insert aperture. In some such embodiments, the first insert member is a stepped insert such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof. In some such embodiments, the first insert opening is a stepped opening such that a medial back portion thereof defines a medial-lateral and / or dorsal-plantar size that is greater than that of a lateral front portion thereof. In some such embodiments, the first insert opening extends medially-laterally past the openings and dorsally-plantarly the openings. In some embodiments, the flexible tether extends in a loop through the first passageway.

[0028]

[0027] In some embodiments, the second medial portion of the second bunion implant plate comprises a second passageway through which the tether passes. In some such embodiments, the second passageway extends between proximally-distally spaced openings that face medially, wherein the second passageway extends in a medial-lateral and proximal-distal arcuate pathway between the proximally-distally spaced openings, and wherein the second passageway comprises substantially smooth internal surfaces. In some such embodiments, the edges of the openings are arcuately convex. In some other such embodiments, the openings are positioned at the medial-most portion of the second bunion implant plate. In some other such embodiments, the second outer side at the second medial portion of the second bunion implant plate comprises at least one medially-extending boss that extends about both of the openings or each of the openings. In some such embodiments, a thickness of the second bunion implant plate between the second outer and inner sides at the at least one medially-extending boss is greater than at a thickness of the second bunion implant plate between the second outer and inner sides at at least one of the second medial portion spaced from the at least one boss, the second dorsal portion and the second lateral portion. In some such embodiments, the second outer side at the second medial portion of the second bunion implant plate comprises a dorsally-plantarly extending rib portion that defines a thickness between the second outer and inner sides that is greater than at thicknesses of portions of the second medial portion that are adjacent to the rib portion. In some such embodiments, the rib portion is substantially aligned medially-laterally between the openings.

[0029]

[0028] In some embodiments, the second passageway is defined by the second medial portion of the second bunion implant plate. In some embodiments, the second passageway is defined by a second passageway component that is separate and distinct from second bunion implant plate. In some such embodiments, the second medial portion of the second bunion implant plate defines a secondary passageway extending between proximally-distally spaced openings, and wherein the second passageway component extends within the second passageway. In some such embodiments, the second passageway component is a tube member with ends that arcuately flare outwardly. In some such embodiments, the second passageway of the second passageway component is exposed at the second bone engagement inner side of the second bunion implant plate.

[0030]

[0029] In some embodiments, the second passageway component is a second insert component that is mated with the second medial portion of the second bunion implant plate. In some such embodiments, the second insert component is a machined component. In some other such embodiments, the second medial portion of the second bunion implant plate comprises a second insert aperture, and wherein the second insert member extends within the second insert aperture. In some such embodiments, the second insert member is a stepped insert such that a lateral back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a medial front portion thereof. In some such embodiments, the second insert opening is a stepped opening such that a lateral back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a medial front portion thereof. In some such embodiments, the second insert opening extends medially-laterally past the openings and dorsally-plantarly the openings. In some embodiments, the flexible tether extends in a loop through the second passageway.

[0031]

[0030] In some embodiments, end portions of the flexible tether are fixedly coupled within the respective tether apertures of the first lateral portion of the first bunion implant plate and / or respective tether apertures of the second medial portion of the second bunion implant plate and / or via respective fittings. In some such embodiments, the fittings are crimped to the end portions of the flexible tether and received within the respective tether apertures. In some such embodiments, the end portions of the flexible tether are fixedly coupled within cavities of the fittings, and wherein opening portions of the cavities of the fittings are radially outwardly, arcuately convex. In some such embodiments, an outer side of the first lateral portion of the first bunion implant plate and / or an outer side of the second medial portion of the second bunion implant plate comprises medially-extending bosses in which tether apertures are formed.

[0032]

[0031] In some embodiments, the flexible tether is looped through at least one of a passageway at the first lateral portion of the first bunion implant and a passageway at the second medial portion of the second bunion implant. In some embodiments, the flexible tether is freely slidably looped through at least one of a passageway at the first lateral portion of the first bunion implant and a passageway at the second medial portion of the second bunion implant.

[0033]

[0032] In some embodiments, the flexible tether is looped through a first passageway at the first lateral portion of the first bunion implant plate. In some such embodiments, end portions of the flexible tether are coupled together within the first passageway of the first lateral portion. In some such embodiments, the first passageway is defined by a first insert member mated within a first insert opening in the first lateral portion. In some such embodiments, the first second passageway comprises a pair of proximally-distally spaced openings extending medially-laterally though the first insert member. In some such embodiments, an interior side of the first insert member comprises a connection recess positioned between the pair of proximally-distally spaced openings. In some such embodiments, the first insert member and the first lateral portion of the first bunion implant plate are configured such that the interior side of the first insert member is laterally spaced from the first inner side of the first lateral portion when mated therein. In some such embodiments, the end portions of the tether are coupled together at a first connection portion that is positioned within the connection recess. In some such embodiments, the first connection portion comprises a knot of the tether that knots the end portions of the tether together. In some such embodiments, the first connection portion comprises a connector member that mechanically couples the end portions of the tether together. In some other such embodiments, the first insert member, the first lateral portion of the first bunion implant plate and the tether are configured such that the interior side of the insert member and the first connection portion are laterally spaced from the first inner side of the first lateral portion when mated therein. In some such embodiments, the first insert member is a stepped insert such that a medial back portion thereof defines a medial- lateral and / or dorsal-plantar size that is greater than that of a lateral front portion thereof. In some such embodiments, the first insert opening is a stepped opening such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof.

[0034]

[0033] In some embodiments, the flexible tether is looped through a second passageway at the second medial portion of the second bunion implant plate. In some such embodiments, end portions of the flexible tether are coupled together within the second passageway of the second medial portion. In some such embodiments, the second passageway is defined by a second insert member mated within a second insert opening in the second medial portion. In some such embodiments, the second passageway comprises a pair of proximally-distally spaced openings extending medially-laterally though the second insert member. In some such embodiments, an interior side of the second insert member comprises a connection recess positioned between the pair of proximally-distally spaced openings. In some such embodiments, the second insert member and the second medial portion of the second bunion implant plate are configured such that the interior side of the second insert member is medially spaced from the second inner side of the second medial portion when mated therein. In some such embodiments, the end portions of the tether are coupled together at a first connection portion that is positioned within the connection recess. In some such embodiments, the first connection portion comprises a knot of the tether that knots the end portions of the tether together. In some such embodiments, the first connection portion comprises a connector member that mechanically couples the end portions of the tether together. In some other such embodiments, the second insert member, the second medial portion of the second bunion implant plate and the tether are configured such that the interior side of the second insert member and the first connection portion are laterally spaced from the second inner side of the second medial portion when mated therein. In some such embodiments, the second insert member is a stepped insert such that a lateral back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a medial front portion thereof. In some such embodiments, the second insert opening is a stepped opening such that a lateral back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a medial front portion thereof.

[0035]

[0034] In some embodiments, the first and second bunion implant plates are configured such that the portions of the tether extending between the and second bunion implant plates converge as they extend from the first bunion implant plate to the second bunion implant plate. In some embodiments, a thickness of the first bunion implant plate extending between the first outer surface and the first inner surface varies between at two of the first medial portion, the first dorsal portion and the first lateral portion. In some such embodiments, a thickness of the second bunion implant plate extending between the second outer surface and the second inner surface varies between at two of the second medial portion, the second dorsal portion and the second lateral portion.

[0036]

[0035] In some such embodiments, free ends of the first bunion implant plate comprises radiused edges, and free ends of the second bunion implant plate comprises radiused edges. In some such embodiments, the first bunion implant plate comprises tapered or sloped surfaces that are adjacent to the free ends and radiused edges thereof. In some such embodiments, the second bunion implant plate comprises tapered or sloped surfaces that are adjacent to the free ends and radiused edges thereof.

[0037]

[0036] In some embodiments, the tether comprises a metal cable. In some embodiments, the tether comprises braided or woven polymer suture tether. In some embodiments, the tether comprises a biocompatible suture.

[0038]

[0037] In another aspect, the present disclosure provides a bunion correction system comprising one of the implant systems described above, and a reduction clamp configured to reduce an intramedullary angle between the first and second respective metatarsal bones. In some embodiments, the reduction clamp comprises a concave engagement cap configured to engage a medial side of the foot of the patient, and a bone and / or tissue engagement tip configured to engage a lateral side of another metatarsal bone of the foot of the patient. In some such embodiments, the bone and / or tissue engagement tip is a pointed tip. In some such embodiments, the reduction clamp comprises a first arm member and a second arm member rotationally coupled at a first pivot point, and wherein the concave engagement cap is positioned at a first end of the first arm, and the bone and / or tissue engagement tip is positioned at a first end of the second arm. In some such embodiments, the concave engagement cap is removably mated with the first end of the first arm. In some such embodiments, the first end of the first arm comprises a second pointed tip. In some such embodiments, the first arm further comprises a first handle portion at a second end of the first arm, and the second arm further comprises a second handle portion at a second end of the second arm, and wherein the pivot point is positioned between the first and seconds ends of the first arm, and positioned between the first and seconds ends of the second arm. In some such embodiments, the first and second arm further comprise a ratchet members that prevent relative movement between the first and second arms such that the concave engagement cap and the bone and / or tissue engagement tip are prevented from relative movement away from each other.

[0039]

[0038] In some embodiments, the first dorsal portion of the first bunion implant plate comprises at least one first aperture extending from the first outer side to the first bone engagement inner side, and the second dorsal portion of the second bunion implant plate comprises at least one second aperture extending from the second outer side to the bone engagement inner side. In some such embodiments, the system further comprises a plurality of fixation members configured to extend through the at least one first aperture or the at least one second aperture and into the first or second respective metatarsal bone, respectively, to fix the first or second bunion implant plate to the first or second respective metatarsal bone, respectively.

[0040]

[0039] In another aspect, the present disclosure provides a bunion correction system comprising one of the implant systems described above, and a tether tying fixture configured to securely position the first and second bunion implant plates at at least one predefined spacing, and allow the tether to be looped through the passageway at the second medial portion.

[0041]

[0040] In some embodiments, tether tying fixture is configured to facilitate passing ends of the tether through openings of a second passageway at the first lateral portion, and securing the ends of the tether together via at least one knot.

[0042]

[0041] In another aspect, the present disclosure provides a method of repositioning a first metatarsal bone relative to an adjacent second metatarsal bone to correct a bunion condition of a foot of a patient, comprising obtaining one of the implant system described above, reducing an intramedullary angle between the first and second respective metatarsal bones from a first intramedullary angle to a reduced intramedullary angle, and positioning the first bunion implant plate of implant system over the first metatarsal bone, and positioning the second bunion implant plate of the implant system over the second metatarsal bone to prevent the intermetatarsal angle from increasing above the reduced intramedullary angle.

[0043]

[0042] In some embodiments, the method further comprises coupling the first bunion implant plate to the first respective metatarsal bone and coupling the second bunion implant plate to the second respective metatarsal by inserting at least one fixation member through at least one aperture in the first dorsal portion of the first bunion implant plate and into the first respective metatarsal bone, and inserting at least one fixation member through at least one aperture in the second dorsal portion of the second bunion implant plate and into the second respective metatarsal bone.

[0044]

[0043] In some embodiments, reducing the intramedullary angle between the first and second respective metatarsal bones comprises utilizing a reduction clamp to reduce the intramedullary angle. In some such embodiments, utilizing the reduction clamp to reduce the intramedullary angle comprises engaging a medial side of the foot of the patient with a concave engagement cap at a first end of a first arm of the clamp, and engaging a lateral side of another metatarsal bone of the foot of the patient with a bone and / or tissue engagement tip at a first end of a second arm of the clamp. In some such embodiments, utilizing the reduction clamp to reduce the intramedullary angle further comprises manually engaging a first handle portion of the first arm and a second handle portion of the second arm, and pivoting the first and second arms relative to one another about a pivot point via the first and second handle portions to translate the concave engagement cap and the bone and / or tissue engagement tip towards each other.

[0045]

[0044] In some embodiments, the method further comprises passing the tether through the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate, and fixing end portions of the tether together. In some such embodiments, fixing end portions of the tether together comprises typing the end portions of the tether together. In some such embodiments, fixing end portions of the tether together further comprises positioning the first and second bunion implant plates in a suture typing fixture that medially-laterally spaces the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate a predetermined distance.

[0046]

[0045] In another aspect, the present disclosure provides a reduction clamp configured to reduce an angle and / or a distance between first and second bones and / or tissues, comprising an engagement cap comprising a front concave engagement side configured to engage a first side of a first bone and / or tissue, and a first pointed tip configured to engage a second side of a second bone and / or tissue.

[0046] In some embodiments, the reduction clamp further comprises a first arm member and a second arm member rotationally coupled at a first pivot point, and wherein the engagement cap is positioned at a first end of the first arm, and the first pointed tip is positioned at a first end of the second arm. In some such embodiments, the engagement cap is removably mated with the first end of the first arm. In some such embodiments, the first end of the first arm comprises a second pointed tip. In some such embodiments, a back side of the engagement cap comprises a plurality of openings configured to accept therein and mate with the second pointed tip. In some other such embodiments, the engagement cap comprises a plurality of through holes extending from the back side to the front concave engagement side.

[0047]

[0047] In some embodiments, the first arm further comprises a first handle portion at a second end of the first arm, and the second arm further comprises a second handle portion at a second end of the second arm, and wherein the pivot point is positioned between the first and seconds ends of the first arm, and positioned between the first and seconds ends of the second arm. In some such embodiments, the first and second arm further comprise a ratchet members that prevent relative movement between the first and second arms such that the engagement cap and the first pointed tip are prevented from relative movement away from each other.

[0048]

[0048] The bunion correction implants, systems and methods of the present disclosure may address one or more of the problems and deficiencies of the art discussed above. However, it is contemplated that the bunion correction implants, systems and methods of the present disclosure may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the disclosed and claimed inventions should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.

[0049]

[0049] Certain embodiments of the presently-disclosed bunion correction implants, systems and methods have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of the bunion correction implants, systems and methods of the present disclosure (e.g., those that are defined by the claims that follow), their more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section of this specification entitled “Detailed Description,” one will understand how the features of the various embodiments disclosed herein provide a number of advantages over the current state of the art.

[0050] These and other features and advantages of this disclosure will become apparent from the following detailed description of the various aspects of the disclosure taken in conjunction with the appended claims and the accompanying drawings.

[0050] BRIEF DESCRIPTION OF DRAWINGS

[0051]

[0051] The accompanying drawings may or may not be drawn to scale. In the drawings, each identical or substantially similar component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. Various embodiments of the disclosure will now be described, by way of example, with reference to the accompanying drawings, in which:

[0052]

[0052] FIG. 1 A illustrates a top view of a healthy foot without a hallux valgus bunion;

[0053]

[0053] FIG. IB illustrates a top view of a foot exhibiting a hallux valgus bunion;

[0054]

[0054] FIG. 2 illustrates a top / dorsal view of an exemplary bunion correction implant system comprising inter alia a first bone engaging bunion implant plate, a second bone engaging bunion implant plate, and a flexible tether coupling the first and second bunion implant plates, engaging a first and second metatarsal bones and correcting a bunion, according to an embodiment the present disclosure;

[0055]

[0055] FIG. 3 illustrates an elevational proximal perspective view of the bunion correction implant system correcting the bunion of FIG. 2;

[0056]

[0056] FIG. 4 illustrates another elevational proximal perspective view of the bunion correction implant system correcting the bunion of FIG. 2;

[0057]

[0057] FIG. 5 illustrates an elevational proximal perspective view of the first and second bone engaging bunion implant plates of the bunion correction implant system of FIG. 2;

[0058]

[0058] FIG. 6 illustrates an elevational proximal perspective view of the bunion correction implant system of FIG. 2;

[0059]

[0059] FIG. 7 illustrates a bottom / plantar proximal perspective view of the bunion correction implant system of FIG. 2;

[0060]

[0060] FIG. 8 illustrates a bottom / plantar view of the bunion correction implant system of FIG. 2;

[0061]

[0061] FIG. 9 illustrates a bottom / plantar perspective view of the bunion correction implant system of FIG. 2;

[0062]

[0062] FIG. 10 illustrates an elevational exploded perspective view of the bunion correction implant system of FIG. 2;

[0063] FIG. 11 illustrates a distal exploded perspective view of the bunion correction implant system of FIG. 2;

[0063]

[0064] FIG. 12 illustrates a proximal perspective view of the bunion correction implant system of FIG. 2 with a plurality of fixation members extending through fixation apertures of the first and second bone engaging bunion implant plates, according to an embodiment the present disclosure;

[0064]

[0065] FIG. 13 illustrates another proximal perspective view of the bunion correction implant system of FIG. 12;

[0065]

[0066] FIG. 14 illustrates a top / dorsal view of the bunion correction implant system of FIG. 12;

[0066]

[0067] FIG. 15 illustrates a bottom / plantar view of the bunion correction implant system of FIG. 12;

[0067]

[0068] FIG. 16 illustrates a proximal side cross-sectional view of the bunion correction implant system of FIG. 2;

[0068]

[0069] FIG. 17 illustrates a medial side cross-sectional view of the first bone engaging bunion implant plate of the bunion correction implant system of FIG. 2;

[0069]

[0070] FIG. 18 illustrates a lateral side cross-sectional view of the second bone engaging bunion implant plate of the bunion correction implant system of FIG. 2;

[0070]

[0071] FIG. 19 illustrates another medial side cross-sectional view of the first bone engaging bunion implant plate of the bunion correction implant system of FIG. 2;

[0071]

[0072] FIG. 20 illustrates another lateral side cross-sectional view of the second bone engaging bunion implant plate of the bunion correction implant system of FIG. 2;

[0072]

[0073] FIG. 21 illustrates an elevational perspective view of a system / kit with the first and second bone engaging bunion implant plates of the bunion correction implant system of FIG. 2 seated within a fixture, according to an embodiment the present disclosure;

[0073]

[0074] FIG. 22 illustrates an elevational perspective view of the system / kit of FIG. 21 with the tether extending through inserts of the first and second bone engaging bunion implant plates of the bunion correction implant system of FIG. 2;

[0074]

[0075] FIG. 23 illustrates an elevational perspective view of the system / kit of FIG. 22 with end portions of the tether fixed together;

[0075]

[0076] FIG. 24 illustrates a perspective view of a metatarsal repositioning clamp, according to an embodiment the present disclosure;

[0076]

[0077] FIG. 25 illustrates a front perspective view of the metatarsal repositioning clamp of FIG. 24 repositioning first and second metatarsal bones to correct a bunion;

[0078] FIG. 26 illustrates a front perspective view of the metatarsal repositioning clamp of FIG. 24 repositioning first and second metatarsal bones to correct a bunion;

[0077]

[0079] FIG. 27 illustrates a rear perspective concave bone engagement paddle attachment of the metatarsal repositioning clamp of FIG. 24;

[0078]

[0080] FIG. 28 illustrates a elevational proximal perspective view of another exemplary bunion correction implant system comprising inter alia a first bone engaging bunion implant plate, a second bone engaging bunion implant plate, and a flexible tether coupling the first and second bunion implant plates, according to an embodiment the present disclosure;

[0079]

[0081] FIG. 29 illustrates another elevational proximal perspective view of the bunion correction implant system of FIG. 28;

[0080]

[0082] FIG. 30 illustrates another elevational proximal perspective view of the bunion correction implant system of FIG. 28;

[0081]

[0083] FIG. 31 illustrates a top view of the bunion correction implant system of FIG. 28;

[0082]

[0084] FIG. 32 illustrates an elevational proximal perspective view of the first bone engaging bunion implant plate of the bunion correction implant system of FIG. 28;

[0083]

[0085] FIG. 33 illustrates a lateral view of the first bone engaging bunion implant plate of the bunion correction implant system of FIG. 28;

[0084]

[0086] FIG. 34 illustrates a proximal cross-sectional view of a portion of the bunion correction implant system of FIG. 28;

[0085]

[0087] FIG. 35 illustrates a front perspective view of an insert coupled with the second bone engaging bunion implant plate of the bunion correction implant system of FIG. 28;

[0086]

[0088] FIG. 36 illustrates a rear perspective view of an insert coupled with the second bone engaging bunion implant plate of the bunion correction implant system of FIG. 28;

[0087]

[0089] FIG. 37 illustrates a proximal cross-sectional view of a portion of the bunion correction implant system of FIG. 28;

[0088]

[0090] FIG. 38 illustrates a top view of another exemplary bunion correction implant system comprising inter alia a first bone engaging bunion implant plate, a second bone engaging bunion implant plate, and a flexible tether coupling the first and second bunion implant plates, according to an embodiment the present disclosure;

[0089]

[0091] FIG. 39 illustrates a top view of another exemplary bunion correction implant system comprising inter alia a first bone engaging bunion implant plate, a second bone engaging bunion implant plate, and a flexible tether coupling the first and second bunion implant plates, according to an embodiment the present disclosure;

[0092] FIG. 40 illustrates an elevational distal perspective view of the bunion correction implant system of FIG. 39;

[0090]

[0093] FIG. 41 illustrates a bottom / plantar proximal perspective view of the bunion correction implant system of FIG. 39;

[0091]

[0094] FIG. 42 illustrates a bottom / plantar distal perspective view of the bunion correction implant system of FIG. 39;

[0092]

[0095] FIG. 43 illustrates an elevational proximal exploded perspective view of the bunion correction implant system of FIG. 39;

[0093]

[0096] FIG. 44 illustrates a bottom / plantar proximal exploded perspective view of the bunion correction implant system of FIG. 39;

[0094]

[0097] FIG. 45 illustrates a top / dorsal view of the bunion correction implant system of FIG. 39;

[0095]

[0098] FIG. 46 illustrates a bottom / plantar view of the bunion correction implant system of FIG. 39;

[0096]

[0099] FIG. 47 illustrates a medial side view of the bunion correction implant system of FIG. 39;

[0097]

[0100] FIG. 48 illustrates a lateral side view of the bunion correction implant system of FIG. 39;

[0098]

[0101] FIG. 49 illustrates a proximal side view of the bunion correction implant system of FIG. 39;

[0099]

[0102] FIG. 50 illustrates a distal side view of the bunion correction implant system of FIG. 39;

[0100]

[0103] FIG. 51 illustrates a top / dorsal view of the bunion correction implant system of FIG.

[0101] 39 affixed to first and second metatarsal bones correcting a bunion, according to an embodiment the present disclosure;

[0102]

[0104] FIG. 52 illustrates an elevational perspective view of the bunion correction implant system of FIG. 51;

[0103]

[0105] FIG. 53 illustrates a top / dorsal perspective view of the bunion correction implant system of FIG. 51;

[0104]

[0106] FIG. 54 illustrates an elevational proximal view of a portion of the bunion correction implant system of FIG. 39;

[0105]

[0107] FIG. 55 illustrates another elevational proximal view of a portion of the bunion correction implant system of FIG. 39;

[0108] FIG. 56 illustrates a proximal side cross-sectional view of a portion of the bunion correction implant system of FIG. 39;

[0106]

[0109] FIG. 57 illustrates an elevational proximal perspective view of another bunion correction implant system comprising inter alia a first bone engaging bunion implant plate, a second bone engaging bunion implant plate, and a flexible tether coupling the first and second bunion implant plates, according to an embodiment the present disclosure;

[0107] [HO] FIG. 58 illustrates a proximal perspective view of the bunion correction implant system of FIG. 57;

[0108] [Hl] FIG. 59 illustrates a top / dorsal view of the bunion correction implant system of FIG. 57;

[0109]

[0112] FIG. 60 illustrates a bottom / plantar view of the bunion correction implant system of FIG. 57;

[0110]

[0113] FIG. 61 illustrates a proximal perspective view of the bunion correction implant system of FIG. 57;

[0111]

[0114] FIG. 62 illustrates a distal perspective view of the bunion correction implant system of FIG. 57;

[0112]

[0115] FIG. 63 illustrates a distal perspective view of the bunion correction implant system of FIG. 57;

[0113]

[0116] FIG. 64 illustrates a proximal perspective view of the bunion correction implant system of FIG. 57;

[0114]

[0117] FIG. 65 top cross-sectional view of a portion of the bunion correction implant system of FIG. 57;

[0115]

[0118] FIG. 66 illustrates a bottom proximal perspective view of the second bone engaging bunion implant plate and a second tether insert of the bunion correction implant system of FIG. 57;

[0116]

[0119] FIG. 67 illustrates a bottom distal perspective view of the first bone engaging bunion implant plate and a first tether insert of the bunion correction implant system of FIG. 57;

[0117]

[0120] FIG. 68 illustrates an elevational proximal exploded perspective view of the first bone engaging bunion implant plate and the first tether insert of the bunion correction implant system of FIG. 57;

[0118]

[0121] FIG. 69 illustrates an elevational distal exploded perspective view of the first bone engaging bunion implant plate and the first tether insert of the bunion correction implant system of FIG. 57;

[0122] FIG. 70 illustrates a proximal cross-sectional view of the bunion correction implant system of FIG. 57;

[0119]

[0123] FIG. 71 illustrates a medial cross-sectional view of the first bone engaging bunion implant plate of the bunion correction implant system of FIG. 57;

[0120]

[0124] FIG. 72 illustrates a lateral cross-sectional view of the second bone engaging bunion implant plate of the bunion correction implant system of FIG. 57; and

[0121]

[0125] FIG. 73 illustrates another lateral cross-sectional view of the second bone engaging bunion implant plate of the bunion correction implant system of FIG. 57.

[0122] DETAILED DESCRIPTION

[0123]

[0126] Aspects of the present disclosure and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting embodiments illustrated in the accompanying drawings. Descriptions of well-known materials, fabrication tools, processing techniques, etc., are omitted so as to not unnecessarily obscure the inventions in detail. It should be understood, however, that the detailed description and the specific example(s), while indicating embodiments of inventions, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions and / or arrangements within the spirit and / or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.

[0124]

[0127] In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, “proximal” means the portion of an implant nearest the torso or hindfoot, while “distal” indicates the portion of the implant farthest from the torso or nearest the forefoot. As for directional terms, “anterior”, “distal” and grammatical equivalents thereof are used to refer to a direction towards the front side of the body (or forefoot), “posterior”, “proximal” and grammatical equivalents thereof are used to refer to a direction towards the back side of the body (or hindfoot), “medial” and grammatical equivalents thereof are used to refer to a direction towards the midline of the body, “lateral” and grammatical equivalents thereof are used to refer to a direction towards the sides or away from the midline of the body, “dorsal”, “superior” and grammatical equivalents thereof are used to refer to a direction above another surface, side, object or structure or the top side / dorsum of a foot, and “plantar”, “inferior” and grammatical equivalents thereof are used to refer to a direction below another surface, side, object or structure or the bottom side / sole of a foot. The terms osteosynthesis, osteotomy and the like are used herein to refer to the promotion of bone formation / growth and bone in-growth, as explained further below.

[0125]

[0128] When introducing elements of various embodiments of the present disclosure, the articles “a,” “an,” “the,” and “said” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Any examples of parameters are not exclusive of other parameters of the disclosed embodiments. Components, aspects, features, configurations, arrangements, uses and the like described, illustrated or otherwise disclosed herein with respect to any particular embodiment may similarly be applied to any other embodiment disclosed herein.

[0126]

[0129] Any examples of parameters are not exclusive of other parameters of the disclosed embodiments. Components, aspects, features, configurations, arrangements, uses and the like described, illustrated or otherwise disclosed herein with respect to any particular embodiment may similarly be applied to any other embodiment disclosed herein.

[0127]

[0130] Hallux valgus and tailor's bunions have a wide variety of causes. Some deformities may be inherited or present at birth, while others develop later and / or are self-inflicted, for example. Self-inflicted causes may include high-heeled or ill-fitting shoes, high-impact exercise, foot injuries, and the like. As used herein, the top side of the foot will be referred to as the dorsal side and the bottom side of the foot will be referred to as plantar side or ventral side. Thus, a top facing surface of the implant may be referred to as the dorsal side and the bottom facing surface of the implant may be referred to as the plantar side or ventral side. In either case, as will be appreciated below, the implant in some embodiments will be positioned on the top side of the metatarsals such that the plantar side (or ventral side) of the implant faces the dorsal side of the metatarsals and the plantar side of the metatarsals is void of the implant.

[0128]

[0131] FIG. 1 A depicts a healthy foot while FIG. IB depicts a foot exhibiting a hallux valgus type bunion. A hallux valgus-type bunion may develop when the pressures of bearing and shifting of weight fall unevenly on the joints and tendons in the feet, for example. This imbalance and pressure may make the metatarsophalangeal (MTP) or big toe joint unstable, leading to splaying of the first 51 and second 52 metatarsals, resulting in a protrusion 94 at the MTP joint of the first metatarsal 51 as shown in FIG. IB. As shown in FIG. 1A, in a normal foot, the intermetatarsal angle 57 between the first 51 and second 52 metatarsal bones is typically less than about 9 degrees. As shown in FIG. IB, a foot exhibiting hallux valgus bunion may include an intermetatarsal angle 58 between the first 51 and second 52 metatarsal bones greater than that of a normal foot, such as within the range of about 9 to about 20 degrees. The systems, implants and related methods of the present disclosure may bring or draw the first metatarsal 51 towards the second metatarsal 12 from the hallux valgus type bunion arrangement in FIG. IB, resulting in a more anatomically correct intermetatarsal angle 57 resembling that of the healthy foot in FIG. 1 A.

[0129]

[0132] Other similar bunions involve other metatarsals than the first and second metatarsals 51, 52. For example, a tailor’s bunion involves instability of the fifth metatarsal that leads to splaying of the fourth and fifth metatarsals. With a tailor’s bunion, splaying of the fourth and fifth metatarsals results in a protrusion at the MTP joint of the fifth metatarsal. In a normal foot, the intermetatarsal angle between the fourth and fifth metatarsal bones is typically less than about 8 degrees. A foot with tailor’s bunion may have an intermetatarsal angle between the fourth and fifth metatarsal bones greater than that of a normal foot, ranging from about 8 to 15 degrees.

[0130]

[0133] While particular bunion correction implants, systems and related methods of the present disclosure may be described and / or illustrated with respect to a hallux valgus type bunion, the systems, implants and related methods of the present disclosure may equally apply or be utilized to correct or treat a tailor’s bunion. For example, the systems, implants and related methods of the present disclosure may bring or draw the fifth metatarsal towards the fourth metatarsal rather than drawing the first metatarsal towards the second metatarsal, resulting in a more anatomically correct intermetatarsal angle resembling that of a healthy foot. Similarly, while particular bunion correction implants, systems and related methods of the present disclosure may be described and / or illustrated with respect to a tailor’s bunion, the systems, implants and related methods of the present disclosure may equally apply or be utilized to correct or treat a hallux valgus type bunion. For example, the systems, implants and related methods of the present disclosure may bring or draw the first metatarsal towards the second metatarsal rather than drawing the fifth metatarsal towards the fourth metatarsal resulting in a more anatomically correct intermetatarsal angle resembling that of a healthy foot.

[0131]

[0134] One challenge with the use of prior bunion correction constructs is their attachment to the involved foot bones. Such prior implants anchor to the foot bones by fully penetrating through the bones and / or wrapping completely around the bones. Arrangements that penetrate completely through the foot are invasive, and they may weaken the structural integrity of the bones and lead to stress fractures, stress risers and other post-operative complications. Arrangements that wrap completely around the metatarsals may also require invasive surgical procedures because of their size resulting in soft tissue complications to the patient, and they may weaken the structural integrity of the bones and lead to stress fractures and stress risers. Arrangements that wrap completely around the metatarsals may also be bulky and uncomfortable to the patient.

[0132]

[0135] According to one aspect of the present disclosure, surgical systems, implants and related methods are provided that partially wrap around a bone, such as a metatarsal bone, rather than penetrate completely through the entire bone or wrap completely around the bone. Further, the implants may be positioned on only the dorsal side of the bones, allowing the implant to engage the bones through a less invasive surgical procedure.

[0133]

[0136] According to one aspect of the present disclosure, as shown in FIGS. 2-27 the systems 100, implants and related methods include first and second bunion implant plates 102, 104 that each includes one or more feature that enables attachment or coupling of the first and second bunion implant plates 102, 104 to corresponding first and second bones 10, 12, such as adjacent first and second metatarsal bones 10, 12 in a hallux valgus type bunion arrangement as depicted in FIG. IB (or fourth and fifth metatarsal bones in a tailor’s type bunion arrangement (not shown)). In this manner, the system 100 can exert an appropriate force on the first and second bones 10, 12 to urge the first bone 10 into its correct anatomical position. As shown in FIGS. 2-27, in one embodiment the first bunion implant plate 102 may be configured to engage and couple to a dorsal portion of the first bone 10, and the second bunion implant plate 104 may be configured to engage and couple to a dorsal portion of the second bone 12. The first and second bunion implant plates 102, 104 may be formed from at least one biocompatible material. The first and second bunion implant plates 102, 104 may be of one-piece construction or monolithic.

[0134]

[0137] As shown in FIGS. 2-27, the first and second bunion implant plates 102, 104 may each be shaped such that the first and second bunion implant plates 102, 104, including a bottom bone engaging surface thereof, is configured (e.g., shaped and sized) to substantially correspond to the shape of a portion of a cortex of the first and second bones 10, 12, respectively, to engage therewith. In some embodiments, the bone engaging surface of the first and second bunion implant plates 102, 104 may be configured to partially wrap around the respective first and second bones 10, 12. In the embodiment shown in FIGS. 2-27, the first and second bunion implant plates 102, 104 each form a generally C-shape, for example, to extend over at least a portion of the dorsal, medial and lateral portions or aspects of the respective first and second bones 10, 12. The first and second bunion implant plates 102, 104 may thereby hook on the lateral or medial aspect of a bone. In some embodiments, at least a portion of the engagement surface or inner side of the first and / or second bunion implant plates 102, 104 may include a surface roughness or other mechanism to enhance the friction between the first and / or second bunion implant plates 102, 104 and the respective first and second bones 10, 12. In some embodiments, at least a portion of the engagement surface or inner side of the first and / or second bunion implant plates 102, 104 may include areas of surface roughness or other suitable features or materials that encourage growth of tissue into the implants 102, 104 to help the integration of the implants 102, 104 into the body. Examples of possible surface treatments for promotion of a surface roughness and / or tissue ingrowth include, but are not limited to: plasma etching, sand blasting, machining and other treatments to roughen the surface or otherwise provide a suitable surface texture.

[0135] Alternatively, or in addition, the implants 102, 104 may include certain features and / or materials in desired locations that resist tissue attachment to help prevent immobilization. In some embodiments, the surface roughness or other surface treatment is applied only to the underside surface of the implants 102, 104 that contacts or engages the bones, and not to the top surface of the implants 102, 104 facing away from the bones.

[0136]

[0138] In some embodiments, the implants 102, 104 may include other types of anchoring elements or bone engaging features such as anchor or fixation holes / apertures 105, as shown in FIGS. 2-20. Fixation members may be passed through the anchor holes and fixed into the bone, thereby anchoring the implants 102, 104 to respective bones. Fixation members include bone screws, surgical screws, orthopedic screws, nails, pins, k-wire, barbs, and other suitable hardware, as this aspect is not limited in this regard. In addition, screws may be of the locking or non-locking type with respect to the bone plate implants 102, 104.

[0137]

[0139] In some embodiments, the implants 102, 104 may include other types of or additional bone engaging features that enhances attachment of the implants 102, 104 to bones. Other types of bone engaging features may include bonding or cementation that adheres the implants 102, 104 to a bone. Such bonding or cementation may be applied at any contacting interface between the implants 102, 104 and the bones.

[0138]

[0140] At least the bone engagement surface or inner side or inner side of the first and second bunion implant plates 102, 104 may include a at least one bone engaging portion with a radius of curvature and arc length, as discussed further below. Each bone engaging portion of the first and second bunion implant plates 102, 104 may have a specific radius of curvature and arc length. The radius of curvature and arc length of each portion of the bone engagement surface or inner side or inner sides of the first and second bunion implant plates 102, 104 may allow each implants 102, 104 to hook onto or make intimate contact with the dorsal, medial and lateral aspects of the respective first and second bones 10, 12, and may mimic the shape and size of the outer surface of the respective first and second bones 10, 12.

[0139]

[0141] In some embodiments, the radius of curvature of each bone engaging surface or feature of the first and second bunion implant plates 102, 104 may range from about 1 mm to 25 mm. In some embodiments, the arc length of each bone engaging surface or feature of the first and second bunion implant plates 102, 104 may range from about 1 mm to about 150 mm. As shown in FIGS. 2-27, the first bunion implant plate 102 of the proximal implant 4 may hook on the medial aspect of the first metatarsal 10 and partially wrap around the first metatarsal 10. Similarly, as also shown in FIGS. 2-27, the second bunion implant plate 104 may hook on the lateral aspect of the second metatarsal 12 and partially wraps around the second metatarsal 12. Depending on its radius of curvature and arc length, the bone engaging feature may partially wrap around bone by extending to a certain dorsal-ventral depth along the lateral or medial aspect of the bone. In some embodiments, as shown in FIGS. 2-27, the first bunion implant plate 102 may partially wrap around the first metatarsal 10 or another bone by extending down to more than half the dorsal -ventral depth of the medial aspect of the first metatarsal 10 or other bone. In some embodiments, the first and second bunion implant plates 102, 104 may partially wrap around a bone by extending to slightly more than half the dorsal -ventral depth, half the dorsal-ventral depth, slightly less than half the dorsal -ventral depth, or less than half the dorsal -ventral depth of the lateral or medial aspect of the bone. In some embodiments, the first and second bunion implant plates 102, 104 may also be shaped to fit the medial-lateral contours of a bone. For example, in one embodiment a distal portion of the first bunion implant plate 102 may curve inward medially (not shown) to meet the first metatarsal 10. Of course, it should be appreciated that the first and second bunion implant plates 102, 104 are not limited in this respect and other suitable shapes may be employed. For example, the first and second bunion implant plates 102, 104 may be formed in a semicircular shape or otherwise have a longer arc length to wrap further, but still partially, around respective bones. In some cases, the first and second bunion implant plates 102, 104 may be arranged to wrap completely around respective bones.

[0140]

[0142] As shown in FIGS. 2-27, the first bunion implant plate 102 may include an arcuate intermediate or dorsal 114 that connects between an outer or medial portion 112 and an inner or lateral portion 116. The outer or medial portion 112, intermediate or dorsal 114 and inner or lateral portion 116 may be configured to engage at least a portion of the lateral, dorsal and medial sides, aspects or portions of the first bone 10, respectively, such as a first metatarsal bone. In some embodiments, at least the bone engagement surface or inner side or inner side of the inner or lateral portion 116 may extend in a dorsal -plantar direction, such as for an arc length within the range of about 3 mm to about 9 mm, such as about 6 mm. In some embodiments, at least the inner side or engagement surface or inner side of the lateral portion 116 and / or the outer or medial portion 112 may be arcuate and / or concave and extend generally in a dorsal-plantar direction. In some embodiments, at least the engagement surface or inner side of the outer or medial portion 112 may be defined by a radius within the range of about 3 mm to about 10 mm (or about 5 mm to about 8 mm) and define an arc length within the range of about 3 mm to about 7 mm (or about 4 mm to about 6 mm) As shown, the outer or medial portion 112 of the first bunion implant plate 102 may extend further in a plantar direction than the inner or lateral portion 116.

[0141]

[0143] In some embodiments, at least the engagement surface or inner side of the intermediate or dorsal 114 may be arcuate and / or concave and extend generally extend in a medial-lateral direction. In some embodiments, at least the engagement surface or inner side of the intermediate or dorsal 114 may be defined by a radius within the range of about 10 mm to about 17 mm (or about 13 mm to about 14 mm), and define an arc length within the range of about 8 mm to about 18 mm (or about 11 mm to about 15 mm). The engagement surface or inner side of the first bunion implant plate 102 may thereby form a concave surface that defines a first width W 1 between the ends of the inner or lateral portion 116 and the outer or medial portion 112 in a medial-lateral direction. In some embodiments, the first width W1 of the engagement surface or inner side of the first bunion implant plate 102 may be within the range of about 11 mm to about 18 mm (or about 13 mm to about 16 mm). However, although the first bunion implant plate 102 may be substantially rigid, in some embodiments the first bunion implant plate 102 may be deformable such that the shape of the engagement surface or inner side may be formed into any shape or configuration to suit a particular first bone 10.

[0142]

[0144] As shown, the transitions between (e.g., join) the intermediate or dorsal 114 and the outer or medial portion 112 and the inner or lateral portion 116 of the first bunion implant plate 102 may be curved. These transitions may comprise an inflection point at which the curvature of the first bunion implant plate 102 changes direction. It should be understood that an object, such as a plate, can have a radius of curvature of zero, in which case the object is flat. In some embodiments, the transition areas of the first bunion implant plate 102 may be a bend that is, or is close to, 90 degrees, greater than 90 degrees, or less than 90 degrees. Each of the transitions of the first bunion implant plate 102 may have a radius of curvature. In some embodiments, the radius of curvature for each transition of the first bunion implant plate 102 may fall within one of the following ranges: 1 to 10 mm, 0.1 to 5 mm, 0.5 to 3 mm, 0.5 to 2 mm, 0.5 to 1 mm, or 0.01 to 1 mm. Each of the radii of curvature of the transitions of the first bunion implant plate 102 may fall within the same or different ranges.

[0143]

[0145] Similar to the first bunion implant plate 102, the second bunion implant plate 104 may include an arcuate intermediate or dorsal portion 124 that extends between an outer or lateral portion 126 and an inner portion or medial portion 122, as shown in FIGS. 2-27. The outer or lateral portion 126, intermediate or dorsal portion 124 and inner portion or medial portion 122 may be configured to engage at least a portion of the lateral, dorsal and medial sides, aspects or portions of the second bone 12, respectively, such as a second metatarsal bone that is adjacent to the first metatarsal bone that the first bunion implant plate 102 engages.

[0144]

[0146] In some embodiments, at least the engagement surface or inner side of the inner portion or medial portion 122 may extend in a dorsal -plantar direction, such as for an arc length within the range of about 3 mm to about 9 mm (e.g., be about 6 mm). In some embodiments, at least a portion of at least the engagement surface or inner side of the inner portion or medial portion 122 may be substantially arcuate and / or concave. In some embodiments, at least a portion of at least the engagement surface or inner side of the outer or lateral portion 126 may be substantially flat or planar in a direction. In some embodiments, at least a portion of at least the engagement surface or inner side of the outer or lateral portion 126 may be arcuate and / or concave and extend generally extend in a dorsal-plantar direction. In some embodiments, at least a portion of at least the engagement surface or inner side of the outer or lateral portion 126 may be defined by a radius of at least about 10 mm (or at least about 15 mm), and define an arc length within the range of about 1 mm to about 10 mm (or about 2 mm to about 3 mm). In some embodiments, at least the engagement surface or inner side of the outer or lateral portion 126 may include a substantially flat or planar portion and an arcuate and / or concave portion, with a total length within the range of about 3 mm to about 10 mm (or about 6 mm to about 8 mm.) As shown in FIGS. 2-27, the outer or lateral portion 126 of the second bunion implant plate 104 is longer in a plantar direction than the inner or lateral portion 116. In some other embodiments, the engagement surface or inner side of the outer or lateral portion 126 may be substantially planar.

[0145]

[0147] In some embodiments, at least the engagement surface or inner side of the intermediate or dorsal portion 124 may be flat in one direction. In some embodiments, at least the engagement surface or inner side of the intermediate or dorsal portion 124 may be arcuate and / or concave and extend generally extend in a medial-lateral direction. In some embodiments, at least the engagement surface or inner side of the intermediate or dorsal portion 124 may be defined by a radius of at least about 10 mm (or within the range of about 14 mm to about 17 mm), and define an arc length within the range of about 3 mm to about 11 mm (or about 6 mm to about 7 mm). The engagement surface or inner side of the second bunion implant plate 104 may thereby form a concave surface that defines a second width W2 between the ends of the inner portion or medial portion 122 and the outer or lateral portion 126 in a medial -lateral direction. In some embodiments, the second width W2 of the engagement surface or inner side of the second bunion implant plate 104 may be within the range of about 5 mm to about 11 mm (or about 7 mm to about 9 mm). However, although the second bunion implant plate 104 may be substantially rigid, in some embodiments the second bunion implant plate 104 may be deformable such that the shape of the engagement surface or inner side may be formed into any shape or configuration to suit a particular second bone 12.

[0146]

[0148] As shown in FIGS. 2-27, the transitions between (e.g., join) the intermediate or dorsal portion 124 and the outer or lateral portion 126 and the inner portion or medial portion 122 of the second bunion implant plate 104 may be curved. These transitions may comprise an inflection point at which the curvature of the second bunion implant plate 104 changes direction. It should be understood that an object, such as a plate, can have a radius of curvature of zero, in which case the object is flat. In some embodiments, the transition areas of the second bunion implant plate 104 may be a bend that is, or is close to, 90 degrees, greater than 90 degrees, or less than 90 degrees. Each of the transitions of the second bunion implant plate 104 may have a radius of curvature. In some embodiments, the radius of curvature for each transition of the second bunion implant plate 104 may fall within one of the following ranges: 1 to 10 mm, 0.1 to 5 mm, 0.5 to 3 mm, 0.5 to 2 mm, 0.5 to 1 mm, or 0.01 to 1 mm. Each of the radii of curvature of the transitions of the second bunion implant plate 104 may fall within the same or different ranges.

[0147]

[0149] In some embodiments, the length of the implants 102, 104 in a distal-proximal direction may vary. As shown in FIGS. 2-27, the outer or medial portion 112 of the first bunion implant plate 102 may be longer or wider in the distal -proximal direction than the intermediate or dorsal 114, and the intermediate or dorsal 114 may be longer or wider in the distal -proximal direction than the inner or lateral portion 116. However, the length or width of the first bunion implant plate 102 may vary and may be configured differently than depicted on FIGS. 2-27. As also shown in FIGS. 2-27, the outer or lateral portion 126 of the second bunion implant plate 104 may be longer or wider in the distal -proximal direction than the intermediate or dorsal portion 124, and the intermediate or dorsal portion 124 may be longer or wider along the distal -proximal direction than the inner portion or medial portion 122. However, the length or width of the second bunion implant plate 104 may vary and may be configured differently than depicted in FIGS. 2-27.

[0148]

[0150] As shown in FIGS. 2-27, the depth of the system 100 in the dorsal -plantar direction, as measured from the dorsal -most surface of the system 100, may vary along the system 100 and / or the first and second bunion implant plates 102, 104. This depth of the first and second bunion implant plates 102, 104 determines how far the first and second bunion implant plates 102, 104 extend along the medial or lateral aspects of their respective bones. As shown in FIGS. 2-27, in the first bunion implant plate 102, the outer depth Z2 is greater than the inner depth Zl. In the second bunion implant plate 104, the inner depth Z3 is smaller than the lateral depth Z4 (e.g., to a lesser (or greater) extent than that of the first bunion implant plate 102). In some embodiments, a greater outer depth Z4 of the second bunion implant plate 104 may help to decrease concentration of stress on the respectively engaged bone, such as a second metatarsal. However, it should be understood that, in other embodiments, the outer depth Z4 of the second bunion implant plate 104 (as well as the outer depth Z2 of the first bunion implant plate 102) may be smaller than that shown in FIGS. 2-27.

[0149]

[0151] In some embodiments, the bone engagement surface or inner side or inner side of the first and / or second bunion implant plate 102, 104 may be configured to provide a close anatomical fit to the respective first and second bones 10, 12 such that the distance between the implants 102, 104 and the respective first and second bones 10, 12 in a plantar-dorsal direction is minimized. Providing a close anatomical fit between the implants 102, 104 and the respective first and second bones 10, 12 may help enhance patient comfort. A large gap or distance between the implants 102, 104 and the respective first and second bones 10, 12 in a plantar-dorsal direction may give rise to a bulky protrusion on the dorsal surface of the foot resulting in soft tissue complications. In addition, a poorly fitting first and / or second bunion implant plates 102, 104 may be more easily disturbed or dislodged by external forces.

[0150]

[0152] In some embodiments, the configuration (e.g., radius of curvature, length, etc.) of the portions of the engagement surface or inner side of the first and / or second bunion implant plates 102, 104 may be adjustable to provide a close anatomical fit to the respective first and second bones 10, 12. The engagement surface or inner side of the first and / or second bunion implant plates 102, 104 may be adjusted preoperatively or intraoperatively. For example, a surgeon may bend (manually or with a tool such as a plate bender) the first and / or second bunion implant plates 102, 104 to change the configuration of at least one portion of the engagement surface or inner sides (e.g., radius of curvature, length, etc.) to custom fit the subject's respective first and second bones 10, 12. In some embodiments, the bone engaging surfaces may be manually adjusted to fit the medial-lateral contours of the respective first and second bones 10, 12 by bending the first and second bunion implant plates 102, 104 in the medial or lateral direction. In some embodiments, the bone engaging surfaces may be heat- shrinkable. In yet another embodiment, the bone engaging surfaces may include multiple segments that can be removed or added to alter the configuration thereof (e.g., radius of curvature and / or arc length). In some embodiments, the configuration of the bone engaging surface may be permanent, and a surgeon may choose from a set of first and / or second bunion implant plates 102, 104 with different bone engaging surfaces or portions to best suit the patent’s anatomy.

[0151]

[0153] As shown in FIGS. 2-27, the first and / or second bunion implant plates 102, 104 may include at least one fixation or anchor hole 105. The at least one fixation or anchor hole 105 of the first and / or second bunion implant plates 102, 104 may be configured to allow a fixation member or anchor element 107 to extend therethrough and into the respective first or second bone 10, 12 to fix the first and second bunion implant plates 102, 104 thereto, as shown in FIGS. 3, 4 and 12-15. The fixation members 107 may be any bone coupling member or device, such as any bone screw, orthopedic screw, nail, barb, tine, pin, k-wire, or any other suitable coupling or affixing hardware.

[0152]

[0154] In some embodiments, as shown in FIGS. 3, 4 and 12-15 of the illustrated exemplary embodiment, the fixation members 107 are bone screws. The bone screws 107 are configured such that a threaded shaft portion passes through a respective fixation hole 105 and into a bone 10, 12, and a head portion engages the first or second bunion implant plate 102, 104 (such as within a countersink or recessed area extending about the fixation hole 105 such that the head portion is positioned at or below the surrounding uppermost top surface of the first or second bunion implant plate 102, 104). In some embodiments, the bone screws 107 may be configured as non-locking screws such that they do not lock with respect to the first or second bunion implant plate 102, 104 (e.g., the threaded shaft portion of the bone screws 107 pull the bone and the underside of the first or second bunion implant plate 102, 104 together, and the head portion does not lock with the plate 102, 104). In such embodiments, the head portion of the bone screws 107 may be non -threaded, and the bone screws 107 and the fixation holes 105 may be configured to permit angulation of the bone screws 107 with respect to the first or second bunion implant plate 102, 104. In some other embodiments, the bone screws 107 and / or the first or second bunion implant plate 102, 104 are configured such that the bone screws 107 are locking screws that lock to the first or second bunion implant plate 102, 104. For example, the head portion of the bone screws 107 and the fixation holes 105 may be threaded, and when the bone screws 107 are fully inserted into the fixation holes 105 the head portion of the bone screws 107 threadably mates with the fixation holes 105 to “lock” to the threaded screw holes 105 of the plate 102, 104. In this way, once a locking bone screw 107 is fully seated, it locks into the plate 102, 104, forming a single solid unit with the plate 102, 104 rather than just compressing the plate the plate 102, 104 against the bone as with non-locking bone screws 107. In some other embodiments, an additional threaded locking member or set screw is utilized to lock a bone screw 107 with the plate 102, 104.

[0153]

[0155] As shown in FIGS. 3, 4 and 12-15, in some embodiments, the head portion of the fixation members 107 (e.g., screws) may include a drive opening (or projection) configured to torque / rotate the fixation members 107 via a corresponding tool. The drive opening (or projection) may be of a non-circular cross-section (taken normal to the longitudinal axis of the fixation member 107) so that a torque can be applied. For example, a powered or hand- driven screw driver, drill or like torque tool may be used to engage the drive opening (or projection) and rotate the fixation members 107 to drive the fixation members 107 through a hole 105 in one of the plates 102, 104 and into the first or second bones 10, 12.

[0154]

[0156] In some other embodiments (not shown), the fixation member 107 (e.g., screws) may not include a drive opening (or projection) for engagement with a driving tool, but may rather include an integrated break-off (or snap-off) drive member. The integrated fixation and break off drive member 107 is thus a single integral component. The drive member portion may extend from a head portion of the fixation member portion along the axis of the fixation member 107, and include a non-circular cross-section so that a torque can be applied thereto (and thereby the fixation member 107). The driver member portion may be configured to engage with a torque tool (such as a powered or hand-driven screw driver, drill or like torque tool) or comprise a toque tool (such as form a handle that can be manually torqued). The break-off drive member portion is configured to break off or break free from the fixation member portion after a certain predetermine amount of torque or force is applied / experienced, leaving the fixation member portion (with a shaft portion and a head portion, for example) behind in one of the first or second bones 10, 12 (and through one of the holes 105). The drive portion / extension may be twisted or bent off at a neck or joint, leaving a clean finished surface / side that may be flush or recessed in the head portion. The drive portion can thus be a non-permanent extension attached to the head portion of the fixation member 107. The snap-off section or portion may be a weakened section or portion for controlled breakage. The snap-off section or portion may be a slightly softer or fragile material or area as the remainder of the integrated fixation and break off drive member 107, or comprise a groove, necking or other stress concentration feature, to ensure a clean breaking point / area.

[0155]

[0157] As shown in FIGS. 2-27, the first and / or second bunion implant plates 102, 104 may include a plurality of fixation / anchoring holes 105. The fixation / anchoring holes 105 may be positioned anywhere along the first and / or second bunion implant plates 102, 104. In some embodiments first bunion implant plate 102 may include fixation / anchoring holes 105 located toward the medial side thereof, and one more fixation / anchoring hole 105 located at the dorsal side thereof. For example, in some embodiments the first bunion implant plate 102 may include at least one fixation / anchoring hole 105 in the intermediate or dorsal 114 and / or the outer or medial portion 112. In some embodiments, the inner or lateral portion 116 may be void of an fixation / anchoring hole 105, while in other embodiments the inner or lateral portion 116 may include at least one fixation / anchoring hole 105. As shown in FIGS. 2-27, all of the fixation / anchoring holes 105 of the first bunion implant plate 102 may not be utilized with an anchoring element. In this way, at least one of the fixation / anchoring holes 105 of the first bunion implant plate 102 may be left void during use of the system 100. For example, in some embodiments, only two fixation members / anchors 107 are used in to fixation / anchoring holes 105 to attach the first bunion implant plate 102 to a bone.

[0156]

[0158] Similar to the first bunion implant plate 102, the second bunion implant plate 104 may include at least one fixation / anchoring hole 105 located at least in the dorsal side 124 thereof. For example, in some embodiments the second bunion implant plate 104 may include at least one fixation / anchoring hole 105 in the intermediate or dorsal portion 124 and / or the outer or lateral portion 126. In some embodiments, the outer or lateral portion 126 may be void of a fixation / anchoring hole 105. In some embodiments, the inner portion or medial portion 122 may be void of a fixation / anchoring hole 105 , while in other embodiments the inner portion or medial portion 122 may include at least one fixation / anchoring hole 105. As shown in FIGS. 2-27, each of the fixation / anchoring holes 105 of the second bunion implant plate 104 may not be utilized with an anchoring element (i.e., left void during use of the system 100). For example, in some embodiments, only two anchors are used to attach the second bunion implant plate 104 to a bone.

[0157]

[0159] As shown in FIGS. 2-27, the system 100 may include a flexible tether member 106 that is coupled to, and extend between, the first and second bunion implant plates 102, 104. The flexible tether member 106 may be positioned between dorsal and plantar sides of the first and second bones 10, 12, when the first and second bunion implant plates 102, 104 are coupled to the first and second bones 10, 12, respectively, as shown in FIGS. 2-27. The flexible tether member 106 may be formed from at least one biocompatible material. The flexible tether member 106 may be formed from one or more components. The flexible tether member 106 may also be substantially flexible. In some embodiments, the flexible tether member 106 may be made from a biocompatible metal (e.g., titanium), a monofilament polymer, a braided polymer, a suture or a combination thereof.

[0158]

[0160] The flexible tether member 106 may be flexible such that it allows for motion in all planes between first and second bunion implant plates 102, 104. However, the flexible tether member 106 may be stiff in tension (e.g., in a medial-lateral direction) such that it restricts any movement of the first and second bunion implant plates 102, 104 apart from each other. In this way, although the flexible tether member 106 prevents movement of the first and second bunion implant plates 102, 104 apart from each other, the flexible tether member 106 may allow the angle 0 between the first and second bunion implant plates 102, 104 (e.g., along an axial view of the first and second bones 10, 12), and thereby the first and second bones 10, 12 coupled thereto, to self-adjust. For example, when the first and second bones 10, 12 are first and second metatarsal bones, the flexible tether member 106 may prevent enlargement of the intermetatarsal angle 0 between the first and second metatarsal bones 10, 12, yet allow the first and second bones 10, 12 to otherwise move or angle with respect to each other. The angle 0 between the first and second bunion implant plates 102, 104, such as the intermetatarsal angle 0, may be measured along the transverse plane.

[0159]

[0161] In some embodiments, the length of the flexible tether member 106 extending between the first and second bunion implant plates 102, 104 (e.g., in a medial -lateral direction) may be configured to move the first bone 10 towards the second bone 12, and thereby decrease an angle 0 formed between the first and second bones 10, 12. In this way, when the first and second bones 10, 12 are first and second metatarsal bones, the length of the flexible tether member 106 extending between the first and second bunion implant plates 102, 104 may be configured to reduce the intermetatarsal angle 0. The length of the flexible tether member 106 extending between the first and second bunion implant plates 102, 104 may be a fixed length or may be adjustable. In some embodiments, the flexible tether member 106 may be provided in fixed lengths, and / or the length thereof may be adjustable before or after the system 100 is implanted.

[0162] As shown in FIGS. 2-27, the flexible tether member 106 may be coupled to the first and / or second bunion implant plates 102, 104 via a rigid attachment or a sliding or slidable attachment such that the respective implants 102, 104 can translate / move along a length of the flexible tether member 106. In some embodiments, the flexible tether member 106 may be rigidly coupled to both the first and second bunion implant plates 102, 104. In some other embodiments, the flexible tether member 106 may be slidably coupled to both the first and second bunion implant plates 102, 104. As shown in FIGS. 2-27, in some embodiments one of the first and second bunion implant plates 102, 104 may be rigidly coupled to the flexible tether member 106 and the other of the first and second bunion implant plates 102, 104 may be slidably coupled to the flexible tether member 106. For example, in the embodiment shown in FIGS. 2-27the flexible tether member 106 may be rigidly or non-slidably coupled to the first bunion implant plate 102, and slidably coupled to the medial portion 122 of the second bunion implant plate 104.

[0160]

[0163] As discussed above, at least one of the first and second bunion implant plates 102, 104 may be slidably coupled to the flexible tether member 106 such that it can translate along the flexible tether member 106, yet is prevented from translating away from the other of the first and second bunion implant plates 102, 104 (and thereby the first and second bones 10, 12 coupled thereto) to prevent the intermetatarsal angle 0 from enlarging. Such a sliding connection between the flexible tether member 106 and the first and / or second bunion implant plates 102, 104 may be accomplished by any mechanism or means.

[0161]

[0164] In some embodiments, the flexible tether member 106 may form at least one loop (a continuous loop) that passes through the first and / or second bunion implant plates 102, 104 at least once, as shown in FIGS. 2-27. For example, two portions of the looped flexible tether member 106 may pass through corresponding apertures of the first and / or second bunion implant plates 102, 104. In this way, the first and / or second bunion implant plate 102, 104 may be slidably coupled to the looped flexible tether member 106 such that the flexible tether member 106 prevents the implants 102, 104 from moving away from each other. However, as the looped flexible tether member 106 is able to feed through the at least one aperture, the respective first and / or second bunion implant plate 102, 104 may be able to slide along the flexible tether member 106. In this way, system 100 may allow the angle 0 between the first and second bunion implant plates 102, 104 (and thereby the intermetatarsal angle 0 between the first and second metatarsal bones 10, 12 coupled, respectively, therewith) to self-adjust to match a patient’s anatomy.

[0165] In some embodiments, the first and / or second bunion implant plate 102, 104 may be attached to the flexible tether member 106 via at least one aperture of the first and / or second bunion implant plate 102, 104 that is configured to accept the flexible tether member 106 therethrough. For example, as shown in FIGS. 2-27, the inner or lateral portion 116 and medial portion 122 of the first and second bunion implant plate 102, 104, respectively, may include at least one aperture, such as a pair of apertures, to allow the flexible tether member 106 to extend therethrough and between the first and second bunion implant plates 102, 104. In some such embodiments, the first and / or second bunion implant plate 102, 104 may include at least one guide portion that provides a smooth guide surface (e.g., groove) for the flexible tether member 106 to translate along as the respective implants 102, 104 slides along the length of the flexible tether member 106, as shown in FIGS. 2-27. In some embodiments, the first and / or second bunion implant plate 102, 104 may include a passageway or channel to guide the flexible tether member 106 through the respective implants 102, 104, as shown in FIGS. 2-27.

[0162]

[0166] The system 100 disclosed herein (e.g., the first and second bunion implant plates and a flexible cable member thereof) may be utilized to reposition a first bone (e.g., a first or fifth metatarsal bone) toward an adjacent second bone (e.g., a second or further metatarsal bone, respectively) to a more anatomically correct position to treat a bunion formed by the first bone. Initially, the system 100 may be introduced into a patient via at least one incision that is proximate to the first and second bones. For example, a first dorsal incision may be formed between the first and second bones and a second dorsal incision may be formed on an opposing side of the first bone. A tissue tunnel may also be formed across and / or between the first and second dorsal incisions over the first and second bones to accommodate placement of the system 100. As another example, a dorsal incision may be formed that bisects the width of the first bone.

[0163]

[0167] After the at least one incision is formed proximate to the first and second bones (e.g., at least one dorsal incision), soft tissue may be released from at least one of the first and second bones. Further, the intermetatarsal angle 0 between the first and second bones may be reduced. For example, the metatarsal angle 0 between the first and second bones may be reduced manually or via surgical instrument (e.g., a bone clamp or another instrument). Once the metatarsal angle 0 between the first and second bones is reduced and maintained, the space or gap between the first and second bones may be gauged. The space or gap between the reduced first and second bones may also be intraoperatively imaged to confirm correct gap size.

[0168] With the metatarsal angle 0 reduced and the gap size corrected, the system 100 may be placed / fit onto the first and second bones to evaluate the fit. For example, the engagement surface or inner side of the first bunion implant plate 102 thereof may be positioned over and on the dorsal side of the first bone, and the engagement surface or inner side of the second bunion implant plate thereof may be positioned over and on the dorsal side of the second bone. The flexible cable member may or may not be coupled to the first and second bunion implant plates during such trial fitting. If the first and / or second bunion implant plates do not fully fit / comply with or mirror the first and second bones, respectively, the first and / or second bunion implant plates may be bend or otherwise deformed to more closely match the profile of the first and second bones.

[0164]

[0169] In some embodiments, an implant system composed of multiple implants may be used. In some cases, the use of multiple implants may depend on the patient’s intermetatarsal angle. In general, a normal intermetatarsal angle is less than about 9 degrees. In some embodiments, if the subject’s intermetatarsal angle is less than about 12 degrees, a single implant may be sufficient. In some embodiments, if the subject’s intermetatarsal angle is over about 12 degrees, two implants may be used. A first bunion implant plate 102 may be implanted at a proximal location and a second bunion implant plate 104 may be implanted at a distal location. Of course, it should be appreciated that the present invention is not limited in this respect and other implantation positions may be used. For example, the first and second bunion implant plates may be implanted closer or further away from each other.

[0165]

[0170] According to one aspect, first and second bunion implant plates may be connected together to form a double-construct implant. For example, the double-construct implant may include a connector or section that joins first and second bunion implant plates together. The connector may be arranged to be positioned in the space between the metatarsals upon implantation such that the double-construct implant forms an H-shape configuration.

[0166]

[0171] According to one aspect, the system 100 is not limited to use with the first and second metatarsals. In some embodiments, the system 100 may be used to treat a condition called tailor’s bunion, also known as a bunionette. The implant system 100, including first and second implants 102, 104 may stabilize a fifth metatarsal to the fourth metatarsal in the same manner that the first metatarsal 10 is stabilized to the second metatarsal 12 in the treatment of hallux valgus. It should be appreciated that this aspect is not limited in this regard. In one embodiment, the first implant 102 may have a uniform proximal-distal width, and the second implant 104 may have an enlarged first and / or second bone engaging feature / surface. In another embodiment, the second implant 104 may have a uniform proximal-distal width, and the first implant 102 may have an enlarged first and / or second bone engaging feature / surface. In yet another embodiment, both implants 102, 104 may have uniform proximal-distal widths. In other embodiments, a single implant or a double-construct implant may be used. Any arrangement suitable to fit the patient’s anatomy may be used, as this aspect is not limited in this regard.

[0167]

[0172] As shown in FIGS. 2-27, and as noted above, the implant system 100 may comprise the first bunion implant plate 102 may comprise the first medial portion 112, the first dorsal portion 114 114 and the first lateral portion 116 that cooperatively form a first outer side and a concave first bone engagement inner side that is configured to couple over the medial side, a dorsal side and a lateral side, respectively, of a first respective metatarsal bone 10. The second bunion implant plate 104 may comprise the second medial portion 122, the second dorsal portion 124 and the second lateral portion 126 that cooperatively form a second outer side and a concave second bone engagement inner side that is configured to couple over the medial side, a dorsal side and a lateral side, respectively, of a second respective metatarsal bone 12. The flexible tether 106 extends between the first lateral portion 116 of the first bunion implant plate 102 and the second medial portion 122 of the second bunion implant plate 104 that allows motion between the first and second bunion implant plates 102, 104 but prevents relative movement of the first and second bunion implant plates 102, 104 away from each other such that a maximum distance therebetween is maintained. The flexible tether 106 is freely slidably looped through a passageway at the second medial portion 122 of the second bunion implant 104. The second lateral portion 126 of the second bunion implant plate 104 comprises a pair of flexible wing portions that extend proximally and distally, respectively, from a middle portion of the second lateral portion 126 past proximal and distal sides of the middle portion and of the second dorsal portion 124, the wing portions being medially-laterally flexible with respect to the middle portion.

[0168]

[0173] As shown in FIGS. 2-27, the first bone engagement inner side is anatomically shaped such that it corresponds to the shape of a corresponding outer surface portion of the first respective metatarsal bone 10, and the second bone engagement inner side is anatomically shaped such that it corresponds to the shape of a corresponding outer surface portion of the second respective metatarsal bone 12. The length of the flexible tether 106 extending between the first lateral portion 116 of the first bunion implant plate 102 and the second medial portion 122 of the second bunion implant plate 104 is configured to decrease an intermetatarsal angle formed between the first and second respective metatarsal bones 10, 12 and prevent the intermetatarsal angle from increasing above a maximum intermetatarsal angle.

[0169]

[0174] As shown in FIGS. 2-27, the first bone engagement inner side is concave in the dorsal-plantar direction as it extends in the medial-lateral direction, and wherein the second bone engagement inner side is concave in the dorsal -plantar direction as it extends in the medial-lateral direction. The first bone engagement inner side defines a first maximum width in the medial-lateral direction between the first medial and lateral portions, and the second bone engagement inner side defines a second maximum width in the medial-lateral direction between the second medial and lateral portions that is less than the first maximum width. The first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof at a distal side of the first bunion implant plate 102 that is larger than at a proximal side of the first bunion implant plate 102. As shown, the first bone engagement inner side tapers inwardly in width in the medial-lateral direction between the first medial and lateral portions as it extends in a proximal-to-distal direction. The first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof that tapers inwardly as it extends distally from proximal sides of the first medial and lateral portions to an intermediate portion of the first bone engagement inner side in the proximal-distal direction. The first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof that tapers inwardly as it extends proximally from distal sides of the first medial and lateral portions to the intermediate portion of the first bone engagement inner side in the proximal-distal direction.

[0170]

[0175] As shown in FIGS. 2-27, the first medial portion 112 of the first bunion implant plate 102 extends further in the plantar direction than the first lateral portion 116 of the first bunion implant plate 102. At least a tip portion of the first bone engagement inner side defined by the first medial portion 112 of the first bunion implant plate 102 extends medially and dorsally. Similarly, at least a tip portion of the first bone engagement inner side defined by the first lateral portion 116 of the first bunion implant plate 102 extends laterally and dorsally. At least a tip portion of the first bone engagement inner side defined by the first medial portion

[0171] 112 of the first bunion implant plate 102 is medially-laterally convex along the proximal- distal direction. At least a tip portion of the first bone engagement inner side defined by the first lateral portion 116 of the first bunion implant plate 102 is medially-laterally convex along the proximal -distal direction.

[0176] As shown in FIGS. 2-27, a portion of the first bone engagement inner side defined by the dorsal portion 114 of the first bunion implant plate 102 extends dorsally as it extends distally. The flexible wing portions comprise notches adjacent to the middle portion. The notches extend from a dorsal side of the flexible wing portions toward a plantar side of the flexible wing portions. Portions of the first bone engagement inner side defined by the flexible wing portions extend laterally as they extend medially and laterally, respectively, from the middle portion. The portions of the first bone engagement inner side defined by the flexible wing portions are curved laterally as they extend proximally and distally, respectively, from the middle portion to proximal and distal tip portions, respectively, thereof. A portion of the first bone engagement inner side defined by the middle portion and the flexible wing portions is medially-laterally convex along the proximal-distal direction.

[0172]

[0177] As shown in FIGS. 2-27, the second dorsal portion 124 of the second bunion implant plate 104 comprises a pair apertures extending from the second outer side to the bone engagement inner side thereof that are proximally-distally spaced. The pair of apertures are substantially aligned with each other in the medial-lateral direction. The pair of apertures are angled in a medial-to-lateral direction as they extend from the second outer side to the second bone engagement inner side. The pair of apertures are substantially aligned in the proximal- distal direction with a pair of openings of the passageway at the second medial portion 122. The pair of apertures comprise a countersink at the second outer side.

[0173]

[0178] As shown in FIGS. 2-27, the first dorsal portion 114 of the first bunion implant plate 102 comprises a plurality of apertures extending from the first outer side to the first bone engagement inner side, the plurality of apertures comprising at least one of a pair of proximally-distally spaced apertures and a pair of medially-laterally spaced apertures. The dorsal portion 114 of the first bunion implant plate 102 comprises the pair of medially- laterally spaced apertures and the pair of proximally-distally spaced apertures. The pair of proximally-distally spaced apertures are substantially aligned with each other in the medial- lateral direction. The pair of proximally-distally spaced apertures are substantially aligned in the proximal-distal direction with a pair of openings of the passageway at the second medial portion 122. The plurality of apertures comprise the pair of proximally-distally spaced apertures, and wherein the pair of proximally-distally spaced apertures are angled medially as they extends from the first outer side to the first bone engagement inner side. The plurality of apertures comprise the pair of medially-laterally spaced apertures, and wherein a medial aperture of the medially-laterally spaced apertures is angled laterally as extends from the first outer side to the first bone engagement inner side, and a lateral aperture of the medially- laterally spaced apertures is angled medially as extends from the first outer side to the first bone engagement inner side. The plurality of apertures comprise a countersink at the first outer side.

[0174]

[0179] As shown in FIGS. 2-27, the first medial portion 112, the first dorsal portion 114 and the first lateral portion 116 of the first bunion implant plate 102 are integral, and wherein the second medial portion 122, the second dorsal portion 124 and the second lateral portion 126 of the second bunion implant plate 104 are integral.

[0175]

[0180] The first bunion implant plate 102 may be an additively manufactured implant (e.g., a 3D printed implant), and wherein the second bunion implant plate 104 is an additively manufactured implant (e.g., a 3D printed implant).

[0176]

[0181] The passageway extends between proximally-distally spaced openings that face medially, wherein the passageway extends in a medial -lateral and proximal-distal arcuate pathway between the proximally-distally spaced openings, and wherein the passageway comprises substantially smooth internal surfaces.

[0177]

[0182] The edges of the openings are arcuately convex. The openings are positioned at the medial-most portion of the second bunion implant plate 104.

[0178]

[0183] The second outer side at the second medial portion 122 of the second bunion implant plate 104 comprises at least one medially -extendi ng boss that extends about both of the openings or each of the openings. A thickness of the second bunion implant plate 104 between the second outer and inner sides at the at least one medially-extending boss is greater than at a thickness of the second bunion implant plate 104 between the second outer and inner sides at at least one of the second medial portion 122 spaced from the at least one boss, the second medial portion 122 and the second lateral portion 126.

[0179]

[0184] As shown in FIGS. 2-27, the passageway is defined by a passageway component 108 that is separate and distinct from second bunion implant 104. The passageway component 108 is connected with the second medial portion 122 of the second bunion implant 104. The passageway component 108 is a machined component. The passageway component 108 is an insert member 108 that is configured to mate within an insert opening in the second medial portion 122. The passageway of the passageway component 108 is exposed at the second bone engagement inner side of the second bunion implant plate 104. The insert member 108 is a stepped insert such that a lateral back portion thereof defines a medial-lateral and / or dorsal-plantar size that is greater than that of a medial front portion thereof. The insert opening is a stepped opening such that a lateral back portion thereof defines a medial -lateral and / or dorsal-plantar size that is greater than that of a medial front portion thereof. The insert opening extends medially-laterally past the openings and dorsally-plantarly the openings.

[0180]

[0185] As shown in FIGS. 2-27, the flexible tether 106 is looped through a second passageway at the first lateral portion 116 of the first bunion implant plate 102. End portions of the flexible tether 106 are coupled together within the second passageway of the first lateral portion 116. The second passageway is defined by a second insert member 110 that is configured to mate within a second insert opening in the first lateral portion 116. The second insert member 110 is stepped insert such that a medial back portion thereof defines a medial- lateral and / or dorsal-plantar size that is greater than that of a lateral front portion thereof. The second insert opening is a stepped opening such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof.

[0181]

[0186] As shown in FIGS. 2-27, a thickness of the first bunion implant plate 102 extending between the first outer surface and the first inner surface varies between at two of the first medial portion 112, the first dorsal portion 114 and the first lateral portion 116. A thickness of the second bunion implant 104 extending between the second outer surface and the second inner surface varies between at two of the second medial portion 122, the second dorsal portion 124 and the second lateral portion 126. Free ends of the first bunion implant plate 102 comprises radiused edges, and free ends of the second bunion implant plate 104 comprises radiused edges. The first bunion implant plate 102 comprises tapered or sloped surfaces that are adjacent to the free ends and radiused edges thereof. The second bunion implant plate 104 comprises tapered or sloped surfaces that are adjacent to the free ends and radiused edges thereof.

[0182]

[0187] As noted above, the tether 106 comprises a biocompatible suture.

[0183]

[0188] As shown in FIGS. 21-23, the system 100 may also comprise a tether tying fixture 150 configured to securely position the first and second bunion implant plates 102, 104 at at least one predefined spacing, and allow the tether 106 to be looped through the passageway at the second medial portion 122 and the second passageway at the first lateral portion 116 (and the tied). As shown, the tether tying fixture 150 is configured to facilitate passing ends of the tether 106 through openings of a second passageway 110 at the first lateral portion 116, and securing the ends of the tether 106 together via at least one knot.

[0184]

[0189] As shown in FIGS. 24-27, the system 100 may also comprise a clamp 152 configured to engage a plantar side of a foot of a patient and one of the first respective metatarsal bone engaging implant 102 and the second bunion implant plate 104 to position the medial portion, the dorsal portion and the lateral portion of the first respective metatarsal bone engaging implant 102 on the medial, the dorsal and the lateral side, respectively, of a first metatarsal bone and / or position the medial portion, the dorsal portion and the lateral portion of the second bunion implant plate 104 on the medial, the dorsal and the lateral side, respectively, of a second metatarsal bone. The clamp 152 comprises a concave bone engagement paddle attachment 154 configured to engage the plantar side of the foot of the patient, and an implant engagement tip (or spike or point) configured to engage an outer side of dorsal portion of the first or second bunion implant plate 104.

[0185]

[0190] According to one aspect, the implant may include one or more tethers 106 that permit the metatarsals that are engaged by the implant to move relative to one another after the implant has been implanted. As a result, even with the implant implanted inside the patient’s foot, the metatarsals of the patient’s foot may have some degree of freedom to move relative to one another. In some cases, permitting relative movement between the engaged metatarsals may provide any one or combination of the following: improve comfort, decrease mechanical stresses or other wear on the implant, decrease mechanical stresses or other wear on the biological tissue surrounding the implant, improve the longevity of the implant or decrease the probability of post-operative complications. In some embodiments, the implant may include one or more tether 106 that permit relative movement between the engaged metatarsals in the dorsal -ventral direction. Alternatively, or in addition, the one or more tether 106 may permit movement between the engaged metatarsals in the lateral-medial direction. The implant may also permit the engaged metatarsals to rotate relative to one another about one or more flexure axes. The tether 106 can be any suitable arrangement that permits relative movement between the engaged metatarsals in the dorsal -ventral direction and / or the lateral-medial direction.

[0186]

[0191] The cables may allow the first and second bone engaging plates 102, 104 to rotate, translate and twist relative to one another. In embodiments where the tether 106 comprises shorter cables, the cables 140 may only permit rotational movement between the first and second bone engaging plates 102, 104. In some cases, however, shorter cables may permit rotation and some, but limited, translation and / or twisting between the first and second bone engaging plates 102, 104.

[0187]

[0192] It should be appreciated that other tether 106 arrangements are possible. For example, the tether 106 may be an accordion-like arrangement, a sliding mechanism, may be stamped, may be bendable, may be thinner than the rest of the implant in a direction that is not limited to the dorsal -ventral direction, may have one or more reliefs, may have one large cutout in the center of the intermediate portion, leaving two side rails of material, may be a chain of links, a hinge, or any other suitable arrangement, as this aspect is not so limited.

[0188]

[0193] The flexible cable may impart multiple degrees of freedom. In the embodiment, cable 120 may permit rotation, translation and twisting of the first and second bone engaging plates 102, 104 relative to one another. In some embodiments, the cables are stretchable to impart an additional degree of freedom. In other embodiments, the cables cannot be stretched. It should be appreciated that any suitable number of cables may be used, as this aspect is not so limited. In one embodiment, tether 106 may be one continuous loop, with one end of the loop being coupled to the first bone engaging plate 102 and the other end of the loop being coupled to the second bone engaging plate 104. In other embodiments, instead of one continuous loop, the tether 106 may be two separate strands that are coupled to the bone engaging plates 102, 104.

[0189]

[0194] In some cases, the length of the cable may impact the degrees of freedom imparted to the implant. In some embodiments, longer cables such as those shown may be used to provide more than a single degree of freedom of relative movement between the first and second bone engaging plates 102, 104. On the other hand, in some embodiments, shorter cables may be used to restrict movement between the first and second bone engaging plates 102, 104 to impart a single degree of freedom to the implant / between the plates 102, 104.

[0190]

[0195] It should be appreciated that the implant may have any suitable number of degrees of freedom, as this aspect is not so limited. Any suitable number of tether 106 may be included and tether 106 of any length may be used.

[0191]

[0196] According to one aspect, in some embodiments, the tether 106 may be configured to limit the maximum distance between the engaged metatarsals so as to prevent the metatarsals from returning to their previous hallux valgus positions. For example, the tether 106 may be arranged such that it can only be shortened from its natural resting position, not elongated. As another example, in the embodiment where the tether 106 may be non-stretchable, thereby limiting the maximum distance between the engaged metatarsals. The tether 106 permits the bone engaging plates 102, 104 to move toward one another, but restricts movement of the bone engaging plates 102, 104 away from one another beyond a maximum distance. In some embodiments, the tether 106 may be stretchable from its natural resting position, but the tether 106 have a maximum elongation length that prevents the metatarsals from returning to their previous hallux valgus positions.

[0192]

[0197] The tether 106 may be coupled to the implant by any suitable means. In some embodiments, the tether 106 may be coupled to the implant by bonding, adhesive, soldering, welding, physical interlock, clamping, embedding at least one or more portions of the tether 106 within the implant, threading the tether 106 through holes in the implant, mechanical attachment, by being integrally formed with the implant as one monolithic structure, by being stamped into the implant, cutout from the implant, or by any other suitable arrangement, as this aspect is not so limited. As non-limiting, illustrative examples, the ends of tether 106 in the embodiment shown in FIG. 45 may be embedded within, welded to or otherwise coupled to first and second bone engaging plates 102, 104. In the case where tether 106 is one continuous loop rather than two independent cables, the ends of the loop may be embedded within, welded to, or otherwise coupled to first and second bone engaging plates 102, 104.

[0193]

[0198] The tether 106 may be made of titanium, nickel, nickel titanium alloy, nitinol or other shape-memory alloy, silver, gold, plastic, an elastomer, metal, metal alloy, stainless steel, a suture, FIBERWIRE, which is a multi-strand, long chain ultra-high molecular weight polythelyene (UHMWPE) core with a braided jacket of polyester and UHMWPE, or any other suitable material, as this aspect is not so limited. The tether 106 may be made from the same material as the rest of the implant or from a different material.

[0194]

[0199] According to one aspect, the tether 106 may be located on only one side of the engaged bones. In some embodiments, where the implant is used in a foot, the tether 106 may be located substantially only dorsal to the metatarsals, such that the tether 106 is located at a height that is positioned above the metatarsals, as opposed to a height that is between the metatarsals or below the metatarsals. In other embodiments, the tether 106 may be located substantially only ventral to the metatarsals, such that tether 106 is located at a height that is positioned below the metatarsals, as opposed to a height that is between the metatarsals or above the metatarsals. The word “substantially” is used to include arrangements where the tether 106 bows slightly inward toward the space between the engaged metatarsals or is otherwise arranged such that a portion of the tether 106 is located at a height that is between the metatarsals. “Substantially only dorsal to or substantially only ventral to the metatarsals” includes such arrangements where a portion of the tether 106 is located at a height that is between the metatarsals.

[0195]

[0200] The Applicant has recognized that passing portions of an implant completely through a bone may decrease the structural integrity of the bone. As such, according to one aspect, the implant is configured to engage with two bones such that an intermediate portion of the implant is positioned substantially between two bones without any portion of the device (including bone anchors associated with the device) passing completely through either of the bones.

[0201] The first bone engaging plate 102 is wrapped partially around a first metatarsal 10 and a second bone engaging plate 104 is wrapped partially around a second metatarsal 12. An intermediate tether 106 couples the first bone engaging plate 102 to the second bone engaging plate 104. In such an arrangement, when the implant is engaged to the first and second bones 10, 12, the intermediate portion 106 is positioned substantially between the bones 10, 12 without passing through the bones 10, 12. Further, no portion of the implant, including any associated bone anchors, passes completely through either of the bones 10, 12.

[0196]

[0202] The tether 106 may couple to the bone engaging plates 102, 104 at medial and lateral coupling points on the plates 102, 104, respectively. In some embodiments, the bone engaging plates 102, 104 may include holes through which the tether 106 may pass. The tether 106 may couple with / to the bone engaging plates 102, 104 by passing through a hole of the first plate 102 and a hole of the second plate 104. For example, in one embodiment, the tether 106 is passed through the holes of the plates 102, 104, and the tether 106 comprises a continuous loop (for example, the ends of the tether 106 may be tied to one another or otherwise attached to one another. In other embodiments, the tether 106 may attach to the coupling points on the bone engaging plates 102, 104 through the holes by an arrangement such as a knot, a cow hitch, via an adhesive, by welding, mechanical interlock, or by any other suitable arrangement.

[0197]

[0203] In some embodiments, when the implant is engaged to the two metatarsals, the coupling portion of the first bone engaging plates 102 is positioned near or substantially aligned with the horizontal plane that bisects the first metatarsal through the lateral and medial aspects of the metatarsal. Similarly, the coupling portion of the second bone engaging plate 104 may be positioned near or substantially aligned with a horizontal plane that bisects the second metatarsal through the lateral and medial aspects of the metatarsal. In some embodiments, when the implant is engaged to the two metatarsals, the intermediate portion is positioned near or substantially along the horizontal plane that bisects one of the metatarsals through the lateral and medial aspects of the metatarsal. In some embodiments, the intermediate portion 200, which may serve as or include a tether 106 (such as a cable or wire), the intermediate portion is only in tension and positioned substantially between the bones engaged by the device.

[0198]

[0204] As discussed previously, a tether 106 may permit the metatarsals that are engaged by the implant to move relative to one another after the implant has been implanted. The tether 106 may permit translation and / or rotation of the bone engaging plates 102, 104 relative to one another. For example, implant may move the second metatarsal 12 slightly downwardly relative to the first metatarsal 10, and / or move the first metatarsal 10 laterally toward the second metatarsal 12.

[0199]

[0205] The Applicant has recognized that one common failure mode for some bone anchors (such as bone screws) is due to shear loads, and that arranging bone anchors to bear loads in tension may help to decrease the occurrence of such failure modes. The Applicant has also recognized that arranging bone anchors to be placed in the body in a position and orientation that is the most easily accessible to a medical practitioner may help to decrease procedure time and risks of complications. The Applicant has appreciated that arranging bone anchors to bear loads in tension may result in the bone anchors being positioned and / or oriented in a manner that is not easily accessible to a medical practitioner. As such, the Applicant has appreciated the need for a balance between these two considerations. According to one aspect, bone anchors used to attach the implant to the metatarsals are angled in a manner that decreases shear loads on the bone anchors, while simultaneously being accessible by a medical practitioner.

[0200]

[0206] According to certain aspects, a surgical procedure is used to deploy the implant. In some embodiments, when treating a patient with hallux valgus, a standard medial approach for hallux valgus repair may be employed. During the procedure, the surgeon may perform a complete lateral release either through a separate distal approach or through the medial incision. A small incision may be placed just lateral to the second metatarsal, thereby exposing the metatarsal. A fascial elevator may be inserted from the medial aspect of the first metatarsal just proximal to the metaphysis, extending to the lateral aspect of the second metatarsal. As a result, the soft tissue may be elevated to form an envelope. The surgeon may then choose an appropriately sized implant based on the patient's anatomical characteristics. The implant may be inserted into the space provided by the fascial elevator, and may be placed around the second metatarsal. The first metatarsal may then be manually reduced, and the implant may be secured to the first metatarsal with locking or non-locking bone screws or other suitable bone engaging feature. Bone screws or other hardware may be drilled just through the cortex of the bone to a depth of about 1 mm, without fully penetrating through the entire bone. As In one embodiment, bone screws or other hardware may be inserted though bone anchor holes 16. An additional screw may be secured dorsally into the second metatarsal. As illustrated in FIG. 25, in one embodiment, the additional screw may be inserted through dorsal bone anchor hole 26. In some embodiments, treatment of tailor’s bunion may employ a similar procedure. Of course, it should be appreciated that the present invention is not limited in this respect and other suitable procedures may be employed.

[0207] FIGS. 28-37 illustrate another system 200 that is substantially similar to the system 200 of FIGS. 2-27, and therefore like reference numerals proceeded by the numeral “2” (or “3) are used to indicate like features or aspects, and the description with respect thereto equally applies to system 200 of FIGS. 28-37 and is not repeated herein for brevity.

[0201]

[0208] The flexible tether member 206 may be coupled to the at least one of the first and second bunion implant plates 202, 204 in any manner or by any mechanism. For example, as shown in FIGS. 28-37, the system 200 may include at least one fitting 209 that is configured to couple to the flexible tether member 206 and one of the first and second bunion implant plates 202, 204. The fitting 209 may be configured to rigidly couple or affix to an end portion or an intermediate portion of the flexible tether member 206. The fitting 209 may extend through a portion of one of the first and second bunion implant plates 202, 204 and rigidly couple or affix thereto. For example, as shown in FIGS. 28-37, the at least one fitting 209 may include a shaft portion with an aperture extending therein or therethrough configured to accept the flexible tether member 206 therein. The shaft portion of the fitting 209 may be crimped or compressed onto the flexible tether member 206 positioned therein to rigidly couple the flexible tether member 206 and the fitting 209. The at least one fitting 209 may be rigidly coupled to the first and second bunion implant plates 202, 204, such as to the inner portions thereof, via any mechanism or configuration. For example, the at least one fitting 209 may extend through an aperture in a portion of the first or second bunion implant plates 202, 204, and may be rigidly coupled within the aperture via any means or mechanism. For example, in some embodiments the fitting 209 may be welded to the aperture (i.e., to the portion of the first or second bunion implant plates 202, 204 proximate to the aperture). In some embodiments, as shown in FIGS. 28-37, the at least one fitting 209 may (or may not) include a rim portion that defines a larger cross-section than the shaft portion and the smallest portion of the aperture. The rim portion of the fitting 209 may thereby prevent the fitting 209 from passing through the aperture of the first and second bunion implant plates 202, 204. In one embodiment, the rim portion (and / or the shaft portion) may be welded to the aperture (i.e., to the portion of the first or second bunion implant plates 202, 204 proximate to the aperture). The aperture of the first or second bunion implant plate 202, 204 may be straight (e.g., cylindrical) or stepped.

[0202]

[0209] As yet another example (not shown), the fitting 209 may be spherical or rounded and may be positioned within a recess or groove formed into the engagement surface or inner side of the first or second bunion implant plate 202, 204. The groove may cooperate with an aperture that allows the flexible tether member 206 to extend therein from the exterior side or surface of the first or second bunion implant plate 202, 204. The flexible tether member 206 may be crimped or otherwise rigidly coupled to the spherical or rounded fitting 209, and the fitting 209 may be able to freely rotate and pivot within the recess in the first or second bunion implant plate 202, 204. In this way, the flexible tether member 206 and the fitting 209 are able to both rotate within the recess during relative movement between the first and second bunion implant plates 202, 204, which may reduce bending forces on the flexible tether member 206. However, the rigid connections between the flexible tether member 206 and one of the first and second bunion implant plates 202, 204 disclosed herein are only exemplary, and any other arrangement or configuration that effectively rigidly couples the flexible tether member 206 and the one of the first and second bunion implant plates 202, 204 (such that the respective first or second bunion implant plate 202, 204 is unable to slide along the flexible tether member 206), may be utilized.

[0203]

[0210] As shown in FIGS. 28-37 , the second outer side at the second medial portion 216 of the first bunion implant 202 plate comprises a dorsal-plantar extending rib portion that defines a thickness between the first outer and inner sides that is greater than at thicknesses of portions of the first medial portion that are adjacent to the rib portion. The rib portion is substantially aligned medially-laterally between the openings.

[0204]

[0211] As shown in FIGS. 28-37 , the system 200 is configured such that the such that the portions of the tether 206 extending between the first and second bunion implant plates 202, 204 converge as they extend from the first bunion implant plate 202 to the second bunion implant plate 204.

[0205]

[0212] As shown in FIGS. 28-37 , the system 200 is configured such that the tether 206 comprises a metal cable.

[0206]

[0213] FIG. 38 illustrates another bunion correction system 300 that is substantially similar to the bunion correction system 100 of FIGS. 2-27 and the bunion correction system 200 of FIGS. 28-37, and therefore like reference numerals proceeded by the numeral “3” are used to indicate like features or aspects, and the description with respect thereto equally applies to system 300 of FIG. 38 and is not repeated herein for brevity.

[0207]

[0214] As shown in FIG. 38, the bunion correction system 300 includes a braided polymer suture tether 306, as opposed to a stainless steel or other metal type tether for example. The braided polymer suture tether 30 may be comprised on a surgical suture made by multiple filaments or fibers of a polymer material woven or twisted together into a braided structure. In some examples, the filaments or fibers may be made from polyglactin (e.g., polyglactin 910), poly glycolic acid, polyester, polydioxanone (PDO) or a combination thereof. In some embodiments of the braided polymer suture tether 30, it is coated with one or more substance (e.g., calcium stearate, polycaprolactone, or waxes) to reduce tissue drag and improve knot tying / securement. The braided polymer suture tether 30 nay provide improved handling, knot security, flexibility / pliability and / or strength as compared to metallic and / or monofilament tethers. In some other embodiments, the tether 306 may be a monofilament polymer tether.

[0208]

[0215] FIGS. 39-56 illustrate another bunion correction system 400 that is substantially similar to the bunion correction system 100 of FIGS. 2-27, the bunion correction system 200 of FIGS. 28-37, and the bunion correction system 300 of FIG. 38, therefore like reference numerals proceeded by the numeral “4” are used to indicate like features or aspects, and the description with respect thereto equally applies to system 400 of FIGS. 39-56 and is not repeated herein for brevity.

[0209]

[0216] As shown in FIGS. 39-56, the bunion correction system 400 is configured such that the second medial portion 422 of the second bunion implant 404 defines a secondary passageway extending between proximally-distally spaced secondary openings. As shown, the passageway component 411 extends within the second passageway 408. Specifically, as shown in FIGS. 39-56, the passageway component 411 is an arcuate tube member with ends that arcuately flare outwardly. The arcuate tube member 411 is configured as an insert that is positioned or resides within a recess or passageway 408 extending in the interior side of the inner portion or medial portion 422 of the second implant 404. The recess or passageway 408 incudes two openings or apertures that are open to the exterior side of the inner portion or medial portion 422, and the flared ends of the arcuate tube member 411 are seated therein (and this are aligned therein or therewith). In some embodiments, the arcuate tube member 411 may be flexible, soft and / or malleable.

[0210]

[0217] As also shown in FIGS. 39-56, the thicknesses of the first and / or second bunion implants 402, 404 are of a substantially similar (or the same) thickness.

[0211]

[0218] FIGS. 57-73 illustrate another bunion correction system 500 that is substantially similar to the bunion correction system 100 of FIGS. 2-27, the bunion correction system 200 of FIGS. 28-37, the bunion correction system 300 of FIG. 38, and the bunion correction system 400 of FIGS. 39-56, and therefore like reference numerals proceeded by the numeral “5” are used to indicate like features or aspects, and the description with respect thereto equally applies to system 500 of FIGS. 39-56 and is not repeated herein for brevity.

[0212]

[0219] It is noted that bunion correction system 500 is particularly substantially similar to the bunion correction system 100 of FIGS. 2-27. As shown in FIG. 57-73, the lateral portion 516 of the first implant plate 502 includes a second insert member 510 mated (e.g., removably) within a second insert opening 540, which couples the medial portion of the tether 506 and the lateral portion 516 of the first implant plate 502 together. The insert member 510 may be a machined one-piece (integral) component. The insert member 510 comprises a smooth curved surface passageway defining a smooth large radii extending between the pair of proximally-distally spaced openings extending medially-laterally though the second insert member 510 from the lateral side thereof. The insert member 510 provides a smooth passageway surface for the tether 506 to extend through, as shown in FIG. 57-73. The proximally-distally spaced openings comprise smooth flared entrance edges at the lateral side of the second insert member 510, and the second insert member 510 comprises additional smooth curved internal surfaces.

[0213]

[0220] As described above, the second insert member 510 is stepped such that a medial interior / back side portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of the lateral front side portion thereof, as shown in FIG. 57-73. The second insert opening 540 is a correspondingly stepped opening such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof, as shown. In this way, the second insert member 510 is seated within the second insert opening 540, but is unable to translate laterally through the second insert opening 540 (but the lateral side of the second insert member 510 is exposed at the lateral side of the second insert opening 540 / first implant plate 502.

[0214]

[0221] As shown in FIG. 57-73, the second insert opening 540 and the first lateral portion 516 of the first bunion implant plate 502 are configured such that at least a portion of the interior side of the second insert member 510 is laterally spaced from the inner side of the first lateral portion 516 when mated therein (and the entirety of the interior side of the second insert member 510 does not extend medially past the inner side of the first lateral portion 516 when mated therein).

[0215]

[0222] As also shown in FIG. 57-73, the interior side of the second insert member 510 comprises a medially-extending connection recess 532 positioned (proximally-distally) between the pair of proximally-distally spaced openings. In some embodiments, the connection recess 532 may comprise smooth arcuate surfaces, such as a general arcuately concave recess extending laterally into the interior side of the second insert member 510. The tether 506 comprises a connection portion 530 where end portions of the tether 506 are coupled together. The tether 506 may be configured such that the connection portion 530 forms the tether 506 into a continuous closed loop. In some embodiments, the first connection portion 530 may comprise a knot (such as, but not limited to, a surgical know or otherwise fixed / non-slipping knot) or interweaving or twisting of the tether 506 that knots or weaves the end portions of the tether 506 together, as shown in FIG. 57-73. In some other embodiments, the first connection portion 530 comprises a connector member that mechanically couples the end portions of the tether 506 together.

[0216]

[0223] The connection recess 532 and the system 500 are configured such that the connection portion 530 of the tether 506 is positioned within the connection recess 532, as shown in FIG. 57-73. The second insert opening 540 / the first lateral portion 516 of the first bunion implant plate 502, the second insert member 510 (e.g., the connection recess 532 and / or the thickness thereof) and the tether 506 are configured such that the interior side of the second insert member 510 and the first connection portion 530 of the tether 506 are laterally spaced from the inner / interior side of the first lateral portion 516 when the second insert member 510 is mated within the second insert opening 540 and the connection portion 530 is mated / resides within the connection recess 532, as shown in FIG. 57-73.

[0217]

[0224] In some embodiments, the tether 506 is inserted and looped through the first and second insert 508, 510 on each plate implant 502, 504, and then tied together (e.g., with a surgical knot) to form the first connection portion 530. The end portions of the tether 506 may alternatively be braided or interwoven together back on itself, or crimped or coupled together via a coupling member or device to form the connection portion 530. The tether 506 may be a flexible component that is of sufficient flexibility that it can be knotted, for example. The connection recess 532 is configured to provide space for / accommodate the connection portion 530. The connection portion 530 may be incorporated into each of the first and second insert 508, 510, or only the second insert 510.

[0218]

[0225] As shown in FIGS. 70-73, the thickness of the implant plates 502, 504 may vary along the plate curvature. For example, the top / medial (dorsal) portions 514, 5244, which may be the highest stress region, may be the thickness portions of the implant plates 502, 504. The medial end portions 512, 522 and lateral end portions 516, 526 may thereby be thinner portions of the implant plates 502, 504. However, the variable thickness is not a requirement.

[0219]

[0226] As noted above and shown in FIGS. 70-73, the outer edges of the implant plates 502, 504 may include a taper or bevel (or chamfer) leading to a radiused edge (arcuately convex) for a gradual transition leading to the thickness sides or dimensions of the implant plates 502, 504. Further, the notches extending from a dorsal side of the flexible wing portions of the lateral end portion 526 of the second implant plate 504 provide additional flexibility of the second implant plate 504. It is also noted that the implant plates 502, 504 are curved or flared medially-laterally as the extend in the proximal -distal directions to achieve an anatomical fit with first and second metatarsal bones for example.

[0220]

[0227] According to one aspect, any implant disclosed herein may be positioned on the dorsal side of a bone, such as a metatarsal bone. Alternatively, any implant may be positioned on the ventral side of a bone. Positioning of implants on the dorsal side of the metatarsals may be preferred due to improved patient comfort and less interference with daily activities. In addition, deployment of an implant on the dorsal side of the metatarsals may require a less invasive surgical procedure.

[0221]

[0228] According to one aspect, depending on the extent of the deformity (e.g. large intermetatarsal angle), an implant disclosed herein may be used as an adjunctive device in combination with an additional surgical procedure. Surgical procedures include wedge osteotomy, transpositional osteotomy, fusionjoint replacement, or other suitable surgical procedure, as this aspect is not limited in this regard.

[0222]

[0229] In some embodiments, an implant disclosed herein may remain permanently within the body. In some cases, the implant may be replaced after a certain amount of time. In others, the implant may be bioabsorbable or may be removed after a certain amount of time.

[0223]

[0230] In some embodiments, the implant (as a whole) and components thereof (e.g., the first implant / plate, the second implant / plate, tether, insert(s) and screws, for example) disclosed herein may be constructed of any biocompatible material such as a metal (e.g., titanium, stainless steel, nickel, nickel titanium alloy, nitinol or other shape-memory alloy, silver or gold), a plastic or polymer (e.g., a biologically resorbable or absorbable polymer), a ceramic, a combination thereof, or other suitable material(s). In some embodiments, at least the portions of the first implant / plate and the second implant / plate that contact or engage with a bone (e.g., a metatarsal bone), and / or the screws or other fixation members utilized to affix the first implant / plate and the second implant / plate to a bone, may be configured for bone integration or ingrowth therein. For example, the first implant / plate, the second implant / plate that and / or the fixation members may include a porous bone engagement surface portion or coating / layer that comprises open cavities or apertures (that are open to the exterior surface) configured to allow bone integration and / growth therein.

[0224]

[0231] In some embodiments, the material of the implant and components thereof may be substantially rigid, as opposed to elastic. In other embodiments, the of the implant and components thereof (such as of the tether and / or implants / plates) may be elastic. In some cases, the material of the implant and components thereof may be substantially deformable by hand.

[0232] According to one aspect, an implant disclosed herein may be formed using any suitable process. The implants may be stamped out of sheet metal or cast from metal and curved at each end by a plate bender or other suitable tool. In some embodiments, the first and second plates of the implant may be formed from a plate or strip of material that is about 0.7 to about 1.2 millimeters thick and about 5 to about 15 millimeters wide. In some other embodiments, the implants (e.g., the first and second implants / plates) are shaped and sized to correspond to particular bones / bone portions of a particular patient. In some such embodiments, the implants (e.g., the first and second implants / plates) may be additively manufactured, such as being 3D printed, such as based on / utilizing imagining of particular bones / bone portions of a particular patient. In some embodiments, any suitable finishing and / or sterilization processes may be applied to the implants or components thereof.

[0225]

[0233] According to one aspect, an implant disclosed herein may have permanent discrete lengths, widths and / or thicknesses. In some embodiments, a range of implants of different sizes may be provided in a kit. For example, in one embodiment, the kit may include a range of five discretely sized implants or implant systems: the first may be suitable for very small patients, the second may be suitable for patients who are somewhat smaller than average, the third may be suitable for average-sized patients, and so on, where the size range of implants or implant systems is scaled (e.g., linearly). In some embodiments, the first bunion implant plate 102 may have a length of about 32 mm, the second may have a length of about 34 mm, the third implant may have a length of about 36 mm, the fourth implant may have a length of about 38 mm, and the fifth implant may have a length of about 40 mm, for example. In some embodiments, kits may be designed to suit a specific gender, age, and / or severity of deformity. For example, kits for pediatric applications may include smaller implants than kits for adult applications. In some embodiments, kits may also include instruments used to adjust the implants, such as a plate bender. Of course, it should be appreciated that the present disclosure is not limited in this respect and other suitable kits may be employed. For example, the kits may include any number of implants at any range of sizes. In another embodiment, each discretely-sized implant may be provided individually rather than in a collective kit.

[0226]

[0234] The above aspects may be employed in any suitable combination, as the present disclosure is not limited in this respect. Also, any or all of the above aspects may be employed in an implant; however, the present disclosure is not limited in this respect, as the above aspects may be employed with other medical devices.

[0235] Also, as described herein, the implants disclosed herein may be used for correction of hallux valgus or tailor’s bunion. However, embodiments are not limited to use for correction of hallux valgus, tailor’s bunion, or deformities of the foot bones. According to some aspects, the implants and systems may be used in other locations of the body, for example, with the metacarpals of the hand, the radius and ulna of the arm, or the fibula and tibia of the leg, etc., as aspects are not limited in this regard. In addition, while some embodiments disclosed herein may discuss use of a surgical implant with a human subject, the surgical implant may be used in non-human subjects as well, as the invention is not limited in this regard.

[0227]

[0236] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of an invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”), “contain” (and any form contain, such as “contains” and “containing”), and any other grammatical variant thereof, are open-ended linking verbs. As a result, a method or article that “comprises”, “has”, “includes” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of an article that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features.

[0228]

[0237] As used herein, the terms “comprising,” "has," “including,” "containing," and other grammatical variants thereof encompass the terms “consisting of’ and “consisting essentially of.”

[0229]

[0238] The phrase “consisting essentially of’ or grammatical variants thereof when / if used herein are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof but only if the additional features, integers, steps, components or groups thereof do not materially alter the basic and novel characteristics of the claimed compositions or methods.

[0230]

[0239] Any publication cited in this specification are herein incorporated by reference as if each individual publication were specifically and individually indicated to be incorporated by reference herein as though fully set forth. Any subject matter incorporated by reference is not considered to be an alternative to any claim limitations, unless otherwise explicitly indicated.

[0231]

[0240] Where one or more ranges are referred to throughout this specification, each range is intended to be a shorthand format for presenting information, where the range is understood to encompass each discrete point within the range as if the same were fully set forth herein.

[0232]

[0241] While several aspects and embodiments of the present disclosure have been described and depicted herein, alternative aspects and embodiments may be affected by those skilled in the art to accomplish the same objectives. Accordingly, this disclosure and the appended claims are intended to cover all such further and alternative aspects and embodiments as fall within the true spirit and scope of inventions of the present disclosure.

[0233]

[0242] It is to be understood that the above description is intended to be illustrative, and not restrictive. Numerous changes and modifications may be made herein by one of ordinary skill in the art without departing from the general spirit and scope of the invention as defined by the following claims and the equivalents thereof. For example, the above-described embodiments (and / or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the various embodiments without departing from their scope. While the dimensions and types of materials described herein are intended to define the parameters of the various embodiments, they are by no means limiting and are merely exemplary. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the various embodiments should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0234] Also, the term “operably connected” is used herein to refer to both connections resulting from separate, distinct components being directly or indirectly coupled and components being integrally formed (i.e., monolithic). Further, the limitations of the following claims are not written in means-plus-function format and are not intended to be interpreted based on 35 U.S.C. § 112, sixth paragraph, unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure. It is to be understood that not necessarily all such objects or advantages described above may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the systems and techniques described herein may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein.

[0235]

[0243] While the invention has been described in detail in connection with only a limited number of embodiments, it should be readily understood that the invention is not limited to such disclosed embodiments. Rather, the invention can be modified to incorporate any number of variations, alterations, substitutions or equivalent arrangements not heretofore described, but which are commensurate with the spirit and scope of the invention. Additionally, while various embodiments of the invention have been described, it is to be understood that aspects of the disclosure may include only some of the described embodiments. Accordingly, the invention is not to be seen as limited by the foregoing description, but is only limited by the scope of the appended claims.

[0236]

[0244] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.

Claims

CLAIMSWhat is claimed is:

1. An implant system for correcting a bunion, the implant system comprising: a first bunion implant plate comprising a first medial portion, a first dorsal portion and a first lateral portion that cooperatively form a first outer side and a concave first bone engagement inner side that is configured to couple over a medial side, a dorsal side and a lateral side, respectively, of a first respective metatarsal bone; a second bunion implant plate comprising a second medial portion, a second dorsal portion and a second lateral portion that cooperatively form a second outer side and a concave second bone engagement inner side that is configured to couple over a medial side, a dorsal side and a lateral side, respectively, of a second respective metatarsal bone; and a flexible tether extending between the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate that allows motion between the first and second bunion implant plates but prevents relative movement of the first and second bunion implant plates away from each other such that a maximum distance therebetween is maintained.

2. The implant system of claim 1, wherein the first respective metatarsal bone is a first metatarsal bone or a second metatarsal bone, and the second respective metatarsal bone is the other of the first metatarsal bone or the second metatarsal bone.

3. The implant system of claim 1, wherein the first respective metatarsal bone is a first metatarsal bone, and the second respective metatarsal bone is a second metatarsal bone.

4. The implant system of claim 1, wherein the first bone engagement inner side is anatomically shaped such that it corresponds to the shape of a corresponding outer surface portion of the first respective metatarsal bone.

5. The implant system of claim 4, wherein the second bone engagement inner side is anatomically shaped such that it corresponds to the shape of a corresponding outer surface portion of the second respective metatarsal bone.

6. The implant system of claim 1, wherein the length of the flexible tether extending between the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate is configured to decrease an intermetatarsal angle formed between the first and second respective metatarsal bones and prevent the intermetatarsal angle from increasing above a maximum intermetatarsal angle.

7. The implant system of claim 1, wherein the first bone engagement inner side is concave in the dorsal-plantar direction as it extends in the medial-lateral direction, and wherein the second bone engagement inner side is concave in the dorsal -plantar direction as it extends in the medial-lateral direction.

8. The implant system of claim 1, wherein the first bone engagement inner side defines a first maximum width in the medial-lateral direction between the first medial and lateral portions, and the second bone engagement inner side defines a second maximum width in the medial-lateral direction between the second medial and lateral portions that is less than the first maximum width.

9. The implant system of claim 8, wherein the first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof at a distal side of the first bunion implant plate that is larger than at a proximal side of the first bunion implant plate.

10. The implant system of claim 1, wherein the first bone engagement inner side tapers inwardly in width in the medial-lateral direction between the first medial and lateral portions as it extends in a proximal-to-distal direction.

11. The implant system of claim 1, wherein the first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereof that tapers inwardly as it extends distally from proximal sides of the first medial and lateral portions to an intermediate portion of the first bone engagement inner side in the proximal- distal direction.

12. The implant system of claim 11, wherein the first bone engagement inner side defines a width in the medial-lateral direction between the first medial and lateral portions thereofthat tapers inwardly as it extends proximally from distal sides of the first medial and lateral portions to the intermediate portion of the first bone engagement inner side in the proximal- distal direction.

13. The implant system of claim 12, wherein the first medial portion of the first bunion implant plate extends further in the plantar direction than the first lateral portion of the first bunion implant plate.

14. The implant system of claim 1, wherein at least a tip portion of the first bone engagement inner side defined by the first medial portion of the first bunion implant plate extends medially and dorsally.

15. The implant system of claim 14, wherein at least a tip portion of the first bone engagement inner side defined by the first lateral portion of the first bunion implant plate extends laterally and dorsally.

16. The implant system of claim 1, wherein at least a tip portion of the first bone engagement inner side defined by the first medial portion of the first bunion implant plate is medially-laterally convex along the proximal -distal direction.

17. The implant system of claim 16, wherein at least a tip portion of the first bone engagement inner side defined by the first lateral portion of the first bunion implant plate is medially-laterally convex along the proximal -distal direction.

18. The implant system of claim 1, wherein a portion of the first bone engagement inner side defined by the dorsal portion of the first bunion implant plate extends dorsally as it extends distally.

19. The implant system of claim 1, wherein the second lateral portion of the second bunion implant plate comprises a pair of proximal and distal wing portions that extend proximally and distally, respectively, from a middle portion of the second lateral portion past proximal and distal sides of the middle portion and of the second dorsal portion.

20. The implant system of claim 19, wherein the proximal and distal wing portions comprise notches adjacent to the middle portion.

21. The implant system of claim 20, wherein the notches extend from a dorsal side of the proximal and distal wing portions toward a plantar side of the proximal and distal wing portions.

22. The implant system of claim 21, wherein portions of the first bone engagement inner side defined by the proximal and distal wing portions extend laterally as they extend medially and laterally, respectively, from the middle portion.

23. The implant system of claim 22, wherein the portions of the first bone engagement inner side defined by the proximal and distal wing portions are curved laterally as they extend proximally and distally, respectively, from the middle portion to proximal and distal tip portions, respectively, thereof.

24. The implant system claim 19, wherein a portion of the first bone engagement inner side defined by the middle portion and the proximal and distal wing portions is medially- laterally convex along the proximal -distal direction.

25. The implant system of claim 1, wherein the second dorsal portion of the second bunion implant plate comprises a pair apertures extending from the second outer side to the second bone engagement inner side that are proximally-distally spaced.

26. The implant system of claim 25, wherein the pair of apertures are substantially aligned with each other in the medial-lateral direction.

27. The implant system of claim 26, wherein the pair of apertures are angled in a medial- to-lateral direction as they extend from the second outer side to the second bone engagement inner side.

28. The implant system of claim 27, wherein the pair of apertures are substantially aligned in the proximal-distal direction with a pair of openings of a passageway at the second medial portion through which the tether passes.

29. The implant system of claim 28, wherein the pair of apertures comprise a countersink at the second outer side.

30. The implant system of claim 1, wherein the first dorsal portion of the first bunion implant plate comprises a plurality of apertures extending from the first outer side to the first bone engagement inner side, the plurality of apertures comprising at least one of a pair of proximally-distally spaced apertures and a pair of medially-laterally spaced apertures.

31. The implant system of claim 30, wherein the dorsal portion of the first bunion implant plate comprises the pair of medially-laterally spaced apertures and the pair of proximally- distally spaced apertures.

32. The implant system of claim 31, wherein the pair of proximally-distally spaced apertures are substantially aligned with each other in the medial-lateral direction.

33. The implant system of claim 32, wherein the pair of proximally-distally spaced apertures are substantially aligned in the proximal -distal direction with a pair of openings of a passageway at the second medial portion through which the tether passes.

34. The implant system of claim 33, wherein the plurality of apertures comprise the pair of proximally-distally spaced apertures, and wherein the pair of proximally-distally spaced apertures are angled medially as they extends from the first outer side to the first bone engagement inner side.

35. The implant system of claim 34, wherein the plurality of apertures comprise the pair of medially-laterally spaced apertures, and wherein a medial aperture of the medially-laterally spaced apertures is angled laterally as extends from the first outer side to the first bone engagement inner side, and a lateral aperture of the medially-laterally spaced apertures is angled medially as extends from the first outer side to the first bone engagement inner side.

36. The implant system of claim 35, wherein the plurality of apertures comprise a countersink at the first outer side.

37. The implant system of claim 1, wherein the first medial portion, the first dorsal portion and the first lateral portion of the first bunion implant plate are integral, and wherein the second medial portion, the second dorsal portion and the second lateral portion of the second bunion implant plate are integral.

38. The implant system of claim 1, wherein at least one of the first bunion implant plate and the second bunion implant plate is an additively manufactured implant plate.

39. The implant system of claim 1, wherein the first lateral portion of the first bunion implant plate comprises a first passageway through which the tether passes.

40. The implant system of claim 39, wherein the first passageway extends between proximally-distally spaced openings that face laterally, wherein the first passageway extends in a medial-lateral and proximal -distal arcuate pathway between the proximally-distally spaced openings, and wherein the first passageway comprises substantially smooth internal surfaces.

41. The implant system of claim 40, wherein the edges of the openings are arcuately convex.

42. The implant system of claim 40, wherein the openings are positioned at the lateral- most portion of the first bunion implant plate.

43. The implant system of any of claims 40, wherein the first outer side at the first lateral portion of the first bunion implant plate comprises at least one laterally-extending boss that extends about both of the openings or each of the openings.

44. The implant system of claim 43, wherein a thickness of the first bunion implant plate between the first outer and inner sides at the at least one laterally-extending boss is greater than at a thickness of the first bunion implant plate between the first outer and inner sides at at least one of the first medial portion spaced from the at least one boss, the first dorsal portion and the first lateral portion.

45. The implant system of claim 44, wherein the first outer side at the first lateral portion of the first bunion implant plate comprises a dorsally-plantarly extending rib portion that defines a thickness between the first outer and inner sides that is greater than at thicknesses of portions of the first medial portion that are adjacent to the rib portion.

46. The implant system of claim 45, wherein the rib portion is substantially aligned medially-laterally between the openings.

47. The implant system of claim 39, wherein the first passageway is defined by the second medial portion of the second bunion implant plate.

48. The implant system of claim 39, wherein the first passageway is defined by a first passageway component that is separate and distinct from first bunion implant plate.

49. The implant system of claim 48, wherein the first lateral portion of the first bunion implant plate defines the passageway extending between proximally-distally spaced openings, and wherein the first passageway component extends within the passageway.

50. The implant system of claim 49, wherein the first passageway component is a tube member with ends that arcuately flare outwardly.

51. The implant system of claim 50, wherein the first passageway of the first passageway component is exposed at the first bone engagement inner side of the first bunion implant plate.

52. The implant system of claims 48, wherein the first passageway component is a first insert component that is mated with the first lateral portion of the first bunion implant plate.

53. The implant system of claim 52, wherein the first insert component is a machined component.

54. The implant system of claim 52, wherein the first lateral portion of the first bunion implant plate comprises a first insert aperture, and wherein the first insert member extends within the first insert aperture.

55. The implant system of claim 54, wherein the first insert member is a stepped insert such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof.

56. The implant system of claim 55, wherein the first insert opening is a stepped opening such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof.

57. The implant system of claim 56, wherein the first insert opening extends medially- laterally past the openings and dorsally-plantarly the openings.

58. The implant system of claim 54, wherein the flexible tether extends in a loop through the first passageway.

59. The implant system of claim 1, wherein the second medial portion of the second bunion implant plate comprises a second passageway through which the tether passes.

60. The implant system of claim 59, wherein the second passageway extends between proximally-distally spaced openings that face medially, wherein the second passageway extends in a medial-lateral and proximal -distal arcuate pathway between the proximally- distally spaced openings, and wherein the second passageway comprises substantially smooth internal surfaces.

61. The implant system of claim 60, wherein the edges of the openings are arcuately convex.

62. The implant system of claim 60, wherein the openings are positioned at the medial- most portion of the second bunion implant plate.

63. The implant system of any of claims 60, wherein the second outer side at the second medial portion of the second bunion implant plate comprises at least one medially-extending boss that extends about both of the openings or each of the openings.

64. The implant system of claim 63, wherein a thickness of the second bunion implant plate between the second outer and inner sides at the at least one medially-extending boss is greater than at a thickness of the second bunion implant plate between the second outer and inner sides at at least one of the second medial portion spaced from the at least one boss, the second dorsal portion and the second lateral portion.

65. The implant system of claim 64, wherein the second outer side at the second medial portion of the second bunion implant plate comprises a dorsally-plantarly extending rib portion that defines a thickness between the second outer and inner sides that is greater than at thicknesses of portions of the second medial portion that are adjacent to the rib portion.

66. The implant system of claim 65, wherein the rib portion is substantially aligned medially-laterally between the openings.

67. The implant system of claim 60, wherein the second passageway is defined by the second medial portion of the second bunion implant plate.

68. The implant system of claim 60, wherein the second passageway is defined by a second passageway component that is separate and distinct from second bunion implant plate.

69. The implant system of claim 68, wherein the second medial portion of the second bunion implant plate defines a secondary passageway extending between proximally-distally spaced openings, and wherein the second passageway component extends within the second passageway.

70. The implant system of claim 69, wherein the second passageway component is a tube member with ends that arcuately flare outwardly.

71. The implant system of claim 70, wherein the second passageway of the second passageway component is exposed at the second bone engagement inner side of the second bunion implant plate.

72. The implant system of claims 68, wherein the second passageway component is a second insert component that is mated with the second medial portion of the second bunion implant plate.

73. The implant system of claim 72, wherein the second insert component is a machined component.

74. The implant system of claim 72, wherein the second medial portion of the second bunion implant plate comprises a second insert aperture, and wherein the second insert member extends within the second insert aperture.

75. The implant system of claim 74, wherein the second insert member is a stepped insert such that a lateral back portion thereof defines a medial-lateral and / or dorsal-plantar size that is greater than that of a medial front portion thereof.

76. The implant system of claim 75, wherein the second insert opening is a stepped opening such that a lateral back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a medial front portion thereof.

77. The implant system of claim 76, wherein the second insert opening extends medially- laterally past the openings and dorsally-plantarly the openings.

78. The implant system of claim 74, wherein the flexible tether extends in a loop through the second passageway.

79. The implant system of claim 1, wherein end portions of the flexible tether are fixedly coupled within the respective tether apertures of the first lateral portion of the first bunion implant plate and / or respective tether apertures of the second medial portion of the second bunion implant plate and / or via respective fittings.

80. The implant system of claim 79, wherein the fittings are crimped to the end portions of the flexible tether and received within the respective tether apertures.

81. The implant system of claim 80, wherein the end portions of the flexible tether are fixedly coupled within cavities of the fittings, and wherein opening portions of the cavities of the fittings are radially outwardly, arcuately convex.

82. The implant system of claim 81, wherein an outer side of the first lateral portion of the first bunion implant plate and / or an outer side of the second medial portion of the second bunion implant plate comprises medially-extending bosses in which tether apertures are formed.

83. The implant system of claim 1, the flexible tether is looped through at least one of a passageway at the first lateral portion of the first bunion implant and a passageway at the second medial portion of the second bunion implant.

84. The implant system of claim 1, the flexible tether is freely slidably looped through at least one of a passageway at the first lateral portion of the first bunion implant and a passageway at the second medial portion of the second bunion implant.

85. The implant system of claim 1, wherein the flexible tether is looped through a first passageway at the first lateral portion of the first bunion implant plate.

86. The implant system of claim 85, wherein end portions of the flexible tether are coupled together within the first passageway of the first lateral portion.

87. The implant system of claim 86, wherein the first passageway is defined by a first insert member mated within a first insert opening in the first lateral portion.

88. The implant system of claim 87, wherein the first second passageway comprises a pair of proximally -distally spaced openings extending medially-laterally though the first insert member.

89. The implant system of claim 88, wherein an interior side of the first insert member comprises a connection recess positioned between the pair of proximally-distally spaced openings.

90. The implant system of claim 89, wherein the first insert member and the first lateral portion of the first bunion implant plate are configured such that the interior side of the first insert member is laterally spaced from the first inner side of the first lateral portion when mated therein.

91. The implant system of claim 90, wherein the end portions of the tether are coupled together at a first connection portion that is positioned within the connection recess.

92. The implant system of claim 91, wherein the first connection portion comprises a knot of the tether that knots the end portions of the tether together.

93. The implant system of claim 92, wherein the first connection portion comprises a connector member that mechanically couples the end portions of the tether together.

94. The implant system of claim 92, wherein the first insert member, the first lateral portion of the first bunion implant plate and the tether are configured such that the interior side of the insert member and the first connection portion are laterally spaced from the first inner side of the first lateral portion when mated therein.

95. The implant system of claim 94, wherein the first insert member is a stepped insert such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof.

96. The implant system of claim 95, wherein the first insert opening is a stepped opening such that a medial back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a lateral front portion thereof.

97. The implant system of claim 1, wherein the flexible tether is looped through a second passageway at the second medial portion of the second bunion implant plate.

98. The implant system of claim 97, wherein end portions of the flexible tether are coupled together within the second passageway of the second medial portion.

99. The implant system of claim 98, wherein the second passageway is defined by a second insert member mated within a second insert opening in the second medial portion.

100. The implant system of claim 99, wherein the second passageway comprises a pair of proximally-distally spaced openings extending medially-laterally though the second insert member.

101. The implant system of claim 100, wherein an interior side of the second insert member comprises a connection recess positioned between the pair of proximally-distally spaced openings.

102. The implant system of claim 101, wherein the second insert member and the second medial portion of the second bunion implant plate are configured such that the interior side of the second insert member is medially spaced from the second inner side of the second medial portion when mated therein.

103. The implant system of claim 102, wherein the end portions of the tether are coupled together at a first connection portion that is positioned within the connection recess.

104. The implant system of claim 103, wherein the first connection portion comprises a knot of the tether that knots the end portions of the tether together.

105. The implant system of claim 104, wherein the first connection portion comprises a connector member that mechanically couples the end portions of the tether together.

106. The implant system of claim 104, wherein the second insert member, the second medial portion of the second bunion implant plate and the tether are configured such that the interior side of the second insert member and the first connection portion are laterally spaced from the second inner side of the second medial portion when mated therein.

107. The implant system of claim 106, wherein the second insert member is a stepped insert such that a lateral back portion thereof defines a medial-lateral and / or dorsal -plantar size that is greater than that of a medial front portion thereof.

108. The implant system of claim 107, wherein the second insert opening is a stepped opening such that a lateral back portion thereof defines a medial-lateral and / or dorsal-plantar size that is greater than that of a medial front portion thereof.

109. The implant system of claim 1, wherein the first and second bunion implant plates are configured such that the portions of the tether extending between the and second bunion implant plates converge as they extend from the first bunion implant plate to the second bunion implant plate.

110. The implant system of claim 1, wherein a thickness of the first bunion implant plate extending between the first outer surface and the first inner surface varies between at two of the first medial portion, the first dorsal portion and the first lateral portion.

111. The implant system of claim 1, wherein a thickness of the second bunion implant plate extending between the second outer surface and the second inner surface varies between at two of the second medial portion, the second dorsal portion and the second lateral portion.

112. The implant system of claim 1, wherein free ends of the first bunion implant plate comprises radiused edges, and free ends of the second bunion implant plate comprises radiused edges.

113. The implant system of claim 112, wherein the first bunion implant plate comprises tapered or sloped surfaces that are adjacent to the free ends and radiused edges thereof.

114. The implant system of claim 113, wherein the second bunion implant plate comprises tapered or sloped surfaces that are adjacent to the free ends and radiused edges thereof.

115. The implant system of claim 1, wherein the tether comprises a metal cable.

116. The implant system of claim 1, wherein the tether comprises braided or woven polymer suture tether.

117. The implant system of claim 1, wherein the tether comprises a biocompatible suture.

118. A bunion correction system, comprising: an implant system according to any one of claims 1-117; and a reduction clamp configured to reduce an intramedullary angle between the first and second respective metatarsal bones.

119. The system of claim 118, wherein the reduction clamp comprises a concave engagement cap configured to engage a medial side of the foot of the patient, and a bone and / or tissue engagement tip configured to engage a lateral side of another metatarsal bone of the foot of the patient.

120. The system of claim 119, wherein the bone and / or tissue engagement tip is a pointed tip.

121. The system of claim 120, wherein the reduction clamp comprises a first arm member and a second arm member rotationally coupled at a first pivot point, and wherein the concave engagement cap is positioned at a first end of the first arm, and the bone and / or tissue engagement tip is positioned at a first end of the second arm.

122. The system of claim 121, wherein the concave engagement cap is removably mated with the first end of the first arm.

123. The system of claim 122, wherein the first end of the first arm comprises a second pointed tip.

124. The system of claim 123, wherein the first arm further comprises a first handle portion at a second end of the first arm, and the second arm further comprises a second handle portion at a second end of the second arm, and wherein the pivot point is positioned between the first and seconds ends of the first arm, and positioned between the first and seconds ends of the second arm.

125. The system of claim 124, wherein the first and second arm further comprise a ratchet members that prevent relative movement between the first and second arms such that the concave engagement cap and the bone and / or tissue engagement tip are prevented from relative movement away from each other.

126. The system of claim 120, wherein the first dorsal portion of the first bunion implant plate comprises at least one first aperture extending from the first outer side to the first bone engagement inner side, and the second dorsal portion of the second bunion implant plate comprises at least one second aperture extending from the second outer side to the bone engagement inner side.

127. The system of claim 126, further comprising a plurality of fixation members configured to extend through the at least one first aperture or the at least one second aperture and into the first or second respective metatarsal bone, respectively, to fix the first or second bunion implant plate to the first or second respective metatarsal bone, respectively.

128. A bunion correction system, comprising: an implant system according to any one of claims 1-117; and a tether tying fixture configured to securely position the first and second bunion implant plates at at least one predefined spacing, and allow the tether to be looped through the passageway at the second medial portion.

129. The system of claim 128, wherein tether tying fixture is configured to facilitate passing ends of the tether through openings of a second passageway at the first lateral portion, and securing the ends of the tether together via at least one knot.

130. A method of repositioning a first metatarsal bone relative to an adjacent second metatarsal bone to correct a bunion condition of a foot of a patient, the method comprising: obtaining the implant system of any of claims 1-117; reducing an intramedullary angle between the first and second respective metatarsal bones from a first intramedullary angle to a reduced intramedullary angle; positioning the first bunion implant plate of implant system over the first metatarsal bone, and positioning the second bunion implant plate of the implant system over the second metatarsal bone to prevent the intermetatarsal angle from increasing above the reduced intramedullary angle.

131. The method of claim 130, further comprising coupling the first bunion implant plate to the first respective metatarsal bone and coupling the second bunion implant plate to thesecond respective metatarsal by inserting at least one fixation member through at least one aperture in the first dorsal portion of the first bunion implant plate and into the first respective metatarsal bone, and inserting at least one fixation member through at least one aperture in the second dorsal portion of the second bunion implant plate and into the second respective metatarsal bone.

132. The method of claim 130, wherein reducing the intramedullary angle between the first and second respective metatarsal bones comprises utilizing a reduction clamp to reduce the intramedullary angle.

133. The method of claim 132, wherein utilizing the reduction clamp to reduce the intramedullary angle comprises engaging a medial side of the foot of the patient with a concave engagement cap at a first end of a first arm of the clamp, and engaging a lateral side of another metatarsal bone of the foot of the patient with a bone and / or tissue engagement tip at a first end of a second arm of the clamp.

134. The method of claim 133, wherein utilizing the reduction clamp to reduce the intramedullary angle further comprises manually engaging a first handle portion of the first arm and a second handle portion of the second arm, and pivoting the first and second arms relative to one another about a pivot point via the first and second handle portions to translate the concave engagement cap and the bone and / or tissue engagement tip towards each other.

135. The method of claim 132, further comprising passing the tether through the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate, and fixing end portions of the tether together.

136. The method of claim 135, wherein fixing end portions of the tether together comprises typing the end portions of the tether together.

137. The method of claim 136, wherein fixing end portions of the tether together further comprises positioning the first and second bunion implant plates in a suture typing fixture that medially-laterally spaces the first lateral portion of the first bunion implant plate and the second medial portion of the second bunion implant plate a predetermined distance.

138. A reduction clamp configured to reduce an angle and / or a distance between first and second bones and / or tissues, comprising: an engagement cap comprising a front concave engagement side configured to engage a first side of a first bone and / or tissue; a first pointed tip configured to engage a second side of a second bone and / or tissue.

139. The reduction clamp of claim 138, wherein the reduction clamp further comprises a first arm member and a second arm member rotationally coupled at a first pivot point, and wherein the engagement cap is positioned at a first end of the first arm, and the first pointed tip is positioned at a first end of the second arm.

140. The reduction clamp of claim 139, wherein the engagement cap is removably mated with the first end of the first arm.

141. The reduction clamp of claim 140, wherein the first end of the first arm comprises a second pointed tip.

142. The reduction clamp of claim 141, wherein a back side of the engagement cap comprises a plurality of openings configured to accept therein and mate with the second pointed tip.

143. The reduction clamp of claim 141, wherein the engagement cap comprises a plurality of through holes extending from the back side to the front concave engagement side.

144. The reduction clamp of claim 140, wherein the first arm further comprises a first handle portion at a second end of the first arm, and the second arm further comprises a second handle portion at a second end of the second arm, and wherein the pivot point is positioned between the first and seconds ends of the first arm, and positioned between the first and seconds ends of the second arm.

145. The reduction clamp of claim 144, wherein the first and second arm further comprise a ratchet members that prevent relative movement between the first and second arms such that the engagement cap and the first pointed tip are prevented from relative movement away from each other.

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