Surgical instruments, guides, and methods of use

Abstract

The present invention relates to a clamp comprising an actuation portion and an engagement portion coupled to the actuation portion by a coupling portion, the engagement portion including a first arm having a first engagement element disposed at a distal end of the first arm and a second arm having a second engagement element disposed at a distal end of the second arm.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims priority to both U.S. Provisional Application No. 63 / 173,043, filed on April 9, 2021, and U.S. Provisional Application No. 63 / 262,845, filed on October 21, 2021, titled "Surgical Instruments, Guides, and Methods of Use", the entire contents of which are incorporated herein by reference.

[0002] This disclosure relates to surgical instruments, guides, and methods of use implemented in surgical procedures. The disclosure relates to instruments, guides, and methodologies for podiatric and orthopedic use implemented in various procedures of the foot and / or ankle, such as arthrodesis. More specifically and without limitation, this disclosure relates to surgical instruments, guides, and methods of use implemented in combination with instruments (and other components, such as implants, devices, systems, assemblies, etc.) for performing arthrodesis of the Lapidus joint.

Background Art

[0003] Many currently available surgical instruments, guides, and methodologies do not fully meet the needs of patients. Furthermore, many currently available surgical instruments, guides, and methodologies do not consider the characteristics of the anatomical structure of the joint, which may reduce the favorable outcome for the patient.

Summary of the Invention

Problems to be Solved by the Invention

[0004] This disclosure is directed to surgical guides implemented in combination with implants, instruments, and methods for arthrodesis.

Means for Solving the Problems

[0005] A first aspect of the present disclosure is a clamp, comprising an operating part and an engaging part coupled to the operating part via a coupling part. The engaging part comprises a first arm and a second arm, the first arm including a first engaging element located at the distal end of the first arm, and the second arm including a second engaging element located at the distal end of the second arm.

[0006] According to a first aspect of this disclosure, the first engaging element and the second engaging element are different.

[0007] According to a first aspect of this disclosure, the second engaging element is integral with the second arm.

[0008] According to a first aspect of the present disclosure, the second engaging element has a tapered shape in the vertical direction.

[0009] According to a first aspect of the present disclosure, the second engaging element includes a flat portion disposed on its inner surface, the flat portion including a textured surface.

[0010] According to a first aspect of the present disclosure, the textured surface is configured to contact at least a portion of the first metatarsal bone such that the second engaging element maintains contact with the first metatarsal bone.

[0011] According to a first aspect of the present disclosure, the first arm includes an opening located at its distal end, the opening being configured to be rotatably coupled to a first engaging element.

[0012] According to a first aspect of this disclosure, the first actuator is located at the end of the first portion opposite to the second portion.

[0013] According to a first aspect of this disclosure, the first engagement element comprises a retaining portion and an actuator.

[0014] According to a first aspect of the present disclosure, the retaining portion includes a post, at least a portion of which is configured to be received in an opening of a first arm. This facilitates a rotatable and detachable coupling between the first engaging element and the first arm.

[0015] According to a first aspect of the present disclosure, the actuator includes a central opening configured to receive at least a portion of the post, such that the actuator is positioned above the opening of the first arm and above the retaining portion.

[0016] According to a first aspect of this disclosure, the retaining portion further includes a first retaining element and a second retaining element extending from the post.

[0017] According to a first aspect of this disclosure, the distance between the first retaining element and the second retaining element is adjusted by operating an actuator around a screw located on the surface of the retaining part.

[0018] According to a first aspect of this disclosure, the first retaining element and the second retaining element each include a textured surface configured to interface with the second metatarsal bone.

[0019] According to a first aspect of the present disclosure, the retaining portion is rotatably coupled to the opening of the first arm so as to include a 360-degree range of motion.

[0020] According to a first aspect of this disclosure, the first arm has a different shape from the second arm.

[0021] According to a first aspect of the present invention, the first engaging element has a depth different from that of the second engaging element.

[0022] A second aspect of the present disclosure is a surgical system, the surgical system including a clamp. The clamp comprises an actuating part and an engaging part. The engaging part is coupled to the actuating part by a coupling part positioned between the engaging part and the actuating part. The engaging part includes a first arm having a first engaging element positioned at the distal end of the first arm, the first engaging element being integral with the first arm and configured to contact the surface of a first bone. The engaging part also includes a second arm having a second engaging element positioned at the distal end of the second arm, the second engaging element comprising an actuator rotatably and releasably coupled to the second arm and configured to adjust the distance between the first retaining element and the second retaining element so that each of the first retaining element and the second retaining element engages with at least a portion of a second bone. The surgical system further includes a fixation device.

[0023] According to a second aspect of this disclosure, the distance between the first engaging element and the second engaging element is increased or decreased by operating the actuation mechanism.

[0024] According to a second aspect of the present disclosure, the second engaging element comprises a retaining portion including a post and a thread, wherein the post is configured to be releasably coupled to a second arm and the thread is configured to be releasably coupled to an actuator.

[0025] The third aspect of the present disclosure is a surgical method. The method includes aligning a retaining element comprising a post and a pair of extensions disposed on opposite sides of the post such that a first bone is at least partially disposed between each of the pair of extensions; releasably coupling a surgical clamp to the post of the retaining element such that the post is received within a portion of a first arm of the surgical clamp; operating an actuator such that each of the pair of extensions contacts at least a portion of the first bone and is releasably coupled. The method also includes operating the surgical clamp such that an engagement element disposed on a second arm of the surgical clamp contacts a surface of a second bone; coupling a first stabilization wire to the second bone; reducing an intramedullary angle between the first bone and the second bone; derotating the second bone by operating the first stabilization wire. The method also includes inserting a second stabilization wire through a through hole in the second arm into the second bone; making one or more incisions in one or more of the bones; applying a fixation device across the first bone and a third bone.

[0026] The fourth aspect of the present disclosure is a surgical system, the surgical system including a clamp. The clamp includes a first portion having a first actuator configured to interface with a first midfoot bone of a patient, the movement range of the actuator being defined by an opening, and a second portion having an extension with a retention mechanism configured to interface with a second midfoot bone of the patient. The second portion is releasably coupled to the first portion, and the first portion and the second portion are translatable relative to each other via a second actuator. The system further includes a stabilization wire configured to be received by at least one of the first portion and the second portion.

[0027] According to the fourth aspect of the present disclosure, the first actuator includes a first bore disposed about a longitudinal axis of the actuator.

[0028] According to a fourth aspect of the present disclosure, the first bore is configured to receive one of the plurality of stabilization wires within the bore and through the bore. Thereby, the stabilization wire can releasably couple the first actuator to the first metatarsal bone.

[0029] According to a fourth aspect of the present disclosure, the operation of the first actuator within the opening applies a rotational force to the first metatarsal bone via the stabilization wire so as to operate the first metatarsal bone from the first position to the second position.

[0030] According to a fourth aspect of the present disclosure, by operating the first actuator within the opening, the stabilization wire moves from a first position forming a first angle with the cross-section to a second position forming a second angle with the cross-section. Here, the first angle is different from the second angle.

[0031] According to a fourth aspect of the present disclosure, the first angle is larger than the second angle.

[0032] According to a fourth aspect of the present disclosure, the retaining mechanism is disposed at the distal end of the extension portion and includes a pair of curved protrusions that define a recess therebetween.

[0033] According to a fourth aspect of the present disclosure, the protrusions are curved in the direction of the first portion of the clamp.

[0034] According to a fourth aspect of the present disclosure, the second actuator is disposed at the end of the second portion opposite the first portion.

[0035] According to a fourth aspect of the present disclosure, the second portion includes a bore extending through the second portion along its longitudinal axis.

[0036] According to a fourth aspect of the present disclosure, the second actuator includes a protrusion having a first coupling mechanism, the protrusion being configured to be received by and extend through the bore, and the protrusion being configured to releasably couple to the second portion via the bore.

[0037] According to a fourth aspect of the present disclosure, the first portion includes a recess comprising a second coupling mechanism, the recess being configured to receive and detachably couple a portion of a projection of the second actuator.

[0038] According to a fourth aspect of the present disclosure, the recess of the first portion and the bore of the second portion share a common axis of the projection when both are releasably coupled to the projection of the second actuator.

[0039] According to a fourth aspect of the present disclosure, the operation of the second actuator causes the first part to be translated relative to the second part around a shared axis.

[0040] According to a fourth aspect of this disclosure, the first actuator and the second actuator each include a texture applied to one or more of their outer surfaces.

[0041] According to a fourth aspect of the present disclosure, the second portion includes one or more projections, each projection including an opening configured to receive one of the stabilizing wires.

[0042] A fifth aspect of the present disclosure is a surgical clamp comprising a first portion having a substantially curved shape. The first portion includes a recess located at the proximal end of the first portion, an elongated opening located at the distal end of the first portion, and a first actuator at least partially positioned within the elongated opening such that the elongated opening defines its range of motion. The first actuator includes a bore extending through its longitudinal axis and configured to receive a stabilizing wire. The surgical clamp also comprises a second portion. The second portion includes an extension having a pair of projections at its distal end, a bore extending along the longitudinal axis of the second portion, and a second actuator including a coupling mechanism received through the bore and configured to be releasably coupled with the bore. The coupling mechanism is configured to be received in the recess and releasably coupled such that the operation of the second actuator causes the first portion and the second portion to translate around the longitudinal axis of the second portion.

[0043] According to a fifth aspect of the present disclosure, the first portion includes at least one bore configured to receive a stabilizing wire.

[0044] According to a fifth aspect of the present disclosure, the second portion includes at least an opening configured to receive a stabilizing wire.

[0045] A sixth aspect of the present disclosure is a method for performing a rapid joint procedure. The method includes connecting a first portion of the device to a second metatarsal bone using a first and second stabilizing wire, and connecting a second portion of the device to a first metatarsal bone using a third stabilizing wire, the third stabilizing wire being received by a first actuator of the second portion. The method also includes operating a second actuator positioned in the first portion of the device to reduce the distance between the first and second metatarsal bones, and operating the first actuator to rotate the first metatarsal bone. The method further includes connecting a surgical guide adjacent to the rapid joint to a fourth stabilizing wire, preparing the distal portion of the medial cuneiform bone and the proximal portion of the first metatarsal bone for fixation such that the distal portion of the medial cuneiform bone has a surface substantially parallel to the proximal surface of the first metatarsal bone, and applying the fixation device across the rapid joint.

[0046] The accompanying drawings, incorporated into and constituting part of the specification, illustrate embodiments of the invention and, together with the detailed description herein, help to illustrate the principles of the invention. It should be emphasized that, in accordance with standard industry practice, various features may and may not be depicted to a constant scale. In fact, for the sake of clarity in the discussion, the dimensions of various features may be arbitrarily enlarged or reduced. The drawings are intended solely to illustrate embodiments of the invention of this disclosure and should not be construed as limiting the invention. [Brief explanation of the drawing]

[0047] [Figure 1] Front perspective view of an exemplary system implemented when performing a surgical procedure as described herein. [Figure 2] Front view of the system in Figure 1, as disclosed herein. [Figure 3] Rear perspective view of the system shown in Figure 1, as disclosed herein. [Figure 4] A top view of the system shown in Figure 1 adjacent to a portion of an anatomical structure, as disclosed herein. [Figure 5]Front perspective view of the system shown in Figure 1 adjacent to a portion of an anatomical structure, as disclosed herein. [Figure 6] Front perspective view of the system shown in Figure 1 adjacent to a portion of an anatomical structure, as disclosed herein. [Figure 7] A front-right oblique view of an exemplary system implemented when performing a surgical procedure as described in this disclosure. [Figure 8] Top view of the system shown in Figure 7, according to this disclosure. [Figure 9] Front view of the system shown in Figure 7, according to this disclosure. [Figure 10] Rear perspective view of the system shown in Figure 7, according to this disclosure. [Figure 11] Front perspective view of an exemplary retention mechanism implemented when performing a surgical procedure as disclosed herein. [Figure 12] Front view of the mechanism shown in Figure 11, according to this disclosure. [Figure 13] A bottom perspective view of the mechanism shown in Figure 11, according to this disclosure. [Figure 14] Top perspective view of the mechanism shown in Figure 11, according to this disclosure. [Figure 15] Front view of a part of the mechanism shown in Figure 11, according to this disclosure. [Figure 16] Top perspective view of other parts of the mechanism shown in Figure 11, according to this disclosure. [Figure 17] Front view of an exemplary mechanism implemented when performing a surgical procedure as disclosed herein. [Figure 18] Front perspective view of the mechanism shown in Figure 17, according to this disclosure. [Figure 19] A bottom perspective view of the mechanism shown in Figure 17, according to this disclosure. [Figure 20] Top perspective view of the mechanism shown in Figure 17, according to this disclosure. [Figure 21] Front view of a part of the mechanism shown in Figure 17, according to this disclosure. [Figure 22] A top perspective view of a part of the mechanism shown in Figure 17, according to this disclosure. [Figure 23] Front perspective view of an exemplary mechanism implemented when performing a surgical procedure as disclosed herein. [Figure 24] A bottom perspective view of the mechanism shown in Figure 23, according to this disclosure. [Figure 25] Top view of the mechanism shown in Figure 23, according to this disclosure. [Figure 26] Front view of a part of the mechanism shown in Figure 23, according to this disclosure. [Figure 27] A top view of an exemplary system implemented when performing a surgical procedure as described in this disclosure. [Figure 28] Top perspective view of the system shown in Figure 27 in this disclosure. [Figure 29] Front view of the system shown in Figure 27, according to this disclosure. [Figure 30] Another front view of the system shown in Figure 27, according to this disclosure. [Figure 31] Side perspective view of the system shown in Figure 27 in this disclosure. [Figure 32] Top view of the system shown in Figure 27, according to this disclosure. [Figure 33] Front view of the holding element of the system shown in Figure 27, according to this disclosure. [Figure 34] Side view of the retaining element in Figure 33, according to this disclosure. [Figure 35A] A flowchart illustrating the steps involved in performing a surgical procedure as described in this disclosure. [Figure 35B] A flowchart illustrating the subsequent steps in the procedure for performing the surgical procedure shown in Figure 35A, as disclosed herein. [Figure 36] Side perspective view of the system for positioning orthopedic implants according to this disclosure. [Figure 37] Another side perspective view of the system for positioning the orthopedic implant shown in Figure 36, according to this disclosure. [Figure 38] A side cross-sectional view of the system for positioning the orthopedic implant shown in Figure 36, according to this disclosure. [Figure 39] Front perspective view of an exemplary system implemented when performing a surgical procedure as described herein. [Figure 40] Rear perspective view of the system shown in Figure 39 in this disclosure. [Figure 41] Right side view of the system shown in Figure 39 in this disclosure [Figure 42]Left side view of the system shown in Figure 39 in this disclosure [Figure 43] Top view of the system shown in Figure 39, according to this disclosure. [Figure 44] The bottom view of the system shown in Figure 39 in this disclosure. [Figure 45] The rear view of the system shown in Figure 39, as disclosed herein. [Figure 46] Front view of the system shown in Figure 39, according to this disclosure. [Figure 47] Figure 39, a dorsal perspective view of the system according to this disclosure, shows the anatomical structure of the foot. [Figure 48] Another dorsal perspective view of the system of Figure 47, as disclosed herein, showing the anatomical structure of the foot. [Figure 49] Figure 39, a dorsal perspective view of the system according to this disclosure, shows the anatomical structure of the foot. [Figure 50] Figure 39, a dorsal perspective view of the system according to this disclosure, includes an exemplary surgical guide shown with respect to the anatomical structure of the foot. [Figure 51] A diagram relating to this disclosure, showing another dorsal perspective view of the system of Figure 39, including the surgical guide of Figure 50 shown with respect to the anatomical structure of the foot. [Figure 52] Figure 39, a dorsal perspective view of the system according to this disclosure, includes an exemplary surgical guide shown with respect to the anatomical structure of the foot. [Figure 53] Figure 39, a high dorsal perspective view of the system according to this disclosure, shows the anatomical structure of the foot. [Figure 54] Perspective view of a stabilization system for facilitating the implementation of a fixed system, as disclosed herein. [Figure 55] Front perspective view of an exemplary system implemented when performing a surgical procedure as described herein. [Figure 56] Rear perspective view of the system shown in Figure 55 in this disclosure. [Figure 57] Right side view of the system shown in Figure 55, according to this disclosure. [Figure 58] Left side view of the system shown in Figure 55, according to this disclosure. [Figure 59] Top view of the system shown in Figure 55, according to this disclosure. [Figure 60] The bottom view of the system shown in Figure 55 in this disclosure. [Figure 61] Rear view of the system shown in Figure 55, according to this disclosure. [Figure 62] Front view of the system shown in Figure 55, according to this disclosure. [Figure 63] Exploded view of the system shown in Figure 55, as disclosed herein. [Figure 64] Perspective view of an exemplary embodiment of a surgical guide according to this disclosure [Figure 65] Side view of the surgical guide shown in Figure 64, according to this disclosure. [Figure 66] Flowchart of a method for performing treatment of the lapidus joint according to this disclosure [Modes for carrying out the invention]

[0048] In this detailed description and claims, the terms proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior, and inferior are defined by standard usage to indicate a particular part or portion of bone or implant, according to the relative arrangement or orientation of natural bone. For example, “proximal” means the part of the device or implant closest to the body, and “distal” means the part of the device or implant furthest from the body. Regarding directional terminology, "anterior" refers to the direction toward the front of the body, "posterior" refers to the direction toward the rear of the body, "medial" refers to the direction toward the midline of the torso, "lateral" refers to the direction toward the side of the body or away from the midline of the body, "superior" means the direction upwards, and "inferior" means the direction downwards of another object or structure. Furthermore, with regard to the feet in particular, the term "dorsal" refers to the top of the foot, and the term "plantar" refers to the bottom of the foot.

[0049] Similarly, location or orientation may be used herein in reference to anatomical structures or surfaces. For example, implants, devices, instruments, and methods described herein with reference to use in the bones of the foot, ankle, and lower leg, and may be used to describe the surface, location, orientation, or setting of implants, devices, instruments, and methods. Furthermore, implants, devices, instruments, and methods disclosed herein, as well as their embodiments, components, features, etc., are described in reference to one side of the body for the sake of brevity. However, since the human body is relatively symmetrical or mirror image around the midline of symmetry, it is clearly understood that implants, devices, instruments, and methods described and / or described herein, as well as their embodiments, components, features, etc., may be changed, altered, modified, reconfigured, or otherwise modified to be used or related to another side of the body for the same or similar purposes without departing from the spirit and scope of the invention. For example, implants, devices, instruments, and methods described herein in reference to the right foot, as well as their embodiments, components, features, etc., may be reflected to function similarly in the left foot. Furthermore, while the implants, devices, instruments, and methods disclosed herein, as well as their embodiments, components, and features, are described in relation to the foot for brevity, it should be understood that these implants, devices, instruments, and methods can also be used on other bones of the body having similar structures.

[0050] The instruments, implants, systems, assemblies, and related methods for maintaining, correcting, and / or resurfacing joint surfaces relating to this disclosure may be similar to, for example, including at least one feature or embodiment of the implants, systems, assemblies, and related methods disclosed below. For example, PCT international application PCT / US2018 / 20046, filed on 27 February 2018, titled “Intramedullary nail alignment guides, fixation guides, devices, systems, and methods of use,” PCT international application PCT / US2018 / 64386, filed on 17 December 2018, titled “Alignment guides, cutting guides, systems, and methods of use and assembly,” and PCT international application PCT / US2018 / 64386, filed on 10 July 2019, titled “Guides, devices, systems, PCT International Application PCT / US2019 / 041146, titled "and method of use", and / or PCT International Application PCT / US2014 / 27086, filed on 14 March 2014, titled "Intramedullary nail fixation guide, device, and method of use", and / or U.S. Patent No. 9,980,760, filed on 19 November 2014, titled "Step-off bone plate, system, and method of use", and / or U.S. Patent No. 9,980,760, filed on 26 July 2012 U.S. Patent No. D720,456, filed on October 23, 2014, titled "Rapidus Bone Wedge," and / or U.S. Patent No. D765,844, filed on December 10, 2013, titled "Rapidus Cut Guide," and / or U.S. Patent No. D904,2016, filed on November 22, 2017, titled "Intramedullary Fastener," and / Alternatively, U.S. Patent No. D865,173, filed on 9 July 2018 and titled “Cut Guide,” and / or U.S. Patent No. 29 / 686,941, filed on 9 April 2019 and titled “Cut Guide,” and / or U.S. Patent No. D904,609, filed on 9 April 2019 and titled “Cut Guide,” and / or U.S. Patent No. D904,2010, filed on 9 April 2019 and titled “Cut Guide.” These are incorporated herein by reference in their entirety.Similarly, the instruments, implants, systems, assemblies, and related methods for maintaining, correcting, and / or resurfacing joint surfaces relating to this disclosure may include one or more instruments (e.g., one or more insertion instruments and / or implantation instruments) disclosed below. For example, U.S. Provisional Application No. 63 / 173,043, filed on 9 April 2021, titled “Surgical Instruments, Guides, and Methods of Use,” and / or PCT International Application PCT / US2018 / 20046, filed on 27 February 2018, titled “Intramedullary Nail Alignment Guide, Fixation Guide, Apparatus, System, and Method of Use,” and / or PCT International Application PCT / US2018 / 20046, filed on 17 December 2018, titled “Alignment Guide, Cutting Guide, System, and Methods of Use and Assembly.” International applications PCT / US2018 / 64368, PCT / US2019 / 041146 filed on 10 July 2019, titled "Guides, devices, systems, and methods of use", and / or PCT / US2014 / 27086 filed on 14 March 2014, titled "Intramedullary nail fixation guides, devices, and methods of use", and / or PCT / US2014 / 27086 filed on 19 November 2014, titled "Step-off bone plates, systems, and methods of use" U.S. Patent No. 9,980,760, and / or U.S. Patent No. D720,456, filed on 26 July 2012 and titled "Rapidus Bone Wedge", and / or U.S. Patent No. D765,844, filed on 23 October 2014 and titled "Bone Plate", and / or U.S. Patent No. D695,402, filed on 10 December 2013 and titled "Rapidus Cut Guide", and / or U.S. Patent No. D695,402, filed on 22 November 2017 and titled "Intramedullary Fastener" Japanese Patent No. D904,2016, and / or U.S. Patent No. D865,173, filed on 9 July 2018 and titled "Cut Guide", and / or U.S. Patent No. 29 / 686,941, filed on 9 April 2019 and titled "Cut Guide", and / or U.S. Patent No. D904,609, filed on 9 April 2019 and titled "Cut Guide", and / or U.S. Patent No. D904,2010, filed on 9 April 2019 and titled "Cut Guide".These are incorporated herein by reference in their entirety.

[0051] Treatment for deformities such as hallux valgus and the lapidus joint and surrounding anatomical structures often requires positioning / repositioning and / or rotation / derotation of the first metatarsal bone. The joint referred to herein as the “lapidus” joint is also known and sometimes called the first tarsometatarsal joint. Treatment of the lapidus joint (e.g., fixation / arthrodesis) typically requires manipulating the first metatarsal bone by applying one or more forces to it. In some treatments, this manipulation is necessary before incision and / or preparation, and subsequent fixation of the lapidus joint. When assessing deformities of the lapidus joint, two different criteria are usually analyzed for correction. One of these criteria is the intramedullary angle formed between the longitudinal axes of the first and second metatarsals. In bunion deformities and other conditions of the rapidus joint, the first metatarsal bone often shifts medially from its normal anatomical position, resulting in an increased intermegaly (IM) angle between the first and second metatarsals from the anatomically correct range. First metatarsal rotation is also analyzed, as hallux valgus deformities and other conditions of the rapidus joint generally involve a first metatarsal bone that is rotated substantially clockwise in the frontal plane (when viewed from anterior to posterior). Generally, treatment of the rapidus joint as described above requires manipulation of the first metatarsal bone. This manipulation is to a) correct (e.g., decrease) the IM angle between the first and second metatarsals by applying a substantially lateral force to the first metatarsal bone, and / or b) reduce the rotation of the first metatarsal bone from its normal anatomical position by applying a substantially counterclockwise rotational force when viewed from anterior to posterior.

[0052] In the drawings, similar reference numerals are used to indicate similar or similar components throughout several figures. Referring to Figures 1 to 6, exemplary embodiments of a clamp 100 are shown that are implemented when performing a procedure on one or more anatomical structures of the foot (e.g., a procedure on the lapidus joint, e.g., arthrodesis or other similar fixation procedure). In some embodiments, the clamp 100 can be operated so that one or more components of the clamp come into contact with one or more anatomical structures of the foot. When force is applied to the clamp by a physician, at least one of the anatomical structures is selectively repositioned by the physician. As shown in Figures 1 to 6, the clamp 100 includes an upper part 110 (e.g., a handle), the upper part 110 being positioned substantially opposite the clamp 100 from the lower part 120 (e.g., an engaging part, a coupling part). A coupling 118 is positioned between the upper part 110 and the lower part 120. The illustrated clamp 100 includes a pair of members pivotably coupled by a coupling 118, each of which includes at least a portion of the upper 110 and a portion of the lower 120. The ratchet 116 may be configured to adjust the clamp from a first position to a second position, or to hold the clamp in a desired position (for example, to maintain some desired straightening). In some embodiments, the coupling 118 may include a geometric shape that defines the range of motion of the upper 110 and / or lower 120 of the clamp 100, such as a ratchet or other coupling mechanism as shown.

[0053] As shown in the figure, the clamp 100 includes a first arm 122 and a second arm 124 extending from the coupling 118 at the lower part 120 of the clamp. As shown in the figure, the first arm 122 and the second arm 124 are integral with a first handle portion 112 and a second handle portion 114 (the first handle portion 112 is integral with the second arm 124, and the second handle portion 114 is integral with the first arm 122). The first arm 122 is shown to include a bend positioned between the coupling 118 and an interface component 123, the interface component 123 being positioned at the end of the first arm 122. As shown in the figure, the interface component 123 is positioned substantially perpendicular to the first arm 122 between the coupling 118 and the aforementioned bend (for example, bent in the sole direction) (however, other arrangements may be had in some embodiments). As shown at least in Figures 4 to 6, the interface component 123 further has a curvature configured to adapt to the curvature of the medial portion of the first metatarsal bone 202. In some embodiments, the interface component 123 can be configured to interface with the distal portion of the first metatarsal bone 202. The interface component 123 may also include a textured surface on at least one surface of the interface component 123 (e.g., a surface having a concave curvature to adapt to the first metatarsal bone 202) to facilitate prolonged contact with the surface of the first metatarsal bone 202 by increasing friction with the surface of the first metatarsal bone 202.

[0054] The second arm 124 is shown to include a retaining element 125 positioned at the end of the second arm 124, the retaining element 125 being able to be releasably coupled to the second arm 124. As shown, the retaining element 125 includes a post 132 (at least as seen in Figures 11 to 12) configured to be received into the opening of the second arm 124 (moving from the sole of the foot toward the instep). In some embodiments, the retaining element 123 is configured in its distal portion to facilitate coupling with the second metatarsal bone 204. The retaining element 123 is configured to be pivotable within the opening of the second arm 124 to facilitate coupling with the second metatarsal bone 204 despite the various lateral geometric shapes of the second metatarsal bone 204.

[0055] The retaining element 125 includes a first element 130 and a second element 140, as further shown in Figures 11 to 16. The first element 130 includes a post 132 (e.g., upper portion) at its upper part and a pair of engaging elements 134 located at its lower part (e.g., opposite the post 132). The illustrated post 132 includes a thread 136 located at least part thereof. As shown, the thread 136 is located at the lower part of the post 132. The illustrated engaging element 134 is a pair of prongs extending from the lower part of the post 132 adjacent to the lower part of the thread 136. The engaging element 134 includes a first segment 138 extending perpendicularly from the lower part of the post 132. The engaging element 134 further includes a second segment 139 extending from the first segment 138 and continuing to the end of the engaging element 134. As shown, the second segments 139 are substantially parallel to each other. The inner surfaces of the second segment 139 (e.g., surfaces facing each other) include a texture configured to induce friction upon contact with bone and to promote bone retention between them.

[0056] As shown in the figure, the retaining element 125 further includes an actuator 140. The actuator 140 is configured to adjust the distance between the engaging elements 134 so that the engaging elements 134 are positioned adjacent to the second metatarsal bone 204, and finally to further adjust the distance between the engaging elements 134 so that contact (e.g., engagement, releaseable connection, etc.) with the second metatarsal bone 204 begins. The actuator 140 includes an opening 142 configured to receive the post 132 through the opening 142. The opening 142 further includes a thread 143 located on the inner surface of the opening 142, having a geometric shape complementary to the geometric shape of the thread 136 to facilitate a screwable and releaseable connection. The actuator 140 also includes a texture 144 located on its outer surface to facilitate the gripping and operation of the actuator 140. The actuator 140 is configured as follows: That is, when the first element 130 is positioned such that the engaging element 134 is positioned adjacent to the second metatarsal bone 204, the threads 136 and 143 engage, and the actuator can be releasably coupled to the post 132 so as to move the actuator 140 downward along the threads 136 of the post 132. Once the actuator 140 begins to contact the engaging element 134, the force applied by the actuator 140 can drive the engaging elements 134 toward each other. (For example, the actuator 140 begins to accept at least a portion of the engaging elements 134 into the opening 142 of the actuator 140, thereby driving the engaging elements 134 toward each other). This reduces the space between the engaging elements 134, and the medial and lateral surfaces of the second metatarsal bone 204 are gripped by the second segment 139 of the retaining element 125. Next, the clamp 100 can be releasably coupled to the post 132 of the retaining element 125 by positioning the clamp so that the opening of the second arm 124 accepts at least a portion of the post 132.

[0057] The clamp 100 is configured to apply force at least medially to the first metatarsal 202 by manipulating the upper part 110 such that the distance between the ends of the first arm 122 and the second arm 124 is reduced, when the interface portion 123 abuts the first metatarsal 202 from the medial side and the retaining element 125 engages the second metatarsal 204 from both the medial and lateral sides. Thus, such force reduces the intramedullary angle between the first metatarsal 202 and the second metatarsal 204 by positioning at least the distal portion of the first metatarsal 202 closer to the second metatarsal 204 prior to the procedure. Furthermore, the clamp 100 is configured such that a space remains between the first arm 122 and the second arm 124 when engaged as described above, allowing for manipulation of the big toe (e.g., "the big toe"). Such manipulation may include repositioning the big toe for assessment of soft tissue or manipulating anatomical structures adjacent to the lapidus joint.

[0058] Referring to Figures 4 to 6, the clamp 100 is shown engaged with the foot 200. The interface element 123 is shown to engage with the distal portion of the first metatarsal bone 202, while the retaining element 125 and a portion thereof engage with the distal portion of the second metatarsal bone 204. As shown, the upper part 110 of the clamp 100 can be operated to apply force to the medial surface of the first metatarsal bone 202 so as to reduce the intramedullary angle formed between the central longitudinal axes of the first metatarsal bone 202 and the second metatarsal bone 204. Once the desired correction to the intramedullary angle is achieved, the ratchet 116 can be engaged to hold the clamp in the desired position so that the clamp 100 holds the position that provides the desired correction.

[0059] Referring next to Figures 7 to 10, another clamp 300 is shown. Clamp 300 can be used as clamp 300, or as other clamps illustrated herein and described later, for similar and / or similar procedures. Clamp 300 includes an upper part 310 (e.g., a handle) positioned substantially opposite the clamp 300 from a lower part 320 (e.g., an engaging part, a coupling part, etc.). A coupling 318 is positioned between the upper part 310 and the lower part 320. The shown clamp 300 includes a pair of members rotatably coupled by the coupling 318, each member of the pair including at least a portion of the upper part 310 and at least a portion of the lower part 320. The ratchet 316 can be configured to adjust the clamp from a first position to a second position, or to hold the clamp in a desired position (e.g., to maintain some desired straightening). In some embodiments, the coupling 318 may include a geometric shape that defines the range of motion of the upper 310 and / or lower 320 of the clamp 300, such as the illustrated ratchet or other coupling mechanism.

[0060] The clamp 300 includes a first arm 322 and a second arm 324, which are substantially symmetrical. Each of the first arm 322 and the second arm 324 includes an opening 321 at its distal end, the opening 321 positioned slightly foot-side (e.g., below the majority of the first arm 322 and the second arm 324). Each of the openings may be similar to and / or analogous to the openings illustrated and described with reference to clamp 100. The openings 321 of the first arm 322 and the second arm 324 are configured to receive and pivotably and retractably connect a first retaining element 323 and a second retaining element 325 (which are substantially the same components as shown). The first retaining element and the second retaining element are configured to interface with, engage with, and releasably connect to the first metatarsal bone 202 and the second metatarsal bone 204, respectively, as illustrated and described above.

[0061] Referring to Figures 17 to 22, the retaining elements 323 and 325 are shown as a retaining system 350, and each of the retaining elements 323 and 325 of the clamp 300 may also be a retaining system, similar to those shown as component 350. The retaining system 350 includes a first element 360 and an actuator 370. The first element 360 includes a post 362 (e.g., upper portion) at its upper part and a pair of engaging elements 366 located at its lower part 364 (e.g., opposite post 132). The illustrated post 362 includes a thread 363 located at least part thereof. As shown, the thread 363 is located at the bottom of the post 362. The illustrated engaging element 366 is a pair of prongs extending from the bottom of the post 362 adjacent to the bottom of the thread 363. The engaging element 366 includes a first segment extending perpendicularly from the bottom of the post 362. The engaging element 366 further includes a second segment 368 extending from the first segment and continuing to the end of the engaging element 366. As shown in the figure, the second segments 368 are substantially parallel to each other. The inner surfaces of the second segments 368 (e.g., the inner surfaces facing each other) include a texture configured to induce friction upon contact with bone and to promote bone retention between them.

[0062] The retaining system 350 is shown to further include an actuator 370, which is configured to adjust the distance between engaging elements 366, positioning the engaging elements 366 adjacent to the second metatarsal bone 204, and ultimately to further adjust the engaging elements 366 to initiate contact with the second metatarsal bone 204 (e.g., engagement, releaseable connection). The actuator 370 includes an opening 372 configured to receive the post 362 through the opening 372. The opening 372 further includes a thread 373 located on the inner surface of the opening 372, having a geometric shape complementary to the geometric shape of the thread 363 to facilitate a screwable and releaseable connection. The actuator 370 also includes a texture 374 located on its outer surface to facilitate gripping and operation of the actuator 370. The actuator 370 is configured as follows: That is, when the first element 360 is positioned such that the engaging element 366 is positioned adjacent to the second metatarsal bone 204, the threads 363 and 373 engage, and the actuator can be releasably coupled to the post 362 so as to move the actuator 370 downward along the threads 363 of the post 362. Once the actuator 370 begins to contact the engaging element 366, the force applied by the actuator 370 can drive the engaging elements 366 toward each other. (For example, the actuator 370 begins to accept at least a portion of the engaging element 370 into the opening 372 of the actuator 370, thereby driving the engaging elements 366 toward each other and reducing the volume of the space 365 between them). As a result, the space 365 between the engaging elements 366 is reduced, and the medial and lateral surfaces of the second metatarsal bone 204 are gripped by the second segment 368 of the retaining system 350. Next, the clamp 300 can be releasably coupled to the post 362 of the holding system 350 by positioning the clamp so that the openings of the first arm 322 and the second arm 324 receive at least a portion of the post 362.

[0063] The clamp 300 is configured to apply a force at least medially to the first metatarsal 202 by manipulating the upper part 110 so that the distance between the ends of the first arm 322 and the second arm 324 decreases, when the first retaining element 323 of the first arm 322 engages with the first metatarsal 202 from both the medial and lateral sides, and the second retaining element 325 of the second arm 324 engages with the second metatarsal 204 from both the medial and lateral sides. Thus, such a force reduces the intramedullary angle between the first metatarsal 202 and the second metatarsal 204 by positioning at least the distal portion of the first metatarsal 202 closer to (e.g., more laterally) the second metatarsal 204 prior to the procedure. Furthermore, the clamp 300 is configured such that a space remains between the first arm 322 and the second arm 324 to allow manipulation of the big toe (e.g., the "big toe") when engaged as described above. Such operations may include repositioning the big toe to assess soft tissue, or manipulating anatomical structures adjacent to the lapidus joint.

[0064] Referring to Figures 23 to 26, a cut guide system 400 is shown, which includes a retaining system 350 and a cut guide 410. Note that the cut guide 410 may be implemented together with the retaining element 125 and the clamp 100. The cut guide 410 may include embodiments other than those shown herein (e.g., left / right counter parts). As shown, the cut guide 410 includes an incision portion 420 and a coupling portion 430, the coupling portion 430 being a rounded projection from the incision portion 420. The cut guide 410 is shown to be releasably coupled to the retaining system 350 via the coupling portion 430 as follows: the opening 434 of the cut guide 410 (extending from the top surface 432 through the coupling portion 430 to the bottom surface) receives the post 362 of the first element 360, and then the actuator 370 also receives the post 362, so as to position the cut guide 410 between the engaging element 366 and the actuator 370.

[0065] As shown in the figure, the incision section 420 includes a plurality of incision slots 422 extending through the incision section 420. The illustrated incision slots 422 are substantially the same size and extend substantially perpendicular to each other, but in some embodiments they may have alternative geometric shapes and arrangements. In some embodiments, the cut guide system 400 can be configured to position the incision slots 422 substantially parallel to another surface (for example, parallel to the surface of the already incised proximal first metatarsal bone 202 so that an incision parallel to the distal first cuneiform bone 204 is made, forming an ideal surface for fixation). The physician can determine which incision slots 422 are best positioned to make the desired incision, and once determined, the physician can make the desired incision using a reciprocating saw or other similar instrument.

[0066] Next, referring to Figures 17 to 24, a clamp 500 is shown. The clamp 500 may be similar to the clamps 100, 300 illustrated and described earlier, and may be used for the same and / or similar procedures (e.g., procedures on the lapidus joint). In some embodiments, the clamp 500 is operated so that one or more components of the clamp 500 come into contact with one or more anatomical structures of the foot, and when force is applied to the clamp by a physician, at least one of the anatomical structures is selectively repositioned by the physician. The clamp 500 includes an upper part 510 (e.g., a handle) positioned substantially opposite the clamp 500 from a lower part 520 (e.g., an engaging part, a coupling part, etc.), as shown in Figures 17 to 24. A coupling 518 is positioned between the upper part 510 and the lower part 520. The illustrated clamp 500 includes a pair of members pivotably coupled by the coupling 518, each member of the pair of members including at least a portion of the upper part 510 and a portion of the lower part 520. The locking mechanism 516 can be configured to adjust the clamp 500 from a first position to a second position, or to hold the clamp 500 in a desired position (for example, to maintain some desired straightening). In some embodiments, the coupling 518 may include a geometric shape that defines the range of movement of the upper 510 and / or lower 520 of the clamp 500, such as a ratchet or other coupling mechanism as shown.

[0067] The clamp 500 is further shown to include a first arm 522 and a second arm 524 extending from the coupling 518 at the lower part 520 of the clamp. As shown, the first and second arms 522, 524 are integral with first and second handle portions 512, 514 (the first handle portion 512 is integral with the second arm 524, and the second handle portion 514 is integral with the first arm 522). The first arm 522 is shown to include a bend positioned between the coupling 518 and an interface component 526, the interface component 526 positioned at the end of the first arm 522. As shown, the interface component 526 is positioned substantially perpendicular to the first arm 522 between the coupling 518 and the aforementioned bend (for example, bent in the sole direction) (however, other arrangements may be had in some embodiments). As shown at least in Figures 31 to 32, the interface component 526 further has a curvature configured to adapt to the curvature of the medial portion of the first metatarsal bone 202. In some embodiments, the interface component 526 can be configured to interface with the distal portion of the first metatarsal bone 202. The interface component 526 may also include a textured surface 527 on at least one surface of the interface component 526 (e.g., a surface having a concave curvature to adapt to the first metatarsal bone 202) to facilitate prolonged contact with the surface of the first metatarsal bone 202 by increasing friction with the surface of the first metatarsal bone 202. The interface component 526 is also shown to include an opening 528 extending through it, the opening 528 configured to receive a stabilizing wire 529. The stabilizing wire 529 may be a K-wire and may be an olive wire with a depth stopper (e.g., a portion of the wire having a diameter larger than the diameter of the opening 528), as shown. The stabilizing wire 529 is inserted through the opening 528 and connected to the first metatarsal bone 202, as shown in the figure, and the stabilizing wire extends from the first metatarsal bone 202 at an oblique angle to the horizontal.

[0068] The second arm 524 is shown to include a retaining element 550 positioned at the end of the second arm 524, the retaining element 550 being releasably coupled to the second arm 524. As shown, the retaining element 550 includes a post 552 (at least as seen in Figures 33 to 34) configured to be received into an opening in the second arm 524 (moving from the sole of the foot toward the instep). In some embodiments, the retaining element 550 is configured in its distal portion to facilitate coupling with the second metatarsal bone 204. The retaining element 550 is configured to be pivotable within the opening of the second arm 524 to facilitate coupling with the second metatarsal bone 204 despite the various lateral geometric shapes of the second metatarsal bone 204.

[0069] The retaining element 550 includes a first element 552 and a second element 560, as further shown in Figures 33 to 34. The first element 552 includes a post 555 (e.g., upper portion) at its upper part and a pair of engaging elements 559, 563 located at its lower part (e.g., opposite the post 555). The post 555 includes a thread (not shown) located at least part thereof, which may be the same as and / or similar to those shown in other similar embodiments previously disclosed herein. The thread is located at the lower part of the post 555. The illustrated engaging elements 559, 563 are a pair of prongs extending from the lower part of the post 555 adjacent to the lower part of the thread. The engaging elements 559, 563 include a pair of extensions 556, 557 extending perpendicularly from the lower part of the post 555 (adjacent to the thread). The engaging elements 559, 563 include a bend along part of them (and at a right angle), and the bend continues substantially parallel to each other between the respective ends of the engaging elements 559, 563. The inner surfaces of the engaging elements 559, 563 (e.g., surfaces facing each other) include a texture configured to induce friction upon contact with bone and to promote bone retention between them.

[0070] As shown in the figure, the retaining element 550 further includes an actuator 560. The actuator 560 is configured to adjust the distance between the engaging elements 559, 563 so that the engaging elements 559, 563 are positioned adjacent to the second metatarsal bone 204, and finally to further adjust the distance between the engaging elements 559, 563 so that contact (e.g., engagement, releaseable connection, etc.) with the second metatarsal bone 204 is initiated. The actuator 560 includes an opening 553 configured to receive a post 555 through the opening 553. The opening 553 further includes threads located on the inner surface of the opening 553, having a geometric shape complementary to the geometric shape of the threads of the post 555, in order to facilitate a screwable and releaseable connection. The actuator 560 also includes a first texture 554 located on the upper part of its outer surface to facilitate gripping and manipulating the actuator 560. The actuator 560 also includes a second texture 562 (larger than the first texture 554). The second texture 562 extends around the actuator 560 (for example, or to another outer dimension) and is located beneath the first texture 554 and above the second texture 564, in a recess. The actuator 560 is configured as follows: When the first element 552 is positioned such that the engaging elements 559, 563 are positioned adjacent to the second metatarsal bone 204, the threads of the post and the opening 553 of the actuator 560 engage, and the actuator can be releasably coupled to the post 555 so as to move the actuator 560 downward along the threads of the post 555. Once the actuator 560 begins to contact the extensions 556, 557, the force applied by the actuator 560 can drive the extensions 556, 557 (and the engaging elements 559, 563) toward each other. (For example, actuator 560 begins to receive at least a portion of extensions 556, 557 into the opening 553 of actuator 560, thereby driving engaging elements 559, 563 closer to each other.) This reduces the space between engaging elements 559, 563, and the medial and lateral surfaces of the second metatarsal bone 204 are gripped by the engaging elements 559, 563 of the retaining element 550.Next, the clamp 500 can be releasably coupled to the post 555 of the retaining element 550 by positioning the clamp such that the opening of the second arm 524 accepts at least a portion of the post 555.

[0071] The clamp 500 is configured to apply force at least medially to the first metatarsal 202 by manipulating the upper part 510 such that the distance between the ends of the first arm 522 and the second arm 524 is reduced, when the interface portion 526 abuts the first metatarsal 202 from the medial side and the retaining element 550 engages the second metatarsal 204 from both the medial and lateral sides. Thus, such force reduces the intramedullary angle between the first metatarsal 202 and the second metatarsal 204 by positioning at least the distal portion of the first metatarsal 202 closer to the second metatarsal 204 prior to the procedure. Furthermore, the clamp 500 is configured such that a space remains between the first arm 522 and the second arm 524 when engaged as described above, allowing for manipulation of the big toe (e.g., "big toe"). Such manipulation may include repositioning the big toe for assessment of soft tissue or manipulating anatomical structures adjacent to the lapidus joint.

[0072] Referring to Figures 31 and 32, the clamp 500 is shown engaged with the foot 200. The interface element 526 is shown to engage with the distal portion of the first metatarsal bone 202, while the retaining element 550 and a portion thereof engage with the distal portion of the second metatarsal bone 204. As shown, the upper part 510 of the clamp 500 can be operated to apply force to the medial surface of the first metatarsal bone 202 so as to reduce the intramedullary angle formed between the central longitudinal axes of the first metatarsal bone 202 and the second metatarsal bone 204. Once the desired correction to the intramedullary angle is achieved, the ratchet 516 can be engaged to hold the clamp in the desired position so that the clamp 500 holds the position that provides the desired correction.

[0073] It should be noted that the clamp 500 and its components may be the same as and / or similar to those previously illustrated and described with reference to clamps 100 and 300, and may also include components that are implemented in combination with clamps 100 and 300. For example, the retaining element 550 may be replaced with the retaining element 125, and vice versa. Similarly, the retaining element 550 and its components may be configured to be releasably coupled to the guide system 400 shown in Figures 23 to 26, or other similar guide or outrigger systems.

[0074] Referring to Figures 35A to 35B, a process or method 3000 for performing a surgical procedure, such as fixation of the rapidus joint (e.g., the first tarsometatarsal joint, aponeurosis correction procedure, etc.) is shown. Process 3000 and its steps may be performed in one or more orders different from the order shown in Figures 35A to 35B. Steps of process 3000 may be omitted, repeated, or performed in an order different from the order shown. In some embodiments, process 3000 may also include performing one or more additional steps not shown in Figures 35A to 35B.

[0075] In some embodiments, process 3000 includes step 3002, in which a first incision is made adjacent to the patient's rapid joint. In some embodiments, the incision in step 3002 may be made in a substantially dorsal-medial position of the rapid joint. Furthermore, the incision in step 3002 may be made using one or more instruments (e.g., scalpels or other incision instruments) provided as part of a surgical kit for performing procedures as illustrated and described with reference to process 3000 and Figures 35A to 35B.

[0076] In some embodiments, process 3000 includes step 3004, which releases and prepares the patient's rapid joint through a first incision. Step 3004 may include various steps and techniques commonly used to release and prepare a joint for arthrodetic procedures such as process 3000. For example, step 3004 may include releasing the rapid joint so that the first metatarsal bone is more easily manipulated in subsequent steps of process 3000. In some embodiments, the incision can be made at the base (e.g., the proximal end) of the first metatarsal bone using the same or similar cutting guides previously shown and described herein. In some embodiments, the incision can also be made in the cuneiform bone in step 3004, and it should be understood that such incision in the cuneiform bone may be made before or after any incision to the first metatarsal bone. In some embodiments, step 3004 may include an incision to the cuneiform bone, along with any incision to the first metatarsal bone made in an earlier or later step. After such an incision, the fragment of the first metatarsal bone (resulting from the incision) is removed from the joint cavity. The lapidus joint and surrounding structures may also be evaluated after joint release and the aforementioned incision, and general adjustments or further manipulations may be performed to achieve the desired outcome. In some embodiments, the distal portion of the first metatarsal bone may be further prepared, for example, by fenestration or other common techniques, to prepare at least a portion of the joint cavity for fixation.

[0077] In some embodiments, process 3000 includes step 3006, in which a second incision is made adjacent to the second metatarsal bone. The incision in step 3006 may be the same as or similar to the incision in step 3008 (e.g., size). In some embodiments, the second incision may be made from a substantially lateral position (e.g., direction) relative to the second metatarsal bone to facilitate access to the second metatarsal bone in subsequent steps of process 3000. In some embodiments, the incision in step 3006 may be made adjacent to the distal portion of one or more anatomical structures, e.g., the second metatarsal bone. As illustrated and described herein, the second incision may be a "stab" incision, but other types and techniques of incisions may be performed by the physician.

[0078] In some embodiments, process 3000 includes step 3008, in which a third incision is made adjacent to the dorsal portion of the first metatarsal bone. In some embodiments, the incision in step 3008 can be made in the distal portion of the first metatarsal bone (e.g., the portion adjacent to the head of the first metatarsal bone), and thus can be made substantially opposite to the first metatarsal bone from the direction of the first incision (distal-proximal). In some embodiments, the third incision may be made substantially medial to the head of the first metatarsal bone to facilitate access to and manipulation of the first metatarsal bone in subsequent steps of process 3000. The third incision in step 3008 may be made adjacent to (and at least with access to) the posterior, lateral, and proximal portions of the head of the second metatarsal bone (where the head is the distal portion of the second metatarsal bone). The incisions in steps 3006 and 3008 may be at least partially within one plane in the frontal plane (for example, substantially equidistant from the nearest portions of the first and second metatarsals, respectively).

[0079] In some embodiments, process 3000 includes step 3010, in which step 3010 releasably connects a first portion of a retaining element to the second metatarsal bone via a second incision. When releasably connecting the first portion of the retaining element, the physician approaches the second metatarsal bone from the dorsal side (e.g., from above) with the first portion of the retaining element in the second incision. The first portion of the retaining element is then inserted until the engaging elements 559, 563 (e.g., prongs, projections, extensions, etc.) contact (or are positioned directly adjacent to) the medial and lateral surfaces (e.g., the flat portion of the lateral part of the second metatarsal bone). The first portion of the retaining element may be, for example, the engaging element 556 of a retaining element 550 as shown in Figures 33 to 34, or it may include other similar portions of other retaining elements shown and described earlier herein. In some embodiments, step 3010 may include the identification and / or manipulation of the extensor tendon by a physician in order to position the first portion of the retaining element.

[0080] In some embodiments, process 3000 includes step 3012, which releasably connects a retaining element to a first arm of a surgical clamp. Step 3012 may include, but is not limited to, the clamp 500 illustrated and described herein, and other clamps described herein. Step 3012 includes aligning the first arm of a surgical clamp, for example, the first arm of the surgical clamp (which may correspond to the second arm 524 of the clamp 500), the naming of the first and second arms of the clamp being arbitrary, and the physician manipulating the first arm of the clamp such that the opening (e.g., the opening 530 of the clamp 500) is a shape complementary to the geometric shape of the upper part of the retaining element (e.g., the post 555 of the retaining element 500). The opening includes a geometric shape complementary to the geometric shape of the upper part of the retaining element (e.g., the post 555). The upper part of the retaining element, when releasably coupled to the clamp, can extend from a downward-upward direction into the opening of the clamp, at least partially through the opening (for example, when the clamp and the retaining element are releasably coupled, the clamp and the opening are positioned above the top of the retaining element).

[0081] In some embodiments, process 3000 includes step 3014, which releasably couples a second portion of a retaining element (also called a cap portion) with a first portion of the retaining element. In some embodiments, step 3014 may also include releasably couplening the cap portion of the retaining element with the upper part of the retaining element so as to hold the distal portion of the first arm of the clamp substantially between the engaging element and the cap portion (and the uppermost part of the upper part of the retaining element). To facilitate coupling the cap portion with the upper part of the retaining element (e.g., the upper part of the post), the cap portion may include an internal thread complementary to an external thread located on the upper part of the post. The cap portion may be positioned above the upper part of the post and coupled via the aforementioned threads such that at least a portion of the post is positioned within the cap portion when the two components are coupled. In the coupled position, the cap portion may be in contact with or adjacent to the upper surface of the distal portion of the first arm.

[0082] Next, refer to Figure 35B. In some embodiments, process 3000 includes step 3016, in which step 3016 positions a portion of the second arm of the surgical clamp adjacent to the first metatarsal bone through a third incision. In some embodiments, the third incision as described in process 3000 is not required, in which case step 3016 may include positioning a portion of the second arm of the surgical clamp adjacent to the first metatarsal bone but outside the skin. The second arm of the clamp (e.g., clamp 500 illustrated and described herein) may correspond to the first arm 522 of clamp 500, where the naming of the first arm and the second arm is arbitrary. With respect to step 3016, the second arm of the clamp may include one or more interface portions in its distal portion, the interface portions extending substantially dorsally (e.g. downward) at an orthogonal or perpendicular angle from the central portion of the second arm. In step 3016, the interface portion can be positioned adjacent to or in contact with the medial portion of the first metatarsal bone by insertion through a third incision (formed in step 3008). The interface portion may have curvature along at least a portion thereof, and step 3016 may include positioning the curvature relative to the medial curvature of the patient's first metatarsal bone. Step 3016 may further include positioning the interface portion such that its opening (e.g., the same as or similar to the opening 528 of clamp 500) is visible to the physician through or adjacent to the third incision.

[0083] In some embodiments, process 3000 includes step 3018, in which step 3018 inserts a first stabilizing wire (e.g., K-wire, olive wire, rotator wire, lever wire, stabilizing member, rotator member, etc.) into the first metatarsal bone through a first incision. The first stabilizing wire may be a conventional K-wire, olive wire, or other stabilizing wires commonly known and used in similar procedures. When inserted into the first metatarsal bone (its proximal portion), the first stabilizing wire may protrude from the first metatarsal bone in a dorsomedial direction. In some embodiments, the physician may determine the placement of the first stabilizing wire in a dorsomedial direction based on an estimate of the desired reduction of the first metatarsal bone. For example, if a large angle of reduction is desired, the first stabilizing wire may be placed more medially than dorsally, while if a small angle of reduction is desired, the first stabilizing wire may be placed more dorsally than medially.

[0084] In some embodiments, process 3000 includes step 3020, which reduces the rotation of the first metatarsal bone. As previously stated, step 3020 can be performed simultaneously with step 3022, which will be described later. Furthermore, in some embodiments, if steps 3020 and 3022 cannot be performed simultaneously, they may be performed in an alternating order. When performing step 3020, the physician manipulates the first stabilizing wire positioned in step 3018 so that, when viewed from the distal portion of the first metatarsal bone, the first metatarsal bone rotates counterclockwise around its central longitudinal axis. To rotate the first metatarsal bone, the physician grasps the first stabilizing wire and applies force thereto, using the first stabilizing wire as a lever, and this force rotates the first metatarsal bone. In some embodiments, this may be done while the intramedullary angle described in step 3022 is reduced. In some embodiments, the physician can perform step 3020 with one hand while maintaining the desired intramedullary correction achieved in step 3022. The first stabilizing wire can also be manipulated by a physician through the implementation of a tool (e.g., a component that assists in gripping the first stabilizing wire and / or applying force to the first stabilizing wire).

[0085] In some embodiments, process 3000 includes step 3022, which reduces the intramedullary angle between the first and second metatarsals. It should be noted that in many surgical procedures, steps 3020 and 3022 can be performed simultaneously, and in some embodiments, it is even advantageous for the physician to perform these two steps simultaneously. Step 3022 may include reducing the intramedullary angle formed between the longitudinal axes extending along the first and second metatarsals by manipulating the handle portion of a clamp (e.g., a handle portion 510 including at least one of the handle elements 512, 514 of clamp 500) so that the distal portion of the first metatarsal approaches the second metatarsal (e.g., moved laterally by the interface portion of the first metatarsal arm to which a lateral force is applied). In some embodiments, the second metatarsal may also be manipulated. In some embodiments, only the first metatarsal may be repositioned while the second metatarsal remains stationary.

[0086] In some embodiments, process 3000 includes step 3024, in which a second stabilizing wire is inserted through a through-hole in the clamp and into the first metatarsal bone through a third incision. In some embodiments, if a third incision is not made, the second stabilizing wire may be inserted percutaneously. The second stabilizing wire in step 3024 may be the same as or similar to the stabilizing wire 529 illustrated and described with reference to the clamp 500. The position of the interface portion in step 3016 is helpful in performing step 3024. This is because the positioning of the opening 528 near the third incision allows the physician to insert the second stabilizing wire into the opening of the interface portion (e.g., the same as or similar to the opening 528) and into the first metatarsal bone through the opening. Once coupled to the patient's first metatarsal bone through the opening of the interface portion and engaged with the clamp, the second stabilizing wire can be held in the desired position by the aforementioned features of the clamp. Furthermore, in some embodiments, the second stabilizing wire may be an olive wire (or possibly a threaded olive wire) including a depth stopper (for example, a portion on the shaft of the wire having a diameter larger than the diameter of the opening of the clamp interface portion).

[0087] In some embodiments, process 3000 includes step 3026, in which one or more guide instruments are releasably coupled to a retaining element. The guide in step 3026 includes the guides shown and described in Figures 23 to 26, or other alternative cut guides. The guide in step 3026 may be configured to be releasably coupled to the cap portion and / or other portion of the retaining element so that the guide can be coupled and positioned while the clamp remains engaged with the first and second metatarsals. The guide instruments may include guides configured to guide one or more incisions into the medial cuneiform bone, the guide instruments may refer to the second metatarsal bone and / or other adjacent anatomical structures. In some embodiments, the guide instruments are configured to guide an incision into the distal surface of the medial cuneiform bone, the distal surface of the medial cuneiform bone being substantially parallel to the surface of the proximal portion of the first metatarsal bone after an incision has been made in process 3000 (to prepare and release the joint).

[0088] In some embodiments, process 3000 includes step 3028, in which one or more incisions are made in the patient's medial cuneiform bone to prepare the articular space for fixation. As described in step 3026, the incision in step 3028 may be guided by a guide instrument so that the incision into the medial cuneiform bone is made such that the resulting distal surface of the medial cuneiform bone is substantially parallel to the already prepared proximal surface of the first metatarsal bone. The incision in step 3026 may be made using a reciprocating saw or other similar instrument commonly used when making similar incisions in similar surgical procedures. After the incision in step 3028 has been made, the guide instrument may be removed from the cap portion and / or retaining element. The articular space of the rapidus joint may also be prepared for fusion (e.g., a fenestrated surface).

[0089] According to several embodiments, process 3000 includes step 3030, in which step 3030 applies a fixation device across the rapidus joint. Step 3030 also includes positioning the first metatarsal bone and the medial cuneiform bone in a desired orientation for fixation. To achieve this orientation, the physician can dorsiflex the big toe (e.g., "big toe") and engage it with the windlass mechanism, positioning the big toe between the arms of the clamp (the arms of the clamp are designed to leave space for dorsiflexion of the big toe). Next, the physician positions third and fourth stabilizing wires across the joint to stabilize it. Once these third and fourth stabilizing wires are in place, a fixation device (e.g., a plate, fixation device, etc.) is applied across the joint and bonded to both the first metatarsal bone and the medial cuneiform bone. After the fixation device is fixed, the clamp is removed (including the second stabilizing wire) and the incision is closed.

[0090] It should be noted that the steps of Process 3000 can be performed in a different order, steps can be added, steps can be omitted, steps can be repeated, or the procedure for Rapidus can be modified in a different way when performing the Rapidus procedure as illustrated and described herein. For example, before fixing the fixation device to the first metatarsal and first cuneiform bones, the physician can manipulate the surrounding structures to ensure that such structures maintain functional and structural stability and otherwise provide the necessary balance to the patient. Similarly, in some embodiments, one or more incisions can be made in the first metatarsal and / or medial cuneiform bones. For example, the physician may make a first incision and determine that a larger amount of bone needs to be removed, and then make a second incision, either the same or using a second guide instrument. In another exemplary procedure, Process 3000 may be modified so that the physician makes incisions (same or similar to those described herein) in the first metatarsal and medial cuneiform bones before applying surgical clamps (e.g., those illustrated and described herein). Incisions into the first metatarsal bone and medial cuneiform bone can be made using one or more cutting guides (or other similar cutting guides) as shown and described herein, which are angled to guide the incisions and achieve the desired correction. The desired correction of the joint can be achieved by applying surgical clamps (which are operated as described herein), and fixation devices (intramedullary nails, plated nails, etc.) are applied before removing the surgical clamps.

[0091] Referring to Figures 36 to 38, a system 3100 for positioning an orthopedic implant according to this disclosure is shown. As illustrated, the system 3100 includes a placement mechanism 3102 configured to facilitate the placement of one or more orthopedic implants (e.g., plates, intramedullary nails, other orthopedic implants, and / or fixation devices), for example, the illustrated implant 3112. The placement mechanism 3102 may be configured to be releasably or otherwise coupled with the implant 3112. This facilitates insertion through a skin opening and / or intraoperative manipulation of the implant 3112 and / or a portion of an anatomical structure. In some embodiments, the system 3100 may be configured to allow the implant to be accepted by a specific portion of an anatomical structure (e.g., the placement mechanism 3102 may have one or more features / components that facilitate coupling with a particular implant to a particular anatomical structure). The system 3100 may also include additional components to those shown in the exemplary embodiments of Figures 36 to 38. For example, fasteners (e.g., screws), alignment guides, drills / drill bits, and other components common to orthopedic systems are included. Similarly, system 3100 (or one or more of its components) can be implemented in conjunction with other systems. For example, the placement mechanism 3102 can be implemented with various implants, alignment systems, or other hardware or software components.

[0092] The placement mechanism 3102 is shown to include a body 3103 having a substantially cylindrical shape, but the body 3103 may have alternative geometric shapes and dimensions in other embodiments. In some embodiments, the body may include a textured outer surface or an alternative geometric shape to the outer surface (e.g., a textured outer surface or an ergonomically designed outer surface). The body 3103 includes a cannula insertion section, as shown in the cross-sectional view of Figure 38. This cannula insertion section extends from a first end 3104 to a second end 3108 of the body, centered on the longitudinal axis of the body 3103. The cannula insertion section of the body 3103 terminates at an opening 3106 at the first end 3104 and similarly at an opening at the second end 3108 (not shown). In some embodiments, the body 3103 may be substantially symmetrical in cross-section about its longitudinal axis and / or about a midline positioned between a first end 3104 and a second end 3108 extending perpendicularly to the cannula insertion section of the body 3103. The shape and dimensions of the cannula insertion section can vary depending on several embodiments of the system 3100. For example, the cannula insertion section of the body 3103 may be configured to accept one or more other components, such as a fixing / stabilizing wire, fasteners, drills and / or drill bits, alignment guides, or other instruments and components common in orthopedic procedures. Furthermore, the placement mechanism 3102 may be operable around one or more components positioned at least partially within the cannula insertion section of the body 3103. For example, a stabilizing wire may be positioned within the cannula insertion section of the body 3103 (and extending through part of the implant 3112) and bond to at least part of the bone. This allows the placement mechanism to be detached from any implant (if it is coupled to such an implant) and withdrawn on the stabilizing wire. In some embodiments, the system 3100 may include components of a size such that they are received by the cannula insertion section of the main body 3103 and are operable therein.

[0093] The arrangement mechanism 3102 is further shown to include a coupling mechanism 3110 extending from a second end 3108 of the main body 3103. As shown, the coupling mechanism 3110 includes a pair of extensions positioned substantially diametrically opposite to each other at the second end 3108 of the main body 3103, each of which extends from the outer surface of the second end 3108. It should be understood that alternative embodiments of the system 3100, and / or any of its components, may include alternative coupling mechanisms similar to the illustrated coupling mechanism 3110. For example, the coupling mechanism 3100 may include even more or fewer extensions, which may be arranged in configurations different from those of the exemplary embodiments in Figures 36 to 38, and may have alternative shapes (e.g., longer / shorter lengths, curvature, radius of curvature, etc.). In some embodiments, the coupling mechanism 3110 (including any extensions or any other components, such as those illustrated and described herein) may extend from the body 3108 in other ways. For example, the coupling mechanism 3110 and any of its components (e.g., extensions) may be integral with the body 3103, or may extend from the second end 3108 adjacent to the opening of the second end 3108, which is the end of the cannula insertion portion of the body 3103.

[0094] As shown in Figures 36 to 38, the system 3100 includes a placement mechanism 3102 releasably coupled to the second metatarsal bone 3150 via a coupling mechanism 3110. The system 3100 further includes an implant 3112, shown as a plate in the exemplary embodiments of Figures 36 to 38, and positioned between the second end 3108 of the placement mechanism 3102 and the upper surface of the second metatarsal bone 3150. Since the system 3100 may include various implants of alternative sizes and / or geometric shapes, implant 3112 is intended to be exemplary. Similarly, the system 3100 and its components can be implemented in the treatment of parts of anatomical structures other than the second metatarsal bone (e.g., other bones such as the foot, ankle, hand, wrist). For example, the placement mechanism 3102 and its components may have alternative geometric shapes (e.g., a longer coupling mechanism) to couple with larger / smaller implants and parts of anatomical structures. In some embodiments, the implant 3112 may be releasably coupled to the placement mechanism 3102 via one or more coupling mechanisms (for example, the geometry of the coupling mechanism 3110 may hold the implant 3112 adjacent to the second end 3108 of the placement mechanism 3102 via one or more of a notch, a compression fit, or other known coupling configurations). The placement mechanism 3102 (whether or not the implant 3112 is releasably coupled) can be releasably coupled to the second metatarsal bone 3150 substantially from a dorsal direction (as shown), and the placement mechanism 3102 is pressed down onto the upper surface of the second metatarsal bone 3150. In alternative embodiments and alternative geometry, the placement mechanism 3102 may be positioned, positioned, and / or coupled in a different manner. In some embodiments, the coupling mechanism 3110 (and any of its components) can receive the second metatarsal bone 3150 so as to be releasably coupled to the second metatarsal bone 3150.In some embodiments, the coupling mechanism 3110 (and its components) may be flexible or otherwise operable, have a geometric configuration that pushes against the placement mechanism 3102, and operate the coupling mechanism 3110 such that the coupling mechanism 3110, which is pressed down onto the upper surface of the second metatarsal bone 3150, extends at least partially around the second metatarsal bone 3150.

[0095] The placement mechanism 3102 can be grasped by the physician at the main body portion 3103 and manipulated relative to the second metatarsal bone 3150. For example, the physician can manipulate the placement mechanism 3102 like a joystick, so that the placement mechanism 3102 and implant 3112 can translate around the surface of the second metatarsal bone 3150 (e.g., distal, proximal, medial, and lateral movements to reposition the placement mechanism 3102 and implant 3112 around the surface of the second metatarsal bone 3150). Once the desired position is reached, the physician can insert a stabilizing wire through the opening 3106 into the cannula insertion portion of the main body 3013 and through the opening of the implant 3100 into the second metatarsal bone 3150. This allows the placement mechanism 3102 and implant 3112 to be held relative to the second metatarsal bone 3150. Once the stabilization wire is in place, the physician can again manipulate the placement mechanism 3102 (similar to using a joystick) to manipulate the second metatarsal bone 3150 (since system 3100 is coupled to the second metatarsal bone 3150). The physician can then remove the placement mechanism 3102 from the stabilization wire (this disengages the placement mechanism 3102 from the second metatarsal bone 3150). Alternatively, the physician may install additional surgical instruments (e.g., cannula insertion drill, fasteners, etc.) on the stabilization wire and within the cannula insertion section of body 3103 to further the ongoing procedure. Finally, the stabilization wire is removed before the procedure is completed. This process may be repeated multiple times using various instruments and components. As shown in the figure, the placement mechanism 3102 is coupled to the end of implant 3112 adjacent to the end opening of implant 3100. However, the placement mechanism 3102 may be releasably coupled to the implant 3112 at various points along the length of the implant 3112, for example, at each opening of the implant 3112. Thus, the physician can releasably couple and uncouple the placement mechanism 3102 to the implant 3112 multiple times at multiple locations along the implant 3112, and perform the same or similar surgical steps described above at each respective coupling location.In some embodiments, a physician may implement multiple systems 3100 and / or their components in a single procedure, for example, two placement mechanisms 3102 simultaneously coupled to a single implant 3112, or two systems 3100 each releasably coupled to different bones or bone portions.

[0096] Referring to Figures 39 to 54, exemplary embodiments of System 4100 are shown that are implemented when performing a procedure on one or more anatomical structures of the foot (e.g., a procedure on the rapidus joint, such as arthrodesis or other similar fixation procedures). System 4100 may include a clamp 4102 and one or more other components, such as one or more surgical guides as illustrated herein, as illustrated and described herein. Furthermore, System 4100 may be implemented in the execution of one or more steps of the method illustrated and described with reference to Figure 66. Furthermore, System 4100 may include one or more additional components (e.g., incision instruments, saws, scalpels, forceps, retractors, etc.) in addition to those illustrated and described herein, and it should be understood that the method illustrated and described with reference to Figure 66 may incorporate such additional components.

[0097] Figures 39 to 54 show exemplary instruments, indicated as clamp 4102, for determining, aligning / realigning, modifying, positioning / repositioning, rotating / de-twisting, or otherwise manipulating one or more anatomical structures of the foot relative to other anatomical structures of the foot. As illustrated and described herein, clamp 4102 is configured to releasably connect to the structure of foot 4200 (indicated as reference numeral 4200), including the first metatarsal bone (indicated as reference numeral 4202) and the second metatarsal bone (indicated as reference numeral 4204), as illustrated and described in Figures 47 to 53, thereby allowing manipulation of the rapidus joint (indicated as reference numeral 4208) formed between the first metatarsal bone 4204 and the medial cuneiform bone (indicated as reference numeral 4206). In some embodiments, the clamp 4102 may be mounted on the distal portion between the first metatarsal bone 4202 and the second metatarsal bone 4204, or it may be mounted at other locations around the first metatarsal bone 4202 and the second metatarsal bone 4204. The clamp 4102 (and its components) is configured to facilitate correction of the IM angle formed between the first longitudinal axis of extension of the first metatarsal bone 4202 and the second longitudinal axis of extension of the second metatarsal bone 4204. Furthermore, the clamp 4102 is configured to facilitate detorsion of the first metatarsal bone 4202 relative to the second metatarsal bone 4204 (e.g., rotation opposite to the rotation that caused hallux valgus or other deformity). Correction and / or reduction of the IM angle of the first metatarsal bone 4202 relative to the second metatarsal bone 4204 may be performed by a physician in treatment to address deformities of the lapidus joint or its vicinity (e.g., hallux valgus, arthrodesis of the lapidus joint, etc.).

[0098] The clamp 4102, as shown in the figure, includes a first portion 4104 and a second portion 4106, the first portion 4104 being releasably coupled to the second portion 4106 by or in the coupling 4108. In some embodiments, the coupling 4108 may include a coupling mechanism (e.g., a screw and a complementary bore), the first component of which is coupled to or integrated with the first portion 4104, and the second component, complementary to the first component, is coupled to or integrated with the second portion 4106. Furthermore, in some embodiments, the coupling 4108 may include a portion of the coupling mechanism, the portion of which is configured to extend at least partially within the second portion 4106. Such portion of the coupling mechanism can be coupled to or integrated with the first portion 4104, and can further extend at least partially within the opening of the second portion 4106. In some embodiments, at least a portion of the coupling may include an incremental marker (e.g., an indicator, a measuring marker, etc.) indicating the expansion of the clamp 4102. The coupling 4108 (and any of its components) can also facilitate the movement of the first portion 4104 relative to the second portion 4106, or the movement of the second portion 4106 relative to the first portion 4104. In some embodiments, an actuator 4124 (e.g., a knob, etc.) positioned substantially along the longitudinal axis of the second portion 4106 may be configured to releasably couple with a portion of the second portion 4106 of the clamp 4102. For example, the actuator 4124 may include a projection (e.g., a male component with threads, a set screw, etc.) which extends longitudinally through a bore into a bore positioned in the second portion 4106 of the clamp and facilitates a releasable coupling (e.g., complementary threads, etc.) in the coupling 4108 with the first portion of the clamp 4104. In some embodiments, the bore may include a coupling mechanism (e.g., a thread) configured to be releasably coupled to a complementary portion of the actuator 4124 (e.g., the projection which may have a coupling mechanism such as a thread).Therefore, operation of the actuator 4124 via the texture 4126 (for example, to facilitate gripping, rotation, manipulation, etc.) can extend the clamp 4102 by translating the second portion 4106 toward the first portion 4104 or away from the first portion 4104. In some embodiments, the translation can be performed along a longitudinal axis (e.g., a common axis) shared by one or more of the actuator 4124, the projection from the actuator 4124, the bore of the second portion 4106, and any complementary coupling mechanisms of the first portion 4104. Furthermore, the first portion 4104 and the second portion 4106 can be coupled so that one or both of these portions are operable about a longitudinal axis (e.g., a shared / common axis).

[0099] As shown in the figures, the second portion 4106 of the clamp 4102 includes a pair of projections 4118 extending laterally from the second portion 4106. As shown in Figures 39 to 54, the projections 4118 are positioned along the second portion 4106 such that the pair of projections are equidistant from the coupling 4108 and are further positioned closer to the actuator 4124 than to the coupling 4108. In some embodiments, the actuator 4124 may include at least a portion of a coupling mechanism configured to complement the coupling mechanism of the coupling 4108. For example, the actuator 4124 may include an extension having threads configured to be received within at least a portion of the coupling 4108. In some embodiments, the extension of the actuator 4124 may be configured to releasably couple the second portion 4106 to the first portion 4104 via the coupling 4108. Although the projections 4118 are shown to be substantially hemispherical, in some embodiments of the clamp 4102, the projections 4118 may have an alternative geometric shape. Each projection is indicated to include a bore 4120, which has a substantially cylindrical shape and extends from the top to the bottom of the second portion 4106, establishing fluid communication between them. The bore 4120 may be configured to receive one or more common surgical instruments, such as stabilization wires, K-wires, olive wires, and / or other stabilizing elements, so as to releasably connect the second portion 4106 to the second metatarsal bone 4204.

[0100] As shown in Figures 47 to 53, the stabilization wire is positioned so that it is received by bore 4120, and the wire can be inserted into the substantially dorsal portion of the second metatarsal bone 4204 (positioned closer to the proximal end than the distal end of the second metatarsal bone 4204, as shown in Figures 47 to 53). For example, as shown in Figure 50, one of the bores 4120 is shown to receive a second stabilization wire 4148, and the second of the two bores 4120 is shown to be empty. In some embodiments, the physician may choose to place the stabilization wire (e.g., the second stabilization wire 4148) in one of the bores 4120 rather than placing a stabilization wire in each of the bores 4120. When the clamp 4102 is releasably coupled to the second metatarsal bone 4204 via a stabilizing wire received through the bore 4120, the second part 4106 of the clamp 4102 can be configured to be in a stationary position (for example, the first part 4104 is translated toward the second part 4106 and the second metatarsal bone 4204 by operation of the actuator 4124, while the second part 4106 fixed to the second metatarsal bone 4204 remains stationary). In some embodiments, the bores 4120 may have different sizes (e.g., both large, both small, or one large / one small) and / or geometric shapes (e.g., rectangle, triangle, etc.) to accommodate the corresponding geometric shapes of various stabilizing elements. Each of the pair of projections 4118 is shown to be of equal size, but in some embodiments, the second portion 4106 of the clamp 4102 may include one, two, or more projections, which are the same as or similar to the projections 4118 (of equal or different sizes) arranged in various ways along the second portion 4106. Furthermore, in some embodiments, one or more of the projections 4118 may include zero, one, two, or two or more bores arranged in various ways around the projection 4118. As shown, each of the bores 4120 is positioned substantially equidistant from the outer edge of the projection 4118, but in some embodiments of the clamp 4102, the bores 4120 may be arranged alternately.

[0101] As shown in the figures, the second portion 4106 of the clamp 4102 includes an extension 4110 configured from the coupling 4108 on the opposite side of the second portion 4106. The extension 4110 extends from the second portion 4106 at an angle substantially perpendicular to the second portion 4106 at a location adjacent to the actuator 4124, as shown in Figures 39 to 54. As shown in the figures, the extension 4110 has a substantially rectangular cross-sectional shape, although in some embodiments of the system 4100 it may have an alternative shape. The extension 4110 includes a retaining mechanism 4114 (for example, on the opposite side of the second portion 4106 adjacent to the actuator 4124), shown in Figures 39 to 54 as a pair of projections located at the distal end of the extension 4110, defining a cavity 4116 substantially located between the pair of projections of the retaining mechanism 4114. As shown in the figure, the retaining mechanism 4114 is integral with the extension 4110 and is substantially curved toward the first portion 4104 of the clamp 4102 (for example, adjacent to the tangent of the curvature which is substantially perpendicular to the second portion 4106). The distal portion of the retaining mechanism 4114 is substantially oriented toward the first portion 4104 of the clamp 4102. The cavity 4116 is shown to have a substantially semi-elliptical geometric shape, and this semi-elliptical geometric shape is located in the most proximal portion of the cavity 4116. However, in some embodiments, the cavity 4116 (and the retaining mechanism 4114) may have alternative thickness / width, length, depth, curvature, and other geometric characteristics.

[0102] The extension 4110 and the retaining mechanism 4114 are configured to at least partially interface (e.g., engage, contact, etc.) with the flat portion of the second metatarsal bone 4204, which is positioned substantially laterally to the second metatarsal bone 4104, as shown in Figures 47 to 53. The retaining mechanism 4114, including its distal portion, can be configured to contact the substantially lower portion of the flat portion on the lateral side of the second metatarsal bone 4204. As shown, the curvature of the distal portion of the retaining mechanism 4114 is configured to at least partially surround the second metatarsal bone 4204. This causes the retaining mechanism 4114 to contact (and thus engage with multiple surfaces of) the plantar surface of the second metatarsal bone 4204. Thus, the curvature of the retaining mechanism 4114 adapts to the geometric shape of the second metatarsal bone 4204. This allows force to be applied to the second metatarsal bone 4204 via the retaining mechanism 4114 (for example, by applying force medially and / or upward on the lateral and / or plantar surface of the second metatarsal bone 4204), thereby maximizing the engagement between the retaining mechanism 4114 and the second metatarsal bone 4204. Thus, the retaining mechanism 4114 can apply more force to the second metatarsal bone 4202 (for example, by operating the actuator 4124 to translate one or both of the first portion 4104 and the second portion 4106 toward or toward each other, causing the extension 4110 and / or the retaining mechanism 4114 to contact the second metatarsal bone 4204), thereby maximizing the engagement of the extension 4110 of the second portion 4106 of the clamp 4102 with the second metatarsal bone 4204 and reducing / preventing the loss of contact / engagement between the clamp 4102 and the second metatarsal bone 4204. In some embodiments, the cavity 4116 may be configured to accept (for example, allow passage of) one or more stabilizing wires.

[0103] The first portion 4104 of the clamp 4102 is shown to have a substantially curved geometric shape (e.g., convex), and the curvature of the first portion 4104 is substantially oriented toward the direction of the second portion 4106. The first portion 4104 includes an opening 4130 located substantially in the distal portion 4128 (e.g., distal half) of the first portion 4104. The opening 4130, shown in Figures 39 to 54, has an elongated round geometric shape (e.g., elliptical, oblong, etc.) and has the same curvature as the first portion 4104. The opening 4130 is located within an inner recess 4133 on the concave surface and an outer recess 4134 on the convex surface of the first portion 4104. The inner recess 4133 and the outer recess 4134 are shown to have similar dimensions of depth, length, and width, and have greater length and width than the opening 4130, which has the same / similar geometric shape. Furthermore, the inner recess 4133 and the outer recess 4134 are located at substantially the same position on the respective surfaces of the distal portion 4128 of the first portion 4104.

[0104] It has been further shown that the first part 4104 includes an actuator 4136 having a first part 4138 and a second part 4140, the first part 4138 and the second part 4140 separated by a connector 4139. As shown, the connector 4139 has a cross-sectional shape substantially smaller than the cross-sectional shape of the first part 4138 or the second part 4140. In some embodiments, the connector 4139 may include an extension having at least a portion of a coupling mechanism (e.g., a thread) configured to be complementary to an opening positioned substantially along the longitudinal axis of the first part 4138. Thus, such a coupling mechanism can facilitate a releasable coupling between the first part 4138 and the second part 4140 of the actuator 4136. As shown in Figures 39 to 54, the connector 4139 has a substantially cylindrical geometric shape with a diameter / lateral dimension slightly smaller than the diameter / lateral dimension of the opening 4130. As shown in Figures 39 to 54, the first portion 4138 has a substantially cylindrical shape with a diameter slightly smaller than the width of the outer recess 4134. As shown, the second portion 4140 also has a lateral dimension slightly smaller than the width of the inner recess 4133. As shown in Figures 39 to 54, the connector 4139 is positioned such that at least a portion of it is located within the opening 4130. Similarly, the most distal portion of the first portion 4140 is located within the outer recess 4134, and the most distal portion of the second portion 4140 is located within the inner recess 4133. Thus, the range of motion of the actuator 4136 is defined by the dimensions of the opening 4130 (and, in some embodiments, the inner recess 4133 and the outer recess 4134). The actuator 4136 is operated through a defined range of motion along the curvature of the first portion 4104. The boundary of the range of motion is defined by the opening 4130 (and, in some embodiments, the inner recess 4133 and / or the outer recess 4134). The actuator 4136 also includes a texture 4142 on the outer surface of the first portion 4138 of the actuator 4136, the texture being configured to facilitate gripping and / or manipulation of the actuator 4136 (e.g., rotation through a range of motion).

[0105] To establish fluid communication along the length of the actuator 4136, the actuator 4136 includes a bore 4144 extending along the longitudinal axis of the actuator 4136 from a first portion 4138 through a connector 4139 to a second portion 4140. As shown in Figures 39 to 54, the bore 4144 has a substantially cylindrical geometric shape configured to receive a stabilizing wire (e.g., a K-wire, an olive wire, etc.), which can pass through the bore 4144 within the bore 4144 of the actuator 4136. Referring to Figures 47 to 53, the first stabilizing wire 4148 is received by the bore 4144 and can be inserted (e.g., releasably coupled) into the first metatarsal bone 4202 (as shown, the substantially medial portion of the first metatarsal bone 4202). Therefore, when the first stabilizing wire 4146 is positioned within the first metatarsal bone 4202, the actuator 4136 is releasably coupled to the first metatarsal bone 4202. By operating the actuator 4136 within the range of motion defined by the movement of the connector 4139 within the opening 4130, the first metatarsal bone 4202 is moved accordingly.

[0106] Figure 47 shows the actuator 4136 in a first position 4150, releasably coupled to the first metatarsal bone 4202 via a first stabilizing wire 4146. The actuator 4136 is coupled such that the distal surface of the second portion 4140 of the actuator 4136 is located on or near the surface of the first metatarsal bone 4202 (substantially the medial surface, as shown). As shown, in the first position 4150, the connector 4139 of the actuator 4136 is at its lowest position within the opening 4130 such that a portion of the connector 4139 abuts against the edges of the medial recess 4133 and the lateral recess 4134 (thus the first portion 4138 of the actuator 4136 is at the bottom of the lateral recess 4134, and the second portion 4140 of the actuator 4136 is at the bottom of the medial recess 4133). The substantially upward movement of the actuator 4136 from the first position 4150 to the second position 4152 (as shown in Figure 48) substantially rotates (or reverses) the first metatarsal bone 4202 around its longitudinal axis. For example, to correct a deformity or part of another problem of the rapidus joint 4208 (or its components, e.g., a rotated first metatarsal bone 4202), a physician may operate the actuator 4136 from the first position 4150 to the second position 4152. In this way, the first metatarsal bone 4202 is rotated / de-torsed in the frontal plane, thereby correcting the rotational deformity of the first metatarsal bone 4202. In some embodiments, the actuator 4136 may be in a third position between the first position 4150 and the second position 4152 when coupled to the first metatarsal bone 4202 by a first stabilizing wire 4146. Similarly, in some embodiments, the actuator 4136 may be operated by a physician to, for example, a fourth position between the third position and the second position 4152, and so on. When the actuator 4136 is operated using the texture 4142, a set of notches 4132 within the outer recess 4134 is visible. The notches 4132 indicate incremental movement as the actuator is operated around a defined range of motion (for example, defined by the opening 4130 and the connector 4139 located therein).In some embodiments, the notches 4132 can correspond to increments of the setting (for example, each notch may represent a rotation of 5 degrees, 10 degrees, or 15 degrees).

[0107] Once the clamp 4102 is secured to the foot 4200, the actuator 4136 is releasably coupled to the first metatarsal bone 4202 via a first stabilizing wire 4146, and at least a second stabilizing wire 4148 (if there are not multiple second stabilizing wires) is releasably coupled to the second portion 4106 to the second metatarsal bone 4204, and one or both of the actuators 4124, 4136 can be operated (e.g., actuated) to position / reposition the first and / or second metatarsals 4202, 4204 in one or more anatomical planes. For example, actuator 4124 is operated to move the first portion 4104 substantially laterally along the longitudinal axis of actuator 4124 (e.g., toward the second portion 4106 as indicated by the double arrow in Figure 48) (e.g., rotating as in the knob / set screw configuration shown in the exemplary embodiments of Figures 39 to 53). Therefore, with the first part 4104 coupled to the first metatarsal bone 4202 via the actuator 4136 and the first stabilizing wire 4146, such movement of the first part 4104 (a substantially lateral movement toward the second part 4106 along the longitudinal axis of the actuator 4124) manipulates the first metatarsal bone 4202 such that the IM angle between the first metatarsal bone 4202 and the second metatarsal bone 4204 (e.g., the angle formed by the longitudinal axes of the first and second metatarsal bones 4202 and 4204) decreases. When such force is applied, the clamp 4102 and its various components remain releasably coupled to and / or otherwise in contact with one or more parts of the first metatarsal bone 4202 and the second metatarsal bone 4204.

[0108] As previously mentioned, the first metatarsal bone 4202 can be further positioned / repositioned by the operation of the actuator 4136 (after the second portion 4106 is coupled to the second metatarsal bone 4204). The operation of the actuator 4136 (via the first portion 4138) within the range of movement defined by the opening 4130 and the connector 4139 located therein (for example, from the first position 4150 in Figure 47 to the second position 4152 in Figure 48, as indicated by the arrow in Figure 48) applies a rotational force to the first metatarsal bone 4202 in the frontal plane (for example, to address rotational deformation) so as to rotate / de-twist the first metatarsal bone. While such a force is applied to the first metatarsal bone via the actuator 4136, the first part 4104, the second part 4106 and other components of the clamp 4102 remain stationary, functioning as releasable connections with the first metatarsal bone 4202 and the second metatarsal bone 4204 (for example, a second stabilizing wire 4148 releasably connecting the second part 4106 to the second metatarsal bone 4202, a retaining mechanism 4114 in contact with at least one surface of the second metatarsal bone 4202, a releasable connection between the actuator 4136 and the first metatarsal bone 4202 via the first stabilizing wire 4146, etc.).

[0109] Referring to Figures 50 to 51, as shown, the surgical guide 4300 is coupled to the proximal portion of the first metatarsal bone 4202 adjacent to the rapidus joint 4208. In some embodiments, the surgical guide 4300 may be provided in a kit or other system together with the system 4100 and / or one or more implants and / or fixation components (as well as various other instruments / components). Furthermore, in some embodiments, the surgical guide 4300 may be configured to facilitate one or more incisions made to the first metatarsal bone 4202. The surgical guide 4300 includes a handle 4302 extending laterally from the cutting guide 4304 of the surgical guide 4300. As shown, the end of the handle 4302 includes a tactile finish configured to facilitate the grip of the handle 4302 of the surgical guide 4300. The cutting guide 4304 includes a slot 4312 located in the central portion of the cutting guide 4304. Figures 50 to 51 show a slot 4312 having a substantially elongated geometric shape configured to receive one or more cutting instruments (e.g., a reciprocating saw). In some embodiments, the slot 4312 may have an alternative geometric shape and / or dimensions, for example, the slot 4312 may have a length and / or width dimension that is greater or smaller than the length and / or width dimension of the illustrated slot. The cut guide 4304 further includes a projection 4306, as shown, which extends laterally from the side of the cut guide 4304 opposite to the side from which the handle 4302 extends. The projection 4306 includes a bore 4308 substantially in the center of the upper surface of the projection 4306, which extends from the upper surface of the projection 4306 to its bottom surface, thereby establishing fluid communication between the upper and bottom surfaces of the projection 4306. As shown in the figure, bore 4308 receives through it a stabilizing wire 4310 (which may be the same as and / or similar to the first and / or second stabilizing wires 4146, 4148), thereby allowing the stabilizing wire 4310 to releasably connect the surgical guide 4300 to the proximal portion of the first metatarsal bone 4202.In some embodiments, for example, the exemplary surgical guide 4300 shown in Figure 51, the projection 4306 may include a plurality of bores 4308, for example, a pair of bores 4308 as shown. In some embodiments, one or more stabilizing wires 4310 can be received through the bores 4308, and the surgical guide 4300 can be releasably coupled to the first metatarsal bone 4202 at one or more locations. Furthermore, in some embodiments, the surgical guide 4300 may include projections (e.g., paddles, not shown in Figures 50 to 51) configured to be inserted into the articular space of the rapidus joint 4208 (e.g., between the first metatarsal bone 4202 and the medial cuneiform bone 4206).

[0110] Referring to Figure 52, as shown, the surgical guide 4400 is coupled to the distal portion of the medial cuneiform bone 4206 and the proximal portion of the first metatarsal bone adjacent to the rapidus joint 4208. In some embodiments, the surgical guide 4400 may be provided in a kit or other system together with a clamp 4100 and / or one or more implants and / or fixation components (as well as various other instruments / components). Furthermore, in some embodiments, the surgical guide 4400 may be configured to facilitate one or more incisions made in the medial cuneiform bone 4206. The surgical guide 4400 includes a body 4401 rotatably coupled to a cutting guide 4402 in a coupling 4403. The cutting guide 4402 includes a slot 4405 located in the central portion of the cutting guide 4402. As shown in Figure 52, the slot 4405 has a substantially elongated geometric shape configured to receive one or more cutting instruments (e.g., a reciprocating saw). In some embodiments, slot 4405 may have an alternative geometric shape and / or dimensions, for example, slot 405 may have a length and / or width dimension greater than or less than the length and / or width dimension of the illustrated slot. As shown, coupling 4403 includes a projection of a body 4401 having a substantially cylindrical shape, which is received by a bore of a cut guide 4402 having a complementary cylindrical shape. This allows coupling 4403 to enable the rotational movement of the cut guide 4402 relative to the body 4401. The body 4401 is shown to include a base 4408, the base 4408 including a pair of bores 4410. The bores 4410 are configured to receive one or more stabilizing wires to facilitate a releaseable connection between the surgical guide 4400 and the medial cuneiform bone 4206 (each bore 4410 may be the same as and / or similar to those previously shown and described herein). The cut guide 4402 includes transverse members 4404 extending on both sides from the most distal portion of the cut guide 4402. The transverse members 4404 are provided with a pair of bores 4406 located at the distal portion of each segment of the transverse member 4404, each bore 4406 configured to receive a stabilizing wire (such as those illustrated and described herein).The cut guide 4402 can be pivoted relative to the body 4401 such that one end of the bore 4406 is positioned adjacent to the medial cuneiform bone 4206 and the other end of the bore is positioned adjacent to the first metatarsal bone 4202. Thus, the transverse member 4404 and its bore 4406 are configured to facilitate connection with the first metatarsal bone 4202 and / or the medial cuneiform bone 4206 after being pivoted relative to the body 4401 (by the cut guide 4402). The body further includes a projection 4412 configured to be positioned within the articular space of the rapidus joint 4208 (for example, between the distal portion of the medial cuneiform bone 4206 and the proximal portion of the first metatarsal bone 4202).

[0111] Referring to Figure 54, a fixation system 4500 on the foot 4200 is shown. The fixation system 4500 shown in Figure 54 is by no means limited and may include one or more other fixation system elements, such as intramedullary nails, one or more plates and / or fasteners, drills, etc. The system 4500 partially shown in Figure 45 includes a pair of wires 4502, including a first wire 4504 and a second wire 4506. As shown, the first wire 4504 is inserted from an anterior to posterior direction into the posterior aspect of the proximal portion of the first metatarsal bone 4202. In some embodiments, the first wire 4504 may traverse the rapidus joint 4208 (or, if the joint is already ready for fixation, where the rapidus joint 4208 was previously located) and extend into the medial cuneiform bone 4206. The second wire 4506 is shown to be inserted medially-to-laterally into the medial surface of the first metatarsal bone 4202, exit from the lateral surface of the first metatarsal bone 4202, and be inserted into the medial surface of the second metatarsal bone 4204. In some embodiments, the second wire 4506 may extend out from the lateral side of the second metatarsal bone 4204. The pair of wires 4502 is configured to provide temporary fixation, and / or stability, and / or immobility, of the first metatarsal bone 4202, the second metatarsal bone 4204, the medial cuneiform bone 4206, and / or other anatomical structures adjacent to the rapidus joint 4208. In some embodiments, the pair of wires 4502 can be positioned before the implantation of fixation elements (e.g., intramedullary nails, one or more plates and supplemental fasteners).

[0112] Referring to Figures 55 to 63, exemplary embodiments of System 4600 for implementation when performing procedures on one or more anatomical structures of the foot (e.g., procedures on the rapid joint, such as arthrodesis or other similar fixation procedures). System 4600 may include one or more components and / or features that are the same and / or similar as those of System 4100 described previously. Similarly, System 4600 and its components may interface (e.g., contact, join, etc.) with the foot 4200 and its components (e.g., first metatarsal bone 4202, second metatarsal bone 4206, medial cuneiform bone 4206, rapid joint 4208, etc.) in the same and / or similar manner as those shown with reference to System 4100. Furthermore, System 4600 may be implemented by utilizing the same and / or similar surgical methods as System 4100, e.g., processes for performing the surgical methods described herein.

[0113] As illustrated and described herein with reference to Figures 46 to 46, system 4600 includes a clamp 4602 and may further include one or more additional components, such as one or more surgical guides as shown and described herein. Furthermore, system 4600 may also be implemented by performing one or more steps of the method illustrated and described with reference to Figure 66. It should be understood that system 4600 may further include one or more components (e.g., incision instruments, saws, scalpels, forceps, retractors, etc.) in addition to those illustrated and described herein. The method illustrated and described with reference to Figure 66 may incorporate the said additional components.

[0114] Figures 55 to 63 show an exemplary instrument, indicated as clamp 4602. Clamp 4602 is a device for determining, aligning / repositioning, correcting, positioning / repositioning, rotating / de-rotating, or otherwise manipulating one or more anatomical structures of the foot relative to other anatomical structures of the foot. Clamp 4602 is configured to releasably connect to a foot structure including a first metatarsal bone (indicated as reference no. 4202) and a second metatarsal bone (indicated as reference no. 4204), the same and / or similar as those shown and described in Figures 47 to 53, and can manipulate the rapidus joint (indicated as reference no. 4208) formed between the first metatarsal bone 4204 and the medial cuneiform bone (indicated as reference no. 4206). In some embodiments, the clamp 4102 may be mounted on the distal portions of the first metatarsal bone 4202 and the second metatarsal bone 4204, but may also be mounted at other locations around the first and second metatarsal bones 4202 and the second metatarsal bone 4204. The clamp (and its components) 4602 is configured to facilitate correction of the intermedium (IM) angle formed between the first longitudinal extension axis of the first metatarsal bone 4202 and the second longitudinal extension axis of the second metatarsal bone 4204. Furthermore, the clamp 4602 is configured to facilitate detorsion of the first metatarsal bone 4202 relative to the second metatarsal bone 4204 (e.g., rotation opposite to the rotation that caused hallux valgus or other deformities). Correction of the IM angle and / or detorsion of the first metatarsal bone 4202 relative to the second metatarsal bone 4204 can be performed by a physician in procedures to address deformities of the lapidus joint or its vicinity (e.g., hallux valgus, arthrodesis of the lapidus joint, etc.).

[0115] As shown in the figure, the clamp 4602 includes a first portion 4604 and a second portion 4606, the first portion 4604 being releasably coupled to the second portion 4606 by / in a coupling 4608. In some embodiments, the coupling 4608 may include a coupling mechanism (e.g., a screw and a complementary bore). A first component of the coupling is coupled to or integrated with the first portion 4604, and a second component complementary to the first component is coupled to or integrated with the second portion 4606. Furthermore, in some embodiments, the coupling 4608 may include a portion of the coupling mechanism, at least a portion of which is configured to extend at least partially within the second portion 4606. Such a portion of the coupling mechanism can be coupled to or integrated with the first portion 4604, and can further extend at least partially within the opening of the second portion 4606. In some embodiments, at least a portion of the coupling may include an incremental marker (e.g., an indicator, a measuring marker, etc.) indicating the expansion of the clamp 4602. The coupling 4608 (and any of its components) can also facilitate the movement of the first portion 4604 relative to the second portion 4606, or the movement of the second portion 4606 relative to the first portion 4604. In some embodiments, an actuator 4624 (e.g., a knob, etc.) substantially positioned along the longitudinal axis of the second portion 4606 may be configured to releasably couple with a portion of the second portion 4606 of the clamp 4602. For example, the actuator 4624 may include a projection (e.g., a male component with threads, a set screw, etc.) which extends longitudinally through the bore into a bore positioned in the second portion 4606 of the clamp, facilitating a releasable coupling with the first portion of the clamp 4604 (e.g., complementary threads, etc.) in the coupling 4608. In some embodiments, the bore may include a coupling mechanism (e.g., a screw thread) therein, which is configured to be releasably coupled to a complementary portion of the actuator 4624 (e.g., the projection having the coupling mechanism such as a screw thread).Therefore, operation of the actuator 4624 via the textured surface 4626 (for example, to facilitate gripping, rotation, manipulation, etc.) can extend the clamp 4602 by translating the second portion 4606 toward or away from the first portion 4604. In some embodiments, the translation can be performed along a longitudinal axis (e.g., a common axis) shared by the actuator 4624, the projection from the actuator 4624, the bore of the second portion 4606, and one or more of any complementary coupling mechanisms of the first portion 4604. Furthermore, the first portion 4604 and the second portion 4606 can be coupled such that one or both portions are operable around a longitudinal axis (e.g., a shared / common axis).

[0116] As shown in the figures, the second portion 4606 of the clamp 4602 includes a pair of projections 4618 extending laterally from the second portion 4606. As shown in Figures 55 to 63, the pair of projections 4618 are positioned along the second portion 4606 so as to be spaced apart from the actuator 4624. This causes the projections 4618 to be substantially adjacent to the coupling 4608 (rather than in an alternative position as shown with reference to system 4100). In some embodiments, the actuator 4624 may include at least a portion of a coupling mechanism configured to be complementary to the coupling mechanism of the coupling 4608. For example, the actuator 4624 may include an extension having threads configured to be received within at least a portion of the coupling 4608. In some embodiments, the extension of the actuator 4624 may be configured to releasably couple the second portion 4606 to the first portion 4604 via the coupling 4608. Although the projection 4618 is shown as substantially hemispherical, in some embodiments of the clamp 4602, the projection 4618 may include an alternative geometric shape. As shown in the figures, each projection includes a bore 4620, which has a substantially cylindrical shape and extends from the top to the bottom of the second portion 4606, with fluid communication established between them. The bore 4620 may be configured to receive one or more common surgical instruments, such as a stabilization wire, K-wire, olive wire, and / or other stabilizing elements, to releasably connect the second portion 4606 to the second metatarsal bone 4204. As shown in Figures 47 to 53, the stabilization wire may be positioned so that the wire is received by the bore 4620. In this case, the wire is inserted substantially into the dorsal portion of the second metatarsal bone 4204 (positioned near the proximal end rather than the distal end of the second metatarsal bone 4204, as shown in Figures 47 to 53). In some embodiments, the physician may choose to place the stabilizing wire in one of the bores 4620 rather than in each of the bores 4620.When the clamp 4602 is releasably coupled to the second metatarsal bone 4204 via a stabilizing wire received through the bore 4620, the second portion 4606 of the clamp 4602 can be configured to be in a stationary position when the actuator 4624 is operated to translate the first portion 4604 toward the second portion 4606 (for example, with the second portion 4606 fixed to the second metatarsal bone 4204 in a stationary position, the operation of the actuator 4624 translates the first portion 4604 toward the second portion 4606 and the second metatarsal bone 4204). In some embodiments, the bore 4620 may have different sizes (e.g., both large, both small, or one larger / one smaller) and / or geometric shapes (e.g., rectangle, triangle, etc.) to accommodate the geometric shapes of various stabilizing elements. Each of the pair of projections 4618 is shown to be of equal size, but in some embodiments, the second part 4606 of the clamp 4602 may include one, two, or more projections, similar to or identical to the projections 4618 (of equal or unequal size) arranged in various ways along the second part 4606. Furthermore, in some embodiments, one or more of the projections 4618 may include 0, 1, 2, or 3 or more bores arranged in various ways around the projection 4618. As shown, each of the bores 4620 is positioned substantially equidistant from the outer edge of the projection 4618, but in some embodiments of the clamp 4602, the bores 4620 may be arranged alternately.

[0117] As shown in the figures, the second portion 4606 of the clamp 4602 includes an extension 4610 configured on the opposite side of the second portion 4606 from the coupling 4608, and as shown in Figures 55 to 63, the extension 4610 extends from the second portion 4606 at a substantially orthogonal angle to the actuator 4624. As shown in the figures, the extension 4610 has a substantially rectangular cross-sectional shape, although in some embodiments of the system 4600 it may have an alternative shape. The extension 4610 includes a retaining mechanism 4614, which is shown in Figures 47 to 53 as a pair of projections located at the distal end of the extension 4610 (e.g., on the opposite side of the second portion 4606 adjacent to the actuator 4624). The retaining mechanism 4614 defines a cavity 4616 located substantially between the pair of projections of the retaining mechanism 4614. The cavity 4616 of clamp 4602 may extend further into the extension 4116 of clamp 4102 (for example, substantially toward projection 4618). As shown, the retaining mechanism 4614 is integral with the extension 4610 and has a curvature substantially toward the first portion 4604 of clamp 4602 (for example, adjacent to the tangent of said curvature which is substantially perpendicular to the second portion 4606), and the distal portion of the retaining mechanism 4614 is substantially oriented toward the first portion 4604 of clamp 4602. The cavity 4616 is shown to have a substantially semi-elliptical geometric shape, the semi-elliptical geometric shape located in the nearest portion of the cavity 4616. However, in some embodiments, the cavity 4616 (and the retaining mechanism 4614) may have alternative thickness / width, length, depth, curvature, and other geometric properties.

[0118] The extension 4610 and the retaining mechanism 4614 are configured to at least partially interface (e.g., engage, contact, etc.) with the flat portion of the second metatarsal bone 4204 located substantially on the lateral surface of the second metatarsal bone 4604. The retaining mechanism 4614, including its distal portion, may be configured to contact the substantially inferior portion of the flat portion on the lateral surface of the second metatarsal bone 4204. The curvature of the distal portion of the retaining mechanism 4614 is configured to at least partially surround the second metatarsal bone 4204 so that the retaining mechanism 4614 contacts (and thus engages with) at least a portion of the plantar surface of the second metatarsal bone 4204. Therefore, the curvature of the retaining mechanism 4614 adapts to the geometric shape of the second metatarsal bone 4204 so as to maximize the engagement of the retaining mechanism 4614 with the second metatarsal bone 4204 when a force is applied to the second metatarsal bone 4204 via the retaining mechanism 4614 (for example, when a force is applied medially and / or upward to the lateral and / or plantar surface of the second metatarsal bone 4204). Therefore, the retaining mechanism 4614 maximizes the engagement of the extension 4610 of the second portion 4606 of the clamp 4602 with the second metatarsal bone 4204, thereby reducing / preventing loss of contact / engagement between the clamp 4602 and the second metatarsal bone 4204 by applying more force to the second metatarsal bone 4204 (e.g., by operating the actuator 4624 to translate one or both of the first portion 4604 and the second portion 4606 toward or toward each other while the extension 4610 and / or the retaining mechanism 4614 are in contact with the second metatarsal bone 4204). In some embodiments, the cavity 4616 may be configured to accept (e.g., allow passage of) one or more stabilizing wires.

[0119] As shown in the figures, the first portion 4604 of the clamp 4602 has a substantially curved geometric shape (e.g., convex), and the curvature of the first portion 4604 is substantially oriented toward the direction of the second portion 4606. The first portion 4604 includes an opening 4630 located substantially in the distal portion 4628 (e.g., distal half) of the first portion 4604. As shown in Figures 55 to 63, the opening 4630 has a rounded, elongated geometric shape (e.g., elliptical, oblong, etc.) with the same curvature as the first portion 4604. The opening 4630 is located within an inner recess 4633 on the concave side and an outer recess 4634 on the convex side of the first portion 4604. The inner recess 4633 and the outer recess 4634 are shown to have similar depth, length, and width dimensions, while the inner recess 4633 and the outer recess 4634 have greater length and width than the opening 4630 of the same / similar geometric shape. Furthermore, the inner recess 4633 and the outer recess 4634 are located at approximately the same position on the surface of the distal portion 4628 of the first portion 4604.

[0120] As shown in the figures, the first part 4604 further includes an actuator 4636 having a first part 4638 and a second part 4640. The first part 4638 and the second part 4640 are separated by a connector 4639. As shown in the figures, the connector 4139 has a cross-sectional shape substantially smaller than the cross-sectional shape of the first part 4638 or the second part 4640. In some embodiments, the connector 4639 may include an extension having at least a portion of a coupling mechanism (e.g., a screw) configured complementary to an opening substantially positioned along the longitudinal axis of the first part 4638. Thus, such a coupling mechanism can facilitate a releasable coupling between the first part 4638 and the second part 4640 of the actuator 4636. As shown in Figures 55 to 63, the connector 4639 has a substantially cylindrical geometric shape with a diameter / lateral dimension slightly smaller than the diameter / lateral dimension of the opening 4630. Referring to Figures 55 to 63, the first portion 4638 is shown to have a substantially cylindrical shape with a diameter slightly smaller than the width of the outer recess 4634. The second portion 4640 is also shown to have a lateral dimension slightly smaller than the width of the inner recess 4633. As shown in Figures 55 to 63, the actuator 4636 is positioned such that at least a portion of the connector 4639 is located within the opening 4630. Similarly, the most distal portion of the first portion 4640 is located within the outer recess 4634, and the most distal portion of the second portion 4640 is located within the inner recess 4633. Thus, the range of motion of the actuator 4636 is defined by the dimensions of the opening 4630 (and in some embodiments, the inner recess 4633 and the outer recess 4634). The actuator 4636 is operated through a defined range of motion along the curvature of the first portion 4604, the boundary of which is defined by an opening 4630 (and in some embodiments, an inner recess 4633 and / or an outer recess 4634). The actuator 4636 also includes a texture 4642 on the outer surface of the first portion 4638 of the actuator 4636, the texture 4642 being configured to facilitate gripping and / or manipulation of the actuator 4636 (e.g., rotation through the range of motion).

[0121] The actuator 4636 includes a bore 4644, which extends from a first portion 4638 through a connector 4639 to a second portion 4640 along the longitudinal axis of the actuator 4636. This establishes fluid communication throughout the length of the actuator 4636. As shown in Figures 55 to 63, the bore 4644 has a substantially cylindrical geometric shape configured to receive a stabilizing wire (e.g., a K-wire, olive wire, etc.) passing through the bore 4644 of the actuator 4636. A first stabilizing wire, the same or similar as the stabilizing wire 4148 described previously, is received by the bore 4644 and can be inserted into (e.g., releasably coupled) the first metatarsal 4202 (as shown, substantially the medial portion of the first metatarsal 4202). Therefore, when the first stabilizing wire is positioned within the first metatarsal bone 4202, the actuator 4636 is releasably coupled to the first metatarsal bone 4202. By operating the actuator 4636 within the range of motion defined by the movement of the connector 4639 within the opening 4630, the first metatarsal bone 4202 is moved accordingly.

[0122] Referring next to Figures 64 to 65, exemplary embodiments of the surgical guide 4700 are shown. In some embodiments, the surgical guide 4700 may be provided as part of a kit or other system together with the system 4600 and / or one or more implants and / or fixation components (as well as various other instruments / components). Furthermore, in some embodiments, the surgical guide 4700 may be configured to facilitate one or more incisions made to the first metatarsal bone 4202 (and may be positioned and / or joined in the same and / or similar manner as illustrated and described with reference to the cut guide 4300). The surgical guide 4700 includes a handle 4702 extending laterally from the cut guide 4704 of the surgical guide 4700. As shown, the end of the handle 4702 includes a tactile finish configured to facilitate the grip of the handle 4702 of the surgical guide 4700. The cut guide 4704 includes a slot 4712 located in the central portion of the cut guide 4702. As shown in Figures 64 to 65, the slot 4712 has a substantially elongated geometric shape configured to receive one or more cutting instruments (e.g., a reciprocating saw). In some embodiments, the slot 4712 may have an alternative geometric shape and / or dimensions, for example, the slot 4712 may have a length and / or width dimension that is greater or smaller than the length and / or width dimension of the illustrated slot. The cut guide 4704 is further shown to include an extension 4706 that extends laterally from the side of the cut guide 4704 opposite to the side from which the handle 4702 extends. The extension 4706 includes a bore 4708 located substantially in the center of the upper surface of the extension 4706, the bore 4708 extending from the upper surface to the bottom surface of the extension 4706, thereby establishing fluid communication between the upper and bottom surfaces of the extension 4706. The bore 4708 is configured to receive a stabilization wire (which may be the same as and / or similar to the stabilization wire illustrated and described earlier herein) through it, so that the stabilization wire can be releasably connected to the proximal portion of the first metatarsal bone 4202.In some embodiments, the surgical guide 4700 and its extension 4706 may include a plurality of bores 4708, for example, a pair of bores 4708. In some embodiments, one or more stabilizing wires may be received through the one or more bores 4708, allowing the surgical guide 4700 to be releasably coupled to the first metatarsal bone 4202 at one or more locations. Furthermore, in some embodiments, the surgical guide 4700 may include a projection 4714 (e.g., a paddle) configured to be inserted into the articular space of the rapidus joint 4208 (e.g., between the first metatarsal bone 4202 and the medial cuneiform bone 4206).

[0123] Referring to Figure 66, an exemplary embodiment of a process or method 6000 for performing treatment of the rapid joint is shown. The process 6000 and its steps shown in Figure 66 can be performed by implementing one or more of the components shown and described herein with reference to Figures 39 to 65. It should also be noted that one or more steps of process 6000 can be performed in a different order (e.g., out of order), repeated, skipped, or otherwise modified. It should also be noted that the steps of process 6000 are not limiting, meaning that additional steps can be added to process 6000 when performing treatment of the rapid joint. The steps of process 6000 described herein may include references to one or more components of the systems 4100, 4600 shown and described herein earlier. It should also be noted that in some embodiments, one or more steps of process 6000 may include one component of systems 4100, 4600 (for example, if the components are included as "systems 4100, 4600", it is not necessary to implement both components of system 4100 and system 4600, or both systems, in order to complete the steps described above).

[0124] In some embodiments, as shown in the figures, process 6000 includes step 6002, in which step 6002 connects a portion of the device to the second metatarsal bone using at least one stabilizing wire. In some embodiments, step 6002 may include implementing one or more stabilizing wires as shown and described previously herein. Step 6002 may correspond to connecting the second portions 4106, 4606 to the second metatarsal bone 4204 as shown and described previously herein.

[0125] In some embodiments, as shown in the figures, process 6000 includes step 6004, in which a portion of the device is attached to the first metatarsal bone. In some embodiments, step 6004 may include mounting one or more stabilizing wires as shown and described herein. Step 6004 may include attaching the first portions 4104, 4604 to the first metatarsal bone 4202 as shown and described herein.

[0126] In some embodiments, as shown in the illustration, process 6000 includes step 6006, in which a surgical guide is joined adjacent to the rapidus joint. In some embodiments, step 6006 may include joining the same or similar surgical guide as the surgical guide 4300 described above. The surgical guide of step 6006 can be joined to at least the first metatarsal bone 4202 at its substantially proximal portion using one or more stabilizing wires, as described herein.

[0127] In some embodiments, as shown in the figure, process 6000 includes step 6008, which prepares the proximal portion of the first metatarsal bone. Step 6008 may include mounting one or more incision instruments (and other possible instruments) to prepare the proximal portion of the first metatarsal bone 4202. When performing step 6008, one or more of the aforementioned incision instruments may be inserted into or through one or more slots 4312, as shown with reference to the surgical guide 4300.

[0128] In some embodiments, as shown in the figures, process 6000 includes step 6010, which reduces the distance between the first and second metatarsals by operating actuators to reduce the distance between the first and second parts of the apparatus. In some embodiments, the actuators operated in step 6010 may be actuators 4124, 4624 illustrated and described with reference to Figures 39 to 54, which can be operated (e.g., rotated) to reduce the distance between the first parts 4104, 4604 and the second parts 4106, 4606 of clamps 4102, 4602. The distance between the first and second metatarsals can be reduced by reducing the distance between the first parts 4104, 4604 and the second parts 4106, 4606 coupled to the first and second metatarsals 4202, 4204.

[0129] In some embodiments, as shown in the figures, process 6000 includes step 6012, which operates an actuator to rotate the first metatarsal bone. In some embodiments, the actuator operated in step 6012 may be actuators 4136, 4636 as shown and described with reference to Figures 39 to 65, which can be translated (e.g., operated) around / through a defined range of motion. Such operation of actuators 4136, 4636 can rotate the first metatarsal bone 4202 substantially counterclockwise when viewed from the front (when applied to the patient's right foot).

[0130] In some embodiments, as shown in the illustration, process 6000 includes step 6014, in which a surgical guide is joined adjacent to the rapidus joint. In some embodiments, the surgical guide in step 6014 may be the same as and / or similar to the surgical guides 4400, 4700 illustrated and described with reference to Figures 52 and 64 to 65. Step 6014 may further include manipulating one or more components of the surgical guides 4400, 4700 (such as those that are operable and rotatable, as described above), and then joining one or more parts / components of the surgical guides 4400, 4700 to the distal portion of the medial cuneiform bone 4206 using one or more stabilizing wires. In some embodiments, step 6014 may include positioning and / or manipulating the surgical guides 4400, 4700 so that the distal portion of the medial cuneiform bone 4206 has a surface substantially parallel to the surface of the proximal surface of the first metatarsal bone (e.g., a parallel plane) by inserting one or more incision instruments into / through the incision slots 4412, 4712.

[0131] In some embodiments, as shown in the figure, process 6000 includes step 6016, which prepares the distal portion of the medial cuneiform bone. In some embodiments, step 6016 may include preparing the most distal surface of the medial cuneiform bone 4206 so that it is parallel to the corresponding proximal surface of the first metatarsal bone 4202 (for example, to facilitate maximum surface area contact between the distal surface of the medial cuneiform bone 4206 and the proximal surface of the first metatarsal bone 4202). Step 6016 may include mounting one or more incision instruments (and other possible instruments) to prepare the distal portion of the medial cuneiform bone 4206. When performing step 6016, one or more of the aforementioned incision instruments may be inserted into or through one or more slots 4412, 4712, as shown with reference to the surgical guide 44400.

[0132] In some embodiments, as shown in the figures, process 6000 includes step 6018, in which step 6018 applies a fixation device across the rapid joint. In some embodiments, the fixation device of step 6018 may include an intramedullary nail and / or one or more plated components (including, but not limited to, those incorporated herein by reference). The fixation device may be coupled to the first metatarsal bone 4202, the medial cuneiform bone 4206, and in some embodiments, may further be coupled to one or more musculoskeletal structures near the rapid joint 4208 using one or more fastening means (e.g., screws, fasteners, etc.).

[0133] The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the invention. As used herein, the singular forms "a," "an," and "the" also include the plural form unless the context clearly indicates otherwise. Furthermore, the terms "comprise" (and any form of "comprise," e.g., "comprises" and "comprising"), "have" (and any form of "have," e.g., "has" and "having"), "include" (and any form of "include," e.g., "includes" and "including"), and "contain" (and any form of "contain," e.g., "contains" and "containing") are open-ended conjunctions. Therefore, a method or apparatus that “comprises,” “have,” “includes,” or “contains” one or more steps or elements includes, but is not limited to, those one or more steps or elements. Similarly, a method or apparatus that “comprises,” “have,” “includes,” or “contains” one or more features includes, but is not limited to, those one or more features. Furthermore, an apparatus or structure configured in a given way can be configured in at least that way, but can also be configured in ways not listed.

[0134] The present invention has been described with reference to preferred embodiments. It should be understood that the architectural and operational embodiments described herein are examples of multiple possible configurations to provide similar general features, characteristics, and general system operation. Others will likely conceive of modifications and changes by reading and understanding the detailed description above. The present invention is intended to be construed as including all such modifications and changes.

Claims

1. A clamp comprising an operating part and an engaging part coupled to the operating part via a coupling part, The aforementioned engaging portion is The first arm includes a first engaging element located at the distal end of the first arm, The second arm includes a second engaging element located at the distal end of the second arm, Equipped with, The first engaging element is rotatably and releasably coupled to the first arm and includes an actuator configured to adjust the distance between the first retaining element and the second retaining element such that each of the first retaining element and the second retaining element engages with at least a portion of the second bone, The second engaging element is configured to contact the surface of the first bone, The operation of the actuation part increases or decreases the distance between the first engaging element and the second engaging element. Clamp.

2. The first engaging element is different from the second engaging element. The clamp according to claim 1.

3. The second engaging element is integrated with the second arm. The clamp according to claim 2.

4. The second engaging element has a tapered shape in the vertical direction. The clamp according to claim 3.

5. The second engaging element includes a flat portion located on its inner surface, the flat portion including a textured surface. The clamp according to claim 4.

6. The second engaging element is located on the textured surface. It is configured to contact at least a portion of the first metatarsal bone. The clamp according to claim 5.

7. The first arm includes an opening located at its distal end, the opening being configured to be rotatably coupled to the first engaging element. The clamp according to claim 1.

8. The first engaging element further comprises a retaining portion, The aforementioned retaining part is A post positioned above the holding portion and configured such that at least a portion of it is received in the opening of the first arm, Displaced below the retaining portion and including the first retaining element and the second retaining element extending from the post, By operating the actuator around a screw positioned on the surface of the retaining portion, the distance between the first retaining element and the second retaining element is adjusted. The first retaining element and the second retaining element are configured to interface with the second metatarsal bone. The clamp according to claim 7.

9. The actuator is positioned below the opening of the first arm and above the holding portion, and the actuator includes a central opening configured to receive at least a portion of the post. The clamp according to claim 8.

10. Each of the first retaining element and the second retaining element includes a textured surface configured to interface with the second metatarsal bone. The clamp according to claim 8.

11. The holding portion is rotatably coupled to the opening of the first arm such that the holding portion has a range of motion of 360 degrees. The clamp according to claim 8.

12. The first arm has a different shape from the second arm. The clamp according to claim 1.

13. The first engaging element has a different depth from the second engaging element. The clamp according to claim 1.

14. A surgical system equipped with clamps, The clamp mentioned above is The operating part and The engaging portion is coupled to the operating portion via a coupling portion positioned between the engaging portion and the operating portion, Equipped with, The engagement portion includes a first arm and a second arm, The first arm includes a first engaging element located at the distal end of the first arm, the first engaging element being rotatably and releasably coupled to the first arm and comprising an actuator configured to adjust the distance between the first retaining element and the second retaining element such that each of the first retaining element and the second retaining element engages with at least a portion of the second bone, The second arm includes a second engaging element located at the distal end of the second arm, the second engaging element being an integral element with the second arm and configured to contact the surface of the first bone. The operation of the actuation part increases or decreases the distance between the first engaging element and the second engaging element. Surgical system.

15. The first engaging element comprises a retaining portion including a post and threads, The post is configured to be releasably coupled to the first arm, and the threads are configured to be releasably coupled to the actuator. The surgical system according to claim 14.

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