Systems and methods for lapidus bunion repair

Abstract

Disclosed are systems, devices, and methods for performing a rapidus bunion resection procedure, including inserting a metatarsal pin into a first metatarsal at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint, resecting the first TMT joint by cutting the base of the first metatarsal and a first cuneiform bone proximate the first TMT joint, inserting a cuneiform pin into the first cuneiform bone at a second predetermined spacing relative to the first TMT joint, compressing the first TMT joint using a compressor block so that the cut surface of the first metatarsal contacts the cut surface of the first cuneiform bone, and fixating the first TMT joint using a bone plate and a plurality of bone screws. At least one of the multiple bone screws may be a cross screw extending at an angle less than 90 degrees relative to the bone plate and may fix the resected first TMT joint to the second metatarsal or second cuneiform bone to prevent recurrence of the bunion.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 978,683, filed February 19, 2020, entitled "SYSTEMS AND METHODS FOR LAPIDUS REPAIR OF BUNIONS," U.S. Provisional Patent Application No. 63 / 018,793, filed May 1, 2020, entitled "SYSTEMS AND METHODS FOR LAPIDUS REPAIR OF BUNIONS," and U.S. Provisional Patent Application No. 63 / 125,272, filed December 14, 2020, entitled "SYSTEMS AND METHODS FOR LAPIDUS REPAIR OF BUNIONS," all of which are incorporated by reference herein for all purposes.

[0002] FIELD OF THEINVENTION The present disclosure relates to medical devices and, more particularly, to systems and methods for repairing bunions using the Rapidus Bunionectomy Technique. [Background technology]

[0003] Bunions are a progressive disorder that typically begins with a tilt of the big toe, gradually changing the angle of the bone and may result in a characteristic bump on the medial side of the metatarsal near the joint between the metatarsal and the proximal phalanx. Specifically, a bunion is a bony protuberance and sometimes an inflamed bursa. Hallux valgus is a condition in which the big toe is displaced from its normal position toward the second toe.

[0004] Bunion correction or repair is a common procedure with over 100,000 procedures performed annually in the United States. In a Lapidus bunionectomy procedure for bunion correction, the first tarsometatarsal joint is fused to correct the deformity of the joint to prevent further movement of the joint. However, existing Lapidus bunionectomy techniques can be difficult to perform with the desired precision. Summary of the Invention [Means for solving the problem]

[0005] The exemplary embodiments described herein have innovative features, none of which is essential to or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the more advantageous features will now be summarized.

[0006] In a first aspect, a method of correcting a bunion includes inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined interval relative to a first tarsometatarsal (TMT) joint, resecting the first TMT joint of the foot, inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined interval relative to the first TMT joint, compressing the first TMT joint using a compressor block such that a cut surface of the first metatarsal contacts a cut surface of the first cuneiform, and immobilizing the first TMT joint. The resecting includes cutting a base of the first metatarsal proximate to the first TMT joint, and cutting a base of the first cuneiform of the foot proximate to the first TMT joint.

[0007] In some embodiments, the first TMT joint is fixed using a bone plate and a plurality of bone screws, at least one of the plurality of bone screws being a cross screw extending at an angle less than 90 degrees relative to the bone plate, in some embodiments, the cross screw extends through the bone plate, the first metatarsal bone, and at least a portion of the second metatarsal bone of the foot or the second cuneiform bone of the foot.

[0008] In some embodiments, the method further includes placing a staple through the bone plate such that a first leg of the staple is seated in the first cuneiform bone and a second leg of the staple is seated in the first metatarsal bone. In some embodiments, the bone plate includes a cross screw opening shaped to guide placement of the cross screw such that the second leg of the staple does not interfere with placement of the cross screw.

[0009] In some embodiments, multiple metatarsal pins are inserted prior to resecting the first TMT joint.

[0010] In some embodiments, the multiple cuneiform pins are inserted prior to cutting the base of the first cuneiform bone.

[0011] In some embodiments, the method further includes positioning a cutting guide over a dorsal side of the first TMT joint prior to inserting the multiple metatarsal pins and the multiple cuneiform pins. The cutting guide may comprise a body, a multiple proximal pin holes extending parallel through the body, a multiple distal pin holes extending through the body parallel to the proximal pin holes, and a joint seeking paddle extending downwardly from the body between the proximal and distal pin holes such that when the joint seeking paddle is at least partially disposed within the first TMT joint, the distal pin hole defines a first predetermined spacing relative to the first TMT joint and the proximal pin hole defines a second predetermined spacing relative to the first TMT joint. In some embodiments, the cutting guide further comprises a proximal slot extending through the body and a distal slot extending through the body on an opposite side of the joint seeking paddle to the proximal slot, the distal slot defining a cutting surface for cutting the base of the first metatarsal bone and the proximal slot defining a cutting surface for cutting the base of the first cuneiform bone.

[0012] In some embodiments, the method further includes adjusting alignment of the first metatarsal in a frontal plane of the foot using a control handle coupled to the multiple metatarsal pins prior to compressing the first TMT joint, and adjusting alignment of the first metatarsal in a transverse plane of the foot using a linear reducer including a medial hook disposed on the medial side of the first metatarsal and a lateral hook disposed on the lateral side of a second metatarsal of the foot, the lateral hook having an adjustable spacing relative to the medial hook. In some embodiments, the method further includes inserting the medial hook pin into the first metatarsal through an opening in the medial hook to rotatably secure the first metatarsal relative to the medial hook prior to adjusting alignment of the first metatarsal in the transverse plane. In some embodiments, at least one of the medial hook and the lateral hook includes a radiolucent material. In some embodiments, the control handle includes a handle portion and an engagement portion, the engagement portion including multiple pin openings spaced apart at a distance equal to the distance between the metatarsal pins. In some embodiments, adjusting the alignment of the first metatarsal in the frontal plane includes sliding the pin opening on the metatarsal pin so that the engagement portion is proximate the first metatarsal and rotating the first metatarsal about the longitudinal axis of the first metatarsal by applying a torque to the control handle. In some embodiments, adjusting the alignment of the first metatarsal in the transverse plane includes reducing an adjustable spacing between the lateral hook and the medial hook to move the distal end of the first metatarsal closer to the second metatarsal. In some embodiments, the transverse plane alignment of the first metatarsal is adjusted while the first metatarsal is rotatably fixed relative to the medial hook of the linear reducer. In some embodiments, the multiple wedge pins are inserted after adjusting the alignment of the first metatarsal in the frontal and transverse planes.

[0013] In some embodiments, the compressor block comprises a body with a top surface and a bottom surface, a plurality of proximal pin holes extending through the body from the top surface to the bottom surface at a first angle less than 90 degrees relative to the top and bottom surfaces, and a plurality of distal pin holes extending through the body from the top surface to the bottom surface at the first angle relative to the top and bottom surfaces such that the proximal and distal pin holes are spaced closer together at the bottom surface than at the top surface. In some embodiments, compressing the first TMT joint comprises inserting a cuneiform pin into the proximal pin hole in the bottom surface, inserting a metatarsal pin into the distal pin hole in the bottom surface, and sliding the compressor block along the cuneiform pin and metatarsal pin toward the first TMT joint. In some embodiments, the compressor block further comprises at least one cross pin hole extending therethrough, each of the at least one cross pin hole defining a linear path that passes obliquely through the first TMT joint when the compressor block is aligned proximate the first TMT joint over the cuneiform pin and the metatarsal pin. In some embodiments, the method further comprises inserting a cross pin through the at least one cross pin hole to temporarily fixate the first TMT joint after compressing the first TMT joint, removing the cuneiform pin and the metatarsal pin from the foot, and removing the compressor block by sliding the compressor block along the cross pin away from the first TMT joint. In some embodiments, the method further comprises removing the cross pin after at least partially fixing the first TMT joint.

[0014] In some embodiments, the method further includes positioning a reversible cutting guide over a dorsal side of the first TMT joint prior to inserting the multiple metatarsal pins and the multiple cuneiform pins, the reversible cutting guide comprising a body, a multiple first pin holes extending parallel through the body, a multiple second pin holes extending through the body parallel to the proximal pin holes, a joint seeking paddle extending downwardly from the body between the proximal and distal pin holes such that when the joint seeking paddle is at least partially disposed within the first TMT joint, the first pin hole defines a first predetermined spacing relative to the first TMT joint, and a slot extending through the body parallel to the plane of the joint seeking paddle such that the slot defines a cutting plane for cutting the base of the first metatarsal or the base of the first cuneiform. In some embodiments, the base of the first metatarsal and the base of the first cuneiform are cut through the slot, and the method further includes removing the reversible cutting guide from the first TMT joint after cutting the base of the first metatarsal and before cutting the base of the first cuneiform, and placing the reversible cutting guide in a reverse orientation across the dorsal side of the first TMT joint such that the slot defines a cutting plane for cutting the base of the first mucosa.

[0015] In some embodiments, the method further includes re-cutting the base of the first metatarsal or first cuneiform bone to remove additional tissue prior to fixating the first TMT joint. In some embodiments, the re-cutting is performed using a re-cutting guide disposed on the metatarsal pin or cuneiform pin, the re-cutting guide defining a predetermined re-cutting interval that is smaller than the predetermined interval defined by the cutting guide used to resect the first TMT joint.

[0016] In some embodiments, the method further includes performing a frontal plane realignment including additional rotation in the frontal plane of the first metatarsal prior to fixating the first TMT joint. In some embodiments, the frontal plane realignment is performed simultaneously with compression of the first TMT joint, and the compressor block is configured as a realignment guide including angularly displaced pin holes such that positioning the compressor block compresses the first TMT joint and maintains the additional rotation. In some embodiments, the frontal plane realignment is performed prior to compressing the first TMT joint, and the frontal realignment includes inserting a plurality of replacement metatarsal pins at a first predetermined interval through the realignment guide to the first TMT joint, the replacement metatarsal pins being angularly displaced relative to the metatarsal pins, and linearly aligning the replacement metatarsal pins with the cuneiform pins prior to compressing the first TMT joint.

[0017] In a second aspect, a method of correcting a bunion includes positioning a cutting guide over a dorsal side of a first tarsometatarsal (TMT) joint of the foot, such that a plurality of first pin holes of the cutting guide are disposed proximate a first metatarsal of the foot, a plurality of second pin holes of the cutting guide are disposed proximate a first cuneiform bone of the foot, and a joint seeking paddle of the cutting guide is disposed at least partially within the first TMT joint; inserting a plurality of metatarsal pins through the first pin holes and into the first metatarsal; and inserting a plurality of metatarsal pins through slots extending through the cutting guide between the first pin holes and the joint seeking paddle into the first metatarsal proximate the first TMT joint. cutting the base of the foot bone, removing the cutting guide from the foot, replacing the cutting guide in an inverted configuration over the dorsal side of the first TMT joint with the metatarsal pins extending through the second pin holes, adjusting the alignment of the first metatarsal in at least one of the frontal and transverse planes of the foot, inserting a plurality of cuneiform pins through the first pin holes and into the first cuneiform bone, cutting the base of the first cuneiform bone proximate the first TMT joint through the slots, compressing the first TMT joint using a compressor block such that the cut surface of the first metatarsal bone contacts the cut surface of the first cuneiform bone, and fixing the first TMT joint.

[0018] In a third aspect, a bunion correction kit includes a cutting guide, a linear reducer, a control handle, and a compressor block. The cutting guide includes a body, a plurality of first pin holes extending parallel through the body and spaced a first distance apart, a plurality of second pin holes extending parallel through the body at the first distance, the plurality of second pin holes being spaced a first distance apart, a joint seeker paddle extending from the body between a proximal pin hole and a distal pin hole, and a slot extending through the body parallel to the joint seeker paddle between the joint seeker paddle and the first pin hole, the slot configured to guide cutting of a base of a first metatarsal or a first cuneiform bone when the joint seeker paddle is disposed at least partially within a tarsometatarsal (TMT) joint. The linear reducer includes a medial hook and a lateral hook, the spacing between which is adjustable to effect a cross-sectional correction when the medial hook is seated against the medial side of a first metatarsal and the lateral hook is seated against the lateral side of a second metatarsal. The control handle includes a handle portion and an engagement portion, the engagement portion including pin openings spaced a first distance apart. The compressor block includes a body having a top and a bottom surface, a plurality of proximal pin holes extending through the body from the top surface to the bottom surface at a first angle less than 90 degrees relative to the top and bottom surfaces, and a plurality of distal pin holes extending through the body from the top surface to the bottom surface at the first angle relative to the top and bottom surfaces, the distal pin holes converging relative to the proximal pin holes such that the proximal and distal pin holes are spaced closer together at the bottom surface relative to the top surface.

[0019] In some embodiments, the bunion correction kit further includes a re-cutting guide comprising a body, a plurality of pin holes extending through the body and spaced apart a first distance, a joint seeking paddle extending from the body, and a slot extending through the body parallel to the joint seeking paddle between the joint seeking paddle and the pin hole, the slot of the re-cutting guide being closer to the pin hole of the re-cutting guide compared to a corresponding distance between the slot of the cutting guide and the first pin hole of the cutting guide.

[0020] In some embodiments, the compressor block is configured as a coronal plane realignment guide, and at least two of the plurality of proximal pin holes are angularly displaced relative to at least two of the plurality of distal pin holes.

[0021] In some embodiments, the bunion correction kit further comprises one or more bone screws and a bone plate configured to receive the one or more bone screws, the bone plate configured to receive at least one of the one or more bone screws as a cross screw extending at an angle less than 90 degrees relative to the bone plate.

[0022] In a fourth aspect, a linear reducer configured to adjust cross-sectional alignment of a first metatarsal comprises a shaft having a proximal end and a distal end; a medial hook coupled to the shaft at the distal end, where at least a portion of the medial hook comprises a concave curved surface shaped to seat against the medial side of the first metatarsal; an lateral hook slidably coupled to the shaft at a location intermediate the proximal and distal ends, where at least a portion of the medial hook comprises a concave curved surface shaped to seat against the lateral side of the second metatarsal while the medial hook is seated against the medial side of the first metatarsal; and a handle coupled to the shaft adjacent a proximal side of the lateral hook, where a linear position of the handle is adjustable along the shaft to move the lateral hook relative to the medial hook to effect cross-sectional correction when the medial hook is seated against the medial side of the first metatarsal and the lateral hook is seated against the lateral side of the second metatarsal.

[0023] In some embodiments, the shaft includes a threaded outer surface and the handle includes a threaded opening extending through the handle and engaging the threaded outer surface of the shaft such that the linear position of the handle is adjustable by twisting the handle about the shaft.

[0024] In some embodiments, the medial hook includes one or more openings extending through the concave curved surface to accommodate a pin extending therethrough to the first metatarsal. In some embodiments, the medial hook is coupled to the shaft by a quick release coupling movable from a locked position to an unlocked position, in which the medial hook is slidable along the longitudinal axis of the shaft. In some embodiments, at least one of the medial hook and the lateral hook comprises a radiolucent material. In some embodiments, the radiolucent material comprises carbon fiber.

[0025] In a fifth aspect, a cutting guide configured to guide cutting of a first metatarsal and a first cuneiform bone in a bunion correction procedure includes a body having a first end and a second end opposite the first end along a longitudinal axis of the cutting guide, a plurality of first pin holes extending parallel through the body proximate the first end, the first pin holes being spaced apart along the longitudinal axis at a predetermined interval, a plurality of second pin holes extending through the body proximate the second end and parallel to the first pin holes, the second pin holes being spaced apart along the longitudinal axis at a predetermined interval, and a first intermediate position between the first pin holes and the second pin holes. a cutting slot extending through the body perpendicular to the longitudinal axis, the cutting slot sized and shaped to guide cutting of the bone by a saw blade inserted therethrough; and a joint seeking paddle extending from the bone-facing surface of the body perpendicular to the longitudinal axis at a second intermediate location between the cutting slot and the second pin hole such that the cutting slot can be positioned across a first tarsometatarsal (TMT) joint with the joint seeking paddle seated within the first TMT joint in either a metatarsal cutting orientation in which the cutting slot cuts the base of the first metatarsal or a cuneiform cutting orientation in which the cutting slot cuts the base of the first cuneiform.

[0026] In some embodiments, the cutting guide further comprises one or more longitudinal openings extending through the body perpendicular to and intersecting the cutting slot.

[0027] In some embodiments, the cutting guide does not include a second cutting slot.

[0028] In some embodiments, the cutting guide further comprises one or more converging pin holes extending through the body at a position displaced laterally relative to the longitudinal axis, each converging pin hole intersecting the bone-facing surface at a first distance from the longitudinal axis and intersecting the upper surface of the body opposite the bone-facing surface at a second distance from the longitudinal axis, the second distance being greater than the first distance.

[0029] In some embodiments, the cutting slot comprises a middle section having a first width and end sections at either end of the middle section, the end sections having a second width greater than the first width. [Brief description of the drawings]

[0030] Aspects and advantages of the embodiments provided herein are described with reference to the following detailed description in conjunction with the accompanying drawings, in which reference numbers may be reused throughout the drawings to indicate correspondence between referenced elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the present disclosure. [Figure 1] FIG. 1 is a perspective view of the bones of the foot with a bunion. [Figure 2A] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2B] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2C] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2D] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2E] 2A-2D depict an exemplary freehand pin guide for orienting pin insertion in the absence of the cutting guide of FIGS. 2A-2D. [Figure 2F] 2A-2D depict an exemplary freehand pin guide for orienting pin insertion in the absence of the cutting guide of FIGS. 2A-2D. [Figure 2G] 2A-2D depict an exemplary freehand pin guide for orienting pin insertion in the absence of the cutting guide of FIGS. 2A-2D. [Figure 2H] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2I] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2J] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2K] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2L] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2M] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 2N] 1 depicts an exemplary cutting guide configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 3A]1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 3B] 1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 3C] 1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 3D] 1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 3E] 1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 3F] 1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 3G] 1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 3H] 1 depicts an exemplary linear reducer configured for use in the Rapidus bunion excision procedure described herein. [Figure 4A] 1 depicts an exemplary control handle configured for use in the Rapidus bunion resection procedure described herein. [Figure 4B] 1 depicts an exemplary control handle configured for use in the Rapidus bunion resection procedure described herein. [Figure 5A] 1 depicts an exemplary compressor block configured for use in the Rapidus bunion resection procedure described herein. [Figure 5B] 1 depicts an exemplary compressor block configured for use in the Rapidus bunion resection procedure described herein. [Figure 5C]1 depicts an exemplary compressor block configured for use in the Rapidus bunion resection procedure described herein. [Figure 5D] 1 depicts an exemplary compressor block configured for use in the Rapidus bunion resection procedure described herein. [Figure 6A] 1 depicts an exemplary bone plate and cross screw configured for use in the Rapidus bunion resection procedure described herein. [Figure 6B] 1 depicts an exemplary bone plate and cross screw configured for use in the Rapidus bunion resection procedure described herein. [Figure 6C] 1 depicts an exemplary bone plate and cross screw configured for use in the Rapidus bunion resection procedure described herein. [Figure 6D] 1 depicts an exemplary bone plate and cross screw configured for use in the Rapidus bunion resection procedure described herein. [Figure 6E] 1 depicts an exemplary bone plate and cross screw configured for use in the Rapidus bunion resection procedure described herein. [Figure 6F] 1 depicts an exemplary bone plate and cross screw configured for use in the Rapidus bunion resection procedure described herein. [Figure 6G] 1 depicts an exemplary bone plate and cross screw configured for use in the Rapidus bunion resection procedure described herein. [Figure 7A] 1 depicts an exemplary fixed angle cross screw drill guide configured for use in the Rapidus bunion resection procedure described herein. [Figure 7B] 1 depicts an exemplary fixed angle cross screw drill guide configured for use in the Rapidus bunion resection procedure described herein. [Figure 7C]1 depicts an exemplary fixed angle cross screw drill guide configured for use in the Rapidus bunion resection procedure described herein. [Figure 7D] 1 depicts an exemplary variable angle cross screw drill guide configured for use in the Rapidus bunion resection procedure described herein. [Figure 7E] 1 depicts an exemplary variable angle cross screw drill guide configured for use in the Rapidus bunion resection procedure described herein. [Figure 7F] 1 depicts an exemplary variable angle cross screw drill guide configured for use in the Rapidus bunion resection procedure described herein. [Figure 8] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 9] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 10] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 11] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 12] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 13] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 14] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 15] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 16] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 17] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 18] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 19] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 20] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 21] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 22] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Diagram 23] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 24] 1A-1C are perspective views of the bones of the foot sequentially illustrating an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Diagram 25]1A-1D are perspective views of the bones of the foot sequentially illustrating portions of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 26] 1A-1D are perspective views of the bones of the foot sequentially illustrating portions of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 27] 1A-1D are perspective views of the bones of the foot sequentially illustrating portions of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 28] 1A-1D are perspective views of the bones of the foot sequentially illustrating portions of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 29] 1A-1D are perspective views of the bones of the foot sequentially illustrating portions of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Figure 30A] 1 depicts an exemplary cutting guide configured as a recutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 30B] 1 depicts an exemplary cutting guide configured as a recutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 30C] 1 depicts an exemplary cutting guide configured as a recutting guide and pin guide for the Rapidus bunion resection procedure described herein. [Figure 31A] 1 depicts an exemplary realignment guide configured as a pin guide for coronal plane adjustment in a Rapidus bunion resection procedure described herein. [Figure 31B] 1 depicts an exemplary realignment guide configured as a pin guide for coronal plane adjustment in a Rapidus bunion resection procedure described herein. [Figure 31C]1 depicts an exemplary realignment guide configured as a pin guide for coronal plane adjustment in a Rapidus bunion resection procedure described herein. [Figure 32A] 1 depicts an exemplary realignment guide configured as a pin guide for coronal plane adjustment in a Rapidus bunion resection procedure described herein. [Figure 32B] 1 depicts an exemplary realignment guide configured as a pin guide for coronal plane adjustment in a Rapidus bunion resection procedure described herein. [Figure 32C] 1 depicts an exemplary realignment guide configured as a pin guide for coronal plane adjustment in a Rapidus bunion resection procedure described herein. [Diagram 33] 1A-1D are perspective views of the bones of the foot sequentially illustrating the resection portion of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Diagram 34] 1A-1D are perspective views of the bones of the foot sequentially illustrating the resection portion of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Diagram 35] 1A-1D are perspective views of the bones of the foot sequentially illustrating the resection portion of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein; [Diagram 36] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Figure 37] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Figure 38] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Figure 39]1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Diagram 40] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Diagram 41] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Diagram 42] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Diagram 43] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Diagram 44] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Diagram 45] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Figure 46] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Figure 47] 1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; [Figure 48]1A-1D are perspective views of the bones of the foot sequentially illustrating the coronal plane realignment portion of an exemplary Rapidus bunion resection procedure using an exemplary bunion resection device disclosed herein; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] The following description is directed to certain specific implementations for purposes of describing the innovative aspects of the present disclosure, however, those skilled in the art will readily recognize that the teachings herein can be applied in many different ways.

[0032] Generally, the systems, devices, and methods described herein provide improved methods and tools that may be used to perform a Rapidus bunionectomy with desired precision. Some or all of the tools and / or components described herein may be provided in a kit and may include multiple optional and / or interchangeable components that may be selected, positioned, secured, and / or used during a bunionectomy procedure. As such, the Rapidus bunionectomy systems, devices, and methods disclosed herein may enable surgeons to perform a bunionectomy more effectively, efficiently, and / or accurately than is possible with conventional devices and procedures.

[0033] The embodiments described herein can be manufactured from a number of different materials or combinations of materials. Nitinol, stainless steel, titanium, and / or other materials may have material properties that are desirable for certain components described herein. Stainless steel and / or titanium may not have shape memory or superelasticity, but may have mechanical properties of embodiments that may benefit from mechanical manipulation to achieve multiple configurations. Still other materials, such as PEEK or other polymers, may also have material properties that are beneficial for the embodiments described herein. Material combinations may also be preferred. For example, a combination of Nitinol and Titanium (e.g., Nitinol plate with titanium screws) may be the material of choice for some embodiments. Those skilled in the art will recognize typical materials and material combinations applicable to current technology.

[0034] FIG. 1 is a perspective view of the bones of a foot 10 having a bunion, also known as hallux valgus. Foot 10 includes a first metatarsal 20 that articulates at its proximal end with a first cuneiform 30 (also known as the medial cuneiform) at a first tarsometatarsal (TMT) joint 40. The distal end of first metatarsal 20 articulates with a first phalange 50 of the big toe. Intermetatarsal angle is defined as the angle between the axis of one metatarsal relative to the second metatarsal in the anatomical transverse plane. Rotation is defined as axial rotation about the axis of the metatarsal in the anatomical frontal plane. 1 is characterized by an increased intermetatarsal angle and / or rotation of the first metatarsal 20 at the first TMT joint 40, such that the first metatarsal 20 extends away or medially from the remainder of the foot 10. When a bunion is present, the first phalange 50 of the big toe is typically angled inward, or laterally, toward the other phalange 60, resulting in a characteristic bump at the metatarsophalangeal joint 70, which is the most noticeable external indicator of a bunion. A prominent metatarsophalangeal joint 70 may also be associated with a distended bursa or bone abnormality that can cause discomfort, shoe-wearing difficulties, and other inconveniences to the person with the bunion.

[0035] 2A-7F, various devices and components are provided for use with the improved Lapidus bunion resection procedure for correcting the TMT joint deformity of FIG 1. Although the following description is made with reference to a Lapidus bunion resection procedure, it will be understood that the various devices and components described herein are not limited to such procedures and may equally be used in other orthopedic surgical procedures as would be understood by one of ordinary skill in the art.

[0036] 2A-2D depict an exemplary cutting guide 100 configured as a cutting guide and pin guide for the rapidus bunion resection procedure described herein. FIGS. 2A and 2B are top and bottom perspective views, respectively, of cutting guide 100. FIG. 2C is a top view of cutting guide 100. FIG. 2D is a cross-sectional side view of cutting guide 100 taken about line 2D-2D in FIG. 2C. Cutting guide 100 may be a single, integrally formed component and may comprise metal, plastic, or other suitable material.

[0037] The cutting guide 100 generally includes a body 105, a proximal extension 110, a distal extension 115, and a paddle 120. The paddle 120 is sized and shaped to seat within a joint, such as a TMT joint (e.g., between the first metatarsal and the first cuneiform bone), for example, after removing soft tissue, such as the symphysis capsule, surrounding the joint. A relatively narrow, angled end portion of the paddle 120 may facilitate insertion of the paddle 120 into the joint. In some embodiments, the handle 120 is integrally formed with the frame 105.

[0038] The body 105 of the cutting guide 100 includes a distal slot 125 and a proximal slot 130. The distal slot 125 and the proximal slot 130 each penetrate the full thickness of the body 105 and are sized and shaped to serve as a positioning guide for a saw blade to facilitate precise sawing on each side of the joint. For example, the distal slot 125 may be positioned at a predetermined distance relative to the distal plane of the paddle 120 to facilitate cutting the base of the first metatarsal bone when the paddle 120 is positioned in the first TMT joint. Similarly, the proximal slot 130 may be positioned on the opposite side (proximal plane) of the paddle to facilitate cutting the first cuneiform bone. The distal slot 125 and the proximal slot 130 may be of the same or similar shape (e.g., may have the same length and / or width) so that the metatarsal and cuneiform bone cuts can be made with the same or the same type of saw blade. In some embodiments, the distal slot 125 and the proximal slot 130 may be parallel to each other and / or to the paddle 120, or may be angled relative to the plane of the paddle 120. In some embodiments, relatively wide end sections 127 at the ends of the slots 125, 130 may be provided for positioning an additional guidewire during cutting to prevent the saw blade from making too wide a cut when using the cutting guide 100.

[0039] The proximal pin holes 112 extend through the entire thickness of the cutting guide 100. One or both of the proximal pin holes 112 can be disposed on the proximal extension 110 or within the body 105. The proximal pin holes 112 can each have a substantially circular profile sized to accommodate a surgical pin or wire for temporarily fixing the cutting guide to the foot. The proximal pin holes 112 act as guides so that the two proximal pins or wires can be inserted at a predetermined interval relative to each other and to the plane in which the first wedge is cut by the saw blade through the proximal slot 130. The proximal pin holes 112 extend parallel and perpendicular to each other as shown in FIG. 2D.

[0040] The distal pin holes 117 extend through the entire thickness of the distal extension 115. Like the proximal pin holes 112, the distal pin holes 117 can each have a substantially circular profile sized to accommodate a surgical pin or wire for temporarily fixing the cutting guide to the foot, and can have the same diameter as the proximal pin holes 112. The distal pin holes 117 serve as guides so that the two distal pins or wires can be inserted at a predetermined interval relative to each other and to the plane in which the first metatarsal is cut by the saw blade through the distal slot 125. The distal pin holes 117 extend parallel to each other and perpendicular to the proximal pin holes 112, as shown in FIG. 2D. The plane intersecting the axis of the proximal pin holes 112 can be coplanar with the plane intersecting the axis of the distal pin holes 117. The combination of the pin holes forms a linear array of holes that span the TMT joint. The bottom or bone-facing surface of distal extension 115 may not be flush with the bottom or bone-facing surface of body 105 and / or proximal extension 110, which may allow cutting guide 100 to be placed closer to the bone while simultaneously spacing apart the bony anatomical structures of the proximal metatarsal and medial cuneiform bones. Further details are provided in U.S. Patent No. 10,292,713, which is incorporated herein by reference.

[0041] In some embodiments, the body 105 of the cutting guide 100 further includes one or more additional openings, such as an additional convergent pin hole 107 and / or a longitudinal opening 109. The convergent pin hole 107 may be utilized for inserting one or more additional pins or wires if additional stability is desired during the bunionectomy procedure. The longitudinal opening 109 extends transversely to the slots 125, 130 and may provide an opening to facilitate x-ray visualization and / or any other suitable surgical imaging procedure to verify and / or monitor the alignment of the cutting guide during the bunionectomy procedure.

[0042] 2E-2G depict an exemplary freehand pin guide 150 including an array of pin holes across the TMT joint for orienting the insertion of pins in the absence of the cutting guide 100 of FIGS. 2A-2D. In some bunionectomy procedures, the cutting guide 100 may not be used, for example, if the cutting guide 100 does not fit within the joint, due to surgeon preference, or due to any other reason that causes a freehand joint cut to be performed rather than cutting using the cutting guide 100. The freehand pin guide 150 generally comprises a body 155 and a paddle 160. The proximal pin holes 165 and the distal pin holes 170 extend through the entire thickness of the body 155. The proximal pin holes 165 may have the same relative spacing as the proximal pin holes 112 of the cutting guide 100. Similarly, the distal pin holes 170 may have the same relative spacing as the distal pin holes 117 of the cutting guide 100. A handle mounting opening 175, which may be threaded, is provided for mounting a side mounted handle that may assist the user in placing the freehand pin guide 150. Similar to the proximal and distal pin holes 112, 117 of the cutting guide 100, the proximal and distal pin holes 165, 170 of the freehand pin guide 150 extend perpendicularly parallel to one another. However, the spacing of the proximal and distal pin holes 165, 170 of the freehand pin guide 150 from the paddle 160 is slightly less than the spacing of the proximal and distal pin holes 112, 117 of the cutting guide 100 to the paddle 120 to compensate for the freehand pin guide 150 being applied after the cut is made. This allows the freehand pin guide 150 to place a pin or wire with the same spacing relative to the first TMT joint following the freehand cut as if the cutting guide 100 was used to make the cut.

[0043] 2H-2K depict an exemplary reversible cutting guide 180 configured as a cutting guide and pin guide for the rapidus bunion resection procedure described herein. FIGS. 2H and 2I are top and bottom perspective views, respectively, of the cutting guide 180. FIG. 2J is a top view of the cutting guide 180. FIG. 2K is a cross-sectional side elevation view of the cutting guide 180 taken about line segment 2K-2K of FIG. 2J. The cutting guide 180 may be a single integrally formed component and may comprise metal, plastic, or other suitable material. The cutting guide 180 is similar to the cutting guide 100 of FIGS. 2A-2D, but may be reversible and is configured with a single slot 182 rather than the proximal and distal slots 125 and 130 of FIGS. 2A-2D.

[0044] The cutting guide 180 generally includes a body 105, a first extension 184, a second extension 188, and a paddle 120. The paddle 120 is sized and shaped to seat within a joint, such as a TMT joint (e.g., between the first metatarsal and the first cuneiform bone), for example, after removing soft tissue, such as the joint capsule, surrounding the joint. A relatively narrow, beveled end portion of the paddle 120 may facilitate insertion of the paddle 120 into the joint. In some embodiments, the paddle 120 is integrally formed with the body 105.

[0045] The body 105 of the cutting guide 180 includes a single cutting slot 182. The slot 182 penetrates the entire thickness of the body 105 and is sized and shaped to act as a positioning guide for the saw blade to facilitate precise saw cuts on each side of the joint. For example, the slot 182 may be positioned at a predetermined distance relative to the plane of the adjacent surface of the paddle 120 to facilitate cutting the base of the first metatarsal or the first cuneiform bone, depending on the orientation of the cutting guide 180, when the paddle 120 is positioned in the first TMT joint. In some embodiments, the slot 182 may be parallel to the paddle 120 or angled relative to the plane of the paddle 120. In some embodiments, a relatively wide end section 127 may be provided at the end of the slot 182 for placement of an additional guide wire during cutting to prevent the saw blade from cutting too wide when using the cutting guide 180.

[0046] The first pin holes 186 extend through the entire thickness of the cutting guide 180. One or both of the first pin holes 186 may be disposed on the first extension 184 or within the body 105. The first pin holes 186 may each have a substantially circular profile sized to accommodate a surgical pin or wire for temporarily securing the cutting guide to the foot. The first pin holes 186 act as guides so that two pins or wires can be inserted at a predetermined distance relative to each other and to the second pin hole 190. The first pin holes 186 extend parallel and perpendicular to each other as shown in FIG. 2K.

[0047] The second pin holes 190 extend through the entire thickness of the cutting guide 180. Like the first pin holes 186, the second pin holes 190 may each have a substantially circular profile sized to accommodate a surgical pin or wire for temporarily fixing the cutting guide 180 to the foot, and may have the same diameter as the first pin holes 186. The second pin holes 190 serve as guides so that two distal pins or wires can be inserted at a predetermined interval relative to each other and to the plane in which the first metatarsal or first cuneiform bone is cut by the saw blade through the slot 182. The second pin holes 190 extend parallel to each other and perpendicular to the first pin holes 186, as shown in FIG. 2K. The plane intersecting the axis of the first pin holes 186 may be coplanar with the plane intersecting the axis of the second pin holes 190. The combination of the pin holes forms a linear array of holes that span the TMT joint. The bottom or bone-facing surface of the second extension 188 may be flush or substantially flush with the bottom or bone-facing surface of the main body 105 and / or first extension 184, which may allow the cutting guide 180 to be positioned across the TMT joint in either of two opposing orientations with the paddle 120 seated within the joint.

[0048] In some embodiments, the body 105 of the cutting guide 180 further includes one or more additional openings, such as an additional converging pin hole 107 and / or a longitudinal opening 109. The converging pin hole 107 may be utilized for inserting one or more additional pins or wires if additional stability is desired during the bunionectomy procedure. The longitudinal opening 109 extends transversely to the slot 182 and may provide an opening to facilitate x-ray visualization and / or any other suitable surgical imaging procedure to verify and / or monitor the alignment of the cutting guide during the bunionectomy procedure.

[0049] 2L-2N depict a further exemplary reversible cutting guide 181 configured as a cutting guide and pin guide for the Rapidus bunion resection procedure described herein. FIGS. 2L and 2M are top and bottom perspective views, respectively, of cutting guide 181. FIG. 2N is a top view of cutting guide 181. Cutting guide 181 may be a single, integrally formed component and may comprise metal, plastic, or other suitable material. Cutting guide 181 is similar to cutting guide 180 of FIGS. 2H-2K and includes a reversible configuration having a single slot 182.

[0050] The cutting guide 181 generally includes a body 105, a first extension 184, a second extension 188, and a paddle 120. The first extension 184 and the second extension 188 can include a first pin hole 186 and a second pin hole 190, as described above with reference to Figures 2H-2K. The paddle 120 is sized and shaped to seat within a joint, such as a TMT joint (e.g., between the first metatarsal and the first cuneiform bone), for example, after removing soft tissue, such as the zygapophyseal capsule, around the joint. A relatively narrow, angled end portion of the paddle 120 can facilitate insertion of the paddle 120 into the joint. In some embodiments, the paddle 120 is integrally formed with the body 105.

[0051] 2L-2N, the body 105 of the cutting guide 181 further includes one or more additional openings, such as an additional convergent pin hole 183, extending through the second extension 188. The convergent pin hole 183 may be utilized to insert one or more additional pins or wires if additional stability is desired during the bunionectomy procedure. Similar to the cutting guide 180 of FIGS. 2H-2K, the longitudinal opening 109 extends transversely to the slot 182 and may provide an opening to facilitate x-ray visualization and / or any other suitable surgical imaging procedure to verify and / or monitor the alignment of the cutting guide during the bunionectomy procedure.

[0052] 3A-3H illustrate an exemplary linear reducer 200 configured for use in the lapidus bunion resection procedure described herein. With reference to FIGS. 3A-3C, linear reducer 200 includes a medial hook 205, a threaded shaft 210, a lateral hook 215, and a handle 220. As described in more detail with reference to FIGS. 10-14, linear reducer 200 is suitable for applying correction in the transverse plane during a lapidus bunion resection procedure by bringing a first metatarsal bone and a second metatarsal bone closer together to reduce the intermetatarsal angle, while maintaining a desired correction in the coronal plane when a pin is placed in medial hook pin hole 209.

[0053] The medial hook 205 includes a coupling opening 206 sized and shaped to couple to a first end 212 of the threaded shaft 210. In some embodiments, the medial hook 205 may be fixedly coupled to the threaded shaft 210 such that the medial hook 205 cannot rotate or translate relative to the threaded shaft 210. The medial hook 205 includes a curved engagement surface 207 configured to rest against the medial side of the foot. One or more medial hook pin holes 209 extend from the engagement surface 207 through the full thickness of the medial hook 205 such that a pin may be placed through the medial hook 205 to temporarily secure the medial hook 205 to the toe.

[0054] The outer hook 215 includes a mating opening 216 sized and shaped to receive the threaded shaft 210 therethrough. The outer hook 215 may have a smooth inner surface with a diameter at least as large as the overall diameter of the threaded shaft 210 so that the outer hook 215 can translate along the threaded shaft 210 without rotating. Other features of the mating opening may include a non-cylindrical profile that prevents rotation of the outer hook 215 about the axis of the threaded shaft 210 when the outer hook 215 is assembled to the threaded shaft 210. The outer hook 217 includes a curved engagement surface 217 configured to rest against the lateral side of a bone, such as the second metatarsal. In some embodiments, the engagement surface 217 may be inserted through an incision between the second and third toes, for example, so that the engagement surface 217 may be positioned against the lateral side of the second metatarsal for cross-sectional correction.

[0055] In various embodiments, the components of the linear reducer 200 may include various materials. For example, the handle 220, the threaded shaft 210, the inner hook 205, and / or the outer hook 215 may include metal, plastic, or polymeric materials, etc. In some embodiments, the inner hook 205 and / or the outer hook 215 may include a radiolucent material. Advantageously, the radiolucent material may be at least partially transparent to x-rays or other radiation associated with medical imaging to facilitate imaging of the foot bones while the linear reducer 200 is being applied. Exemplary radiolucent materials suitable for the inner hook 205 and / or the outer hook 215 include carbon fiber, polymeric materials, and / or composite materials, such as carbon fiber reinforced polymers.

[0056] The handle 220 includes one or more gripping features 222, such as knurling, to facilitate a user's grip while rotating the handle 220. A threaded opening 224 extends longitudinally through the handle 220. The internal threads of the threaded opening 224 are sized and spaced to mate with the external threads of the threaded shaft 210. In some embodiments, only a portion of the threaded opening 224 is threaded, with any remaining length being drilled to a larger diameter, e.g., to allow the threaded shaft 210 to pass cleanly through. The internal threads of the threaded opening 224 thereby allow the handle 220 to be translated along the threaded shaft 210 to a desired position by rotating the handle 220 about the threaded shaft 210. Thus, when a user desires to reduce the spacing between the inner hook 205 and the outer hook 215, the user twists the handle 220 clockwise about the threaded shaft 210 such that the handle 220 pushes the outer hook 215 along the threaded shaft 210 toward the inner hook 205. Friction between the female threads of the threaded opening 224 and the male threads of the threaded shaft 210 prevents the outer hook 215 and handle 220 from being pushed outward, away from the inner hook 205, unless the handle 220 is twisted.

[0057] 3D illustrates an alternative embodiment of the lateral hook 215. In the alternative lateral hook 215 of FIG. 3D, the engagement surface 217 includes one or more bone engaging features 218 configured to provide an improved grip on the lateral aspect of the second metatarsal during a rapidus bunion resection procedure. In some cases, the bone engaging features 218 may reduce the likelihood of the lateral hook 215 sliding upwardly off the second metatarsal during or after reduction of the intermetatarsal angle in the transverse plane.

[0058] 3E-3G illustrate a quick release feature that may be incorporated into the inner hook of the linear reducer 200. In the quick release embodiment of the linear reducer 200, the fixedly coupled inner hook 205 of FIGS. 3A-3C is replaced by a quick release inner hook 235. The quick release inner hook 235 includes an opening 236 large enough to slidably accommodate the threaded shaft 210. A quick release insert 237 is insertable into an upper portion of the quick release inner hook 235. The quick release insert 237 has a coupling opening 239 including a locking portion 238 configured to couple with the notch 214 near the first end 212 of the threaded shaft 210. Thus, when the quick release insert 237 is in the raised position shown in FIG. 3E, the locking portion 238 is engaged within the notch 214 to fixedly couple the quick release inner hook 235 to the threaded shaft.

[0059] When it is desired to remove the linear reducer 200 from the foot, the quick release insert 237 is pushed downward along direction 240. As the quick release insert 237 moves downward, the locking portion 238 disengages from the notch 214 of the threaded shaft 210, thereby allowing the entire quick release inner hook to slide along a longitudinal direction 242 relative to the threaded shaft 210. For example, with the quick release inner hook 235 pinned to the bone, the threaded shaft 210 can be removed through the coupling opening 216 of the outer hook 215, which can be removed substantially perpendicularly from the foot. The inner hook 205 can then be unpinned and easily removed from the foot.

[0060] 3H, in some embodiments, a shoulder pin 260 may be used in conjunction with the linear reducer 200. While any type of pin may be used, the shoulder pin 260 may advantageously prevent damage to the skin on the inside of the foot when the linear reducer 200 is used. The shoulder pin 260 includes a tip 262 that enters the foot and a shoulder 264 that extends radially outward from the side of the shoulder pin 260. The shoulder 264 is preferably larger than the inner hook pin hole 209 such that the shoulder 264 prevents the shoulder pin 260 from sliding outward through the inner hook pin hole 209. As such, when shoulder pin 260 is inserted medially into the first metatarsal and linear reducer 200 is manipulated to reduce the intermetatarsal angle of the foot, the lateral force applied by medial hook 205 is transferred to the first metatarsal via shoulder 264 rather than along engagement surface 207 and through the skin, reducing the probability of compression and / or damage to the skin of the foot. In some embodiments, shoulder pin 260 may be used in conjunction with quick release medial hook 235 depicted in Figures 3E-3G.

[0061] 4A and 4B depict an exemplary control handle 300 configured for use in the lapidus bunion resection procedure described herein. As described in more detail with reference to FIGS. 11-14, the linear reducer 200 is suitable for applying corrections in the coronal or other planes during a lapidus bunion resection procedure by rotating the first metatarsal bone relative to the first cuneiform bone. The control handle 300 is only one example of a handle that may be attached to the cutting guide 100. Those skilled in the art will appreciate that various attachments may be made between the control handle and the cutting guide 100 without departing from the scope of the present technology.

[0062] The control handle 300 includes a handle 305 and an engagement portion 310 connected thereto. The openings 312 in the engagement portion 310 and / or the pin guides 314 disposed therein are spaced to receive a pin disposed in the first metatarsal according to the spacing of the distal pin holes 117 or 170 of the cutting guide 100 or freehand pin guide 150. The spacing of the openings 312 also corresponds to the spacing of the proximal pin holes 112 or 165. A space 316 in the pin guide 314 is suitably sized to receive a surgical pin or wire.

[0063] 5A-5D depict an exemplary compressor block 400 configured for use in the rapidus bunion resection procedure described herein. FIGS. 5A and 5B are top and bottom perspective views, respectively, of compressor block 400. FIG. 5C is a top view of compressor block 400. FIG. 5D is a cross-sectional side elevation view of compressor block 400 taken about line segment 5D-5D of FIG. 5C. As will be described in more detail with reference to FIGS. 16-18, compression block 400 is configured to aid in compressing and immobilizing a resected joint that has been cut freehand or using cutting guide 100.

[0064] The compressor block 400 includes a body 405 having a proximal pin hole 410 and a distal pin hole 415 extending therethrough. The proximal pin hole 410 is spaced apart from one another by the same distance as the proximal pin holes 112, 165 of the cutting guide 100 and the freehand pin guide 150. Similarly, the distal pin hole 415 is spaced apart from one another by the same distance as the distal pin holes 117, 170 of the cutting guide 100 and the freehand pin guide 150. However, the proximal pin hole 410 and the distal pin hole 415 are located closer to the center of the compressor block 400 than the proximal pin holes 112, 165 and the distal pin holes 117, 170 of the cutting guide 100 and the freehand pin guide 150, respectively. In addition, as shown in the cross-sectional view of Figure 5D, the proximal and distal pin holes 410, 415 are not parallel, but rather are disposed at a converging angle such that their spacing at the bottom edge 407 of the compressor block 400 is relatively close. This causes the parallel pins threaded into the proximal and distal openings 410, 415 to be squeezed closer together as the compressor block 400 slides downward over the pins, as shown in Figures 15-16. The handle mounting openings 425 may be threaded, but are provided for mounting a side mounted handle that may assist a user in sliding the compressor block 400 downward to squeeze the pins or wires passing through it.

[0065] The compressor block 400 further includes an expanded section 409 that includes cross pin holes 420. As shown in Figures 5A and 5B, each cross pin hole 420 extends downwardly and inwardly from an outer edge of the expanded section 409 such that a pin or wire inserted into the cross pin hole 420 will exit the bottom edge 407 of the compressor block 400 relatively close to the centerline of the compressor block 400. As shown in Figures 16-18, the cross pin holes 420 are aligned so that when the compressor block 400 is used with the cutting guide 100 or freehand pin guide 150 at the first TMT joint, the compressor block 400 will bring the cut surfaces of the resected first TMT joint into contact with each other and a pin inserted through either cross pin hole 420 will extend at an angle through the compressed joint interface to temporarily maintain contact at the articular surfaces until the first cuneiform and first metatarsal can be fixed with a plate or other fixation component.

[0066] 6A-6G depict an exemplary bone plate 500 and cross screw 530 configured for use in the Rapidus bunion resection procedure described herein. The bone plate 500 and / or cross screw 530 may be formed from a variety of metals or metal alloys. For example, the bone plate may be formed from a shape memory alloy such as titanium, nitinol, or the like.

[0067] The bone plate 500 is sized and shaped to be applied across a resected first TMT joint. To that end, the bone plate 500 includes a body 505 that includes a staple opening 510, a wedge screw opening 515, a metatarsal screw opening 520, and a cross screw opening 525. The staple opening 510 includes two holes 512 that are sized and shaped to receive two legs of a bone staple, such that one of the legs is seated in the first wedge bone near the wedge screw opening 515 and the other leg is seated in the first metatarsal bone near the metatarsal screw opening 520 and the cross screw opening 525.

[0068] Each of the staple openings 510 and screw openings 515, 520, 525 is shaped to include a countersink to reduce movement of the staples and / or screws seated therein. Additionally, the countersink may allow the staples or screws applied therein to not extend significantly above the outer surface of the body 505 of the bone plate 500. Due to the angle at which the cross screw must be applied to the cross screw opening 525, the cross screw opening 525 includes a shelf 527 that has an elliptical shape when viewed perpendicular to the bone plate 500 (e.g., corresponding to a cylindrical profile along the thread path through the cross screw opening 525) and occupies approximately half of the circumference of the cross screw opening 525. The shelf 527 is shaped to engage the head of the cross screw when the cross screw is inserted into the pre-drilled angle, such that the cross screw positively engages the bone plate 500 and seats within the countersink.

[0069] FIG. 6D is an enlarged partial view of the bone plate 500 illustrating the cross screw opening 525 and shelf 527 in detail. FIG. 6E illustrates an exemplary cross screw 530 configured to be seated within the cross screw opening 525, including a head 532 and a threaded shaft 534. As shown in FIG. 6D, which is taken perpendicular to the axis of the cross screw path, the shelf 527 can be sloped or tapered such that the inner edge of the shelf 527 is higher relative to the outer edge where the shelf 527 meets the inner wall of the cross screw opening 525. As shown in FIG. 6E, the head 532 of the cross screw 530 has an undercut shelf 537. The shelf 537 tapers downward as it increases in diameter in this embodiment. As such, as shown in Figures 6F and 6G, when the cross screw 530 is inserted through the cross screw opening 525, the undercut shelf 537 of the head 532 of the cross screw 530 engages with the upwardly tapered shelf 527 of the bone plate 500 such that the bone screw 530 seats at a desired angle within the bone.

[0070] Figures 7A-7F depict an exemplary cross screw drill guide configured for use with bone plate 500 when applying cross screws through cross screw openings 525. Figures 7A-7C depict an exemplary fixed angle cross screw drill guide 600. Figures 7D-7F depict an exemplary variable angle cross screw drill guide 650 that allows the surgeon to select one of a range of angles for inserting the cross screws.

[0071] The fixed angle cross screw drill guide 600 includes a body 605 and a tip 615. A longitudinal opening 610 extends the entire length of the body 605. The diameter of the longitudinal opening 610 may be selected such that a drill bit suitably sized to drill pilot holes for the cross screws can fit through the longitudinal opening 610. In some embodiments, the diameter of the longitudinal opening 610 may be selected such that a k-wire or other guide structure can fit through the longitudinal opening 610 such that the guide can be removed and a cannulated drill bit can be used to drill the pilot holes. The tip 615 includes a shelf-engaging surface 627 and a toe 629. The toe 629 and the shelf-engaging surface 627 are shaped such that the toe 629 can seat within the cross screw opening 525 with the shelf-engaging surface 627 seated against the shelf 527 of the cross screw opening 525. The elliptical shape of the cross screw opening 525 defines a single stable orientation for seating the tip 615 of the fixed angle cross screw drill guide 600 therein. The fixed angle cross screw drill guide 600 facilitates consistent and repeatable application of cross screws at a predetermined preferred angle to prevent bunion recurrence. In addition, the fixed angle cross screw drill guide 600 can force the drill bit into the bone at a position concentric with the radius of curvature of the shelf 527 of the bone plate 500 (e.g., because even if the hole is drilled incorrectly, the screw can still pass through the bone plate 500). Furthermore, the fixed angle cross screw drill guide 600 prevents the cross screw from interfering with the staple legs, prevents the cross screw from crossing the TMT joint, and establishes the drill bit at an angle that directs the cross screw toward the base of the second metatarsal or second cuneiform bone.

[0072] The variable angle cross screw drill guide 650 similarly includes a body 655 and a tip 665, and an opening 660 extending through the body 655. The tip 665 has the same shape as the tip 615 of the fixed angle cross screw drill guide 600, including a shelf-engaging surface 677 and a toe 679, such that the elliptical shape of the cross screw opening 525 similarly defines a single stable orientation for seating the tip 665 of the variable angle cross screw drill guide 650. The variable angle cross screw drill guide 650 has a generally wedge-shaped body 655 that surrounds a wedge-shaped slot 662 that communicates with the opening 660. The wedge-shaped slot 662 accommodates a range of drilling angles 652 whose paths pass through the opening 660. The elliptical shape of the cross screw opening 525 thereby defines a single seating orientation for the variable angle cross screw drill guide 650, while the wedge shaped slot 662 allows the surgeon to select a variety of angles within a given plane. The available drilling paths can range from a first extreme path that is perpendicular or nearly perpendicular to the bone plate 500 to a second extreme path that is at a smaller angle relative to the bone plate 500. Depending on the geometry of the bone structure of an individual's foot, the variable angle cross screw drill guide 650 can allow the surgeon to select a cross screw trajectory, for example, to enter the second metatarsal or second cuneiform bone, as desired.

[0073] An exemplary lapidus bunionectomy using certain devices disclosed herein is described with reference to Figures 8-24. Although the procedure of Figures 8-24 illustrates a particular implementation of a lapidus bunionectomy using a particular subset of the devices disclosed herein, it will be understood that the components and steps illustrated and described with reference to Figures 8-24 may equally be applied in different orders and / or with different combinations of components to correct a bunion.

[0074] 8-24 depict the bones of a foot 10 initially having a bunion. Similar to the foot 10 of FIG. 1, the foot 10 includes a first metatarsal 20 that is angled and rotated relative to the first cuneiform 30 at the first TMT joint 40, causing the big toe to have undesirable medial prominence and an increased intermetatarsal angle. As shown in FIG. 8, the procedure may begin by placing and temporarily securing the cutting guide 100 of FIGS. 2A-2D. Prior to placing the cutting guide, the surgeon may prepare the first TMT joint 40 by making an incision, such as a dorsal medial incision, to expose the first TMT joint 40 and resecting soft tissues surrounding the joint, such as the joint capsule or other soft tissues, to create a space in which the paddle 120 of the cutting guide 100 (FIGS. 2A-2D) can be seated.

[0075] Once the joint is prepared, the cutting guide 100 is positioned by seating a paddle 120 (not visible in FIG. 8 ) within the first TMT joint 40 such that the proximal extension 110 seats adjacent to or against the first cuneiform bone 30 and the distal extension 115 seats adjacent to or against the first metatarsal bone 20. The paddle 120 is inserted into the first TMT joint 40 such that the cutting guide 100 is oriented along the axis of the first metatarsal bone 20. Alignment of the cutting guide 100 may be confirmed with fluoroscopy or other suitable imaging technique prior to proceeding.

[0076] Once the cutting guide 100 is in place and suitably aligned, the cutting guide 100 is temporarily secured to the first metatarsal 20 by inserting two metatarsal pins 802 or wires into or through the first metatarsal 20 through the distal pin holes 117 of the distal extension 115. The metatarsal pins 802 or wires, as well as any of the other pins or wires described in the following description, may be, for example, Kirschner wires ("K-wires"), or any other suitable type of wire or pin that may be placed into a bone to secure the cutting guide 100.

[0077] Continuing with FIG. 9, once the metatarsal pin 802 or wire has been inserted, the base of the first metatarsal 20 is cut using a saw blade 804 inserted through the distal slot 125 of the cutting guide 100.

[0078] 10, the linear reducer 200 may be provisionally positioned around the first metatarsal 20 and the second metatarsal 25. In some embodiments, an incision is made on the lateral side of the second metatarsal 25 between the second and third toes to accommodate insertion of the lateral hook 215, such that the engagement surface 217 contacts the lateral side of the second metatarsal 25. The engagement surface 207 of the medial hook 205 may be positioned against the medial side of the first metatarsal 20, and the handle 220 of the linear reducer 200 may be rotated clockwise relative to the threaded shaft 210 until the handle 220 contacts the lateral fork 215. The initial positioning of the linear reducer 200 may be provisional, without initially inserting any pin through the medial fork 205.

[0079] Continuing with FIG. 11, the control handle 300 may be further positioned by inserting a metatarsal pin 802 through the space 316 in the pin guide 314 of the control handle 300. Referring to FIG. 12, the control handle 300 may then be rotated in the coronal plane to correct the rotation of the first metatarsal 20 about its axis. For example, when a clockwise rotation 806 is imparted to the control handle 300, the torque applied to the control handle 300 is transferred through the metatarsal pin 802, thereby rotating the first metatarsal and phalanges 50 of the big toe clockwise 808. In addition, any necessary adjustments of the joint in the sagittal plane may be applied manually at this point. In some embodiments, other corrections, such as applying a torque in the transverse plane to reduce the intermetatarsal angle, may also be applied using the control handle 300. When the coronal and sagittal planes have been suitably corrected using the control handle 300, the surgeon may then proceed to adjust the position of the first metatarsal 20 in the transverse plane.

[0080] 12 and 13 together, the transverse plane may be corrected using the linear reducer 200. In some implementations, the medial hook pin 816 is inserted through one of the medial hook pin holes 209 or through the first metatarsal 20 to fix the rotational position of the first metatarsal 20 in the frontal plane (e.g., to lock in a frontal plane correction previously applied using the control handle 300). The medial hook pin may be a shouldered pin, such that the lateral pressure exerted by the medial hook 205 is applied directly to the first metatarsal 20 through the pin shoulder, rather than through the skin along the engagement surface 207 of the medial hook.

[0081] A transverse plane correction may be applied by redirecting the handle 220 of the linear reducer 200, with or without insertion of the medial hook pin 816. For example, clockwise rotation 810 of the handle 220 reduces the distance along the threaded shaft between the medial fork 205 and the lateral fork 215, causing the medial fork 205 to move laterally along direction 812 relative to the lateral fork 215. As a result, the medial fork 205 applies a lateral force to the first metatarsal 20 in the transverse plane, causing a corresponding lateral movement 814 of the first metatarsal 20 in the transverse plane.

[0082] At this stage, the misalignment of the first TMT joint 40 has been addressed. With continued reference to FIG. 13, two cuneiform pins 818 or wires are inserted through the proximal pin holes 112 of the cutting guide and into or through the first cuneiform bone 30. The cuneiform pins 818 or wires temporarily fix the cutting guide 100 relative to the first cuneiform bone 30. At this point, the four pins 802 and 814 form an array that establishes and / or locks the surgeon's desired correction.

[0083] 14, once the cuneiform pin 818 or wire is inserted, the base of the first cutout 30 is cut using a saw blade 820 inserted through the proximal slot 130 of the cutting guide 100. Cutting the base of the first cuneiform 30 completes the resection of the first TMT joint 40. With reference to FIG. 15, the cutting guide 100, linear reducer 200, and control handle 300 have been removed from the foot 10. The control handle 300 may be removed by sliding it upwards until it is free of the metatarsal pin 802 or wire. The cutting guide 100 may similarly be removed by sliding it upwards until it is free of the metatarsal pin 802 or wire and the cuneiform pin 818 or wire. The linear reducer 200 is removed by removing the medial hook pin 816 and lifting the medial hook 205 and lateral hook 215 away from the foot 10. In some embodiments, a quick release medial hook 235 may be used to facilitate removal of the linear reducer. After removal of the cutting guide 100, linear reducer 200, and control handle 300, a fully disarticulated first TMT joint is left with the metatarsal pin 802 or wire and cuneiform pin 818 or wire remaining in place. At this point, the surgeon may further use any desired means to distract and further prepare the joint in preparation for union.

[0084] 16, the compressor block 400 is applied over the metatarsal pins 802 or wires and the cuneiform pins 818 or wires. Preferably, the metatarsal pins 802 or wires are either shorter or longer than the cuneiform pins 818 or wires (e.g., by approximately the height of the compressor block 400, as shown in FIG. 16). In the example of FIG. 16, the compressor block 400 is applied by first threading the proximal pin holes 410 onto the relatively long cuneiform pins 818 or wires, followed by threading the distal pin holes 415 onto the relatively short metatarsal pins 802 or wires. As discussed above with reference to FIGS. 5A-5D, unlike the pin holes of the cutting guide 100, the pin holes of the compressor block 400 are slightly closer together and tapered inward, such that it may be difficult to attempt to insert all four pins or wires into the compressor block 400 at the same time.

[0085] Due to the convergence angle of the proximal pin holes 410 relative to the distal pin holes 415, by sliding the compressor block 400 downwardly over the cuneiform pin 818 or wire, the metatarsal pin 802 or wire pulls the metatarsal pin 802 or wire closer to the cuneiform pin 818 or wire. Application of the compressor block 400 thereby moves the first metatarsal 20 along the direction 822 toward the first cuneiform 30, bringing the cut surface of the first metatarsal 20 into contact with the cut surface of the first cuneiform 30. The angled holes cause rotation of the pin in the sagittal plane such that the plantar side of the joint is compressed. This may be desirable because compression only against the dorsal aspect of the bone may in some cases cause a plantar gap in the joint that is undesirable for fusion.

[0086] Continuing with reference to FIG. 17, the cross pin 824 is inserted through one of the cross pin holes 420 so that it passes through the compressed joint to temporarily fix the joint in place. As shown in FIG. 18, the metatarsal pin 802 or wire and the cuneiform pin 818 or wire are removed. As shown in FIG. 19, the compressor block 400 may then be removed by sliding the compressor block outwardly along the cross pin 824, remaining in place to fixate the joint until the bone plate 500 can be applied. Any number of cross pin hole tracks may be applied to the compression block 400 for placement of the cross wires. Although the cross pin 824 is shown inserted distally and extending proximally into the joint, in other embodiments, the compression block 400 may have proximally located cross pin holes 420 instead of or in addition to distally. In such an embodiment, the cross pin 824 would be inserted from the proximal end of the compression block 400 and extend distally through the joint.

[0087] 20, the bone plate 500 is placed across the resected first TMT joint 40 while the joint is fixed in place by the cross pin 824. Pilot holes are drilled, if necessary. To secure the first metatarsal 20 to the first cuneiform 30, the staples 826 are placed in the staple openings 510, the metatarsal screws 828 are placed in the metatarsal screw openings 520, and the wedge screws 830 are placed in the wedge screw openings 515. The staples 826, metatarsal screws 828, and wedge screws 830 can be placed in any order. However, it may be preferable to place the staples 826 and metatarsal screws 828 before placing the cross screws 834. As shown in FIG. 21, when the first metatarsal 20 and the first cuneiform 30 are fixed using the bone plate 500, the cross pin 824 is no longer needed and can be removed. The staples 826 may be made of a shape memory material. In some embodiments, the staples 826 are held in a deformed configuration, with the staple legs approximately parallel while being inserted through the plate 500. After insertion, the staples 826 may be allowed to relax toward a non-deformed configuration, with the legs angled toward each other, such that after insertion, the staples 826 provide a compressive force across the TMT joint 40. Further details of the plate-staple system may be found in U.S. Pat. No. 10,299,842, which is incorporated herein by reference in its entirety. Further details regarding staples suitable for use as described herein may be found in U.S. Patent Application Publication No. 2018 / 0317906, which is incorporated herein by reference in its entirety.

[0088] 22, a cross screw drill guide is placed in the cross screw opening 525 of the bone plate 500. Although the fixed angle cross screw drill guide 600 of FIGS. 7A-7C is shown in FIG. 22, the procedure may equally be performed using the variable angle cross screw drill guide 650 of FIGS. 7D-7F. The cross screw drill guide 600 is seated in the cross screw opening 525 by seating the shelf engagement surface 627 (or shelf engagement surface 677 if the variable angle cross screw drill guide 650 is used) against the shelf 527 of the cross screw opening 525. A drill bit 832 is inserted through the cross screw drill guide 600 and redirected to drill a pilot hole for the cross screw in the cross screw opening 525. The drill bit 832 and cross screw drill guide 600 are removed and a cross screw 834 is placed in the cross screw opening 525 to complete the Rapidus bunionectomy procedure.

[0089] 23 and 24 show the completion of a rapidus bunionectomy according to the present technique. FIG. 24 is an enlarged view of a portion of the foot with the first metatarsal 20 shown in transparency to illustrate the internal placement of the cross screws 834. As shown in FIG. 23 and 24, the first metatarsal 20 is fixed in a desired orientation relative to the first cuneiform 30 with a reduced intermetatarsal angle relative to the second metatarsal 25 by the bone plate 500, staples 826, metatarsal screws 828, and cuneiform screws 830.

[0090] Advantageously, the cross screw 834 further functions to prevent future recurrence of the bunion. Because the foot may still be subject to daily pressures that may cause the bunion to return, the cross screw 834 secures the first metatarsal 20 to either the second metatarsal 25 or the second cuneiform 35, depending on the foot geometry and the insertion angle of the cross screw 834. In this way, the Lapidus Bunionectomy of Figures 8-24 advantageously goes beyond simply repairing the bunion by providing additional structural connections to the more laterally disposed bones of the midfoot to prevent recurrence.

[0091] With reference to Figures 25-29, a portion of an alternative Lapidus bunionectomy procedure using certain devices herein is described. The portion of the Lapidus bunionectomy illustrated in Figures 25-29 provides an alternative method of performing the first metatarsal and first cuneiform cuts using a single slotted cutting guide 180 illustrated in Figures 2H-2K. Thus, as described in more detail below, the portion of the Lapidus bunionectomy illustrated in Figures 25-29 may be used in conjunction with the portion of the Lapidus bunionectomy illustrated in Figures 8-24 and / or other bunion excision procedures. While the procedure of Figures 25-29 illustrates a particular implementation of a Lapidus bunionectomy using a particular subset of the devices disclosed herein, it will be understood that the components and steps illustrated and described with reference to Figures 25-29 may equally be applied in different orders and / or with different combinations of components to correct a bunion.

[0092] As shown in Figure 25, the procedure may begin by placing and temporarily securing the cutting guide 180 of Figures 2H-2K on the foot 10. Similar to the starting configuration of Figure 8, the first TMT joint 40 may have been prepared by making an incision, such as a dorsomedial incision, to expose the first TMT joint 40 and resecting soft tissue surrounding the joint, such as the joint capsule or other soft tissue, to create a space in which the paddle 120 of the cutting guide 180 (Figures 2H-2K) can seat.

[0093] Once the joint is prepared, the cutting guide 180 is positioned by seating the paddle 120 (not visible in FIG. 25 ) within the first TMT joint 40 such that the first extension 184 seats adjacent or against the first cuneiform bone 30 and the second extension 188 seats adjacent or against the first metatarsal bone 20. The paddle 120 is inserted into the first TMT joint 40 such that the cutting guide 180 is oriented along the axis of the first metatarsal bone 20 with the slot 182 positioned over the first metatarsal bone 20. Alternatively, in some embodiments, the cutting guide 180 may be oriented with the slot 182 positioned over the first cuneiform bone 30 and the bunionectomy may be performed such that the first cuneiform bone 30 is cut before the first metatarsal bone 20. Alignment of cutting guide 180 may be confirmed with fluoroscopy or other suitable imaging technique prior to proceeding.

[0094] Once the cutting guide 180 is positioned and suitably aligned, the cutting guide 180 is temporarily secured to the first metatarsal 20 by inserting one or more metatarsal pins 802 or wires into or through the first metatarsal 20 through the second pin holes 190 of the second extension 188. The metatarsal pins 802 or wires, as well as any of the other pins or wires described in the following description, may be, for example, Kirschner wires ("K-wires"), or any other suitable type of wire or pin that may be placed into a bone to secure the cutting guide 180. Although two metatarsal pins 802 or wires are illustrated in this example, the cutting guide 180 may be suitably rigid and stable when held in place by the paddle 120 and a single metatarsal pin 802 or wire.

[0095] With continued reference to FIG. 26, once the metatarsal pin 802 or wire has been inserted, the base of the first metatarsal 20 is cut using a saw blade 804 inserted through the slot 182 in the cutting guide 180.

[0096] 27 and 28, after the base of the first metatarsal 20 has been cut, the cutting guide 180 can be reoriented so that the same slot 182 can be used to guide the cut of the first cuneiform bone 30 later in the rapidus bunion resection procedure. The cutting guide 180 can be removed by sliding the cutting guide 180 upwards, as shown in FIG. 27, until the second pin hole 190 is free of the metatarsal pin 802 or wire. At this stage, the resected portion of bone from the first metatarsal 20 (or from the first cuneiform bone 30, if the first cuneiform bone 30 was cut first) can be removed from the foot 10. The cutting guide 180 can then be inverted (e.g., rotated 180 degrees about an axis parallel to the metatarsal pin 802 or wire). The metatarsal pin 802 or wire may then be inserted through the first pin hole 186 and the cutting guide 180 may be moved down along the metatarsal pin 802 or wire until the paddle 120 is again seated in the first TMT joint 40, as shown in FIG. 28. In some embodiments, the first pin hole 186 and the second pin hole 190 have different spacings about the center of the paddle 120. For example, the first pin hole 186 may be closer to the paddle 120 by a distance equal to the thickness of bone removed by the first cut, such that inverting the cutting guide 180 will seat the paddle 120 firmly against the cut surface of the first metatarsal 20.

[0097] In the configuration of FIG. 28, with the inversion of the cutting guide 180, the second hole 190 is disposed over the first cuneiform bone 30 and the slot 182 is positioned to guide the cutting of the first cuneiform bone 30 rather than the first metatarsal bone 20. From the state illustrated in FIG. 28, the lapidus bunion resection procedure can proceed substantially as shown and described with reference to FIGS. 10-13 to correct the position of the first metatarsal bone 20 and the phalanges 50 in the coronal and transverse planes. In the same process described with reference to FIG. 13, two cuneiform bone pins 818 or wires are inserted through the second pin holes 190 of the cutting guide 180 and into or through the first cuneiform bone 30. The cuneiform bone pins 818 or wires temporarily fix the cutting guide 180 to the first cuneiform bone 30. At this point, the four pins 802 and 814 form an array that establishes and / or locks in the surgeon's desired correction.

[0098] 29, by inversion of the cutting guide 180 following the cut of the first metatarsal 20, the slot 182 is now positioned on the cuneiform side of the first TMT joint 40. This positions the slot 182 to guide the cut of the first cuneiform 30 following correction of Boynning in at least the coronal and / or transverse planes and placement of the cuneiform pin 818 or wire.

[0099] Once the cuneiform pin 818 or wire has been inserted, the base of the first cuneiform bone 30 is cut using a saw blade 820 inserted through the slot 182 of the cutting guide 180. Cutting the base of the first cuneiform bone 30 completes the resection of the first TMT joint 40. The cutting guide 180, linear reducer 200, and control handle 300 may then be removed from the foot 10 by the same or similar operations as those described above with reference to FIG. 15. After removal of the cutting guide 180, linear reducer 200, and control handle 300, a fully disarticulated first TMT joint 40 is left with the metatarsal pin 802 or wire and the cuneiform pin 818 or wire remaining in place. At this point, the surgeon may further use any desired means to distract and further prepare the joint in preparation for union. The remainder of the Rapidus bunion excision procedure may then proceed substantially as shown and described with reference to Figures 16-24.

[0100] With reference to Figures 30A-32C, various additional devices and components are provided for use with the improved Lapidus bunion resection procedure for correcting the TMT joint deformity of Figure 1. The devices and components of Figures 30A-32C may be used to perform additional optional steps in the Lapidus bunion resection procedure described herein, such as additional removal of bone and / or additional rotational correction of the coronal plane prior to fixation. Although the following description is made with reference to a Lapidus bunion resection procedure, it will be understood that the various devices and components described herein are not limited to such procedures and may equally be used in other orthopedic procedures, as will be appreciated by those skilled in the art.

[0101] 30A-30C depict a cutting guide 900 configured as a recutting guide and pin guide for a lapidus bunion resection procedure described herein. In some lapidus bunion resection procedures, the surgeon may desire to remove additional bone from the first metatarsal and / or first cuneiform bone at the first TMT joint during the procedure. For example, the edges of the first metatarsal and / or first cuneiform bone that form the TMT joint may have various levels of recession in different individuals, such that some first metatarsal and / or first cuneiform bones may require more bone to be cut to reach a plane where the internal bone is exposed across the complete cross-section of the cut area.

[0102] 30A and 30B are top and bottom perspective views, respectively, of cutting guide 900. FIG. 30C is a top view of cutting guide 900. Cutting guide 900 may be a single, integrally formed component and may comprise metal, plastic, or other suitable material. Cutting guide 900 may be sized and shaped to be used in conjunction with (e.g., subsequently to) another cutting guide, such as cutting guide 181 of FIGS. 2L-2N.

[0103] The cutting guide 900 generally comprises a body 910, an extension 920, and a paddle 930. The extension 920 can have a similar or identical size and shape as the second extension 188 of the cutting guide 181 and can include pin holes 922 having spacing corresponding to the spacing of the second pin holes 190 of the cutting guide 181. The body 910 includes a slot 912. The paddle 930 is sized and shaped to seat within a joint, such as, for example, the TMT joint.

[0104] To achieve the desired re-cutting functionality, the spacing between the slot 912 and the pin hole 922 of the cutting guide 900 is closer than the corresponding spacing in the associated cutting guide used for the initial joint cut. For example, in a kit including cutting guide 900 and cutting guide 181 (FIGS. 2L-2N), the distance between the slot 912 and the closer of the pin hole 922 is less than the distance between the slot 182 and the closer of the second pin hole 190 of the cutting guide 180. As such, after a cut is made using the cutting guide 181 held in place by a pin extending through the second pin hole 190, the cutting guide 181 can be removed and the cutting guide 900 can be placed over the same pin through the pin hole 922, such that the slot 912 defines a cutting surface closer to the pin for re-cutting. Use of the cutting guide 900 as a re-cutting guide is described in more detail with reference to FIGS. 33-35.

[0105] 31A-31C depict an exemplary realignment guide 1000 configured as a pin guide for coronal plane adjustment in the rapidus bunion resection procedure described herein. FIGS. 31A and 31B are top and bottom perspective views, respectively, of realignment guide 1000. FIG. 31C is a cross-sectional side elevation view of realignment guide 1000 taken about line segment 31C-31C in FIG. 31B. Realignment guide 1000 includes a body 1010 having two or more pairs of pin holes therethrough. Body 1010 is generally wedge-shaped and may be integrally formed from metal, plastic, or other suitable material.

[0106] In the exemplary realignment guide 1000 of FIGS. 31A-31C, the body 1010 includes four pairs of pin holes 1012, 1014, 1016, and 1018. Each pair of pin holes 1012, 1014, 1016, 1018 may be parallel, with the pairs oriented in a converging configuration. Each pair of pin holes 1012, 1014, 1016, 1018 may be spaced apart a distance corresponding to the pin hole spacing of the associated cutting guide (e.g., cutting guides 180, 181, 900, etc.). Thus, the pin holes 1012, 1014, 1016, 1018 may be used to perform further coronal plane corrections by serving as a guide for placing a second pair of parallel pins similarly spaced apart at a predetermined angular offset around the metatarsal bone relative to the existing pair, positioned over the existing pair of pins. The use of realignment guide 100 will be described in more detail with reference to Figures 39-48.

[0107] 32A-32C depict an exemplary realignment guide 1020 configured as a pin guide and compression block for coronal plane adjustment in the Rapidus bunion resection procedure described herein. FIGS. 32A and 32B are top and bottom perspective views, respectively, of the realignment guide 1020. FIG. 32C is a top view of the realignment guide 1020. The realignment guide 1020 may be integrally formed from metal, plastic, or other suitable material. The realignment guide 1020 may have a generally similar shape to the compressor block 400 and may function as both a realignment guide and a compressor block in operation.

[0108] The realignment guide 1020 includes a body 1025 having two pairs of proximal pin holes 1030, 1032 and two pairs of distal pin holes 1035, 1037. Similar to the proximal and distal pin holes 410, 415 of the compressor block 400, the proximal and distal pin holes 1030, 1032 and 1035, 1037 converge toward the center of the realignment guide 1020. The widened section 1040 may include cross pin holes 1042 for additional stabilization and / or temporary fixation while a permanent fixation device is in place. As will be described in more detail with reference to FIGS. 36-38, the realignment guide 1020 may be used to perform additional frontal plane correction of the first metatarsal bone without requiring the insertion of additional pins into the bone.

[0109] 33-35 are perspective views of the bones of the foot 10 sequentially illustrating a recut portion of an exemplary Rapidus bunion resection procedure performed using an exemplary bunion resection device disclosed herein. The recut portion of the Rapidus bunion resection illustrated in FIGS. 33-35 may be performed at any time after the initial cut is made to the first metatarsal 20 and / or first cuneiform 30 if further removal of bone is desired. For example, in some procedures, the surgeon may inspect the cut end of the first metatarsal 20 and / or first cuneiform 30 and determine that further bone should be removed due to the concavity or desired spacing of the bone. Thus, as described in more detail below, the portion of the Rapidus bunion resection illustrated in FIGS. 33-35 may be used in conjunction with any of the other Rapidus bunion resection procedures described herein.

[0110] As shown in FIG. 33, a re-cut portion may begin with the foot 10 in a configuration similar to that of FIG. 15. In the configuration of FIG. 33, a cutting guide (e.g., cutting guide 100, cutting guide 180, cutting guide 181, etc., as disclosed elsewhere herein) may be used to remove a portion of the first metatarsal 20 and / or first cuneiform 30. The metatarsal pins 802 and / or cuneiform pins 818 may remain in the foot 10 after removal of the cutting guides used to make the initial cut to the first metatarsal 20 and / or first cuneiform 30. In the exemplary re-cut portion illustrated in FIGS. 33-35, it is desired to remove an additional portion of the first metatarsal 20 facing the first TMT joint 40.

[0111] 34, the cutting guide 900 configured as a re-cutting guide is positioned by inserting the metatarsal pin 802 through the pin hole 922 of the cutting guide 900 and sliding the cutting guide 900 over the metatarsal pin 802 until the cutting guide 900 seats against the previously cut surface of the first metatarsal 20. In this configuration of FIG. 34, the slot 912 of the cutting guide 900 is aligned closer to the metatarsal pin 802 than the end of the first metatarsal 20 that faces the TMT joint due to the closer spacing of the cutting guide 900 relative to the spacing of the cutting guides 100, 180, 181. Once the cutting guide 900 is positioned, the base of the first metatarsal 20 can be re-cut using a saw blade 836 inserted through the slot 912 of the cutting guide 900. The remainder of the lapidus bunion resection procedure may proceed substantially as shown and described with reference to FIGS. 16-24, or as described elsewhere herein. It will be appreciated that the above recutting may be applied equally to the first metatarsal 20 or the first cuneiform 30.

[0112] 36-38 are perspective views of the bones of the foot 10 sequentially illustrating the frontal plane realignment portion of an exemplary Lapidus bunionectomy procedure using the realignment guide 1020 illustrated in FIGS. 32A-32C. The frontal plane realignment portion of the Lapidus bunionectomy illustrated in FIGS. 36-38 may be performed any time after the first metatarsal 20 and first cuneiform 30 are cut and before fixation, as described elsewhere herein. Because the realignment guide 1020 is configured as both a pin guide and a compression block for the frontal plane realignment, the realignment portion illustrated in FIGS. 36-38 may be performed instead of or in addition to (e.g., before or after) the compression portion of the Lapidus bunionectomy as illustrated in FIGS. 16-18. For example, in some procedures, the surgeon may perform an initial coronal plane correction and then determine that further correction or realignment of the first metatarsal 20 in the coronal plane is necessary, such as when initially engaging the compression block as shown in FIG.

[0113] A coronal plane realignment begins with the foot 100 in the configuration illustrated in Figure 15 or 33 above, with the metatarsal pin 802 remaining in the first metatarsal 20 and the cuneiform pin 818 remaining in the first cuneiform 30 after cutting the bones using the cutting guide described herein. The realignment portion continues with the configuration shown in Figure 36, with the alignment guide 1020 positioned by inserting the metatarsal pin 802 through the first pair of distal pin holes 1035 and the cuneiform pin 818 through the first pair of proximal pin holes 1030. When the metatarsal pin 802 and the cuneiform pin 818 are disposed in a pair of holes on the same side of the realignment guide 1020, as shown in Figure 36, the realignment guide 1020 functions similarly to the compression block 400, compressing the cut ends of the first metatarsal 20 and the first cuneiform 30 without applying any frontal plane realignment. At the stage illustrated in Figure 36, the surgeon may determine that the initial frontal plane adjustment was insufficient and that the first metatarsal 20 should be realigned by further rotating clockwise to reach the desired alignment.

[0114] 37 and 38, the realignment guide 1020 is removed from the foot 10 (FIG. 37) and replaced over the cuneiform pins 818 and metatarsal pins 802. However, in replacing the realignment guide 1020, the cuneiform pins 818 are inserted through a second pair of proximal pin holes 1032 that are angularly displaced relative to the first pair of proximal pin holes 1030. The metatarsal pins 802 are inserted through the same first pair of distal pin holes 1035 through which they were previously inserted in FIG. 36. Replacement of the realignment guide 1020 thereby provides an additional clockwise rotational adjustment of the first metatarsal 20, compressing the TMT joint 40 for fixation. Alternatively, a counterclockwise adjustment may be performed by reinserting the cuneiform pin 818 through the same first pair of proximal pin holes 1030 and inserting the metatarsal pin 802 through the second set of distal pin holes 1037. Following realignment as shown in Figures 36-38, the lapidus bunionectomy procedure may proceed with fixation of the bones of the TMT joint 40, for example, as shown and described with reference to Figures 17-24. A cross pin 824 for temporary fixation may be inserted through any of the cross pin holes 1042, as shown in Figures 18-20.

[0115] 39-48 are perspective views of the foot bones sequentially illustrating the frontal plane realignment portion of an exemplary lapidus bunionectomy procedure using the realignment guide 1000 illustrated in FIGS. 31A-31C. The frontal plane realignment portion of the lapidus bunionectomy illustrated in FIGS. 39-48 may be performed at various stages of the procedure, for example, prior to placing a compression block as illustrated in FIG. 16. In some embodiments, the frontal plane realignment portion of the lapidus bunionectomy illustrated in FIGS. 39-48 may be performed after initial placement of the compression block 400 indicates that some frontal plane correction is required prior to fixation. As described in more detail, realignment using realignment guide 1000 differs from realignment using realignment guide 1020 (e.g., Figures 36-38) in that realignment guide 1000 guides the placement of a second pair of metatarsal pins that are rotationally displaced relative to the initial pair of metatarsal pins, and may then be used in combination with compression block 400 to complete the coronal plane realignment.

[0116] A frontal plane realignment begins with the foot 100 in a configuration as illustrated in FIG. 15 or FIG. 33 above, where the metatarsal pin 802 remains in the first metatarsal 20 and the cuneiform pin 818 remains in the first cuneiform 30 after cutting the bones using the cutting guide described herein. The realignment portion continues with the configuration shown in FIG. 39, where the realignment guide 1000 is placed by inserting the metatarsal pin 802 through a first pair of pin holes 1012 of the realignment guide 1000. In this configuration, the other three pairs of pin holes 1014, 1016, 1018 define pin placement positions for three increasing amounts of clockwise frontal plane realignment. Alternatively, if counterclockwise frontal plane realignment is desired, the realignment guide 1000 may be positioned by inserting the metatarsal pins 802 through the fourth pair of pin holes 1018, such that the other three pairs of pin holes 1012, 1014, 1016 define the pin placement positions for counterclockwise frontal plane realignment.

[0117] After the realignment guide 1000 is in place, the process continues in FIG. 40 where the first alternative metatarsal pin 803a is partially inserted into the first metatarsal 20 through one of the pair of pin holes 1016. Due to the convergence of the paths of the pin holes 1012, 1014, 1016, 1018 in the first metatarsal 20, it may be impossible or undesirable to fully insert the alternative metatarsal pin while the metatarsal pin 802 remains inserted. Therefore, the first alternative metatarsal pin 803a may only be partially inserted such that the first alternative metatarsal pin 803a does not impinge on the corresponding metatarsal pin 802. Preferably, the first alternative metatarsal pin 803a extends sufficiently into the bone to retain the position and orientation of the realignment guide 1000 relative to the first metatarsal 802 when one of the metatarsal pins 802 is removed.

[0118] 41, the proximal metatarsal pin 802 corresponding to the first replacement metatarsal pin 803a has been removed from the first metatarsal 20. In this configuration, the partially inserted first replacement metatarsal pin 803a and the remaining metatarsal pins 802 are sufficient to maintain the position and orientation of the realignment guide 1000 relative to the first metatarsal. As shown in FIG. 42, the first replacement metatarsal pin 803a can then be further inserted through the pin hole 1016 and the first metatarsal to a fully inserted position, with the realignment guide 1000 serving as a pin placement guide for the first replacement metatarsal pin 803a.

[0119] 43-45, a similar replacement procedure is performed for the remaining metatarsal pin 802. As shown in FIG. 43, a second replacement metatarsal pin 803b is partially inserted through the other pin hole of the pair of pin holes 1016. As shown in FIG. 44, the remaining metatarsal pin 802 is removed to allow the second replacement metatarsal pin 803b to be fully inserted. As shown in FIG. 45, the second replacement metatarsal pin 803b is further inserted through the realignment guide 1000.

[0120] 46, the realignment guide 1000 is removed from the foot 10 such that the replacement metatarsal pins 803a, 803b remain in the first metatarsal 20 but are angularly displaced relative to the removed metatarsal pin 802. As shown in FIG. 47, the first metatarsal 20 is then rotated in the coronal plane relative to the first cuneiform 30 to a final orientation in which the replacement metatarsal pins 803a, 803b are aligned with the cuneiform pin 818. Following this final coronal plane realignment process, a compression block, such as compression block 400, may then be placed over the cuneiform pin 818 and replacement metatarsal pins 803a, 803b to compress the TMT joint 40 for fixation. The lapidus bunion resection procedure may then proceed to conclusion, for example, as shown and described with reference to FIGS. 17-24.

[0121] The embodiments described herein are exemplary. Modifications, rearrangements, alternative processes, and the like may be made to these embodiments and still fall within the teachings described herein. Depending on the embodiment, certain acts, events, or functions of any of the methods described herein may be performed in a different order, may be added, combined, or excluded entirely (e.g., not all of the acts or events described are required to practice a method). Furthermore, in certain embodiments, acts or events may be performed simultaneously rather than sequentially.

[0122] The phrases "connected," "coupled," and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components can be operatively coupled to one another even if they are not in direct contact with one another. The term "abutting" refers to items that are in direct physical contact with one another, although the items do not necessarily have to be attached together.

[0123] Conditional language used herein, particularly "can," "could," "might," "may," "eg," and the like, is generally intended to convey that certain embodiments include certain features, elements, and / or conditions, while other embodiments do not, unless specifically specified otherwise or understood otherwise within the context in which it is used. Such conditional language is thereby not generally intended to imply that features, elements, and / or conditions are somehow required by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or conditions are included in or performed in any particular embodiment, with or without author input or prompting. Terms such as "comprising," "including," "having," "involving," and the like are synonymous and are used in an inclusive, open-ended manner and do not exclude additional elements, features, operations, etc. Also, when the term "or" is used, for example, to connect a list of elements, the term "or" is used in its inclusive sense (and not its exclusive sense) to mean one, some, or all of the listed elements.

[0124] Alternative language, such as the phrase "at least one of X, Y, or Z," is understood otherwise in the context in which it is generally used to indicate that an item, term, etc., can be either X, Y, or Z, or any combination thereof (e.g., X, Y, and / or Z), unless expressly stated otherwise. Thus, such alternative language is generally not intended to, and should not, imply that a particular embodiment requires that at least one of X, at least one of Y, or at least one of Z, respectively, be present.

[0125] Unless otherwise specified, articles such as "a" or "an" should generally be construed to include one or more of the listed items. Thus, a phrase such as "a device configured to" is intended to include one or more of the listed devices. Such one or more of the listed devices may also be collectively configured to perform the stated enumeration. For example, a processor configured to perform "recording A, B, and C" may include a first processor configured to perform enumeration A in conjunction with a second processor configured to perform reprocessing B and C.

[0126] Although the above detailed description has shown, described and pointed out novel features applied to the exemplary embodiments, it will be understood that various omissions, substitutions and changes in the form and details of the illustrated devices or algorithms can be made without departing from the spirit of the present disclosure. As will be recognized, certain embodiments described herein can be embodied in forms that do not provide all of the features and advantages described herein, since some features can be used or practiced separately from other features. All changes that come within the meaning and range of equivalence of the claims are intended to be embraced within their scope.

[0127] [Embodiment] (1) A method for correcting a bunion, the method comprising: inserting a plurality of metatarsal pins into a first metatarsal bone of the foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint; resecting the first TMT joint of the foot, said resecting comprising: amputating a base of the first metatarsal bone proximate the first TMT joint; cutting a base of a first cuneiform bone of the foot proximate the first TMT joint; inserting a plurality of cuneiform pins into the first cuneiform bone at a second predetermined interval relative to the first TMT joint; compressing the first TMT joint using a compressor block such that the cut surface of the first metatarsal bone contacts the cut surface of the first cuneiform bone; and immobilizing the first TMT joint. (2) The method of embodiment 1, wherein the first TMT joint is fixed using a bone plate and a plurality of bone screws, at least one of the plurality of bone screws being a cross screw extending at an angle of less than 90 degrees relative to the bone plate. (3) The method of embodiment 2, wherein the cross screw extends through the bone plate, the first metatarsal bone, and at least a portion of a second metatarsal bone of the foot or a second cuneiform bone of the foot. (4) The method of embodiment 1, further comprising placing the staple through the bone plate such that a first leg of the staple is seated in the first cuneiform bone and a second leg of the staple is seated in the first metatarsal bone. (5) The method of embodiment 4, wherein the bone plate comprises a cross screw opening shaped to guide placement of the cross screw such that the second leg of the staple does not interfere with placement of the cross screw.

[0128] (6) The method of embodiment 1, wherein the multiple metatarsal pins are inserted prior to resecting the first TMT joint. (7) The method of embodiment 1, wherein the plurality of cuneiform bone pins are inserted prior to cutting the base of the first cuneiform bone. (8) The method further comprising positioning a cutting guide over a dorsal side of the first TMT joint prior to inserting the plurality of metatarsal pins and the plurality of cuneiform pins, the cutting guide comprising: The main body, a plurality of proximal pin holes extending parallel through the body; a plurality of distal pin holes extending through the body parallel to the proximal pin holes; 2. The method of claim 1, comprising: a joint exploring paddle extending downwardly from the body between the proximal pin hole and the distal pin hole such that, when the joint exploring paddle is at least partially disposed within the first TMT joint, the distal pin hole defines the first predetermined distance relative to the first TMT joint and the proximal pin hole defines the second predetermined distance relative to the first TMT joint. (9) The method of embodiment 8, wherein the cutting guide further comprises a proximal slot extending through the body and a distal slot extending through the body on an opposite side of the joint seeking paddle to the proximal slot, the distal slot defining a cutting surface for cutting the base of the first metatarsal bone and the proximal slot defining a cutting surface for cutting the base of the first cuneiform bone. (10) prior to compressing the first TMT joint; adjusting an alignment of the first metatarsal within a frontal plane of the foot using a control handle coupled to the plurality of metatarsal pins; 2. The method of claim 1, further comprising adjusting alignment of the first metatarsal in a transverse plane of the foot using a linear reducer having a medial hook disposed on the medial side of the first metatarsal and an lateral hook disposed on the lateral side of a second metatarsal of the foot, the lateral hook having an adjustable spacing relative to the medial hook.

[0129] 11. The method of claim 10, further comprising inserting a medial hook pin through an opening in the medial hook and into the first metatarsal to rotatably fix the first metatarsal relative to the medial hook prior to adjusting the alignment of the first metatarsal in the transverse plane. 12. The method of claim 10, wherein at least one of the inner hook and the outer hook comprises a radiolucent material. (13) The method of claim 10, wherein the control handle comprises a handle portion and an engagement portion, the engagement portion comprising a plurality of pin openings spaced apart at a distance equal to the distance between the metatarsal pins. (14) Adjusting the alignment of the first metatarsal in the frontal plane comprises: sliding the pin opening over the metatarsal pin so that the engagement portion is adjacent to the first metatarsal; 14. The method of claim 13, further comprising rotating the first metatarsal about its longitudinal axis by applying a torque to the control handle. (15) The method of claim 10, wherein adjusting the alignment of the first metatarsal in the transverse plane includes reducing the adjustable spacing between the lateral hook and the medial hook to move a distal end of the first metatarsal closer to the second metatarsal.

[0130] (16) The method of claim 15, wherein the transverse alignment of the first metatarsal is adjusted while the first metatarsal is rotatably fixed relative to the medial hook of the linear reducer. (17) The method of claim 10, wherein the plurality of cuneiform pins are inserted after adjusting the alignment of the first metatarsal bone in the coronal and transverse planes. (18) The compressor block, a body having a top surface and a bottom surface; a plurality of proximal pin holes extending through the body from the top surface to the bottom surface at a first angle less than 90 degrees relative to the top and bottom surfaces; The method of embodiment 1, comprising: a plurality of distal pin holes extending through the body from the top surface to the bottom surface at the first angle relative to the top surface and the bottom surface such that the proximal pin holes and the distal pin holes are spaced closer together at the bottom surface than at the top surface. (19) Compressing the first TMT joint; inserting the cuneiform bone pin into the proximal pin hole of the bottom surface; inserting the metatarsal pin into the distal pin hole in the bottom surface; 20. The method of claim 18, further comprising sliding the compressor block along the cuneiform pin and the metatarsal pin toward the first TMT joint. (20) The method of embodiment 18, wherein the compressor block further comprises at least one cross pin hole extending therethrough, each of the at least one cross pin hole defining a linear path that passes obliquely through the first TMT joint when the compressor block is aligned proximate to the first TMT joint over the cuneiform pin and the metatarsal pin.

[0131] (21) compressing the first TMT joint; inserting a cross pin through the at least one cross pin hole to temporarily immobilize the first TMT joint; removing the cuneiform pin and the metatarsal pin from the foot; 21. The method of claim 20, further comprising removing the compressor block by sliding the compressor block along the cross pin away from the first TMT joint. (22) The method of embodiment 21, further comprising removing the cross pin after at least partially immobilizing the first TMT joint. (23) The method of claim 1, further comprising positioning a reversible cutting guide over a dorsal side of the first TMT joint prior to inserting the plurality of metatarsal pins and the plurality of cuneiform pins, the reversible cutting guide comprising: The main body, a plurality of first pin holes extending in parallel through the body; a plurality of second pin holes extending through the body parallel to the proximal pin holes; a joint exploring paddle extending downwardly from the body between the proximal pin hole and the distal pin hole such that the first pin hole defines the first predetermined spacing relative to the first TMT joint when the joint exploring paddle is at least partially disposed within the first TMT joint; 2. The method of claim 1, further comprising: a slot extending through the body parallel to a plane of the joint-seeking paddle such that the slot defines a cutting surface for cutting the base of the first metatarsal bone or the base of the first cuneiform bone. (24) The base of the first metatarsal and the base of the first cuneiform are cut through the slot, the method including, after cutting the base of the first metatarsal and before cutting the base of the first cuneiform, Removing the reversible cutting guide from the first TMT joint; 24. The method of claim 23, further comprising positioning the reversible cutting guide across the dorsal side of the first TMT joint in a reverse orientation such that the slot defines a cutting plane for cutting the base of the first cuneiform bone. (25) The method of embodiment 1, further comprising recutting the base of the first metatarsal bone or the base of the first cuneiform bone to remove additional tissue prior to fixing the first TMT joint.

[0132] (26) The method of embodiment 25, wherein the re-cutting is performed using a re-cutting guide disposed on the metatarsal pin or the cuneiform pin, the re-cutting guide defining a predetermined re-cutting interval that is smaller than the predetermined interval defined by a cutting guide used to resect the first TMT joint. (27) The method of embodiment 1, further comprising performing a frontal plane realignment including additional rotation of the first metatarsal in the frontal plane prior to fixing the first TMT joint. (28) The method of embodiment 27, wherein the coronal plane realignment is performed simultaneously with compression of the first TMT joint, and the compressor block is configured as a realignment guide with angularly displaced pin holes such that positioning the compressor block compresses the first TMT joint and maintains the additional rotation. (29) The coronal plane realignment is performed prior to the compression of the first TMT joint, and the coronal plane realignment comprises: inserting a plurality of replacement metatarsal pins at the first predetermined interval through a realignment guide to the first TMT joint, the replacement metatarsal pins being angularly displaced relative to the metatarsal pins; 28. The method of claim 27, further comprising linearly aligning the replacement metatarsal pin with the cuneiform pin prior to compressing the first TMT joint. (30) A method for correcting a bunion, the method comprising: placing a cutting guide over a dorsal side of a first tarsometatarsal (TMT) joint of the foot such that a first plurality of pin holes of the cutting guide are disposed proximate a first metatarsal bone of the foot, a second plurality of pin holes of the cutting guide are disposed proximate a first cuneiform bone of the foot, and a joint seeking paddle of the cutting guide is disposed at least partially within the first TMT joint; inserting a plurality of metatarsal pins through the first pin holes into the first metatarsal; cutting a base of the first metatarsal bone proximate the first TMT joint through a slot extending through the cutting guide between the first pin hole and the joint seeking paddle; removing the cutting guide from the foot; replacing the cutting guide over the dorsal side of the first TMT joint in an inverted configuration with the metatarsal pin extending through the second pin hole; adjusting the alignment of the first metatarsal bone in at least one of a frontal plane and a transverse plane of the foot; inserting a plurality of cuneiform pins through the first pin holes and into the first cuneiform; cutting a base of the first cuneiform bone proximal to the first TMT joint through the slot; compressing the first TMT joint using a compressor block such that the cut surface of the first metatarsal bone contacts the cut surface of the first cuneiform bone; and immobilizing the first TMT joint.

[0133] (31) A bunion correction kit, comprising: A cutting guide comprising: The main body, a plurality of first pin holes extending parallel through the body and spaced a first distance apart; a plurality of second pin holes extending through the body parallel to the first pin holes, the plurality of second pin holes being spaced apart by the first distance; and a joint seeker paddle extending from the body between the proximal and distal pin holes; a slot extending through the body parallel to the joint seeking paddle between the joint seeking paddle and the first pin hole, the slot configured to guide cutting of a base of a first metatarsal or a first cuneiform bone when the joint seeking paddle is disposed at least partially within a tarsometatarsal (TMT) joint; a linear reducer including a medial hook and a lateral hook, the spacing between the medial hook and the lateral hook being adjustable to provide cross-sectional correction when the medial hook is seated against the medial side of the first metatarsal and the lateral hook is seated against the lateral side of a second metatarsal; a control handle comprising a handle portion and an engagement portion, the engagement portion comprising pin openings spaced apart the first distance; A compressor block comprising: a body having a top surface and a bottom surface; a plurality of proximal pin holes extending through the body from the top surface to the bottom surface at a first angle less than 90 degrees relative to the top and bottom surfaces; a compressor block comprising: a plurality of distal pin holes extending through the body from the top surface to the bottom surface at the first angle relative to the top and bottom surfaces, the distal pin holes converging relative to the proximal pin holes such that the proximal and distal pin holes are spaced closer together at the bottom surface relative to the top surface; (32) Further comprising a re-cutting guide, the re-cutting guide comprising: The main body, a plurality of pin holes extending through the body and spaced apart at the first distance; an articulated seeker paddle extending from the body; A bunion correction kit as described in embodiment 31, comprising a slot extending through the body parallel to the joint exploration paddle between the joint exploration paddle and the pin hole, the slot of the re-cutting guide being closer to the pin hole of the re-cutting guide compared to the corresponding distance between the slot of the cutting guide and the first pin hole of the cutting guide. (33) The bunion correction kit of embodiment 31, wherein the compressor block is configured as a coronal plane realignment guide and at least two of the plurality of proximal pin holes are angularly displaced relative to at least two of the plurality of distal pin holes. (34) The bunion correction kit of embodiment 31, further comprising one or more bone screws and a bone plate configured to receive the one or more bone screws, the bone plate configured to receive at least one of the one or more bone screws as a cross screw extending at an angle of less than 90 degrees relative to the bone plate. (35) A linear reducer configured to adjust a transverse alignment of a first metatarsal, the linear reducer comprising: a shaft having a proximal end and a distal end; a medial hook coupled to the shaft at the distal end, at least a portion of the medial hook comprising a concave curved surface shaped to seat against a medial side of a first metatarsal bone; an outer hook slidably coupled to the shaft at a location intermediate the proximal and distal ends, at least a portion of the inner hook comprising a concave curved surface shaped to seat against a lateral side of a second metatarsal while the inner hook seats against the medial side of the first metatarsal; a handle coupled to the shaft proximally adjacent the lateral hook, the linear position of the handle being adjustable along the shaft to move the lateral hook relative to the medial hook to provide a cross-sectional correction when the medial hook is seated against the medial side of the first metatarsal and the lateral hook is seated against the lateral side of the second metatarsal.

[0134] (36) The linear reducer of embodiment 35, wherein the shaft includes a threaded outer surface, and the handle includes a threaded opening extending through the handle and engaging the threaded outer surface of the shaft such that the linear position of the handle is adjustable by twisting the handle about the shaft. (37) The linear reducer of embodiment 35, wherein the medial hook includes one or more openings extending through the concave curved surface to accommodate a pin extending therethrough into the first metatarsal. (38) The linear reducer of embodiment 37, wherein the inner hook is coupled to the shaft by a quick release coupling movable from a locked position to an unlocked position, and in the unlocked position, the inner hook is slidable along the longitudinal axis of the shaft. (39) The linear reducer of embodiment 37, wherein at least one of the inner hook and the outer hook comprises a radiolucent material. (40) The linear reducer of embodiment 39, wherein the radiolucent material includes carbon fiber.

[0135] (41) A cutting guide configured to guide cutting of a first metatarsal bone and a first cuneiform bone in a bunion correction procedure, the cutting guide comprising: a body having a first end and a second end opposite the first end along a longitudinal axis of the cutting guide; a plurality of first pin holes extending in parallel through the body proximate the first end, the first pin holes being spaced apart along the longitudinal axis at predetermined intervals; a plurality of second pin holes extending through the body proximate the second end and parallel to the first pin holes, the second pin holes being spaced apart along the longitudinal axis at the predetermined intervals; a cutting slot extending through the body perpendicular to the longitudinal axis at a first intermediate location between the first pin hole and the second pin hole, the cutting slot sized and shaped to guide cutting of bone by a saw blade inserted therethrough; and a joint locating paddle extending from the bone-facing surface of the body perpendicular to the longitudinal axis at a second intermediate location between the cutting slot and the second pin hole such that the cutting guide can be positioned across a first tarsometatarsal (TMT) joint with the joint seeking paddle seated within the first TMT joint in either a metatarsal cutting orientation in which the cutting slot guides the cut of the base of the first metatarsal or a cuneiform cutting orientation in which the cutting slot guides the cut of the base of the first cuneiform. (42) The cutting guide of embodiment 41, further comprising one or more longitudinal openings extending through the body perpendicular to and intersecting the cutting slot. (43) The cutting guide of embodiment 41, wherein the cutting guide does not include a second cutting slot. (44) The cutting guide of embodiment 41, further comprising one or more converging pin holes extending through the body at a position displaced laterally relative to the longitudinal axis, each converging pin hole intersecting the bone-facing surface at a first distance from the longitudinal axis and intersecting the upper surface of the body opposite the bone-facing surface at a second distance from the longitudinal axis, the second distance being greater than the first distance. (45) The cutting guide of embodiment 41, wherein the cutting slot comprises an intermediate section having a first width and end sections at opposite ends of the intermediate section, the end sections having a second width greater than the first width.

Claims

1. A bunion correction kit, A cutting guide comprising: The main body, a plurality of first pin holes extending parallel through the body and spaced a first distance apart; a plurality of second pin holes extending through the body parallel to the plurality of first pin holes, the plurality of second pin holes being spaced apart by the first distance; and an articulation exploration paddle extending from the body between the first plurality of pin holes and the second plurality of pin holes; a slot extending through the body parallel to the joint seeking paddle between the joint seeking paddle and the first plurality of pin holes, the slot configured to guide cutting of a base of a first metatarsal or a first cuneiform bone when the joint seeking paddle is disposed at least partially within a tarsometatarsal (TMT) joint; a linear reducer including a medial hook and a lateral hook, the spacing between the medial hook and the lateral hook being adjustable to provide cross-sectional correction when the medial hook is seated against the medial side of the first metatarsal and the lateral hook is seated against the lateral side of a second metatarsal; a control handle comprising a handle portion and an engagement portion, the engagement portion comprising pin openings spaced apart the first distance; A compressor block comprising: a body having a top surface and a bottom surface; a plurality of proximal pin holes extending through the body of the compressor block from the top surface to the bottom surface at a first angle less than 90 degrees relative to the top and bottom surfaces; 1. A bunion correction kit comprising: a compressor block comprising: a plurality of distal pin holes extending through the body of the compressor block from the top surface to the bottom surface at the first angle relative to the top and bottom surfaces, the plurality of distal pin holes converging relative to the plurality of proximal pin holes such that the plurality of proximal pin holes and the plurality of distal pin holes are spaced closer together at the bottom surface relative to the top surface.

2. The re-cutting guide further comprises: The main body, a plurality of pin holes extending through the body of the re-cutting guide and spaced apart at the first distance; a joint seeker paddle extending from the body of the recutting guide; 2. The bunion correction kit of claim 1, further comprising: a slot extending through the body of the re-cutting guide parallel to the joint seeker paddle of the re-cutting guide between the joint seeker paddle of the re-cutting guide and the plurality of pin holes, the slot of the re-cutting guide being closer to the plurality of pin holes of the re-cutting guide compared to a corresponding distance between the slot of the cutting guide and the plurality of first pin holes of the cutting guide.

3. 2. The bunion correction kit of claim 1, wherein the compressor block is configured as a coronal plane realignment guide, and at least two of the plurality of proximal pin holes are angularly displaced relative to at least two of the plurality of distal pin holes.

4. 10. The bunion correction kit of claim 1, further comprising one or more bone screws and a bone plate configured to receive the one or more bone screws, the bone plate configured to receive at least one of the one or more bone screws as a cross screw extending at an angle less than 90 degrees relative to the bone plate.

5. 1. A cutting guide configured to guide cutting of a first metatarsal bone and a first cuneiform bone in a bunion correction procedure, the cutting guide comprising: a body having a first end and a second end opposite the first end along a longitudinal axis of the cutting guide; a plurality of first pin holes extending in parallel through the body proximate the first end, the plurality of first pin holes being spaced apart along the longitudinal axis at predetermined intervals; a plurality of second pin holes extending through the body proximate the second end and parallel to the plurality of first pin holes, the plurality of second pin holes being spaced apart along the longitudinal axis at the predetermined intervals; a cutting slot extending through the body perpendicular to the longitudinal axis at a first intermediate location between the first plurality of pin holes and the second plurality of pin holes, the cutting slot sized and shaped to guide cutting of bone by a saw blade inserted therethrough; a joint seeking paddle extending from the bone-facing surface of the body perpendicular to the longitudinal axis at a second intermediate location between the cutting slot and the plurality of second pin holes such that with the joint seeking paddle seated within a first tarsometatarsal (TMT) joint, the cutting guide may be positioned across the first TMT joint in either a metatarsal cutting orientation in which the cutting slot guides the cut of the base of the first metatarsal bone or a cuneiform cutting orientation in which the cutting slot guides the cut of the base of the first cuneiform bone; one or more longitudinal openings extending through the body perpendicular to and intersecting the cutting slot.

6. A cutting guide configured to guide cutting of a first metatarsal bone and a first cuneiform bone in a bunion correction procedure, the cutting guide comprising: a body having a first end and a second end opposite the first end along a longitudinal axis of the cutting guide; a plurality of first pin holes extending in parallel through the body proximate the first end, the plurality of first pin holes being spaced apart along the longitudinal axis at predetermined intervals; a plurality of second pin holes extending through the body proximate the second end and parallel to the plurality of first pin holes, the plurality of second pin holes being spaced apart along the longitudinal axis at the predetermined intervals; a cutting slot extending through the body perpendicular to the longitudinal axis at a first intermediate location between the first plurality of pin holes and the second plurality of pin holes, the cutting slot sized and shaped to guide cutting of bone by a saw blade inserted therethrough; a joint seeking paddle extending from the bone-facing surface of the body perpendicular to the longitudinal axis at a second intermediate location between the cutting slot and the plurality of second pin holes such that with the joint seeking paddle seated within a first tarsometatarsal (TMT) joint, the cutting guide may be positioned across the first TMT joint in either a metatarsal cutting orientation in which the cutting slot guides the cut of the base of the first metatarsal bone or a cuneiform cutting orientation in which the cutting slot guides the cut of the base of the first cuneiform bone; wherein the cutting guide does not include a second cutting slot.

7. A cutting guide configured to guide cutting of a first metatarsal bone and a first cuneiform bone in a bunion correction procedure, the cutting guide comprising: a body having a first end and a second end opposite the first end along a longitudinal axis of the cutting guide; a plurality of first pin holes extending in parallel through the body proximate the first end, the plurality of first pin holes being spaced apart along the longitudinal axis at predetermined intervals; a plurality of second pin holes extending through the body proximate the second end and parallel to the plurality of first pin holes, the plurality of second pin holes being spaced apart along the longitudinal axis at the predetermined intervals; a cutting slot extending through the body perpendicular to the longitudinal axis at a first intermediate location between the first plurality of pin holes and the second plurality of pin holes, the cutting slot sized and shaped to guide cutting of bone by a saw blade inserted therethrough; a joint seeking paddle extending from the bone-facing surface of the body perpendicular to the longitudinal axis at a second intermediate location between the cutting slot and the plurality of second pin holes such that with the joint seeking paddle seated within a first tarsometatarsal (TMT) joint, the cutting guide may be positioned across the first TMT joint in either a metatarsal cutting orientation in which the cutting slot guides the cut of the base of the first metatarsal bone or a cuneiform cutting orientation in which the cutting slot guides the cut of the base of the first cuneiform bone; one or more converging pin holes extending through the body at locations displaced laterally relative to the longitudinal axis; a cutting guide, wherein each of the convergent pin holes intersects the bone-facing surface at a first distance from the longitudinal axis and intersects the top surface of the body opposite the bone-facing surface at a second distance from the longitudinal axis, the second distance being greater than the first distance.

8. 6. The cutting guide of claim 5, wherein the cutting slot comprises a middle section having a first width and end sections at opposite ends of the middle section, the end sections having a second width greater than the first width.

Images