Systems and methods for lapidus arthroplasty for hallux valgus

Abstract

This invention discloses a system, apparatus, and method for performing a procedure for excising a Lapidus bunion. One method includes: inserting a metatarsal pin into a first metatarsal at a first predetermined distance relative to the first tarsometatarsal (TMT) joint; excising the first TMT joint by cutting the base of the first metatarsal and first cuneiform bone near the first TMT joint; inserting a cuneiform pin into the first cuneiform bone at a second predetermined distance relative to the first TMT joint; compressing the first TMT joint using a compressor block such that the cut surface of the first metatarsal contacts the cut surface of the first cuneiform bone; and fixing the first TMT joint using a bone plate and a plurality of bone screws. At least one of the bone screws may be a Phillips screw extending at an angle of less than 90 degrees relative to the bone plate, and may anchor the excised first TMT joint to a second metatarsal or second cuneiform bone to prevent recurrence of bunion.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefits of the following applications: U.S. Provisional Application Serial No. 62 / 978,683, filed February 19, 2020, entitled “SYSTEMS AND METHODS FOR LAPIDUS REPAIR OF BUNIONS”; U.S. Provisional Application Serial No. 63 / 018,793, filed May 1, 2020, entitled “SYSTEMS AND METHODS FOR LAPIDUS REPAIR OF BUNIONS”; and U.S. Provisional Application Serial No. 63 / 125,272, filed December 14, 2020, the entire contents of which are incorporated herein by reference and used for all purposes. Technical Field

[0003] This disclosure relates to medical devices, and more specifically to systems and methods for repairing bunions using the Lapidus bunion excision technique. Background Technology

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

[0005] Bunion correction or repair is a common surgical procedure, with over 100,000 surgeries performed annually in the United States. In the Lapidus bunionectomy procedure, the first tarsometatarsal joint is fused to correct the joint deformity and prevent further joint movement. However, existing Lapidus bunionectomy techniques may be difficult to perform with the desired precision. Summary of the Invention

[0006] The exemplary embodiments described herein are innovative in nature, none of which is essential or solely responsible for their desired properties. Without limiting the scope of the claims, some advantageous features will now be summarized.

[0007] In a first aspect, a method for correcting bunions includes: inserting a plurality of metatarsal pins into a first metatarsal bone of the foot at a first predetermined distance relative to a first tarsometatarsal (TMT) joint; resecting the first TMT joint of the foot; inserting a plurality of cuneiform pins into a first cuneiform bone at a second predetermined distance 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 fixing the first TMT joint. The resection includes cutting the base of the first metatarsal bone near the first TMT joint and cutting the base of the first cuneiform bone of the foot near the first TMT joint.

[0008] In some embodiments, a bone plate and multiple bone screws are used to fix the first TMT joint, and at least one of the multiple bone screws is a Phillips screw extending at an angle of less than 90 degrees relative to the bone plate. In some embodiments, the Phillips screw extends through at least a portion of the bone plate, the first metatarsal, and the second metatarsal or the second cuneiform bone of the foot.

[0009] In some embodiments, the method further includes placing a nail through a bone plate such that a first leg of the nail is seated within a first cuneiform bone and a second leg of the nail is seated within a first metatarsal bone. In some embodiments, the bone plate includes a Phillips screw hole shaped to guide the placement of a Phillips screw such that the second leg of the nail does not obstruct the placement of the Phillips screw.

[0010] In some implementations, multiple metatarsal pins are inserted before the first TMT joint is removed.

[0011] In some implementations, multiple wedge-shaped pins are inserted before cutting the base of the first wedge bone.

[0012] In some embodiments, the method further includes placing a cutting guide across the dorsal side of the first TMT joint before inserting a plurality of metatarsal pins and a plurality of wedge-shaped pins. The cutting guide may include a body, a plurality of proximal pin holes extending parallel to the body, a plurality of distal pin holes extending parallel to the proximal pin holes through the body, and a joint-seeking paddle extending downward 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 holes define a first predetermined spacing relative to the first TMT joint and the proximal pin holes define a second predetermined spacing relative to the first TMT joint. In some embodiments, the cutting guide further includes a proximal slot extending through the body and a distal slot extending through the body on the opposite side of the joint-seeking paddle relative to the proximal slot, such that the distal slot defines a cutting plane for cutting the base of the first metatarsal and the proximal slot defines a cutting plane for cutting the base of the first wedge-shaped bone.

[0013] In some embodiments, the method further includes adjusting the alignment of the first metatarsal bone in the anteroposterior plane of the foot using a control handle coupled to a plurality of metatarsal pins before compressing the first TMT joint, and adjusting the alignment of the first metatarsal bone in the transverse plane of the foot using a linear tapering device including a medial hook disposed on the medial side of the first metatarsal bone and a lateral hook disposed on the lateral side of the second metatarsal bone of the foot, the lateral hook having an adjustable spacing relative to the medial hook. In some embodiments, the method further includes inserting a medial hook pin through an orifice of the medial hook and into the first metatarsal bone before adjusting the alignment of the first metatarsal bone in the transverse plane to rotatably secure the first metatarsal bone relative to the medial hook. In some embodiments, at least one of the medial hook and the lateral hook comprises a radiopaque material. In some embodiments, the control handle includes a handle portion and an engagement portion including a plurality of pin orifices 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 anteroposterior plane includes sliding a pin hole above the metatarsal pins such that the engaging portion is close to the first metatarsal, and rotating the first metatarsal about its longitudinal axis by applying torque to a control handle. In some embodiments, adjusting the alignment of the first metatarsal in the transverse plane includes reducing the adjustable gap between the lateral and medial hooks to bring 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 secured relative to the medial hook of the linear reducer. In some embodiments, a plurality of wedge-shaped bone pins are inserted after adjusting the alignment of the first metatarsal in the anteroposterior and transverse planes.

[0014] In some embodiments, the compressor block includes a body comprising a top surface and a bottom surface; a plurality of proximal pin holes extending from the top surface through the body to the bottom surface at a first angle of less than 90 degrees relative to the top and bottom surfaces; and a plurality of distal pin holes extending from the top surface through the body to the bottom surface at a first angle relative to the top and bottom surfaces, such that the proximal and distal pin holes are more closely spaced relative to the top surface at the bottom surface. In some embodiments, compressing the first TMT joint includes inserting a wedge-shaped pin into a proximal pin hole at the bottom surface, inserting a metatarsal pin into a distal pin hole at the bottom surface, and sliding the compressor block along the wedge-shaped and metatarsal pins toward the first TMT joint. In some embodiments, the compressor block further includes at least one cross pin hole extending through it, each of the at least one cross pin hole defining a linear path diagonally through the first TMT joint when the compressor block is aligned on the wedge-shaped and metatarsal pins near the first TMT joint. In some embodiments, the method further includes, after compressing the first TMT joint, inserting a cross pin through at least one cross pin hole to temporarily secure the first TMT joint, removing the wedge-shaped bone pin and metatarsal pin from the foot, and removing the compressor block by sliding the compressor block away from the first TMT joint along the cross pin. In some embodiments, the method further includes removing the cross pin after at least partially securing the first TMT joint.

[0015] In some embodiments, the method further includes placing a reversible cutting guide across the dorsal side of the first TMT joint before inserting a plurality of metatarsal pins and a plurality of wedge-shaped pins. The reversible cutting guide includes a body, a plurality of first pin holes extending parallel through the body, a plurality of second pin holes extending parallel to the proximal pin holes through the body, and a joint-seeking paddle extending downward 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 holes define a first predetermined spacing relative to the first TMT joint; and a slot extending parallel to the plane of the joint-seeking paddle through the body, such that the slot defines a cutting plane for cutting the base of the first metatarsal or the base of the first wedge-shaped bone. In some embodiments, the method further includes cutting the base of the first metatarsal and the base of the first cuneiform bone through a slot, 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 bone, and placing the reversible cutting guide across the dorsal side of the first TMT joint in the opposite orientation, such that the slot defines a cutting plane for cutting the base of the first cuneiform bone.

[0016] In some embodiments, the method further includes recutting the base of the first metatarsal or the base of the first cuneiform bone to remove additional tissue before stabilizing the first TMT joint. In some embodiments, a recutting guide disposed on the metatarsal pin or cuneiform pin is used to perform the recutting, the recutting guide defining a predetermined recutting interval smaller than a predetermined interval defined by a cutting guide for the resection of the first TMT joint.

[0017] In some embodiments, the method further includes performing an anterior plane realignment, including additional rotation within the anterior plane of the first metatarsal, prior to securing the first TMT joint. In some embodiments, the anterior plane realignment is performed simultaneously with compression of the first TMT joint, and the compressor block is configured as a realignment guide including angledly displaced pin holes, such that the compressor block is positioned to compress the first TMT joint while maintaining additional rotation. In some embodiments, the anterior plane realignment is performed prior to compression of the first TMT joint, and the anterior plane realignment includes inserting a plurality of replacement metatarsal pins through the realignment guide at a first predetermined spacing relative to the first TMT joint, the replacement metatarsal pins being angled relative to the metatarsal pins; and linearly aligning the replacement metatarsal pins with wedge-shaped pins prior to compression of the first TMT joint.

[0018] In a second aspect, a method for correcting bunions includes placing a cutting guide dorsally across the first tarsometatarsal (TMT) joint of the foot, such that a plurality of first pin holes of the cutting guide are positioned near the first metatarsal bones of the foot, a plurality of second pin holes of the cutting guide are positioned near the first cuneiform bone of the foot, and a joint-seeking paddle of the cutting guide is at least partially disposed within the first TMT joint; inserting a plurality of metatarsal pins into the first metatarsal bones through the first pin holes; and cutting near the first TMT joint through a slot extending through the cutting guide between the first pin holes and the joint-seeking paddle. The base of the first metatarsal; removal of the cutting guide from the foot; replacement of the cutting guide across the dorsal side of the first TMT joint with the opposite configuration, wherein the metatarsal pin extends through the second pin hole; adjustment of the alignment of the first metatarsal in at least one of the anteroposterior and transverse planes of the foot; insertion of a plurality of wedge-shaped bone pins through the first pin hole into the first cuneiform bone; cutting the base of the first cuneiform bone near the first TMT joint using a compressor block such that the cutting surface of the first metatarsal bone contacts the cutting surface of the first cuneiform bone; and fixation of the first TMT joint.

[0019] 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 to the body and spaced apart by a first distance; a plurality of second pin holes extending parallel to the first pin holes and spaced apart by the first distance; a joint-seeking paddle extending from the body between the proximal and distal pin holes; and a slot extending parallel to the joint-seeking paddle and through the body between the joint-seeking paddle and the first pin holes, the slot being configured to guide cutting of the base of the first metatarsal or first cuneiform bone when the joint-seeking paddle is at least partially positioned within the tarsometatarsal (TMT) joint. The linear reducer includes a medial hook and a lateral hook, wherein the spacing between the medial and lateral hooks is adjustable to achieve transverse plane correction when the medial hook seat is medial to the first metatarsal and the lateral hook seat is lateral to the second metatarsal. The control handle includes a handle portion and a engagement portion, the engagement portion including pin holes spaced apart at a first distance. The compressor block includes a body having a top surface and a bottom surface; a plurality of proximal pin holes extending from the top surface through the body to the bottom surface at a first angle of less than 90 degrees relative to the top and bottom surfaces; and a plurality of distal pin holes extending from the top surface through the body to the bottom surface at a first angle relative to the top and bottom surfaces, wherein the distal pin holes converge relative to the proximal pin holes such that the proximal and distal pin holes are more closely spaced at the bottom surface relative to the top surface.

[0020] In some embodiments, the bunion correction kit also includes a recutting guide comprising a body, a plurality of pin holes extending through the body and spaced apart by a first distance, a joint-searching paddle extending from the body, and a slot extending through the body parallel to the joint-searching paddle between the joint-searching paddle and the pin holes, wherein the slot of the recutting guide is closer to the pin holes of the recutting guide than the corresponding distance between the slot of the recutting guide and the first pin hole of the recutting guide.

[0021] In some implementations, the compressor block is configured as a front plane realignment guide, with at least two of the proximal pin holes angled relative to at least two of the distal pin holes.

[0022] In some embodiments, the bunion correction kit also includes one or more bone screws and a bone plate configured to receive the one or more bone screws, wherein the bone plate is configured to receive at least one of the one or more bone screws as a cross-shaped screw extending at an angle of less than 90 degrees relative to the bone plate.

[0023] In a fourth aspect, a linear reducer configured for adjusting the lateral plane alignment of a first metatarsal includes 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 including a concave surface shaped to sit on the medial side of the first metatarsal; a lateral hook slidably coupled to the shaft at an intermediate position between the proximal and distal ends, at least a portion of the medial hook including a concave surface shaped to sit on the medial side of the first metatarsal while simultaneously sitting on the lateral side of the second metatarsal; and a handle coupled to the shaft proximally adjacent to 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 achieve lateral plane alignment when the medial hook sits on the medial side of the first metatarsal and the lateral hook sits on the lateral side of the second metatarsal.

[0024] In some embodiments, the shaft includes a threaded outer surface, and the handle includes a threaded orifice extending through it and engaging with the threaded outer surface of the shaft, such that the linear position of the handle can be adjusted by twisting the handle about the shaft.

[0025] In some embodiments, the medial hook includes one or more orifices extending through a concave surface to receive a pin extending therethrough into the first metatarsal. In some embodiments, the medial hook is coupled to a shaft via a quick-release coupling capable of moving from a locked position to an unlocked position, and in the unlocked position, the medial hook is capable of sliding along the longitudinal axis of the shaft. In some embodiments, at least one of the medial and lateral hooks comprises a radiopaque material. In some embodiments, the radiopaque material comprises carbon fiber.

[0026] In a fifth aspect, a cutting guide configured to guide the cutting of a first metatarsal and a first cuneiform bone during a bunion correction procedure includes a body comprising a first end portion along a longitudinal axis of the cutting guide and a second end portion opposite the first end portion; a plurality of first pin holes extending parallel to the first end portion through the body, the first pin holes being spaced apart at predetermined intervals along the longitudinal axis; a plurality of second pin holes extending parallel to the first pin holes through the body, the second pin holes being spaced apart at predetermined intervals along the longitudinal axis; and a cutting slot between the first pin holes and the second pin holes. A cutting slot, sized and shaped to guide the cutting of bone by a saw blade inserted therethrough, extends perpendicularly through the body at an intermediate position between the cutting slot and the second pin hole, and a joint-seeking paddle extends perpendicularly to the longitudinal axis from the bone-facing surface of the body at a second intermediate position between the cutting slot and the second pin hole, such that the cutting guide can be placed across the first tarsometatarsal (TMT) joint, wherein the joint-seeking paddle is seated within the first TMT joint in either of the following orientations: metatarsal cutting orientation, wherein the cutting slot guides the cutting of the base of the first metatarsal; or cuneiform cutting orientation, wherein the cutting slot guides the cutting of the base of the first cuneiform.

[0027] In some embodiments, the cutting guide also includes one or more longitudinal orifices that extend through the body perpendicular to and intersect the cutting slot.

[0028] In some implementations, the cutting guide does not include a second cutting slot.

[0029] In some embodiments, the cutting guide further includes one or more converging pin holes extending through the body at a position laterally displaced relative to the longitudinal axis, wherein each converging pin hole encounters a bone-facing surface at a first distance from the longitudinal axis and an 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.

[0030] In some embodiments, the cutting slot includes an intermediate segment having a first width and an end segment at the opposite end of the intermediate segment, the end segment having a second width greater than the first width. Attached Figure Description

[0031] The aspects and advantages of the embodiments provided herein are described in detail below, in conjunction with the accompanying drawings. Reference numerals may be used repeatedly throughout the drawings to indicate correspondences between reference elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of this disclosure.

[0032] Figure 1 It is a perspective view of the bones of the foot with bunions.

[0033] Figures 2A to 2D An exemplary cutting guide is depicted as a cutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein.

[0034] Figures 2E to 2G Describing the use of in the absence Figures 2A to 2D An exemplary freehand pin guide for inserting a directional pin in the case of a cutting guide.

[0035] Figures 2H to 2K An exemplary cutting guide is depicted as a cutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein.

[0036] Figures 2L to 2N An exemplary cutting guide is depicted as a cutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein.

[0037] Figures 3A to 3H An exemplary linear tapering device configured for use in the Lapidus bunion excision procedure described herein is depicted.

[0038] Figure 4A and Figure 4B An exemplary control handle configured for use in the Lapidus bunion excision procedure described herein is depicted.

[0039] Figures 5A to 5D An exemplary compressor block configured for use in the Lapidus bunion excision procedure described herein is depicted.

[0040] Figures 6A to 6G An exemplary bone plate and cruciate screw configured for use in the Lapidus bunion excision procedure described herein are depicted.

[0041] Figures 7A to 7C An exemplary fixed-angle Phillips screw drilling guide configured for use in the Lapidus bunion excision procedure described herein is depicted.

[0042] Figures 7D to 7F An exemplary variable-angle Phillips screw drilling guide configured for use in the Lapidus bunion excision procedure described herein is depicted.

[0043] Figures 8 to 24 It is a perspective view of the bones of the foot, sequentially illustrating an exemplary Lapidus bunion excision procedure performed using the exemplary bunion excision device disclosed herein.

[0044] Figures 25 to 29It is a perspective view of the bones of the foot, sequentially showing a portion of an exemplary Lapidus bunion excision procedure performed using the exemplary bunion excision device disclosed herein.

[0045] Figures 30A to 30C An exemplary cutting guide is depicted as a recutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein.

[0046] Figures 31A to 31C An exemplary realignment guide is depicted as a pin guide configured for frontal plane adjustment in the Lapidus bunion excision procedure described herein.

[0047] Figures 32A to 32C An exemplary realignment guide is depicted as a pin guide configured for frontal plane adjustment in the Lapidus bunion excision procedure described herein.

[0048] Figures 33 to 35 It is a perspective view of the bones of the foot, sequentially showing the recutting portions of an exemplary Lapidus bunion excision procedure performed using the exemplary bunion excision device disclosed herein.

[0049] Figures 36 to 38 It is a perspective view of the bones of the foot, sequentially showing the frontal plane realignment portion of the exemplary Lapidus bunion excision procedure using the exemplary bunion excision device disclosed herein.

[0050] Figures 39 to 48 It is a perspective view of the bones of the foot, sequentially showing the frontal plane realignment portion of the exemplary Lapidus bunion excision procedure using the exemplary bunion excision device disclosed herein. Detailed Implementation

[0051] The following description relates to certain implementations intended to describe the innovative aspects of this disclosure. However, those skilled in the art will readily recognize that the teachings herein can be applied in a variety of different ways.

[0052] In general terms, the systems, apparatus, and methods described herein provide improved methods and tools for performing Lapidus bursitis excision 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 can be selected, positioned, secured, and / or used during the bursitis excision procedure. Therefore, the Lapidus bursitis excision system, apparatus, and methods disclosed herein can allow surgeons to perform bursitis excision more effectively, efficiently, and / or precisely than conventional apparatus and procedures.

[0053] The embodiments described herein can be made from a number of different materials or combinations thereof. Nitino, stainless steel, titanium, and / or other materials may have the desired material properties for some of the components described herein. Stainless steel and / or titanium may not have shape memory or hyperelasticity, but may have mechanical properties suitable for embodiments that may benefit from mechanical manipulation to achieve a variety of configurations. Other materials such as PEEK or other polymers may also have material properties beneficial to the embodiments described herein. Combinations of materials may also be preferred. For example, a combination of nitino and titanium (e.g., a nitino plate with titanium screws) may be the material of choice for some embodiments. Typical materials and combinations of materials suitable for the present art are known to those skilled in the art.

[0054] Figure 1 This is a perspective view of the skeleton of foot 10, which has hallux valgus, also known as bunion. Foot 10 includes a first metatarsal 20, which hinges at its proximal end to a first cuneiform bone 30 (also called the medial cuneiform bone) at the first tarsometatarsal (TMT) joint 40. The distal end of the first metatarsal 20 hinges to the phalanx 50 of the big toe. The intermetrocar angle is defined as the angle between the axes of one metatarsal bone and the second metatarsal bone in the anatomical transverse plane. Rotation is defined as axial rotation about the metatarsal axis in the anatomical anterior plane. Figure 1 The hallux bursitis shown is characterized by an increased intermetastatic angle and / or rotation of the first metatarsal 20 at the first TMT joint 40, causing the first metatarsal 20 to extend away from or medially from the rest of the foot 10. In the presence of hallux bursitis, the phalanx 50 of the big toe is typically angled medially or laterally toward the other phalanges 60, resulting in a characteristic bulge at the metatarsophalangeal joint 70, which is the most prominent external indicator of hallux bursitis. The bulging metatarsophalangeal joint 70 can further be associated with cystic or bony abnormalities of the swollen bursa, which can cause discomfort, difficulty wearing shoes, and other inconveniences in individuals with hallux bursitis.

[0055] refer to Figures 2A to 7F Provided for correction Figure 1Various devices and components of the improved Lapidus bunion excision procedure for TMT joint deformities. Although the following description is made with reference to the Lapidus bunion excision procedure, it should be understood that the various devices and components described herein are not limited to such procedures and can be used equally in other orthopedic procedures, as will be understood by those skilled in the art.

[0056] Figures 2A to 2D An example cutting guide 100 is depicted as a cutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein. Figure 2A and Figure 2B These are the top and bottom perspective views of the cutting guide 100, respectively. Figure 2C This is a top plan view of the cutting guide 100. Figure 2D It is along Figure 2C The image shows a 2D-2D side cross-sectional view of the cutting guide 100. The cutting guide 100 may be a single, integrally formed component and may comprise metal, plastic, or other suitable materials.

[0057] 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 sit within a joint such as a TMT joint (e.g., between the first metatarsal and the first cuneiform bone), for example, after the removal of soft tissue such as the joint capsule around the joint. The relatively narrow and angled terminal portion of the paddle 120 facilitates insertion of the paddle 120 into the joint. In some embodiments, the paddle 120 is integrally formed with the body 105.

[0058] The body 105 of the cutting guide 100 includes a distal slot 125 and a proximal slot 130. The distal slot 125 and proximal slot 130 each extend through the entire thickness of the body 105 and are sized and shaped to serve as positioning guides for the saw blade, facilitating 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 within 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 proximal slot 130 may be identically or similarly shaped (e.g., may have the same length and / or width) so that the same or the same type of saw blade can be used to perform metatarsal and cuneiform bone cutting. In some embodiments, the distal slot 125 and the proximal slot 130 may be parallel to each other and / or parallel to the paddle 120, or may be angled relative to the plane of the paddle 120. In some embodiments, relatively wide end segments 127 may be provided at the ends of the slots 125, 130 for placing additional guide lines during cutting to prevent the saw blade from making excessively wide cuts when using the cutting guide 100.

[0059] The proximal pin holes 112 extend through the entire thickness of the cutting guide 100. One or both of the proximal pin holes 112 may be provided on the proximal extension 110 or within the body 105. Each of the proximal pin holes 112 may have a generally circular profile, sized to accommodate a surgical pin or guide for temporarily securing the cutting guide to the foot. The proximal pin holes 112 serve as guides such that two proximal pins or guides can be inserted at predetermined intervals by the saw blade along its cutting plane through the proximal slot 130 relative to each other and relative to the first cuneiform bone. The proximal pin holes 112 extend vertically parallel to each other, as... Figure 2D As shown.

[0060] The distal pin hole 117 extends through the entire thickness of the distal extension 115. Similar to the proximal pin hole 112, the distal pin holes 117 may each have a generally circular outline, their dimensions set to accommodate surgical pins or wires for temporarily securing the cutting guide to the foot, and may have the same diameter as the proximal pin hole 112. The distal pin holes 117 serve as guides, allowing two distal pins or wires to be inserted at predetermined intervals relative to each other and relative to the first metatarsal bone via the distal slot 125 by the saw blade along its cutting plane. The distal pin holes 117 extend vertically parallel to each other and parallel to the proximal pin hole 112, as... Figure 2DAs shown. The plane intersecting the axis of the proximal pin hole 112 may be coplanar with the plane intersecting the axis of the distal pin hole 117. The combination of pin holes forms a linear array of holes spanning the TMT joint. The bottom surface or bone-facing surface of the distal extension 115 may not be coplanar with the bottom surface or bone-facing surface of the body 105 and / or the proximal extension 110, which allows the cutting guide 100 to be placed closer to the bone while allowing space for the bony anatomy 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.

[0061] In some embodiments, the body 105 of the cutting guide 100 also includes one or more additional openings, such as additional converging pin holes 107 and / or longitudinal apertures 109. If additional stability is desired during the bunion excision procedure, the converging pin holes 107 can be used to insert one or more additional pins or guides. The longitudinal apertures 109 extend transversely to the slots 125, 130 and can provide openings to facilitate x-ray visualization and / or any other suitable surgical imaging procedures to confirm and / or monitor the alignment of the cutting guide during the bunion excision procedure.

[0062] Figures 2E to 2G An exemplary freehand pin guide 150 is depicted, which includes an array of pin holes spanning a TMT joint for use without... Figures 2A to 2DThe insertion of the directional pin is performed in the case of the cutting guide 100. In some bunion excision procedures, for example, if the cutting guide 100 is fitted inside the joint, it may not be used due to the surgeon's preference or for any other reason that would lead to a freehand joint cut instead of using the cutting guide 100. The freehand pin guide 150 generally comprises a body 155 and a paddle 160. A proximal pin hole 165 and a distal pin hole 170 extend through the entire thickness of the body 155. The proximal pin hole 165 may have the same relative spacing as the proximal pin hole 112 of the cutting guide 100. Similarly, the distal pin hole 170 may have the same relative spacing as the distal pin hole 117 of the cutting guide 100. A threaded handle attachment port 175 is provided for attaching a side-mounted handle that can help the user place the freehand pin guide 150. Similar to the proximal pin hole 112 and distal pin hole 117 of the cutting guide 100, the proximal pin hole 165 and distal pin hole 170 of the freehand pin guide 150 extend vertically parallel to each other. However, the distance between the proximal pin hole 165 and distal pin hole 170 of the freehand pin guide 150 and the paddle 160 is slightly smaller than the distance between the proximal and distal pin holes 112, 117 of the cutting guide 100 and the paddle 120, to compensate for the freehand pin guide 150 applied after cutting has already been performed. Therefore, as if the cutting guide 100 had already been used to perform the cutting, the freehand pin guide 150 allows for the placement of pins or wires after a freehand cut with the same spacing relative to the first TMT joint.

[0063] Figures 2H to 2K An exemplary reversible cutting guide 180 is depicted as a cutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein. Figure 2H and Figure 2I These are the top and bottom perspective views of the cutting guide 180, respectively. Figure 2J This is the top plan view of the cutting guide 180. Figure 2K It is along Figure 2J The image shows a side cross-sectional view of the cutting guide 180 taken along line 2K-2K. The cutting guide 180 can be a single, integrally formed component and can comprise metal, plastic, or other suitable materials. The cutting guide 180 is similar to... Figures 2A to 2D The cutting guide 100, but may be flip-up and configured with a single slot 182, instead of Figures 2A to 2D The proximal and distal slits are 125 and 130.

[0064] 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 sit within a joint such as a TMT joint (e.g., between the first metatarsal and the first cuneiform bone), for example, after the removal of soft tissue such as the joint capsule around the joint. The relatively narrow and angled terminal portion of the paddle 120 facilitates insertion of the paddle 120 into the joint. In some embodiments, the paddle 120 is integrally formed with the body 105.

[0065] The body 105 of the cutting guide 180 includes a single cutting slot 182. The slot 182 extends through the entire thickness of the body 105 and is sized and shaped to serve as a positioning guide for the saw blade, facilitating precise sawing cuts on each side of the joint. For example, when the paddle 120 is positioned within the first TMT joint, 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 first cuneiform bone, depending on the orientation of the cutting guide 180. In some embodiments, the slot 182 may be parallel to the paddle 120 or may be angled relative to the plane of the paddle 120. In some embodiments, a relatively wide end segment 127 may be provided at the end of the slot 182 for placing additional guide lines during cutting to prevent the saw blade from making excessively wide cuts when using the cutting guide 180.

[0066] The first pin hole 186 extends through the entire thickness of the cutting guide 180. One or both of the first pin holes 186 may be provided on the first extension 184 or within the body 105. Each of the first pin holes 186 may have a generally circular profile, sized to accommodate a surgical pin or wire for temporarily securing the cutting guide to the foot. The first pin holes 186 serve as guides, allowing two pins or wires to be inserted relative to each other and relative to the second pin hole 190 at a predetermined distance. The first pin holes 186 extend vertically parallel to each other, as... Figure 2K As shown.

[0067] The second pin hole 190 extends through the entire thickness of the cutting guide 180. Similar to the first pin hole 186, the second pin hole 190 may each have a generally circular outline, its dimensions set to accommodate surgical pins or guides for temporarily securing the cutting guide 180 to the foot, and may have the same diameter as the first pin hole 186. The second pin hole 190 serves as a guide, allowing two distal pins or guides to be inserted at predetermined intervals by the saw blade along its cutting plane through the slot 182 relative to each other and relative to the first metatarsal or first cuneiform bone. The second pin holes 190 extend vertically parallel to each other and parallel to the first pin hole 186, as... Figure 2KAs shown. The plane intersecting the axis of the first pin hole 186 may be coplanar with the plane intersecting the axis of the second pin hole 190. The combination of pin holes forms a linear array of holes spanning the TMT joint. The bottom surface or bone-facing surface of the second extension 188 may be coplanar or substantially coplanar with the bottom surface or bone-facing surface of the body 105 and / or the first extension 184, which allows the cutting guide 180 to be placed across the TMT joint in either of two opposite orientations, with the paddle 120 seated within the joint.

[0068] In some embodiments, the body 105 of the cutting guide 180 also includes one or more additional openings, such as additional converging pin holes 107 and / or longitudinal apertures 109. If additional stability is desired during the bunion excision procedure, the converging pin holes 107 can be used to insert one or more additional pins or guides. The longitudinal aperture 109 extends transversely to the slot 182 and may provide an opening to facilitate x-ray visualization and / or any other suitable surgical imaging procedures to confirm and / or monitor the alignment of the cutting guide during the bunion excision procedure.

[0069] Figures 2L to 2N Another exemplary reversible cutting guide 181 is depicted as a cutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein. Figure 2L and Figure 2M These are the top and bottom perspective views of the cutting guide 181, respectively. Figure 2N This is a top plan view of the cutting guide 181. The cutting guide 181 can be a single, integrally formed component and can comprise metal, plastic, or other suitable materials. The cutting guide 181 is similar to... Figures 2H to 2K The cutting guide 180 includes a flip-up configuration with a single slot 182.

[0070] 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 may include, as referenced above. Figures 2H to 2K The first pin hole 186 and the second pin hole 190 are described. The size and shape of the paddle 120 are configured to be seated within a joint such as a TMT joint (e.g., between the first metatarsal and the first cuneiform bone), for example, after the removal of soft tissue such as the joint capsule around the joint. The relatively narrow and 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.

[0071] exist Figures 2L to 2NIn an exemplary embodiment, the body 105 of the cutting guide 181 also includes one or more additional openings, such as additional converging pin holes 183, extending through the second extension 188. If additional stability is desired during the bunion removal procedure, the converging pin holes 183 can be used to insert one or more additional pins or wires. Similar to... Figures 2H to 2K The cutting guide 180 has a longitudinal orifice 109 extending transversely to the slot 182 and may provide an opening to facilitate X-ray visualization and / or any other suitable surgical imaging protocol to confirm and / or monitor the alignment of the cutting guide during the bunion excision procedure.

[0072] Figures 3A to 3H An exemplary linear tapering device 200 configured for use in the Lapidus bunion excision procedure described herein is depicted. References Figures 3A to 3C The linear tapered device 200 includes an inner hook 205, a threaded shaft 210, an outer hook 215, and a handle 220. (See reference...) Figures 10 to 14 In more detail, the linear reducer 200 is suitable for applying correction in the transverse plane during the Lapidus bunion excision procedure by reducing the intermetastatic angle by moving the first and second metatarsals closer together, and for maintaining the desired correction of the frontal plane when the pin is placed within the medial hook pin hole 209.

[0073] The inner hook 205 includes a connection orifice 206 sized and shaped to engage with a first end 212 of a threaded shaft 210. In some embodiments, the inner hook 205 may be fixedly engaged with the threaded shaft 210 such that the inner hook 205 is neither rotatable nor translatable relative to the threaded shaft 210. The inner hook 205 includes a curved engagement surface 207 configured to rest against the inside of the foot. One or more inner hook pin holes 209 extend from the engagement surface 207 through the entire thickness of the inner hook 205, allowing a pin to be placed through the inner hook 205 to temporarily secure the inner hook 205 to the toes.

[0074] The outer hook 215 includes a connecting aperture 216, the size and shape of which are configured to receive a threaded shaft 210 passing through it. The outer hook 215 may have a smooth inner surface with a diameter at least as large as the full diameter of the threaded shaft 210, allowing the outer hook 215 to translate along the threaded shaft 210 without rotation. Other features of the connecting aperture may include a non-cylindrical profile that prevents the outer hook 215 from rotating about the axis of the threaded shaft 210 when it is assembled to the threaded shaft 210. The outer hook 217 includes a curved engagement surface 217 configured to abut 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, for example, between the second and third toes, allowing the engagement surface 217 to be positioned against the lateral side of the second metatarsal for lateral plane correction.

[0075] In various embodiments, components of the linear reducer 200 may include a variety of materials. For example, the handle 220, threaded shaft 210, inner hook 205, and / or outer hook 205 may include metal, plastic, or polymer materials, etc. In some embodiments, the inner hook 205 and / or outer hook 215 may include a radiation-permeable material. Advantageously, the radiation-permeable material may at least partially transmit X-rays or other radiation associated with medical imaging, thereby facilitating imaging of the foot bones while the linear reducer 200 is applied. Exemplary radiation-permeable materials suitable for the inner hook 205 and / or outer hook 215 include carbon fibers, polymer materials, and / or composite materials, such as carbon fiber reinforced polymers.

[0076] The handle 220 includes one or more gripping features 222, such as knurling, to facilitate gripping by the user while rotating the handle 220. A threaded orifice 224 extends longitudinally through the handle 220. The internal threads of the threaded orifice 224 are sized and spaced to engage with the external threads of the threaded shaft 210. In some embodiments, only a portion of the threaded orifice 224 is threaded, for example, where any remaining length is drilled to a larger diameter to allow the threaded shaft 210 to pass through completely. Thus, the internal threads of the threaded orifice 224 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 the user wishes to reduce the gap between the inner hook 205 and the outer hook 215, the user rotates the handle 220 clockwise about the threaded shaft 210, causing the handle 220 to push the outer hook 215 towards the inner hook 205 along the threaded shaft 210. The friction between the internal thread of the threaded orifice 224 and the external thread of the threaded shaft 210 prevents the outer hook 215 and the handle 220 from being pushed outward away from the inner hook 205 unless the handle 220 is twisted.

[0077] Figure 3DAn alternative embodiment of the outer hook 215 is shown. Figure 3D In the alternative lateral hook 215, the engagement surface 217 includes one or more bone engagement features 218 configured to provide improved grip on the lateral surface of the second metatarsal during Lapidus bunion resection. In some cases, the bone engagement features 218 can reduce the probability of the lateral hook 215 sliding upward away from the second metatarsal during or after the decrease in the intermetrocar angle in the transverse plane.

[0078] Figures 3E to 3G A quick-release feature that can be incorporated into the inner hook of the linear reducer 200 is shown. In a quick-release embodiment of the linear reducer 200, Figures 3A to 3C The fixed inner hook 205 is replaced by a quick-release inner hook 235. The quick-release inner hook 235 includes an orifice 236 large enough to slidably accommodate the threaded shaft 210. A quick-release insert 237 is insertable into the upper portion of the quick-release inner hook 235. The quick-release insert 237 has a coupling orifice 239 including a locking portion 238 configured to interlock with a recess 214 near the first end 212 of the threaded shaft 210. Therefore, when the quick-release insert 237 is in position... Figure 3E When in the raised position, the locking portion 238 engages within the recess 214 to securely connect the quick-release inner hook 235 to the threaded shaft.

[0079] When it is desired to remove the linear tapered device 200 from the foot, the quick-release insert 237 is pushed downward in direction 240. As the quick-release insert 237 moves downward, the locking portion 238 disengages from the notch 214 in the threaded shaft 210, allowing the entire quick-release inner hook to slide relative to the threaded shaft 210 in the longitudinal direction 242. For example, if the quick-release inner hook 235 is secured to the bone, the threaded shaft 210 can be removed through the connecting hole 216 of the outer hook 215, and the outer hook 215 can be removed substantially vertically from the foot. The inner hook 205 can then be released and easily removed from the foot.

[0080] Now for reference Figure 3HIn some embodiments, the shoulder pin 260 can be used in conjunction with the linear reducer 200. Although any type of pin can be used, the shoulder pin 260 advantageously prevents damage to the skin on the medial side 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 medial hook hole 209, such that the shoulder 264 prevents the shoulder pin 260 from sliding outward through the medial hook hole 209. Therefore, when the shoulder pin 260 is inserted into the medial side of the first metatarsal and the linear reducer 200 is manipulated to reduce the intermetrocar angle of the foot, the lateral force applied by the medial hook 205 is transmitted to the first metatarsal via the shoulder 264, rather than through the skin along the engagement surface 207, thereby reducing the possibility of compression and / or damage to the skin of the foot. In some implementations, the shoulder pin 260 can be used with Figures 3E to 3G The quick-release inner hook 235 described herein is used in conjunction with this device.

[0081] Figure 4A and Figure 4B An exemplary control handle 300 configured for use in the Lapidus bunion excision procedure described herein is depicted. (See reference...) Figures 11 to 14 Described in more detail, the linear reducer 200 is adapted to apply correction in the anteroposterior plane or other planes during the Lapidus bunion resection procedure by rotating the first metatarsal relative to the first cuneiform bone. The control handle 300 is merely one example of a handle that can be attached to the cutting guide 100. Those skilled in the art will understand that various attachments can be made between the control handle and the cutting guide 100 without departing from the scope of the art.

[0082] The control handle 300 includes a handle 305 and a connecting portion 310 connected to the handle. Orifices 312 within the connecting portion 310 and / or pin guides 314 disposed within the orifices 312 are spaced apart to receive pins placed within the first metatarsal bone, according to the spacing of the distal pin holes 117 or 170 of the cutting guide 100 or the freehand pin guide 150. The spacing of the orifices 312 also corresponds to the spacing of the proximal pin holes 112 or 165. A space 316 within the pin guide 314 is appropriately large to receive surgical pins or wires.

[0083] Figures 5A to 5D An exemplary compressor block 400 configured for use in the Lapidus bunion excision procedure described herein is depicted. Figure 5A and 5B These are the top and bottom perspective views of compressor block 400, respectively. Figure 5C This is a top plan view of compressor block 400. Figure 5D It is along Figure 5CThe image shows a side cross-sectional view of compressor block 400 taken from line 5D-5D. For a more detailed description, please refer to [reference needed]. Figures 16 to 18 The compressor block 400 is configured to help compress and secure the joint that has been cut or removed by hand using the cutting guide 100.

[0084] 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 each other by the same spacing 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 each other by the same spacing 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 each positioned 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. Additionally, as... Figure 5D As shown in the cross-sectional view, the proximal pin hole 410 and the distal pin hole 415 are not parallel and are arranged at a converging angle, making their spacing at the bottom edge 407 of the compressor block 400 relatively closer. Therefore, when the compressor block 400 slides downwards over the pins, the parallel pins threaded into the proximal hole 410 and the distal hole 415 are compressed closer together, as... Figures 15 to 16 As shown. A threaded handle attachment port 425 is provided for attaching a side-mounted handle, which can help the user slide the compressor block 400 down to compress a pin or wire passing through the compressor block 400.

[0085] The compressor block 400 also includes a widened section 409 containing a cross-pin hole 420. For example... Figure 5A and Figure 5B As shown, each crosspin hole 420 extends downward and inward from the outer edge of the widened segment 409, such that the pin or wire inserted into the crosspin hole 420 is relatively closer to the center line of the compressor block 400 than the bottom edge 407 of the compressor block 400. Figures 16 to 18 As shown, the cross pin holes 420 are aligned such that when the compressor block 400 is used in conjunction with the cutting guide 100 or the freehand pin guide 150 at the first TMT joint, the compressor block 400 brings the cut surfaces of the first TMT joint that have been removed into contact with each other, and a pin inserted through either cross pin hole 420 will extend through the interface of the compressed joint at an angle to temporarily maintain contact at the joint surfaces until the first cuneiform bone or the first metatarsal bone can be secured by a plate or other fixation component.

[0086] Figures 6A to 6GAn exemplary bone plate 500 and Phillips screw 530 configured for use in the Lapidus bunion excision procedure described herein are depicted. The bone plate 500 and / or Phillips screw 530 can be formed of various metals or alloys. For example, the bone plate can be formed of titanium, shape memory alloys (such as nitinol), etc.

[0087] The bone plate 500 is sized and shaped to be applied across the first TMT joint to which the bone has been removed. Therefore, the bone plate 500 includes a body 505, which includes screw holes 510, wedge screw holes 515, metatarsal screw holes 520, and Phillips screw holes 525. Screw holes 510 include two holes 512 sized and shaped to receive two legs of the bone screw, such that one leg is seated within the first cuneiform bone near the wedge screw hole 515, and the other leg is seated within the first metatarsal bone near the metatarsal screw holes 520 and Phillips screw holes 525.

[0088] Each of the pin hole 510 and screw holes 515, 520, 525 is shaped to include a countersunk hole to reduce movement of the pins and / or screws seated therein. Additionally, the countersunk hole allows the pin or screw 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 Phillips screw must be applied in the Phillips screw hole 525, when viewed perpendicularly to the bone plate 500, the Phillips screw hole 525 has an elliptical shape (e.g., corresponding to a cylindrical profile along the screw path through the Phillips screw hole 525) and includes a shelf 527 occupying approximately half of the periphery of the Phillips screw hole 525. The shelf 527 is shaped to engage with the head of the Phillips screw when it is inserted at a pre-drilled angle, such that the Phillips screw securely engages the bone plate 500 and is seated within the countersunk hole.

[0089] Figure 6D This is an unfolded view of the bone plate 500, showing in detail the cross screw holes 525 and the shelf 527. Figure 6E An example Phillips head screw 530 configured to sit within a Phillips head screw hole 525 is shown, including a head 532 and a threaded shaft 534. Figure 6D As shown, it is a section cut perpendicular to the axis of the Phillips screw path. The shelf 527 can be tilted or tapered, so that the inner edge of the shelf 527 is higher than the outer edge, wherein the shelf 527 meets the inner wall of the Phillips screw hole 525. Figure 6E As shown, the head 532 of the Phillips head screw 530 has an undercut shelf 537. In this embodiment, the shelf 537 tapers downwards as the diameter increases. Therefore, as... Figure 6F and Figure 6GAs shown, when the cross screw 530 is inserted through the cross screw hole 525, the undercut shelf 537 of the head 532 of the cross screw 530 engages with the upwardly tapering shelf 527 of the bone plate 500, so that the bone screw 530 is seated in the bone at the desired angle.

[0090] Figures 7A to 7F An exemplary Phillips screw drilling guide is depicted for use in conjunction with a bone plate 500 when a Phillips screw is applied through a Phillips screw hole 525. Figures 7A to 7C An exemplary fixed-angle Phillips screw drilling guide 600 is depicted. Figures 7D to 7F An exemplary variable-angle Phillips screw drilling guide 650 is depicted, which allows a surgeon to select an angle within a certain range for inserting a Phillips screw.

[0091] The fixed-angle Phillips screw drilling guide 600 includes a body 605 and a tip 615. A longitudinal aperture 610 extends through the entire length of the body 605. The diameter of the longitudinal aperture 610 can be selected such that a drill bit sized appropriately to drill a guide hole for the Phillips screw can fit through the longitudinal aperture 610. In some embodiments, the diameter of the longitudinal aperture 610 can be selected such that a guide wire or other guiding structure can fit through the longitudinal aperture 610, allowing the guide to be removed and the guide hole to be drilled using a tubular drill bit. The tip 615 includes a shelf engagement surface 627 and a toe 629. The toe 629 and the shelf engagement surface 627 are shaped such that the toe 629 can be seated within a Phillips screw hole 525, wherein the shelf engagement surface 627 is seated against a shelf 527 of the Phillips screw hole 525. The elliptical shape of the Phillips screw hole 525 defines a single, stable orientation for seating the tip 615 of the fixed-angle Phillips screw drilling guide 600. The fixed-angle Phillips screw drilling guide 600 facilitates consistent and reproducible application of the Phillips screw at a predetermined, suitable angle, thereby preventing recurrence of bunions. Additionally, the fixed-angle Phillips screw drilling guide 600 forces 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 Phillips screw drilling guide 600 prevents the Phillips screw from interfering with the screw leg, prevents the Phillips screw from passing through the TMT joint, and establishes the angle of the drill bit towards the base of the second metatarsal or second cuneiform bone.

[0092] The variable-angle Phillips screw drill guide 650 similarly includes a body 655 and a tip 665, as well as an orifice 660 extending through the body 655. The tip 665 has the same shape as the tip 615 of the fixed-angle Phillips screw drill guide 600, including a shelf engagement surface 677 and a toe 679, such that the elliptical shape of the Phillips screw orifice 525 similarly defines a single stable orientation for seating the tip 665 of the variable-angle Phillips screw drill guide 650 therein. The variable-angle Phillips screw drill guide 650 has a generally wedge-shaped body 655 surrounding a wedge-shaped slot 662 communicating with the orifice 660. The wedge-shaped slot 662 accommodates a range 652 of drilling angles through the orifice 660. Thus, while the elliptical shape of the Phillips screw orifice 525 defines a single seating orientation of the variable-angle Phillips screw drill guide 650, the wedge-shaped slot 662 allows the surgeon to select various angles within a predetermined plane. Available drilling paths range from a first extreme path perpendicular or nearly perpendicular to bone plate 500 to a second extreme path at a smaller angle relative to bone plate 500. Depending on the geometry of the individual foot's skeletal structure, the variable-angle cross screw drilling guide 650 allows the surgeon to select the cross screw trajectory, for example, to enter the second metatarsal or second cuneiform bone as needed.

[0093] refer to Figures 8 to 24 This will describe an exemplary Lapidus bunion excision procedure using some of the devices disclosed herein. Although Figures 8 to 24 The procedure illustrates a specific implementation of the Lapidus bunion excision using a specific subset of the devices disclosed herein, but it should be understood that reference to... Figures 8 to 24 The components and steps shown and described can be applied in the same way to different sequences and / or different combinations of components to correct bunions.

[0094] Figures 8 to 24 Depicts the bones of foot 10, which originally had bunions. Similar to... Figure 1 The foot 10 includes a first metatarsal 20, which is angled and rotated relative to a first cuneiform bone 30 at a first TMT joint 40, such that the big toe has an undesirable medial bulge and an increased intermetatarsal angle. Figure 8 As shown, the procedure can be achieved through placement and temporary tightening. Figures 2A to 2D The cutting guide 100 is used to begin. Before placing the cutting guide, the surgeon can expose the first TMT joint 40 by making an incision (such as a dorsal medial incision) and removing soft tissue around the joint (such as the joint capsule or other soft tissue) to expose the first TMT joint 40 and create the paddle 120 of the cutting guide 100 therein. Figures 2A to 2D This provides space to accommodate the first TMT joint 40.

[0095] Once the joint is ready, the paddle 120 (in) Figure 8 The cutting guide 100 (not visible in the center) is positioned within the first TMT joint 40 such that the proximal extension 110 is positioned adjacent to or abutting the first cuneiform bone 30, and the distal extension 115 is positioned adjacent to or abutting 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. The alignment of the cutting guide 100 can be confirmed under fluoroscopy or other suitable imaging techniques before proceeding.

[0096] Once the cutting guide 100 has been placed and properly aligned, the cutting guide 100 is temporarily secured relative to the first metatarsal 20 by inserting two metatarsal pins 802 or wires through the distal pin holes 117 of the distal extension 115 and into or through the first metatarsal 20. Any of the metatarsal pins 802 or wires, and any other pins or wires described below, can be, for example, a Kirschner wire (“K-wire”) or any other suitable type of wire or pin that can be placed in the bone to secure the cutting guide 100.

[0097] Continue to Figure 9 Once the metatarsal pin 802 or wire is 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.

[0098] refer to Figure 10 The linear reducer 200 can be temporarily placed around the first metatarsal 20 and the second metatarsal 25. In some embodiments, a cut is made transversely to the second metatarsal 25 between the second and third toes to accommodate the 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 is positioned against the medial side of the first metatarsal 20, and the handle 220 of the linear reducer 200 can be rotated clockwise relative to the threaded shaft 210 until the handle 220 contacts the lateral hook 215. The initial placement of the linear reducer 200 can be temporary without initially inserting any pin through the medial hook 205.

[0099] Continue to Figure 11 The control handle 300 can be further positioned by inserting the metatarsal pin 802 into the space 316 within the pin guide 314 passing through the control handle 300. (See reference) Figure 12The control handle 300 can then be rotated in the anteroposterior plane to correct rotation about the axis of the first metatarsal 20. For example, when a clockwise rotation 806 is applied to the control handle 300, the torque applied to the control handle 300 is transmitted via the metatarsal pin 802, causing the first metatarsal and phalanx 50 of the big toe to rotate clockwise 808. Additionally, any necessary adjustments to the joint in the sagittal plane can be applied manually at this time. In some embodiments, the control handle 300 can also be used to apply other corrections, such as applying torque in the transverse plane to reduce the intermetropodial angle. Once the anteroposterior and sagittal planes have been properly corrected using the control handle 300, the surgeon can then proceed to adjust the position of the first metatarsal 20 in the transverse plane.

[0100] Joint Reference Figure 12 and Figure 13 A linear tapering device 200 can be used to correct the transverse plane. In some embodiments, a medial hook pin 816 is inserted through one of the medial hook pin holes 209 and into or through the first metatarsal 20 to fix the rotational position of the first metatarsal 20 in the anterior plane (e.g., in an anterior plane correction previously applied using the control handle 300). The medial hook pin may be a shouldered pin such that the lateral pressure applied by the medial hook 205 is applied directly to the first metatarsal 20 through the pin shoulder, rather than being applied through the skin along the engagement surface 207 of the medial hook.

[0101] With or without the inner hook pin 816 inserted, lateral plane correction can be applied by rotating the handle 220 of the linear reducer 200. For example, clockwise rotation 810 of the handle 220 reduces the distance along the threaded axis between the inner hook 205 and the outer hook 215, thereby causing the inner hook 205 to move laterally relative to the outer hook 215 in direction 812. Therefore, the inner hook 205 applies a lateral force to the first metatarsal 20 in the lateral plane, resulting in a corresponding lateral movement 814 of the first metatarsal 20 in the lateral plane.

[0102] At this stage, the misalignment of the first TMT joint 40 has been resolved. Continue to refer to... Figure 13 Two wedge-shaped bone pins 818 or wires are inserted through the proximal pin holes 112 of the cutting guide and into or through the first wedge-shaped bone 30. The wedge-shaped bone pins 818 or wires temporarily secure the cutting guide 100 relative to the first wedge-shaped bone 30. At this time, the four pins 802 and 814 form an array to establish and / or lock the surgeon's desired correction.

[0103] Continue to Figure 14Once the wedge-shaped bone pin 818 or guide wire is inserted, the base of the first wedge-shaped bone 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 wedge-shaped bone 30 completes the resection of the first TMT joint 40. (Reference) Figure 15 The cutting guide 100, linear reducer 200, and control handle 300 are removed from foot 10. The control handle 300 can be removed by sliding upwards until it no longer contains the metatarsal pin 802 or guide wire. Similarly, the cutting guide 100 can be removed by sliding upwards until it no longer contains the metatarsal pin 802 or guide wire and the wedge pin 818 or guide 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 foot 10. In some embodiments, a rapid release of the medial hook 235 can be used to facilitate the removal of the linear reducer. After removing the cutting guide 100, linear reducer 200, and control handle 300, a completely unhinged first TMT joint is left, with the metatarsal pin 802 or guide wire and the wedge pin 818 or guide wire held in place. At this point, the surgeon can further use any desired means to disperse and further prepare the joint for fusion.

[0104] Now for reference Figure 16 The compressor block 400 is applied over the metatarsal pin 802 or guide and the wedge-shaped pin 818 or guide. Preferably, the metatarsal pin 802 or guide is shorter or longer than the wedge-shaped pin 818 or guide (e.g., by being approximately or longer than the height of the compressor block 400, such as...). Figure 16 (As shown). In Figure 16 In the example, the compressor block 400 is applied by first screwing the proximal pin hole 410 onto the relatively long wedge-shaped bone pin 818 or guide wire, and then screwing the distal pin hole 415 onto the relatively short metatarsal pin 802 or guide wire. (See above reference.) Figures 5A to 5D The pin holes discussed here are different from those of the cutting guide 100. The pin holes of the compressor block 400 are slightly closer together and taper inward, making it possible to attempt to insert all four pins or wires through the compressor block 400 at the same time.

[0105] Due to the convergence angle between the proximal pin hole 410 and the distal pin hole 415, sliding the compressor block 400 downwards above the wedge pin 818 or guide and the metatarsal pin 802 or guide will pull the metatarsal pin 802 or guide closer to the wedge pin 818 or guide. Therefore, applying the compressor block 400 causes the first metatarsal 20 to move in direction 822 toward the first wedge 30, so that the cutting surface of the first metatarsal 20 contacts the cutting surface of the first wedge 30. The angled holes cause the pin to rotate in the sagittal plane, resulting in compression of the plantar side of the joint. This is likely desirable because compression only on the posterior side of the bone could, in some cases, cause plantar septum of the joint, which is undesirable for fusion.

[0106] Continue to Figure 17 Then, the cross pin 824 is inserted through one of the cross pin holes 420, so that the cross pin 824 passes through the compressed joint to temporarily fix the joint in place. Figure 18 As shown, remove the metatarsal pin 802 or guide wire and the wedge-shaped pin 818 or guide wire. (As indicated) Figure 19 As shown, the compressor block 400 can then be removed by sliding the compressor block outward along the crosspin 824, with the crosspin held in place to secure the joint until the bone plate 500 can be applied. Any number of crosspin hole tracks can be applied to the compressor block 400 to place the crosspin. Although the crosspin 824 is shown as inserting distally and extending proximally into the joint, in other embodiments, as an alternative or supplement to the distal side, the compressor block 400 may have a crosspin hole 420 located proximally. In such embodiments, the crosspin 824 will be inserted from the proximal end of the compressor block 400 and will extend distally through the joint.

[0107] refer to Figure 20 When the joint is secured in place by the cross pin 824, the bone plate 500 is placed across the resected first TMT joint 40. Guide holes are drilled as needed. To fix the first metatarsal 20 relative to the first cuneiform bone 30, a nail 826 is placed at the nail hole opening 510, a metatarsal screw 828 is placed at the metatarsal screw hole opening 520, and a cuneiform screw 830 is placed at the cuneiform screw hole opening 515. The nail 826, metatarsal screw 828, and cuneiform screw 830 can be placed in any order; however, it is preferred that the nail 826 and metatarsal screw 828 be placed before the cross pin 834. Figure 21As shown, once the first metatarsal 20 and the first cuneiform 30 have been fixed using the bone plate 500, the cross pin 824 is no longer needed and can be removed. The nail 826 can be made of a shape memory material. In some embodiments, the nail 826 is held in a deformable configuration, where the legs are substantially parallel during insertion through the plate 500. After insertion, the nail 826 can be allowed to relax toward a non-deformable configuration, where the legs are angled toward each other. Thus, after insertion, the nail 826 provides compressive force across the TMT joint 40. Further details regarding the plate-nail system can be found in U.S. Patent No. 10,299,842, the entire contents of which are incorporated herein by reference. Further details regarding nails suitable for use as described herein can be found in U.S. Publication No. 2018 / 0317906, the entire contents of which are incorporated herein by reference.

[0108] Continue to Figure 22 The cross-head screw drilling guide is placed within the cross-head screw hole 525 of the bone plate 500. Although Figure 22 It shows Figures 7A to 7C The fixed-angle Phillips head screw drilling guide 600, but the same procedure can be used. Figures 7D to 7F The procedure is performed using a variable-angle Phillips screw drilling guide 650. The Phillips screw drilling guide 600 is positioned in the Phillips screw hole 525 by abutting the shelf engagement surface 627 (or shelf engagement surface 677, if the variable-angle Phillips screw drilling guide 650 is used) against the shelf 527. A drill bit 832 is inserted through the Phillips screw drilling guide 600 and rotated to drill a guide hole for the Phillips screw within the Phillips screw hole 525. The drill bit 832 and the Phillips screw drilling guide 600 are removed, and the Phillips screw 834 is placed in the Phillips screw hole 525, thus completing the Lapidus bunion excision procedure.

[0109] Figure 23 and Figure 24 The completed state of the Lapidus bunion excision procedure according to this technique is shown. Figure 24 This is an enlarged view of a portion of the foot, showing the first metatarsal 20 with transparency to reveal the internal placement of the cross-shaped screw 834. (See image.) Figure 23 and Figure 24 As shown, the first metatarsal 20 is fixed relative to the first wedge 30 in a desired orientation by means of bone plate 500, nail 826, metatarsal screw 828 and wedge screw 830, wherein the inter-metatarsal angle is reduced relative to the second metatarsal 25.

[0110] Advantageously, the Phillips screw 834 further functions to prevent future recurrence of bunions. Since the foot may still experience daily pressures that could lead to recurrence of bunions, the Phillips screw 834 anchors the first metatarsal 20 to the second metatarsal 25 or the second cuneiform bone 35, depending on the geometry of the foot and the insertion angle of the Phillips screw 834. Therefore, Figures 8 to 24 The Lapidus bunion excision procedure not only repairs bunions but also prevents recurrence by providing additional structural connections to the bones of the midfoot that are set more laterally.

[0111] refer to Figures 25 to 29 This will describe a portion of an alternative procedure for excising bursitis of the laparostomia using certain devices described herein. Figures 25 to 29 The Lapidus bunion excision procedure shown in the image provides the use of Figures 2H to 2K The single-slot cutting guide 180 shown performs an alternative method of cutting the first metatarsal and first cuneiform bones. Therefore, as will be described in more detail below, Figures 25 to 29 The part of the Lapidus bunion excision shown can be combined with Figures 8 to 24 The various parts of the Lapidus bunion excision procedure shown are used in combination and / or in conjunction with other bunion excision procedures. Although Figures 25 to 29 The procedure illustrates a specific implementation of the Lapidus bunion excision using a specific subset of the devices disclosed herein, but it should be understood that reference to... Figures 25 to 29 The components and steps shown and described can be applied in the same way to different sequences and / or different combinations of components to correct bunions.

[0112] like Figure 25 As shown, this procedure can be achieved by... Figures 2H to 2K The cutting guide 180 is placed and temporarily secured to the foot 10 to begin. Similar to... Figure 8 The initial configuration involves exposing the first TMT joint 40 by making incisions (such as a dorsal medial incision) and removing soft tissue around the joint (such as the joint capsule or other soft tissue) to expose the first TMT joint 40 and create a paddle 120 in which the cutting guide 180 is located. Figures 2H to 2K The space available for placement may already be ready for the first TMT joint 40.

[0113] Once the joint is ready, the paddle 120 (in) Figure 25The cutting guide 180 (not visible in the center) is positioned within the first TMT joint 40 such that the first extension 184 is positioned adjacent to or abutting the first cuneiform bone 30, and the second extension 188 is positioned adjacent to or abutting 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, wherein the slot 182 is positioned above the first metatarsal bone 20. Alternatively, in some embodiments, the cutting guide 180 may be oriented using the slot 182 positioned above the first cuneiform bone 30, and a bunion resection may be performed such that the first cuneiform bone 30 is cut before the first metatarsal bone 20. The alignment of the cutting guide 180 may be confirmed under fluoroscopy or other suitable imaging techniques before proceeding.

[0114] When the cutting guide 180 has been placed and properly aligned, the cutting guide 180 is temporarily secured relative to the first metatarsal 20 by inserting one or more metatarsal pins 802 or wires through the second pin hole 190 of the second extension 188 and into or through the first metatarsal 20. Any of the metatarsal pins 802 or wires, and any other pins or wires described below, can be, for example, Kirschner wires (“K-wires”) or any other suitable type of wire or pin that can be placed in the bone to secure the cutting guide 180. Although two metatarsal pins 802 or wires are shown in this example, the cutting guide 180 can be appropriately secured and stable when held in place by the paddle 120 and a single metatarsal pin 802 or wire.

[0115] Continue to Figure 26 Once the metatarsal pin 802 or wire is inserted, the base of the first metatarsal 20 is cut using a saw blade 804 inserted through the slot 182 of the cutting guide 180.

[0116] refer to Figure 27 and Figure 28 After cutting the base of the first metatarsal 20, the cutting guide 180 can be reoriented so that the same slot 182 can be used to guide the subsequent cutting of the first cuneiform bone 30 in the Lapidus bunion resection procedure. The cutting guide 180 can be removed by sliding it upward until the second pin hole 190 is free of metatarsal pins 802 or guide wires, as... Figure 27As shown. At this stage, the removed 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 flipped (e.g., rotated 180 degrees about an axis parallel to the metatarsal pin 802 or the guide wire). The metatarsal pin 802 or the guide wire can then be inserted through the first pin hole 186, and the cutting guide 180 can be moved downward along the metatarsal pin 802 or the guide wire until the paddle 120 is seated again within the first TMT joint 40, as shown. Figure 28 As shown. In some embodiments, the first pin hole 186 and the second pin hole 190 have different spacings around the center of the paddle 120. For example, the first pin hole 186 may be closer to the paddle 120 at a distance equal to the thickness of bone removed by the first cut, such that flipping the cutting guide 180 causes the paddle 120 to be firmly positioned against the cutting surface of the first metatarsal 20.

[0117] exist Figure 28 In this configuration, due to the flipping of the cutting guide 180, the second hole 190 is positioned above 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. According to Figure 28 The procedure for excision of the bursa of Fabricius, as shown in the reference, can be basically as follows. Figures 10 to 13 The procedures shown and described are for correcting the position of the first metatarsal 20 and phalanx 50 in the frontal and transverse planes. (In conjunction with reference...) Figure 13 In the same procedure described, two wedge-shaped bone pins 818 or wires are inserted through the second pin hole 190 of the cutting guide 180 and into or through the first wedge-shaped bone 30. The wedge-shaped bone pins 818 or wires temporarily secure the cutting guide 180 relative to the first wedge-shaped bone 30. At this time, the four pins 802 and 814 form an array to establish and / or lock the surgeon's desired correction.

[0118] Now for reference Figure 29 Since the cutting guide 180 is flipped after cutting the first metatarsal 20, the slot 182 is now positioned on the wedge-shaped side of the first TMT joint 40. Therefore, after correcting the bunion in at least the frontal and / or transverse planes and placing the wedge-shaped pin 818 or guide wire, the slot 182 is positioned to guide the cutting of the first wedge-shaped bone 30.

[0119] Once the wedge-shaped bone pin 818 or the guide wire is inserted, the base of the first wedge-shaped 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 wedge-shaped bone 30 completes the resection of the first TMT joint 40. This can then be done by referring to the above... Figure 15The same or similar procedures described involve removing the cutting guide 180, linear reducer 200, and control handle 300 from the foot 10. After removing the cutting guide 180, linear reducer 200, and control handle 300, a completely unhinged first TMT joint 40 is left, with the metatarsal pin 802 or guide and the wedge pin 818 or guide held in place. At this point, the surgeon can further disperse and prepare the joint for fusion using any desired means. Then, essentially as described in the reference... Figures 16 to 24 The remainder of the procedure for performing a bursitis excision on a patient with bursitis of the thumb, as shown and described.

[0120] refer to Figures 30A to 32C Provided for correction Figure 1 Various additional devices and components for the improved Lapidus bunion excision procedure for TMT joint deformities. Figures 30A to 32C The devices and components described herein can be used to perform additional optional steps in the Lapidus bunion excision procedure described herein, such as additional bone removal and / or additional rotational correction of the frontal plane prior to fixation. Although the following description is made with reference to the Lapidus bunion excision procedure, it should be understood that the various devices and components described herein are not limited to such procedures and can be used equally in other orthopedic procedures, as will be understood by those skilled in the art.

[0121] Figures 30A to 30C A cutting guide 900 is depicted as a recutting guide and pin guide configured for use in the Lapidus bunion excision procedure described herein. In some Lapidus bunion excision procedures, the surgeon may expect 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 forming the TMT joint may have different levels of indentation in different individuals, such that some first metatarsal and / or first cuneiform bones may require further bone removal to reach a plane exposing the internal bone over the entire cross-section of the cutting area.

[0122] Figure 30A and Figure 30B These are the top and bottom perspective views of the cutting guide 900. Figure 30C This is a top plan view of the cutting guide 900. The cutting guide 900 can be a single, integrally formed component and can comprise metal, plastic, or other suitable materials. The dimensions and shape of the cutting guide 900 can be configured to work with another cutting guide (such as...). Figures 2L to 2N The cutting guide 181) is used in conjunction with (and subsequently thereafter).

[0123] The cutting guide 900 generally includes a body 910, an extension 920, and a paddle 930. The extension 920 may have similar or identical dimensions and shape to the second extension 188 of the cutting guide 181, and may include pin holes 922 having a spacing corresponding to the spacing of the second pin holes 190 of the cutting guide 181. The body 910 includes a slot 912. For example, the paddle 930 is sized and shaped to sit within a joint such as a TMT joint.

[0124] To achieve the desired recutting function, 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 system including cutting guide 900 and cutting guide 181 ( Figures 2L to 2N In the kit, the distance between the slot 912 and the nearby pin hole 922 is shorter than the distance between the slot 182 of the cutting guide 180 and the nearby second pin hole 190. Therefore, after cutting using the cutting guide 181, which extends through the pin 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 plane closer to the pin for recutting. (Refer to...) Figures 33 to 35 The use of the cutting guide 900 as a re-cutting guide is described in more detail.

[0125] Figures 31A to 31C An exemplary realignment guide 1000 is depicted as a pin guide configured for frontal plane adjustment in the Lapidus bunion excision procedure described herein. Figure 31A and Figure 31B These are the top and bottom perspective views of the realigned guide 1000. Figure 31C It is along Figure 31B The image shows a side cross-sectional view of the realignment guide 100 taken along line 31C-31C. The realignment guide 1000 includes a body 1010 having two or more pairs of pin holes passing through it. The body 1010 is generally wedge-shaped and may be integrally formed from metal, plastic, or other suitable material.

[0126] exist Figures 31A to 31CIn the example realignment guide 1000, the body 1010 includes four pairs of pin holes 1012, 1014, 1016, and 1018. Each pair of pin holes 1012, 1014, 1016, and 1018 can be parallel, and the pin hole pairs are oriented in a converging configuration. Each pair of pin holes 1012, 1014, 1016, and 1018 can be spaced apart by a distance corresponding to the pin hole spacing of an associated cutting guide (e.g., cutting guides 180, 181, 900, etc.). Thus, the pin holes 1012, 1014, 1016, and 1018 can be used to implement further frontal plane correction by placing them above an existing pair of pins and serving as a guide for placing a second pair of similarly spaced parallel pins, which are positioned relative to the existing pair at a predetermined angle offset around the phalanx bone. (See reference...) Figures 39 to 48 The use of the realignment guide 100 is described in more detail.

[0127] Figures 32A to 32C An example realignment guide 1020 is depicted as a pin guide and compressor block configured for frontal plane adjustment in the Lapidus bunion excision procedure described herein. Figure 32A and Figure 32B These are the top and bottom perspective views of the realigned guide 1020. Figure 32C This is a top plan view of the realignment guide 1020. The realignment guide 1020 can be integrally formed from metal, plastic, or other suitable materials. The realignment guide 1020 can have a shape generally similar to the compressor block 400 and can be used simultaneously as both a realignment guide and a compressor block in operation.

[0128] 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 pin holes 410 and distal pin holes 415 of the compressor block 400, the proximal pin holes 1030, 1032 and distal pin holes 1035, 1037 converge toward the center of the realignment guide 1020. The widened segment 1040 may include cross pin holes 1042 for additional stabilization and / or temporary fixation while a permanent fixing device is placed. (See reference...) Figures 36 to 38 In more detail, the realignment guide 1020 can be used to perform additional frontal plane correction of the first metatarsal without the need to insert additional pins into the bone.

[0129] Figures 33 to 35 It is a perspective view of the bones of the foot 10, sequentially showing the recutting portions of the exemplary Lapidus bunion excision procedure performed using the exemplary bunion excision device disclosed herein. Figures 33 to 35The recut portion of the Lapidus bunion excision shown can be performed at any time after the initial cut of the first metatarsal 20 and / or the first cuneiform 30 (where further bone removal is required). For example, in some procedures, the surgeon may examine the cut ends of the first metatarsal 20 and / or the first cuneiform 30 and determine that additional bone should be removed due to bone indentation or desired spacing. Therefore, as will be described in more detail below, Figures 33 to 35 The portion of the Lapidus bunion excision procedure shown can be used in conjunction with any of the other Lapidus bunion excision procedures described herein.

[0130] like Figure 33 As shown, the recut portion can be in a similar manner to... Figure 15 The configuration starts with foot 10. Figure 33 In this configuration, cutting guides (e.g., cutting guide 100, cutting guide 180, cutting guide 181, etc., as disclosed elsewhere herein) may have been used to remove a portion of the first metatarsal 20 and / or the first cuneiform bone 30. After the cutting guides used for the initial cutting of the first metatarsal 20 and / or the first cuneiform bone 30 have been removed, the metatarsal pin 802 and / or the cuneiform pin 818 may remain in the foot 10. Figures 33 to 35 In the example recut section shown, it is intended to remove the additional portion of the first metatarsal 20 facing the first TMT joint 40.

[0131] Continue to Figure 34 The metatarsal pin 802 is inserted through the pin hole 922 of the cutting guide 900, and the cutting guide 900 is slid onto the metatarsal pin 802 until the cutting guide 900 abuts against the previously cut surface of the first metatarsal 20, and the cutting guide 900, which will be configured as a re-cutting guide, is placed. Figure 34 In this configuration, because the cutting guide 900 is closer to the cutting guides 100, 180, and 181 in terms of spacing, the slot 912 of the cutting guide 900 is aligned closer to the metatarsal pin 802 than the end of the first metatarsal 20 facing the TMT joint. Once the cutting guide 900 is in place, the base of the first metatarsal 20 can be recut using a saw blade 836 inserted through the slot 912 of the cutting guide 900. Then, it can be done essentially as described in the reference. Figures 16 to 24 The remainder of the procedure for excision of the bursa of Fabricius, as shown and described or as described elsewhere in this document, shall be performed. It should be understood that the aforementioned recutting can also be applied to the first metatarsal 20 or the first cuneiform 30.

[0132] Figures 36 to 38 This is a perspective view of the bones of foot 10, showing sequentially the use of Figures 32A to 32CThe frontal plane realignment portion of the exemplary Lapidus bunion excision procedure shown in the realignment guide 1020. Figures 36 to 38 The frontal plane realignment portion of the Lapidus bunion resection shown can be performed at any time after the first metatarsal 20 and the first cuneiform bone 30 have been cut and before fixation, as described elsewhere herein. When the realignment guide 1020 is configured as both a pin guide and a compressor block for simultaneous frontal plane realignment, it can function as... Figures 16 to 18 The procedure shown is performed by replacing or supplementing the compressed portion of the bursa of Fabricius (e.g., before or after it). Figures 36 to 38 The realignment is shown in the diagram. For example, in some procedures, the surgeon may perform an initial frontal plane correction and may subsequently determine (such as in the initial...) Figure 16 When assembling the compressor block as shown, further correction or realignment of the first metatarsal 20 in the frontal plane is required.

[0133] The front plane is realigned as described above. Figure 15 or Figure 33 The configuration shown begins at foot 100, where, after cutting the bone using the cutting guide described herein, the metatarsal pin 802 remains in the first metatarsal 20 and the cuneiform pin 818 remains in the first cuneiform 30. The realignment continues to... Figure 36 The configuration shown involves placing the realignment guide 1020 by inserting the metatarsal pin 802 through the first pair of distal pin holes 1035 and the wedge-shaped bone pin 818 through the first pair of proximal pin holes 1030. When as... Figure 36 When metatarsal pins 802 and wedge-shaped pins 818 are provided in multiple pairs of holes on the same side of the realignment guide 1020, the realignment guide 1020 functions similarly to a compressor block 400, thereby compressing the cutting ends of the first metatarsal 20 and the first wedge-shaped bone 30 without applying any frontal plane realignment. Figure 36 At the stage shown, the surgeon can determine that the initial frontal plane adjustment is insufficient and that the first metatarsal 20 should be realigned by further clockwise rotation to achieve the desired alignment.

[0134] like Figure 37 and Figure 38 As shown, from the foot 10 ( Figure 37 Remove the realignment guide 1020 and replace it above the wedge-shaped bone pin 818 and the metatarsal pin 802. However, when replacing the realignment guide 1020, insert the wedge-shaped bone pin 818 through the second pair of proximal pin holes 1032, which are angled relative to the first pair of proximal pin holes 1030. Insert the metatarsal pin 802 through the previously placed... Figure 36The same first pair of distal pin holes 1035 are inserted through the center. Therefore, the replacement of the realignment guide 1020 allows for further clockwise rotational adjustment of the first metatarsal 20 and compression of the TMT joint 40 for fixation. Alternatively, counterclockwise adjustment can be performed by re-inserting the wedge-shaped bone 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. Figures 36 to 38 After the realignment shown, the Lapidus bunion excision procedure can proceed to fix the bone of the TMT joint 40, for example, as referenced. Figures 17 to 24 As shown and described. Figures 18 to 20 As shown, the cross pin 824 used for temporary fixation can be inserted through any of the cross pin holes 1042.

[0135] Figures 39 to 48 It is a perspective view of the foot bones, showing the use of... Figures 31A to 31C The frontal plane realignment portion of the exemplary Lapidus bunion excision procedure shown in the realignment guide 1000. Figures 39 to 48 The frontal plane realignment portion of the Lapidus bunion excision procedure shown can be performed at various stages of the procedure, such as before placing the compressor block, as... Figure 16 As shown. In some implementations, Figures 39 to 48 The frontal realignment portion of the Lapidus bunion excision shown can be performed after the initial placement indication of the compressor block 400 requires more or less frontal plane correction before fixation. As will be described in more detail, realignment using realignment guide 1000 differs from realignment using realignment guide 1020 (e.g., Figures 36 to 38 The realignment is performed because the realignment guide 1000 guides the placement of the second pair of metatarsal pins, which are rotated relative to the initial pair of metatarsal pins. This second pair of metatarsal pins can then be used in conjunction with the compressor block 400 to complete the frontal plane realignment.

[0136] The front plane is realigned as described above. Figure 15 or Figure 33 The configuration shown begins at foot 100, where, after cutting the bone using the cutting guide described herein, the metatarsal pin 802 remains in the first metatarsal 20 and the cuneiform pin 818 remains in the first cuneiform 30. The realignment continues to... Figure 39The configuration shown places the realignment guide 1000 by inserting the metatarsal pin 802 through the first pair of pin holes 1012. In this configuration, the other three pairs of pin holes 1014, 1016, and 1018 define pin placement positions for clockwise frontal plane realignment for three increased amounts. Alternatively, if counterclockwise frontal plane realignment is desired, the realignment guide 1000 is placed by inserting the metatarsal pin 802 through the fourth pair of pin holes 1018, such that the other three pairs of pin holes 1012, 1014, and 1016 define pin placement positions for counterclockwise frontal plane realignment.

[0137] After placing and realigning the guide 1000, the process continues to... Figure 40 The first replacement metatarsal pin 803a is partially inserted into the first metatarsal 20 through one of a pair of pin holes 1016. Due to the convergence of the paths within the first metatarsal 20 of pin holes 1012, 1014, 1016, and 1018, it may be impossible or undesirable for the metatarsal pin 802 to remain inserted while the replacement metatarsal pin is fully inserted. Therefore, the first replacement metatarsal pin 803a can be inserted only partially, such that the first replacement metatarsal pin 803a does not impinge on the corresponding metatarsal pin 802. Preferably, the first replacement metatarsal pin 803a extends sufficiently into the bone to maintain the position and orientation of the realignment guide 1000 relative to the first metatarsal 802 even after one of the metatarsal pins 802 has been removed.

[0138] Continue to Figure 41 The proximal metatarsal pin 802 corresponding to the first replacement metatarsal pin 803a is removed from the first metatarsal 20. In this configuration, the partially inserted first replacement metatarsal pin 803a and the retained metatarsal pin 802 are sufficient to maintain the position and orientation of the realignment guide 1000 relative to the first metatarsal. Figure 42 As shown, the first replacement metatarsal pin 803a can then be further inserted through the pin hole 1016 and the first metatarsal to the fully inserted position, wherein the realignment guide 1000 serves as a pin placement guide for the first replacement metatarsal pin 803a.

[0139] Continue to Figures 43 to 45 A similar replacement procedure should be performed for the retained metatarsal pin 802. For example... Figure 43 As shown, the second replacement metatarsal pin 803b is partially inserted into the other pin holes passing through a pair of pin holes 1016. (As indicated...) Figure 44 As shown, the retained metatarsal pin 802 is removed to allow full insertion of the second replacement metatarsal pin 803b. Figure 45 As shown, the second replacement metatarsal pin 803b is further inserted through the realignment guide 1000.

[0140] Continue to Figure 46Remove and realign the guide 1000 from the foot 10, so that the replacement metatarsal pins 803a, 803b remain in the first metatarsal 20, having the same spacing but angularly displaced relative to the removed metatarsal pin 802. Figure 47 As shown, the first metatarsal 20 is then rotated in the frontal plane relative to the first wedge 30 into a final orientation, in which the replacement metatarsal pins 803a, 803b are aligned with the wedge pin 818. After this final frontal plane realignment process, a compressor block, such as a compressor block 400, can then be placed over the wedge pin 818 and the replacement metatarsal pins 803a, 803b to compress the TMT joint 40 for fixation. For example, as referenced... Figures 17 to 24 As shown and described, the procedure for excising the bursa of Fabricius can continue until completion.

[0141] The embodiments described herein are exemplary. Modifications, rearrangements, substitutions, etc., can be made to these embodiments, and these modifications are still covered within the teachings set forth herein. Depending on the embodiment, certain actions, events, or functions of any method described herein may be performed in a different order, and may be added, combined, or excluded entirely (e.g., not all described actions or events are necessary for the practice of the method). Furthermore, in some embodiments, actions or events may be performed simultaneously rather than sequentially.

[0142] The phrases “connected to,” “linked to,” and “connected to” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be functionally coupled to each other even if they are not in direct contact. The term “adjacent” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together.

[0143] Unless otherwise specifically stated or otherwise understood in the context in which they are used, the conditional language used herein, such as “may,” “can,” “may,” “for example,” etc., is generally intended to convey that certain embodiments include certain features, elements, and / or states that are not included in other embodiments. Therefore, such conditional language is not generally intended to imply that one or more embodiments require features, elements, and / or states in any way, or that one or more embodiments necessarily include logic for determining, with or without author input or prompting, whether such features, elements, and / or states are included in any particular embodiment or whether they will be performed in any particular embodiment. The terms “comprising,” “including,” “having,” “involving,” etc., are synonymous and used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Moreover, the term “or” is used in its inclusive sense (rather than in its exclusive sense) such that when used, for example, to connect a series of elements, the term “or” refers to one, some, or all of the elements in that series.

[0144] Unless otherwise specifically stated, disjunctive languages ​​such as “at least one of X, Y, or Z” are understood in context as can be X, Y, or Z or any combination thereof (e.g., X, Y, and / or Z) as commonly used to represent items, terms, etc. Therefore, such disjunctive languages ​​are generally not intended, and should not imply, that certain embodiments require the separate presence of at least one X, at least one Y, or at least one Z.

[0145] Unless otherwise expressly stated, articles such as “a” or “an” should generally be interpreted as including one or more of the described items. Thus, phrases such as “a device configured to…” are intended to include one or more of the described devices. Such one or more described devices may also be collectively configured to perform the stated descriptions. For example, “a processor configured to perform descriptions A, B, and C” could include a first processor configured to perform description A combined with a second processor configured to perform descriptions B and C.

[0146] While the foregoing detailed description has shown, described, and pointed out novel features applicable to the illustrative embodiments, it should be understood that various omissions, substitutions, and changes may be made to the form and details of the illustrated apparatus or algorithm without departing from the spirit of this disclosure. As will be appreciated, certain embodiments described herein may be embodied in forms that do not provide all the features and beneficial effects set forth herein, as some features may be used or practiced separately from other features. All changes within the equivalent meaning and scope of the claims are covered within the scope of the claims.

Claims

1. A bunion correction kit, comprising: Cutting guide, the cutting guide comprising: main body; A plurality of first pin holes, the plurality of first pin holes extending parallel through the body and spaced apart by a first distance; A plurality of second pin holes, the plurality of second pin holes extending through the body parallel to the first pin hole, the plurality of second pin holes being spaced apart at the first distance; A joint-probing propeller extending from the body between the first pin hole and the second pin hole; and A cutting slot extends parallel to the joint-seeking paddle and through the body between the joint-seeking paddle and the first pin hole, the cutting slot being configured to guide cutting the base of the first metatarsal or first cuneiform bone when the joint-seeking paddle is at least partially disposed within the tarsometatarsal (TMT) joint. A linear reducer, comprising a medial hook and a lateral hook, wherein the spacing between the medial hook and the lateral hook is adjustable to achieve transverse plane correction when the medial hook seat is against the medial side of the first metatarsal and the lateral hook seat is against the lateral side of the second metatarsal. A control handle, comprising a handle portion and a engagement portion, the engagement portion including pin holes spaced apart by the first distance; and The compressor block includes: The main body has a top surface and a bottom surface; Multiple proximal pin holes, the multiple proximal pin holes extending from the top surface through the body to the bottom surface at a first angle of less than 90 degrees relative to the top surface and the bottom surface; and A plurality of distal pin holes, the plurality of distal pin holes extending from the top surface through the body to the bottom surface at a first angle relative to the top surface and the bottom surface, wherein the distal pin holes converge relative to the proximal pin holes such that the proximal pin holes and the distal pin holes are more closely spaced relative to the top surface at the bottom surface.

2. The bunion correction kit according to claim 1 further includes a recut guide, the recut guide comprising: main body; Multiple pin holes, the multiple pin holes extending through the body and spaced apart by the first distance; Joint-probing paddle, which extends from the main body; and A slot extending parallel to the joint-seeking propeller and through the body between the joint-seeking propeller and the pin hole, wherein the slot of the recutting guide is closer to the pin hole of the recutting guide than the corresponding distance between the slot of the cutting guide and the first pin hole of the cutting guide.

3. The bunion correction kit of claim 1, wherein the compressor block is configured as a frontal 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. The bunion correction kit of claim 1 further includes one or more bone screws and a bone plate configured to receive the one or more bone screws, wherein the bone plate is configured to receive at least one of the one or more bone screws as a Phillips screw extending at an angle of less than 90 degrees relative to the bone plate.

5. The bunion correction kit of claim 1, wherein the linear tapering device comprises: A shaft having a proximal end and a distal end; The medial hook is coupled to the shaft at the distal end, and at least a portion of the medial hook includes a concave surface shaped to sit on the medial side of the first metatarsal bone. The outer hook is slidably coupled to the shaft at a midpoint between the proximal end and the distal end, and at least a portion of the inner hook includes a concave surface shaped to seat on the medial side of the first metatarsal bone while simultaneously seating on the lateral side of the second metatarsal bone; and A handle is connected to the axis proximally adjacent to the outer hook. The linear position of the handle along the axis is adjustable to move the outer hook relative to the inner hook so as to achieve transverse plane correction when the inner hook seat is against the medial side of the first metatarsal and the outer hook seat is against the lateral side of the second metatarsal.

6. The bunion correction kit of claim 5, wherein the shaft includes a threaded outer surface, and wherein the handle includes a threaded orifice extending therethrough and engaging with the threaded outer surface of the shaft, such that the linear position of the handle can be adjusted by twisting the handle about the shaft.

7. The bunion correction kit of claim 5, wherein the medial hook includes one or more orifices extending through the concave surface to receive a pin extending through it into the first metatarsal bone.

8. The bunion correction kit of claim 7, wherein the medial hook is coupled to the shaft via a quick-release coupling capable of moving from a locked position to an unlocked position, and wherein in the unlocked position, the medial hook is capable of sliding along the longitudinal axis of the shaft.

9. The bunion correction kit of claim 7, wherein at least one of the inner hook and the outer hook comprises a radiopaque material.

10. The bunion correction kit of claim 9, wherein the radiation-permeable material comprises carbon fiber.

11. The bunion correction kit according to claim 1, wherein: The main body includes a first end along the longitudinal axis of the cutting guide and a second end opposite to the first end; The plurality of first pin holes extend parallel to each other through the body near the first end; The plurality of second pin holes are located near the second end and extend through the body parallel to the first pin holes; The cutting slot extends perpendicularly through the body at a first intermediate position between the first pin hole and the second pin hole, and the size and shape of the cutting slot are set to guide the bone to be cut by a saw blade inserted through it. and The joint-finding paddle extends perpendicularly to the longitudinal axis from the bone-facing surface of the body at a second intermediate position between the cutting slot and the second pin hole, such that the cutting guide can be placed across the first tarsometatarsal (TMT) joint, wherein the joint-finding paddle is seated within the first tarsometatarsal (TMT) joint in either of the following orientations: metatarsal cutting orientation, wherein the cutting slot guides the cutting of the base of the first metatarsal; or cuneiform cutting orientation, wherein the cutting slot guides the cutting of the base of the first cuneiform.

12. The bunion correction kit of claim 11, wherein the cutting guide further comprises one or more longitudinal orifices extending through the body perpendicular to and intersecting the cutting slot.

13. The bunion correction kit of claim 11, wherein the cutting guide does not include a second cutting slot.

14. The bunion correction kit of claim 11, wherein the cutting guide further comprises one or more converging pin holes extending through the body at a laterally displaced position relative to the longitudinal axis, wherein each converging pin hole encounters the bone-facing surface at a first distance from the longitudinal axis and encounters an 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.

15. The bunion correction kit of claim 11, wherein the cutting slot includes an intermediate segment having a first width and an end segment at an opposite end of the intermediate segment, the end segment having a second width greater than the first width.

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