Bone repositioning guide systems and procedures

Abstract

This invention relates to a surgical system and technique for correcting aponeurosis, i.e., hallux valgus, and more generally, for bone realignment. [Solution] The kit comprises a guide 1500, which comprises a first end portion having a first cannula and a second end portion having a second cannula, the second cannula being parallel to the first cannula, and the guide 1500 is configured such that when the first and second bones 104 and 108 are in a deformed configuration and the first and second k-wires 1300 are fixed within the first and second bones 104 and 108, and the first and second k-wires 1300 are non-parallel, sliding the guide 1500 over the first and second k-wires 1300 while the first and second k-wires 1300 are received within the individual first and second cannulas of the guide 1500 realigns the first and second bones 104 and 108 to a corrective configuration.

Description

Technical Field

[0001] The present invention generally relates to surgical systems and techniques for correcting the alignment between two bones and joints, and more particularly, to surgical systems and techniques for correcting a sesamoiditis in a patient's foot.

Background Art

[0002] Bone misalignment and / or deformation can cause discomfort and reduced mobility in patients, particularly in a patient's foot. One particularly common foot disorder is sesamoiditis. Sesamoiditis is typically a progressive disorder that begins with the deviation of the big toe of the foot. The deviation of the big toe of the foot can gradually change the angle of the bone and generate a characteristic bulge on the inner side of the midfoot bone near the joint of the midfoot bone and the proximal phalanx. Specifically, sesamoiditis is a protrusion consisting of a bone, and in some cases, an inflammatory sac. Hallux valgus is a condition in which the big toe of the foot deviates from its normal position towards the direction of the second toe. Therefore, the present invention is directed to surgical systems and techniques for correcting sesamoiditis, i.e., hallux valgus, and more generally, for bone realignment.

Summary of the Invention

Means for Solving the Problems

[0003] The foregoing summary is illustrative only and not intended to be limiting. The systems, devices, and methods, and / or other aspects, features, and advantages of other subject matters described in this application will become apparent from the teachings described below. The summary is provided to introduce a series of concepts of the present disclosure. The summary is not intended to identify the main or essential features of any subject matter described in this specification.

[0004] According to one aspect of this disclosure, a method for correcting misalignment between a first bone and a second bone by fusing the joint between the first bone and the second bone includes the step of providing a first guide. The first guide includes a first end portion with a first cannula aligned along a first axis. The second end portion has a second cannula aligned along a second axis. The first axis is non-parallel to the second axis. When the first and second bones are in a deformed configuration, the first axis is configured to intersect the first bone and the second axis is configured to intersect the second bone. A first k-wire is inserted into the first bone through the first cannula. A second k-wire is inserted into the second bone through the second cannula. The first guide is removed from the first and second k-wires. The second guide includes a first end portion with the first cannula. The second end portion has a second cannula. The first cannula is parallel to the second cannula. The second guide slides across the first and second k-wires. The first k-wire is received in the first cannula of the second guide, and the second k-wire is received in the second cannula of the second guide. The second guide acts on the first and second k-wires to realign the first and second bones to the orthodontic configuration.

[0005] In another aspect, the method includes the steps of fixing the first and second bones in an orthodontic configuration and removing the second guide and the first and second k-wires from the first and second bones.

[0006] In another aspect, the method includes a step of fixing the first and second bones in an orthodontic configuration, which includes a step of inserting a first stabilizing wire into the first and second bones.

[0007] In another aspect, this method involves attaching the first end of the bone plate to the first bone and the second end of the bone plate to the second bone so that the first and second bones are retained in the orthodontic configuration. Includes a step of kicking.

[0008] In another aspect, the method includes the step of inserting bone plate clips into the first and second bones.

[0009] In another respect, the method includes the step of excising the first end of the first bone.

[0010] In another aspect, the first end portion of the first guide includes a third cannula aligned parallel to the first axis.

[0011] In another aspect, the method includes the step of inserting a third k-wire into the first bone through a third cannula, and the step of resecting the first end of the first bone includes inserting a first resection guide across the first and third k-wires and aligning the first resection guide with the first end of the first bone.

[0012] In another respect, this method includes the step of excising the first end of the second bone.

[0013] On another side, the second end of the first guide includes a fourth cannula that is aligned parallel to the second axis.

[0014] In another respect, this method includes the step of excising the first end of the second bone.

[0015] In another aspect, the method includes inserting a second resection guide across a second k-wire and a fourth k-wire that are inserted into the second bone, and aligning the second resection guide with the first end of the second bone.

[0016] In another aspect, the first bone is the metatarsal bone, the second bone is the medial cuneiform bone, the deformed structure of the first and second bones includes a fasciocele, and the corrective structure of the first and second bones corrects the fasciocele.

[0017] On another level, the second guide adjusts the angle of the first bone within three orthogonal planes between the deformed and corrective configurations.

[0018] On another level, the second guide adjusts the position of the first bone within three orthogonal planes between the deformed and corrective structures.

[0019] In another aspect, the method includes the step of centering the first guide between the first bone and the second bone by inserting a centering k-wire through a centering cannula on the first guide.

[0020] In another aspect, the method includes the step of removing the first guide from the first and second k-wires, which includes the step of disassembling the first guide at least partially.

[0021] In another respect, the method includes the steps of: scanning the first and second bones in the deformation configuration and rendering a 3D model including the first and second virtual bones in the virtual deformation configuration; adjusting the first and second virtual bones in the 3D model and aligning the first and second virtual bones in the virtual correction configuration; fixing a first virtual axis with respect to the first virtual bone and fixing a second virtual axis with respect to the second virtual bone in the virtual correction configuration, wherein the first virtual axis is parallel to the second virtual axis; and returning the first and second virtual bones to the virtual deformation configuration, wherein the first and second virtual axes are parallel to the virtual deformation This includes a step that defines the correction coefficient during the configuration process.

[0022] In another aspect, the method includes the step of identifying a virtual resection plane in which the first virtual bone and the second virtual bone overlap in a virtual orthodontic configuration, and the step of fixing the first virtual axis to the first virtual bone includes the step of aligning the first virtual axis parallel to the virtual resection plane.

[0023] In another aspect, the method includes the step of forming a first guide based on a correction coefficient.

[0024] In another aspect, the correction coefficient includes a first virtual vector passing through a first virtual point in the virtual coordinate plane and a second virtual vector passing through a second virtual point in the virtual coordinate plane.

[0025] In another aspect, the step of forming the first guide includes correlating the virtual coordinate plane with the coordinate plane of the first guide such that a first axis corresponds to the first virtual vector and the first virtual point and a second axis that is aligned corresponds to the second virtual vector and the second virtual point.

[0026] In another aspect, each correction coefficient includes a position vector and two direction vectors corresponding to the first and second axes of an individual guide within the plurality of guides.

[0027] In another aspect, the first guide is selected from the plurality of guides, and the plurality of guides each have a different angle between the first axis and the second axis.

[0028] According to another aspect, a method of manufacturing a kit for correcting alignment between a first bone and a second bone includes receiving a correction coefficient, the correction coefficient including a first virtual vector passing through a first virtual point in the virtual coordinate plane and a second virtual vector passing through a second virtual point in the virtual coordinate plane.

[0029] The first guide is formed based on the correction coefficient and includes a first end portion having a first cannula aligned along a first axis and a second end portion having a second cannula aligned along a second axis. The first axis corresponds to the first virtual vector and the first virtual point, the second axis corresponds to the second virtual vector and the second virtual point, and the first and second axes are non-parallel. The first guide is configured such that, in a deformed configuration, a first k-wire inserted through the first cannula intersects the first bone and a second k-wire inserted through the second cannula intersects the second bone.

[0030] In another aspect, the method includes the step of receiving dimensions for a second guide, the second guide including a first end portion with a first cannula and a second end portion with a second cannula. The first cannula is parallel to the second cannula. The first guide is configured such that, as the second guide is slid over the first and second k-wires, the first and second k-wires are received within the separate first and second cannulas of the second guide, and the second guide realigns the first and second bones to the orthodontic configuration.

[0031] In another aspect, the method includes the step of receiving scans of the first and second bones in the deformation configuration and rendering a 3D model of them including the first and second virtual bones in the virtual deformation configuration. The first and second virtual bones are adjusted in the 3D model to align the first and second virtual bones in the virtual correction configuration. In the virtual correction configuration, the first virtual axis is fixed to the first virtual bone and the second virtual axis is fixed to the second virtual bone. The first virtual axis is parallel to the second virtual axis. Each hypothetical bone is returned to its virtual deformation configuration, along with the first and second virtual vectors of the correction coefficients and the first and second virtual axes that define the first and second virtual points.

[0032] In another aspect, the method includes the step of identifying a virtual resection plane in which the first virtual bone and the second virtual bone overlap in a virtual orthodontic configuration, and the step of fixing the first virtual axis to the first virtual bone includes the step of aligning the first virtual axis parallel to the virtual resection plane.

[0033] According to another aspect of this disclosure, a kit for correcting misalignment between a first bone and a second bone by fusing the joint between the first bone and the second bone includes a first guide. The first guide includes a first end portion with a first cannula aligned along a first axis and a second end portion with a second cannula aligned along a second axis. The first axis is non-parallel to the second axis. The first guide is configured such that, when the first and second bones are in a deformed configuration, the step of inserting a first k-wire through the first cannula crosses the first bone and the step of inserting a second k-wire through the second cannula crosses the second bone. The second guide includes a first end portion with a first cannula and a second end portion with a second cannula. The first cannula may be parallel to the second cannula. The second guide is configured such that, in the deformed configuration, the first k-wire is fixed in the first bone and the second k-wire is fixed in the second bone, and the first and second k-wires are received in the separate first and second cannulas of the second guide, and the step of sliding the second guide over the first and second k-wires realigns the first and second bones to the corrective configuration.

[0034] On another side, stabilizing wires fix the first and second bones in the orthodontic configuration by being inserted into the first and second bones.

[0035] In another aspect, a bone plate with a first end configured to attach to a first bone and a second end configured to attach to a second bone retains the first and second bones in the orthodontic configuration.

[0036] On another side, bone plate clips are inserted into the first and second bones during orthodontic construction.

[0037] On another side, the first excision guide aligns the excision tool with the excision site on the first bone.

[0038] In another aspect, the first resection guide includes first and second cannulas configured to advance across the first and third k-wires, with the third k-wire being parallel to the first k-wire.

[0039] On another side, the second excision guide aligns the excision tool with the excision site on the second bone.

[0040] According to another aspect, a method for correcting misalignment between a first bone and a second bone by fusing the joint between the first bone and the second bone includes the step of aligning a first end portion of a first guide with the first bone. The first end portion has a first cannula and a second cannula, which are aligned in a first direction. A first k-wire is inserted into the first bone through the first cannula, and a second k-wire is inserted into the first bone through the second cannula. The first end of the first bone is excised through a slot to form a first excision surface. The slot is aligned with the first end of the first bone by the first and second k-wires. A third k-wire and a fourth k-wire are inserted through the first guide. It is inserted into the second bone. The first end of the second bone is excised to form the second excision surface. The second guide slides across the first, second, third, and fourth k-wires to adjust the positioning of the first and second bones so that the first and second excision surfaces abut in the orthodontic configuration. The first and second bones are fixed in the orthodontic configuration.

[0041] In another aspect, the method includes the step of fixing the first and second bones in the orthodontic configuration by inserting stabilizing wires into the first and second bones.

[0042] In another aspect, the method includes the step of fixing the first and second bones in an orthodontic configuration by attaching the first end of a bone plate to the first bone and the second end of a bone plate to the second bone, so that the first and second bones are retained in the orthodontic configuration.

[0043] In another aspect, the method includes the step of sliding a second guide across first, second, third, and fourth k-wires to translate the first cutting surface toward the second cutting surface.

[0044] In another aspect, the method includes the step of sliding a second guide across first, second, third, and fourth k-wires to rotate the alignment between the first and second bones.

[0045] In another aspect, the third and fourth k-wires are inserted into the second bone through the second end portion of the first guide, which includes the third and fourth cannulas. The third and fourth cannulas are aligned in the second direction.

[0046] On another side, the first end of the second bone is excised through a slot. The slot is aligned with the first end of the second bone by third and fourth k-wires.

[0047] On another side, the slots are located on the resection guide, including first and second openings configured to align with the first and second k-wires.

[0048] In another aspect, the first bone is the metatarsal bone, and the second bone is the medial cuneiform bone; the corrective structure of the first and second bones corrects the aponeurosis.

[0049] On another level, the second guide adjusts the angle of the first bone within three orthogonal planes between the deformed and corrective configurations.

[0050] In another aspect, the method includes the step of removing the first guide from the first and second k-wires after excising the first end of the second bone and forming a second excision surface.

[0051] In another aspect, the method includes the step of fixing the first and second bones in an orthodontic configuration, and then removing the second guide, as well as the first, second, third, and fourth k-wires, from the first and second bones.

[0052] According to another aspect, a method for correcting misalignment between a first bone and a second bone by fusing the joint between the first bone and the second bone includes the step of positioning a cutting guide at a first position adjacent to the first end of the first bone, the cutting guide including a cutting slot and first and second cannulas through the cutting guide. The cutting guide at the first position includes first and second k-wires positioned in the first bone through the first and second cannulas. The first end of the first bone is excised through the cutting slot to form a first excision surface. The cutting guide is removed from the first and second k-wires. The cutting guide is positioned at a second position adjacent to the first end of the second bone. The cutting guide at position 2 includes third and fourth k-wires, which are positioned within the second bone through the first and second cannulas. The first end of the second bone is excised through the cutting slot to form the second excision surface. The cutting guide is removed from the third and fourth k-wires. The second guide slides across the first, second, third, and fourth k-wires. The second guide adjusts the positioning of the first and second bones so that the first and second excision surfaces abut in the orthodontic configuration. The first and second bones are fixed in the orthodontic configuration.

[0053] In another aspect, the method includes the steps of positioning a first end portion of a first guide together with a first bone, the first end portion having a third cannula and a fourth cannula, the third and fourth cannulas being aligned in a first direction, and inserting a first k-wire into the first bone through the third cannula and a second k-wire into the first bone through the fourth cannula.

[0054] In another aspect, the procedure includes the steps of positioning a second end portion of a first guide together with a second bone, the second end portion having a fifth cannula and a sixth cannula, the fifth and sixth cannulas being aligned in a second direction, and inserting a third k-wire into the second bone through the fifth cannula and a fourth k-wire into the second bone through the sixth cannula.

[0055] In another aspect, the step of fixing the first and second bones in the orthodontic configuration includes the step of inserting stabilizing wires into the first and second bones.

[0056] In another aspect, the step of fixing the first and second bones in the orthodontic configuration includes attaching the first end of the bone plate to the first bone and the second end of the bone plate to the second bone so that the first and second bones are retained in the orthodontic configuration.

[0057] In another aspect, the step of sliding the second guide across the first, second, third, and fourth k-wires translates the first resection plane toward the second resection plane.

[0058] In another aspect, the step of sliding the second guide across the first, second, third, and fourth k-wires rotates the first bone relative to the second bone, adjusting the alignment between them. [Brief explanation of the drawing]

[0059] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the embodiments in any way. Various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure.

[0060] [Figure 1] Figure 1 shows a top view of the patient's foot in a deformed state.

[0061] [Figure 2A]Figure 2A shows a front perspective view of the alignment guide.

[0062] [Figure 2B] Figure 2B shows a rear perspective view of the alignment guide.

[0063] [Figure 3A] Figure 3A shows a front view of the alignment guide.

[0064] [Figure 3B] Figure 3B shows a cross-sectional view obtained along line 15B-15B in Figure 15A.

[0065] [Figure 4] Figure 4 shows an exploded view of the alignment guide.

[0066] [Figure 5] Figure 5 shows the angle between the cannulas of the alignment guide.

[0067] [Figure 6] Figure 6 shows the second angle between the cannulas of the alignment guide.

[0068] [Figure 7] Figure 7 shows the third angle between the cannulas of the alignment guide.

[0069] [Figure 8] Figure 8 shows the alignment guide that aligns with the medial cuneiform and metatarsal bones in the patient's foot.

[0070] [Figure 9] Figure 9 shows the insertion of multiple k-wires into the medial cuneiform and metatarsal bones through a matching guide.

[0071] [Figure 10] Figure 10 shows a partial decomposition of the alignment guide.

[0072] [Figure 11A]Figure 11A shows a perspective view of the resection guide.

[0073] [Figure 11B] Figure 11B shows a front view of the resection guide.

[0074] [Figure 12A] Figures 12A-B show the placement of the removed matching guide and the first resection guide. [Figure 12B] Figures 12A-B show the placement of the removed matching guide and the first resection guide.

[0075] [Figure 13] Figure 13 shows the placement of the second resection guide.

[0076] [Figure 14A] Figure 14A shows a perspective view of the orthodontic guide.

[0077] [Figure 14B] Figure 14B shows a top view of the orthodontic guide.

[0078] [Figure 15A] Figures 15A-B show orthodontic guides assembled across multiple k-wires to align the medial cuneiform and metatarsal bones of the patient's foot with the orthodontic configuration. [Figure 15B] Figures 15A-B show orthodontic guides assembled across multiple k-wires to align the medial cuneiform and metatarsal bones of the patient's foot with the orthodontic configuration.

[0079] [Figure 16] Figure 16 shows the insertion of the first and second fixation k-wires into the medial cuneiform and metatarsal bones.

[0080] [Figure 17] Figure 17 shows the patient's foot after multiple k-wires have been removed.

[0081] [Figure 18] Figure 18 shows an exploded view of the bone plate assembly, aligned with the medial cuneiform and metatarsal bones during orthodontic construction.

[0082] [Figure 19] Figure 19 shows a top view of the bone plate.

[0083] [Figure 20] Figure 20 shows a side view of the bone plate.

[0084] [Figure 21] Figure 21 shows the bone plate assembly assembled with the medial cuneiform and metatarsal bones during orthodontic construction.

[0085] [Figure 22] Figure 22 shows a lateral view of the patient's foot during orthodontic treatment.

[0086] [Figure 23] Figure 23 shows how to calculate the correction coefficient using a virtual model.

[0087] [Figure 24A] Figure 24A shows the virtual model when the virtual deformation configuration is in place.

[0088] [Figure 24B] Figure 24B shows a virtual model adjusted to a virtual orthodontic configuration.

[0089] [Figure 24C] Figure 24C shows the steps in the virtual orthodontic configuration to fix two virtual axes in the first virtual bone and the second virtual bone, respectively.

[0090] [Figure 24D] Figure 24D shows the virtual model being returned to the virtual deformation configuration, with orientations resulting from two virtual axes that define the correction coefficients for the virtual model.

[0091] [Figure 25] Figure 25 shows a method for manufacturing an adjustment guide based on the correction coefficient.

[0092] [Figure 26A] Figure 26A shows a side view of another implementation of the alignment guide.

[0093] [Figure 26B] Figure 26B shows a top view of the alignment guide in Figure 26A.

[0094] [Figure 27] Figure 27 shows an exploded view of the alignment guide shown in Figure 26A.

[0095] [Figure 28A] Figure 28A shows a perspective view of another implementation of the resection guide.

[0096] [Figure 28B] Figure 28B shows a front view of the resection guide shown in Figure 28A.

[0097] [Figure 29] Figure 29 shows the alignment of the alignment guide in Figure 26A with the patient's foot.

[0098] [Figure 30] Figure 30 shows the insertion of multiple k-wires into the medial cuneiform and metatarsal bones through a matching guide.

[0099] [Figure 31] Figure 31 shows a partial decomposition of the alignment guide.

[0100] [Figure 32] Figure 32 shows the placement of the removed alignment guide and the resection guide in Figure 28A.

[0101] [Figure 33]Figure 33 shows the insertion of the fixation k-wires and the orthodontic guide assembled across multiple k-wires to align the medial cuneiform and metatarsal bones of the patient's foot with the orthodontic configuration.

[0102] [Figure 34] Figure 34 shows the bone plate assembly assembled with the medial cuneiform and metatarsal bones during orthodontic construction. [Modes for carrying out the invention]

[0103] Detailed explanation Overview Aponeurosis correction or repair is a common surgical procedure, with over 100,000 surgeries performed annually in the United States. Many surgical techniques for aponeurosis repair are invasive and painful, requiring incisions of several inches and a long recovery period of up to 10–12 weeks. Minimally invasive surgery... The surgery has been performed in orthopedics for decades. One common procedure is known as the rapidus aponeurosis excision. In the rapidus aponeurosis excision, the aponeurosis is corrected in the big toe by adjusting the alignment at the first tarsometatarsal joint. The metatarsal bones may also be stabilized using bone screws and / or plates to promote fusion between the metatarsal bones and the medial cuneiform bones.

[0104] However, existing rapidus aponeurosis resection techniques have various drawbacks and risks. These drawbacks include demanding more than minimally invasive surgery, using realignment devices that offer little control over metatarsal rotation and relative angles, techniques that rely on trial and error during surgery to identify the best alignment of the patient's foot bones and on surgical judgment to identify the site for resection, a lack of customization to consider the individual patient's foot condition, and / or the lack of available guides for performing pre-planned resection of the foot bones. Various aspects of bone realignment systems and techniques described herein overcome and improve upon these existing techniques, leading to better patient outcomes.

[0105] The various features and advantages of the systems, devices, and methods for bone repositioning described herein will become more fully apparent from the following description of the illustrated embodiments. These embodiments are intended to illustrate the principles of the disclosure, and the disclosure should not be limited to the illustrated embodiments. Features of the illustrated embodiments can be modified, combined, removed, and / or substituted in accordance with consideration of the principles disclosed herein, as will be apparent to those skilled in the art. Deformity correction techniques

[0106] Figure 1 shows a skeletal diagram of a patient's foot 100 having one or more bones with deformity configuration 102. Deformity configuration 102 may be a fasciocele, as shown. Deformity configuration 102 may be a misalignment between the metatarsal bone 108 and phalanx 112 of the big toe of the patient's foot. The metatarsal bone 108 may be at a certain angle to the phalanx at 112. A severe misalignment between the metatarsal bone 108 and phalanx 112 can lead to severe pain and friction, as well as discomfort and other problems in the patient's foot 100. Therefore, correcting the misalignment between the metatarsal bone 108 and phalanx 112 of the big toe may be beneficial.

[0107] The patient's foot 100 may further include a medial cuneiform bone 104. The medial cuneiform bone 104 may be connected to the proximal end of a metatarsal bone 108 (for example, by one or more ligaments). Figure 1-22 illustrates a system and method for correcting the alignment between the medial cuneiform bone 104 and the metatarsal bone 108. Thus, proper alignment between the medial cuneiform bone 104 and the metatarsal bone 108 can correct the alignment between the metatarsal bone 108 and the phalanges 112. Therefore, the deformed configuration 102 of the patient's foot 100 can be corrected. This disclosure relates to a system and method for correcting the deformed configuration 102. Furthermore, the systems and methods described herein can be used more generally to correct the alignment between any two bones of a patient's body.

[0108] As shown in Figure 2A-4, a system for correcting alignment in a patient's foot 100 may include an alignment guide 200. The alignment guide 200 may be formed from a rigid material. The alignment guide 200 may include a first end portion 204. The first end portion 204 may include one or more openings 210a, 212a. Two openings are described and illustrated, but more or fewer openings may be included on the first end portion 204. The openings 210a, 212a may each include internal threads 221, 222. The openings 210a, 212a may be chamfered on one or both sides of the alignment guide 200. The openings 210a, 212a may extend throughout the alignment guide 200. The openings 210a, 212a may be on individual shafts 230. Axes 230 and 232 can be aligned along 232. Axes 230 and 232 can be parallel. Alternatively, axes 230 and 232 can converge. Axes 230 and 232 can be spaced apart by a distance of 204a. The distance 204a can be based on the length of the medial cuneiform bone 104.

[0109] As shown in Figure 4, the alignment guide 200 may include one or more removable pipes 240, 242. A removable pipe 240 may include a first end 240a and a second end 240b. The first end 240a may be received within the opening 210a. A removable pipe 240 may include a threaded portion 244. The threaded portion 244 may engage with the internal threads 221 of the opening 210a. A removable pipe 242 may include a first end 242a and a second end 242b. The first end 242a may be received within the opening 212a. A removable pipe 240 may include a threaded portion 246. The threaded portion 246 may engage with the internal threads 222 of the opening 212a.

[0110] The removable tube 240 can define cannula 210. When placed in opening 210a, cannula 210 can be aligned along the axis 230 of opening 210a. The removable tube 242 can define cannula 212. When placed in opening 212a, cannula 212 can be aligned along the axis 232 of opening 212a. Cannulas 210 and 212 can define different diameters through them. Cannula 212 can have a larger diameter than cannula 210 (and vice versa). In other implementations, cannulas 210 and 212 can define different diameters through them. In other implementations, cannulas 210 and 212 can define various diameters through them.

[0111] The alignment guide 200 may include a second end portion 208. The second end portion 208 may include one or more cannulas 214, 216. The cannulas 214, 216 may be defined through the body of the alignment guide 200 and / or through its separate extensions 219, 218. Two cannulas are described and illustrated, but more or fewer cannulas may be included on the second end portion 208. Furthermore, the second end portion 208 may include a removable insert or removable portion (e.g., a removable tube) around the cannulas 214, 216.

[0112] Cannulas 214 and 216 can extend throughout the alignment guide 200 (including, for example, extensions 218 and 219). Cannulas 214 and 216 can define different diameters through them. Cannula 214 can have a larger diameter than cannula 216 (and vice versa). In other implementations, cannulas 214 and 216 can define the same different diameters through them. In other implementations, cannulas 214 and 216 can define various diameters through them.

[0113] Cannulas 214 and 216 can be aligned along separate parallel axes 234 and 236. Axes 234 and 236 can be spaced apart by a distance of 208a. The distance 208a can be based on the length of the metatarsal bone 108.

[0114] Figure 5-7 shows the assembled alignment guide 200. The first end portion 204 can define the positioning and orientation of the first set of cannulas (e.g., cannulas 210, 212). The second end portion 208 can define the positioning and orientation of the second set of cannulas (e.g., cannulas 214, 216). The first set of cannulas and the second set of cannulas can be angled relative to each other and / or offset from each other.

[0115] Figure 5 shows the angle α between the axis 230 of cannula 210 and the axis 236 of cannula 216. Angle α defines the relative orientation angle between the first set of cannulas on the first end 204 and the second set of cannulas on the second end 208. Angle α can be defined in the zx plane within a Cartesian coordinate system (having x, y, and z axes). Cannula 210 may include point A. Alternatively, point A may be any fixed position along cannula 210. Point A may have x, y, and z coordinate locations within a Cartesian coordinate system (having x, y, and z axes). Cannula 216 may include point B. Alternatively, point B may be any fixed position along cannula 216. Point B may have x, y, and z coordinate locations within a Cartesian coordinate system. Points A and B can define the relative positions of axes 230 and 236 in the Cartesian coordinate system.

[0116] Figure 6 shows the angle β between the axis 230 of cannula 210 and the axis 236 of cannula 216. Angle β defines the relative orientation angle between the first set of cannulas on the first end 204 and the second set of cannulas on the second end 208 in the yx plane. Figure 7 shows the angle γ between the axis 230 of cannula 210 and the axis 236 of cannula 216. Angle γ defines the relative orientation angle between the first set of cannulas on the first end 204 and the second set of cannulas on the second end 208 in the yz plane.

[0117] Together, the relative positions of points A and B, as well as at least two of the relative angles α, β, and γ, can define the axis of the cannula on the alignment guide 200. Using a suitable selection of relative angles α, β, and / or γ, as well as the relative positions of points A and B, the alignment guide 200 can be used to properly align the bones in the patient's foot 100, as further described below.

[0118] As shown in Figure 8, the alignment guide 200 can be aligned with the patient's foot 100. The first end portion 204 can generally be aligned with the medial cuneiform bone 104. The second end portion 208 can generally be aligned with the metatarsal bone 108. As shown in Figure 9, multiple k-wires 300 can be extended through individual cannulas of the alignment guide 200. The k-wires can be extended through the cannulas into the individual medial cuneiform bones 104 and metatarsal bones 108. The first k-wire 310 can be inserted into the medial cuneiform bone 104 through the cannula 210. The first k-wire 310 can be inserted at the insertion point 320 on the medial cuneiform bone 104. The second k-wire 312 can be inserted through the cannula 212. The second k-wire 312 can be inserted through the medial cuneiform bone 104 at insertion point 322. The third k-wire 314 can be inserted through the cannula 214. The third k-wire 314 can cross the metatarsal bone 108 at insertion point 324 and be inserted into it. The fourth k-wire 316 can be inserted through the fourth cannula 216. The fourth k-wire 316 can be inserted into the metatarsal bone 108 at insertion point 326.

[0119] The first and second k-wires 310, 312 may be parallel to each other based on the parallel cannulas 210, 212. The third and fourth k-wires 314, 316 may be parallel to each other based on the cannulas 214, 216. One or more of the insertion points 320, 322, 324, 326 (e.g., at least one above each bone 104, 108) may be located at a pre-determined location on the patient's foot. The length of the extensions 218, 219 and / or tubes 240, 242 can provide further stability to the k-wire 300 received therein. The diameter of the k-wire 300 may be sized according to the diameter of the individual cannulas of the matching guide 200 to ensure accurate insertion at an angle into the bones 104, 108. Furthermore, the k-wire 300 may be matched to the correct cannula based on different diameter sizes.

[0120] Figure 10 shows the removal of tubes 240, 242 from the first end 204 of the alignment guide 200. The first and second tubes 240, 242 are removed from the first end portion 204 so that the alignment guide 200 can be removed from the multiple k-wires 300 inserted within the medial cuneiform and metatarsal bones 108. In some circumstances, without removable or otherwise disassemblable elements, misalignment between the first and second ends 204, 208 may make it difficult for the user to remove the alignment guide 200 from the multiple k-wires 300.

[0121] As shown in Figures 11A-B, a system for correcting alignment in the patient's foot 100 may include an excision guide 404. The excision guide 404 can be used to align an excision tool (not shown), such as a saw, broach, or equivalent, with the end of the medial cuneiform bone 104 and / or the end of the metatarsal bone 108, respectively.

[0122] The excision guide 404 may include a cannula portion 411. The cannula portion 411 may include one or more openings 415, 417. The excision guide 404 may include a planar portion 409. The planar portion may include a slot 407 for aligning an excision tool. The openings 415, 417 may interact with one or more k-wires (e.g., k-wire 300) or pins to align the planar portion 409 with a desired target location for the excision tool.

[0123] The planar portion 409 (for example, the plane defining the slot 407) may be approximately perpendicular to the cannula portion 411 (for example, the axis between openings 415 and 417). In other implementations, the planar portion 409 may be angled relative to the cannula portion 411.

[0124] Openings 415 and 417 can extend through the cannula portion 411. Openings 415 and 417 can be sized to align with a k-wire or similar. Slot 407 can extend through the planar portion 409. Slot 407 can have a height and thickness that are sized to accommodate the cutting portion of the resection tool. Slot 407 can have sufficient depth to maintain alignment of the resection tool with the desired target location.

[0125] Depending on the planned corrective configuration of the first cuneiform bone 104 with respect to the metatarsal bone 108, it may be necessary to remove material from the medial ends of one or both of the cuneiform bone 104 and the metatarsal bone 108. The angle between the cuneiform bone 104 and the metatarsal bone 108 can be adjusted during the corrective configuration. The length of one or both of the cuneiform bone 104 and the metatarsal bone 108 can also be adjusted during the corrective configuration. Each of these adjustments can contribute to the correction of the deformity in the patient's foot 100.

[0126] Therefore, Figures 12A-B show the use of a first resection guide 404 to align the resection tool with the first inner end of the first cuneiform bone 104. The cannula portion 411 can be received across the first and second k-wires 310, 312 on openings 415, 417, respectively. This allows the planar portion (e.g., slot 407) to be aligned with the end of the first cuneiform bone 104. The resection surface 104a can be cut into the first cuneiform bone 104 using the resection tool through the slot 407. The resection surface 104a can be aligned with the first and second k-wires 310, 312.

[0127] Figure 13 shows the use of a second resection guide 408 to align the resection tool with the first medial end of the metatarsal bone 108. The second resection guide 408 may include the same components as the resection guide 404 (e.g., a planar portion 409 and a cannula portion 411).

[0128] The cannula portion 411 of the second resection guide 408 can be received over third and fourth k-wires 314 and 316 on openings 415 and 417, respectively. The third and fourth k-wires can align the planar portion 409 and slot 407 with the end of the metatarsal bone 108. The resection surface 108a can be cut into the metatarsal bone 108 using a resection tool through the slot 407. The resection surface 108a can be aligned with the third and fourth k-wires 314 and 316. In some implementations, the resection guide 404 can be used to form the resection surface 108a instead of the cross-sectional resection guide 408.

[0129] As shown in Figures 14A-B, a system for correcting alignment in a patient's foot 100 may include a corrective guide 500. The corrective guide 500 can align the bones in the patient's foot 100 to a corrective configuration 103, as shown in Figure 15. The corrective guide 500 may include a first end portion 504. The first end portion 504 may include one or more cannulas 510, 512. The cannulas 510, 512 may extend through the corrective guide 500. The cannulas 510, 512 may correspond to first and second k-wires 310, 312, respectively, which are inserted into the medial cuneiform bone 104. The cannulas 510, 512 may be aligned along first and second axes 530, 532, respectively. The first and second axes 530, 532 may be parallel.

[0130] The orthodontic guide 500 may include a second end portion 508. The second end portion 508 may include one or more cannulas 514, 516. The cannulas 514, 516 may extend through the orthodontic guide 500. The cannulas 514, 516 may correspond to third and fourth k-wires 314, 362, respectively, which are inserted into the metatarsal bones 108. The cannulas 514, 516 may be aligned along third and fourth axes 534, 536, respectively. The third and fourth axes 534, 536 may be parallel.

[0131] The first and second axes 530 and 532 may be parallel to the third and fourth axes 534 and 536. The first and second axes 530 and 532 may be aligned in the same plane as the third and fourth axes 534 and 536. In other implementations, the first and second axes 530 and 532 may be aligned out of the plane with the third and fourth axes 534 and 536 (e.g., offset from them).

[0132] The first axis 530 can extend through point C, which may have a position (x,y,z) in the Cartesian coordinate plane. The fourth axis 536 can extend through point D, which may have a position (x,y,z) in the Cartesian coordinate plane. Points C and D can define the relative positions of the first and fourth axes 530 and 536 in the Cartesian coordinate system.

[0133] As shown in Figure 15, the orthodontic guide 500 can be accommodated on the k-wire 300. The first and second k-wires 310 and 312 can be accommodated in cannulas 510 and 512 on the first end 504 of the orthodontic guide 500, respectively. The third and fourth k-wires 314 and 316 can be accommodated in cannulas 514 and 516 on the second end 508 of the orthodontic guide 500, respectively.

[0134] Therefore, as the orthodontic guide 500 is advanced on the k-wire 300, the metatarsal bone 108 can be aligned with the medial cuneiform bone 104. The orthodontic guide can orient the metatarsal bone 108 and the proximal phalanx 112 into the orthodontic configuration 103. The reorientation of the metatarsal bone 108 with respect to the medial cuneiform bone 104 is performed by the metatarsal bone 108 in Cartesian coordinates (e.g., in three orthogonal planes). This may include rotation and / or translation. The degree of rotation and / or translation of the metatarsal bone 108 can be determined based on angles α, β, and / or γ, and / or any difference in the relative position of the axis between the alignment guide 200 and the corrective guide 500 (for example, any difference in the relative position defined by points A, B, and points C, D).

[0135] The corrective configuration 103 may include one or more corrections to the alignment of the bones of the patient's foot 100. For example, the metatarsal bone 108 may be aligned with the proximal phalanx 112 of the big toe. The corrective configuration 103 may promote the healing of aponeurosis and / or hallux valgus malformations. The excised surface 104a of the medial cuneiform bone 104 may be abutted against the excised surface 108a of the metatarsal bone 108. True abutment may promote the fusion or union of the metatarsal bone 108 with the medial cuneiform bone 104. Appropriate abutment may require a parallel displacement of the metatarsal bone 108 relative to the medial cuneiform bone 104.

[0136] As shown in Figure 16, the medial cuneiform bone 104 can be temporarily or permanently fixed to the metatarsal bone 108 in the orthodontic configuration 103. A first fixation k-wire 610 can be inserted into the medial cuneiform bone 104 and the metatarsal bone 108. The first fixation wire 610 can extend through the excision surfaces 104a and 108a. A second fixation k-wire 612 can be inserted into the medial cuneiform bone 104 through the metatarsal bone 108. The second fixation k-wire 612 can extend through the excision surfaces 104a and 108a. In other implementations, any temporary or permanent fixation means can be used to connect the medial cuneiform bone 104 to the metatarsal bone 108 in the orthodontic configuration. For example, the medial cuneiform bone 104 and the metatarsal bone 108 can be temporarily or permanently screwed together, reinforced together, bonded together, or otherwise connected together.

[0137] As shown in Figure 17, with the medial cuneiform bone 104 and metatarsal bone 108 fixed by the orthodontic configuration 103, the orthodontic guide 500 can be removed from the multiple k-wires 300. The multiple k-wires 300 can be removed from the medial cuneiform bone 104 and / or metatarsal bone 108.

[0138] As shown in Figure 18, a system for correcting alignment in a patient's foot 100 may include a bone plate assembly 700. The bone plate assembly 700 attaches the medial cuneiform bone 104 and the metatarsal bone 108, as shown in Figures 21-22. The bone plate assembly 700 may include a bone plate 710. The bone plate 710 may include a first end 704 and a second end 708. The bone plate assembly 700 may include a bone clip 720. The bone clip 720 can be connected between the medial cuneiform bone 104 and the metatarsal bone 108. The bone clip 720 may include a first cusp 724 and a second cusp 728 connected by a transverse member 726. The bone plate assembly 700 may include a plurality of fasteners 730, such as bone screws, pins, or other fasteners known within the field of orthopedics.

[0139] Figures 19-20 show further details of the bone plate 710. The bone plate 710 can be contoured to interlock with the medial cuneiform bone 104 and the metatarsal bone 108. The bone plate 710 can be manufactured from titanium, aluminum, steel, or other suitable materials within the orthopedic field.

[0140] The first end 704 of the bone plate 710 may have a plurality of openings 715, 716, 717. The openings 716, 717 may be sized to receive fasteners 730. The opening 715 may be sized to receive the fork 724 of the clip 720. The second end 708 of the bone plate 710 may have a plurality of openings 711, 712, 713. The openings 711, 712 may be sized to receive fasteners 730. The opening 713 can be sized to receive the fork 728 of the clip 720. The clip 720 may include a recess 719 for receiving, or at least partially receiving, the transverse member 726 of the clip 720. This can reduce the overall shape of the assembled bone plate assembly 700.

[0141] Figures 21-22 show a bone plate assembly 710 assembled with a patient's foot 100. The first end 704 of the bone plate 710 can be attached to the medial cuneiform bone 104 by a fastener 730. The fastener 730 can extend into the medial cuneiform bone 104 through openings 716, 717. The second end 708 of the bone plate 710 can be attached to the metatarsal bone 108. The fastener 730 can extend into the metatarsal bone 108 through openings 711, 712. In some implementations, the fastener 730 can be received within individual intersections 320, 322, 324, and / or 326 of the k-wire 300. Alternatively, the fastener can create a new hole in the bone of the patient's foot.

[0142] The clip 720 can straddle the joint between the medial cuneiform bone 104 and the metatarsal bone 108. The first acupoint 724 can be received into the metatarsal bone 108 within the opening 715. The second acupoint 728 can be received into the medial cuneiform bone 104 through the opening 713. In one implementation, the acupoints 724, 728 can be received within separate intersections 322, 324. The acupoints 724, 728 may include multiple serrated edges for improved engagement features for attachment within the bone in the patient's foot 100.

[0143] In one implementation, different alignment guides 200 can be used depending on the intended fixation means for the medial cuneiform bone 104 with the metatarsal bone 108. The different alignment guides 200 may include cannulas that align the k-wire 300 at different points within the bone and align the openings at different fixation means. Virtual modeling of the correction coefficient

[0144] Figure 23 illustrates process 800 for designing an alignment guide customized to the patient's unique biostructure. Although described herein in relation to the patient's foot, process 800 can be used for other parts of the patient's body. Process 800 is further illustrated in Figures 24A–24D. In step 812, a virtual model 840 of the patient's foot is generated. The virtual model 840 may be based on scans of the patient's foot, including malformations such as fasciobulge and / or hallux valgus. The scans used to generate or render the virtual model 840 may be based on CT, PET, X-ray, ultrasound, MRI, or other types of medical imaging scans.

[0145] The virtual model 840 may include a virtual representation of the bones of the patient's foot. The virtual model 840 may include a virtual deformed configuration 802 of the patient's bones. The virtual model 840 may include a virtual first bone 804 and a virtual second bone 808. The virtual first bone 804 may correspond to the medial cuneiform bone in the patient's foot, and the virtual second bone 808 may correspond to the metatarsal bone.

[0146] The virtual model 840 can be displayed to the user through a graphical user interface (e.g., on a computer). The virtual model 840 may be manipulated by the user. In some implementations, the virtual model 840 can approximate the natural connections between bones in a patient's foot (e.g., ligaments, cartilage, and / or muscles). Therefore, moving one virtual bone can alter the location of connected virtual bones. In other implementations, the virtual bones of model 840 can be freely moved and manipulated by the user. Therefore, the viable repositioning of bones and the resulting movement of connected virtual bones can be manipulated by the user. It can be approximated based on skills and knowledge.

[0147] In step 814, the user adjusts the configuration of the first and second virtual bones 804, 808 to the virtual orthodontic configuration 803. The virtual orthodontic configuration 803 may include the correction of a deformity of one or more of the patient's feet. The adjustment to the virtual orthodontic configuration 803 may include steps to change the relative angle and position between the first and second virtual bones 804, 808. Furthermore, the virtual orthodontic configuration 803 may include one or more overlapping portions of the first and second virtual bones 804, 808. One or more virtual resection surfaces 804a, 808a may be identified by the user to remove the overlapping portion of the first and second virtual bones 804, 808, or to adjust their length and dimensions in a different manner.

[0148] In step 816, a first virtual axis 830 is added so as to intersect the first virtual bone 804. A second virtual axis 836 is added so as to intersect the second virtual bone 808. The first virtual axis 830 is fixed to the first virtual bone 804. The second virtual axis 836 is fixed to the second virtual bone 808. The first and second virtual axes 830, 836 can be aligned with the virtual model 840 in a location that is easily accessible during surgery on the patient's foot.

[0149] The first and second virtual axes 830 and 836 are parallel to each other. Conveniently, the first and second virtual axes 830 and 836 can be aligned with one or more of the virtual cutting planes 804a and 808a. The first virtual axis 830 extends through point G located in the virtual Cartesian coordinate system. The second virtual axis 836 extends through point H located in the virtual Cartesian coordinate system.

[0150] In step 818, the first and second virtual bones 804, 808 are returned to the original deformed configuration 802 of model 840. The first and second virtual axes 830, 836 are rotated to different angles and / or translated relative to each other from the corrected configuration 803 to the deformed configuration 802. In the deformed configuration 802, the first and second virtual axes 830, 836 can be defined as vectors passing through separate points E, F in a virtual Cartesian coordinate system, respectively.

[0151] In step 820, the relative positions of the first and second virtual axes 830, 836 in the deformed configuration 802 can be used to define the correction coefficient for the alignment guide. The relative positions may include relative angles in two or more of the virtual Cartesian coordinate planes (e.g., zx, zy, xy). The relative angles may correspond to the α, β, and / or γ angles in the alignment guide (e.g., alignment guide 200 or equivalent). The relative positions of the first and second virtual axes 830, 836 can be based on individual points E, F. Points E, F may correspond to individual points A, B in the alignment guide (e.g., alignment guide 200 or equivalent). Thus, the dimensions of the virtual model 840 can be used to form the correction coefficient for the alignment guide for use in surgical procedures on a patient's foot.

[0152] Furthermore, the relative positions of the first and second virtual axes 830 and 836 in the orthodontic configuration 803 can be used to define the dimensions of the orthodontic guide. Points G and H can correspond to individual points C and D in the matching guide (e.g., matching guide 500 or equivalent). The first and second virtual axes 830 and 836 in the orthodontic configuration 803 can correspond to the parallel axes of the cannula within the orthodontic guide.

[0153] Furthermore, the relative positions of the first and second virtual axes 830, 836 in the deformed configuration 802 can be used to define the dimensions of the resection guide. The dimensions are determined by the slot within the resection guide. The orientation of the slot (e.g., slot 407) may be included. The slot may be aligned parallel to one or more of the cutting surfaces 804a, 808a. The cutting guide may also include one or more openings aligned with the first and / or second virtual axes 830, 836 in the deformed configuration 802.

[0154] As an alternative to generating Model 803, a user (e.g., a surgeon) may describe the angles (α, β, and / or γ) and / or translations required to correct a deformity in the patient's foot 100. This description may be based on the user's knowledge and experience and / or may be combined with a visual scan of the patient's foot 100. User-provided information may indicate the alignment guide 200 required during the surgical procedure. For example, the user may be provided with a kit containing multiple alignment guides, each selected from a pre-determined set of alignment guides 200, each correcting a different but commonly seen deformity in a patient's foot. In one implementation, the alignment guide 200 may include multiple sets of cannulas corresponding to different correction coefficients. Manufacturing of the Rapidus system

[0155] Process 900 is a method for manufacturing a system for correcting alignment in a patient's foot 100 based on a correction coefficient. In step 912, the manufacturer can receive the correction coefficient. The correction coefficient can define a dimension of one or more alignment guides (e.g., alignment guide 200). In some implementations, the correction coefficient may be a CAD model. The dimension may include the orientation and positioning of one or more cannulas through it. For example, the correction coefficient may be based on process 800 and / or user-provided information as described above. The correction coefficient may be customized for individual patient feet. Alternatively, the correction coefficient may be one of a standard set of commonly used correction coefficients.

[0156] In step 914, the manufacturer can form a matching guide based on the correction coefficient. For example, the manufacturer can 3D print the matching guide.

[0157] In step 916, the manufacturer can receive the dimensions for producing the orthodontic guide. The dimensions for the orthodontic guide can be based on process 800 described above, or otherwise customized to the individual patient's foot.

[0158] In step 918, the manufacturer can form the orthodontic guide based on the received dimensions. For example, the manufacturer can 3D print the alignment guide. Alternative component structure

[0159] Figures 26A-26B illustrate possible configurations for the adjustment guide 1000. The adjustment guide 1000 may include the same features and functionality as the adjustment guide 200 described above, with some of the differences noted below. The adjustment guide 1000 may include a first part 1004 and a second part 1008. The first part 1004 may be releasably connectable to the second part 1008. The first part 1004 may include a handle 1004a. The handle part 1004a may include an opening through it. The handle part 1004a may function to allow the user to easily hold the adjustment guide 1000 in place during use. The first part 1004 of the adjustment guide 1000 may include one or more cannulas 1010, 1012 extending through it. The cannulas 1010, 1012 may extend through the first part 1004. Cannulas 1010 and 1012 can extend along parallel axes 1020 and 1022.

[0160] The second portion 1008 may include one or more cannulas 1014, 1016. The cannulas 1014, 1016 may extend through the second portion 1008. The cannulas 1014, 1016 may extend along parallel axes 1024, 1026, respectively. Axes 1020, 1022 may be non-parallel to axes 1024, 1026.

[0161] The first or second portion 1004, 1008 may include a centering cannula 1009. The centering cannula 1009 may be used to align the adjustment guide 1000 at the tarsometatarsal joint between the medial cuneiform bone 104 and the metatarsal bone 108.

[0162] As shown in Figure 27, the first part 1004 may be connectable to the second part 1008 by a mounting mechanism 1006. The mounting mechanism 1006 may be a wing nut. As a wing nut, the mounting mechanism 1006 may include a threaded end 1006a. The mounting mechanism 1006 may extend through an opening 1006b in the first part 1004. The mounting mechanism 1006 may extend through an opening 1006c in the second part 1008. At least one of the openings 1006b, 1006c may be internally threaded to connect with the threaded end 1006a. Thus, the first and second parts 1004, 1008 can be joined together by the mounting mechanism 1006.

[0163] The second portion 1008 may include a recess 1008a. The first portion 1004 may include a projection 1004b. The projection 1004b can be received within the recessed portion 1008a. The recess / projection arrangement can improve the stability of the bond between the first portion 1004 and the second portion 1008.

[0164] Figures 28A–28B show another implementation of the excision guide 1100. The excision guide 1100 can be structured similarly to the excision guide 404 described above, including some of the differences noted herein. The excision guide 1100 may include a first portion 1111. The first portion 1111 may include one or more openings 1115, 1117 extending through it. The first portion 1111 may be coupled with a planar portion 1109. The planar portion 1109 may include a slot 1107 therein. The slot 1107 may be sized to allow an excision tool to extend through it to excise bone in the patient's body (e.g., the patient's foot 100). In some implementations, the planar portion 1109 may include a curved shape to allow the slot 1107 to be positioned closer to and / or in contact with the patient's body. This can reduce errors associated with the process of excising bone.

[0165] Figure 29 shows one method of using adjustment guide 1100 in a procedure to correct alignment between two bones in a patient's body. Adjustment guide 1000 can be used to correct alignment between the medial cuneiform bone 104 and the metatarsal bone 108 in the patient's foot 100. The process shown in Figures 29-34 is similar to, and may include, any of the steps and details described above in the process shown in Figure 1-22.

[0166] The centering cannula 1009 can align the adjustment guide 1000 at the tarsometatarsal joint between the medial cuneiform bone 104 and the metatarsal bone 108. A k-wire (not shown) can extend through the centering cannula 1009 into the space between the medial cuneiform bone 104 and the metatarsal bone 108. The first end 1004 of the adjustment guide 1000 can generally be aligned with the medial cuneiform bone 104. The second end 1008 of the adjustment guide 1000 can generally be aligned with the metatarsal bone 108. As further shown in Figure 30. Multiple k-wires 1300 can be inserted into the medial cuneiform bone 104 and metatarsal bone 108 through individual cannulas of the adjustment guide 1000. The first k-wire 1310 can be received within cannula 1010 and cross over the medial cuneiform bone 104. The second k-wire 1312 can be received through cannula 1012. The third k-wire 1314 can be inserted into the metatarsal bone 108 through cannula 1014. The fourth k-wire 1316 can extend into the metatarsal bone 108 through cannula 1016. The k-wires 1300 can extend along the individual axes of the cannulas of the adjustment guide 1000. Therefore, the alignment guide can define the crossing angle of the k-wires 1300.

[0167] As shown in Figure 31, the first portion 1004 of the adjustment guide 1000 can be removed from the second portion 1008. The mounting mechanism 1006 can be removed from between the first portion 1004 and the second portion 1008. The first portion 1004 can be removed from the K-wire 1300. The second portion 1008 can be removed from the k-wire 1300.

[0168] As shown in Figure 32, the resection guide 1100 can be slid over the k-wire 1300. The planar portion 1109 can be aligned with one or both of the medial cuneiform bones 104 and / or metatarsal bones 108. The resection tool 1400 can be inserted through the slot 1107 to form resection surfaces 104a and / or 108a on the individual medial cuneiform bones 104 and metatarsal bones 108. As described above, this can facilitate alignment of the medial cuneiform bones 104 and metatarsal bones 108 during the corrective configuration 103.

[0169] As shown in Figure 33, the orthodontic guide 1500 can slide over the k-wire 1300. The orthodontic guide 1500 may be similar to the orthodontic guide 500. The orthodontic guide 1500 may include multiple cannulas extending along a parallel axis. The k-wire 1300 can be received within the cannula of the collection guide 1500. This can realign and adjust the positions of the medial cuneiform bone 104, metatarsal bone 108, and / or proximal phalanx 112 to form an orthodontic configuration 103 of the patient's foot 100.

[0170] In the orthodontic configuration 103, a fixation k-wire 1600 (or a similar mechanism) can be inserted to fix the position of the first metatarsal bone 108 and the medial cuneiform bone 104. As shown in Figure 34, a bone plate assembly 1700 similar to the bone plate assembly 700 can be attached to the medial cuneiform bone 104 and the metatarsal bone 108 to maintain the relative position of the two bones in the orthodontic configuration 103. A term

[0171] The orientation terms used herein, such as “top,” “bottom,” “proximal,” “distal,” “longitudinal,” “lateral,” and “end,” are used in reference to the illustrated embodiments. However, this disclosure should not be limited to the illustrated orientations. In fact, other orientations are also possible and within the scope of this disclosure. Terms relating to circles as used herein, such as diameter or radius, should not be interpreted as requiring a perfectly circular structure, but rather should apply to any suitable structure with a cross-sectional area that can be measured from left to right. In general, terms relating to shapes, such as “circular,” “cylindrical,” “semicircular,” or “semi-tubular,” or any related or similar terms, are not required to strictly adhere to the mathematical definitions of a circle or cylinder or other structure, but may encompass structures that are reasonably close approximations.

[0172] Conditional terms such as "can," "could," "might," or "may" should be written separately. Unless otherwise understood in the context in which they are used or not, such conditional terms are generally intended to convey that a particular embodiment includes or does not include a particular feature, element, and / or step. Therefore, such conditional terms are generally not intended to imply that a feature, element, and / or step is required for any one or more embodiments.

[0173] Connecting terms such as "at least one of X, Y, and Z" are generally understood in contexts in which they are used to indicate that an item, term, etc., may be X, Y, or Z, unless specifically otherwise described. Therefore, such connecting terms are generally not intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0174] As used herein, the terms “approximately,” “about,” and “substantially” still refer to an amount close to the amount described that performs the desired function or achieves the desired result. For example, in some embodiments, as the context may determine, the terms “approximately,” “about,” and “substantially” may refer to an amount less than or equal to 10% of the amount described. As used herein, the term “generally” refers to a value, quantity, or characteristic that primarily includes, or tends toward, a particular value, quantity, or characteristic. As an example, in some embodiments, as the context may determine, the term “approximately parallel” may refer to something that deviates from exactly parallel by less than or equal to 20 degrees. All ranges include the endpoint. overview

[0175] Several illustrative embodiments of the Rapidus procedure system and method are disclosed. While this disclosure is described in terms of a particular illustrative embodiment and application, other embodiments and applications, including those that do not provide all of the features and benefits described herein, are also within the scope of this disclosure. Components, elements, features, actions, or steps may be arranged or performed differently than those described, and components, elements, features, actions, or steps may be combined, merged, added, or omitted in various embodiments. All possible combinations and secondary combinations of the elements and components described herein are intended to be included within this disclosure. None of the features or groups of features are required or essential.

[0176] Some features described in this disclosure in relation to separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in this disclosure in relation to a single implementation may also be implemented in multiple implementations, either separately or in any preferred secondary combination. Furthermore, features may be described above as acting in a combination, but one or more features from a claimed combination may, in some cases, be excluded from the combination, and the combination may be claimed as a secondary combination or a variation of a secondary combination.

[0177] Any part of any step, process, structure, and / or device disclosed or illustrated in one embodiment of this disclosure may be combined with, or (instead of) combined with, any other part of any step, process, structure, and / or device disclosed or illustrated in a different embodiment or flowchart. The embodiments described herein are not intended to be discrete or separate from one another. Combinations, variations, and some implementations of the disclosed features are within the scope of this disclosure.

[0178] While operations may be depicted in drawings or described herein in a specific order, such operations do not necessarily need to be performed in a specific or sequential order shown, or not all operations need to be performed, in order to achieve the desired result. Other operations not depicted or described may also be incorporated into exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or in between any of the operations described. In addition, operations may be rearranged or rearranged in some implementations. Furthermore, the separation of various components in the implementations described above should not be understood as requiring such separation in all implementations, and the components and systems described may generally be integrated together in a single product or packaged in multiple products. In addition, other implementations are also within the scope of this disclosure.

[0179] Furthermore, while illustrative examples have been described, any embodiment having equivalent elements, modifications, omissions, and / or combinations is also within the scope of this disclosure. Additionally, while certain aspects, advantages, and novel features are described herein, not all such advantages may necessarily be achieved according to any particular embodiment. For example, some embodiments within the scope of this disclosure achieve one or a group of advantages as taught herein without necessarily achieving other advantages taught or suggested herein. Furthermore, some embodiments may achieve advantages different from those taught or suggested herein.

[0180] Several embodiments have been described in reference to the accompanying drawings. The drawings are drawn and / or shown to a certain scale, but such scale should not be limiting, as dimensions and proportions other than those shown are also considered and disclosed within the scope of the invention. Distances, angles, etc., are illustrative only and do not necessarily have an exact relationship to the actual dimensions and layout of the illustrated devices. Components may be added, removed, and / or rearranged. Furthermore, any particular features, aspects, methods, properties, characteristics, qualities, attributes, elements, or equivalents of the various embodiments described herein may be used in all other embodiments described herein. In addition, any method described herein may be put into practice using any device suitable for carrying out the enumerated steps.

[0181] For the purpose of summarizing this disclosure, certain aspects, advantages, and features of the present invention have been described herein. Not all or any such advantages are necessarily achieved according to any particular embodiment of the invention disclosed herein. None of the aspects of this disclosure are essential or indispensable. In many embodiments, devices, systems, and methods may be configured differently from those illustrated in the figures or descriptions herein. For example, the various functionalities provided by illustrated modules may be combined, rearranged, added, or removed. In some implementations, additional or different processors or modules may perform some or all of the functionalities described with reference to the figures and illustrated embodiments. Many implementation variations are possible. Any of the features, structures, steps, or processes disclosed herein may be included in any embodiment.

[0182] In summary, various embodiments of the Rapidus procedure system and related methods have been disclosed. This disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, as well as certain modifications and equivalents thereof. Furthermore, this disclosure explicitly considers that various features and aspects of the disclosed embodiments can be combined with or substituted for each other. Therefore, the scope of this disclosure should not be limited by the specific disclosed embodiments described above, nor should it be determined solely by an impartial reading of the claims.

Claims

1. A kit for correcting the alignment between a first bone and a second bone by fusing the joint between the first bone and the second bone, The aforementioned kit includes a guide, The aforementioned guide, A first end portion having a first cannula, A second end portion having a second cannula, wherein the first cannula is parallel to the second cannula of the guide, and Equipped with a guide and Equipped with, The kit is configured such that when the first and second bones are in a deformed configuration, the first k-wire is fixed in the first bone, the second k-wire is fixed in the second bone, and when the first and second k-wires are non-parallel, sliding the guide across the first and second k-wires, with the first and second k-wires received in the individual first and second cannulas of the guide, realigns the first and second bones to a corrective configuration.

2. The kit according to claim 1, further comprising a stabilizing wire for fixing the first and second bones in the orthodontic configuration by inserting the stabilizing wire into the first and second bones.

3. The kit according to claim 1, further comprising a bone plate, a first end configured to be attached to the first bone, and a second end of the bone plate configured to be attached to the second bone, such that the first and second bones are retained by the orthodontic configuration.

4. The kit according to claim 3, further comprising bone plate clips configured for insertion into the first and second bones during the orthodontic configuration.

5. The kit according to claim 1, further comprising a first excision guide configured to align the excision tool with the excision site on the first bone.

6. The kit according to claim 5, wherein the first resection guide includes first and second cannulas configured to advance across the first k-wire and the third k-wire, the third k-wire being parallel to the first k-wire.

7. The kit according to claim 6, further comprising a second excision guide configured to align the excision tool with the excision site on the second bone.

8. The kit includes a second guide, The second guide mentioned above is, A first end portion having a first cannula aligned along a first axis, A second end portion having a second cannula aligned along a second axis, wherein the first axis is non-parallel to the second axis, and Equipped with, The second guide has an extension that protrudes from the body of the second guide, and the second cannula of the second guide is defined through the extension. The kit according to claim 1, wherein the second guide is configured such that, when the first and second bones are in the deformed configuration, inserting the first k-wire through the first cannula of the second guide crosses the first bone, and inserting the second k-wire through the second cannula of the second guide crosses the second bone.

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