Bone reduction guidance system and method

Abstract

An improved surgical system and method for correcting a deformity between a first and a second bone using a correction factor-based alignment guide. The correction factor can be based on virtual models of the first and second bones in a deformed configuration and a corrected configuration. In the virtual corrected configuration, first and second virtual axes can be fixed in the respective first and second bones. When reverted to the virtual deformed configuration, the orientations of the first and second axes can be used to determine the correction factor. The alignment guide is used to insert one or more Kirschner wires into each of the first and second bones in the deformed configuration. The correction guide is passed along the Kirschner wires to rotate and / or translate the first bone relative to the second bone into the corrected configuration.

Description

Technical Field

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

[0002] Bone misalignment and / or deformation can cause discomfort and reduced mobility in patients, especially in the patient's foot. A particularly common foot disorder is a bunion. A bunion is a progressive disorder that typically begins with a deviation of the big toe. The deviation of the big toe gradually changes the angle of the bone and creates a characteristic bulge on the medial side of the metatarsal bone, near the joint between the metatarsal bone and the proximal phalanx. Specifically, a bunion is a protrusion formed by the bone and sometimes an inflamed bursa. Hallux valgus is a condition in which the big toe deviates from its normal position towards the second toe. Accordingly, the present invention relates to surgical systems and methods for bunion and hallux valgus correction and more generally for bone realignment. Summary of the Invention

[0003] The above summary is illustrative only and not restrictive. The systems, devices, and methods and / or other aspects, features, and advantages of the other subject matter described in this application will become apparent in the teachings set forth below. This summary is provided to introduce a selection of concepts of the present disclosure. This summary is not intended to identify key or essential features of any subject matter described herein.

[0004] According to one aspect of the present invention, a method for correcting the alignment between a first bone and a second bone by performing arthrodesis between the first bone and the second bone includes providing a first guide. The first guide includes a first end portion having a first channel disposed along a first axis. A second end portion has a second channel disposed along a second axis. The first axis is not parallel to the second axis. The first axis is configured to intersect the first bone when the first bone and the second bone are in a deformed configuration, and the second axis is configured to intersect the second bone when the first bone and the second bone are in a deformed configuration. A first Kirschner wire is inserted through the first channel and into the first bone. A second Kirschner wire is inserted through the second channel and into the second bone. The first guide is removed from the first and second Kirschner wires. A second guide includes a first end portion having a first channel. A second end portion has a second channel. The first channel is parallel to the second channel. The second guide slides over the first and second Kirschner wires. The first Kirschner wire is received within the first channel of the second guide, and the second Kirschner wire is received within the second channel of the second guide. The second guide acts on the first and second Kirschner wires to realign the first and second bones into a corrected configuration.

[0005] In another aspect, the method includes fixing the first and second bones in a corrected configuration and removing the second guide and the first and second Kirschner wires from the first and second bones.

[0006] In another aspect, the method includes fixing the first and second bones in a corrected configuration, which includes inserting a first stabilizing pin / thread / wire into the first and second bones.

[0007] In another aspect, the method includes connecting a first end portion of a bone plate to the first bone and connecting a second end portion of the bone plate to the second bone such that the first and second bones are held in the corrected configuration.

[0008] In another aspect, the method includes inserting a bone plate clamp into the first and second bones.

[0009] In another aspect, the method includes excising a first end portion of the first bone.

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

[0011] In another aspect, the method includes inserting a third Kirschner wire into the first bone through the third channel and excising a first end portion of the first bone, including sleeving a first excision guide on the first and third Kirschner wires to align the first excision guide with the first end portion of the first bone.

[0012] In another aspect, the method includes excising a first end portion of the second bone.

[0013] In another aspect, a second end portion of the first guide includes a fourth channel disposed parallel to a second axis.

[0014] In another aspect, the method includes excising a first end portion of the second bone.

[0015] In another aspect, the method includes sleeving a second excision guide on the fourth Kirschner wire and the second Kirschner wire inserted into the second bone to align the second excision guide with the first end portion of the second bone.

[0016] In another aspect, the first bone is a metatarsal bone, the second bone is a medial cuneiform bone, the deformed configuration of the first and second bones includes hallux valgus, and the corrected configuration of the first and second bones corrects hallux valgus.

[0017] In another aspect, the second guide adjusts the angle of the first bone in three orthogonal planes between the deformed configuration and the corrected configuration.

[0018] In another aspect, the second guide adjusts the position of the first bone in three orthogonal planes between the deformed configuration and the corrected configuration.

[0019] In another aspect, the method includes centering a first guide between a first bone and a second bone by inserting a centering Kirschner wire through a centering channel in the first guide.

[0020] In another aspect, the method includes removing the first guide from the first and second Kirschner wires, including at least partially disassembling the first guide.

[0021] In another aspect, the method includes: scanning a first bone and a second bone in a deformed configuration to present a 3D model thereof, the 3D model including a first virtual bone and a second virtual bone in a virtual deformed configuration; adjusting the first virtual bone and the second virtual bone in the 3D model to align the first virtual bone and the second virtual bone in a virtual corrected configuration; in the virtual corrected configuration, fixing a first virtual axis relative to the first virtual bone and fixing a second virtual axis relative to the second virtual bone; and returning the first and second virtual bones to the virtual deformed configuration, the first and second virtual axes defining a correction factor therebetween in the virtual deformed configuration.

[0022] In another aspect, the method includes: identifying a virtual resection plane in the virtual corrected configuration at which the first virtual bone and the second virtual bone overlap; fixing the first virtual axis relative to the first virtual bone includes arranging the first virtual axis parallel to the virtual resection plane.

[0023] In another aspect, the method includes forming the first guide based on the correction factor.

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

[0025] In another aspect, forming the first guide includes: associating 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 such that a second axis arranged corresponds to the second virtual vector and the second virtual point.

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

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

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

[0029] Form a first guide based on a correction factor, the first guide including a first end portion and a second end portion, the first end portion having a first channel disposed along a first axis and the second end portion having a second channel disposed along a second axis. The first axis corresponds to a first virtual vector and a first virtual point, and the second axis corresponds to a second virtual vector and a second virtual point, and the first and second axes are not parallel. The first guide is configured such that: in a deformed configuration, a first Kirschner wire inserted through the first channel intersects a first bone, and a second Kirschner wire inserted through the second channel intersects a second bone.

[0030] In another aspect, the method includes receiving dimensions of a second guide, the second guide including a first end portion with a first channel and a second end portion with a second channel. The first channel is parallel to the second channel. The second guide is configured such that when the second guide is slid over the first and second Kirschner wires, the first and second Kirschner wires are received within respective first and second channels of the second guide, and the second guide realigns the first and second bones into a corrected configuration.

[0031] In another aspect, the method includes receiving scans of a first bone and a second bone in a deformed configuration to present a 3D model of the first bone and the second bone, the 3D model including a first virtual bone and a second virtual bone in a virtual deformed configuration. Adjust the first virtual bone and the second virtual bone in the 3D model to align the first virtual bone and the second virtual bone into a virtual corrected configuration. In the virtual corrected configuration, fix a first virtual axis relative to the first virtual bone and fix a second virtual axis relative to the second virtual bone. The first virtual axis is parallel to the second virtual axis. The first and second virtual bones together with the first and second virtual axes respectively defining the correction factor and the first and second virtual vectors and the first and second virtual points are returned to the virtual deformed configuration.

[0032] In another aspect, the method includes: identifying a virtual resection plane in the virtual corrected configuration at which the first virtual bone and the second virtual bone overlap, and fixing the first virtual axis relative to the first virtual bone includes arranging the first virtual axis to be parallel to the virtual resection plane.

[0033] In another aspect of the present invention, a kit for correcting the alignment between a first bone and a second bone by arthrodesis between the first bone and the second bone includes a first guide. The first guide includes a first end portion having a first channel disposed along a first axis and a second end portion having a second channel disposed along a second axis. The first axis is not parallel to the second axis. The first guide is configured such that when the first and second bones are in a deformed configuration, a first Kirschner wire inserted through the first channel intersects the first bone, and a second Kirschner wire inserted through the second channel intersects the second bone. The second guide includes a first end portion having a first channel and a second end portion having a second channel. The first channel may be parallel to the second channel. The second guide is configured such that when the first Kirschner wire is fixed within the first bone in the deformed configuration and the second Kirschner wire is fixed within the second bone in the deformed configuration, the second guide is slidable on the first and second Kirschner wires with the first and second Kirschner wires received within the respective first and second channels of the second guide such that the first and second bones are realigned into a corrected configuration.

[0034] In another aspect, stabilizing pins fix the first and second bones in the corrected configuration by insertion into the first and second bones.

[0035] In another aspect, a bone plate having a first end configured to connect to the first bone and a second end configured to connect to the second bone holds the first and second bones in the corrected configuration.

[0036] In another aspect, bone plate clamps are inserted into the first and second bones in the corrected configuration.

[0037] In another aspect, a first resection guide aligns a resection tool with a resection location on the first bone.

[0038] In another aspect, the first resection guide includes a first channel and a second channel configured to travel on a first Kirschner wire and a third Kirschner wire, the third Kirschner wire being parallel to the first Kirschner wire.

[0039] In another aspect, a second resection guide aligns a resection tool with a resection location on the second bone.

[0040] According to another aspect, a method for correcting the alignment between a first bone and a second bone by arthrodesis between the first bone and the second bone includes aligning a first end portion of a first guide with the first bone. The first end portion has a first channel and a second channel disposed along a first direction. A first Kirschner wire is inserted through the first channel and into the first bone, and a second Kirschner wire is inserted through the second channel and into the first bone. A first end of the first bone is resected via a slot to form a first resection surface. The slot is aligned with the first end of the first bone by the first and second Kirschner wires. A third Kirschner wire and a fourth Kirschner wire are inserted through the first guide and into the second bone. A first end of the second bone is resected to form a second resection surface. A second guide slides over the first, second, third, and fourth Kirschner wires to adjust the positions of the first and second bones such that in the corrected configuration, the first and second resection surfaces abut. The first and second bones are fixed in the corrected configuration.

[0041] In another aspect, the method includes fixing the first and second bones in the corrected configuration by inserting stabilizing pins into the first and second bones.

[0042] In another aspect, the method includes holding the first and second bones in the corrected configuration by connecting a first end of a bone plate to the first bone and connecting a second end of the bone plate to the second bone to fix the first and second bones in the corrected configuration.

[0043] In another aspect, the method includes sliding the second guide over the first, second, third, and fourth Kirschner wires to translate the first resection surface toward the second resection surface.

[0044] In another aspect, the method includes sliding the second guide over the first, second, third, and fourth Kirschner wires to achieve rotational alignment between the first bone and the second bone.

[0045] In another aspect, the third Kirschner wire and the fourth Kirschner wire are inserted into the second bone through a second end portion of the first guide including a third channel and a fourth channel. The third and fourth channels are disposed along a second direction.

[0046] In another aspect, a first end of the second bone is resected via the slot. The slot is aligned with the first end of the second bone by the third and fourth Kirschner wires.

[0047] In another aspect, the slot is located on a resection guide including first and second holes configured to align with the first and second Kirschner wires.

[0048] In another aspect, the first bone is a metatarsal bone, the second bone is a medial cuneiform bone, and the corrected configuration of the first and second bones corrects a bunion.

[0049] In another aspect, the second guide adjusts the angle of the first bone in three orthogonal planes between a deformed configuration and a corrected configuration.

[0050] In another aspect, the method includes removing the first guide from the first and second Kirschner wires after excising a first end portion of the second bone to form a second resection surface.

[0051] In another aspect, the method includes removing the second guide and the first, second, third, and fourth Kirschner wires from the first and second bones after fixing the first and second bones in the corrected configuration.

[0052] According to another aspect, a method for correcting the alignment between a first bone and a second bone by arthrodesis between the first bone and the second bone includes: positioning a cutting guide at a first position near a first end portion of the first bone, the cutting guide including a cutting slot and first and second channels extending through the cutting guide. The cutting guide at the first position includes first and second Kirschner wires positioned to pass through the first and second channels and into the first bone. Resecting the first end portion of the first bone via the cutting slot to form a first resection surface. Removing the cutting guide from the first and second Kirschner wires. Positioning the cutting guide at a second position near a first end portion of the second bone. The cutting guide at the second position includes third and fourth Kirschner wires positioned to pass through the first and second channels and into the second bone. Resecting the first end portion of the second bone via the cutting slot to form a second resection surface. Removing the cutting guide from the third and fourth Kirschner wires. Sliding a second guide over the first, second, third, and fourth Kirschner wires. The second guide adjusts the position between the first and second bones such that the first and second resection surfaces abut in the corrected configuration. Fixing the first and second bones in the corrected configuration.

[0053] In another aspect, positioning a first end portion of the first guide on the first bone, the first end portion having a third channel and a fourth channel, the third and fourth channels being arranged in a first direction, inserting a first Kirschner wire through the third channel and into the first bone, and inserting a second Kirschner wire through the fourth channel and into the first bone.

[0054] In another aspect, positioning a second end portion of the first guide on the second bone, the second end portion having a fifth channel and a sixth channel, the fifth channel and the sixth channel being arranged in a second direction, inserting a third Kirschner wire through the fifth channel and into the second bone, and inserting a fourth Kirschner wire through the sixth channel and into the second bone.

[0055] In another aspect, fixing the first and second bones in the corrected configuration includes inserting stability pins into the first and second bones.

[0056] In another aspect, fixing the first and second bones in a corrective configuration includes attaching a first end portion of the bone plate to the first bone and attaching a second end portion of the bone plate to the second bone such that the first and second bones are held in the corrective configuration.

[0057] In another aspect, the sliding of the second guide on the first, second, third, and fourth Kirschner wires causes the first resection surface to translate toward the second resection surface.

[0058] In another aspect, the sliding of the second guide on the first, second, third, and fourth Kirschner wires causes the first bone to rotate relative to the second bone to adjust the alignment between the first and second bones. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] For illustrative purposes, various examples are depicted in the drawings, which should not be construed as limiting the scope of the examples. The various features of the different disclosed examples can be combined to form additional examples, which are part of this disclosure.

[0060] Figure 1 A top view of a patient's foot in a deformed configuration is shown;

[0061] Figure 2A A front perspective view of an alignment guide is shown;

[0062] Figure 2B A rear perspective view of the alignment guide is shown;

[0063] Figure 3A A front view of the alignment guide is shown.

[0064] Figure 3B A cross-sectional view taken along line 15B–15B in Figure 15A is shown;

[0065] Figure 4 An exploded view of the alignment guide is shown;

[0066] Figure 5 An angle between channels of the alignment guide is shown;

[0067] Figure 6 A second angle between channels of the alignment guide is shown;

[0068] Figure 7 A third angle between channels of the alignment guide is shown;

[0069] Figure 8 An alignment guide aligned with the medial cuneiform and metatarsal bones of a patient's foot is shown;

[0070] Figure 9 Insertion of multiple Kirschner wires into the medial cuneiform and metatarsal bones through the alignment guide is shown;

[0071] Figure 10 Shows a partially unassembled view of the alignment guide;

[0072] Figure 11A Shows a perspective view of the resection guide;

[0073] Figure 11B Shows a front view of the resection guide;

[0074] Figure 12A -B shows the alignment guide removed and the first resection guide installed;

[0075] Figure 13 Shows the installation of the second resection guide;

[0076] Figure 14A Shows a perspective view of the correction guide; [[ID=,25]]

[0077] Figure 14B Shows a top view of the correction guide;

[0078] Figure 15A -B shows the correction guide assembled on multiple Kirschner wires for aligning the medial cuneiform and metatarsal bones of the patient's foot into a corrected configuration;

[0079] Figure 16 Shows the insertion of the first and second fixed Kirschner wires into the medial cuneiform and metatarsal bones;

[0080] Figure 17 Shows the patient's foot after removal of multiple Kirschner wires;

[0081] Figure 18 Shows an exploded view of the bone plate assembly aligned with the medial cuneiform and metatarsal bones in a corrected configuration;

[0082] Figure 19 Shows a top view of the bone plate;

[0083] Figure 20 Shows a side view of the bone plate;

[0084] Figure 21 Shows the bone plate assembly assembled with the medial cuneiform and metatarsal bones in a corrected configuration;

[0085] Figure 22 Shows a side view of the patient's foot in a corrected configuration;

[0086] Figure 23 Shows a method for calculating a correction factor using a virtual model;

[0087] Figure 24A Shows a virtual model in a virtual deformed configuration;

[0088] Figure 24B Shows a virtual model adjusted to a virtual correction configuration;

[0089] Figure 24C Shows fixing two virtual axes in a first virtual bone and a second virtual bone respectively in the virtual correction configuration;

[0090] Figure 24D Shows the virtual model returned to the virtual deformation configuration, where the resulting orientations of the two virtual axes define the correction factor of the virtual model;

[0091] Figure 25 Shows a method of manufacturing an adjustment guide based on the correction factor;

[0092] Figure 26A Shows a side view of another embodiment of the alignment guide;

[0093] Figure 26B Shows Figure 26A The top view of the alignment guide of

[0094] Figure 27 Shows Figure 26A The exploded view of the alignment guide of

[0095] Figure 28A Shows a perspective view of another embodiment of the resection guide;

[0096] Figure 28B Shows Figure 28A The front view of the resection guide shown in

[0097] Figure 29 Shows Figure 26A The alignment of the alignment guide with the patient's foot;

[0098] Figure 30 Shows inserting multiple Kirschner wires into the medial cuneiform and metatarsal bones through the alignment guide;

[0099] Figure 31 Shows a partially unassembled view of the alignment guide;

[0100] Figure 32 Shows the alignment guide removed and the resection guide in Figure 28A Installed;

[0101] Figure 33 Shows a correction guide assembled on multiple Kirschner wires to align the medial cuneiform and metatarsal bones of the patient's foot into a correction configuration and insert and fix the Kirschner wires;

[0102] Figure 34 Shows a bone plate assembly assembled with the medial cuneiform and metatarsal bones in the correction configuration. Detailed Implementation Modes

[0103] Overview

[0104] Hallux valgus correction or repair is a common surgical procedure, with over 100,000 surgeries performed annually in the United States. Many surgical procedures for hallux valgus repair are invasive and painful, requiring incisions several inches long and a long recovery period of up to 10 - 12 weeks. Minimally invasive surgery has been performed in orthopedic surgery for decades. A common procedure is called the Lapidus bunionectomy. In the Lapidus bunionectomy, the hallux valgus is corrected at the big toe by adjusting the alignment of the first tarsometatarsal joint. Bone screws and / or plates can also be used to stabilize the metatarsal bone to facilitate fusion between the metatarsal bone and the medial cuneiform bone.

[0105] However, existing Lapidus bunionectomies have various disadvantages and risks. These disadvantages include: not only requiring minimally invasive surgery, but also using realignment devices with little control over the rotation and relative angles of the metatarsal bone, a process that relies on trial and error during surgery to identify the optimal alignment of the patient's foot bones and relies on judgment during surgery to identify the location for resection, its lack of customization considering the individual patient's foot condition, and / or the lack of available guidance for pre - planned foot bone resection. Various aspects of the bone reduction systems and methods described herein overcome and improve these existing methods, leading to better patient outcomes.

[0106] The various features and advantages of the systems, devices, and methods for bone reduction described herein will become more apparent from the following description of the examples shown in the accompanying drawings. These examples are intended to illustrate the principles of the present disclosure, and the present disclosure should not be limited to the examples shown. Given the principles disclosed herein, it will be apparent to those of ordinary skill in the art that the features of the examples shown can be modified, combined, removed, and / or replaced.

[0107] Deformation Correction Process

[0108] Figure 1 A skeletal view of a patient's foot 100 is shown, having one or more bones in a deformed configuration 102. As shown, the deformed configuration 102 can be a hallux valgus. The deformed configuration 102 can be a misalignment between the metatarsal bone 108 and the phalanx 112 of the patient's big toe. The metatarsal bone 108 can be angled relative to the phalanx at 112. A significant height misalignment between the metatarsal bone 108 and the phalanx 112 can cause severe pain, friction, and discomfort in the patient's foot 100, as well as other problems. Therefore, correcting the alignment between the metatarsal bone 108 and the phalanx 112 of the big toe is beneficial.

[0109] The patient's foot 100 may also include a medial cuneiform bone 104. The medial cuneiform bone 104 may be connected to the proximal end of the metatarsal bone 108 (e.g., by one or more ligaments). Figure 1 - 22 Systems and methods for correcting the alignment between the medial cuneiform bone 104 and the metatarsal bone 108 are shown. In turn, the correct 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. Thus, the deformed configuration 102 of the patient's foot 100 can be corrected. The present disclosure relates to systems and methods for correcting the deformed configuration 102. In addition, the systems and methods described herein can be more generally used to correct the alignment between any two bones of a patient's body.

[0110] As Figure 2A - 4 shown, a system for correcting the alignment of a patient's foot 100 may include an alignment guide 200. The alignment guide 200 may be formed of a rigid material. The alignment guide 200 may include a first end portion 204. The first end portion 204 may include one or more holes 210a, 212a. Although two holes are described and shown, more or fewer holes may be included on the first end portion 204. The holes 210a, 212a may include internal threads 221, 222, respectively. The holes 210a, 212a may be chamfered on one or both sides of the alignment guide 200. The holes 210a, 212a may extend completely through the alignment guide 200. The holes 210a, 212a may be arranged / aligned along respective axes 230, 232. The axes 230, 232 may be parallel. Alternatively, the axes 230, 232 may be convergent. The axes 230, 232 may be spaced apart by a distance 204a. The distance 204a may be based on the length of the medial cuneiform bone 104.

[0111] As Figure 4 shown, the alignment guide 200 may include one or more removable tubes 240, 242. The removable tube 240 may include a first end 240a and a second end 240b. The first end 240a may be received within the hole 210a. The removable tube 240 may include a threaded portion 244. The threaded portion 244 may engage the internal thread 221 of the hole 210a. The removable tube 242 may include a first end 242a and a second end 242b. The first end 242a may be received within the hole 212a. The removable tube 240 may include a threaded portion 246. The threaded portion 246 may engage the internal thread 222 of the hole 212a.

[0112] The removable tube 240 may define a channel 210. When installed within the bore 210a, the channel 210 may be disposed along the axis 230 of the bore 210a. The removable tube 242 may define a channel 212. When installed within the bore 212a, the channel 212 may be disposed along the axis 232 of the bore 212a. The channels 210, 212 may define different diameters there-through. The channel 212 may have a larger diameter than the channel 210 (or vice versa). In other embodiments, the channels 210, 212 may define the same different diameters there-through. In other embodiments, the channels 210, 212 may define varying diameters there-through.

[0113] The alignment guide 200 may include a second end portion 208. The second end portion 208 may include one or more channels 214, 216. The channels 214, 216 may be defined through the body of the alignment guide 200 and / or through its respective extensions 219, 218. Although two channels are described and illustrated, more or fewer channels may be included on the second end portion 208. Additionally, the second end portion 208 may include a removable insert or removable portion (e.g., a removable tube) surrounding the channels 214, 216.

[0114] The channels 214, 216 may extend through the alignment guide 200 (e.g., including the extensions 218, 219). The channels 214, 216 may define different diameters there-through. The channel 214 may have a larger diameter than the channel 216 (or vice versa). In other embodiments, the channels 214, 216 may define the same different diameters there-through. In other embodiments, the channels 214, 216 may define varying diameters there-through.

[0115] The channels 214, 216 may be disposed along respective parallel axes 234, 236. The axes 234, 236 may be spaced apart by a distance 208a. The distance 204a may be based on the length of the metatarsal 108.

[0116] Figure 5 - 7 The assembled alignment guide 200 is shown. The first end portion 204 may define the positioning and orientation of a first set of channels (e.g., channels 210, 212). The second end portion 208 may define the positioning and orientation of a second set of channels (e.g., channels 214, 216). The first set of channels and the second set of channels may be offset from one another and / or angled relative to one another.

[0117] Figure 5Shows the angle α between the axis 230 of the channel 210 and the axis 236 of the channel 216. The angle α defines the relative orientation angle between the first set of channels on the first end portion 204 and the second set of channels on the second end portion 208. The angle α can be defined in the z-x plane in a Cartesian coordinate system (having x, y, and z axes). The channel 210 can include point A. Alternatively, point A can be any fixed position along the channel 210. Point A can have x, y, and z coordinate positions in a Cartesian coordinate system (having x, y, and z axes). The channel 216 can include point B. Alternatively, point B can be any fixed position along the channel 216. Point B can have x, y, and z coordinate positions in the Cartesian coordinate system. Points A and B can define the relative positions of the axes 230, 236 in the Cartesian coordinate system.

[0118] Figure 6 Shows the angle β between the axis 230 of the channel 210 and the axis 236 of the channel 216. The angle β defines the relative orientation angle between the first set of channels on the first end portion 204 and the second set of channels on the second end portion 208 in the y-x plane. Figure 7 Shows the angle γ between the axis 230 of the channel 210 and the axis 236 of the channel 216. The angle γ defines the relative orientation angle between the first set of channels on the first end portion 204 and the second set of channels on the second end portion 208 in the y-z plane.

[0119] The relative positions of points A and B and at least two of the relative angles α, β, and γ can jointly define the channel axes on the alignment guide 200. By appropriately selecting the relative angles α, β, and / or γ, and / or the relative positions of points A and B, the alignment guide 200 can be used to correctly align the bones in the patient's foot 100, as further described below.

[0120] As Figure 8 shown, the alignment guide 200 can be aligned with the patient's foot 100. The first end portion 204 can be generally aligned with the medial cuneiform 104. The second end portion 208 can be generally aligned with the metatarsal 108. As Figure 9As shown, multiple Kirschner wires 300 can extend through corresponding channels of the alignment guide 200. The Kirschner wires can extend through the channels and into the corresponding medial cuneiform bone 104 and metatarsal bone 108. The first Kirschner wire 310 can be inserted into the medial cuneiform bone 104 through the channel 210. The first Kirschner wire 310 can be inserted onto the medial cuneiform bone 104 at the insertion point 320. The second Kirschner wire 312 can be inserted through the channel 212. The second Kirschner wire 312 can be inserted through the medial cuneiform bone 104 at the insertion point 322. The third Kirschner wire 314 can be inserted through the channel 214. The third Kirschner wire 314 can intersect with the metatarsal bone 108 at the insertion point 324 and be inserted into the metatarsal bone 108. The fourth Kirschner wire 316 can be inserted through the fourth channel 216. The fourth Kirschner wire 316 can be inserted into the metatarsal bone 108 at the insertion point 326.

[0121] Based on the parallel channels 210, 212, the first and second Kirschner wires 310, 312 can be parallel to each other. Based on the channels 214, 216, the third and fourth Kirschner wires 314, 316 can be parallel to each other. One or more of the insertion points 320, 322, 324, 326 (e.g., at least one on each bone 104, 108) can be located at a predetermined position on the patient's foot. The lengths of the extensions 218, 219 and / or the tubes 240, 242 can provide greater stability for the Kirschner wires 300 received therein. The diameter size of the Kirschner wires 300 can be determined according to the diameter of the corresponding channels of the alignment guide 200 to ensure accurate insertion into the bones 104, 108 at a certain angle. In addition, the Kirschner wires 300 can be matched to the correct channels based on different diameter sizes.

[0122] Figure 10 Removing the tubes 240, 242 from the first end portion 204 of the alignment guide 200 is shown. 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 Kirschner wires 300 inserted into the medial cuneiform bone and the metatarsal bone 108. In some cases, due to misalignment between the first and second end portions 204, 208, without removable or otherwise deconstructible elements, it may be difficult for the user to remove the alignment guide 200 from the multiple Kirschner wires 300.

[0123] As Figure 11A -B shows, a system for correcting the alignment of a patient's foot 100 can include a resection guide 404. The resection guide 404 can align a resection tool (not shown), such as a saw, a broach, etc., with one end of the medial cuneiform bone 104 and / or one end of the metatarsal bone 108 respectively.

[0124] The resection guide 404 may include a channeled portion 411. The channeled portion 411 may include one or more holes 415, 417. The resection guide 404 may include a planar portion 409. The planar portion may include a slot 407 for aligning a resection tool. The holes 415, 417 may interact with one or more Kirschner wires (e.g., Kirschner wire 300) or pins to align the planar portion 409 with a desired target location for the resection tool.

[0125] The planar portion 409 (e.g., the plane defining the slot 407) may be generally perpendicular to the channeled portion 411 (e.g., the axis between the holes 415, 417). In other embodiments, the planar portion 409 may be angled relative to the channeled portion 411.

[0126] The holes 415, 417 may extend through the channeled portion 411. The size of the holes 415, 417 may be registered with a Kirschner wire or pin. The slot 407 may extend through the planar portion 409. The height and thickness of the slot 407 are sized to receive a cutting portion of the resection tool. The slot 407 may have a depth sufficient to maintain alignment of the resection tool with the desired target location.

[0127] According to a planned corrective configuration of the first cuneiform 104 and the metatarsal 108, it may be necessary to remove material from one or both of the inner ends of the cuneiform 104 and the metatarsal 108. The angle between the cuneiform 104 and the metatarsal 108 may be adjusted according to the corrective configuration. The length of one or both of the cuneiform 104 and the metatarsal 108 may also be adjusted according to the corrective configuration. Each of these adjustments contributes to correcting the deformity in the patient's foot 100.

[0128] Therefore, Figure 12A -B shows aligning a resection tool with the first inner end of the first cuneiform 104 using the first resection guide 404. The channeled portion 411 may be received on first and second Kirschner wires 310, 312, respectively, through the holes 415, 417. This may align the planar portion (e.g., the slot 407) with the end of the first cuneiform 104. A resection tool passed through the slot 407 may be used to cut a resection plane 104a in the first cuneiform 104. The resection plane 104a may be aligned with the first and second Kirschner wires 310, 312.

[0129] Figure 13 Aligning a resection tool with the first inner end of the metatarsal 108 using a second resection guide 408 is shown. The second resection guide 408 may include the same components as the resection guide 404 (e.g., the planar portion 409 and the channeled portion 411).

[0130] The channeled portion 411 of the second resection guide 408 can be received on the third and fourth Kirschner wires 314, 316 respectively through the holes 415, 417. The third and fourth Kirschner wires can align the planar portion 409 and the slot 407 with the end of the metatarsal 108. A resection tool passing through the slot 407 can be used to cut a resection plane 108a on the metatarsal 108. The resection plane 108a can be aligned with the third and fourth Kirschner wires 314, 316. In some embodiments, instead of the partial resection guide 408, a resection guide 404 can be used to form the resection plane 108a.

[0131] As Figure 14A -B shows, a system for correcting the alignment of a patient's foot 100 can include a correction guide 500. As shown in FIG. 15, the correction guide 500 can arrange the bones in the patient's foot 100 into a corrected configuration 103. The correction guide 500 can include a first end portion 504. The first end portion 504 can include one or more channels 510, 512. The channels 510, 512 can extend through the correction guide 500. The channels 510, 512 can correspond to the first and second Kirschner wires 310, 312 inserted into the medial cuneiform 104 respectively. The channels 510, 512 can be arranged along the first and second axes 530, 532 respectively. The first and second axes 530, 532 can be parallel.

[0132] The correction guide 500 can include a second end portion 508. The second end portion 508 can include one or more channels 514, 516. The channels 514, 516 can extend through the correction guide 500. The channels 514, 516 can correspond to the third and fourth Kirschner wires 314, 362 inserted into the metatarsal 108 respectively. The channels 514, 516 can be arranged along the third and fourth axes 534, 536 respectively. The third and fourth axes 534, 536 can be parallel.

[0133] The first and second axes 530, 532 can be parallel to the third and fourth axes 534, 536. The first and second axes 530, 532 can be in the same plane as the third and fourth axes 534, 536. In other embodiments, the first and second axes 530, 532 may not be in the same plane as the third and fourth axes 534, 536 (e.g., offset with respect to the plane in which the third and fourth axes 534, 536 are located).

[0134] The first axis 530 can extend through point C. Point C can have a position (x, y, z) in the Cartesian coordinate plane. The fourth axis 536 can extend through point D. Point D can 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, 536 in the Cartesian coordinate system.

[0135] As shown in FIG. 15, the correction guide 500 can be received on the Kirschner wire 300. The first and second Kirschner wires 310, 312 can be received in channels 510, 512 on the first end portion 504 of the correction guide 500, respectively. The third and fourth Kirschner wires 314, 316 can be received in channels 514, 516 on the second end portion 508 of the correction guide 500, respectively.

[0136] Thus, when the correction guide 500 advances on the Kirschner wire 300, it can align the metatarsal 108 relative to the medial cuneiform 104. The correction guide can orient the metatarsal 108 and the proximal phalanx 112 into the corrected configuration 103. The reorientation of the metatarsal 108 relative to the medial cuneiform 104 can include rotation and / or translation of the metatarsal 108 in a Cartesian coordinate system (e.g., in three orthogonal planes). The degree of rotation and / or translation of the metatarsal 108 can be determined based on the angles α, β, and / or γ, and / or any difference in the relative position of the axes between the alignment guide 200 and the correction guide 500 (e.g., any difference in the relative position defined by points A, B and points C, D).

[0137] The corrected configuration 103 can include one or more corrections to the alignment of the bones of the patient's foot 100. For example, the metatarsal 108 can be generally aligned with the proximal phalanx 112 of the big toe. The corrected configuration 103 can facilitate the healing of bunions and / or hallux valgus deformities. The resection surface 104a of the medial cuneiform 104 can abut against the resection surface 108a of the metatarsal 108. Such abutment can facilitate the union or fusion of the metatarsal 108 with the medial cuneiform 104. Proper abutment may require translation of the metatarsal 108 relative to the medial cuneiform 104.

[0138] As Figure 16 shown, the medial cuneiform 104 can be temporarily or permanently fixed relative to the metatarsal 108 in the corrected configuration 103. The first fixation Kirschner wire 610 can be inserted into the medial cuneiform 104 and the metatarsal 108. The first fixation Kirschner wire 610 can extend through the resection surfaces 104a, 108a. The second fixation Kirschner wire 612 can pass through the metatarsal 108 and be inserted into the medial cuneiform 104. The second fixation Kirschner wire 612 can be inserted through the resection planes 104a, 108a. In other embodiments, any temporary or permanent fixation means can be used to connect the medial cuneiform 104 to the metatarsal 108 in the corrected configuration. For example, the medial cuneiform 104 and the metatarsal 108 can be threaded together, tightened together, adhered together, or otherwise temporarily or permanently connected together.

[0139] As Figure 17As shown, with the medial cuneiform bone 104 and the metatarsal bone 108 fixed in the corrective configuration 103, the corrective guide 500 can be removed from the multiple Kirschner wires 300. The multiple Kirschner wires 300 can be removed from the medial cuneiform bone 104 and / or the metatarsal bone 108.

[0140] As Figure 18 shown, a system for correcting the alignment of a patient's foot 100 can include a bone plate assembly 700. The bone plate assembly 700 attaches the medial cuneiform bone 104 and the metatarsal bone 108, as Figure 21 - 22 shown. The bone plate assembly 700 can include a bone plate 710. The bone plate 710 can include a first end 704 and a second end 708. The bone plate assembly 700 can include a bone clamp 720. The bone clamp 720 can be coupled between the medial cuneiform bone 104 and the metatarsal bone 108. The bone clamp 720 can include a first jaw 724 and a second jaw 728 connected by a transverse member 726. The bone plate assembly 700 can include a plurality of fasteners 730, such as bone screws, pins, or other fasteners known in the orthopedic field.

[0141] Figure 19 - 20 More details of the bone plate 710 are shown. The contour of the bone plate 710 can be designed to conform to the medial cuneiform bone 104 and the metatarsal bone 108. The bone plate 710 can be made of titanium, aluminum, steel, or other suitable materials in the orthopedic field.

[0142] The first end 704 of the bone plate 710 can have a plurality of holes 715, 716, 717. The sizes of the holes 716, 717 can be sized to receive the fasteners 730. The size of the hole 715 can be sized to receive the jaw 724 of the bone clamp 720. The second end 708 of the bone plate 710 can have a plurality of holes 711, 712, 713. The sizes of the holes 711, 712 can be sized to receive the fasteners 730. The size of the hole 713 can be sized to receive the jaw 728 of the bone clamp 720. The bone clamp 720 can include a groove 719 for receiving or at least partially receiving the transverse member 726 of the bone clamp 720. This can reduce the overall profile of the assembled bone plate assembly 700.

[0143] Figure 21 - 22 Shown is the bone plate assembly 710 assembled with the patient's foot 100. The first end 704 of the bone plate 710 can be connected to the medial cuneiform bone 104 by fasteners 730. The fasteners 730 can extend through the holes 716, 717 and into the medial cuneiform bone 104. The second end 708 of the bone plate 710 can be connected to the metatarsal bone 108. The fasteners 730 can extend through the holes 711, 712 and into the metatarsal bone 108. In some embodiments, the fasteners 730 can be received within the respective intersection points 320, 322, 324, and / or 326 of the Kirschner wires 300. Alternatively, the fasteners can form new holes in the patient's foot bones.

[0144] Bone clamp 720 can span the joint between the medial cuneiform bone 104 and the metatarsal bone 108. The first chuck 724 can be received within the hole 715 and enter the metatarsal bone 108. The second chuck 728 can be received through the hole 713 and enter the medial cuneiform bone 104. In certain embodiments, the chucks 724, 728 can be received within the respective intersection points 322, 324. The chucks 724, 728 can include a plurality of serrated edges for enhancing the engagement features for attachment within the bones of the patient's foot 100.

[0145] In certain embodiments, different alignment guides 200 can be used depending on the intended fixation of the medial cuneiform bone 104 and the metatarsal bone 108. The different alignment guides 200 can include channels that align the Kirschner wire 300 at different points in the bone to match the holes in different fixation devices.

[0146] Virtual Modeling of Correction Factor / Corrective Factor

[0147] Figure 23 A method 800 for designing an alignment guide customized to a patient's unique anatomy is described. Although described herein in the context of a patient's foot, the method 800 can be used for other parts of the patient's body. In Figure 24A - 24D Method 800 is further illustrated. In step 812, a virtual model 840 of the patient's foot is created. The virtual model 840 can be based on a scan of the patient's foot including deformities such as bunions and / or hallux valgus. The scan used to create or render the virtual model 840 can be based on CT, PET, X-ray, ultrasound, MRI, or other types of medical imaging scans.

[0148] The virtual model 840 can include a virtual representation of the bones of the patient's foot. The virtual model 840 can include a virtual deformed configuration 802 of the patient's bones. The virtual model 840 can include a virtual first bone 804 and a virtual second bone 808. The virtual first bone 804 can correspond to the medial cuneiform bone of the patient's foot, and the virtual second bone 808 can correspond to the metatarsal bone.

[0149] The virtual model 840 can be displayed to the user via a graphical user interface (e.g., on a computer). The virtual model 840 can be manipulated by the user. In some embodiments, the virtual model 840 can simulate the natural connections (e.g., ligaments, cartilage, and / or muscles) between the bones of the patient's foot. Thus, the movement of one virtual bone can change the position of the connected virtual bone. In other implementations, the virtual bones of the model 840 can be freely moved and manipulated by the user. Thus, feasible bone repositioning and the final movement of the connected virtual bones can be simulated based on the user's skills and knowledge.

[0150] In step 814, the user adjusts the configurations of the first and second virtual bones 804, 808 to the virtual correction configuration 803. The virtual correction configuration 803 may include the correction of one or more deformities of the patient's foot. Adjusting to the virtual correction configuration 803 may include changing the relative angles and positions between the first and second virtual bones 804, 808. Additionally, the virtual correction configuration 803 may include one or more overlapping portions of the first and second virtual bones 804, 808. The user may identify one or more virtual resection planes 804a, 808a to remove the overlapping portions of the first and second virtual bones 804, 808 or adjust their lengths and dimensions.

[0151] In step 816, a first virtual axis 830 is added to intersect the first virtual bone 804. A second virtual axis 836 is added to intersect the second virtual bone 808. The first virtual axis 830 is fixed relative to the first virtual bone 804. The second virtual axis 836 is fixed relative to the second virtual bone 808. The first and second virtual axes 830, 836 can be aligned with the virtual model 840 at positions that are easily accessible during the patient's foot surgery.

[0152] The first and second virtual axes 830, 836 are parallel to each other. Advantageously, the first and second virtual axes 830, 836 can be aligned with one or both of the virtual resection planes 804a, 808a. The first virtual axis 830 extends through a point G located in the virtual Cartesian coordinate system. The second virtual axis 836 extends through a point H located in the virtual Cartesian coordinate system.

[0153] In step 818, the first and second virtual bones 804, 808 return to the original deformed configuration 802 of the model 840. The first and second virtual axes 830, 836 rotate relative to each other from the correction configuration 803 to different angles and / or translate relative to each other to become the deformed configuration 802. In the deformed configuration 802, the first and second virtual axes 830, 836 can be defined as vectors passing through corresponding points E, F within the virtual Cartesian coordinate system, respectively.

[0154] 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 factors for the alignment guide. The relative positions may include relative angles in two or more virtual Cartesian coordinate planes (e.g., z - x, z - y, x - y). The relative angles may correspond to the α, β, and / or γ angles in the alignment guide (e.g., alignment guide 200, etc.). The relative positions of the first and second virtual axes 830, 836 may be based on the corresponding points E, F. The points E, F may correspond to the corresponding points A, B in the alignment guide (e.g., alignment guide 200, etc.). Thus, the dimensions of the virtual model 840 can be used to form the correction factors for the alignment guide used in the patient's foot surgery.

[0155] In addition, the relative positions of the first and second virtual axes 830, 836 in the correction configuration 803 can be used to define the dimensions of the correction guide. Points G, H can correspond to corresponding points C, D in the correction guide (e.g., correction guide 500, etc.). The first and second virtual axes 830, 836 in the correction configuration 803 can correspond to the parallel axes of the channels in the correction guide.

[0156] In addition, the relative positions of the first and second virtual axes 830, 836 in the deformation configuration 802 can be used to define the dimensions of the resection guide. These dimensions can include the orientation of the slot (e.g., slot 407) in the resection guide. The slot can be aligned parallel to one or more resection planes 804a, 808a. The resection guide can also include one or more holes aligned with the first and / or second virtual axes 830, 836 in the deformation configuration 802.

[0157] As an alternative to creating the model 803, a user (e.g., a surgeon) can describe the angles (α, β, and / or γ) and / or translations required to correct the deformity of the patient's foot 100. This description can be based on the user's knowledge and experience and / or in combination with viewing a scan of the patient's foot 100. The information provided by the user can indicate the alignment guide 200 required during the surgical procedure. For example, a kit with multiple alignment guides can be provided to the user, and a selection can be made from a set of predetermined alignment guides 200, each alignment guide 200 correcting a different but common patient foot deformity. In some embodiments, the alignment guide 200 can include multiple sets of channels corresponding to different correction factors.

[0158] Manufacture of the Lapidus system

[0159] Method 900 is a method of manufacturing a system for aligning a patient's foot 100 based on correction factors. In step 912, the manufacturer can receive the correction factors. The correction factors can define one or more dimensions of the alignment guide (e.g., alignment guide 200). In some embodiments, the correction factors can be a CAD model. These dimensions can include the orientation and position of one or more channels passing therethrough. For example, the correction factors can be based on the above method 800 and / or the information provided by the user. The correction factors can be customized according to the foot of an individual patient. Alternatively, the correction factors can be one of a standard set of commonly used correction factors.

[0160] In step 914, the manufacturer can form the alignment guide based on the correction factors. For example, the manufacturer can 3D print the alignment guide.

[0161] In step 916, the manufacturer may receive dimensions for creating an orthotic guide. The dimensions of the orthotic guide may be customized for an individual patient's foot based on the method 800 described above, or otherwise.

[0162] In step 918, the manufacturer may form the orthotic guide based on the received dimensions. For example, the manufacturer may 3D print the orthotic guide.

[0163] Alternative component structure

[0164] Figure 26A - 26B Another possible configuration of the adjustment guide 1000 is shown. The adjustment guide 1000 may include the same features and functions as the adjustment guide 200 described above, but includes some differences described below. The adjustment guide 1000 may include a first portion 1004 and a second portion 1008. The first portion 1004 may be releasably connected to the second portion 1008. The first portion 1004 may include a handle 1004a. The handle portion 1004a may include a hole therethrough. The handle portion 1004a may be used to enable a user to easily hold the adjustment guide 1000 in place during use. The first portion 1004 of the adjustment guide 1000 may include one or more channels 1010, 1012 extending therethrough. The channels 1010, 1012 may extend through the first portion 1004. The channels 1010, 1012 may extend along parallel axes 1020, 1022.

[0165] The second portion 1008 may include one or more channels 1014, 1016. The channels 1014, 1016 may extend through the second portion 1008. The channels 1014, 1016 may extend along parallel axes 1024, 1026 respectively. The axes 1020, 1022 may not be parallel to the axes 1024, 1026.

[0166] The first or second portion 1004, 1008 may include a centering channel 1009. The centering channel 1009 may be used to align the adjustment guide 1000 at the tarsometatarsal joint between the medial cuneiform 104 and the metatarsal 108.

[0167] As Figure 27As shown, the first part 1004 can be connected to the second part 1008 by an attachment mechanism 1006. The attachment mechanism 1006 can be a thumb screw. As a thumb screw, the attachment mechanism 1006 can include a threaded end 1006a. The attachment mechanism 1006 can extend through a hole 1006b in the first part 1004. The attachment mechanism 1006 can extend through a hole 1006c in the second part 1008. At least one of the holes 1006b, 1006c can be internally threaded to connect with the threaded end 1006a. Thus, the first and second parts 1004, 1008 can be coupled together by the attachment mechanism 1006.

[0168] The second part 1008 can include a recess 1008a. The first part 1004 can include a protrusion 1004b. The protrusion 1004b can be received within the recess 1008a. The recess / protrusion arrangement can enhance the stability of the connection between the first part 1004 and the second part 1008.

[0169] Figure 28A - 28B Another embodiment of the resection guide 1100 is shown. The resection guide 1100 can be constructed similarly to the aforementioned resection guide 404, but includes some differences mentioned herein. The resection guide 1100 can include a first part 1111. The first part 1111 can include one or more holes 1115, 1117 extending therethrough. The first part 1111 can be coupled to a planar part 1109. The planar part 1109 can include a slot 1107 therein. The size of the slot 1107 can be determined to allow a resection tool to extend therethrough for resection of a bone in a patient's body (e.g., the patient's foot 100). In some embodiments, the planar part 1109 can include a curved shape to allow the slot 1107 to be placed closer to and / or in contact with the patient's body. This can reduce errors associated with the process of bone resection.

[0170] Figure 29 A method of using an adjustment guide 1100 in the process of aligning two bones in a patient's body is shown. The adjustment guide 1000 can be used to correct the alignment of the medial cuneiform 104 and the metatarsal 108 in a patient's foot 100. Figure 29 - 34 The process shown is similar to Figure 1 - 22 the process shown, and can include any steps and details of the aforementioned process.

[0171] The centering channel 1009 can align the adjustment guide 1000 at the tarsometatarsal joint between the medial cuneiform 104 and the metatarsal 108. A Kirschner wire (not shown) can extend through the centering channel 1009 and into the space between the medial cuneiform 104 and the metatarsal 108. The first end 1004 of the adjustment guide 1000 can be generally aligned with the medial cuneiform 104. The second end 1008 of the adjustment guide 1000 can be generally aligned with the metatarsal 108. As Figure 30 Further shown in, multiple Kirschner wires 1300 can be inserted through the respective channels of the adjustment guide 1000 and into the medial cuneiform 104 and the metatarsal 108. The first Kirschner wire 1310 can be received within the channel 1010 and intersect the medial cuneiform 104. The second Kirschner wire 1312 can be received through the channel 1012. The third Kirschner wire 1314 can be inserted through the channel 1014 and into the metatarsal 108. The fourth Kirschner wire 1316 can extend through the channel 1016 and into the metatarsal 108. The Kirschner wires 1300 can extend along the respective axes of the channels of the adjustment guide 1000. Thus, the alignment guide can define the crossing angles of the Kirschner wires 1300.

[0172] As Figure 31 shown, the first part 1004 of the adjustment guide 1000 can be removed from the second part 1008. The attachment mechanism 1006 can be removed from between the first part 1004 and the second part 1008. The first part 1004 can be removed from the Kirschner wires 1300. The second part 1008 can be removed from the Kirschner wires 1300.

[0173] As Figure 32 shown, the resection guide 1100 can slide over the Kirschner wires 1300. The planar portion 1109 can be aligned with one or both of the medial cuneiform 104 and / or the metatarsal 108. The resection tool 1400 can be inserted through the slot 1107 to form resection planes 104a and / or 108a on the respective medial cuneiform 104 and metatarsal 108. As described above, this can assist in correcting the alignment of the medial cuneiform 104 and the metatarsal 108 in the corrective configuration 103.

[0174] As Figure 33 shown, the correction guide 1500 can slide over the Kirschner wires 1300. The correction guide 1500 can be similar to the correction guide 500. The correction guide 1500 can include multiple channels extending along parallel axes. The Kirschner wires 1300 can be received within the channels of the correction guide 1500. This can realign and adjust the positions of the medial cuneiform 104, the metatarsal 108, and / or the proximal phalanx 112 to form the corrective configuration 103 of the patient's foot 100.

[0175] In the corrective configuration 103, a fixation Kirschner wire 1600 (or similar mechanism) can be inserted to fix the positions of the first metatarsal 108 and the medial cuneiform 104. As Figure 34 shown, a bone plate assembly 1700 similar to the bone plate assembly 700 can be attached to the medial cuneiform 104 and the metatarsal 108 to maintain the relative positions of the two bones in the corrective configuration 103.

[0176] Certain terms

[0177] The orientation terms used herein, such as "top", "bottom", "proximal", "distal", "longitudinal", "transverse", and "end", are used in the context of the illustrated examples. However, the present disclosure should not be limited to the illustrated orientations / directions. In fact, other orientations are possible and fall within the scope of the present disclosure. The terms related to a circle used herein, such as diameter or radius, should be understood to not require a perfect circular structure, but rather should be applied to any suitable structure having a cross-sectional area that can be measured from one side to the other. The terms generally related to a shape, such as "circular", "cylindrical", "semicircular", or "semicylindrical" or any related or similar terms, do not need to strictly conform to the mathematical definitions of a circle or a cylinder or other structures, but can include fairly close approximations.

[0178] Conditional terms, such as "can", "may", "could", or "might", unless otherwise specifically stated or otherwise understood in the context in which they are used, generally are intended to convey that certain examples include or do not include certain features, elements, and / or steps. Thus, such conditional terms generally are not intended to imply that one or more examples in any way require features, elements, and / or steps.

[0179] Unless otherwise expressly stated, the connectivity terms commonly used in the context, such as the phrase "at least one / at least a" of X, Y, and Z, should be understood to express that the items, terms, etc. can be X, Y, or Z. Thus, such connectivity terms generally are not intended to imply that certain examples require the presence of at least one of X, at least one of Y, and at least one of Z.

[0180] The terms "about", "approximately", and "substantially" used herein represent amounts close to the stated amount that can still achieve the desired function or reach the desired result. For example, in some examples, as described in the context, the terms "about", "approximately", and "substantially" can refer to amounts within a range of less than or equal to 10% of the stated amount. The term "generally" used herein represents values, amounts, or characteristics that mainly include or tend to a particular value, amount, or characteristic. As an example, in certain examples, as the context may indicate, the term "substantially parallel" can refer to something that deviates from being perfectly parallel by less than or equal to 20 degrees. All ranges include the endpoint values.

[0181] Overview

[0182] Several illustrative examples of Lapidus surgical systems and methods have been disclosed. Although the present disclosure has been described in terms of certain illustrative examples and uses, other examples and other uses, including examples and uses that do not provide all of the features and advantages set forth herein, also fall within the scope of the present disclosure. Components, elements, features, acts, or steps may be arranged or performed in a manner different from that described, and components, elements, features, acts, or steps may be combined, merged, added, or omitted in various examples. All possible combinations and subcombinations of the elements and components described herein are intended to be included in the present disclosure. No single feature or group of features is necessary or indispensable.

[0183] Certain features that are described in the context of separate implementations in the present disclosure may also be implemented in combination in a single implementation. Conversely, the various features that are described in the context of a single implementation may also be implemented separately in multiple implementations or in any suitable subcombination. Additionally, although features may be described as acting in certain combinations above, one or more features from a claimed combination may in some cases be deleted from that combination, and the combination may be claimed as a subcombination or a variant of a subcombination.

[0184] Any part of any step, process / procedure, structure, and / or device that is disclosed or illustrated in an example of the present disclosure may be combined with or used together with (or substituted by any other part of any step, process / procedure, structure, and / or device that is disclosed or illustrated in a different example or flowchart). The examples described herein are not intended to be discrete and separate from one another. Combinations, variations, and some implementations of the disclosed features are within the scope of the present disclosure.

[0185] Although operations may be depicted in a particular order in the figures or described in the specification, such operations need not be performed in the particular order shown or in a sequential order, nor need all operations be performed to achieve the desired result. Other operations that are not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Additionally, in some implementations, the operations may be rearranged or reordered. Further, the separation of the various components in the above-described embodiments should not be understood to be required in all embodiments, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged into multiple products. Additionally, some implementations are also within the scope of the present disclosure.

[0186] In addition, although illustrative examples have been described, any examples with equivalent elements, modifications, omissions, and / or combinations are also within the scope of the present disclosure. Moreover, although certain aspects, advantages, and novel features are described herein, not all of these advantages may necessarily be achieved in accordance with any particular example. For example, some examples within the scope of the present disclosure achieve one advantage or a set of advantages taught herein, but do not necessarily achieve other advantages taught or suggested herein. Additionally, some examples may achieve advantages different from those taught or suggested herein.

[0187] Some examples are described in conjunction with the accompanying drawings. The drawings are drawn and / or shown to scale, but such scale should not be limiting since other dimensions and scales in addition to those shown are contemplated and also fall within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship to the actual dimensions and layout of the devices shown. Components may be added, deleted, and / or rearranged. Moreover, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. disclosed herein in connection with various examples may be used in all other examples set forth herein. Additionally, any method described herein may be practiced using any device suitable for performing the described steps.

[0188] For purposes of summarizing the disclosure, certain aspects, advantages, and features of the invention are described herein. Not all or any such advantages must be achieved in accordance with any particular example of the invention disclosed herein. No aspect of the present disclosure is necessary or indispensable. In many examples, the devices, systems, and methods may be configured differently from those shown in the accompanying drawings or described herein. For example, the various functions provided by the shown modules may be combined, rearranged, added, or deleted. In some implementations, additional or different processors or modules may perform some or all of the functions described and shown in the examples described with reference to the accompanying drawings. Many implementation variations are possible. Any feature, structure, step, or process disclosed in this specification may be included in any example.

[0189] In summary, multiple different examples of the Lapidus surgical system and related methods have been disclosed. The present disclosure extends beyond the specifically disclosed examples to other alternative examples and / or other uses of the examples, as well as certain modifications and equivalents thereof. Moreover, the present disclosure clearly contemplates that the various features and aspects of the disclosed examples may be combined or substituted for one another. Accordingly, the scope of the present disclosure should not be limited by the specifically disclosed examples above, but should be determined only by a fair reading of the claims.

Claims

1. A method of manufacturing a kit for correcting the alignment between a first bone and a second bone, the method comprising: Receiving a correction factor, the correction factor including a first virtual vector passing through a first virtual point in a virtual coordinate plane and a second virtual vector passing through a second virtual point in the virtual coordinate plane; Forming a first guide based on the correction factor, the first guide including a first end portion and a second end portion, the first end portion having a first channel disposed along a first axis, and the second end portion having a second channel disposed along a second axis; Wherein 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 axis and the second axis are not parallel; Wherein the first guide is configured such that: in a deformed configuration, a first Kirschner wire inserted through the first channel intersects the first bone, and a second Kirschner wire inserted through the second channel intersects the second bone; The method further comprises: Receiving dimensions of a second guide, the second guide including a first end portion with a first channel and a second end portion with a second channel, the first channel of the second guide being parallel to the second channel of the second guide; Wherein the first guide is configured such that: sliding the second guide on the first Kirschner wire and the second Kirschner wire with the first Kirschner wire and the second Kirschner wire received in respective first and second channels of the second guide will realign the first bone and the second bone into a corrected configuration.

2. The method according to claim 1, further comprising: Receiving a scan of the first bone and the second bone in the deformed configuration to present a 3D model of the first bone and the second bone, the 3D model including a first virtual bone and a second virtual bone in a virtual deformed configuration; Adjusting the first virtual bone and the second virtual bone in the 3D model to align the first virtual bone and the second virtual bone into a virtual corrected configuration; In the virtual corrected configuration, fixing a first virtual axis relative to the first virtual bone and fixing a second virtual axis relative to the second virtual bone, the first virtual axis being parallel to the second virtual axis; and Returning the first virtual bone and the second virtual bone to the virtual deformed configuration, the first virtual axis and the second virtual axis respectively defining the first virtual vector and the second virtual vector and the first virtual point and the second virtual point of the correction factor.

3. The method according to claim 2, further comprising: Identifying a virtual resection plane in the virtual corrected configuration where the first virtual bone and the second virtual bone overlap; and Wherein fixing the first virtual axis relative to the first virtual bone includes arranging the first virtual axis to be parallel to the virtual resection plane.

4. A kit for correcting the alignment between a first bone and a second bone by arthrodesis between the first bone and the second bone, the kit comprising: A first guide, the first guide comprising: A first end portion having a first channel disposed along a first axis; and a second end portion having a second channel disposed along a second axis, the first axis being non-parallel to the second axis; wherein the first guide is configured such that when the first bone and the second bone are in a deformed configuration, a first Kirschner wire inserted through the first channel intersects the first bone, and a second Kirschner wire inserted through the second channel intersects the second bone; A second guide, the second guide comprising: a first end portion having a first channel; and a second end portion having a second channel, the first channel of the second guide being parallel to the second channel of the second guide; wherein the second guide is configured such that when the first Kirschner wire is fixed within the first bone in a deformed configuration and the second Kirschner wire is fixed within the second bone in a deformed configuration, sliding the second guide over the first Kirschner wire and the second Kirschner wire while the first Kirschner wire and the second Kirschner wire are received within the respective first and second channels of the second guide causes the first bone and the second bone to realign into a corrected configuration.

5. The kit according to claim 4, further comprising: A stabilizing pin for fixing the first bone and the second bone in the corrected configuration by inserting the stabilizing pin into the first bone and the second bone.

6. The kit according to claim 4, further comprising: A bone plate, a first end of the bone plate being configured to attach to the first bone and a second end of the bone plate being configured to attach to the second bone such that the first bone and the second bone are held in the corrected configuration.

7. The kit according to claim 6, further comprising a bone plate clamp configured to be inserted into the first bone and the second bone in the corrected configuration.

8. The kit according to claim 4, further comprising: A first resection guide configured to align a resection tool with a resection location on the first bone.

9. The kit according to claim 8, wherein The first resection guide includes a first channel and a second channel, the first channel and the second channel of the first resection guide being configured to travel on a first Kirschner wire and a third Kirschner wire, the third Kirschner wire being parallel to the first Kirschner wire.

10. The kit according to claim 9, further comprising a second resection guide configured to align the resection tool with a resection location on the second bone.

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