# US 2024/0189031 A1 · Patient-specific osteotomy instrumentation

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- Number: US 2024/0189031 A1
- Document ID: US20240189031A1
- Status: Published application
- Kind: A1
- Application number: 18/412,197
- Filed: 2024-01-12
- Published: 2024-06-13
- Earliest claimed: 2019-09-13
- Assignees: Treace Medical Concepts, Inc.
- Applicants: Treace Medical Concepts, Inc.
- Inventors: Adam D. PERLER; Samuel ADAMS; Adam SCHIFF; James Q. SPITLER
- Web page: https://patentgrep.com/patent/US20240189031A1

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 17/151: {for corrective osteotomy}
- A61B 17/1775: {for the foot or ankle}
- A61B 17/8095: {Wedge osteotomy devices}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/565: {for surgical correction of axial deviation, e.g. hallux valgus or genu valgus}
- A61B 2017/568: {produced with shape and dimensions specific for an individual patient}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A patient-specific instrument is disclosed for performing an osteotomy. The patient-specific instrument includes a body that includes a proximal side, a distal side, a medial side, a lateral side, and an inferior side having a bone engagement surface shaped to match at least one of a first surface of a first bone, a second surface of a second bone, a third surface of a third bone, and a fourth surface of a fourth bone of adjacent joints. The instrument also includes a superior side having one or more guide features that are positioned to guide resection of at least one of the first bone, the second bone, the third bone, and the fourth bone. The body is configured to seat transverse to the adjacent joints with the bone engagement surface engaging at least one of the first surface, the second surface, the third surface, and the fourth surface.

## Claims

### Claim 1

A method for correcting a condition present in a patient's foot, the method comprising:
obtaining a bone model of one or more bones of a patient's foot;
using the bone model to generate a patient-specific cutting guide comprising:
a body configured to seat transverse to a plurality of joints, the body comprising:
a proximal side, a distal side, a medial side, a lateral side and a superior side;
an inferior side comprising a plurality of bone engagement surfaces shaped to match two surfaces of a first surface of a first bone, a second surface of a second bone, a third surface of a third bone, and a fourth surface of a fourth bone; and
one or more guide features positioned to guide resection of at least one of the first bone, the second bone, the third bone, and the fourth bone during an osteotomy;
an anchor feature coupled to the body and configured to receive one or more fasteners to anchor the body to at least one of the first bone, the second bone, the third bone, and the fourth bone;
using the patient-specific cutting guide in a surgical procedure to correct a condition present in the patient's foot.

### Claim 2 (depends on 1)

The method of claim 1, wherein the patient-specific cutting guide comprises a plurality of anchor features, the plurality of anchor features comprising a proximal anchor feature extending proximally from the body and a distal anchor feature extending distally from the body.

### Claim 3 (depends on 2)

The method of claim 2, wherein the proximal anchor feature anchors the body to the first bone and the distal anchor feature anchors the body to the fourth bone, the fourth bone diagonally adjacent to the first bone.

### Claim 4 (depends on 2)

The method of claim 2, wherein the proximal anchor feature extends proximally from the body and dorsal to one of two bones on a proximal side of two adjacent joints and the distal anchor feature extends distally from the body and dorsal to one of two bones on a distal side of the two adjacent joints.

### Claim 5 (depends on 4)

The method of claim 4, wherein the proximal anchor feature comprises a first hole that passes through the proximal anchor feature and the proximal anchor feature is configured to guide a fastener deployed through the first hole toward a longitudinal axis of one of two bones on a proximal side of the two adjacent joints, when the patient-specific cutting guide is in use.

### Claim 6 (depends on 5)

The method of claim 5, wherein the distal anchor feature comprises a second hole that passes through the distal anchor feature and the distal anchor feature is configured to guide a fastener deployed through the second hole toward a longitudinal axis of one of two bones on a distal side of the two adjacent joints, when the patient-specific cutting guide is in use.

### Claim 7 (depends on 1)

The method of claim 1, wherein the anchor feature comprises a guide for at least one of a K-wire and a pin into a bone and wherein the one or more guide features are configured to be patient-specific.

### Claim 8 (depends on 7)

The method of claim 7, wherein the body comprises a longitudinal axis that extends from a medial side of the body to a lateral side of the body and wherein at least one the one or more guide features are positioned at a first angle relative to the longitudinal axis, the first angle within a transverse plane of a patient's foot and the first angle determined at least in part by the bone model.

### Claim 9 (depends on 8)

The method of claim 8, wherein the patient-specific cutting guide comprises:
a first guide feature that extends between a medial side of the patient-specific cutting guide and a lateral side of the patient-specific cutting guide, the first guide feature being coincident with the longitudinal axis;
a second guide feature extends between the medial side and the lateral side and positioned between the first guide feature and a distal side of the patient-specific cutting guide; and
wherein the second guide feature extends away from the first guide feature at the first angle on the superior side of the patient-specific cutting guide.

### Claim 10 (depends on 9)

The method of claim 9, wherein:
the first guide feature extends from the superior side to the inferior side at a first orientation perpendicular to a longitudinal axis of one of one of the first bone, the second bone, the third bone, and the fourth bone; and
the second guide feature extends from the superior side to the inferior side at a second orientation that intersects the longitudinal axis of the one of one of the first bone, the second bone, the third bone, and the fourth bone at a second angle defined based at least in part on patient imaging data.

### Claim 11

A method for making a patient-specific cutting guide configured for an osteotomy procedure, the method comprising:
accessing a bone model of one or more bones of adjacent joints of a patient;
defining one or more guide features of a preliminary cutting guide model for an osteotomy procedure, the preliminary cutting guide model comprising a superior surface and an inferior surface;
defining at least a portion of the inferior surface of the preliminary cutting guide model according to a topographical surface of at least one bone of the bone model such that the inferior surface substantially matches a contour of the topographical surface; and
wherein the preliminary cutting guide model is configured for fabrication of a patient-specific cutting guide corresponding to the preliminary cutting guide model.

### Claim 12 (depends on 11)

The method of claim 11, wherein defining one or more guide features of the preliminary cutting guide model further comprises defining a registration key of the inferior surface of the preliminary cutting guide model according to a topographical surface of two or more bones of adjacent joints of the bone model such that the registration key substantially matches a gap between two or more bones of the bone model.

### Claim 13 (depends on 11)

The method of claim 11, wherein defining one or more guide features of the preliminary cutting guide model further comprises:
defining a first slot configured to guide formation of a first cut surface of a first bone of the patient corresponding to a first modeled bone;
defining a second slot configured to guide formation of a second cut surface of a second bone of the patient corresponding to a second modeled bone;
defining a third slot configured to guide formation of a third cut surface of a third bone of the patient corresponding to a third modeled bone;
defining a fourth slot configured to guide formation of a fourth cut surface of a fourth bone of the patient corresponding to a fourth modeled bone; and
wherein the first slot, second slot, third slot, and fourth slot are positioned such that fixing the first cut surface of the first bone to the second cut surface and the third cut surface of the third bone to the fourth cut surface of the fourth bone mitigates a condition of the patient.

### Claim 14

A method for making a patient-specific cutting guide configured for an osteotomy procedure, the method comprising:
accessing a bone model of four bones of a plurality of adjacent joints of a patient;
defining one or more guide features of a preliminary cutting guide model, the one or more guide features are defined based at least in part on patient imaging data and are positioned to guide resection of at least one of a first bone, a second bone, a third bone, and a fourth bone during an osteotomy; and
fabricating a patient-specific cutting guide corresponding to the preliminary cutting guide model, the patient-specific cutting guide comprising:
a body configured to seat transverse to the plurality of adjacent joints, the body comprising:
a proximal side, a distal side, a medial side, a lateral side and a superior side;
an inferior side comprising a bone engagement surface shaped to match a plurality of surfaces of one or more of the first bone, the second bone, the third bone, and the fourth bone; and
one or more guide features positioned to guide resection of at least one of the first bone, the second bone, the third bone, and the fourth bone during an osteotomy;
a first anchor feature coupled to the body and configured to receive one or more fasteners to anchor the body to at least one of the first bone, the second bone, the third bone, and the fourth bone.

### Claim 15 (depends on 14)

The method of claim 14, wherein the plurality of adjacent joints comprises a first tarsometatarsal (“TMT”) joint and a second TMT joint and the one or more guide features comprises a first guide feature configured to guide resection of a proximal bone in each of the adjacent joints and a second guide feature configured to guide resection of a distal bone in each of the adjacent joints.

### Claim 16 (depends on 14)

The method of claim 14, further comprising:
a proximal bone comprising one of the bones of the first bone, the second bone, the third bone, and the fourth bone;
a distal bone comprising another one of the bones of the first bone, the second bone, the third bone, and the fourth bone;
a second anchor feature;
wherein the first anchor feature extends proximally from the body and perpendicular to one of the one or more guide features, the first anchor feature positioned along a proximal side of the body such that the first anchor feature extends from the body parallel to and dorsal to a longitudinal axis of the proximal bone; and
wherein the second anchor feature extends distally from the body and parallel to the first anchor feature, the second anchor feature positioned along a distal side of the body such that the second anchor feature extends from the body parallel to and dorsal to a longitudinal axis of the distal bone.

### Claim 17 (depends on 14)

The method of claim 14, wherein the inferior side comprises a plurality of bone engagement surfaces shaped to match at least two surfaces of a first surface of the first bone, a second surface of the second bone, a third surface of the third bone, and a fourth surface of the fourth bone.

### Claim 18 (depends on 14)

The method of claim 14, wherein the inferior side further comprises a registration key configured to fit between two or more bones of the plurality adjacent joints.

### Claim 19 (depends on 14)

The method of claim 14, wherein the first anchor feature comprises a guide for at least one of a K-wire and a pin into a bone and wherein at least one of the one or more guide features comprise a position and an orientation, at least one of which is based on patient imaging data.

### Claim 20 (depends on 14)

The method of claim 14, wherein the patient-specific cutting guide comprises a stop configured based on a maximum depth defined using patient imaging data, the stop configured to limit a cutting tool within at least one of the one or more guide features to the maximum depth.
