# US 11,304,735 B2 · Systems and methods for Lapidus repair of bunions

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- Number: US 11,304,735 B2
- Document ID: US11304735B2
- Status: Granted
- Kind: B2
- Application number: 17/178,109
- Filed: 2021-02-17
- Published: 2021-08-19
- Granted: 2022-04-19
- Earliest claimed: 2020-02-19
- Assignees: Crossroads Extremity Systems, LLC
- Applicants: CrossRoads Extremity Systems, LLC
- Inventors: Daniel Sayger; Michael Chad Hollis; Craig Squires
- Web page: https://patentgrep.com/patent/US11304735B2

## CPC

- A61B 17/151: {for corrective osteotomy}
- A61B 17/1775: {for the foot or ankle}
- A61B 17/15: Guides therefor
- A61B 17/3403: {Needle locating or guiding means}
- A61B 17/7225: {for bone compression}
- A61B 17/7283: {with special cross-section of the nail}
- A61B 17/7291: {for small bones, e.g. in the foot, ankle, hand or wrist}
- A61B 17/8061: {specially adapted for particular bones (A61B17/70 and A61B17/74 take precedence)}
- A61B 17/8866: {for gripping or pushing bones, e.g. approximators (joint distractors A61B17/025)}
- A61B 17/0642: {for bones, e.g. for osteosynthesis or connecting tendon to bone}
- A61B 17/1728: {for holes for bone plates or plate screws}
- A61B 17/848: {Kirschner wires, i.e. thin, long nails}
- A61B 2017/0645: {being elastically deformed for insertion}
- A61B 2017/3407: {including a base for support on the body}
- A61B 2017/3411: {with a plurality of holes, e.g. holes in matrix arrangement}
- A61B 2017/3492: {against the outside of the body}
- A61B 2017/565: {for surgical correction of axial deviation, e.g. hallux valgus or genu valgus}
- A61B 2017/681: {Alignment, compression, or distraction mechanisms}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems, devices, and methods for performing Lapidus bunionectomy procedures are disclosed. An example method includes inserting a plurality of metatarsal pins into the first metatarsal at a first predetermined spacing relative to the first tarsometatarsal (TMT) joint, excising the first TMT joint by cutting the bases of the first metatarsal and the first cuneiform proximate the first TMT joint, inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint, compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform, and fixing the first TMT joint using a bone plate and a plurality of bone screws. At least one of the plurality of bone screws may be a cross screw extending at an angle of less than 90 degrees relative to the bone plate and may anchor the resected first TMT joint to the second metatarsal or the second cuneiform to prevent recurrence of the bunion.

## Claims

### Claim 1

A method of correcting a bunion, the method comprising:
inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint;
excising the first TMT joint of the foot, the excising comprising:
cutting a base of the first metatarsal proximate the first TMT joint; and
cutting a base of a first cuneiform of the foot proximate the first TMT joint;
inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform; and
fixing the first TMT joint, wherein the first TMT joint is fixed using a bone plate and a plurality of bone screws, and wherein at least one of the plurality of bone screws is a cross screw extending at an angle of less than 90 degrees relative to the bone plate.

### Claim 2 (depends on 1)

The method of claim 1, wherein the cross screw extends through the bone plate, the first metatarsal, and at least a portion of a second metatarsal of the foot or a second cuneiform of the foot.

### Claim 3 (depends on 1)

The method of claim 1, further comprising placing a staple through the bone plate such that a first leg of the staple is seated within the first cuneiform and a second leg of the staple is seated within the first metatarsal.

### Claim 4 (depends on 3)

The method of claim 3, wherein the bone plate comprises a cross screw aperture shaped to guide placement of the cross screw such that the second leg of the staple does not impede placement of the cross screw.

### Claim 5 (depends on 1)

The method of claim 1, wherein the plurality of metatarsal pins are inserted prior to excising the first TMT joint.

### Claim 6 (depends on 1)

The method of claim 1, wherein the plurality of cuneiform pins are inserted prior to cutting the base of the first cuneiform.

### Claim 7 (depends on 1)

The method of claim 1, further comprising placing a reversible cut guide across a dorsal side of the first TMT joint prior to inserting the plurality of metatarsal pins and the plurality of cuneiform pins, the reversible cut guide comprising:
a body;
a plurality of first pin holes extending parallel through the body;
a plurality of second pin holes extending through the body parallel to the proximal pin holes;
a joint-seeking paddle extending downward from the body between the proximal pin holes and the distal pin holes such that, when the joint-seeking paddle is at least partially disposed within the first TMT joint, the first pin holes define the first predetermined spacing relative to the first TMT joint; and
a slot extending through the body parallel to a plane of the joint-seeking paddle such that the slot defines a cutting plane for cutting the base of the first metatarsal or the base of the first cuneiform.

### Claim 8 (depends on 7)

The method of claim 7, wherein the base of the first metatarsal and the base of the first cuneiform are cut through the slot, the method further comprising, after cutting the base of the first metatarsal and prior to cutting the base of the first cuneiform:
removing the reversible cut guide from the first TMT joint; and
placing the reversible cut guide across the dorsal side of the first TMT joint in a reversed orientation such that the slot defines a cutting plane for cutting the base of the first cuneiform.

### Claim 9 (depends on 1)

The method of claim 1, further comprising, prior to fixing the first TMT joint, re-cutting the base of the first metatarsal or the base of the first cuneiform to remove additional tissue.

### Claim 10 (depends on 1)

The method of claim 1, further comprising, prior to fixing the first TMT joint, performing a frontal plane realignment comprising additional rotation within the frontal plane of the first metatarsal.

### Claim 11

A method of correcting a bunion, the method comprising:
inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint;
excising the first TMT joint of the foot, the excising comprising:
cutting a base of the first metatarsal proximate the first TMT joint; and
cutting a base of a first cuneiform of the foot proximate the first TMT joint;
inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform; and
fixing the first TMT joint,
the method further comprising placing a cut guide across a dorsal side of the first TMT joint prior to inserting the plurality of metatarsal pins and the plurality of cuneiform pins, the cut guide comprising:
a body;
a plurality of proximal pin holes extending parallel through the body;
a plurality of distal pin holes extending through the body parallel to the proximal pin holes; and
a joint-seeking paddle extending downward from the body between the proximal pin holes and the distal pin holes such that, when the joint-seeking paddle is at least partially disposed within the first TMT joint, the distal pin holes define the first predetermined spacing relative to the first TMT joint and the proximal pin holes define the second predetermined spacing relative to the first TMT joint.

### Claim 12 (depends on 11)

The method of claim 11, wherein the cut guide further comprises a proximal slot extending through the body and a distal slot extending through the body on an opposite side of the joint-seeking paddle relative to the proximal slot, such that the distal slot defines a cutting plane for cutting the base of the first metatarsal and the proximal slot defines a cutting plane for cutting the base of the first cuneiform.

### Claim 13

A method of correcting a bunion, the method comprising:
inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint;
excising the first TMT joint of the foot, the excising comprising:
cutting a base of the first metatarsal proximate the first TMT joint; and
cutting a base of a first cuneiform of the foot proximate the first TMT joint;
inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform; and
fixing the first TMT joint,
the method further comprising, prior to compressing the first TMT joint:
adjusting an alignment of the first metatarsal within a frontal plane of the foot using a control handle coupled to the plurality of metatarsal pins; and
adjusting an alignment of the first metatarsal within a transverse plane of the foot using a linear reducer comprising a medial hook disposed on a medial side of the first metatarsal and a lateral hook disposed on a lateral side of a second metatarsal of the foot, the lateral hook having an adjustable spacing relative to the medial hook.

### Claim 14 (depends on 13)

The method of claim 13, further comprising inserting a medial hook pin through an aperture of the medial hook and into the first metatarsal to rotationally fix the first metatarsal relative to the medial hook prior to adjusting the alignment of the first metatarsal within the transverse plane.

### Claim 15 (depends on 13)

The method of claim 13, wherein at least one of the medial hook and the lateral hook comprises a radiolucent material.

### Claim 16 (depends on 13)

The method of claim 13, wherein the control handle comprises a handle portion and an engagement portion, the engagement portion comprising a plurality of pin apertures spaced apart at a same spacing as a distance between the metatarsal pins.

### Claim 17 (depends on 16)

The method of claim 16, wherein adjusting the alignment of the first metatarsal within the frontal plane comprises:
sliding the pin apertures over the metatarsal pins such that the engagement portion is proximate the first metatarsal; and
rotating the first metatarsal about a longitudinal axis of the first metatarsal by applying torque to the control handle.

### Claim 18 (depends on 13)

The method of claim 13, wherein adjusting the alignment of the first metatarsal within the transverse plane comprises reducing the adjustable spacing between the lateral hook and the medial hook to bring a distal end of the first metatarsal closer to the second metatarsal.

### Claim 19 (depends on 18)

The method of claim 18, wherein the transverse plane alignment of the first metatarsal is adjusted while the first metatarsal is rotationally fixed relative to the medial hook of the linear reducer.

### Claim 20 (depends on 13)

The method of claim 13, wherein the plurality of cuneiform pins are inserted subsequent to adjusting the alignment of the first metatarsal in the frontal plane and the transverse plane.

### Claim 21

A method of correcting a bunion, the method comprising:
inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint;
excising the first TMT joint of the foot, the excising comprising:
cutting a base of the first metatarsal proximate the first TMT joint; and
cutting a base of a first cuneiform of the foot proximate the first TMT joint;
inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform; and
fixing the first TMT joint,
wherein the compressor block comprises:
a body comprising a top surface and a bottom surface;
a plurality of proximal pin holes extending through the body from the top surface to the bottom surface at a first angle of less than 90 degrees relative to the top surface and the bottom surface; and
a plurality of distal pin holes extending through the body from the top surface to the bottom surface at the first angle relative to top surface and the bottom surface such that the proximal and distal pin holes are more closely spaced at the bottom surface relative to the top surface.

### Claim 22 (depends on 21)

The method of claim 21, wherein compressing the first TMT joint comprises:
inserting the cuneiform pins into the proximal pin holes at the bottom surface;
inserting the metatarsal pins into the distal pin holes at the bottom surface; and
sliding the compressor block along the cuneiform pins and the metatarsal pins toward the first TMT joint.

### Claim 23 (depends on 21)

The method of claim 21, wherein the compressor block further comprises at least one cross pin hole extending therethrough, each of the at least one cross pin holes defining a linear path passing diagonally through the first TMT joint when the compressor block is aligned proximate the first TMT joint on the cuneiform pins and the metatarsal pins.

### Claim 24 (depends on 23)

The method of claim 23, further comprising, after compressing the first TMT joint:
inserting a cross pin through the at least one cross pin hole to temporarily fix the first TMT joint;
removing the cuneiform pins and the metatarsal pins from the foot; and
removing the compressor block by sliding the compressor block away from the first TMT joint along the cross pin.

### Claim 25 (depends on 24)

The method of claim 24, further comprising removing the cross pin after at least partially fixing the first TMT joint.

### Claim 26

A method of correcting a bunion, the method comprising:
inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint;
excising the first TMT joint of the foot, the excising comprising:
cutting a base of the first metatarsal proximate the first TMT joint; and
cutting a base of a first cuneiform of the foot proximate the first TMT joint;
inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform;
re-cutting the base of the first metatarsal or the base of the first cuneiform to remove additional tissue; and
fixing the first TMT joint subsequent to the re-cutting,
wherein the re-cutting is performed using a re-cut guide disposed on the metatarsal pins or the cuneiform pins, the re-cut guide defining a predetermined re-cut spacing smaller than a predetermined spacing defined by a cut guide used for the excising of the first TMT joint.

### Claim 27

A method of correcting a bunion, the method comprising:
inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint;
excising the first TMT joint of the foot, the excising comprising:
cutting a base of the first metatarsal proximate the first TMT joint; and
cutting a base of a first cuneiform of the foot proximate the first TMT joint;
inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform;
performing a frontal plane realignment comprising additional rotation within the frontal plane of the metatarsal; and
fixing the first TMT joint subsequent the frontal plane realignment,
wherein the frontal plane realignment is performed simultaneously with the compressing of the first TMT joint, and wherein the compressor block is configured as a realignment guide comprising angularly displaced pin holes such that placing the compressor block compresses the first TMT joint and maintains the additional rotation.

### Claim 28

A method of correcting a bunion, the method comprising:
inserting a plurality of metatarsal pins into a first metatarsal of a foot at a first predetermined spacing relative to a first tarsometatarsal (TMT) joint;
excising the first TMT joint of the foot, the excising comprising:
cutting a base of the first metatarsal proximate the first TMT joint; and
cutting a base of a first cuneiform of the foot proximate the first TMT joint;
inserting a plurality of cuneiform pins into the first cuneiform at a second predetermined spacing relative to the first TMT joint;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform;
performing a frontal plane realignment comprising additional rotation within the frontal plane of the metatarsal; and
fixing the first TMT joint subsequent the frontal plane realignment,
wherein the frontal plane realignment is performed prior to the compressing of the first TMT joint, and wherein the frontal plane realignment comprises:
inserting, through a realignment guide, a plurality of replacement metatarsal pins at the first predetermined spacing relative to the first TMT joint, the replacement metatarsal pins being angularly displaced relative to the metatarsal pins; and
aligning the replacement metatarsal pins linearly with the cuneiform pins prior to compressing the first TMT joint.

### Claim 29

A method of correcting a bunion, the method comprising:
placing a cut guide across a dorsal side of a first tarsometatarsal (TMT) joint of a foot such that a plurality of first pin holes of the cut guide are disposed proximate a first metatarsal of the foot, a plurality of second pin holes of the cut guide are disposed proximate a first cuneiform of the foot, and a joint-seeking paddle of the cut guide is at least partially disposed within the first TMT joint;
inserting a plurality of metatarsal pins into the first metatarsal through the first pin holes;
cutting a base of the first metatarsal proximate the first TMT joint through a slot extending through the cut guide between the first pin holes and the joint-seeking paddle;
removing the cut guide from the foot;
replacing the cut guide across the dorsal side of the first TMT joint in a reversed configuration in which the metatarsal pins extend through the second pin holes;
adjusting an alignment of the first metatarsal within at least one of a frontal plane and a transverse plane of the foot;
inserting a plurality of cuneiform pins into the first cuneiform through the first pin holes;
cutting a base of the first cuneiform proximate the first TMT joint through the slot;
compressing the first TMT joint using a compressor block such that a cut face of the first metatarsal contacts a cut face of the first cuneiform; and
fixing the first TMT joint.