# US 10,245,086 B2 · Bone plating kit for foot and ankle applications

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- Number: US 10,245,086 B2
- Document ID: US10245086B2
- Status: Granted
- Kind: B2
- Application number: 15/047,343
- Filed: 2016-02-18
- Published: 2016-08-18
- Granted: 2019-04-02
- Earliest claimed: 2015-02-18
- Assignees: Treace Medical Concepts, Inc.
- Applicants: Treace Medical Concepts, Inc.
- Inventors: John T. Treace; F. Barry Bays; Paul Dayton
- Web page: https://patentgrep.com/patent/US10245086B2

## CPC

- A61B 17/8061: {specially adapted for particular bones (A61B17/70 and A61B17/74 take precedence)}
- A61B 17/1728: {for holes for bone plates or plate screws}
- A61B 17/60: for external osteosynthesis, e.g. distractors, contractors
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61B 17/8028: {Cushions, i.e. elements forming interface between bone plate and bone}
- A61B 17/8052: {immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded}
- A61B 17/8057: {the interlocking form comprising a thread}
- A61B 17/808: {Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms}
- A61B 17/8085: {with pliable or malleable elements or having a mesh-like structure, e.g. small strips (A61B17/8071, A61B17/8076 take precedence)}
- A61B 17/848: {Kirschner wires, i.e. thin, long nails}
- A61B 17/8863: {Apparatus for shaping or cutting osteosynthesis equipment by medical personnel}
- A61B 17/15: Guides therefor
- A61B 17/151: {for corrective osteotomy}
- A61B 17/152: {for removing a wedge-shaped piece of bone}
- A61B 17/16: Instruments for performing osteoclasis; Drills or chisels for bones; Trepans {(arthroscopic bone cutters A61B17/320016)}
- A61B 17/6458: {with pin-clamps fixed at ends of connecting element}
- A61B 17/8875: {Screwdrivers, spanners or wrenches}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A bone plate kit may be provided for a foot or ankle orthopedic procedure, such as a lapidus procedure. In some examples, the bone plate kit includes a sterile container that holds multiple unicortical bone plate fasteners and one or more bone plates. For example, the kit may contain two bone plates configured to be used together during a tarsal-metatarsal fusion procedure. Each of the two bone plates may be configured to span different regions of a tarsal-metatarsal joint. The unicortical bone plate fasteners can be used to secure the two bone plates to the first metatarsal and medial cuneiform of a patient undergoing a procedure. In some configurations, one of the bone plates is a helical bone plate while the other bone plate may or may not be a helical bone plate.

## Claims

### Claim 1

A disposable single-use surgical kit for a foot or ankle orthopedic procedure comprising:
a sterile container;
a plurality of unicortical bone plate fasteners included in the sterile container; and
at least one bone plate but no more than four bone plates included in the sterile container, each bone plate comprising:
a body having a top surface and a bone facing surface opposite the top surface; and
a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of unicortical bone plate fasteners included in the sterile container,
wherein at least one bone plate of the at least one but no more than four bone plates comprises the body extending from a proximal region to a distal region and having a helical curvature between the proximal region and the distal region.

### Claim 2 (depends on 1)

The kit of claim 1, wherein each bone plate is configured to be positioned across a tarsal-metatarsal joint for tarsal-metatarsal joint fusion.

### Claim 3 (depends on 1)

The kit of claim 1, wherein the at least one bone plate but no more than four bone plates is two bone plates, a first one of the two bone plates being configured to span from a dorsal region of a medial cuneiform to a medial region of a first metatarsal and a second one of the two bone plates being configured to span from a plantar region of the first metatarsal to a medial region of the medial cuneiform.

### Claim 4 (depends on 3)

The kit of claim 3, wherein each of the two bone plates has four fixation holes with two of the four fixation holes positioned on a distal region of the bone plate and two of the four fixation holes positioned on a proximal region of the bone plate.

### Claim 5 (depends on 4)

The kit of claim 4, wherein the plurality of unicortical bone plate fasteners is at least eight.

### Claim 6 (depends on 1)

The kit of claim 1, wherein the helical curvature comprises both a bend of the body along a central longitudinal axis and a twist of the body about the central longitudinal axis, and wherein the distal region lies in a first plane and the proximal region lies in a second plane offset from the first plane both along and about the central longitudinal axis such that the helical curvature provides a transition from the first plane to the second plane.

### Claim 7 (depends on 1)

The kit of claim 1, wherein each of the plurality of unicortical bone plate fasteners is sized to be inserted through a fixation hole of a bone plate and through one cortical wall of at least one of a first metatarsal and a medial cuneiform but not an opposed cortical wall of the at least one of the first metatarsal and the medial cuneiform.

### Claim 8 (depends on 1)

The kit of claim 1, wherein a number of the plurality of unicortical bone plate fasteners included in the sterile container is greater than or equal to a total number of fixation holes of the bone plates included in the sterile container.

### Claim 9 (depends on 1)

The kit of claim 1, wherein a number of the plurality of unicortical bone plate fasteners included in the sterile container is equal to a total number of fixation holes of the bone plates included in the sterile container plus at least one and no more than four, and no other bone plate fasteners are included in the sterile container.

### Claim 10 (depends on 1)

The kit of claim 1, wherein the bone facing surface of each bone plate includes a pad extending out a distance from a first surface.

### Claim 11 (depends on 10)

The kit of claim 10, wherein the pad extends out the distance from the first surface at a location on the bone facing surface adjacent the first fixation hole.

### Claim 12 (depends on 1)

The kit of claim 1, wherein the body has a length defining a central longitudinal axis and a width defining an extent of the bone plate transverse to the central longitudinal axis, and wherein the width of the body is greater at a location along the central longitudinal axis having the first fixation hole compared to the width of the body at a location remote from the first fixation hole.

### Claim 13 (depends on 1)

The kit of claim 1, wherein at least one bone plate further comprises one of the plurality of unicortical bone plate fasteners at least partially within the first fixation hole.

### Claim 14 (depends on 1)

The kit of claim 1, wherein each one of the plurality of unicortical bone plate fasteners included in the sterile container comprises a head and a shaft, wherein the shaft of each one of the plurality of unicortical bone plate fasteners consists of one of one of two lengths, and there are no other lengths of bone plate fasteners within the sterile container.

### Claim 15 (depends on 1)

The kit of claim 1, wherein each one of the plurality of unicortical bone plate fasteners included in the sterile container comprises a head and a shaft, wherein the shaft of each one of the plurality of unicortical bone plate fasteners consists of one of a first diameter, a second diameter, a third diameter, and a fourth diameter, and there are no other diameters of bone plate fasteners within the sterile container.

### Claim 16 (depends on 1)

The kit of claim 1, further comprising at least one and no more than three plate manipulation instruments included in the sterile container.

### Claim 17 (depends on 16)

The kit of claim 16, wherein at least one of the plate manipulation instruments includes an end configured to drive one of the plurality of unicortical bone plate fasteners received within the first fixation hole into a bone.

### Claim 18 (depends on 1)

The kit of claim 1, further comprising a bone preparation instrument included in the sterile container.

### Claim 19 (depends on 18)

The kit of claim 18, further comprising at least one and no more than ten bone preparation fixation pins included in the sterile container.

### Claim 20 (depends on 1)

The kit of claim 1, further comprising at least one and no more than six bone cut pins included in the sterile container.

### Claim 21 (depends on 20)

The kit of claim 20, wherein at least one of the bone cut pins includes a collar at a location on the bone cut pin spaced from an end of the bone cut pin.

### Claim 22 (depends on 1)

The kit of claim 1, further comprising at least one and no more than four bone fixation pins included in the sterile container.

### Claim 23 (depends on 22)

The kit of claim 22, wherein each of the bone fixation pins includes a collar at a location on the bone fixation pin spaced from an end of the bone fixation pin.

### Claim 24 (depends on 1)

The kit of claim 1, further comprising at least one and no more than three external fasteners included in the sterile container and at least one and no more than three washers sized to receive the at least one and no more than three external fasteners.

### Claim 25 (depends on 1)

The kit of claim 1, further comprising at least one and no more than two external fasteners included in the sterile container, wherein the at least one and no more than two external fasteners have a length different than a length of each one of the plurality of unicortical bone plate fasteners included in the sterile container, and further including at least one and no more than two washers sized to receive the at least one and no more than two external fasteners.

### Claim 26 (depends on 1)

The kit of claim 1, further comprising at least one and no more than two saw blades included in the sterile container.

### Claim 27 (depends on 1)

The kit of claim 1, further comprising at least one and no more than four reamer sizes.

### Claim 28

A method for performing a surgical operation, the method comprising the steps of:
removing a plurality of bone plate fasteners from a sterile container, wherein each one of the plurality of bone plate fasteners comprises a head and a shaft, and wherein the shaft of each one of the plurality of bone plate fasteners consists of one of a first length, a second length, a third length, and a fourth length, and further wherein the diameter of each one of the plurality of bone plate fasteners consists of one of a first diameter, a second diameter, a third diameter, or a fourth diameter, and there are no other lengths or diameters of bone plate fasteners within the sterile container;
removing at least one and no more than four bone plates from the sterile container, the at least one and no more than four bone plates each comprising:
a body having a top surface and a bone facing surface opposite the top surface; and
a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of bone plate fasteners;
contacting a bone with the at least one and no more than four bone plates removed from the sterile container; and
inserting one of the plurality of bone plate fasteners removed from the sterile container through the first fixation hole and into the bone,
wherein removing at least one and no more than four bone plates comprises removing a bone plate comprising the body extending from a proximal region to a distal region and having a helical curvature between the proximal region and the distal region.

### Claim 29 (depends on 28)

The method of claim 28, wherein contacting the bone with the at least one and no more than four bone plates removed from the sterile container comprises contacting the bone with a pad extending out a distance from the first surface of each of the at least one and no more than four bone plates.

### Claim 30 (depends on 28)

The method of claim 28,
wherein removing at least one and no more than four bone plates from the sterile container is removing two bone plates from the sterile container, and
contacting the bone comprises positioning each of the two bone plates across a tarsal-metatarsal joint.

### Claim 31 (depends on 30)

The method of claim 30, wherein the plurality of bone plate fasteners comprise unicortical bone plate fasteners, and inserting one of the plurality of bone plate fasteners comprises inserting one of the plurality of unicortical bone plate fasteners.

### Claim 32 (depends on 28)

The method of claim 28, further comprising:
removing at least one and no more than ten bone preparation fixation pins from the sterile container; and
fixing the single bone preparation instrument to the bone at a position near the bone location to be cut using the at least one and no more than ten bone preparation fixation pins.

### Claim 33 (depends on 28)

The method of claim 28, further comprising:
removing at least one and no more than three plate manipulation instruments from the sterile kit;
inserting an end of one of the plate manipulation instruments into an attachment member configured at least partially within the first fixation hole of one of the bone plates removed from the sterile container; and
bending one of the bone plates while the end of the plate manipulation instrument is inserted in the attachment member.
