# US 10,441,317 B2 · Bone fixation system and method using a clamping instrument to guide fastener placement

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- Number: US 10,441,317 B2
- Document ID: US10441317B2
- Status: Granted
- Kind: B2
- Application number: 15/658,198
- Filed: 2017-07-24
- Published: 2018-04-26
- Granted: 2019-10-15
- Earliest claimed: 2016-10-26
- Assignees: SIGN Fracture Care International
- Applicants: SIGN Fracture Care International
- Inventors: Paul DeVasConCellos
- Web page: https://patentgrep.com/patent/US10441317B2

## CPC

- A61B 17/6441: {Bilateral fixators, i.e. with both ends of pins or wires clamped}
- A61B 17/1615: {Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material}
- A61B 17/62: Ring frames, i.e. devices extending around the bones to be positioned ({A61B17/6433} , A61B17/66 take precedence)
- A61B 17/6425: {specially adapted to be fitted across a bone joint}
- A61B 17/645: {comprising a framework (A61B17/6425, A61B17/6441 take precedence)}
- A61B 17/683: {comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut}
- A61B 17/844: {with expandable anchors or anchors having movable parts}
- A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)}
- A61B 17/8866: {for gripping or pushing bones, e.g. approximators (joint distractors A61B17/025)}
- A61B 17/17: Guides {or aligning means} for drills {, mills, pins or wires}
- A61B 2017/088: {Sliding fasteners}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

System and method for fixing bone. An exemplary system may comprise a clamping instrument, a first fastener, and a second fastener. The clamping instrument may include a first tube and a second tube. The tubes may have an adjustable separation from one another while remaining coaxially aligned with one another on an axis, and may be configured to apply pressure to opposite sides of a bone to compress the bone. The first fastener may be configured to pass through the first tube on the axis. The second fastener may be configured to attach to the first fastener and to pass through the second tube on the axis. In some embodiments, the system also may comprise an insertion tool configured to carry the second fastener into the second tube and prevent the second fastener from turning.

## Claims

### Claim 1

A system for fixing bone, comprising:
a clamping instrument including a first tube and a second tube, the tubes having an adjustable separation from one another while remaining coaxially aligned with one another on an axis and being configured to apply pressure to opposite skies of a bone to compress the bone;
a first fastener configured to pass through the first tube on the axis; and
a second fastener configured to attach to the first fastener and to pass through the second tube on the axis; and
an insertion tool that mates with the second fastener, the insertion tool being configured to be inserted into the second tube along the axis while the second tube remains engaged with bone;
wherein the insertion tool is configured to be locked to the clamping instrument.

### Claim 2 (depends on 1)

The system of claim 1, where the separation between the first tube and the second tube is adjustable by translational motion of the tubes relative to one another and also by rotational motion of the tubes relative to one another.

### Claim 3 (depends on 1)

The system of claim 1, wherein the clamping instrument includes a frame that holds each of the tubes, and wherein at least one of the tubes is in threaded engagement with the frame that permits rotation of the at least one tube about the axis.

### Claim 4 (depends on 1)

The system of claim 1, wherein the insertion tool defines an axial channel that extends through the insertion tool.

### Claim 5 (depends on 4)

The system of claim 4, further comprising a drill bit having an outer diameter that matches a diameter of the axial channel.

### Claim 6 (depends on 1)

The system of claim 1, wherein the insertion tool has a graspable handle configured to remain outside the second tube when the insertion tool is locked to the clamping instrument.

### Claim 7 (depends on 1)

The system of claim 1, further comprising a drill bit having an outer diameter that substantially matches an inside diameter of the tube.

### Claim 8 (depends on 1)

The system of claim 1, wherein the first fastener has an external thread, wherein the second fastener has a barrel, a flange, and a head, and wherein the external thread of the first fastener is configured to be engaged with an interior surface of the barrel to produce threaded engagement that attaches the fasteners to one another.

### Claim 9

A system for fixing bone, comprising:
a clamping instrument including a first tube and a second tube, the tubes having an adjustable separation from one another while remaining coaxially aligned with one another on an axis and being configured to apply pressure to opposite sides of a bone to compress the bone parallel to the axis;
a first fastener configured to pass through the first tube on the axis;
a second fastener configured to pass through the second tube on the axis; and
an insertion tool configured to carry the second fastener into the second tube along the axis, and to hold the second fastener and prevent it from turning while the first fastener is being turned to attach the fasteners to one another.

### Claim 10

A method of fixing bone, the method comprising, in any order:
compressing a bone with a clamping instrument, wherein the clamping instrument has a first tube and a second tube that apply pressure to opposite sides of the bone and are coaxially aligned with one another on an axis;
creating a hole through the bone on the axis;
passing a leading end of a first fastener through the first tube and into the hole;
inserting a second fastener into the second tube along the axis; and
attaching the first and second fasteners to one another;
wherein the steps of creating, passing, inserting, and attaching are performed while the first and second tubes remain engaged with the bone.

### Claim 11 (depends on 10)

The method of claim 10, further comprising a step of mating the second fastener and an insertion tool with one another, wherein the step of inserting includes a step of manipulating the insertion tool while the insertion tool carries the second fastener.

### Claim 12 (depends on 11)

The method of claim 11, wherein the step of inserting includes a step of locking the insertion tool to the clamping instrument.

### Claim 13 (depends on 11)

The method of claim 11, wherein the insertion tool defines an axial channel, and wherein the step of creating a hole includes a step of guiding a drill bit into the bone using the axial channel.

### Claim 14 (depends on 13)

The method of claim 13, wherein the hole includes a bore and a counterbore, wherein the second tube defines a channel, and wherein the step of creating a hole includes a step of forming the counterbore with a drill bit guided into the bone using the channel of the second tube.

### Claim 15 (depends on 10)

The method of claim 10, wherein the step of creating a hole includes a step of advancing a tip of a drill through the second tube and into contact with the bone.

### Claim 16 (depends on 10)

The method of claim 10, wherein the step of creating a hole includes a step of forming a bore through the bone, and a step of forming a counterbore extending into the bone near the second tube.

### Claim 17 (depends on 16)

The method of claim 16, wherein the step of attaching includes a step of engaging a surface of the bone with a flange of the second fastener, such that a barrel of the second fastener is located inside the counterbore formed in the bone.

### Claim 18 (depends on 10)

The method of claim 10, further comprising a step of placing a gauge into the hole to measure a dimension corresponding a length of the hole, and a step of selecting a first fastener from a set of first fasteners of different length based on the dimension measured.
