# US 9,433,439 B2 · Radiolucent stabilizing rod with radiopaque marker

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- Number: US 9,433,439 B2
- Document ID: US9433439B2
- Status: Granted
- Kind: B2
- Application number: 12/557,081
- Filed: 2009-09-10
- Published: 2011-03-10
- Granted: 2016-09-06
- Earliest claimed: 2009-09-10
- Assignees: Innovasis, Inc.
- Applicants: Brent A. Felix; David N. McKean; David A. Hershgold
- Inventors: Brent A. Felix; David N. McKean; David A. Hershgold
- Web page: https://patentgrep.com/patent/US9433439B2

## CPC

- A61B 17/7002: {Longitudinal elements, e.g. rods}
- A61B 17/7011: {Longitudinal element being non-straight, e.g. curved, angled or branched (adjustable length longitudinal elements A61B17/7014; A61B17/7019 takes precedence, e.g. coil springs)}
- A61B 2017/00526: {Methods of manufacturing}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A stabilizing rod includes an elongate shaft extending between a proximal end and an opposing distal end. The shaft is comprised of a radiolucent material and bounds a passageway that at least partially extends between the proximal end and the distal end. A core is disposed within the passageway of the shaft. The core can be comprised of a radiopaque material. The stabilizing rod can also include a radiopaque marker disposed on or within the shaft.

## Claims

### Claim 1

A stabilizing rod for use in positioning adjacent vertebrae with respect to each other, the stabilizing rod comprising:
an elongate shaft extending longitudinally between a proximal end and an opposing distal end, the shaft having a first end face disposed at the proximal end, a second end face disposed at the distal end, and an encircling side surface extending between the end faces, the shaft having a central longitudinal axis extending between the proximal end and the distal end and bounding a passageway that extends along the central longitudinal axis so that the central longitudinal axis is disposed within the passageway, the shaft being comprised of a radiolucent material and the encircling side surface consisting entirely of a radiolucent material, the radiolucent material comprising a matrix of fiber and adhesive; and
a solid core having an encircling exterior side surface that extends between opposing end faces, the solid core being disposed within the passageway of the shaft and extending between the proximal and distal ends of the shaft so that the core extends along the central longitudinal axis of the shaft, the solid core being comprised of a radiopaque material and being bonded to the shaft by the adhesive of the shaft along the entire length of the core, the solid core having the configuration of a rod and being the only rod that extends along the length of the shaft, wherein the matrix of fiber and adhesive is wound around the core so that the fiber encircles the core in a helical pattern, wherein the matrix of fiber and adhesive is bonded together so that at least a section of the shaft extends continuously as a unitary bonded structure between the opposing end faces of the shaft without encircling the core.

### Claim 2 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the rod has a diameter that is between about 3 mm to about 8 mm and the rod has a length that is between about 25 mm to about 460 mm.

### Claim 3 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the passageway extends longitudinally completely through the shaft.

### Claim 4 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the shaft is substantially straight.

### Claim 5 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the shaft and the core are curved in a continuous arc between the proximal end and the distal end.

### Claim 6 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the radiolucent material comprises a carbon fiber epoxy matrix.

### Claim 7 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the core has a cross-sectional shape that is polygonal, oval, non-symmetrical, or has at least one linear surface.

### Claim 8 (depends on 1)

The stabilizing rod as recited in claim 1, further comprising at least one positioning marker disposed on or within the shaft, the at least one marker being comprised of a radiopaque material.

### Claim 9 (depends on 8)

The stabilizing rod as recited in claim 8, wherein the at least one positioning marker is in the form of a ring that encircles the core.

### Claim 10 (depends on 8)

The stabilizing rod as recited in claim 8, wherein the at least one positioning marker comprises an end cap disposed on the proximal end or distal end of the shaft.

### Claim 11 (depends on 8)

The stabilizing rod as recited in claim 8, wherein the at least one positioning marker comprises a paint or ink that is painted or printed on an exterior surface of the shaft.

### Claim 12 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the core has an interior surface that bounds a passageway longitudinally extending through the core.

### Claim 13 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the core is a tubular member comprised of a metal wire or ribbon that is coiled in a helical configuration.

### Claim 14 (depends on 1)

A bone stabilizing system, comprising:
a bone screw having a collar with a channel transversely extending therethrough;
a rod according to claim 1, the rod having a cross section that is configured to fit within the channel; and
a fastener configured to secure the rod to the bone screw within the channel.

### Claim 15 (depends on 14)

The bone stabilizing system as recited in claim 14, wherein a portion of the rod is disposed within the channel and is secured to the bone screw by the fastener.

### Claim 16 (depends on 15)

The bone stabilizing system as recited in claim 15, further comprising:
a second bone screw having a second collar with a second channel transversely extending therethrough; and
a second fastener that secures a second portion of the rod to the second bone screw within the second channel.

### Claim 17 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the core comprises a solid metal rod.

### Claim 18 (depends on 17)

The stabilizing rod as recited in claim 17, wherein the diameter of the rod is between about 3 mm to about 8 mm and the length of the rod is between about 30 mm to about 100 mm.

### Claim 19 (depends on 17)

A bone stabilizing system comprising:
a bone screw having a collar with a channel transversely extending therethrough;
a rod according to claim 17, the rod having a cross section that is configured to fit within the channel; and
a fastener configured to secure the rod to the bone screw within the channel.

### Claim 20 (depends on 17)

The stabilizing rod as recited in claim 17, wherein the core is the only rod secured to the shaft.

### Claim 21 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the core has a central longitudinal axis extending along the length thereof, the central longitudinal axis of the core being disposed along the central longitudinal axis of the shaft.

### Claim 22 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the matrix of fiber and adhesive is in the form of a sheet that is wound around the core.

### Claim 23 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the adhesive comprises polyetheretherketone (PEEK) or polyaryletherketone (PAEK).

### Claim 24 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the fiber comprises a carbon fiber.

### Claim 25 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the encircling exterior side surface of the solid core is entirely covered by the shaft between the opposing end faces of the shaft with no slits extending through the shaft to the core.

### Claim 26 (depends on 1)

The stabilizing rod as recited in claim 1, wherein for an entire length of the core the fiber encircles the core in a helical pattern and the entire encircling exterior side surface of the core is completely covered by the shaft with no slits extending through the shaft to the core.

### Claim 27 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the matrix of fiber and adhesive wound around the core forms a portion of the shaft that is circumferentially continuous at least at the given length of the core completely covered by the shaft.

### Claim 28 (depends on 1)

The stabilizing rod as recited in claim 1, wherein for at least portions of the core, the encircling exterior side surface of the core is covered by the two or more overlapping layers of the fibers.

### Claim 29 (depends on 1)

The stabilizing rod as recited in claim 1, wherein the section of the shaft that extends continuously as a unitary bonded structure between the opposing end faces of the shaft without encircling the core extends linearly between the opposing end faces of the shaft.

### Claim 30

A stabilizing rod for use in positioning adjacent vertebrae with respect to each other, the stabilizing rod comprising:
an elongate shaft extending longitudinally between a proximal end and an opposing distal end, the shaft bounding and completely encircling a passageway at least partially extending between the proximal end and the distal end, the shaft being comprised of a radiolucent material, the radiolucent material comprising a matrix of fiber and adhesive; and
a solid core having an encircling exterior side surface that extends between opposing end faces, the solid core being disposed within the passageway of the shaft and extending between the proximal and distal ends of the shaft, the solid core having the configuration of a rod and being configured so that the entire length of the core is disposed within a plane, the core being comprised of a radiopaque material and being bonded to the shaft by the adhesive of the shaft along the entire length of the core, the core being the only rod secured to the shaft, wherein the matrix of fiber and adhesive is wound around the core so that the fiber encircles the core in a helical pattern, wherein the matrix of fiber and adhesive is bonded together so that at least a section of the shaft extends continuously as a unitary bonded structure between the proximal end and the opposing distal end of the shaft without encircling the core.

### Claim 31

A stabilizing rod for use in positioning adjacent vertebrae with respect to each other, the stabilizing rod comprising:
an elongate shaft having a central longitudinal axis extending between a proximal end and an opposing distal end, the shaft bounding and completely encircling a passageway that extends along the central longitudinal axis at least partially between the proximal end and the distal end so that the central longitudinal axis is disposed within the passageway, the shaft being comprised of a radiolucent material, the radiolucent material comprising a matrix of fiber and adhesive; and
a solid core disposed within the passageway of the shaft and extending between the proximal and distal ends of the shaft, the solid core being comprised of a radiopaque material such that when the stabilizing rod is X-rayed, the solid core is the only portion of the stabilizing rod viewable on the corresponding X-ray image, the core having an encircling exterior side surface extending along the length thereof that is bonded to the shaft by the adhesive of the shaft along the entire length of the core, wherein the matrix of fiber and adhesive is wound around the core so that the fiber encircles the core along the length thereof in a helical pattern, wherein the matrix of fiber and adhesive is bonded together so that at least a section of the shaft extends continuously as a unitary bonded structure between the proximal end and the opposing distal end of the shaft without encircling the core.
