# US 2019/0167310 A1 · Radiolucent screw with radiopaque marker

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- Number: US 2019/0167310 A1
- Document ID: US20190167310A1
- Status: Published application
- Kind: A1
- Application number: 16/267,198
- Filed: 2019-02-04
- Published: 2019-06-06
- Earliest claimed: 2008-09-11
- Assignees: Innovasis, Inc.
- Applicants: Innovasis, Inc.
- Inventors: Brent A. Felix; David N. McKean; David A. Hershgold
- Web page: https://patentgrep.com/patent/US20190167310A1

## CPC

- A61B 17/8685: {comprising multiple separate parts}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7037: {wherein pivoting is blocked when the rod is clamped}
- A61B 17/866: {Material or manufacture}
- A61B 17/8625: {Shanks, i.e. parts contacting bone tissue}
- A61B 17/864: {hollow, e.g. with socket or cannulated}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2017/0088: {ceramic}
- A61B 2017/0092: {for X-rays}
- A61B 2017/00955: {thermoplastic}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A bone screw includes an elongate shaft extending longitudinally between a proximal end and an opposing distal end. The shaft bounds a first passageway at least partially extending between the proximal end and the distal end. The shaft is comprised of a radiolucent material. A core is disposed within the first passageway of the shaft. The core can be comprised of a radiolucent or radiopaque material. A head is either integrally formed with or secured to the proximal end of the shaft or the proximal end of the core. The head can also bound a second passageway that extends through the head and is aligned with the first passageway. The core can also be disposed within the second passageway.

## Claims

### Claim 1

A bone screw comprising:
an elongate shaft extending longitudinally between a proximal end and an opposing distal end, the shaft bounding a first passageway at least partially extending between the proximal end and the distal end, the shaft being comprised of a radiolucent material; and
a core disposed within the first passageway of the shaft, the core being comprised of a radiopaque material.

### Claim 2 (depends on 1)

The bone screw as recited in claim 1, wherein the shaft comprises an exterior surface having a radially outwardly projecting helical thread formed thereon.

### Claim 3 (depends on 1)

The bone screw as recited in claim 1, further comprising a head or a collar rigidly secured to the proximal end of the shaft.

### Claim 4 (depends on 3)

The bone screw as recited in claim 3, wherein the head or the collar is comprised of a radiopaque material.

### Claim 5 (depends on 3)

The bone screw as recited in claim 3, wherein the head or the collar is comprised of a metal.

### Claim 6

A bone screw comprising:
an elongate shaft extending longitudinally between a proximal end and an opposing distal end, the shaft bounding a first passageway at least partially extending between the proximal end and the distal end, the shaft being comprised of a radiolucent material;
a core disposed within the first passageway of the shaft, the core being comprised of a radiopaque material that comprises a metal, that shaft being comprised of a pre-fabricated sheet comprised of the one or more radiolucent fibers and an adhesive that encircles the radiopaque core so that the one or more radiolucent fibers radially encircling the core;
an enlarged head disposed at an end of the core and being comprised of the same radiopaque material as the core, the core and the head being integrally formed as a single, one piece, unitary member, the enlarged head having a maximum diameter that is larger than a maximum diameter of the core; and
a helical thread recessed into the pre-fabricated sheet encircling the radiopaque core.

### Claim 7 (depends on 6)

The bone screw as recited in claim 6, wherein the head is secured to the proximal end of the shaft.

### Claim 8 (depends on 6)

The bone screw as recited in claim 6, wherein the first passageway extends completely through the shaft.

### Claim 9 (depends on 6)

The bone screw as recited in claim 6, wherein the core has an outer surface with a projection projecting therefrom.

### Claim 10 (depends on 6)

The bone screw as recited in claim 6, wherein the head and the core have an interior surface that bound a passageway that longitudinally extends through the core and the head.

### Claim 11 (depends on 6)

The bone screw as recited in claim 6, wherein the head comprises an annular shoulder, an annular head portion, and a neck formed therebetween, the neck inwardly constricting relative to the annular shoulder and the annular head.

### Claim 12 (depends on 6)

The bone screw as recited in claim 6, wherein the shaft encircles the core but does not encircle the head.

### Claim 13 (depends on 6)

The bone screw as recited in claim 6, wherein the core extends the entire length of the shaft.

### Claim 14

A method of manufacturing a bone screw, the method comprising:
forming an elongated shaft about a core, an enlarged head being integrally formed on an end of the core, the shaft having a longitudinal axis extending between a proximal end and an opposing distal end with a first passageway that extends completely through the shaft along the longitudinal axis, the core being disposed within the first passageway and extending along the longitudinal axis, the shaft being comprised of a radiolucent material that includes one or more radiolucent fibers that radially encircles the core, the core and head being comprised of a radiopaque material, wherein the shaft is formed by:
winding the one or more radiolucent fibers having an adhesive thereon about the radiopaque core; or
winding a sheet comprised of the one or more radiolucent fibers and an adhesive about the radiopaque core; and
forming a helical thread on an exterior surface of the shaft by removing a portion of the exterior surface of the shaft.

### Claim 15 (depends on 14)

The bone screw as recited in claim 14, wherein the one or more radiolucent fibers radially encircle the core in a helical pattern that extends along a length of the core.

### Claim 16 (depends on 14)

The bone screw as recited in claim 14, wherein the radiopaque material of the core is comprised of titanium, stainless steel, tungsten, cobalt based alloys, cobalt chrome alloys, nickel titanium alloys, platinum, iridium, gold, barium and alloys thereof.

### Claim 17 (depends on 14)

The method as recited in claim 14, wherein the step of removing a portion of the exterior surface of the shaft is accomplished through the use of a grinder, lathe or cutting tool.

### Claim 18 (depends on 14)

The method as recited in claim 14, wherein the one or more radiolucent fibers radially encircle the core in a helical pattern that extends along a length of the core.

### Claim 19 (depends on 14)

The method as recited in claim 14, wherein the core and the head are comprised of a metal.