# US 11,026,723 B2 · Pedicle screw assemblies with 3D printed components

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- Number: US 11,026,723 B2
- Document ID: US11026723B2
- Status: Granted
- Kind: B2
- Application number: 16/380,739
- Filed: 2019-04-10
- Published: 2020-10-15
- Granted: 2021-06-08
- Earliest claimed: 2019-04-10
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc.
- Inventors: William Alan Rezach; Jason M. May
- Web page: https://patentgrep.com/patent/US11026723B2

## CPC

- A61B 17/7034: {characterised by a lateral opening}
- A61B 17/7038: {to a different extent in different directions, e.g. within one plane only}
- A61B 17/7037: {wherein pivoting is blocked when the rod is clamped}
- B33Y 80/00: Products made by additive manufacturing
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- B22F 5/06: of threaded articles, e.g. nuts
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B22F: WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER (making alloys by powder metallurgy C22C); APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER

## Abstract

A bone fastener assembly including a bone screw, a receiver, a crown, a first retaining ring, and a second retaining ring is provided. The crown is received in an interior cavity of the receiver, and the first retaining ring is provided to hold the crown in the receiver. At least a portion of a head portion is received in the interior cavity of the receiver, and the second retaining ring is provided to hold at least a portion of the head portion in the receiver. The crown, the first retaining ring, and/or the second retaining ring can be manufactured using a 3D printing process that provides a higher surface finish (Ra).

## Claims

### Claim 1

A bone fastener assembly comprising:
a bone screw including a head portion, a threaded shaft portion, and a central axis, the head portion including an exterior surface;
a receiver including a body portion having a first end, an opposite second end, and an interior surface defining a first cavity extending between the first end and the second end;
a crown including a first end, an opposite second end, an exterior surface, and an interior surface defining at least a first interior cavity portion extending from the first end of the crown to a position intermediate the first end and the second end of the crown; and
a retaining ring having an annular shape and including a generally cylindrical exterior surface, an upwardly-facing interior surface, a downwardly-facing interior surface, and a generally cylindrical interior surface between the upwardly-facing interior surface and the downwardly-facing interior surface; and
an expansion ring having an annular shape and including a generally cylindrical exterior surface and a generally cylindrical interior surface;
wherein, when the bone fastener assembly is assembled,
at least a portion of the crown is positioned within the first cavity of the receiver at a position at and adjacent the second end of the body portion,
the retaining ring is positioned within the first cavity of the receiver at a position between the crown and the first end of the body portion,
the expansion ring is positioned within the first cavity of the receiver at a position between the second end of the body portion and the retaining ring,
at least a portion of the head portion is receivable between the crown and the retaining ring,
the exterior surface the head portion contacts the upwardly-facing surface of the retaining ring,
wherein the retaining ring has a maximum outside diameter at the generally cylindrical exterior surface thereof and a minimum inside diameter at the generally cylindrical interior surface thereof, and the expansion ring has a maximum outside diameter at the generally cylindrical interior surface thereof and a minimum inside diameter at the generally cylindrical interior surface thereof, the maximum outside diameter of the retaining ring being smaller than the maximum outside diameter of the expansion ring, and the minimum inside diameter of the retaining ring being smaller than the minimum inside diameter of the expansion ring, and
wherein the retaining ring is manufactured using a first 3D printing process that provides for a Ra (Surface Finish) of at least the upwardly-facing surface of the retaining ring ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 2 (depends on 1)

The bone fastener assembly of claim 1, wherein the exterior surface of the head portion is substantially spherical and the upwardly-facing surface of the retaining ring is substantially frusto-conical.

### Claim 3 (depends on 1)

The bone fastener assembly of claim 1, wherein, when the bone fastener assembly is assembled, the exterior surface of the head portion contacts the interior surface of the crown, and wherein the crown is manufactured using a second 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the crown ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 4 (depends on 3)

The bone fastener assembly of claim 3, wherein the receiver is manufactured using a third 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the receiver ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 5 (depends on 1)

The bone fastener assembly of claim 1, wherein the interior surface of the receiver includes a first recess for receiving the retaining ring therein, and the receiver is manufactured using a second 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the receiver ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 6 (depends on 1)

The bone fastener assembly of claim 1, wherein the expansion ring is manufactured using a second 3D printing process that provides for a Ra (surface finish) ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin), and the interior surface of the receiver includes a second recess for receiving the expansion ring therein.

### Claim 7 (depends on 6)

The bone fastener assembly of claim 6, wherein, when the bone fastener assembly is assembled, at least a portion of the crown contacted with the expansion ring, and wherein the crown is manufactured using a third 3D printing process that provides for a Ra (surface finish) ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 8

A bone fastener assembly comprising:
a bone screw including a head portion, a threaded shaft portion, and a central axis, the head portion including an exterior surface;
a receiver including a body portion, a first arm portion, and a second arm portion, the body portion having a first end, an opposite second end, and an interior surface defining a first cavity extending between the first end and the second end, the first arm portion including a first interior arm surface and the second arm portion including a second interior arm surface, the first interior arm surface and the second interior arm surface defining a second cavity therebetween, the first cavity and the second cavity communicating with one another;
a crown including a first end, an opposite second end, an exterior surface, and an interior surface defining at least a first interior cavity portion extending from the first end of the crown to a position intermediate the first end and the second end of the crown;
a retaining ring having an annular shape and including a generally cylindrical exterior surface, an upwardly-facing interior surface, a downwardly-facing interior surface, and a generally cylindrical interior surface between the upwardly-facing interior surface and the downwardly-facing interior surface; and
an expansion ring having an annular shape and including a generally cylindrical exterior surface and a generally cylindrical interior surface;
wherein, when the bone fastener assembly is assembled,
the retaining ring is positioned within the first cavity of the receiver at a position between the crown and the first end of the body portion,
the expansion ring is positioned within the first cavity of the receiver at a position between the second end of the body portion and the retaining ring;
at least a portion of the crown is received within the expansion ring;
at least a portion of the head portion is receivable between the crown and the retaining ring, and
the exterior surface the head portion contacts the upwardly-facing surface of the retaining ring;
wherein the retaining ring has a maximum outside diameter at the generally cylindrical exterior surface thereof and a minimum inside diameter at the generally cylindrical interior surface thereof, and the expansion ring has a maximum outside diameter at the generally cylindrical interior surface thereof and a minimum inside diameter at the generally cylindrical interior surface thereof, the maximum outside diameter of the retaining ring being smaller than the maximum outside diameter of the expansion ring, and the minimum inside diameter of the retaining ring being smaller than the minimum inside diameter of the expansion ring, and
wherein the retaining ring is manufactured using a first 3D printing process that provides for a Ra (surface finish) of at least the upwardly-facing surface of the retaining ring ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin), and
wherein the expansion ring is manufactured using a second 3D printing process that provides for Ra (surface finish) ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 9 (depends on 8)

The bone fastener assembly of claim 8, wherein the exterior surface of the head portion is substantially spherical and the upwardly-facing surface of the retaining ring is substantially frusto-conical.

### Claim 10 (depends on 8)

The bone fastener assembly of claim 8, wherein, when the bone fastener assembly is assembled, the exterior surface of the head portion contacts the interior surface of the crown, and wherein the crown is manufactured using a third 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the crown ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 11 (depends on 10)

The bone fastener assembly of claim 10, wherein the receiver is manufactured using a fourth 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the receiver ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 12 (depends on 8)

The bone fastener assembly of claim 8, wherein the interior surface of the receiver includes a first recess for receiving the retaining ring therein, and the receiver is manufactured using a 3D printing process that provides for a Ra (surface finish) of at least the ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 13 (depends on 12)

The bone fastener assembly of claim 12, wherein the interior surface of the receiver includes a second recess for receiving the expansion ring therein, and the expansion ring is manufactured using a fourth 3D printing process that provides for a the Ra (surface finish) ranging from about 0.8 μm (32 μin) to about 3.2 μm.

### Claim 14 (depends on 13)

The bone fastener assembly of claim 13, wherein the crown is manufactured using a fifth 3D printing process that provides for a Ra (surface finish) ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 15

A bone fastener assembly comprising:
a bone screw including a head portion, a threaded shaft portion, and a central axis, the head portion including an exterior surface;
a receiver including a body portion having a first end, an opposite second end, and an interior surface defining a first cavity extending between the first end and the second end; and
a retaining ring having an annular shape and including a generally cylindrical exterior surface, a generally cylindrical interior surface, and an upwardly-facing surface;
an expansion ring having an annular shape and including a generally cylindrical exterior surface and a generally cylindrical interior surface;
wherein, when the bone fastener assembly is assembled,
the retaining ring is positioned within the first cavity of the receiver at a position between the first end and the second end of the body portion,
the expansion ring is positioned within the first cavity of the receiver at a position between the second end of the body portion and the retaining ring,
at least a portion of the head portion is receivable between the retaining ring and the second end of the body portion, and
the exterior surface the head portion contacts the upwardly-facing surface of the retaining ring;
wherein the retaining ring has a maximum outside diameter at the generally cylindrical exterior surface thereof and a minimum inside diameter at the generally cylindrical interior surface thereof, and the expansion ring has a maximum outside diameter at the generally cylindrical interior surface thereof and a minimum inside diameter at the generally cylindrical interior surface thereof, the maximum outside diameter of the retaining ring being smaller than the maximum outside diameter of the expansion ring, and the minimum inside diameter of the retaining ring being smaller than the minimum inside diameter of the expansion ring, and
wherein the retaining ring is manufactured using a first 3D printing process that provides for a Ra (surface finish) of at least the upwardly-facing surface of the retaining ring ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 16 (depends on 15)

The bone fastener assembly of claim 15, wherein the exterior surface of the head portion is substantially spherical and the upwardly-facing surface of the retaining ring is substantially frusto-conical.

### Claim 17 (depends on 16)

The bone fastener assembly of claim 16, further comprising a crown including a first end, an opposite second end, an exterior surface, and an interior surface defining at least a first interior cavity portion extending from the first end of the crown to a position intermediate the first end and the second end of the crown, wherein at least a portion of the crown is positioned within the first cavity of the receiver at a position at and adjacent the second end of the body portion, and the at least a portion of the head portion is receivable between the crown and the retaining ring.

### Claim 18 (depends on 17)

The bone fastener assembly of claim 17, wherein, when the bone fastener assembly is assembled, the exterior surface of the head portion contacts the interior surface of the crown, and wherein the crown is manufactured using a second 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the crown ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 19 (depends on 18)

The bone fastener assembly of claim 18, wherein the receiver is manufactured using a third 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the receiver ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).

### Claim 20 (depends on 15)

The bone fastener assembly of claim 15, wherein the interior surface of the receiver includes a first recess for receiving the retaining ring therein, and the receiver is manufactured using a second 3D printing process that provides for a Ra (surface finish) of at least the interior surface of the receiver ranging from about 0.8 μm (32 μin) to about 3.2 μm (125 μin).
