# US 11,304,731 B2 · Anti-splay head and set screw for spinal fixation

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- Number: US 11,304,731 B2
- Document ID: US11304731B2
- Status: Granted
- Kind: B2
- Application number: 16/723,381
- Filed: 2019-12-20
- Published: 2021-06-24
- Granted: 2022-04-19
- Earliest claimed: 2019-12-20
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc.
- Inventors: Christel Italiaie
- Web page: https://patentgrep.com/patent/US11304731B2

## CPC

- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/8685: {comprising multiple separate parts}
- A61B 17/7082: {for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws}
- A61B 34/30: Surgical robots
- A61B 2017/00526: {Methods of manufacturing}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An anti-splaying system having a base, first and second arms, first and second locking channels. Each of the first and second locking channels is formed in a respective one of the arms, from a proximal opening to a proximal bottom at or adjacent a proximal beginning of an inner thread in the arm. The system can instead or also include a set screw having a driving portion, a body portion, external threads extending from the body portion, and an intermediate locking component connected rotatably to the body portion. The intermediate locking component and the channels are configured such that the locking component can, in operation of the system, be moved into a securing position in the locking channels and, when in the secured position, fixes the two arms from splaying away from each other. The technology also includes methods for making the system or components thereof.

## Claims

### Claim 1

An anti-splaying system comprising:
a receiver having a base, a first arm, a second arm, a first locking channel, and a second locking channel, the first arm and the second arm each extending from the base defining a rod-receiving cavity between the arms, the first and second arms including first and second inner threads formed in respective inner surfaces of the first and second arms, the first locking channel being formed in the inner surface of the first arm and extending from a proximal opening to a proximal bottom at or adjacent a first proximal beginning of the first inner thread, and the second locking channel being formed in the inner surface of the second arm and extending from a proximal opening to a proximal bottom at or adjacent a second proximal beginning of the second inner thread; and
a set screw having a driving portion, a body portion, external threads extending from the body portion, and an intermediate locking component connected rotatably to the body portion;
wherein the intermediate locking component of the set screw and the locking channels of the receiver are configured such that the intermediate locking component can, in operation of the system, be moved into a securing position in the locking channels and, when in the secured position, fixes the two arms from splaying away from each other.

### Claim 2 (depends on 1)

The system of claim 1, wherein the intermediate locking component is connected rotatably to the body portion intermediate the driving portion and the external threads of the set screw.

### Claim 3 (depends on 1)

The system of claim 1, wherein the intermediate locking component comprises opposing lateral ends sized and shaped corresponding to a size and shape of the locking channels, for mating engagement between the intermediate locking component and the locking channels.

### Claim 4 (depends on 3)

The system of claim 3, wherein a first lateral end of the lateral ends comprises opposing shoulders sized and shaped to engage opposing shoulders of a first locking channel of the locking channels.

### Claim 5 (depends on 3)

The system of claim 3, wherein the lateral ends include first and second lateral ends, and the intermediate locking component includes first and second arms connecting the first and second lateral ends respectively to the ring.

### Claim 6 (depends on 3)

The system of claim 3, wherein the locking channels have a depth that is about twice as deep as the locking lateral ends are tall or less.

### Claim 7 (depends on 1)

The system of claim 1, wherein the intermediate locking component includes a ring surrounding a portion of the set screw body.

### Claim 8 (depends on 7)

The system of claim 7, wherein the body has a reduced diameter where the ring surrounds the body.

### Claim 9

An anti-splaying system comprising:
a bone anchor;
a spinal rod;
a receiver being configured for connection with the bone anchor, the receiver having a base, a first arm, a second arm, a first locking channel, and a second locking channel, the first arm and the second arm each extending from the base defining a rod-receiving cavity between the arms, the first and second arms including first and second inner threads formed in respective inner surfaces of the first and second arms, the first locking channel being formed in the inner surface of the first arm and extending from a proximal opening to a proximal bottom at or adjacent a first proximal beginning of the first inner thread, and the second locking channel being formed in the inner surface of the second arm and extending from a proximal opening to a proximal bottom at or adjacent a second proximal beginning of the second inner thread; and
a set screw for securing a rod in place in the receiver in a portion of the system, the set screw having a driving portion, a body portion, external threads extending from the body portion, and an intermediate locking component connected rotatably to the body portion;
wherein the intermediate locking component of the set screw and the locking channels of the receiver are configured such that the locking component can, in operation of the system, be moved into a securing position in the locking channels and, when in the secured position, fixes the two arms from splaying away from each other.

### Claim 10 (depends on 9)

The system of claim 9, wherein the intermediate locking component is connected rotatably to the body portion intermediate the driving portion and the external threads of the set screw.

### Claim 11 (depends on 9)

The system of claim 9, wherein the intermediate locking component comprises opposing lateral ends sized and shaped corresponding to a size and shape of the locking channels, for mating engagement between the locking component and the locking channels.

### Claim 12 (depends on 11)

The system of claim 11, wherein a first lateral end of the lateral ends comprises opposing shoulders sized and shaped to engage opposing shoulders of a first locking channel of the locking channels.

### Claim 13 (depends on 11)

The system of claim 11, wherein the lateral ends include first and second lateral ends, and the intermediate locking component includes first and second arms connecting the first and second lateral ends respectively to the ring.

### Claim 14 (depends on 11)

The system of claim 11, wherein the locking channels have a depth that is about twice as deep as the lateral ends are tall or less.

### Claim 15 (depends on 9)

The system of claim 9, wherein the intermediate locking component includes a ring surrounding a portion of the set screw body.

### Claim 16 (depends on 15)

The system of claim 15, wherein the body has a reduced diameter where the ring surrounds the body.

### Claim 17

A method for making an anti-splaying system comprising:
forming a receiver configured for connection with a bone anchor, the receiver having a base, a first arm, a second arm, a first locking channel, and a second locking channel, the first arm and the second arm each extending from the base defining a rod-receiving cavity between the arms, the first and second arms including first and second inner threads formed in respective inner surfaces of the first and second arms, the first locking channel being formed in the inner surface of the first arm and extending from a proximal opening to a proximal bottom at or adjacent a first proximal beginning of the first inner thread, and the second locking channel being formed in the inner surface of the second arm and extending from a proximal opening to a proximal bottom at or adjacent a second proximal beginning of the second inner thread; and
presenting a set screw for securing a rod in place in the receiver in portion of the system, the set screw having a driving portion, a body portion, external threads extending from the body portion, and an intermediate locking component connected rotatably to the body portion and having opposing locking ends,
wherein the intermediate locking component of the set screw and the locking channels of the receiver are configured such that the locking component can, in operation of the system, be moved into a securing position in the locking channels and, when in the secured position, fixes the two arms from splaying away from each other.

### Claim 18 (depends on 17)

The method of claim 17, wherein the intermediate locking component comprises a central ring connected to the locking ends.

### Claim 19

A method of forming an anti-splaying system comprising:
presenting a set screw for securing the rod in place in a receiver in a portion of the system, the set screw having a driving portion, a body portion, external threads extending from the body portion, and an intermediate locking component connected rotatably to the body portion and having opposing locking ends,
wherein the intermediate locking component comprises a central ring and opposing lateral ends connected to the ring, the ring surrounding part of the body portion up to the driving portion.

### Claim 20 (depends on 19)

The method of claim 19, wherein the part of the body portion is an outer surface of the body portion.
