# US 11,076,887 B2 · Orthopedic fixation devices and methods of installation thereof

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- Number: US 11,076,887 B2
- Document ID: US11076887B2
- Status: Granted
- Kind: B2
- Application number: 15/982,587
- Filed: 2018-05-17
- Published: 2018-09-20
- Granted: 2021-08-03
- Earliest claimed: 2011-07-15
- Assignees: Globus Medical, Inc.
- Applicants: Globus Medical, Inc.
- Inventors: George Yacoub; Jeff Nichols
- Web page: https://patentgrep.com/patent/US11076887B2

## CPC

- A61B 17/7035: {Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other}
- 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 17/7056: {Hooks with specially-designed bone-contacting part}
- 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 17/8605: {Heads, i.e. proximal ends projecting from bone}
- A61B 17/8615: {at the central region of the screw head}
- A61B 17/888: {the driver bit acting on the central region of the screw head}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Orthopedic fixation devices and methods of installing the same. The orthopedic fixation device may include a coupling element and a bone fastener, whereby the bone fastener can be loaded into the coupling element through the bottom of a bore in the coupling element. A retaining clip disposed below the fastener in an annular channel of the coupling element has an inner diameter which is less than a maximum diameter of the head of the bone fastener.

## Claims

### Claim 1

An orthopedic fixation device comprising:
a coupling element having a bore extending therethrough, an interior surface disposed about the bore, and an annular channel formed in a distal portion of the interior surface;
a bone fastener, wherein the bone fastener comprises a head and an extension that extends from the head, wherein the head is configured for loading into the coupling element through the bottom of the bore;
a locking cap assembly, wherein the locking clamp assembly comprises:
a body having a bore extending through the body and a pair of tabs extending from opposite sides of the body, wherein the bore includes a threaded portion, and wherein a radially outermost surface of each tab includes a flat portion; and
a set screw extending through the bore of the body and having threads corresponding to the threaded portion of the bore of the body;
a saddle having a bore extending through the saddle, wherein the saddle includes a lower portion sized and shaped to receive at least a portion of the head of the bone fastener; and
a retaining clip disposed on an underside of the head of the fastener in the annular channel of the coupling element, wherein an inner diameter of the retaining clip is less than a maximum diameter of the head of the bone fastener, wherein an upper surface of the retaining clip has a plurality of peaks and troughs such that the peaks are adapted to lock the retaining clip to the fastener to prevent the fastener from moving relative to the coupling element;
wherein the retaining clip includes:
an upper annular portion having an upper inner surface and an outer surface that extends vertically downwardly and then laterally inwardly;
a lower annular portion having a lower inner surface and having an exterior surface that extends vertically downwardly from the laterally extending outer surface of the upper annular portion;
wherein the upper and lower inner surfaces of the retaining clip provide a continuous concave inner surface that contacts an outer surface of the fastener head.

### Claim 2 (depends on 1)

The orthopedic fixation device of claim 1, wherein a lower portion of the saddle has an elliptical cross-section in the axial direction.

### Claim 3 (depends on 1)

The orthopedic fixation device of claim 1, wherein the retaining clip is annular and includes an opening disposed through a thickness of the retaining clip.

### Claim 4 (depends on 3)

The orthopedic fixation device of claim 3, wherein an inner surface of the retaining clip is angled.

### Claim 5 (depends on 1)

The orthopedic fixation device of claim 1, wherein the saddle comprises engagement features disposed on opposite sides of an outer surface of the saddle and configured to engage inwardly protruding shoulders of the coupling element.

### Claim 6 (depends on 5)

The orthopedic fixation device of claim 5, wherein the engagement features are protrusions.

### Claim 7 (depends on 1)

The orthopedic fixation device of claim 1, wherein the saddle further comprises at least two elliptical axial cross-sectional portions configured to prevent the saddle from rotating relative to and within the coupling element.

### Claim 8 (depends on 1)

The orthopedic fixation device of claim 1, wherein the saddle further comprises a first elliptical cross-sectional portion and a second elliptical cross-sectional portion extending perpendicular to the first elliptical cross-sectional portion.

### Claim 9 (depends on 1)

The orthopedic fixation device of claim 1, wherein the coupling element is a tulip element having a plurality of arms configured to receive an elongate rod.

### Claim 10 (depends on 1)

The orthopedic fixation device of claim 1, wherein a lower surface of the retaining clip also has a plurality of peaks and troughs.

### Claim 11 (depends on 10)

The orthopedic fixation device of claim 10, wherein the plurality of peaks and troughs are arranged in an undulating manner.

### Claim 12

An orthopedic fixation device comprising:
a tulip element, wherein the tulip element comprises a bore extending therethrough, an interior surface disposed about the bore, an annular channel formed in a distal portion of the interior surface, and a plurality of arms configured to receive an elongate rod;
a bone fastener, wherein the bone fastener comprises a head and an extension that extends from the head, wherein the head is configured for loading into the tulip element through the bottom of the bore;
a locking cap assembly, wherein the locking clamp assembly comprises:
a body having a bore extending through the body and a pair of tabs extending from opposite sides of the body, wherein the bore includes a threaded portion, and wherein a radially outermost surface of each tab includes a flat portion; and
a set screw extending through the bore of the body and having threads corresponding to the threaded portion of the bore of the body;
a saddle comprising:
a bore extending through the saddle;
a lower portion sized and shaped to receive at least a portion of the head of the bone fastener;
engagement features disposed on opposite sides of an outer surface of the saddle and configured to engage inwardly protruding shoulders of the tulip element; and
at least two elliptical cross-sectional portions; and
a retaining clip disposed on an underside of the head of the fastener in the annular channel of the tulip element, wherein an inner diameter of the retaining clip is less than a maximum diameter of the head of the bone fastener, wherein an upper surface of the retaining clip has a plurality of peaks and troughs such that the peaks are adapted to lock the retaining clip to the fastener to prevent the fastener from moving relative to the coupling element;
wherein the retaining clip includes:
an upper annular portion having an upper inner surface and an outer surface that extends vertically downwardly and then laterally inwardly;
a lower annular portion having a lower inner surface and having an exterior surface that extends vertically downwardly from the laterally extending outer surface of the upper annular portion;
wherein the upper and lower inner surfaces of the retaining clip provide a continuous concave inner surface that contacts an outer surface of the fastener head.

### Claim 13 (depends on 12)

The orthopedic fixation device of claim 12, wherein a lower portion of the saddle has an elliptical cross-section in the axial direction.

### Claim 14 (depends on 12)

The orthopedic fixation device of claim 12, wherein the retaining clip is annular and includes an opening disposed through a thickness of the retaining clip.

### Claim 15 (depends on 14)

The orthopedic fixation device of claim 14, wherein an inner surface of the retaining clip is angled.

### Claim 16 (depends on 12)

The orthopedic fixation device of claim 12, wherein a lower surface of the retaining clip also has a plurality of peaks and troughs.

### Claim 17

An orthopedic fixation device comprising:
a coupling element having a bore extending therethrough, an interior surface disposed about the bore, and an annular channel formed in a distal portion of the interior surface;
a bone fastener, wherein the bone fastener comprises a head and an extension that extends from the head, wherein the head is configured for loading into the coupling element through the bottom of the bore;
a threaded locking cap having threads that engage a corresponding threaded portion of the coupling element, wherein lower surfaces of the threads of the threaded locking cap and upper surfaces of threads of the threaded portion of the coupling element slope downward and outward;
a saddle having a bore extending through the saddle, wherein the saddle includes a lower portion sized and shaped to receive at least a portion of the head of the bone fastener; and
a retaining clip disposed on an underside of the head of the fastener in the annular channel of the coupling element, wherein an inner diameter of the retaining clip is less than a maximum diameter of the head of the bone fastener, wherein an upper surface of the retaining clip has a plurality of peaks and troughs such that the peaks are adapted to lock the retaining clip to the fastener to prevent the fastener from moving relative to the coupling element;
wherein the retaining clip includes:
an upper annular portion having an upper inner surface and an outer surface that extends vertically downwardly and then laterally inwardly;
a lower annular portion having a lower inner surface and having an exterior surface that extends vertically downwardly from the laterally extending outer surface of the upper annular portion;
wherein the upper and lower inner surfaces of the retaining clip provide a continuous concave inner surface that contacts an outer surface of the fastener head.

### Claim 18 (depends on 17)

The orthopedic fixation device of claim 17, wherein a lower surface of the retaining clip also has a plurality of peaks and troughs.
