# US 10,368,917 B2 · Orthopedic fixation devices and methods of installation thereof

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- Number: US 10,368,917 B2
- Document ID: US10368917B2
- Status: Granted
- Kind: B2
- Application number: 15/645,006
- Filed: 2017-07-10
- Published: 2017-10-26
- Granted: 2019-08-06
- Earliest claimed: 2011-07-15
- Assignees: Globus Medical, Inc.
- Applicants: Globus Medical, Inc.
- Inventors: Devjeet Mishra; Michael Harper; Milan George; Katherine Manninen; John Perkins
- Web page: https://patentgrep.com/patent/US10368917B2

## CPC

- A61B 17/7038: {to a different extent in different directions, e.g. within one plane only}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7035: {Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other}
- A61B 17/7037: {wherein pivoting is blocked when the rod is clamped}
- 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 2017/681: {Alignment, compression, or distraction mechanisms}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The present invention is generally directed to orthopedic fixation devices that comprise 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. The orthopedic fixation devices described herein can include modular locking clamp assemblies that can be fixed onto fasteners that are already implanted in bone. The modular locking clamp assemblies can include polyaxial locking clamp assemblies, as well as monoaxial locking clamp assemblies.

## Claims

### Claim 1

An orthopedic fixation device comprising:
a coupling element, wherein the coupling element comprises a bore there through and an interior surface disposed about the bore;
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 clamp assembly, wherein the locking clamp assembly comprises:
a clamp element, wherein the clamp element comprises a first clamp portion and a second clamp portion, wherein the first and second clamp portions each have an outer surface and an inner surface, wherein at least a portion of the outer surface is configured to engage the interior surface of the coupling element, and wherein at least a portion of the inner surface is configured to engage the head of the bone fastener; and
a wedge element, wherein the wedge element comprises a wedge bore configured to receive an upper portion of the clamp element and an inner wedge surface disposed around at least a lower portion of the wedge bore, wherein the inner wedge surface is configured to engage at least portion of the outer surface of the first and second clamp portions; and
a locking cap assembly, wherein the locking cap assembly comprises:
a body having upper tabs and lower tabs;
a plurality of protuberances that extend from the body above the lower tabs,
wherein each of the protuberances is configured to interact with a corresponding recessed surface in a corresponding arm that extends from the body of the coupling element.

### Claim 2 (depends on 1)

The orthopedic fixation device of claim 1, wherein the locking cap assembly comprises a set screw threaded into a bore in the body for engaging a rod and to secure the rod to the coupling element when the locking cap assembly is locked onto the coupling element.

### Claim 3 (depends on 2)

The orthopedic fixation device of claim 2, wherein each of the lower tabs is configured to fit into a corresponding slot in the corresponding arm that extends from a body of the coupling element.

### Claim 4 (depends on 3)

The orthopedic fixation device of claim 3, wherein the protuberances are integral with a portion of the upper tabs.

### Claim 5 (depends on 1)

The orthopedic fixation device of claim 1 wherein the coupling element comprises a body and arms that extend from the body, wherein the arms define a channel configured to receive a rod.

### Claim 6 (depends on 5)

The orthopedic fixation device of claim 5 wherein at least a portion of an interior surface of each arm is threaded for engaging a threaded portion on a tool.

### Claim 7 (depends on 1)

The orthopedic fixation device of claim 1 wherein at least a portion of the interior surface of the coupling element forms a conical wedge configured to engage at least a portion of the outer surface of each of the first and second clamp portions.

### Claim 8 (depends on 1)

The orthopedic fixation device of claim 1 wherein the coupling element is an offset iliac connector, wherein the offset iliac connector comprises an offset housing having a bore therethough, a set screw configured to engage threads in the offset housing, a spring washer configured to be loaded in the bore of offset housing below the set screw, and a locking clamp assembly configured to loaded in the bore of the offset housing below the set screw.

### Claim 9 (depends on 1)

The orthopedic fixation device of claim 1 wherein the extension from the bone fastener is a tapered extension configured for installation into bone.

### Claim 10 (depends on 1)

The orthopedic fixation device of claim 1 wherein the extension from the bone fastener is a hook configured for installation into bone.

### Claim 11 (depends on 1)

The orthopedic fixation device of claim 1 wherein the wedge element has an upper surface that defines a seat for receiving a rod.

### Claim 12 (depends on 11)

The orthopedic fixation device of claim 11 wherein the wedge element further includes seat extensions that extend upwardly from the upper surface of the wedge element, wherein the seat extensions are configured to cradle a rod.

### Claim 13 (depends on 1)

The orthopedic fixation device of claim 1 wherein an outer surface of the wedge element is generally elliptical in shape.

### Claim 14 (depends on 1)

The orthopedic fixation device of claim 1 wherein the wedge element further comprises an inner protruding surface above the inner wedge surface, wherein the inner protruding surface is configured to engage an external lip disposed at or near the top of each of the first and second clamp portions.

### Claim 15 (depends on 1)

The orthopedic fixation device of claim 1 wherein the outer surface of the wedge element comprises a recessed surface configured to engage a corresponding protuberance on the interior surface of the coupling element.

### Claim 16 (depends on 1)

The orthopedic fixation device of claim 1 wherein the wedge element comprises downwardly extending tabs configured to be received in corresponding slots in the head of the bone fastener.

### Claim 17 (depends on 1)

The orthopedic fixation device of claim 1 wherein the extension of the bone fastener has a diameter that is larger than a largest diameter of the bore through the coupling element.

### Claim 18 (depends on 1)

The orthopedic fixation device of claim 1 wherein the head of the fastener and the coupling element have a combined size that is larger than a largest diameter of an upper portion of the bore through the coupling element.

### Claim 19

An orthopedic fixation device comprising:
a tulip element, wherein the tulip element comprises a body and arms that extend from the body and a bore there through, wherein an interior surface of each arm comprises a threaded portion, a slot above the threaded portion, and a recessed surface above the slot, wherein one or more protuberances are formed on an interior surface of the tulip element;
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, and wherein the extension is configured for installation into bone; and
a locking clamp assembly, wherein the locking clamp assembly comprises:
a clamp element, wherein the clamp element comprises a first clamp portion and a second clamp portion, wherein the first and second clamp portions each have an outer surface, an inner surface, and an upper lip, wherein at least a portion of the outer surface is configured to engage the interior surface of the tulip element, and wherein at least a portion of the inner surface is configured to engage the head of the bone fastener; and
a wedge element, wherein the wedge element comprises a wedge bore configured to receive an upper portion of the clamp element, an inner wedge surface disposed around at least a lower portion of the wedge bore, and an outer surface, wherein the inner wedge surface is configured to engage at least portion of the outer surface of the first and second clamp portions, and wherein the outer surface of the wedge element comprises a recessed surface configured to engage the protuberances on the interior surface of the tulip element.

### Claim 20

A method of installing an orthopedic fixation device comprising:
inserting a locking clamp assembly into a bore in a coupling element, wherein the locking clamp assembly comprises a wedge element and a clamp element secured to the wedge element;
moving the locking clamp assembly through the bore in the coupling element until a recessed surface on the wedge element engages a protuberance on an interior surface of the coupling element to secure the locking clamp assembly in the coupling element;
inserting a head of a bone fastener into the clamp element such that the clamp element engages the head;
inserting a rod member into the bore of the coupling element;
inserting a locking cap into the bore of the coupling element, the locking cap bearing against the rod member; and
moving the wedge element downward past the protuberance on the interior surface of the coupling element such that the exterior surfaces of the clamp element engage the interior surface of the coupling element forcing the clamp element to clamp onto the head of the bone fastener to secure the bone fastener in the coupling element.
