# US 11,896,269 B2 · Inserter and method for securing an implant to a spinal process with a flexible fastening system

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- Number: US 11,896,269 B2
- Document ID: US11896269B2
- Status: Granted
- Kind: B2
- Application number: 16/857,711
- Filed: 2020-04-24
- Published: 2020-09-03
- Granted: 2024-02-13
- Earliest claimed: 2015-03-11
- Assignees: K2M, Inc.
- Applicants: K2M, Inc.
- Inventors: Brian Hsu; Greg Mundis, Jr.; Burt Yaszay; Suken Shah; Behrooz Akbarnia; Catherine Ross; Brian Kunes; Brandon Moore
- Web page: https://patentgrep.com/patent/US11896269B2

## CPC

- A61B 17/7083: {Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7053: {with parts attached to bones or to each other by flexible wires, straps, sutures or cables}
- A61B 17/7076: {for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation}
- A61B 17/8869: {Tensioning devices}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A surgical instrument includes a body, a securement arm, a clamp lock, and a tensioning assembly. The body defines a longitudinal axis and has proximal and distal portions. The distal portion defines a recess. The securement arm is coupled to the body and translatable along the body in a direction parallel to the longitudinal axis between first and second position. The clamp lock is pivotally coupled to the distal portion of the body. The clamp lock is pivotable between secured and unsecured configurations. The tensioning assembly translatable in a direction parallel to the longitudinal axis between proximal and distal position. The tensioning assembly configured to draw a flexible band to tension the flexible band about a bony element.

## Claims

### Claim 1

A surgical instrument comprising:
a body defining a longitudinal axis extending along a first direction and having a distal portion, the distal portion extending from the body at an angle to the longitudinal axis and defining a recess configured to receive an implant;
a tensioning assembly offset from the body; and
a rotatable actuator rotatable about a rotation axis extending along the first direction and offset from the longitudinal axis to translate the tensioning assembly.

### Claim 2 (depends on 1)

The surgical instrument of claim 1, wherein the rotation axis is parallel to the longitudinal axis.

### Claim 3 (depends on 1)

The surgical instrument of claim 1, wherein the rotatable actuator is proximal to the tensioning assembly.

### Claim 4 (depends on 1)

The surgical instrument of claim 1, wherein the rotatable actuator is coupled to an extension projecting outwardly away from the longitudinal axis of the body.

### Claim 5 (depends on 4)

The surgical instrument of claim 4, wherein the extension is a securement arm coupled to a distal end of the rotatable actuator and configured to support the rotatable actuator.

### Claim 6 (depends on 4)

The surgical arm of claim 4, wherein the extension projects orthogonal to the longitudinal axis of the body.

### Claim 7 (depends on 1)

The surgical arm of claim 1, wherein the extension is a proximal portion of the body, the extension having a longitudinal dimension extending outwardly away from the longitudinal axis.

### Claim 8 (depends on 1)

The surgical instrument of claim 1, wherein the tensioning assembly is translatable along a direction parallel to the rotation axis.

### Claim 9 (depends on 1)

The surgical instrument of claim 1, wherein the tensioning assembly is translatable along a portion of the rotatable actuator.

### Claim 10 (depends on 1)

The surgical instrument of claim 1, further comprising a securement arm coupled to the body and translatable along the body in a direction parallel to the longitudinal axis.

### Claim 11 (depends on 1)

The surgical instrument of claim 1, further comprising a clamp lock pivotally coupled to the distal portion of the body, the clamp lock pivotable between a secured configuration and an unsecured configuration for securing to the implant and releasing from the implant, respectively.

### Claim 12

A method of surgery comprising:
positioning a distal portion extending from a body of a surgical instrument in engagement with an implant implanted within a patient, the body of the surgical instrument defining a longitudinal axis extending along a first direction, the distal portion extending at an angle to the longitudinal axis;
securing a portion of a flexible band within a band lock of the surgical instrument; and
rotating a rotatable actuator about an rotation axis extending along the first direction and offset from the longitudinal axis to translate the band lock to tension the flexible band.

### Claim 13 (depends on 12)

The method of claim 12, wherein the rotation axis is parallel to the longitudinal axis.

### Claim 14 (depends on 12)

The method of claim 12, further comprising moving a securement arm of the surgical instrument to a position adjacent the implant while the implant is positioned within the recess.

### Claim 15 (depends on 14)

The method of claim 14, wherein moving the securement arm includes rotating a securement screw of the surgical instrument to translate the securement arm distally such that securement fingers of the securement arm secure a rod received within the a rod cavity of the implant.

### Claim 16 (depends on 14)

The method of claim 14, further comprising passing ends of the flexible band through the implant.

### Claim 17 (depends on 14)

The method of claim 14, wherein securing the portion of the flexible band within the band lock includes passing ends of the flexible band through a band passage that is defined by the band lock.

### Claim 18 (depends on 14)

The method of claim 14, wherein securing the flexible band within the band lock includes rotating a band locking lever of the band lock to a locked configuration to fix the flexible band relative to the band lock.

### Claim 19

A method of surgery comprising:
positioning a distal portion extending from a body of a surgical instrument in engagement with an implant implanted within a patient, the body of the surgical instrument defining a longitudinal axis extending along a first direction;
advancing a securement member of the implant along a second axis to secure the implant with respect to an elongate member, the second axis being oriented at an angle to the longitudinal axis;
securing a portion of a flexible band within clamping members of a band lock of the surgical instrument; and
translating the band lock along the first direction to tension the flexible band.

### Claim 20 (depends on 19)

The method of claim 19, further comprising securing the implant to an elongate member.
