# US 10,869,693 B2 · Spinal correction system and method of use thereof

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- Number: US 10,869,693 B2
- Document ID: US10869693B2
- Status: Granted
- Kind: B2
- Application number: 16/071,212
- Filed: 2017-01-19
- Published: 2020-03-19
- Granted: 2020-12-22
- Earliest claimed: 2016-01-19
- Assignees: K2M, Inc.
- Applicants: K2M, Inc.
- Inventors: Larry McClintock
- Web page: https://patentgrep.com/patent/US10869693B2

## CPC

- A61B 17/7022: {Tethers, i.e. longitudinal elements capable of transmitting tension only, e.g. straps, sutures or cables (A61B17/702 takes precedence)}
- A61B 17/70: Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- A61B 17/7031: {made wholly or partly of flexible material}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/8625: {Shanks, i.e. parts contacting bone tissue}
- A61B 17/8869: {Tensioning devices}
- A61B 17/842: {Flexible wires, bands or straps (A61B17/72, A61B17/82, A61B17/86 take precedence)}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0414: {having a suture-receiving opening, e.g. lateral opening}
- A61B 2017/044: {with a threaded shaft, e.g. screws}
- A61B 2017/0448: {Additional elements on or within the anchor}
- A61B 2017/0496: {for tensioning sutures}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A spinal correction system includes a tensioning member and a fulcrum tensioner device including a housing defining a chamber having a biasing member therein and a camming pin operatively coupled with the biasing member. The tensioning member is configured to be received in the biasing member and looped around the camming pin, such that a first end of the tensioning member is oriented in a first direction and a second end of the tensioning member is oriented in a second direction. The camming pin is transitionable between an extended position in which the biasing member applies tension to the tensioning member and a retracted position in which the biasing member is compressed to inhibit application of tension to the tensioning member.

## Claims

### Claim 1

A spinal correction system comprising:
a tensioning member; and
a fulcrum tensioner device including:
a housing defining a chamber having a biasing member therein;
a camming pin operatively coupled with the biasing member, the tensioning member configured to be received in the biasing member and looped around the camming pin such that a first end of the tensioning member is oriented in a first direction and a second end of the tensioning member is oriented in a second direction, wherein the camming pin is transitionable between an extended position in which the biasing member applies tension to the tensioning member and a retracted position in which the biasing member is compressed to inhibit application of tension to the tensioning member; and
a securing portion defining a bore configured to receive a screw to secure the fulcrum tensioner device to a vertebral body.

### Claim 2 (depends on 1)

The spinal correction system according to claim 1, wherein the housing defines a longitudinal axis and a slot extending along the longitudinal axis, the slot configured to slidably receive the camming pin.

### Claim 3 (depends on 1)

The spinal correction system according to claim 1, wherein the fulcrum tensioner device further includes a cap defining a bore dimensioned to receive the camming pin, the cap configured to retain the biasing member within the chamber of the housing.

### Claim 4 (depends on 1)

The spinal correction system according to claim 1, wherein the camming pin is biased towards the extended position.

### Claim 5 (depends on 1)

The spinal correction system according to claim 1, further including a fixation member including a cannulated screw defining a passage dimensioned to receive the tensioning member.

### Claim 6 (depends on 5)

The spinal correction system according to claim 5, wherein the cannulated screw includes a housing and a shaft extending distally from the housing, the housing including a recess dimensioned to receive the tensioning member.

### Claim 7 (depends on 6)

The spinal correction system according to claim 6, wherein the fixation member further includes a set screw having a base portion and a threaded portion rotatably coupled with the base portion, the threaded portion configured to threadably engage an inner surface of the housing of the cannulated screw.

### Claim 8 (depends on 7)

The spinal correction system according to claim 7, wherein the base portion includes a planar surface adapted to engage the tensioning member.

### Claim 9 (depends on 7)

The spinal correction system according to claim 7, wherein the base portion has a non-circular cross-section to inhibit rotation of the base portion when disposed in the housing of the cannulated screw.

### Claim 10 (depends on 1)

The spinal correction system according to claim 1, wherein the securing portion defines a groove configured to guide the tensioning member.

### Claim 11 (depends on 1)

The spinal correction system according to claim 1, wherein the fulcrum tensioner device further includes a release tab dimensioned to be detachably received in the camming slot to maintain the camming pin in the retracted position.

### Claim 12 (depends on 1)

The spinal correction system according to claim 1, wherein the securing portion includes a screw configured to secure the fulcrum tensioner device to a vertebral body.

### Claim 13 (depends on 1)

The spinal correction system according to claim 1, wherein the tensioning member is formed of a flexible material.

### Claim 14

A spinal construct for correcting a spinal deformity, the spinal construct comprising:
first and second fixation members, the first fixation member attachable to a first vertebra and the second fixation member attachable to a second vertebra;
a fulcrum tensioner device attachable to a third vertebra, the fulcrum tensioner device including:
a housing,
a biasing member disposed in the housing, and
a camming pin operatively coupled with the biasing member and transitionable between an extended position and a retracted position;
a tensioning member operatively coupled with the first fixation member, the second fixation member, and the fulcrum tensioner device, a first end of the tensioning member securable to the first fixation member, a second end of the tensioning member securable to the second fixation member, and an intermediate portion of the tensioning member looped around the camming pin; and
a securing portion with a bore and is attachable to the third vertebra using a screw inserted through the bore.

### Claim 15 (depends on 14)

The spinal construct of claim 14, wherein the fulcrum tensioner device further includes a camming slot and a release tab, the release tab received in the camming slot to maintain the camming pin in the retracted position.

### Claim 16 (depends on 14)

The spinal construct of claim 14, wherein the first fixation member is positioned on a first side of a spine and the second fixation member is positioned on a second side of the spine opposite the first side.

### Claim 17 (depends on 14)

The spinal construct of claim 14, wherein the first fixation member, the second fixation member, and the fulcrum tensioner device are all positioned on one side of a spine.

### Claim 18 (depends on 17)

The spinal construct of claim 17, wherein the tensioning member wraps around a vertebra adjacent the first vertebra and wraps around a vertebra adjacent the second vertebra such that the tensioning member is positioned along both sides of the spine.

### Claim 19 (depends on 18)

The spinal construct of claim 18, wherein moving the first end of the tensioning member away from the fulcrum tensioner device imparts a first rotational force along the spine in a first direction.

### Claim 20 (depends on 19)

The spinal construct of claim 19, wherein moving the second end of the tensioning member from the fulcrum tensioner device imparts a second rotational force along the spine in a second direction opposite from the first direction.

### Claim 21 (depends on 14)

The spinal construct of claim 14, further comprising a tensioning instrument configured to apply tension to the tensioning member, the tensioning instrument including a tensioning screw and a clamping mechanism, the clamping mechanism including a clamp arm having a free position, in which the tensioning member is free to slide through the clamping mechanism, and a locked position, in which the tensioning member is fixed relative to the clamping mechanism, the tensioning screw configured to move the clamping mechanism away from one of the first and second fixation members to apply tension to the tensioning member when the clamping mechanism is in the locked position.

### Claim 22

A spinal correction method comprising:
securing first and second fixation members to cranial and caudal vertebral bodies;
securing a fulcrum tensioner device to a vertebral body interposed between the cranial and caudal vertebral bodies;
inserting a portion of a tensioning member through a biasing member of the fulcrum tensioner device and looping around a camming pin operatively coupled with the biasing member to provide tension in the tensioning member, whereby a first end of the tensioning member is directed to a first direction and a second end of the tensioning member is directed to a second direction different from the first direction;
wrapping a first end portion of the tensioning member around a first vertebral body adjacent the cranial vertebral body;
wrapping a second end portion of the tensioning member around a second vertebral body adjacent the caudal vertebral body;
securing the first end portion of the tensioning member with the first fixation member; and
securing the second end portion of the tensioning member with the second fixation member.

### Claim 23 (depends on 22)

The spinal correction method according to claim 22, wherein securing the fulcrum tensioner device includes positioning the fulcrum tensioner device adjacent an inflection point of a spinal curvature.

### Claim 24 (depends on 22)

The spinal correction method according to claim 22, wherein securing the first end portion of the tensioning member includes extending at least a portion of the tensioning member through a cannulated shank of the first fixation member.

### Claim 25 (depends on 22)

The spinal correction method according to claim 22, further comprising placing a release tab within a camming slot defined in a housing of the fulcrum tensioner device to compress the biasing member to inhibit application of tension to the tensioning member.

### Claim 26

A spinal correction system comprising:
a tensioning member; and
a fulcrum tensioner device including:
a housing defining a chamber having a biasing member therein;
a divider operatively coupled with the biasing member, the divider defining a pair of slots configured to receive the tensioning member therethrough, the tensioning member configured to be received in the biasing member and looped through the divider, wherein the divider is transitionable between an extended position in which the biasing member applies tension to the tensioning member and a retracted position in which the biasing member is compressed; and
a securing portion with a bore and is attachable to the third vertebra using a screw inserted through the bore.

### Claim 27 (depends on 26)

The spinal correction system according to claim 26, wherein the housing includes a body and a flange extending radially outward from the body, the body configured to be received in a vertebral body.

### Claim 28 (depends on 26)

The spinal correction system according to claim 26, wherein the divider is biased towards the extended position.
