# US 9,750,545 B2 · Devices and methods for inserting a vertebral fixation member

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- Number: US 9,750,545 B2
- Document ID: US9750545B2
- Status: Granted
- Kind: B2
- Application number: 14/516,631
- Filed: 2014-10-17
- Published: 2015-02-19
- Granted: 2017-09-05
- Earliest claimed: 2009-03-27
- Assignees: Globus Medical, Inc.
- Applicants: Globus Medical, Inc.
- Inventors: Joel Cryder; Matthew Bechtel; Andrew Iott; Edward Karpowicz; Douglas Cahill; Robert Rightler
- Web page: https://patentgrep.com/patent/US9750545B2

## CPC

- A61B 17/7085: {for insertion of a longitudinal element down one or more hollow screw or hook extensions, i.e. at least a part of the element within an extension has a component of movement parallel to the extension's axis}
- A61B 17/7004: {with a cross-section which varies along its length (A61B17/7019 takes precedence)}
- A61B 17/708: {with tubular extensions coaxially mounted on the bone anchors}
- A61B 17/7086: {Rod reducers, i.e. devices providing a mechanical advantage to allow a user to force a rod into or onto an anchor head other than by means of a rod-to-bone anchor locking element; rod removers}
- A61B 17/0206: {with antagonistic arms as supports for retractor elements}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices, systems, and methods for inserting a vertebral stabilization member, such as a rod. The insertion device includes an outer guide tube, a pin assembly including a pin and a pusher member extending therethrough. The insertion device is configured to actuate a rod between a first orientation and a second orientation angled with respect to the first orientation in order to position the rod in an appropriate location for attachment to bone.

## Claims

### Claim 1

An insertion device suitable for installing an elongate stabilization member in a first orientation and pivoting the elongate stabilization member to a second orientation, the device comprising:
an outer guide tube having a longitudinal axis and having an elongate body extending from a first end to a second end and having a central longitudinal opening extending therethrough;
a pin assembly including a pin extending through the central longitudinal opening of the outer guide tube, the pin having a first end engaged with a thumb wheel and a second end configured to engage a clamping element including first and second clamping members, such that when the thumb wheel is rotated, the pin engages a portion of the clamping element such that the first and second clamping members are moved into a locked position;
a clamping element including first and second clamping members engaged with the pin assembly; and
a pusher member extending through the central longitudinal opening of the outer guide tube having a first end connected to a handle and a second end connected to the clamping element, such that when the handle is depressed, the pusher member linearly moves to cause the clamping element and the elongate stabilization member to pivot.

### Claim 2 (depends on 1)

The device of claim 1, wherein the handle includes a first handle connected to the pusher member by a first linking element and a second handle connected to the outer guide tube.

### Claim 3 (depends on 2)

The device of claim 2, wherein the first and second handles are connected together by a ratchet in the shape of a wheel having a plurality of teeth positioned around a periphery of the wheel.

### Claim 4 (depends on 3)

The device of claim 3, wherein the first and second handles are locked in position relative to one another by depressing a locking member having teeth corresponding to and designed to engage the ratchet.

### Claim 5 (depends on 2)

The device of claim 2, wherein the pusher member is connected to the clamping element with a second linking element configured to pivot in response to linear motion of the pusher member.

### Claim 6 (depends on 1)

The device of claim 1, wherein the elongate stabilization member comprises a rod.

### Claim 7 (depends on 6)

The device of claim 6, wherein the rod has a curvilinear shape.

### Claim 8 (depends on 6)

The device of claim 6, wherein the rod has at least one indentation along its length, wherein the insertion device is clampably linked to the stabilization member about the indentation.

### Claim 9 (depends on 6)

The device of claim 6, wherein a proximal end of the rod is configured and dimensioned to interact with the insertion device.

### Claim 10 (depends on 9)

The device of claim 9, wherein the proximal end of the rod is angled with respect to a longitudinal axis of the rod and wherein the proximal end defines a concave surface.

### Claim 11 (depends on 1)

The device of claim 1, wherein the second orientation is angled at about 90° relative to the first orientation.

### Claim 12

A minimally invasive vertebral stabilization system, comprising:
a first anchor deliverable to a vertebral body of a patient through a first opening with at least one extended tab connected thereto, the at least one extended tab defining an open central portion and a central longitudinal axis;
an elongate stabilization member extending from a proximal end to a distal end; and
a stabilization member insertion device releasably and rotatably linked to the elongate stabilization member, the stabilization member insertion device including an outer guide tube having a longitudinal axis and having an elongate body extending from a first end to a second end and having a central longitudinal opening extending therethrough, a pin assembly including a pin extending through the central longitudinal opening of the outer guide tube, the pin having a first end engaged with a thumb wheel and a second end configured to engage a clamping element, and a pusher member extending through the central longitudinal opening of the outer guide tube having a first end connected to a handle and a second end connected to the clamping element, wherein the stabilization member insertion device is configured and dimensioned to be received within the open central portion such that the insertion device is moveable along the central longitudinal axis; and
a clamping element including first and second clamping members engaged with the pin, wherein the pusher member linearly moves to cause the clamping element to pivot,
wherein rotation of the thumb wheel in a first direction moves the pin linearly along the direction of the longitudinal axis engaging a portion of the clamping element such that the clamping element is in a locked position, and when the thumb wheel is rotated in a second direction, opposite to the first direction, the pin is linearly retracted and disengages from the clamping element such that the clamping element is in an unlocked position,
wherein the elongate stabilization member is deliverable in a first orientation substantially parallel to the central longitudinal axis of the open central portion; and, independent of movement along the central longitudinal axis, the elongate stabilization member is rotatably actuatable by the stabilization member insertion device to extend in a second orientation angled with respect to the first orientation to position the stabilization member in relation to the first anchor.

### Claim 13 (depends on 12)

The system of claim 12, wherein the elongate stabilization member is cantilevered off the stabilization member insertion device such that at least a portion of the elongate stabilization member is positioned outside the at least one extended tab.

### Claim 14 (depends on 12)

The system of claim 12, wherein the proximal end of the elongate stabilization member is not contained within the open central portion in the first orientation.

### Claim 15 (depends on 12)

The system of claim 12, wherein the at least one extended tab includes a first extension element connected to the first anchor at a break point and a second extension element connected to the first extension element.

### Claim 16 (depends on 12)

The system of claim 12, wherein the at least one extended tab includes a pair of diametrically opposed extended tabs defining opposed longitudinal openings, the longitudinal openings providing lateral access to the open central portion.

### Claim 17 (depends on 16)

The system of claim 16, wherein a portion of the elongate stabilization member is extendable through the longitudinal openings.

### Claim 18 (depends on 12)

The system of claim 12, wherein the elongate stabilization member is releasably clampable to the insertion device between first and second clamping members at a clamping location spaced from a midline of the elongate stabilization member.

### Claim 19 (depends on 18)

The system of claim 18, wherein the first clamping member includes a first generally cylindrical protrusion insertable into a distal portion of the insertion device and the second clamping member includes a second generally cylindrical protrusion insertable into the distal portion of the insertion device, and wherein the first and second clamping members are coupled by a pin extending through a first and second opening in the first and second clamping members, respectively.

### Claim 20

A minimally invasive vertebral stabilization system, comprising:
an anchor deliverable to a vertebral body of a patient with at least one extended tab connected thereto, the at least one extended tab including a first extension element connected to the first anchor at a break point and a second extension element connected to the first extension element, and the at least one extended tab defining an open central portion and a central longitudinal axis;
an elongate stabilization member extending from a proximal end to a distal end; and
a stabilization member insertion device releasably and rotatably linked to the proximal end of the elongate stabilization member, the stabilization member insertion device including an outer guide tube having a longitudinal axis and having an elongate body extending from a first end to a second end and having a central longitudinal opening extending therethrough, a pin assembly including a pin extending through the central longitudinal opening of the outer guide tube, the pin having a first end engaged with a thumb wheel and a second end configured to engage a clamping element, and a pusher member extending through the central longitudinal opening of the outer guide tube having a first end connected to a handle and a second end connected to the clamping element, wherein the stabilization member insertion device is configured and dimensioned to be received within the open central portion such that the insertion device is moveable along the central longitudinal axis; and
a clamping element including first and second clamping members engaged with the pin, wherein the pusher member linearly moves to cause the clamping element to pivot,
wherein rotation of the thumb wheel in a first direction moves the pin linearly along the direction of the longitudinal axis engaging a portion of the clamping element such that the clamping element is in a locked position, and when the thumb wheel is rotated in a second direction, opposite to the first direction, the pin is linearly retracted and disengages from the clamping element such that the clamping element is in an unlocked position,
wherein the elongate stabilization member is cantilevered off the stabilization member insertion device such that at least a portion of the elongate stabilization member is positioned outside the second extension element of the at least one extended tab, and
wherein the elongate stabilization member is deliverable in a first orientation substantially parallel to the central longitudinal axis of the open central portion; and, independent of movement along the central longitudinal axis, the elongate stabilization member is rotatably actuatable by the stabilization member insertion device to extend in a second orientation angled with respect to the first orientation to position the stabilization member proximate to the anchor.
