# US 11,026,736 B2 · Surgical instrument and method

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- Number: US 11,026,736 B2
- Document ID: US11026736B2
- Status: Granted
- Kind: B2
- Application number: 15/899,103
- Filed: 2018-02-19
- Published: 2019-08-22
- Granted: 2021-06-08
- Earliest claimed: 2018-02-19
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc.
- Inventors: Alexander J. Rohlfing; Jason M. May; Dustin Bobbitt
- Web page: https://patentgrep.com/patent/US11026736B2

## CPC

- A61B 17/8877: {characterised by the cross-section of the driver bit}
- A61B 17/8891: {at its periphery}
- A61B 17/7001: {Screws or hooks combined with longitudinal elements which do not contact vertebrae (A61B17/7058 takes precedence)}
- 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 17/861: {specially shaped for gripping driver}
- 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

A surgical system includes a bone fastener having a head and a shaft. The head has a drive interface surface including elliptical edges. A surgical instrument includes an inner drive and an outer sleeve that is engageable with an outer surface of the head to dispose the inner drive and the outer sleeve with the head in a co-axial, capture orientation. The inner drive has a drive interface surface including a plurality of spaced apart lobes. Each lobe has an elliptical edge engageable with one of the elliptical edges of the drive interface surface of the head. Spinal constructs, implants and methods are disclosed.

## Claims

### Claim 1

A surgical system comprising:
a bone fastener including a head and a shaft extending from the head in co-axial alignment and configured for penetrating tissue, the head having a drive interface surface including a plurality of elliptical edges spaced apart about the interface surface; and
a surgical instrument including an inner drive and an outer sleeve, the inner drive including a shank, a drive interface extending from the shank and spaced apart arms disposed about the drive interface, the shank defining a longitudinal axis, the outer sleeve comprising a flange extending perpendicular to the longitudinal axis, the arms defining a collet that is expandable to receive the head, the shank comprising a first thread that mates with a second thread of the outer sleeve such that rotation of the inner drive relative to the outer sleeve translates the inner drive relative to the outer sleeve to move the collet between a first orientation in which the arms are spaced apart by a first distance and a second orientation in which the arms are spaced apart by an increased second distance, the flange engaging surfaces of the arms that extend perpendicular to the longitudinal axis when the collet is in the first orientation to prevent translation of the inner drive relative to the outer sleeve along the longitudinal axis in one direction, the drive interface surface including a plurality of spaced apart lobes, each lobe having an elliptical edge engageable with one of the elliptical edges of the drive interface surface of the head.

### Claim 2 (depends on 1)

A surgical system as recited in claim 1, wherein the interface surface of the head comprises a plurality of protrusions including the elliptical edges of the head circumferentially disposed about the interface surface of the head.

### Claim 3 (depends on 1)

A surgical system as recited in claim 1, wherein the interface surface of the head comprises a hexalobe socket having six spaced apart protrusions including the elliptical edges of the head.

### Claim 4 (depends on 1)

A surgical system as recited in claim 1, wherein the elliptical edges of the head are defined by an ellipse having a major axis of between about 2.0 mm and 2.3 mm and a minor axis of between about 1.00 mm and 1.3 mm.

### Claim 5 (depends on 1)

A surgical system as recited in claim 1, wherein the interface surface of the inner drive comprises a plurality of recesses disposed between the lobes and including the elliptical edges of the inner drive.

### Claim 6 (depends on 1)

A surgical system as recited in claim 1, wherein the lobes are circumferentially disposed about the interface surface of the inner drive and each lobe includes a leading elliptical edge, a tip edge and a trailing elliptical edge.

### Claim 7 (depends on 1)

A surgical system as recited in claim 1, wherein the interface surface of the inner drive comprises a hexalobe drive having six lobes with grooves, and the elliptical edges of the inner drive are disposed between the lobes.

### Claim 8 (depends on 1)

A surgical system as recited in claim 1, wherein the elliptical edges of the inner drive are defined by an ellipse having a major axis of between about 1.8 mm and 2.2 mm and a minor axis of between about 1.0 mm and 1.4 mm.

### Claim 9 (depends on 1)

A surgical system as recited in claim 1, wherein the lobes are configured to transmit and/or withstand a torque in a range of between about 18 Nm to 24 Nm.

### Claim 10 (depends on 1)

A surgical system as recited in claim 1, wherein the inner drive includes cannulation.

### Claim 11 (depends on 1)

A surgical system as recited in claim 1, wherein the shaft includes cannulation.

### Claim 12 (depends on 1)

A surgical system as recited in claim 1, wherein the outer sleeve includes an end that moves along the arms to move the collet between the orientation and the second orientation.

### Claim 13 (depends on 1)

A surgical system as recited in claim 1, wherein the arms each include an element engageable with an outer surface of the head.

### Claim 14 (depends on 1)

A surgical system as recited in claim 1, wherein the outer sleeve comprises a tissue depth stop.

### Claim 15 (depends on 1)

A surgical system as recited in claim 1, wherein the outer sleeve comprises a barrel having a proximal limit and a distal limit limiting axial translation of the inner drive relative to the outer sleeve.

### Claim 16 (depends on 1)

A surgical system as recited in claim 1, wherein the drive interface surface of the head includes a plurality of elliptical edges spaced apart about the drive interface surface of the head, the drive interface surface of the shaft including a plurality of spaced apart lobes, each lobe having an elliptical edge engageable with one of the elliptical edges of the drive interface surface of the head.

### Claim 17

A surgical system comprising:
a bone fastener including a head and a shaft extending from the head, the head having a drive interface surface; and
a surgical instrument including a shaft and a sleeve, the shaft of the surgical instrument including a shank, a drive interface extending from the shank and spaced apart arms disposed about the drive interface, the shank defining a longitudinal axis, the arms defining a collet that is expandable to receive the head, the sleeve comprising a stop extending perpendicular to the longitudinal axis, the shaft comprising a first thread that mates with a second thread of the sleeve such that rotation of the shaft of the surgical instrument relative to the sleeve translates the shaft of the surgical instrument relative to the sleeve to move the collet between a first orientation in which the arms are spaced apart by a first distance and a second orientation in which the arms are spaced apart by an increased second distance, the stop engaging surfaces of the arms that extends perpendicular to the longitudinal axis when the collet is in the first orientation to prevent translation of the shaft relative to the sleeve along the longitudinal axis in one direction, the shaft of the surgical instrument having a drive interface configured to engage the drive interface surface of the head.

### Claim 18

A surgical system comprising:
a bone fastener including a head and a shaft extending from the head, the head having a drive interface surface; and
a surgical instrument including a shaft and a sleeve, the shaft of the surgical instrument including a shank, a drive interface extending from the shank and spaced apart arms disposed about the drive interface, the shank defining a longitudinal axis, the sleeve including a first stop surface extending transverse to the longitudinal axis, the head including a threaded portion attachable with the sleeve, the arms defining a collet that is expandable to receive the head, the shaft comprising a first thread that mates with a second thread of the sleeve such that rotation of the shaft relative to the sleeve translates the shaft relative to the sleeve to move the collet between a first orientation in which the arms are spaced apart by a first distance and a second orientation in which the arms are spaced apart by an increased second distance, the first stop surface engaging second stop surface of the arms that extend transverse to the longitudinal axis when the collet is in the first orientation to prevent translation of the shaft relative to the sleeve along the longitudinal axis in one direction, the shaft having a drive interface configured to engage the drive interface surface of the head.
