# US 11,992,227 B2 · Handheld devices for use in medical procedures

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,992,227 B2
- Document ID: US11992227B2
- Status: Granted
- Kind: B2
- Application number: 17/170,491
- Filed: 2021-02-08
- Published: 2021-07-22
- Granted: 2024-05-28
- Earliest claimed: 2018-03-05
- Assignees: Edge Surgical, Inc.
- Applicants: Edge Surgical, Inc.
- Inventors: Tomas Matusaitis; Kenneth Hoos; Christopher Wilson; Robert F. Rioux; Nitin Khanna; Frank Phillips; Jim A. Youssef; Aniruddha Raina; Antonio Belton; Quinn J. Kesser; Liad Marom; Michael Brown; Allison P. Zadravecz; Nathan H. White; James A. Gilbert; David Jon Farrell; Christopher Pouzou; Patricia Black
- Web page: https://patentgrep.com/patent/US11992227B2

## CPC

- A61B 17/1633: {Sleeves, i.e. non-rotating parts surrounding the bit shaft, e.g. the sleeve forming a single unit with the bit shaft (A61B17/1644 takes precedence)}
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4893: {Nerves}
- A61B 5/6851: {Guide wires}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/1604: {Chisels; Rongeurs; Punches; Stamps}
- A61B 17/1615: {Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material}
- A61B 17/1655: {for tapping}
- A61B 17/1671: {for the spine}
- A61B 18/14: Probes or electrodes therefor
- A61N 1/36142: {for improving safety}
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/395: Details of stimulation, e.g. nerve stimulation to elicit EMG response
- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B 17/8897: {Guide wires or guide pins}
- A61B 2017/00115: {with audible or visual output}
- A61B 2017/00407: {Ratchet means}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00986: {Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts}
- A61B 2018/00077: {high, i.e. electrically conducting}
- A61B 2018/00565: {Bone}
- A61B 2090/062: {penetration depth}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2505/05: Surgical care
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The invention is a system and a device for use in open or minimally invasive surgical procedures, such as a bone implant fixation procedure. The device is configured to perform various functions during a bone implant fixation procedure, including performing at least one of: penetration of a bone to form a hole or opening for receipt of a screw; neuromonitoring, in cooperation with a neuromonitoring device, of the hole during, or post-, formation of the hole so as to sense any nearby nerves adjacent to the hole that may be in the path of a screw, or otherwise affected, when a screw is placed within the hole; neurostimulation, in cooperation with a neuromonitoring device, of nerves adjacent to the hole during, or post-, formation of the hole; and measuring of a depth of the hole and providing a digital measurement of the depth to assist the surgeon in selecting the appropriate length of screw.

## Claims

### Claim 1

A device for a bone implant fixation procedure, the device comprising:
an awl-tap member comprising an electrically conductive body having a cannulated portion extending therethrough, and a placement wire comprising a distal tip for penetrating bone, wherein at least a portion of the placement wire is configured to be received within the cannulated portion of the electrically conductive body, wherein the awl-tap member is configured to deliver electrical current to the bone and the electrical current is used for the determination of the presence of a nerve adjacent or in proximity to one or more portions of the awl-tap member;
a depth sleeve member comprising an elongate body including a lumen extending therethrough and having a distal end, wherein at least a portion of the awl-tap member is received within the lumen and wherein the depth sleeve member and awl-tap member are configured to move independent of one another; and
a sensor operably associated with the depth sleeve member and configured to detect movement of the depth sleeve member relative to the awl-tap member and to generate an electronic signal indicative of a depth of a hole created by the awl-tap member based on the detected movement.

### Claim 2 (depends on 1)

The device of claim 1, wherein the depth sleeve and awl-tap member are configured to be releasably associated with a handle.

### Claim 3 (depends on 1)

The device of claim 1, wherein the depth sleeve is configured to be releasably attached to the implant, and the implant is configured to be fixated in the bone.

### Claim 4 (depends on 1)

The device of claim 1, wherein the placement wire is electrically conductive and is configured to deliver the electrical current to the bone.

### Claim 5 (depends on 4)

The device of claim 4, wherein the distal tip of the placement wire comprises a hexagonal shaped awl point, a sharp awl point, and/or a conical awl point.

### Claim 6 (depends on 2)

The device of claim 2, wherein a portion of the awl-tap member adjacent to the distal tip is externally threaded such that rotation of the awl-tap member in a first direction causes external threading to penetrate bone and draw the distal tip in a direction towards the bone to form a hole therein and rotation of the awl-tap member in a second direction opposite the first direction causes external threading to withdraw from within the hole and move the awl-tap member in a direction away from the bone.

### Claim 7 (depends on 6)

The device of claim 6, wherein the externally threaded portion of the awl-tap member adjacent to the distal tip comprises a tapered first thread.

### Claim 8 (depends on 6)

The device of claim 6, the device further comprising a ratchet assembly and the handle, and wherein the handle is rotatably coupled to the awl-tap member via the ratchet assembly.

### Claim 9 (depends on 1)

The device of claim 1, wherein the distal end of the depth sleeve member is tapered.

### Claim 10 (depends on 1)

The device of claim 1, wherein the depth sleeve member comprises a non-conductive material.

### Claim 11 (depends on 1)

The device of claim 1, wherein the depth sleeve comprises a radiopaque filler of sufficient weight to: (a) allow the depth sleeve to have greater radiodensity relative to the bone; and (2) allow the awl-tap to be visible through the depth sleeve by radio wave or x-ray.

### Claim 12 (depends on 8)

The device of claim 8, wherein the ratchet assembly comprises a switch for toggling between a first rotation setting and a second rotation setting, wherein:
in the first rotation setting, rotation of the handle in a first direction results in the awl-tap member rotating in the same direction and rotation of the handle in an opposite second direction is independent of any rotation of the awl-tap member such that awl-tap member remains stationary; and
in the second rotation setting, rotation of the handle in the first direction is independent of any rotation of the awl-tap member such that the awl-tap member remains stationary and rotation of the handle in the opposite second direction results in the awl-tap member rotating in the same direction.

### Claim 13 (depends on 12)

The device of claim 12, further comprising pawls, wherein:
in the first rotation setting, the pawls release such that rotation of the handle in a first direction results in the awl-tap member rotating in the same direction and engage such that rotation of the handle in an opposite second direction is independent of any rotation of the awl-tap member such that awl-tap member remains stationary; and
in the second rotation setting, the pawls release such that rotation of the handle in the first direction is independent of any rotation of the awl-tap member such that the awl-tap member remains stationary and engage such that rotation of the handle in the opposite second direction results in the awl-tap member rotating in the same direction.

### Claim 14 (depends on 13)

The device of claim 13, wherein the switch may further toggle to a third setting, wherein the pawls engage such that rotation of the handle in the first direction or the second direction is independent of any rotation of the awl-tap member such that the awl-tap member remains stationary.

### Claim 15 (depends on 1)

The device of claim 1, further comprising an output configured to provide an indication of the presence of a nerve adjacent or in proximity to one or more portions of the awl-tap member.

### Claim 16 (depends on 15)

The device of claim 15, wherein the output is configured to provide the indication in a real-time continuous manner of the presence of a nerve adjacent or in proximity to one or more portions of the awl-tap member.

### Claim 17 (depends on 15)

The device of claim 15, wherein the output comprises a display, wherein the indication provided by the output is a visual indication, and wherein the display is a liquid crystal display, an LED display, or an OLED display.

### Claim 18 (depends on 15)

The device of claim 15, wherein the indication provided by the output is an auditory indication.

### Claim 19

A system for a bone implant fixation procedure, the system comprising:
a device comprising:
an awl-tap member, the awl-tap member comprising an electrically conductive body including a distal tip at a distal end thereof for penetrating bone, wherein the awl-tap member is configured to deliver electrical current to the bone and the electrical current is used for the determination of the presence of a nerve adjacent or in proximity to one or more portions of the awl-tap member;
a depth sleeve member comprising an elongate body including a lumen extending therethrough and having a distal end, wherein at least a portion of the awl-tap member is received within the lumen and wherein the depth sleeve member and awl-tap member are configured to move independent of one another; and
a sensor operably associated with the depth sleeve member and configured to detect movement of the depth sleeve member relative to the awl-tap member and to generate an electronic signal indicative of a depth of a hole created by the awl-tap member based on the detected movement; and
a neuromonitoring device configured to communicate with at least the awl-tap member, the neuromonitoring device configured to receive the electrical current delivered from the awl-tap member and through the bone and determine the presence of a nerve adjacent or in proximity to one or more portions of the awl-tap member.