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Publication Number

US-11992227-B2

Patent

Publication Date

2024-05-28

Expiration Date


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.

Core Innovation

The invention relates to a device for a bone implant fixation procedure that combines an electrically conductive awl-tap member with a placement wire and a depth sleeve member. The awl-tap member includes an electrically conductive body with a cannulated portion extending therethrough, and the placement wire includes a distal tip for penetrating bone. At least a portion of the placement wire is configured to be received within the cannulated portion, and the awl-tap member is configured to deliver electrical current to the bone for the determination of the presence of a nerve adjacent or in proximity to one or more portions of the awl-tap member.

The device further includes a depth sleeve member comprising an elongate body including a lumen extending therethrough and having a distal end. At least a portion of the awl-tap member is received within the lumen, and the depth sleeve member and awl-tap member are configured to move independent of one another. A sensor is operably associated with the depth sleeve member and is configured to detect movement of the depth sleeve member relative to the awl-tap member and generate an electronic signal indicative of a depth of a hole created by the awl-tap member based on the detected movement.

In the system configuration, the invention adds a neuromonitoring device configured to communicate with at least the awl-tap member. The neuromonitoring device is configured to receive the electrical current delivered from the awl-tap member and through the bone, and to determine the presence of a nerve adjacent or in proximity to one or more portions of the awl-tap member.

Claims Coverage

Two independent claims are provided, directed to a device and a system. Across both independent claims, there are three core inventive areas: electrical current delivery for nerve determination, independent depth sleeve movement with a movement-detecting sensor generating a depth signal, and neuromonitoring device communication for nerve presence determination.

Electrically conductive awl-tap for nerve determination via electrical current

An awl-tap member comprising an electrically conductive body having a cannulated portion extending therethrough, 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.

Placement wire received within the awl-tap cannulated portion

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.

Independent depth sleeve movement

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.

Relative-movement sensor generating an electronic hole-depth signal

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.

Neuromonitoring device communicating with the awl-tap to determine nerve presence

A neuromonitoring device configured to communicate with at least the awl-tap member, wherein the neuromonitoring device is 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.

The independent claims cover a bone implant fixation device and system that deliver electrical current via an electrically conductive cannulated awl-tap to determine nerve presence, use a depth sleeve that moves independently from the awl-tap with a sensor generating an electronic signal indicative of hole depth, and include a neuromonitoring device that communicates with the awl-tap to receive the delivered electrical current and determine nerve presence.

Stated Advantages

Documented Applications

No documented applications found

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