Method and Apparatus for Detecting Neural Injury

Patent metadata

Field	Value
Publication number	US-2016166164-A1
Application number	US-201514954529-A
Country	US
Kind code	A1
Filing date	Nov 30, 2015
Priority date	Dec 11, 2014
Publication date	Jun 16, 2016
Grant date	—

Abstract

An implantable device for monitoring for neural injury has a plurality of electrodes including stimulus electrodes and sense electrodes. A stimulus source provides a stimulus to be delivered to a nerve in order to give rise to an evoked action potential. Measurement circuitry records a neural compound action potential signal sensed at the sense electrodes. A stream of control stimuli are applied to the nerve over time and the evoked neural responses are measured. A diagnostic parameter of the measured neural responses is monitored over time, in order to detect a change in the diagnostic parameter. If a change in the diagnostic parameter occurs over time, an indication is output that neural injury has occurred.

First claim

1 . A method of monitoring for neural injury. the method comprising:
delivering a stream of control stimuli to a neural pathway over time; measuring neural responses evoked by the control stimuli over time; monitoring a diagnostic parameter of the measured neural responses over time, in order to detect a change in the diagnostic parameter, and if a change in the diagnostic parameter occurs over time, outputting an indication that neural injury has occurred.

2 . The method of claim 1 when used to provide an essentially immediate diagnostic to rapidly detect the onset of the effects of neural injury.

3 . The method of claim 1 or claim 2 wherein the control stimuli are delivered, and the diagnostic ECAP parameter is monitored, substantially continuously.

4 . The method of any one of claims 1 to 3 when performed throughout a surgical procedure.

5 . The method of any one of claims 1 to 3 when performed throughout a postoperative period of interest.

6 . The method of any one of claims 1 to 5 wherein the diagnostic parameter comprises ECAP amplitude, and wherein a change in ECAP amplitude is taken as a diagnostic indicator of neural injury.

7 . The method of any one of claims 1 to 6 wherein the diagnostic parameter comprises ECAP conduction velocity, and whereby a change in conduction velocity is taken as a diagnostic indicator of neural injury.

8 . The method of any one of claims 1 to 7 wherein the diagnostic parameter comprises ECAP peak latency, whereby a change in ECAP peak latency is taken as a diagnostic indicator of neural injury.

9 . The method of any one of claims 1 to 8 further comprising observing the diagnostic indicator over multiple stimulus-measurement cycles, so that a curve of the diagnostic indicator can be identified from multiple measurement points.

10 . The method of any one of claims 1 to 9 when performed during implantation of an electrode lead during surgery, whereby electrodes of the electrode lead being implanted serve as both the stimulus and sense electrodes, so as to continuously intraoperatively monitor the spinal cord or nerve for damage.

11 . The method of any one of claims 1 to 10 wherein a plurality of diagnostic indicators are monitored and the indication that a neural injury has occurred contains an indication of a likely mode of injury.

12 . An implantable device for monitoring for neural injury, the device comprising:
a plurality of electrodes including one or more nominal stimulus electrodes and one or more nominal sense electrodes; a stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to a neural pathway in order to give rise to an evoked action potential on the neural pathway; measurement circuitry for recording a neural compound action potential signal sensed at the one or more sense electrodes; and a control unit configured to:
deliver a stream of control stimuli to the neural pathway over time;
measure neural responses evoked by the control stimuli over time;
monitor a diagnostic parameter of the measured neural responses over time, in order to detect a change in the diagnostic parameter, and
if a change in the diagnostic parameter occurs over time, output an indication that neural injury has occurred.

13 . A non-transitory computer readable medium for monitoring for neural injury, comprising the following instructions for execution by one or more processors:
computer program code means for delivering a stream of control stimuli to a neural pathway over time; computer program code means for measuring neural responses evoked by the control stimuli over time; computer program code means for monitoring a diagnostic parameter of the measured neural responses over time in order to detect a change in the diagnostic parameter, and computer program code means for, if a change in the diagnostic parameter occurs over time, outputting an indication that neural injury has occurred.

Assignees

• Saluda Medical Pty Ltd

Inventors

• Obradovic Milan
• Cameron Tracy
• Gorman Robert Bruce
• Shariati Nastaran Hesam
• Parker John Louis

Classifications

• A61N1/3605

  Implantable neurostimulators for stimulating central or peripheral nerve system · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title

• A61B5/407

  Evaluating the spinal cord (for locating the epidural space A61B5/4896) · CPC title

• A61N1/00

  Electrotherapy; Circuits therefor (A61N2/00 takes precedence; irradiation apparatus A61N5/00) · CPC title

• A61B5/7282

  Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818) · CPC title