SYSTEMS AND METHODS FOR DETECTING NERVE FUNCTION

• US 20160270679A1
• Filed: 11/06/2014
• Published: 09/22/2016
• Est. Priority Date: 11/07/2013
• Status: Active Grant

• Current Assignee: SafeOp Surgical, Inc. (Alphatec Holdings Incorporated)
• Original Assignee: SafeOp Surgical, Inc. (Alphatec Holdings Incorporated)
• Inventors: Labelle, Curt H., Mahon, Cameron
• Granted Patent: US 11,083,387 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/14 Coupling media or elements to improve sensor contact with skin or tissue
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625

Abstract

The present technology relates generally to the field of electrophysiology and specifically to automated devices, components, systems, and related methods for monitoring potential injury to the nervous system using evoked potentials during intraoperative neurophysiologic monitoring.

Claims

1. A method comprising:

outputting a plurality of time-locked electrical stimuli to a stimulating electrode positioned on a body;

recording a plurality of resultant electrical waveforms received from a recording electrode positioned on the body, the resultant electrical waveforms generated by the body'"'"'s nervous system in response to the time-locked electrical stimuli;

developing an initial baseline waveform from an average of the plurality of resultant electrical waveforms;

outputting an additional electrical stimulus to the stimulating electrode;

recording an additional resultant electrical waveform from the recording electrode;

determining if the additional resultant electrical waveform is acceptable by

comparing the additional resultant electrical waveform to the initial baseline; and

if the additional resultant electrical waveform is acceptable, developing an updated baseline waveform, wherein the updated baseline waveform is a weighted average of the initial baseline waveform and the additional resultant electrical waveform.

2. The method of claim 1, further comprising sending a data output to a user interface, the data output comprising an indication of whether the additional resultant electrical waveform is acceptable.

3. (canceled)

4. (canceled)

5. A system for detecting positioning effect in a body, comprising:

a signal output operable to couple directly or indirectly to a stimulating electrode to deliver an electrical stimulus to a peripheral nerve in the body;

a signal input operable to couple directly or indirectly to a recording electrode to record a resultant electrical waveform generated by the body'"'"'s nervous system in response to the electrical stimulus;

a signal generation circuit and/or processor coupled to the signal output and the signal input and configured to generate the electrical stimulus and process the resultant electrical waveform; and

a detection processor configured to detect a positioning effect by calculating a moving baseline and comparing the processed resultant electrical waveform to the moving baseline.

6. The system of claim 5, wherein processing the resultant electrical waveform comprises filtering and amplifying the resultant electrical waveform.

7. The system of claim 5, wherein a single processor comprises the signal generation processor and the detection processor.

8. The system of claim 5, wherein the signal generation circuit and/or processor is separably electrically coupled to the detection processor.

9. The system of claim 5, wherein the system further comprises a first wireless antenna coupled to the signal generation processor and a second wireless antenna coupled to the detection processor, and wherein the signal generation processor is in wireless communication with the detection processor.

10. The system of claim 9, wherein the first and second wireless antennas are each selected from the group consisting of:

a wireless transmitter, a wireless receiver, and

a wireless transmitter/receiver.

11. The system of claim 5, further comprising:

the stimulating electrode; and

a plurality of recording electrodes, reference electrodes, and ground electrodes positioned at a plurality of peripheral recording sites, wherein each peripheral recording site has one ground electrode, one reference electrode, and one recording electrode, and wherein the recording electrode and the reference electrode are positioned between the ground electrode and the signal input.

12. The system of claim 11, wherein at least two of the reference electrode, the recording electrode, and the ground electrode are disposed on a single electrode unit.

13. The system of claim 5, further comprising:

the stimulating electrode; and

the recording electrode, wherein at least one of the stimulating electrode and the recording electrode comprise a wet gel electrode.

14. The system of claim 5, further comprising:

a first triaxially shielded cable coupled to and connecting the signal output and the stimulating electrode; and

a second triaxially shielded cable coupled to and connecting the signal input and the recording electrode.

21. The system of claim 5, further comprising:

a radio frequency receiver;

wherein the signal generation processor and/or the detection processor is configured to detect a radiofrequency signal received from the radiofrequency receiver and cease signal acquisition upon detection of the radiofrequency signal.

15. A method for detecting positioning effect in a body, comprising:

generating an electrical stimulus;

delivering the electrical stimulus to a peripheral nerve in the body;

recording a resultant electrical waveform generated by the body'"'"'s nervous system in response to the electrical stimulus;

processing the resultant electrical waveform; and

detecting a positioning effect at least in part by calculating a moving baseline and comparing the processed resultant electrical waveform to the moving baseline.

16. The method of claim 15, wherein the resultant electrical waveform is recorded at a plurality of peripheral recording sites using a plurality of single electrode units, each single electrode unit comprising a ground electrode, a reference electrode, and a recording electrode.

17. The method of claim 15, wherein delivering the electrical stimulus comprises delivering the electrical stimulus from an output, through a triaxially shielded cable, to a stimulating electrode.

18. The method of claim 15, wherein recording the resultant electrical waveform comprises receiving the resultant electrical waveform at a recording electrode and sending the resultant electrical waveform through a triaxially shielded cable to an input.

19. The method of claim 15, wherein delivering the electrical stimulus comprises delivering the electrical stimulus via a wet gel electrode.

20. The method of any of claim 15, wherein recording the resultant electrical waveform comprises receiving the resultant electrical waveform via a wet gel electrode.

22-25. -25. (canceled)