Neural monitoring system

• US 8,942,797 B2
• Filed: 06/18/2010
• Issued: 01/27/2015
• Est. Priority Date: 10/18/2007
• Status: Active Grant

• Current Assignee: Innovative Surgical Solutions, LLC (Johnson & Johnson)
• Original Assignee: Innovative Surgical Solutions, LLC (Johnson & Johnson)
• Inventors: Bartol, Stephen, Wybo, Christopher
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US12/818,319
• Publication Number:
  US 20110237974A1
• Time in Patent Office: 1,684 Days
• Field of Search: 600/549, 600/554, 600/509, 600/587, 600/546, 600/372, 600/544, 600/547, 600/595, 607/42, 607/48, 607/63, 607/118, 607/2
• US Class Current: 600/546
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker

Abstract

A system for detecting the presence of a nerve within a subject includes a stimulator configured to provide a stimulus to a portion of the subject, a sensing device configured to be placed in communication with a muscle of the subject and to generate an output signal corresponding to a monitored parameter of the muscle, the sensing device including a mechanical sensor configured to monitor a mechanical parameter of the muscle, and a receiver configured to receive the output signal from the sensing device and to determine if the output signal corresponds to the stimulus provided by the stimulator.

Claims

1. A system for detecting the presence of a nerve within a subject comprising:

a stimulator configured to provide a stimulus to a portion of the subject;

a sensing device configured to be placed in communication with a muscle of the subject and to generate an output signal corresponding to a monitored parameter of the muscle, wherein the sensing device includes a mechanical sensor; and

wherein the monitored parameter includes a mechanical parameter of the muscle, and

a processor configured to;

receive the output signal from the sensing device;

determine if a portion of the output signal was induced by the stimulus provided by the stimulator;

provide a first indicator if the portion of the output signal was induced by the stimulus; and

provide a second indicator if the portion of the output signal was not induced by the stimulus.

2. The system of claim 1, wherein the sensing device further includes an electrical sensor;

and wherein the monitored parameter further includes an electrical parameter of the muscle.

3. The system of claim 2, wherein the electrical sensor includes a plurality of electrodes configured to be placed in electrical communication with the muscle of the subject.

4. The system of claim 3, wherein the plurality of electrodes include needle electrodes.

5. The system of claim 3, wherein the plurality of electrodes include surface electrodes.

6. The system of claim 3, wherein the sensing device further includes a power circuit configured to monitor the plurality of electrodes and energize the mechanical sensor when contact with the subject is detected.

7. The system of claim 2, wherein the output signal comprises a mechanical output signal and an electrical output signal.

8. The system of claim 7, wherein the mechanical output signal and electrical output signal each comprise a voltage.

9. The system of claim 7, wherein the processor is configured to use the electrical output signal to filter the mechanical output signal.

10. The system of claim 2, wherein the processor is further configured to determine if the portion of the output signal was induced by a mechanical manipulation of the nerve.

11. The system of claim 2, wherein the processor is further configured to:

determine a distance between the stimulator and the nerve by comparing a magnitude of the provided stimulus with a magnitude of the received output signal; and

provide an indication of the determined distance.

12. The system of claim 11, wherein the processor is further configured to:

compare the determined distance to a threshold; and

provide an alert if the determined distance is below the threshold.

13. The system of claim 2, wherein the stimulator is configured for intrabody stimulation.

14. The system of claim 13, wherein the stimulator further includes a transdermal stimulator;

and wherein the processor is further configured to determine if the portion of the output signal was induced by the stimulus provided by the transdermal stimulator.

15. The system of claim 1, wherein the mechanical sensor includes an accelerometer configured to monitor an acceleration parameter of the muscle.

16. The system of claim 15, wherein the acceleration parameter includes a magnitude of acceleration in a direction substantially normal to the skin of the subject.

17. The system of claim 1, wherein the processor is configured to determine if the portion of the output signal was induced by the stimulus provided by the stimulator by deriving a time derivative of acceleration from the output signal and by comparing the derived time derivative of acceleration to a threshold.

18. The system of claim 1, wherein the stimulus is an electrical stimulus having a current amplitude in the range of 0 - 10 mA.

19. The system of claim 1, wherein the stimulator is incorporated with an invasive medical instrument.

20. The system of claim 1, wherein the processor is further configured to:

determine a distance between the stimulator and the nerve by comparing a magnitude of the provided stimulus with a magnitude of the received output signal; and

provide an indication of the determined distance.

21. The system of claim 20, wherein the processor is further configured to:

compare the determined distance to a threshold; and

provide an alert if the determined distance is below the threshold.

22. The system of claim 1, wherein the stimulator includes a button configured to initiate a stimulus.

23. The system of claim 1, wherein the first indicator is indicative of the nerve being proximate to the stimulator, and wherein the second indicator is indicative of a condition where it is safe to proceed with a surgical procedure.

24. The system of claim 1, wherein the mechanical parameter of the muscle includes at least one of a motion, an acceleration, a displacement, and a vibration of the muscle.

25. A system for detecting the presence of a nerve within a subject comprising:

a stimulator configured to provide an electrical stimulus within an intracorporeal treatment area of a subject, the electrical stimulus having a current amplitude in the range of 0 -10 mA;

a sensing device configured to be placed in communication with a muscle of the subject, the sensing device including a mechanical sensor configured to generate an output signal corresponding to a monitored mechanical parameter of the muscle; and

a processor configured to;

receive the output signal from the sensing device;

determine if a portion of the output signal was induced by the stimulus provided by the stimulator;

provide a first indicator if the portion of the output signal was induced by the stimulus; and

provide a second indicator if the portion of the output signal was not induced by the stimulus.

26. The system of claim 25, wherein the processor is further configured to:

determine a distance between the stimulator and the nerve by comparing a magnitude of the provided stimulus with a magnitude of the received output signal; and

provide an indication of the determined distance.

27. The system of claim 25, wherein the first indicator is indicative of the nerve being proximate to the stimulator, and wherein the second indicator is indicative of a condition where it is safe to proceed with a surgical procedure.

28. The system of claim 25, wherein the monitored mechanical parameter of the muscle includes at least one of a motion, an acceleration, a displacement, and a vibration of the muscle.