Minimally invasive nerve monitoring device and method

• US 9,084,550 B1
• Filed: 10/23/2009
• Issued: 07/21/2015
• 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:
  US12/605,020
• Time in Patent Office: 2,097 Days
• Field of Search: 600/595, 600/549, 600/547, 600/554, 600/544, 600/546, 600/587, 600/373
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• 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 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker

Abstract

A neural monitoring device includes a stimulator configured to provide a stimulus, a mechanical sensor configured to generate an output signal corresponding to a sensed event, and a receiver configured to receive an output signal from the mechanical sensor and determine if the output signal corresponds to the stimulus provided by the stimulator.

Claims

1. A neural monitoring device, comprising:

a stimulator configured to provide a stimulus within an intracorporeal treatment area of a subject;

a non-invasive mechanical sensor configured to;

be placed in contact with an external skin surface of the subject and in direct mechanical communication with a muscle of the subject; and

generate an output signal corresponding to a sensed mechanical response of the muscle; and

a processor configured to

receive the output signal from the mechanical sensor;

provide a first indicator if the sensed mechanical response is attributable to a depolarization of a nerve that is caused by the provided stimulus; and

provide a second indicator if the sensed mechanical response is not attributable to the provided stimulus.

2. The neural monitoring device 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.

3. The neural monitoring device of claim 1, wherein the stimulus is an electrical stimulus having a constant current.

4. The neural monitoring device of claim 1, wherein the stimulator includes a button, and wherein the stimulator is configured to selectively provide the stimulus upon actuation of the button.

5. The neural monitoring device of claim 1, wherein the processor is in communication with the stimulator;

and wherein the processor is configured to selectively vary the magnitude of the stimulus.

6. The neural monitoring device of claim 1, wherein the mechanical sensor includes a contact detection device configured to detect whether the mechanical sensor is in mechanical communication with the subject.

7. The neural monitoring device of claim 6, wherein the contact detection device is configured to selectively enable the mechanical sensor when contact is detected.

8. The neural monitoring device of claim 7, wherein selectively enabling the mechanical sensor includes providing power to the mechanical sensor.

9. The neural monitoring device of claim 6, wherein the contact detection device is configured to provide an indication to the processor of detected contact between the mechanical sensor and the subject.

10. The neural monitoring device of claim 9, wherein the processor is configured to provide an alert if the mechanical sensor is not in mechanical communication with the patient.

11. The neural monitoring device of claim 1, wherein the mechanical sensor is configured to wirelessly communicate with the processor.

12. The neural monitoring device of claim 1, wherein the mechanical sensor includes an accelerometer, and wherein the output signal of the mechanical sensor corresponds to a sensed acceleration.

13. The neural monitoring device of claim 6, wherein the contact detection device is configured to monitor an electrical parameter of the subject.

14. The neural monitoring device of claim 1, wherein the processor is further configured to:

derive a time derivative of acceleration from the output signal of the mechanical sensor;

compare the derived time derivative of acceleration to a first threshold; and

determine that the sensed mechanical response is attributable to an induced depolarization of a nerve, caused by the provided stimulus, if the time derivative of acceleration exceeds the first threshold.

15. The neural monitoring device of claim 14, wherein the processor is further configured to:

compare the magnitude of the output signal to a second threshold; and

provide an alert if the time derivative of acceleration exceeds the first threshold and the magnitude of the output signal exceeds the second threshold.

16. The neural monitoring device of claim 1, wherein the processor is further configured to:

receive an indication of the magnitude of the stimulus provided by the stimulator; and

determine a distance between the stimulator and the nerve innervating the muscle of the subject from the magnitude of the stimulus and the magnitude of the output signal from the mechanical sensor; and

provide an indication of the determined distance.

17. The neural monitoring device of claim 1, wherein the stimulator includes an elongate probe having a distal end portion and wherein the stimulus is provided from the distal portion of the probe.

18. The neural monitoring device of claim 17, wherein the distal end portion of the elongate probe is movable within the intracorporeal treatment area;

and

wherein the processor is further configured to provide an indicator corresponding to the position of the stimulator within the intracorporeal treatment area relative to the nerve innervating the muscle of the subject.

19. The neural monitoring device of claim 1, wherein the stimulator includes a handle and an elongate stimulator probe, and wherein the elongate stimulator probe is selectively detachable from the handle.

20. A method, comprising:

providing an electrical stimulus to a distal end portion of an elongate stimulator;

monitoring a muscle for a mechanical response to the electrical stimulus using a non-invasive mechanical sensor configured to be placed in contact with an external skin surface of a subject;

generating an output signal from the mechanical sensor, the output signal corresponding to the monitored mechanical response; and

determining, via a processor in communication with the non-invasive mechanical sensor, if the output signal from the mechanical sensor corresponds to a depolarization of a nerve in response to the stimulus provided by the stimulator;

providing a first indication to a user, via a display associated with the processor, if it is determined that the output signal from the mechanical sensor corresponds to the depolarization of the nerve in response to the stimulus provided by the stimulator;

providing a second indication to the user, via the display, if it is determined that the output signal from the mechanical sensor does not correspond to the depolarization of the nerve in response to the stimulus provided by the stimulator; and

wherein the first indication is representative that the distal end portion of the elongate stimulator is proximate to the nerve, and wherein the second indication is representative that it is safe to proceed with a medical procedure.

21. The method of claim 20, wherein the mechanical sensor includes an accelerometer;

and

wherein monitoring a muscle for a mechanical response to the electrical stimulus includes monitoring an acceleration of the muscle.

22. The method of claim 20, wherein determining if the output signal from the mechanical sensor corresponds to the stimulus provided by the stimulator includes:

deriving an amount of muscle jerk from the output signal of the mechanical sensor;

comparing the derived amount of muscle jerk to a first threshold.

23. The method of claim 22, further comprising:

comparing the magnitude of the output signal to a second threshold; and

providing an alert if the amount of muscle jerk exceeds the first threshold and the magnitude of the output signal exceeds the second threshold.

24. The method of claim 20, further comprising:

determining, via the processor, a distance between the stimulator and the nerve from the magnitude of the provided stimulus and the magnitude of the output signal from the mechanical sensor.

25. The method of claim 20, further comprising providing the electrical stimulus to an intracorporeal treatment area of a subject, the intracorporeal treatment area including at least one nerve innervating the at least one muscle;

and

determining the position of the stimulator within the intracorporeal treatment area relative to the at least one nerve.

26. The method of claim 20, further comprising receiving an input via a button disposed on the handle of the stimulator;

and

wherein providing the electrical stimulus occurs in response to the received input.