Neuromonitoring systems and methods

• US 10,039,461 B2
• Filed: 02/29/2016
• Issued: 08/07/2018
• Est. Priority Date: 11/27/2012
• Status: Active Grant

• Current Assignee: Cadwell Laboratories, Incorporated (Cadwell Industries Incorporated)
• Original Assignee: Cadwell Laboratories, Incorporated (Cadwell Industries Incorporated)
• Inventors: Cadwell, John
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US15/056,681
• Publication Number:
  US 20160174861A1
• Time in Patent Office: 890 Days
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61N 1/20 continuous direct currents

Abstract

Systems, devices, and methods are described for neuromonitoring. A minimum stimulus signal required to elicit a threshold neuromuscular response is determined by delivery of stimulus signals to tissue and detection of neuromuscular responses in muscle tissue. The strength of the delivered stimulus signals is varied, for example by adjusting the current amplitude or pulse width of the signals, and muscle responses are measure, for example by detecting EMG signals. The delivered stimuli and corresponding responses are then used to determine a stimulation threshold. The stimulation threshold may be used to indicate at least one of nerve proximity and pedicle integrity.

Claims

1. A method for neuromonitoring, comprising:

delivering a first stimulus signal having a first pulse width and a second stimulus signal having a second pulse width to tissue including or adjacent to a nerve, the first pulse width being different from the second pulse width;

detecting, in muscle tissue, a first neuromuscular response in response to the first stimulus signal and a second neuromuscular response in response to the second stimulus signal;

determining a stimulation threshold for the nerve from the first and second pulse widths and the first and second neuromuscular responses, the stimulation threshold being an estimate of a minimum pulse width required to elicit a neuromuscular response greater than or equal to a predetermined threshold, wherein the stimulation threshold is different from the first and second pulse widths; and

communicating to a user an indicator of the stimulation threshold to indicate at least one of nerve proximity and pedicle integrity.

2. The method of claim 1, wherein the first and second stimulus signals are delivered at a constant current.

3. The method of claim 1, wherein the first and second stimulus signals are delivered at a constant voltage.

4. The method of claim 1, further comprising delivering a plurality of stimulus signals, each stimulus signal having a larger pulse width than a preceding stimulus signal.

5. The method of claim 4, wherein the pulse width of the stimulus signals in the plurality of stimulus signals increase at a constant increment.

6. The method of claim 4, wherein the pulse width of the stimulus signals in the plurality of stimulus signals increase at varying increments.

7. The method of claim 4, wherein delivering the plurality of stimulus signals comprises delivering stimulus signals until a neuromuscular response greater than or equal to the predetermined threshold is detected.

8. The method of claim 1, wherein the second neuromuscular response is the first detected neuromuscular response greater than or equal to the predetermined threshold.

9. The method of claim 1, wherein communicating an indicator comprises communicating the second pulse width to the user.

10. The method of claim 1, wherein the first and second pulse widths define an initial pulse width range, and determining the stimulation threshold comprises delivering stimulus signals having pulse widths selected from within the initial pulse width range to determine the minimum pulse width required to elicit a neuromuscular response greater than or equal to the predetermined threshold.

11. The method of claim 10, wherein delivering stimulus signals having pulse widths selected from within the initial pulse width range comprises delivering a sequence of stimulus signals having pulse widths that either increase by a constant increment or decrease by a constant decrement.

12. The method of claim 11, further comprising delivering the sequence of stimulus signals from a first stimulus signal near a lower bound of the initial pulse width range and increasing the pulse width of subsequent stimulus signals to a value near an upper bound of the initial pulse width range.

13. The method of claim 11, further comprising delivering the sequence of stimulus signals from a first stimulus signal near an upper bound of the initial pulse width range and decreasing the pulse width of subsequent stimulus signals to a value near a lower bound of the initial pulse width range.

14. The method of claim 10, further comprising delivering a subsequent stimulus pulse having a pulse width equal to a midpoint of the initial pulse width range.

15. The method of claim 9 wherein communicating the indicator comprises displaying an indication of electric charge.

16. The method of claim 15, wherein the indication of electric charge is displayed in coulombs.

17. The method of claim 9, wherein communicating the indicator comprises displaying a distance between the nerve and a surgical instrument.

18. The method of claim 17, further comprising calculating the displayed distance from an electric charge corresponding to the stimulation threshold.

19. The method of claim 9, wherein communicating the indicator comprises displaying a pulse width corresponding to the stimulation threshold.

20. The method of claim 1, further comprising communicating at least one of a constant current or a constant voltage at which the first and second stimulus signals are delivered.

21. The method of claim 1, wherein the first neuromuscular response is detected before the second stimulus signal is delivered.

22. The method of claim 1, wherein the second stimulus pulse is delivered before the first neuromuscular response is detected.

23. The method of claim 1, wherein an offset time between delivery of the first stimulus pulse and delivery of the second stimulus pulse is greater than or equal to a refractory period associated with the nerve and the muscle tissue.

24. A method for neuromonitoring, comprising:

delivering by a stimulating electrode located on a surgical accessory first and second stimulation signals to tissue including or adjacent to a nerve;

detecting by a sensor associated with muscle tissue associated with the nerve respective first and second neuromuscular responses elicited by the first and second stimulation signals;

calculating a stimulation threshold for the nerve by extrapolation from the respective first and second neuromuscular responses, wherein the stimulation threshold is different from the first and second stimulation signals; and

communicating an indicator of the stimulation threshold to a user to indicate one of nerve proximity and pedicle integrity.

25. The method of claim 24, wherein delivering the first and second stimulation signals comprises delivering the first and second stimulation signals each having a different amplitude.

26. The method of claim 24, wherein delivering the first and second stimulation signals comprises delivering the first and second signals each having a different pulse width.