System and methods for performing neurophysiologic assessments during spine surgery

• US 9,700,228 B2
• Filed: 05/12/2016
• Issued: 07/11/2017
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Gharib, James E., Farquhar, Allen, Layman, Doug
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US15/153,703
• Publication Number:
  US 20170007145A1
• Time in Patent Office: 425 Days
• 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 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A system and methods for performing neurophysiology assessments during surgery, such as assessing the health of the spinal cord via at least one of MEP and SSEP monitoring and assessing bone integrity, nerve proximity, neuromuscular pathway, and nerve pathology during spine surgery.

Claims

1. A system for performing neurophysiologic assessments during surgery, comprising:

a stimulator configured to deliver first and second sets of electrical stimulation signals to the motor cortex of a patient;

first and second sensors, each configured to detect at least one motor evoked potential response evoked by the first and second sets of electrical stimulation signals; and

a control unit in communication with the stimulator and the first and second sensors, the control unit being configured to (a) maintain first and second channels, said first channel associated with said first sensor and said second channel associated with said second sensor;

(b) in response to a user input to initiate stimulation, direct transmission of the first and second sets of electrical stimulation signals, each of said first and second sets of electrical stimulation signals including stimulation signals having different electrical current amplitude, (c) receive evoked motor evoked potential response data from the first and second sensors, (d) determine a first lowest stimulation current amplitude for the first channel from the first set of electrical stimulation signals that evokes a motor evoked potential response greater than a threshold level, (e) determine a second lowest stimulation current amplitude for the second channel from the second set of electrical stimulation signals that evokes a motor evoked potential response greater than said threshold level, wherein determining the second lowest stimulation current amplitude is based at least in part on a determination of the lowest stimulation signal amplitude of the first set of stimulation signals that recruited on the second channel and the highest stimulation signal amplitude of the first set of stimulation signals that did not recruit on the second channel; and

(f) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to (d) and (e).

2. The system of claim 1, wherein each of the first and second sets of electrical stimulation signals comprises a predetermined number of pulses separated by an interpulse gap, each pulse having a pulse width.

3. The system of claim 2, wherein the number of pulses ranges from 1to 8 monophasic pulses, the interpulse gap ranges from 1 ms to 10 ms, and the pulse width ranges from 50 μ

s to 400 μ

s.

4. The system of claim 3, wherein the monophasic pulses are positive phases pulses for all stimulation signals in the set of stimulation signals.

5. The system of claim 2, wherein each of the first and second sets of electrical stimulation signals have amplitudes within a range from 0 milliamps to 1000 milliamps.

6. The system of claim 2, wherein the control unit is configured to optimize at least one stimulation signal from the first and second sets of electrical stimulation signals at least one of before conducting a neurophysiologic assessment of the spinal cord and after a response to the stimulation signal stops being detected during the neurophysiologic assessment.

7. The system of claim 6, wherein the control unit optimizes said at least one stimulation signal by modifying at least one of the number of pulses, the interpulse gap, the pulse width, and the current level before the neurophysiologic assessment of the spinal cord.

8. The system of claim 6, wherein the onscreen assessment of the spinal cord health status is dependent upon at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude.

9. The system of claim 7, wherein the onscreen assessment of the spinal cord health status communicated by the control unit comprises:

(i) a numerical representation of at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude, and (ii) a color identifier to be displayed to a user.

10. The system of claim 1, wherein the control unit is configured to perform a threshold hunting algorithm to identify at least one of the lowest first stimulation current amplitude and the second lowest stimulation current amplitude.

11. The system of claim 10, wherein the threshold hunting algorithm is based on successive approximation from different stimulation current amplitudes.

12. The system of claim 11, wherein the successive approximation involves:

(a) establishing a bracket within which at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude is contained; and

(b) successively bisecting the bracket until at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude is determined within a specified accuracy.

13. The system of claim 10, wherein the control unit is configured to perform the threshold hunting algorithm for motor evoked potential responses from multiple muscle myotomes.

14. The system of claim 1, further comprising a display in communication with the control unit for displaying the onscreen assessment of the spinal cord health status.

15. The system of claim 14, wherein the display includes touch-screen control capabilities to allow a user to interface with the control unit.

16. The system of claim 15, wherein the touch-screen control allows a user to at least one of select the parameters of the first and second sets of electrical stimulation signals and set a reminder to apply the stimulation signal at a specified time.

17. The system of claim 15, wherein the display is configured to communicate at least one of a baseline motor evoked potential response threshold, a secondary motor evoked potential response threshold, and the difference between the baseline motor evoked potential response threshold and the secondary motor evoked potential response threshold.

18. The system of claim 1, wherein the control unit is further configured to, in response to user input, transition into a manual mode in which the user selects a fixed stimulation current amplitude for a manual mode stimulation signal.

19. The system of claim 18, wherein the controller, when transitioned to the manual mode, is configured to receive the selection of the fixed stimulation current amplitude for the manual mode stimulation signal and to communicate to the user whether or not a motor evoked potential response has been detected for the selected stimulation current amplitude.

20. The system of claim 1, comprising a bite-block for placement in the patient'"'"'s mouth.

21. The system of claim 20, wherein the bite-block is in communication with the control unit and the control unit cannot generate a stimulation signal unless the bite-block is positioned within the patient'"'"'s mouth.

22. The system of claim 21, wherein the bite-block contains at least one electrode in communication with the control unit.

23. The system of claim 1, comprising a second stimulator configured to deliver a third set of electrical stimulation signals to one or more nerves within the patient, the control unit being further configured to direct transmission of the third set of stimulation signals, (b) receive evoked neuromuscular response data from the first and second sensors in response to the third set of stimulation signals, (c) assess a status of at least one of bone integrity, nerve direction, nerve pathology, and neuromuscular pathway integrity by identifying a relationship between a third lowest stimulation current amplitude from the third set stimulation signals that evokes a neuromuscular response greater than a predefined threshold, and (d) communicate the assessed status of the at least one of bone integrity, nerve direction, nerve pathology, and neuromuscular pathway integrity to a user.

24. The system of claim 23, further comprising a display in communication with the control unit for displaying the onscreen assessment of the spinal cord health status and the assessed status of at least one of bone integrity, nerve direction, nerve pathology, and neuromuscular pathway integrity status, wherein the display includes touch-screen control capabilities to allow a user to interface with the control unit.

25. The system of claim 24, wherein the touch-screen control allows a user to selectively switch between any of a variety of screens associated with each of the functions of motor-evoked potential monitoring, bone integrity assessment, nerve direction assessment, nerve pathology assessment, and neuromuscular pathway assessment.

26. The system of claim 1, wherein the control unit and the stimulator communicate via at least one of wire communication and wireless communication.

27. A system for performing neurophysiologic assessment surgery, comprising:

a first stimulator configured to deliver first and second sets of electrical stimulation signals to the motor cortex of a patient to perform motor-evoked potential monitoring, the first set of stimulation signals including a first electrical stimulation signal having a first stimulation current amplitude and a second electrical stimulation signal having a second stimulation current amplitude different from the first electrical current amplitude and the second set of electrical stimulation signals including a third electrical stimulation signal having a third stimulation current amplitude and a fourth electrical stimulation signal having a fourth stimulation current amplitude different from the third electrical current amplitude;

a second stimulator configured to deliver a third set of electrical stimulation signals to one or more peripheral nerves within the patient to perform at least one of somatosensory evoked potential monitoring, nerve direction assessment, nerve pathology assessment, and neuromuscular pathway assessment;

a processor in communication with the first and second stimulators and a plurality of sensors for detecting the responses to the first, second, and third sets of stimulation signals, the processor being configured to (a) direct transmission of the first, second, and third sets of stimulation signals, wherein at least the first set of stimulation signals is transmitted in response to a user input to initiate stimulation, (b) receive data from the sensors, (c) determine a first lowest stimulation current amplitude from the first set of stimulation signals delivered from the first stimulator that evokes a motor evoked potential response greater than a first threshold level, (d) determine a second lowest stimulation current amplitude from the second set of stimulation signals delivered from the first stimulator that evokes a corresponding neuromuscular response greater than a second threshold level, wherein determining the second lowest stimulation current amplitude is based at least in part on a determination of the lowest stimulation signal amplitude of the first set of stimulation signals that recruited and the highest signal amplitude of the first set of stimulation signals that did not recruit, (e) determine a third lowest stimulation current amplitude from the third set of stimulation signals delivered from the second stimulator that evokes a corresponding neuromuscular response greater than a third threshold level; and

(f) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to (c) and (d) and an onscreen assessment of at least one of nerve direction, nerve pathology, and neuromuscular pathway integrity status to be displayed to a user in response to (e).

28. The system of claim 27, wherein each stimulation signal of the first set of stimulation signals comprises a predetermined number of pulses separated by an interpulse gap, each pulse having a pulse width.

29. The system of claim 28, wherein the number of pulses ranges from 1 to 8 monophasic pulses, the interpulse gap ranges from 1 ms to 10ms, the pulse width ranges from 50 μ

s to 400 μ

s, and the respective current level falls within a range from 0 milliamps to 1000 milliamps.

30. The system of claim 29, wherein the monophasic pulses are positive phase pulses for all stimulation signals of the first set of stimulation signals.

31. The system of claim 27, wherein the processor is configured to optimize the parameters of the first set of stimulation signals at least one of prior to performing motor evoked potential monitoring and after a response to the first set of stimulation signals stops being detected during the motor evoked potential monitoring.

32. The system of claim 31, wherein the processor optimizes the first set of stimulation signals by modifying at least one of the number of pulses, the inter pulse gap, the pulse width, and the respective current level for each of the stimulation signals of the first set of stimulation signals before performing motor evoked potential monitoring.

33. The system of claim 27, wherein the onscreen assessment of the spinal cord health status is dependent upon at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude, and the onscreen assessment of nerve direction, nerve pathology, and neuromuscular pathway integrity is dependent upon the third lowest stimulation current amplitude.

34. The system of claim 27, wherein the processor is configured to perform a threshold hunting algorithm to identify at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude.

35. The system of claim 34, wherein the threshold hunting algorithm is based on successive approximation from different stimulation current amplitudes.

36. The system of claim 35, wherein the successive approximation involves:

(a) establishing a bracket within which at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude is contained; and

(b) successively bisecting the bracket until at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude is determined within a specified accuracy.

37. The system of claim 35, wherein the processor is configured to perform the threshold hunting algorithm for responses from multiple sites.

38. The system of claim 27, further comprising a display in communication with the processor for displaying the onscreen assessment of the spinal cord health status and the onscreen assessment of the at least one of bone integrity, nerve direction, nerve pathology, and neuromuscular pathway integrity status.

39. The system of claim 38, wherein the display includes touch-screen control capabilities to allow a user to interface with the processor.

40. The system of claim 38, wherein the touch-screen control allows a user to at least one of select the parameters of the first stimulation signal and set a reminder to apply the first stimulation signal at a specified time.

41. The system of claim 38, wherein the display is configured to communicate at least one of a baseline response threshold, a secondary response threshold, and the difference between the baseline response threshold and the secondary response threshold.

42. The system of claim 27, wherein the processor is further configured to, in response to user input, transition into a manual mode in which the user selects a fixed stimulation current amplitude for a manual mode stimulation signal for delivery from the first stimulator for assessment the spinal cord health status.

43. The system of claim 42, wherein the onscreen assessment of the spinal cord health status communicated by the processor comprises:

(i) a numerical representation of at least one of the first lowest stimulation current amplitude and the second lowest stimulation current amplitude, and (ii) a color identifier to be displayed to a user.

44. The system of claim 42, wherein the processor, when transitioned to the manual mode, is configured to receive the selection of the fixed stimulation current amplitude for the manual mode stimulation signal and to communicate to the user whether or not a motor evoked potential response has been detected based on the selected stimulation current amplitude.

45. The system of claim 27, comprising a bite-block for placement in the patient'"'"'s mouth.

46. The system of claim 45, wherein the bite-block is in communication with the processor and the processor cannot generate a stimulation signal unless the bite-block is positioned within the patient'"'"'s mouth.

47. The system of claim 46, wherein the bite-block contains at least one electrode in communication with the processor.