Multi-channel stimulation threshold detection algorithm for use in neurophysiology monitoring

• US 8,206,312 B2
• Filed: 09/22/2006
• Issued: 06/26/2012
• Est. Priority Date: 09/22/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Farquhar, Allen
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US11/994,409
• Publication Number:
  US 20080167574A1
• Time in Patent Office: 2,104 Days
• Field of Search: 600/554, 600546-548, 607/39, 607/40, 607/48, 607/61, 607/66, 607 68- 76, 607115-118, 607/148
• US Class Current: 600/554
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence

Abstract

The present invention relates generally to an algorithm aimed at neurophysiology monitoring, and more particularly to an algorithm capable of quickly finding stimulation thresholds over multiple channels of a neurophysiology monitoring system.

Claims

1. A method for performing neurophysiologic assessments, comprising:

determining a threshold current level on a first channel of a neuromonitoring device, said first channel associated with a first myotome, wherein determining the threshold current level on the first channel includes;

delivering stimulation signals within tissue and monitoring neuromuscular responses on said first channel to determine when said stimulation signals evoke a significant neuromuscular response, wherein said stimulation signals are delivered as a sequence of pulses and wherein the current level of each pulse is adjusted from an immediately preceding pulse until the current level required to evoke a significant neuromuscular response is determined; and

determining a threshold current level on a second channel of the neuromonitoring device, said second channel associated with a second myotome, wherein determining the threshold current level on the second channel includes;

delivering stimulation signals within tissue and monitoring neuromuscular responses on said second channel to determine when said stimulation signals evoke a significant neuromuscular response wherein said stimulation signals are delivered as a sequence of pulses and wherein the current level of each pulse is adjusted from an immediately preceding pulse until the current level required to evoke said significant neuromuscular response is determined, and omitting one or more pulses from the sequence of pulses when the neuromuscular response to the omitted pulse is predictable based upon data obtained while determining the threshold current level of the first channel.

2. The method of claim 1, further comprising identifying a relationship between said current levels and said neuromuscular responses, said relationship indicative of at least one of pedicle integrity, nerve proximity, nerve pathology, and spinal cord health.

3. The method of claim 2, wherein said identified relationship is the threshold current level required to evoke a significant neuromuscular response of a predetermined magnitude.

4. The method of claim 3, wherein said neuromuscular response is detected by an EMG sensor and said pre-determined magnitude is measured as a peak-to-peak voltage.

5. The method of claim 4, wherein said predetermined magnitude is a peak-to-peak voltage from within the range of 20 uV to 100 uV.

6. The method of claim 1, comprising the additional step of determining a threshold current level on at least one additional channel of the neuromonitoring device, each additional channel associated with a myotome, wherein determining the threshold current level on each additional channel includes:

delivering stimulation signals within tissue and monitoring neuromuscular responses on said additional channel to determine when said stimulation signals evoke a significant neuromuscular response wherein said stimulation signals are delivered as a sequence of pulses and wherein the current level of each pulse is adjusted from an immediately preceding pulse until the current level required to evoke said significant neuromuscular response is determined, and omitting one or more pulses from the sequence of pulses when the neuromuscular response to the omitted pulse is predictable based upon data obtained while determining the threshold current level of another channel.

7. The method of claim 1, wherein determining the threshold current level for each channel comprises establishing for each channel a bracket within which the threshold current level must lie.

8. The method of claim 1, wherein determining the threshold current level for each channel comprises bisecting to a predetermined range a bracket established on each channel.

9. The method of claim 1, wherein an algorithm is executed to determine the threshold current level for each channel.

10. The method of claim 9, wherein said algorithm is biased to find one of the threshold current level on the channel with the lowest threshold and the threshold current level on the channel with the highest threshold prior to finding the threshold current level on the remaining channels.

11. The method of claim 9, wherein said algorithm operates by assigning a channel specific status to each pulse comprising a current level, said status being one of a first status and a second status, said first status applying to a current level which evokes a neuromuscular response one of equal to and greater than said predetermined magnitude and said second status applying to a current level which evokes a neuromuscular response less than said predetermined magnitude.

12. The method of claim 11, wherein said algorithm determines said status of a pulse by at least one of stimulating at said current level and measuring the magnitude of the neuromuscular response, and inferring the status based on the previously obtained data.

13. The method of claim 12, wherein said previously obtained data includes the neuromuscular response measured on one channel in relation to a pulse delivered to determine the threshold current level on another channel.

14. The method of claim 11, wherein said first status is assigned without directing a pulse at said current level if said current level is one of equal to and greater than a current level previously assigned said first status on the applicable channel.

15. The method of claim 11, wherein said second status is assigned without directing a pulse at said current level if said current level is less than a current level previously assigned said second status on the applicable channel.

16. The method of claim 11, wherein said algorithm is based on successive approximation.

17. The method of claim 11, wherein said algorithm comprises a first step of establishing a bracket within which the threshold current level must lie and a second step of bisecting the bracket to a predetermined width.

18. The method of claim 17, wherein said bracketing step is carried out for each channel before the algorithm transitions to said bisection step.

19. The method of claim 17, wherein said first step of establishing a bracket and said second step of bisecting the bracket are completed on one channel before beginning the steps again on another channel.

20. The method of claim 17, wherein said first bracket is determined by assigning on each channel one of said first status and said second status to a series of pulses of successively doubling stimulation current levels, wherein an upper boundary of said first bracket comprises the first stimulation current level assigned said first status and a lower boundary of said first bracket comprises the last stimulation current level assigned said second status.

21. The method claim 20, wherein said first bracket is bisected on each channel by assigning one of said first status and said second status to a stimulation current level at the midpoint of said first bracket, said midpoint forming a second bracket with one of said upper boundary and said lower boundary of said first bracket, said midpoint forming a lower boundary of said second bracket when said midpoint is assigned said second status and said midpoint forming an upper boundary of said second bracket when said midpoint is assigned said first status.

22. The method of claim 1, wherein the current level of said stimulation signals is automatically adjusted in a first sequence to establish a bracket which contains the threshold current level on a first channel.

23. The method of claim 22, wherein the current level of said stimulation signals is automatically adjusted in a second sequence to establish a bracket which contains the threshold current level on a second channel, wherein at least one of said stimulation current levels in said second sequence equals one of said pulses comprising a stimulation current level in said first sequence, and said pulse is omitted from said second sequence.

24. The method of claim 3, wherein delivery of said stimulation signals is directed from a control unit, said control unit communicating with a stimulation source and a sensor configured to detect the neuromuscular responses.

25. The method of claim 24, comprising the additional step of displaying on a display linked to said control unit at least one of alpha-numeric, graphic, and color based indicia to communicate the threshold current level results.

26. The method of claim 25, wherein said display includes a graphical user interface and comprising the further step of inputting user instructions including one or more of starting stimulation, stopping stimulation, selecting a function, and adjusting system parameters.

27. The method of claim 24, wherein the stimulation source is an MEP stimulator and wherein the stimulation signals are delivered to the motor cortex.

28. The method of claim 27, comprising the further step of determining the threshold current level for each channel at least twice during a surgical procedure and comparing the later threshold current level to the earlier threshold current level to indicate the health of the spinal cord.

29. The method of claim 24, comprising the further step of retracting a nerve out of a surgical corridor using a nerve retractor electrically coupled to said stimulation source.

30. The method of claim 29, comprising the further step of determining the threshold current level for each channel at least twice while the nerve is retracted and comparing the later threshold current level to the earlier threshold current level to indicate the pathology of the nerve.

31. The method of claim 24, wherein the threshold current level is determined for each of between two and eight channels.

32. The method of claim 24 wherein said control unit directs automatic adjustment of said stimulation signals according to an algorithm.

33. The method of claim 32, wherein said algorithm operates by assigning a channel specific status to each pulse comprising a current level, said status being one of a first status and a second status, said first status applying to a current level which evokes an EMG response equal to or greater than said predetermined magnitude and said second status applying to a current level which evokes an EMG response less than said predetermined magnitude.

34. The method of claim 33, wherein said algorithm determines said status of a pulse by at least one of stimulating at said current level and measuring the magnitude of the EMG response, and inferring the status based on previously obtained data.

35. The method of claim 34, wherein said previously obtained data includes the EMG response measured on one channel in relation to a pulse delivered to determine the threshold current level on another channel.

36. The method of claim 35, wherein said first status is assigned without directing a pulse at said current level if said current level is one of equal to and greater than a current level previously assigned said first status on the applicable channel and said second status is assigned without directing a pulse at said current level if said current level is less than a current level previously assigned said second status on the applicable channel.

37. The method of claim 36, wherein said first bracket is determined by assigning on each channel one of said first status and said second status to a series of pulses of successively doubling stimulation current levels, wherein an upper boundary of said first bracket comprises the first stimulation current level assigned said first status and a lower boundary of said first bracket comprises the last stimulation current level assigned said second status.

38. The method claim 37, wherein said first bracket is bisected on each channel by assigning one of said first status and said second status to a stimulation current level at the midpoint of said first bracket, said midpoint forming a second bracket with one of said upper boundary and said lower boundary of said first bracket, said midpoint forming a lower boundary of said second bracket when said midpoint is assigned said second status and said midpoint forming an upper boundary of said second bracket when said midpoint is assigned said first status.

39. The method of claim 38, wherein the algorithm determines the bracket for each channel before the algorithm transitions to bisect each channel.

40. The method of claim 38, wherein the algorithm establishes a bracket and bisects the bracket on one channel before establishing a bracket on another channel.

41. The method of claim 40, wherein said algorithm is biased to find the threshold current level on the channel with the lowest threshold prior to finding the threshold current level on the remaining channels.

42. The method of claim 40, wherein said algorithm is biased to find the threshold current level on the channel with the highest threshold prior to finding the threshold current level on the remaining channels.

43. The method of claim 38, wherein the stimulation source is an MEP stimulator and wherein the stimulation signals are delivered to the motor cortex.

44. The method of claim 43, comprising the further step of determining the threshold current level for each channel at least twice during a surgical procedure and comparing the later threshold current level for each channel to the earlier threshold current level for the same channel to indicate the health of the spinal cord.

45. The method of claim 44, wherein the display indicates the health of the spinal cord with color based indicia.

46. The method of claim 45, wherein the color based indicia includes the color red to indicate an unsafe condition, the color green to indicate a safe condition, and the color yellow to indicate an intermediate condition between the unsafe and safe conditions.