Nerve proximity and status detection system and method

• US 7,177,677 B2
• Filed: 10/16/2002
• Issued: 02/13/2007
• Est. Priority Date: 11/24/1999
• Status: Expired due to Term

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Marino, James F., Kaula, Norbert F., Blewett, Jeffrey J.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/271,388
• Publication Number:
  US 20030045808A1
• Time in Patent Office: 1,581 Days
• Field of Search: 600546-548, 600/554, 607/72, 607115-118, 606/34, 606/41
• US Class Current: 600/546
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• 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 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4893 Nerves

Abstract

A method and system is disclosed for detecting proximity of a nerve to a proximity electrode and status of nerve. The method of detecting the proximity of the nerve to the proximity electrode applies a first electrical signal with multiple current levels to a calibration electrode. The method applies a second electrical signal with multiple current levels to the proximity electrode. Based on the response of the nerve to the first and second electrical signals, the method determines the proximity of the proximity electrode to the nerve. The method determines the status of the nerve by applying the first electrical signal with multiple signal levels to the calibration electrode.

Claims

1. A method of intraoperatively determining nerve health to assess success of a surgical procedure comprising the steps of:

(a) intraoperatively applying an electrical signal to a conductive element located near the nerve;

(b) intraoperatively measuring the responses of the nerve to the applied electrical signal;

(c) intraoperatively comparing successive responses of the nerve to the applied electrical signal; and

(d) intraoperatively determining the nerve health based on the comparisons of the successive responses of the nerve to the applied electrical signal.

2. The method of claim 1, wherein step c) includes mapping the responses of the nerve to the applied electrical signal for a fixed latency, and wherein step d) includes determining the nerve health based on mapping the responses of the nerve to the applied electrical signal for the fixed latency.

3. The method of claim 2, wherein step a) includes placing a conductive element near the nerve, and applying an electrical signal having a plurality of predetermined current levels to the conductive element.

4. The method of claim 1, wherein each response is an EMG.

5. The method of claim 1, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

6. The method of claim 3, wherein step a) includes placing a conductive element in the epidural space above the dura of the spinal column in which the nerve is located.

7. The method of claim 1, wherein step d) of determining nerve health is based on an interpretation of a slope of mapped responses of the nerve to the applied electrical signal.

8. The method of claim 1, wherein step d) of determining nerve health is based on an interpretation of a comparison between mapped responses of the nerve to the applied electrical signal and known mappings for at least one of healthy and unhealthy nerves.

9. The method of claim 1, wherein the conductive element is coupled to a medical device.

10. The method of claim 9, wherein the medical device comprises at least one of a cannula, a catheter, and a needle.

11. A method of determining nerve status comprising the steps of:

(a) applying an electrical signal to a conductive element located near the nerve;

(b) measuring the responses of the nerve to the applied electrical signal; and

(c) determining the nerve status based on the responses of the nerve to the applied electrical signal, including the sub-steps of (i) mapping the responses of the nerve to the applied electrical signal for a fixed latency; and

(ii) determining the nerve status based on the mapping of the responses of the nerve to the applied electrical signal for the fixed latency, wherein the fixed latency is a function of peaks in each response of the nerve to the applied electrical signal.

12. The method of claim 11, wherein each response is an EMG.

13. The method of claim 11, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

14. An article of manufacture for use in intraoperatively determining nerve health to assess the success of a surgical procedure, the article of manufacture comprising computer readable storage media including program logic embedded therein that causes control circuitry to perform the steps of:

(a) intraoperatively applying an electrical signal to a conductive element located near the nerve;

(b) intraoperatively measuring the responses of the nerve to the applied electrical signal;

(c) intraoperatively successively comparing the responses of the nerve to the applied electrical signal; and

(d) intraoperatively determining the nerve health based on the comparisons of the successive responses of the nerve to the applied electrical signal.

15. The article of manufacture for use in determining nerve health of claim 14, wherein step c) includes mapping the responses of the nerve to the applied electrical signal for a fixed latency, and wherein step d) includes determining the nerve status based on the mapping of the responses of the nerve to the applied electrical signal for the fixed latency.

16. The article of manufacture for use in determining nerve health of claim 14, wherein each response is an EMG.

17. The article of manufacture for use in determining nerve health of claim 14, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

18. The article of manufacture of claim 14, wherein step d) of determining nerve health is based on an interpretation of a slope of mapped responses of the nerve to the applied electrical signal.

19. The article of manufacture of claim 14, wherein step d) of determining nerve health is based on an interpretation of a comparison between mapped responses of the nerve to the applied electrical signal and known mappings for at least one of healthy and unhealthy nerves.

20. The article of manufacture of claim 14, wherein the conductive element is coupled to a medical device.

21. The article of manufacture of claim 20, wherein the medical device comprises at least one of a cannula, a catheter, and a needle.

22. An article of manufacture for use in determining nerve status, the article of manufacture comprising computer readable storage media including program logic embedded therein that causes control circuitry to perform the steps of:

(a) applying an electrical signal to a conductive element located near the nerve;

(b) measuring the responses of the nerve to the applied electrical signal; and

(c) determining the nerve status based on the responses of the nerve to the applied electrical signal, including the sub-steps of (i) mapping the responses of the nerve to the applied electrical signal for a fixed latency; and

(ii) determining the nerve status based on the mapping of the responses of the nerve to the applied electrical signal for the fixed latency, wherein the fixed latency is a function of peaks in each response of the nerve to the applied electrical signal.

23. An apparatus for intraoperatively determining nerve health to assess success of a surgical procedure, the apparatus comprising:

(a) means for intraoperatively applying an electrical signal to a conductive element located near the nerve;

(b) means for intraoperatively measuring the responses of the nerve to the applied electrical signal;

(c) means for intraoperatively comparing successive responses of the nerve to the applied electrical signal; and

(d) means for intraoperatively determining the nerve health based on the comparisons of the successive responses of the nerve to the applied electrical signal.

24. The apparatus of claim 23, wherein the means for mapping the responses of the nerve to the applied electrical signal includes means for mapping the responses of the nerve to the applied electrical signal for a fixed latency.

25. The apparatus of claim 23, wherein each response is an EMG.

26. The apparatus of claim 23, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

27. The apparatus of claim 23, wherein the determination of nerve health is based on an interpretation of a slope of mapped responses of the nerve to the applied electrical signal.

28. The apparatus of claim 23, wherein the determination of nerve health is based on an interpretation of a comparison between mapped responses of the nerve to the applied electrical signal and known mappings for at least one of healthy and unhealthy nerves.

29. The apparatus of claim 23, wherein the conductive element is coupled to a medical device.

30. The apparatus of claim 29, wherein the medical device comprises at least one of a cannula, a catheter, and a needle.

31. An apparatus for determining nerve status, the apparatus comprising:

(a) means for applying an electrical signal to a conductive element located near the nerve;

(b) means for measuring the responses of the nerve to the applied electrical signal; and

(c) means for determining the nerve status based on the responses of the nerve to the applied electrical signal, including (i) means for mapping the responses of the nerve to the applied electrical signal for a fixed latency, (ii) means for determining the nerve status based on the mapping of the responses of the nerve to the applied electrical signal for the fixed latency, and (iii) means for determining the fixed latency as a function of peaks in each response of the nerve to the applied electrical signal.

32. The apparatus of claim 31, wherein each response is an EMG.

33. The apparatus of claim 31, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

34. A method of determining proximity of a nerve to a second conductive element comprising the steps of:

(a) applying a first electrical signal to a first conductive element located near the nerve;

(b) measuring the responses of the nerve to the first applied electrical signal;

(c) applying a second electrical signal to the second conductive element;

(d) measuring the responses of the nerve to the second applied electrical signal; and

(e) determining the nerve proximity to the second conductive element based on the responses of the nerve to the first applied electrical signal and the responses of the nerve to the second applied electrical signal, including the sub-steps of;

(i) mapping the responses of the nerve to the first applied electrical signal for a first fixed latency;

(ii) mapping of the responses of the nerve to the second applied electrical signal for a second fixed latency;

(iii) determining the nerve proximity to the second conductive element based on the mapping of the responses of the nerve to the first applied electrical signal for the first fixed latency and the mapping of the responses of the nerve to the second applied electrical signal for the second fixed latency; and

(iv) determining the first fixed latency as a function of peaks in each response of the nerve to the first applied electrical signal.

35. The method of claim 34, wherein each response is an EMG.

36. The method of claim 34, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

37. The method of claim 36, wherein the second fixed latency is equal to the first fixed latency.

38. An article of manufacture for use in determining proximity of a nerve to a second conductive element, the article of manufacture comprising computer readable storage media including program logic embedded therein that causes control circuitry to perform the steps of:

(a) applying a first electrical signal to a first conductive element located near the nerve;

(b) measuring the responses of the nerve to the first applied electrical signal;

(c) applying a second electrical signal to the second conductive element;

(d) measuring the responses of the nerve to the second applied electrical signal; and

(e) determining the nerve proximity to the second conductive element based on the responses of the nerve to the first applied electrical signal and the responses of the nerve to the second applied electrical signal, including the sub-steps of;

(i) mapping the responses of the nerve to the first applied electrical signal for a first fixed latency;

(ii) mapping the responses of the nerve to the second applied electrical signal for a second fixed latency;

(iii) determining the nerve proximity to the second conductive element based on the mapping of the responses of the nerve to the first applied electrical signal for the first fixed latency and the mapping of the responses of the nerve to the second applied electrical signal for the second fixed latency; and

(iv) determining the first fixed latency as a function of peaks in each response of the nerve to the first applied electrical signal.

39. The article of manufacture for use in determining proximity of a nerve to a second conductive element of claim 38, wherein each response is an EMG.

40. The article of manufacture for use in determining proximity of a nerve to a second conductive element of claim 38, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

41. The article of manufacture for use in determining proximity of a nerve to a second conductive element of claim 40, wherein the second fixed latency is equal to the first fixed latency.

42. An apparatus for determining proximity of a nerve to a second conductive element, the apparatus comprising:

(a) means for applying a first electrical signal to a first conductive element located near the nerve;

(b) means for measuring the responses of the nerve to the first applied electrical signal;

(c) means for applying a second electrical signal to the second conductive element;

(d) means for measuring the responses of the nerve to the second applied electrical signal; and

(e) means for determining the nerve proximity to the second conductive element based on the responses of the nerve to the first applied electrical signal and the responses of the nerve to the second applied electrical signal, including;

(i) means for mapping the responses of the nerve to the first applied electrical signal for a first fixed latency;

(ii) means for mapping the responses of the nerve to the second applied electrical signal for a second fixed latency;

(iii) means for determining the nerve proximity to the second conductive element based on the mapping of the responses of the nerve to the first applied electrical signal for the first fixed latency and the mapping of the responses of the nerve to the second applied electrical signal for the second fixed latency; and

(iv) means for determining the first fixed latency as a function of peaks in each response of the nerve to the first applied electrical signal.

43. The apparatus for determining proximity of a nerve to a second conductive element of claim 42, wherein each response is an EMG.

44. The apparatus for determining proximity of a nerve to a second conductive element of claim 42, wherein each response is an EMG measured at a muscle physiologically coupled to the nerve.

45. The apparatus for determining proximity of a nerve to a second conductive element of claim 42, wherein the second fixed latency is equal to the first fixed latency.