System and method for computationally determining migration of neurostimulation leads

• US 7,831,307 B1
• Filed: 11/07/2006
• Issued: 11/09/2010
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A.
• Primary Examiner(s): EL-KAISSI, HIBA CARINE
• Assistant Examiner(s): Narayanaswamy; Shubatra
• Application Number:
  US11/557,484
• Time in Patent Office: 1,463 Days
• Field of Search: 607/46, 607/55, 607/57, 607/117
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A tissue stimulation system and computer software and method of monitoring a neurostimulation lead having a plurality of electrodes implanted within a patient (e.g., adjacent the spinal cord) is provided. Neurostimulation lead models are provided, each of which includes estimated electrical parameter data (e.g., electrical field potential data) corresponding to a predetermined position of the neurostimulation lead. Electrical energy is transmitted to or from the electrodes, and electrical parameter data (e.g., electrical field potential data) is measured in response to the transmitted electrical energy. The measured electrical parameter data is compared with the estimated electrical parameter data of each of the neurostimulation lead models, and a position of the neurostimulation lead is determined based on the comparison.

Claims

1. A method of monitoring neurostimulation leads, each having a plurality of electrodes implanted within a patient, the method comprising:

providing a plurality of neurostimulation lead models, each of which includes estimated electrical parameter data corresponding to a predetermined relative position between the neurostimulation leads;

transmitting electrical energy to or from the electrodes of the neurostimulation leads;

measuring electrical parameter data in response to the transmitted electrical energy;

comparing the measured electrical parameter data with the estimated electrical parameter data of each of the neurostimulation lead models; and

determining a relative position between the neurostimulation leads based on the comparison.

2. The method of claim 1, wherein the neurostimulation leads are implanted in a side-by-side arrangement.

3. The method of claim 2, wherein the determined relative position is a stagger between the neurostimulation leads.

4. The method of claim 1, wherein the neurostimulation leads are implanted adjacent a spinal cord of the patient.

5. The method of claim 1, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

6. The method of claim 1, wherein the determined relative position is the predetermined relative position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

7. The method of claim 1, wherein the comparison is performed computationally.

9. The method of claim 1, wherein each of the neurostimulation lead models is selecting from the group consisting of an analytical model, a spatially discretized model, and an empirical data-based model.

10. The method of claim 1, wherein the estimated electrical parameter data in each of the neurostimulation lead models comprises a two-dimensional array of data having transmitting ones of the electrodes in one dimension of the data array, and recording ones of the electrodes in the other dimension of the data array.

11. The method of claim 1, further comprising determining whether one of the neurostimulation leads has migrated based on the determined relative position.

12. The method of claim 11, further comprising taking corrective action in response to a determination that the one neurostimulation lead has migrated.

13. The method of claim 12, wherein the corrective action comprises reprogramming the electrodes.

8. The method of clam 7, wherein the comparison is computationally performed using a comparison function selected from the group consisting of a correlation coefficient function, a least squares based function, and a cross-correlation function.

14. A method of monitoring a neurostimulation lead having a plurality of electrodes implanted within a patient, comprising:

providing a plurality of neurostimulation lead models, each of which includes estimated electrical parameter data corresponding to a predetermined position of the neurostimulation lead;

transmitting electrical energy to or from the electrodes;

measuring electrical parameter data in response to the transmitted electrical energy;

comparing the measured electrical parameter data with the estimated electrical parameter data of each of the neurostimulation lead models; and

determining a position of the neurostimulation lead based on the comparison.

15. The method of claim 14, wherein the position of the neurostimulation lead is determined relative to another neurostimulation lead implanted within the patient.

16. The method of claim 15, wherein the neurostimulation leads are implanted in a side-by-side arrangement.

17. The method of claim 16, wherein the determined relative position is a stagger between the neurostimulation leads.

18. The method of claim 14, wherein the position of the neurostimulation lead is determined relative to an anatomical feature.

19. The method of claim 14, wherein the neurostimulation lead is implanted adjacent a spinal cord of the patient.

20. The method of claim 14, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

21. The method of claim 14, wherein the determined position is the predetermined position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

22. The method of claim 14, wherein the comparison is performed computationally.

24. The method of claim 14, wherein each of the neurostimulation lead models is selected from the group consisting of an analytical model, a spatially discretized model, and an empirical data-based model.

25. The method of claim 14, further comprising determining whether the neurostimulation lead has migrated based on the determined position.

26. The method of claim 25, further comprising taking corrective action in response to a determination that the neurostimulation lead has migrated.

27. The method of claim 26, wherein the corrective action comprises reprogramming the electrodes.

23. The method of clam 14, wherein the comparison is computationally performed using a comparison function selecting from the group consisting of a correlation coefficient function, a least squares based function, and a cross-correlation function.

28. A tissue stimulation system, comprising:

implantable neurostimulation leads, each having a plurality of electrodes;

a plurality of neurostimulation lead models, each of which includes estimated electrical parameter data corresponding to a predetermined relative position between the neurostimulation leads;

a controller configured for transmitting electrical energy to or from the electrodes of the neurostimulation leads, and measuring electrical parameter data in response to the transmitted electrical energy; and

a processor configured for comparing the measured electrical parameter data with the estimated electrical parameter data of each of the neurostimulation lead models, and determining a relative position between the neurostimulation leads based on the comparison.

29. The tissue stimulation system of claim 28, wherein the determined relative position is a stagger between the neurostimulation leads.

30. The tissue stimulation system of claim 28, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

31. The tissue stimulation system of claim 28, wherein the determined relative position is the predetermined relative position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

32. The tissue stimulation system of claim 31, wherein the comparison is computationally performed using a comparison function selected from the group consisting of a correlation coefficient function, a least squares based function, and a cross-correlation function.

33. The tissue stimulation system of claim 28, wherein the comparison is performed computationally.

34. The tissue stimulation system of claim 28, wherein each of the neurostimulation lead models is selecting from the group consisting of an analytical model, a spatially discretized model, and an empirical data-based model.

35. The tissue stimulation system of claim 28, wherein the estimated electrical parameter data in each of the neurostimulation lead models comprises a two-dimensional array of data having transmitting ones of the electrodes in one dimension of the data array, and recording ones of the electrodes in the other dimension of the data array.

36. The tissue stimulation system of claim 28, wherein the processor is further configured for determining whether one of the neurostimulation leads has migrated based on the determined relative position.

37. The tissue stimulation system of claim 36, wherein the estimated electrical parameter data and the measured electrical parameter data are electrical field potential data.

38. The tissue stimulation system of claim 36, wherein the determined position is the predetermined position corresponding to the estimated electrical parameter data that best matches the measured electrical parameter data.

39. The tissue stimulation system of claim 36, wherein the comparison is performed computationally.

40. The tissue stimulation system of claim 36, wherein the comparison is computationally performed using a comparison function selecting from the group consisting of a correlation coefficient function, a least squares based function, and a cross-correlation function.

41. The tissue stimulation system of claim 36, wherein each of the neurostimulation lead models is selected from the group consisting of an analytical model, a spatially discretized model, and an empirical data-based model.

42. The tissue stimulation system of claim 36, wherein the processor is further configured for determining whether one of the neurostimulation leads has migrated based on the determined relative position.

43. The tissue stimulation system of claim 36, wherein the processor is further configured for reprogramming the electrodes in response to a determination that the one neurostimulation lead has migrated.

44. The tissue stimulation system of claim 28, wherein the processor is further configured for reprogramming the electrodes in response to a determination that the one neurostimulation lead has migrated.

45. A tissue stimulation system, comprising:

an implantable neurostimulation lead having a plurality of electrodes;

a plurality of neurostimulation lead models, each of which includes estimated electrical parameter data corresponding to a predetermined position of the neurostimulation lead;

a controller configured for transmitting electrical energy to or from the electrodes and measuring electrical parameter data in response to the transmitted electrical energy; and

a processor configured for comparing the measured electrical parameter data with the estimated electrical parameter data of each of the neurostimulation lead models, and determining a position of the neurostimulation lead based on the comparison.

46. The tissue stimulation system of claim 45, further comprising another implantable neurostimulation lead, wherein the position of the neurostimulation lead is determined relative to the other neurostimulation lead.

47. The tissue stimulation system of claim 46, wherein the determined relative position is a stagger between the neurostimulation leads.

48. The tissue stimulation system of claim 45, wherein the position of the neurostimulation lead is determined relative to an anatomical feature.