Apparatus and methods for detecting migration of neurostimulation leads

• US 8,131,357 B2
• Filed: 04/01/2005
• Issued: 03/06/2012
• Est. Priority Date: 04/01/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Bradley, Kerry, Kapoor, Sunil K.
• Primary Examiner(s): Bertram, Eric D.
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US11/096,483
• Publication Number:
  US 20060224222A1
• Time in Patent Office: 2,531 Days
• Field of Search: 600/547, 600/554, 600/424, 607/2, 607/27, 607/28, 607/62, 607/116, 128/898, 128/899
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

Apparatus and methods for detecting lead migration through the use of measured artifactual data about the tissue in the vicinity of the lead.

Claims

1. A method of monitoring the position of a neurostimulation lead having at least one electrode, the method comprising:

taking a baseline evoked potential measurement by supplying a first stimulation pulse to tissue with the neurostimulation lead while at a baseline location, and measuring the resulting evoked potential;

taking a subsequent evoked potential measurement by supplying a second stimulation pulse to tissue with the neurostimulation lead at a subsequent time after the neurostimulation lead has migrated from the baseline location, and measuring the resulting evoked potential; and

determining a magnitude that the neurostimulation lead has migrated from the baseline position by comparing the subsequent evoked potential measurement to the baseline evoked potential measurement.

2. A method as claimed in claim 1, further comprising taking corrective action in response to a determination that the neurostimulation lead has migrated.

3. A method as claimed in claim 2, wherein taking corrective action comprises reprogramming a therapeutic regimen in response to a determination that the neurostimulation lead has migrated.

4. A method as claimed in claim 1, wherein the second electrode is on the neurostimulation lead.

5. A method as claimed in claim 1, wherein the second electrode is on a second neurostimulation lead.

6. A method as claimed in claim 1, further comprising maintaining the baseline evoked potential measurement as a non-trended baseline evoked potential measurement.

7. A method as claimed in claim 1, further comprising creating a trended baseline evoked potential measurement based on the baseline evoked potential measurement.

8. A method as claimed in claim 7, wherein the trended baseline evoked potential measurement is based on a difference between the baseline evoked potential measurement and the subsequent evoked potential measurement.

9. A method as claimed in claim 8, wherein the trended baseline evoked potential measurement is created by replacing the baseline evoked potential measurement with a new baseline evoked potential measurement if the difference is relatively small, and maintaining the baseline evoked potential measurement if the difference is relatively large.

10. A method as claimed in claim 9, wherein the new baseline evoked potential measurement is the subsequent baseline evoked potential measurement.

11. A method as claimed in claim 9, wherein the new baseline evoked potential measurement is an average of the baseline evoked potential measurement and the subsequent baseline evoked potential measurement.

12. A method as claimed in claim 7, wherein the trended baseline evoked potential measurement is a moving average that includes the baseline evoked potential measurement and the subsequent baseline evoked potential measurement.

13. A method as claimed in claim 1, further comprising determining a direction in which the neurostimulation lead has migrated from the baseline location by comparing the subsequent evoked potential measurement to the baseline evoked potential measurement.

14. A method as claimed in claim 1, wherein the other subsequent evoked potential measurement is compared to the baseline evoked potential measurement using a feature comparison analysis.

15. A method as claimed in claim 1, wherein the baseline evoked potential measurement is taken by supplying the first stimulation pulse to the tissue with a first electrode on the neurostimulation lead and measuring the resulting evoked potential at a second electrode, and the subsequent evoked potential measurement is taken by supplying the second stimulation pulse to the tissue with a third electrode on the neurostimulation lead and measuring the resulting evoked potential at a fourth electrode.

16. A method as claimed in claim 15, wherein the first, second, third, and fourth electrodes are on the neurostimulation lead.

17. A method as claimed in claim 15, wherein the magnitude to which the neurostimulation lead has migrated is determined to be the distance between the third electrode and the fourth electrode if the subsequent evoked potential measurement is similar to the baseline evoked potential measurement.

18. A method as claimed in claim 15, wherein the first and third electrodes are different electrodes.

19. A method of monitoring an individual implanted neurostimulation lead, comprising:

measuring baseline artifactual data concerning tissue in the vicinity of the individual neurostimulation lead using only the individual neurostimulation lead and an implantable pulse generator;

measuring subsequent artifactual data concerning the tissue in the vicinity of the individual neurostimulation lead at a subsequent time with only the individual neurostimulation lead and the implantable pulse generator; and

determining a magnitude that the individual neurostimulation lead has migrated from a baseline location by comparing the baseline artifactual data to the subsequent artifactual data, wherein the baseline location is a location of the individual neurostimulation lead during the measuring of the baseline artifactual data.

20. A method as claimed in claim 19, wherein the artifactual data comprises tissue impedance data.

21. A method as claimed in claim 19, wherein the artifactual data comprises evoked potential data.

22. A method as claimed in claim 19, further comprising taking corrective action in response to a determination that the individual neurostimulation lead has migrated.

23. A method as claimed in claim 22, wherein taking corrective action comprises reprogramming a therapeutic regimen in response to a determination that the individual neurostimulation lead has migrated.

24. A method as claimed in claim 19, further comprising maintaining the baseline artifactual data measurement as a non-trended baseline artifactual data measurement.

25. A method as claimed in claim 19, further comprising creating a trended baseline artifactual data measurement based on the baseline artifactual data measurement.

26. A method as claimed in claim 25, wherein the trended baseline artifactual data measurement is based on a difference between the baseline artifactual data measurement and the subsequent artifactual data measurement.

27. A method as claimed in claim 26, wherein the trended baseline artifactual data measurement is created by replacing the baseline artifactual data measurement with a new baseline artifactual data measurement if the difference is relatively small, and maintaining the baseline artifactual data measurement if the difference is relatively large.

28. A method as claimed in claim 27, wherein the new baseline artifactual data measurement is the subsequent baseline artifactual data measurement.

29. A method as claimed in claim 27, wherein the new baseline artifactual data measurement is an average of the baseline artifactual data measurement and the subsequent baseline artifactual data measurement.

30. A method as claimed in claim 25, wherein the trended baseline artifactual data measurement is a moving average that includes the baseline artifactual data measurement and the subsequent baseline artifactual data measurement.

31. A method as claimed in claim 19, further comprising determining a direction in which the neurostimulation lead has migrated from a baseline location by comparing the baseline artifactual data to the subsequent artifactual data.