Apparatus and methods for detecting position and migration of neurostimulation leads

• US 8,972,023 B2
• Filed: 03/04/2013
• Issued: 03/03/2015
• 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): GETZOW, SCOTT M
• Application Number:
  US13/784,565
• Publication Number:
  US 20130184798A1
• Time in Patent Office: 729 Days
• Field of Search: 607/62, 607/48, 607/27, 607/45, 607/37
• US Class Current: 607/62
• 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 to determine whether a medical lead has migrated, comprising:

measuring first artifactual data concerning tissue in the vicinity of the medical lead to establish a baseline artifactual data value;

measuring second artifactual data concerning the tissue in the vicinity of the medical lead at a subsequent time to establish a subsequent artifactual data value;

determining whether the medical lead has migrated by comparing the subsequent artifactual data value to the baseline artifactual data value; and

creating a trended baseline artifactual data value based on the baseline artifactual data value.

2. The method of claim 1, wherein the medical lead is a neurostimulation lead.

3. The method of claim 1, wherein the first and second artifactual data comprises tissue impedance data.

4. The method of claim 1, wherein the first and second artifactual data comprises evoked potential data.

5. The method of claim 1, wherein the medical lead includes an electrode, the first artifactual data is measured in the vicinity of the electrode, and the second artifactual data is measured in the vicinity of the electrode.

6. The method of claim 5, wherein the first and second artifactual data are measured by the electrode.

7. The method of claim 1, wherein the medical lead includes a plurality of electrodes, the first artifactual data is measured in the vicinity of the plurality of electrodes to establish respective baseline artifactual data values, the second artifactual data is measured in the vicinity of the plurality of electrodes to establish respective subsequent artifactual data values, determining whether the migration lead has migrated comprises comparing the subsequent artifactual data values to the baseline artifactual data values, the method further comprising creating trended baseline artifactual data values based on the baseline artifactual data values.

8. The method of claim 1, wherein determining whether the medical lead has migrated comprises determining the direction and magnitude of the migration.

9. The method of claim 8, wherein determining the direction and magnitude of the migration comprises performing a feature comparison analysis.

10. The method of claim 1, further comprising taking corrective action in response to a determination that the medical lead has migrated.

11. The method of claim 10, wherein taking corrective action comprises reprogramming a therapeutic regimen in response to a determination that the migration lead has migrated.

12. The method of claim 1, wherein the trended baseline artifactual data value is based on a difference between the baseline artifactual data value and the subsequent artifactual data value.

13. The method of claim 12, wherein the trended baseline artifactual data value is created by replacing the baseline artifactual data value with a new baseline artifactual data value if the difference is relatively small, and maintaining the baseline artifactual data value if the difference is relatively large.

14. The method of claim 13, wherein the new baseline artifactual data value is the subsequent baseline artifactual data value.

15. The method of claim 13, wherein the new baseline artifactual data value is an average of the baseline artifactual data value and the subsequent baseline artifactual data value.

16. The method of claim 1, wherein the trended baseline artifactual data value is a moving average that includes the baseline artifactual data value and the subsequent baseline artifactual data value.

17. A medical system for use with an implantable medical lead, comprising:

first circuitry configured for measuring first artifactual data concerning tissue in the vicinity of the medical lead to establish a baseline artifactual data value, and for measuring second artifactual data concerning the tissue in the vicinity of the medical lead at a subsequent time to establish a subsequent artifactual data value; and

second circuitry configured for determining whether the medical lead has migrated by comparing the subsequent artifactual data value to the baseline artifactual data value, and creating a trended baseline artifactual data value based on the baseline artifactual data value.

18. The medical system of claim 17, further comprising a lead connector configured for connecting to the medical lead, wherein the first circuitry is operably connected to the lead connector.

19. The medical system of claim 17, wherein the first and second artifactual data comprises tissue impedance data.

20. The medical system of claim 17, wherein the first and second artifactual data comprises evoked potential data.

21. The medical system of claim 17, wherein the medical lead includes an electrode, the first circuitry is configured for measuring the first artifactual data in the vicinity of the electrode, and for measuring the second artifactual data in the vicinity of the electrode.

22. The medical system of claim 21, wherein the first circuitry is configured for measuring the first and second artifactual data with the electrode.

23. The medical system of claim 17, wherein the medical lead includes a plurality of electrodes, the first circuitry is configured for measuring the first artifactual data in the vicinity of the plurality of electrodes to establish respective baseline artifactual data values, for measuring the second artifactual data in the vicinity of the plurality of electrodes to establish respective subsequent artifactual data values, and the second circuitry is configured for determining whether the migration lead has migrated by comparing the subsequent impedance values to the baseline impedance values, and for creating trended baseline artifactual data values based on the baseline artifactual data values.

24. The medical system of claim 17, wherein the second circuitry is configured for determining the direction and magnitude of the migration of the medical lead.

25. The medical system of claim 24, wherein the second circuitry is configured for determining the direction and magnitude of the migration by performing a feature comparison analysis.

26. The medical system of claim 17, wherein the trended baseline artifactual data value is based on a difference between the baseline artifactual data value and the subsequent artifactual data value.

27. The medical system of claim 26, wherein the second circuitry is configured for creating the trended baseline artifactual data value by replacing the baseline artifactual data value with a new baseline artifactual data value if the difference is relatively small, and maintaining the baseline artifactual data value if the difference is relatively large.

28. The medical system of claim 27, wherein the new baseline artifactual data value is the subsequent baseline artifactual data value.

29. The medical system of claim 27, wherein the new baseline artifactual data value is an average of the baseline artifactual data value and the subsequent baseline artifactual data value.

30. The medical system of claim 17, wherein the trended baseline artifactual data value is a moving average that includes the baseline artifactual data value and the subsequent baseline artifactual data value.

31. The medical system of claim 17, further comprising:

an implantable medical device containing the first circuitry; and

an external control device containing the second circuitry.

32. The medical system of claim 17, wherein the medical lead is a neurostimulation lead, the medical system further comprising:

a pulse generator configured for supplying electrical pulses to the medical lead; and

third circuitry configured for supplying therapeutic pulses in accordance with a programmed therapeutic regimen and for adjusting the programmed therapeutic regimen in response to a determination that the neurostimulation has migrated.

33. A medical system of claim 32, wherein the neurostimulation lead includes a plurality of lead electrodes, and the third circuitry is configured for adjusting which of the plurality of lead electrodes receives therapeutic pulses in response to a determination that the neurostimulation lead has migrated.