Apparatus and methods for detecting position and migration of neurostimulation leads

• US 8,401,665 B2
• Filed: 04/01/2005
• Issued: 03/19/2013
• 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:
  US11/096,662
• Publication Number:
  US 20060224187A1
• Time in Patent Office: 2,909 Days
• Field of Search: 607/45, 607/48, 607/27, 607/28, 607/37, 607/62
• 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 neurostimulation lead has migrated, comprising:

measuring the impedance of tissue in the vicinity of an electrode on the neurostimulation lead to establish a baseline impedance value;

measuring the impedance of the tissue in the vicinity of the electrode at a subsequent time to establish a subsequent impedance value;

determining whether the neurostimulation lead has migrated by comparing the subsequent impedance value to the baseline impedance value; and

creating a trended baseline impedance value based on the baseline impedance value.

2. A method as claimed in claim 1, wherein

the neurostimulation lead includes a plurality of electrodes;

measuring the impedance of tissue to establish a baseline impedance value comprises measuring the impedance of the tissue in the vicinity of multiple electrodes to establish respective baseline impedance values;

measuring the impedance of the tissue to establish a subsequent impedance value comprises measuring the impedance of the tissue in the vicinity of each of the multiple electrodes at a subsequent time to establish respective subsequent impedance values; and

determining whether the neurostimulation lead has migrated comprises comparing the subsequent impedance values to the baseline impedance values.

3. A method as claimed in claim 2, wherein determining whether the neurostimulation lead has migrated further comprises determining the direction and magnitude of the migration.

4. A method as claimed in claim 3, wherein determining the direction and magnitude of the migration comprises performing a feature comparison analysis.

5. A method as claimed in claim 1, wherein measuring the impedance of tissue in the vicinity of an electrode comprises sourcing current into tissue at an implantable pulse generator and sinking the current at the electrode.

6. A method as claimed in claim 1, wherein measuring the impedance of tissue in the vicinity of an electrode comprises sourcing current into tissue at an implantable pulse generator and sinking the current at the electrode in between therapeutic pulses supplied by the implantable pulse generator to the electrode.

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

8. A method as claimed in claim 7, wherein taking corrective action comprises reprogramming a therapeutic regimen in response to a determination that the neurostimulation lead has migrated.

9. A method as claimed in claim 1, wherein the trended baseline impedance value is based on a difference between the baseline impedance value and the subsequent impedance value.

10. A method as claimed in claim 9, wherein the trended baseline impedance value is created by replacing the baseline impedance value with a new baseline impedance value if the difference is relatively small, and maintaining the baseline impedance value if the difference is relatively large.

11. A method as claimed in claim 10, wherein the new baseline impedance value is the subsequent baseline impedance value.

12. A method as claimed in claim 10, wherein the new baseline impedance value is an average of the baseline impedance value and the subsequent baseline impedance value.

13. A method as claimed in claim 1, wherein the trended baseline impedance value is a moving average that includes the baseline impedance value and the subsequent baseline impedance value.

14. A neurostimulation system for use with an implantable lead including at least one lead electrode, the neurostimulation system comprising:

a pulse generator including a lead connector;

circuitry, operably connected to the lead connector, to measure the impedance of tissue in the vicinity of the at least one lead electrode to establish a baseline impedance value and measure the impedance of the tissue in the vicinity of the at least one lead electrode at a subsequent time to establish a subsequent impedance value; and

circuitry to determine whether the implantable lead has migrated by comparing the subsequent impedance value to the baseline impedance value, and to create a trended baseline impedance value based on the baseline impedance value.

15. A neurostimulation system as claimed in claim 14, wherein

the at least one lead electrode comprises a plurality of lead electrodes;

the circuitry to measure comprises circuitry to measure the impedance of the tissue in the vicinity of multiple lead electrodes to establish respective baseline impedance values and to measure the impedance of the tissue in the vicinity of each of the multiple lead electrodes at a subsequent time to establish subsequent impedance values; and

the circuitry to determine comprises circuitry to determine whether the implantable lead has migrated by comparing the subsequent impedance values to the baseline impedance values.

16. A neurostimulation system as claimed in claim 14, wherein the circuitry to determine comprises circuitry to determine the direction and magnitude of the migration.

17. A neurostimulation system as claimed in claim 14, further comprising:

an electrode associated with the pulse generator;

wherein the circuitry to measure comprises circuitry to source current into tissue at the electrode associated with the pulse generator and sink the current at the at least one lead electrode.

18. A neurostimulation system as claimed in claim 17, wherein the electrode associated with the pulse generator comprises a pulse generator case.

19. A neurostimulation system as claimed in claim 14, wherein the pulse generator comprises an implantable pulse generator and the circuitry to determine is located within the implantable pulse generator.

20. A neurostimulation system as claimed in claim 14, further comprising:

at least one external device that communicates with the implantable pulse generator;

wherein the circuitry to determine is located in the at least one external device.

21. A neurostimulation system as claimed in claim 14, further comprising circuitry to supply therapeutic pulses in accordance with a programmed therapeutic regimen and to adjust the programmed therapeutic regimen in response to a determination that the implantable lead has migrated.

22. A neurostimulation system as claimed in claim 21, wherein the at least one lead electrode comprises a plurality of lead electrodes, the neurostimulation system further comprising circuitry to adjust which of the plurality of lead electrodes receives therapeutic pulses in response to a determination that the implantable lead has migrated.

23. A neurostimulation system as claimed in claim 14, wherein the trended baseline impedance value is based on a difference between the baseline impedance value and the subsequent impedance value.

24. A neurostimulation system as claimed in claim 23, wherein the trended baseline impedance value is created by replacing the baseline impedance value with a new baseline impedance value if the difference is relatively small, and maintaining the baseline impedance value if the difference is relatively large.

25. A neurostimulation system as claimed in claim 24, wherein the new baseline impedance value is the subsequent baseline impedance value.

26. A neurostimulation system as claimed in claim 24, wherein the new baseline impedance value is an average of the baseline impedance value and the subsequent baseline impedance value.

27. A neurostimulation system as claimed in claim 14, wherein the trended baseline impedance value is a moving average that includes the baseline impedance value and the subsequent baseline impedance value.