Apparatus and methods for detecting migration of neurostimulation leads

• US 20060224222A1
• Filed: 04/01/2005
• Published: 10/05/2006
• 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.
• Granted Patent: US 8,131,357 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• 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 stimulation pulse to tissue with a first electrode on the neurostimulation lead and measuring the resulting evoked potential at a second electrode;

taking a subsequent evoked potential measurement supplying a stimulation pulse to tissue with the first electrode at a subsequent time and measuring the resulting evoked potential at the second electrode; and

determining whether the neurostimulation lead has migrated by comparing the subsequent evoked potential measurement to the baseline evoked potential measurement.

2. A method as claimed in claim 1, wherein

taking a baseline evoked potential measurement comprises supplying a stimulation pulse to tissue with a first electrode on the neurostimulation lead and measuring the resulting evoked potential at second and third electrodes;

taking a subsequent evoked potential measurement comprises supplying a stimulation pulse to tissue with the first electrode at a subsequent time and measuring the resulting evoked potential at the second and third electrodes; and

determining whether the neurostimulation lead has migrated comprises comparing the subsequent evoked potential measurements at the second and third electrodes to the baseline evoked potential measurements at the second and third electrodes.

3. A method as claimed in claim 1, further comprising:

determining, in response to a determination that the neurostimulation lead has migrated, whether there is another set of electrodes on the neurostimulation lead that produces the baseline evoked potential measurement.

4. A method as claimed in claim 1, further comprising:

taking corrective action in response to a determination that the neurostimulation lead has migrated.

5. A method as claimed in claim 4, wherein taking corrective action comprises reprogramming a therapeutic regimen in response to a determination that the neurostimulation lead has migrated.

6. A method as claimed in claim 1, wherein the first and second electrodes comprise the same electrode.

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

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

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

a pulse generator including a lead connector;

circuitry, operably connected to the lead connector, to take a baseline evoked potential measurement associated with a first electrode on the implantable lead and a second electrode and take a subsequent evoked potential measurement associated with the first and second electrodes; and

circuitry to determine whether the implantable lead has migrated by comparing the subsequent evoked potential measurement to the baseline evoked potential measurement.

10. A neurostimulation system as claimed in claim 9, wherein

the circuitry to take a baseline evoked potential measurement further comprises circuitry to take a baseline evoked potential measurement associated with the first electrode on the implantable lead and a third electrode and take a subsequent evoked potential measurement associated with the first and third electrodes;

and

the circuitry to determine further comprises circuitry to determine whether the implantable lead has migrated by comparing the subsequent evoked potential measurement associated with the first and third electrodes to the baseline evoked potential measurement associated with the first and third electrodes.

11. A neurostimulation system as claimed in claim 9, wherein the circuitry to determine comprises circuitry to determine, in response to a determination that the implantable lead has migrated, whether there is another set of electrodes that produces the baseline evoked potential measurement associated with the first and second electrodes.

12. A neurostimulation system as claimed in claim 9, wherein the first and second electrode comprise the same electrode.

13. A neurostimulation system as claimed in claim 9, wherein the second electrode is on the implantable lead.

14. A neurostimulation system as claimed in claim 9, wherein the second electrode is on a second implantable lead.

15. A neurostimulation system as claimed in claim 9, further comprising:

circuitry to supply therapeutic pulses in accordance with a programmed therapeutic regimen; and

circuitry to adjust the programmed therapeutic regimen in response to a determination that the implantable lead has migrated.

16. A neurostimulation system as claimed in claim 15, further comprising:

at least one communications device that communicates with the pulse generator, and wherein

the circuitry to adjust is located in the at least one communications device, and

the circuitry to adjust includes circuitry to adjust which of the plurality of electrodes receives therapeutic pulses in response to a determination that the implantable lead has migrated.

17. A neurostimulation system as claimed in claim 16, wherein the circuitry to adjust is located within the pulse generator.

18. 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 whether the individual neurostimulation lead has migrated from a baseline location by comparing the baseline artifactual data to the subsequent artifactual data.

19. A method as claimed in claim 18, wherein the artifactual data comprises tissue impedance data.

20. A method as claimed in claim 18, wherein the artifactual data comprises evoked potential data.

21. A method as claimed in claim 18, further comprising:

taking corrective action in response to a determination that the individual neurostimulation lead has migrated.

22. A method as claimed in claim 21, wherein taking corrective action comprises reprogramming a therapeutic regimen in response to a determination that the individual neurostimulation lead has migrated.