Apparatus and method for determining the relative position and orientation of neurostimulation leads

• US 10,022,540 B2
• Filed: 03/15/2017
• Issued: 07/17/2018
• Est. Priority Date: 12/04/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Bradley, Kerry, Thacker, James R., Moffitt, Michael A.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US15/459,660
• Publication Number:
  US 20170182314A1
• Time in Patent Office: 489 Days
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A method for determining whether the relative position of electrodes used by a neurostimulation system has changed within a patient comprises determining the amplitude of a field potential at each of at least one of the electrodes, determining if a change in each of the determined electric field amplitudes has occurred, and analyzing the change in each of the determined electric field amplitudes to determine whether a change in the relative position of the electrodes has occurred. Another method comprises measuring a first monopolar impedance between a first electrode and a reference electrode, measuring a second monopolar impedance between second electrode and the reference electrode, measuring a bipolar impedance between the first and second electrodes, and estimating an amplitude of a field potential at the second electrode based on the first and second monopolar impedances and the bipolar impedance.

Claims

1. A system, comprising:

an implantable pulse generator configured to be operably coupled to a plurality of electrodes, the plurality of electrodes including activated electrodes and non-activated electrodes,

wherein the implantable pulse generator includes control circuitry configured to;

deliver current using all of the activated electrodes;

determine an amplitude of a field potential at each of all the non-activated electrodes; and

determine relative positions of each of the non-activated electrodes based on each of the determined field potential amplitudes.

2. The system of claim 1, further comprising a plurality of leads that include the at least one of the electrodes, wherein entireties of the leads are implanted within a patient, and wherein the control circuitry is further configured to determine the relative positions of the leads based on the determined field potential amplitude of the each of the non-activated electrodes.

3. The system of claim 1 wherein the control circuitry is further configured to

analyze the determined field potential amplitudes to determine whether a change in the relative position of the non-activated electrodes has occurred.

4. The system of claim 3, wherein the control circuitry is further configured to initiate corrective action when the relative position of the electrodes has changed.

5. The system of claim 4, wherein the corrective action is initiated automatically.

6. The system of claim 4, wherein the corrective action includes adjusting the amplitude of tissue stimulating electrical energy applied to a subset of the electrodes.

7. The system of claim 4, wherein the corrective action includes changing a subset of the electrodes through which tissue stimulating electrical energy is applied.

8. The system of claim 1, further comprising a plurality of leads that include the at least one of the electrodes, wherein entireties of the leads are implanted within a patient, and wherein the control circuitry is further configured to analyze a change in each of the determined field amplitudes to determine migration of the leads relative to each other.

9. The system of claim 1, wherein the non-activated electrodes include a plurality of the electrodes.

10. The system of claim 1, wherein the control circuitry is further configured to determine the amplitude of the field potential at each of the non-activated electrodes by measuring the field potential amplitude direction at each of the at least one of the electrodes.

11. The system of claim 1, wherein the control circuitry is further configured to measure electrical impedances using the non-activated electrodes and wherein the control circuitry is configured to determine the amplitude of the field potential at each of the non-activated electrodes by estimating the field potential amplitudes, at least in part, from the measured electrical impedances.

12. The system of claim 11, wherein the measured electrical impedances includes a measured first monopolar electrical impedance between the first one of the non-activated electrodes and a return or reference electrode, a measured second monopolar electrical impedance between a second one of the non-activated electrodes and the return or reference electrode, and a measured electrical impedance between the first and second ones of the non-activated electrodes, wherein the amplitude of the field potential at each of the first and second ones of the non-activated electrodes is determined using the measured first monopolar electrical impedance, the second monopolar electrical impedance, and the measured electrical impedance between the first and second ones of the non-activated electrodes.

13. The system of claim 1, wherein the control circuitry is further configured to store each of the determined field potential amplitudes.

14. The system of claim 1, further comprising at least two leads, the at least two leads including the plurality of electrodes, wherein the control circuitry is configured to determine relative positions of the at least two leads based on each of the determined field potential amplitudes.

15. The system of claim 1, wherein the control circuitry is configured to convey tissue stimulating electrical energy to a subset of the electrodes to provide therapy to a patient.

16. The system of claim 1, wherein the plurality of electrodes are implanted within a spinal column of a patient.

17. A system configured to be connected to a plurality of electrodes, comprising:

an implantable pulse generator including control circuitry configured to;

deliver a current to a source electrode in the plurality of electrodes;

receive the delivered current from a return electrode in the plurality of electrodes;

measure a field potential at all other electrodes in the plurality of electrodes other than the source electrode and the return electrode; and

determine a relative electrode position for each of all the other electrodes in the plurality of electrodes based on the measured field potential at all the other electrodes.

18. The system of claim 17, wherein the control circuitry is further configured to analyze the determined field potential amplitudes to determine whether a change in the relative electrode positions has occurred.

19. A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to:

instruct a current source to deliver a current from a source electrode in a plurality of electrodes to a return electrode in the plurality of electrodes;

measure a field potential at all other electrodes in the plurality of electrodes other than the source electrode and the return electrode; and

,

determine a relative electrode position for each of all the other electrodes in the plurality of electrodes based on the measured field potential at all the other electrodes.

20. The non-transitory machine-readable medium of claim 19, further including instructions, which when executed by the machine, cause the machine to analyze the determined field potential amplitudes to determine whether a change in the relative electrode positions has occurred.