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

• US 7,853,330 B2
• Filed: 11/12/2007
• Issued: 12/14/2010
• 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: Thacker, James, Bradley, Kerry, Moffitt, Michael
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/938,490
• Publication Number:
  US 20080125833A1
• Time in Patent Office: 1,128 Days
• Field of Search: 607/1, 607 28- 63, 607/117, 607/2
• US Class Current: 607/62
• 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 method of performing a medical procedure using a plurality of electrodes implanted within a patient, comprising:

measuring a first monopolar electrical impedance between a first one of the electrodes and a return or reference electrode;

measuring a second monopolar electrical impedance between each of at least one of the electrodes and the return or reference electrode;

measuring a bipolar electrical impedance between the first one of the electrodes and each of the at least one electrode;

determining the amplitude of a field potential at each of at least one of the electrodes based on the measured first monopolar electrical impedance, each of the second monopolar electrical impedances, and each of the measured bipolar electrical impedances; and

determining the relative positions of the electrodes based on each of the determined field potential amplitudes.

2. The method of claim 1, wherein the electrodes are carried by a plurality of leads, the method further comprising determining the relative positions of the leads based on the determined field potential amplitude of the each of the at least one electrode.

3. The method of claim 2, wherein the entireties of the leads are implanted within the tissue of the patient.

4. The method of claim 1, further comprising:

determining if a change in each of the determined field potential amplitudes has occurred; and

analyzing the change in each of the determined field potential amplitudes to determine whether a change in the relative position of the electrodes has occurred.

5. The method of claim 4, further including initiating corrective action when a determination is made that the relative position of the electrodes has changed.

6. The method of claim 5, wherein the corrective action is initiated automatically.

7. The method of claim 5, wherein the corrective action includes adjusting the amplitude of tissue stimulating electrical energy applied to selected ones of the electrodes.

8. The method of claim 5, wherein the corrective action includes changing selected ones of the electrodes through which tissue stimulating electrical energy is applied.

9. The method of claim 5, wherein the corrective action includes performing a surgical revision on the patient to physically readjust the electrodes.

10. The method of claim 1, wherein the electrodes are carried by a plurality of leads, and wherein the change in each of the determined field amplitudes are analyzed to determine migration of the leads relative to each other.

11. The method of claim 10,

wherein the entireties of the leads are implanted within the tissue of the patient.

12. The method of claim 1, further comprising displaying the determined relative positions of the electrodes.

13. The method of claim 1, wherein the at least one electrode comprises a plurality of the electrodes.

14. The method of claim 1, where the field potential amplitude determination comprises directly measuring the field potential amplitude directly at each of the at least one electrode.

15. The method of claim 1, wherein the amplitude of the field potential at each of the at least one electrode is estimated in accordance with the equation Φ

=(I_bp−

I_mp1−

I_mp2)/2, where Φ

equals the amplitude of the field potential, I_bp equals the respective bipolar electrical impedance, I_mp1 equals the first monopolar electrical impedance, and I_mp2 equals the respective second monopolar electrical impedance.

16. The method of claim 1, further comprising storing each of the determined field potential amplitudes.

17. The method of claim 1, further applying conveying tissue stimulating electrical energy to selected ones of the electrodes, thereby providing therapy to the patient.

18. A method for performing a medical procedure using a plurality of electrodes implanted within a patient, comprising:

measuring a first monopolar impedance between a first one of the electrodes and a return or reference electrode;

measuring a second monopolar impedance between a second one of the electrodes and the return or reference electrode;

measuring a bipolar impedance between the first electrode and the second electrode; and

estimating an amplitude of a field potential at the second electrode based on the first and second monopolar impedances and the bipolar impedance.

19. The method of claim 18, wherein the estimated field potential amplitude is approximately equal to the actual field potential at the second electrode when an electrical stimulus is conveyed between the first electrode and the return or reference electrode.

20. The method of claim 18, further comprising determining whether a change in the relative positions of the electrodes has occurred based on the estimated field potential amplitude.

21. The method of claim 20, further comprising performing a function unrelated to the determining whether a change in the relative positions of the electrodes has occurred based on at least one of the first monopolar impedance, second monopolar impedance, and bipolar impedance.

22. The method of claim 21, wherein the function is one or more of determining a remaining battery life of neurostimulator and detecting an electrical short within the neurostimulator.

23. The method of claim 20, further including initiating corrective action when a determination is made that the relative position of the electrodes has changed.

24. The method of claim 20, wherein the corrective action is initiated automatically.

25. The method of claim 20, further comprising displaying the determined relative positions of the electrodes.

26. The method of claim 21, wherein the amplitude of the field potential is estimated in accordance with the equation Φ

=(I_bp−

I_mp1−

I_mp2)/2, where Φ

equals the magnitude of the field potential, I_bp equals the bipolar electrical impedance, I_mp1 equals the first monopolar electrical impedance, and I_mp2 equals the second monopolar electrical impedance.

27. A method for performing a medical procedure using a plurality of electrodes implanted within a patient, comprising:

performing two of the following;

(1) measuring a first monopolar impedance between a first one of the electrodes and a return or reference electrode, and measuring a second monopolar impedance between a second one of the electrodes and the return or reference electrode;

(2) measuring a bipolar impedance between the first electrode and the second electrode; and

(3) measuring a field potential at the second electrode; and

estimating a remaining one of the (1) first and second monopolar impedances;

(2) the bipolar impedance; and

(3) the field potential based on the performance of the two measurements.

28. The method of claim 27, wherein the remaining one of the (1) first and second monopolar impedances;

(2) the bipolar impedance; and

(3) the field potential is estimated in accordance with the equation Φ

=(I_bp−

I_mp1−

I_mp2)/2, where Φ

equals the field potential, I_bp equals the bipolar electrical impedance, I_mp1 equals the first monopolar electrical impedance, and I_mp2 equals the second monopolar electrical impedance.