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

• US 6,993,384 B2
• Filed: 12/03/2002
• Issued: 01/31/2006
• Est. Priority Date: 12/04/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Thacker, James R., Bradley, Kerry
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/310,202
• Publication Number:
  US 20030139781A1
• Time in Patent Office: 1,155 Days
• Field of Search: 607 1-158, 600/508, 600/547
• US Class Current: 607/2
• 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

Abstract

Interelectrode impedance or electric field potential measurements are used to determine the relative orientation of one lead to other leads in the spinal column or other body/tissue location. Interelectrode impedance is determined by measuring impedance vectors. The value of the impedance vector is due primarily to the electrode-electrolyte interface, and the bulk impedance between the electrodes. The bulk impedance between the electrodes is, in turn, made up of (1) the impedance of the tissue adjacent to the electrodes, and (2) the impedance of the tissue between the electrodes. In one embodiment, the present invention makes both monopolar and bipolar impedance measurements, and then corrects the bipolar impedance measurements using the monopolar measurements to eliminate the effect of the impedance of the tissue adjacent the electrodes. The orientation and position of the leads may be inferred from the relative minima of the corrected bipolar impedance values. These corrected impedance values may also be mapped and stored to facilitate a comparison with subsequent corrected impedance measurement values. Such comparison allows a determination to be made as to whether the lead position and/or orientation has changed appreciably over time. In another embodiment, one or more electrodes are stimulated and the resulting electric field potential on the non-stimulated electrodes is measured. Such field potential measurements provide an indication of the relative orientation of the electrodes. Once known, the relative orientation may be used to track lead migration, to setup stimulation configurations and parameters for nominal stimulation and/or navigation. Also, such measurements allow automatic adjustment of stimulation energy to a previously-defined optimal potential field in the case of lead migration or postural changes.

Claims

1. A method for determining the relative lead position of multipolar leads in a multi-lead configuration comprising

measuring impedance vectors between electrodes;

and

inferring the relative position of the lead by the relative minima and maxima of the impedance values.

2. The method of claim 1 wherein measuring the impedance vectors comprises:

measuring the monopolar impedances for all electrodes;

measuring bipolar impedances between each electrode on opposing leads; and

correcting the bipolar impedances for adjacent tissue impedance.

3. The method of claim 2 further including mapping the corrected bipolar impedances to create an impedance map, which impedance map reveals the relative orientation of the leads.

4. The method of claim 3 further including storing the map for future reference.

5. The method of claim 4 further including referring to the map at a future time to see if the lead position has changed, and if so, how much.

6. A method for determining whether the relative position of electrodes used by a neurostimulation system has changed, the method comprising steps for:

(a) applying a stimulus to a selected group of the electrodes;

(b) measuring the electric field at the electrodes not included in the group of electrodes to which the stimulus is applied;

(c) repeating steps (a) and (b) over time and determining if changes in the measured electric field have occurred;

(d) analyzing the changes in the electric field to determine whether changes in the relative position of the electrodes has occurred.

7. The method of claim 6 wherein step (a) comprises applying a stimulus monopolarly between one selected electrode and a return or reference electrode.

8. The method of claim 6 wherein step (a) comprises applying a stimulus tripolarly between three selected electrodes, wherein at least one of the three electrodes comprises an anode, and at least one of the three electrodes comprises a cathode.

9. The method of claim 8 wherein at least two of the three electrodes are configured as an anode, and one of the three electrodes is configured as a cathode.

10. The method of claim 9 further including flanking the electrode configured as a cathode with the electrodes configured as an anode, thereby creating a guarded cathode bipolar electrode configuration through which the stimulus is applied.

11. The method of claim 6 further including storing the electric field measured at the electrodes not included in the group of electrodes through which the stimulus is applied.

12. The method of claim 6 wherein step (c) includes plotting the measured electric field as a function of the selected electrode groups through which the stimulus is applied.

13. The method of claim 6 further including initiating corrective action when a determination is made that the relative position of the electrodes has changed.

14. The method of claim 13 further including initiating the corrective action automatically.

15. The method of claim 13 wherein the corrective action includes adjusting the amplitude of the stimulus applied to selected electrodes during operation of the neurostimulation system.

16. The method of claim 13 wherein the corrective action includes changing the electrodes through which a stimulus is applied during operation of the neurostimulation system.

17. The method of claim 13 wherein the corrective action includes adjusting the stimulation energy produced by the neurostimulation system to a previously-defined optimal potential field.

18. The method of claim 13 wherein the corrective action comprises setting up stimulation configurations and parameters that provide nominal stimulation suitable for the electrodes in their new relative positions.

19. A method for determining the relative position of electrodes used by a neurostimulation system, the method comprising steps for:

(a) applying a stimulus to a selected group of the electrodes;

(b) measuring the electric field potential at the electrodes not included in the group of electrodes to which the stimulus is applied;

(c) analyzing the measured electric field potential at each electrode relative to the measured electric field potential at other electrodes to determine the position of the electrodes relative to each other.

20. The method of claim 19 wherein step (a) comprises applying a stimulus monopolarly between one selected electrode and a return or reference electrode.

21. The method of claim 19 wherein step (a) comprises applying a stimulus tripolarly between three selected electrodes, wherein at least one of the three electrodes comprises an anode, and at least one of the three electrodes comprises a cathode.

22. The method of claim 21 further including flanking the electrode configured as a cathode with electrodes configured as an anode, thereby creating a guarded cathode tripolar electrode configuration through which the stimulus is applied.

23. The method of claim 19 wherein step (c) includes plotting the measured electric field as a function of the selected electrode groups through which the stimulus is applied.

24. An apparatus for determining the relative position or orientation of electrodes carried on neurostimulation leads, comprising:

a multiplicity of implantable electrodes;

means for applying a stimulus to a selected group of the multiplicity of electrodes;

means for measuring the electric field at the electrodes not included in the group of electrodes to which the stimulus is applied;

means for analyzing the measured electric field to determine the relative position or orientation of the electrodes; and

means for automatically initiating corrective action in the event that a changes in the relative position or orientation of the leads has occurred.

25. The apparatus of claim 24 further including:

means for determining if changes in the measured electric field have occurred over time; and

means for analyzing whether the changes that have occurred in the electric field over time are indicative of a change in the relative position or orientation of the electrodes.

26. The apparatus of claim 24 wherein means for automatically initiating corrective action includes tracking the electrode orientation to determine appropriate reprogramming.

27. The apparatus of claim 26 wherein appropriate reprogramming involves a setup of navigation tables for steering the multiple electrodes.

28. The apparatus of claim 24 wherein means for automatically initiating corrective action includes tracking the electrode orientation to determine a need for surgical revision.