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

• US 9,610,439 B2
• Filed: 11/05/2015
• Issued: 04/04/2017
• Est. Priority Date: 12/04/2001
• Status: Active Grant

• 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:
  US14/933,576
• Publication Number:
  US 20160129245A1
• Time in Patent Office: 516 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;

a plurality of electrodes configured to be operably coupled to the implantable pulse generator, the plurality of electrodes including a return or reference electrode and further including other electrodes; and

a programmable external device configured to program the implantable pulse generator,

wherein the system configured to;

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

measure a second monopolar electrical impedance between each of the other ones of the other electrodes and the return or reference electrode;

measure a bipolar electrical impedance between the first one of the other electrodes and each of the other ones of the other electrodes;

determine the amplitude of a field potential at each of the other 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

determine the relative positions of the 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 electrode, wherein the system is configured to determine the relative positions of the leads based on the determined field potential amplitude at each of the at lea one electrode.

3. The system of claim 1, wherein the system is further configured to:

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

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

4. The system of claim 1, wherein the system is configured to automatically initiate corrective action when a determination is made that the relative position of the electrodes has changed.

5. The system of claim 4, wherein the system is configured to automatically initiate corrective action by adjusting the amplitude of tissue stimulating electrical energy applied to selected ones of the electrodes.

6. The system of claim 4, wherein the system is configured to automatically initiate corrective action by changing selected ones of the electrodes through which tissue stimulating electrical energy is applied.

7. The system of claim 1, further comprising a plurality of leads that include the at least one electrode, wherein the system is configured to:

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

analyze the change in each of the determined field potential amplitudes to determine whether the leads have migrated relative to each other.

8. The system of claim 1, wherein the system is configured to display the determined relative positions of the electrodes.

9. The system of claim 1, wherein the system is configured to directly measure the field potential amplitude directly at each of the at least one electrode to determine the amplitude of the field potential.

10. The system of claim 1, wherein the system is configured to determine the amplitude of the field potential by estimating the amplitude of the field potential at each of the at least one electrode 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.

11. The system of claim 1, wherein the system is configured to store each of the determined field potential amplitudes.

12. The system of claim 1, wherein the system is configured to use the determined relative positions of the electrodes to provide therapy by delivering tissue stimulating electrical energy to selected ones of the electrodes.

13. A system, comprising:

an implantable pulse generator;

a plurality of electrodes configured to be operably coupled to the implantable pulse generator, the plurality of electrodes including a return or reference electrode and further including other electrodes; and

a programmable external device configured to program the implantable pulse generator,

wherein the system configured to;

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

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

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

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

14. The system of claim 13, wherein the system is configured to apply an electrical stimulation between the first electrode and the return or reference electrode, and the estimated field potential amplitude is approximately equal to the actual field potential at the second electrode when the electrical stimulus is conveyed between the first electrode and the return or reference electrode.

15. The system of claim 13, wherein the system is configured to determine whether a change in the relative positions of the electrodes has occurred based on the estimated field potential amplitude.

16. The system of claim 13, wherein the system is configured to perform a function based on at least one of the first monopolar impedance, second monopolar impedance, and bipolar impedance, wherein the function is one or more of determining a remaining battery life of the pulse generator and detecting an electrical short.

17. The system of claim 13, wherein the system is configured to automatically initiate corrective action when a determination is made that the relative position of the electrodes has changed.

18. The system of claim 13, wherein the system is configured to display the determined relative positions of the electrodes.

19. The system of claim 13, wherein the system is configured to estimate the amplitude of the field potential 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.

20. A system, comprising:

an implantable pulse generator;

a plurality of electrodes configured to be operably coupled to the implantable pulse generator, the plurality of electrodes including at least one electrode and further including a return or reference electrode; and

a programmable external device configured to program the implantable pulse generator,

wherein the system configured to perform two measurement processes selected from the following measurement processes;

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

(2) a measurement process of a bipolar impedance between the first electrode and the second electrode; and

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

wherein the system is further configured to estimate 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 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.