Method and apparatus for determining relative positioning between neurostimulation leads

• US 8,463,402 B2
• Filed: 06/28/2012
• Issued: 06/11/2013
• Est. Priority Date: 08/28/2009
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Zhu, Changfang, Moffitt, Michael
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/536,688
• Publication Number:
  US 20120316617A1
• Time in Patent Office: 348 Days
• Field of Search: 607/117
• US Class Current: 607/117
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/3603 Control systems
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A method and neurostimulation control system for operating two leads disposed adjacent tissue of a patient are provided. A plurality of cross-lead electrical parameters are measured to generate a measured electrical profile of the electrode leads. A plurality of cross-lead electrical parameters are estimated to generate a first reference electrical profile for the electrode leads in a first known staggered configuration. The first reference electrical profile is spatially shifted to generate a second reference electrical profile for the electrode leads in a second known staggered configuration. The measured electrical profile is compared to the first and second reference electrical profiles, and a longitudinal stagger between the electrode leads is quantified based on the comparison.

Claims

1. A method of operating two electrode leads disposed adjacent tissue of a patient using a first reference electrical profile for the electrode leads in a first known staggered configuration, the first reference electrical profile containing a plurality of reference cross-lead electrical parameters, the method comprising:

measuring a plurality of cross-lead electrical parameters to generate a measured electrical profile of the electrode leads;

spatially shifting the first reference electrical profile to generate a second reference electrical profile for the electrode leads in a second known staggered configuration;

comparing the measured electrical profile to the first and second reference electrical profiles; and

quantifying a longitudinal stagger between the electrode leads based on the comparison.

2. The method of claim 1,

wherein the generation of the measured electrical profile of the electrode leads comprises activating at least one electrode carried by one of the leads to source electrical current through the tissue, and measuring an amplitude of the electrical parameter in response to the sourced electrical current at each of a plurality of electrodes carried by another of the leads;

wherein the plurality of reference cross-lead electrical parameters comprises a plurality of amplitudes associated with a first set of the electrodes; and

wherein the generation of the second reference electrical profile comprises shifting the amplitudes from the first set of electrodes to a second set of the electrodes carried by the other lead.

3. The method of claim 2, wherein the first set of the electrodes comprises an end one of the electrodes carried by the other lead.

4. The method of claim 1, wherein the first and second lead stagger configurations are offset from each other by one center-to-center electrode spacing, and the plurality of reference cross-lead electrical parameters is spatially shifted by one center-to-center electrode spacing.

5. The method of claim 4 using a third reference electrical profile for the electrode leads in a third known staggered configuration offset from the first known staggered configuration a distance less than one center-to-center electrode spacing, the third reference profile containing another plurality of reference cross-lead electrical parameters, the method further comprising:

spatially shifting the other plurality of reference cross-lead electrical parameters the single electrode spacing to generate a fourth reference electrical profile for the electrode leads in a fourth known staggered configuration that is offset from the third known staggered configuration by one center-to-center electrode spacing;

comparing the measured electrical profile to the third and fourth reference electrical profiles; and

quantifying the longitudinal stagger between the electrode leads based on the comparison between the measured electrical profile and the first, second, third, and fourth reference electrical profiles.

6. The method of claim 1 using an additional plurality of reference electrical profiles for the electrode leads in an additional plurality of known staggered configurations offset from each other by a distance less than one center-to-center electrode spacing, each of the additional reference electrical profiles containing an additional plurality of reference cross-lead electrical parameters, the method further comprising:

comparing the measured electrical profile to the additional reference electrical profiles; and

quantifying the longitudinal stagger between the electrode leads based on the comparison between the measured electrical profile and the first, second, and additional reference electrical profiles.

7. The method of claim 6, wherein the distance that the additional known staggered configurations are offset from each other is predetermined.

8. The method of claim 6, wherein the distance that the additional known staggered configurations are offset from each other is dynamically selected based on the comparison between the measured electrical profile and at least some of the additional reference electrical profiles.

9. The method of claim 1, wherein the second reference electrical profile is generated subsequent to comparing the measured electrical profile to the first reference electrical profile.

10. The method of claim 1, further comprising estimating the plurality of reference cross-lead electrical parameters by generating an analytical model of the leads.

11. The method of claim 10, wherein the analytical model is an optimal fit to a numerical integration model of the leads and tissue.

12. The method of claim 1, wherein the known stagger configuration corresponding to the known electrical profile that best matches the measured electrical profile is selected as the quantified longitudinal stagger.

13. The method of claim 1, wherein the electrical parameter is an electrical field potential.

14. The method of claim 1, further comprising displaying a graphical representation of the leads with the quantified longitudinal stagger.

15. The method of claim 1, further comprising programming a neurostimulator with a plurality of stimulation parameters based on the quantified longitudinal stagger.

16. The method of claim 1, wherein the tissue is spinal cord tissue.

17. A neurostimulation control system for use with electrode leads, comprising:

a user interface configured for receiving an input from a user;

memory configured for storing a first reference electrical profile for the electrode leads in a first known staggered configuration, the first reference electrical profile containing a plurality of reference cross-lead electrical parameters; and

at least one processor configured for generating instructions to measure a plurality of cross-lead electrical parameters, generating a measured electrical profile of the electrode leads from the measured cross-lead electrical parameters, spatially shifting the first reference electrical profile to generate a second reference electrical profile for the electrode leads in a second known staggered configuration, comparing the measured electrical profile to the first and second reference electrical profiles, and quantifying a longitudinal stagger between the electrode leads based on the comparison.

18. The neurostimulation control system of claim 17,

wherein the generation of the measured electrical profile of the electrode leads comprises activating at least one electrode carried by one of the leads to generate an electrical field within the tissue, and measuring an amplitude of the electrical parameter in response to the generated electrical field at each of a plurality of electrodes carried by another of the leads;

wherein the plurality of reference cross-lead electrical parameters comprises a plurality of amplitudes associated with a first set of the electrodes; and

wherein the generation of the second reference electrical profile comprises shifting the amplitudes from the first set of electrodes to a second set of the electrodes carried by the other lead.

19. The neurostimulation control system of claim 18, wherein the first set of the electrodes comprises an end one of the electrodes carried by the other lead.

20. The neurostimulation control system of claim 17, wherein the first and second lead stagger configurations are offset from each other by one center-to-center electrode spacing, and the plurality of reference cross-lead electrical parameters is spatially shifted by one center-to-center electrode spacing.

21. The neurostimulation control system of claim 20,

wherein the memory is further configured for storing a third reference electrical profile for the electrode leads in a third known staggered configuration offset from the first known staggered configuration a distance less than one center-to-center electrode spacing, the third reference profile containing another plurality of reference cross-lead electrical parameters;

and

wherein the at least one processor is further configured for spatially shifting the other plurality of reference cross-lead electrical parameters the single electrode spacing to generate a fourth reference electrical profile for the electrode leads in a fourth known staggered configuration that is offset from the third known staggered configuration by one center-to-center electrode spacing, comparing the measured electrical profile to the first, second, third, and fourth reference electrical profiles quantifying the longitudinal stagger between the electrode leads based on the comparison between the measured electrical profile and the first, second, third, and fourth reference electrical profiles.

22. The neurostimulation control system of claim 17,

wherein the memory is further configured for storing an additional plurality of reference electrical profiles for the electrode leads in an additional plurality of known staggered configurations offset from each other by a distance less than one center-to-center electrode spacing, each of the additional reference electrical profiles containing an additional plurality of reference cross-lead electrical parameters;

and

wherein the at least one processor is further configured for comparing the measured electrical profile to the additional reference electrical profiles, and quantifying the longitudinal stagger between the electrode leads based on the comparison between the measured electrical profile and the first, second, and additional reference electrical profiles.

23. The neurostimulation control system of claim 22, wherein the distance that the additional known staggered configurations are offset from each other is predetermined by the at least one processor.

24. The neurostimulation control system of claim 22, wherein the at least one processor is configured for dynamically selecting the distance that the additional known staggered configurations are offset from each other based on the comparison between the measured electrical profile and at least some of the additional reference electrical profiles.

25. The neurostimulation control system of claim 17, wherein the second reference electrical profile is generated subsequent to comparing the measured electrical profile to the first reference electrical profile.

26. The neurostimulation control system of claim 17, wherein the at least one processor is further configured for estimating of the plurality of reference cross-lead electrical parameters by generating an analytical model of the leads.

27. The neurostimulation control system of claim 26, wherein the analytical model is an optimal fit to a numerical integration model of the leads and tissue.

28. The neurostimulation control system of claim 17, wherein the at least one processor is configured for selecting the known stagger configuration corresponding to the reference electrical profile that best matches the measured electrical profile as the quantified longitudinal stagger.

29. The neurostimulation control system of claim 17, wherein the electrical parameter is a field potential of the generated electrical field.

30. The neurostimulation control system of claim 17, further comprising a display for displaying a graphical representation of the leads with the quantified longitudinal stagger.

31. The neurostimulation control system of claim 17, further comprising telemetry circuitry, wherein the at least one processor is configured for programming the neurostimulator with a plurality of stimulation parameters via the telemetry circuitry based on the quantified longitudinal stagger.

32. The neurostimulation control system of claim 17, further comprising an external control device containing the user interface, the memory, and the at least one processor.

33. The neurostimulation control system of claim 17, further comprising telemetry circuitry, wherein the at least one processor is configured for wirelessly transmitting instructions to a neurostimulator via the telemetry circuitry to measure the plurality of cross-lead electrical parameters.