System and method for avoiding, reversing, and managing neurological accommodation to electrical stimulation

• US 8,660,644 B2
• Filed: 10/31/2012
• Issued: 02/25/2014
• Est. Priority Date: 07/24/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Jaax, Kristen, Lane, Courtney, Moffitt, Michael, DiGiore, Andrew, Pierre, Mark, Bradley, Kerry, Baldwin, Gregory
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/664,422
• Publication Number:
  US 20130053923A1
• Time in Patent Office: 482 Days
• Field of Search: 607/59, 607/45, 607/116
• US Class Current: 607/22
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

A method of operating a neurostimulation device comprises outputting a pulsed electrical waveform from the neurostimulation device between a plurality of electrodes while at least one of the electrodes has a first polarity, thereby stimulating neural tissue adjacent the electrode(s), allowing the neural tissue to undergo neurological accommodation in response to the electrical energy output between the electrodes, switching the electrode(s) from the first polarity to a second polarity, outputting the pulsed electrical waveform from the neurostimulation device between the electrodes while the electrode(s) has the second polarity, thereby hyperpolarizing the neural tissue to reverse the neurological accommodation, switching the electrode(s) from the second polarity to the first polarity, and outputting the pulsed electrical waveform from the neurostimulation device between the electrodes while the electrode(s) has the first polarity, thereby stimulating the previously hyperpolarized neural tissue.

Claims

1. A method of programming a neurostimulation device, comprising:

varying an electrode combination under user control;

automatically varying an electrical pulse parameter as the electrode combination is varied under user control;

generating a plurality of stimulation parameter sets from the varied electrode combination and varied electrical pulse parameter;

outputting a pulsed electrical waveform from the neurostimulation device between a plurality of electrodes in accordance with the plurality of stimulation parameter sets, such that neural tissue is stimulated without undergoing neurological accommodation that would otherwise occur if the electrical pulse parameter were not varied; and

programming the neurostimulation device with a new set of stimulation parameters based on a result of the neural tissue stimulation.

2. The method of claim 1, wherein the electrode combination is a fractionalized electrode combination.

3. The method of claim 2, wherein the fractionalized electrode combination is varied by gradually shifting current between anodic ones of the electrodes or gradually shifting current between cathodic ones of the electrodes.

4. The method of claim 1, wherein the electrical pulse parameter is pseudo-randomly or randomly varied.

5. The method of claim 1, wherein the electrical pulse parameter is a pulse amplitude.

6. The method of claim 5, wherein pulse amplitude is varied by both increasing and decreasing the amplitude of the pulses.

7. The method of claim 1, wherein the electrical pulse parameter is a pulse width.

8. The method of claim 5, wherein the pulse amplitude and a pulse width for each pulse are inversely varied relative to each other.

9. The method of claim 8, wherein the pulse amplitude and pulse width for each pulse are varied, such that the pulsed electrical waveform is maintained within a predetermined range of a strength-duration curve for the neural tissue.

10. The method of claim 1, wherein the electrical pulse parameter is a pulse shape.

11. The method of claim 1, wherein the electrical pulse parameter is a burst rate.

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

13. A method of operating a neurostimulation device, comprising:

outputting a pulsed electrical waveform from the neurostimulation device between a plurality of electrodes while at least one of the electrodes has a first polarity, thereby stimulating neural tissue adjacent the at least one electrode;

allowing the neural tissue to undergo neurological accommodation in response to the electrical energy output between the electrodes;

switching the at least one electrode from the first polarity to a second polarity;

outputting the pulsed electrical waveform from the neurostimulation device between the electrodes while the at least one electrode has the second polarity, thereby hyperpolarizing the neural tissue to reverse the neurological accommodation;

switching the at least one electrode from the second polarity to the first polarity; and

outputting the pulsed electrical waveform from the neurostimulation device between the electrodes while the at least one electrode has the first polarity, thereby stimulating the previously hyperpolarized neural tissue.

14. The method of claim 13, further comprising programming the neurostimulation device with a new set of stimulation parameters based on a result of the neural tissue stimulation.

15. The method of claim 13, wherein the pulsed electrical waveform is output between the electrodes in accordance with a set of stimulation parameters, the method further comprising varying one or more of the stimulation parameters under user control as the pulsed electrical waveform is output between the electrodes while the at least one electrode has the first polarity.

16. The method of claim 13, wherein each of the at least one electrode is a cathode when in the first polarity, and the each electrode is an anode when in the second polarity.

17. The method of claim 13, wherein the pulsed electrical waveform output has a first amplitude when the at least one electrode has the first polarity, and the pulsed electrical waveform output has a second lesser amplitude when the at least one electrode has the second polarity.

18. The method of claim 17, wherein the second amplitude is equal to a third or less of the first amplitude.

19. The method of claim 13, wherein the switching of the at least one electrode from the first polarity to the second polarity is automatically initiated.

20. The method of claim 13, wherein the switching of the at least one electrode from the second polarity to the first polarity is automatically initiated.