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

• US 8,315,707 B2
• Filed: 03/18/2012
• Issued: 11/20/2012
• 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, DiGiore, Andrew
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert N
• Application Number:
  US13/423,245
• Publication Number:
  US 20120179222A1
• Time in Patent Office: 247 Days
• Field of Search: 607/59
• US Class Current: 607/59
• 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 varying a first stimulation parameter under user control while fixing a second stimulation parameter, generating a plurality of stimulation parameter sets from the varied first stimulation parameter and the fixed second stimulation parameter, outputting a pulsed electrical waveform from the neurostimulation device between electrodes in accordance with the stimulation parameter sets, such that a therapeutic effect is achieved while allowing neural tissue to undergo neurological accommodation, changing the second stimulation parameter, varying the first stimulation parameter under user control while fixing the second changed stimulation parameter, generating another plurality of stimulation parameter sets from the varied first stimulation parameter and the fixed changed second stimulation parameter, and outputting the pulsed electrical waveform from the neurostimulation device between the electrodes in accordance with the other stimulation parameter sets to maintain the therapeutic effect while the neural tissue is neurologically accommodated.

Claims

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

varying a first stimulation parameter under user control while fixing a second stimulation parameter;

generating a plurality of stimulation parameter sets from the varied first stimulation parameter and the fixed second stimulation 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 a therapeutic effect is achieved while allowing neural tissue to undergo neurological accommodation;

changing the second stimulation parameter;

varying the first stimulation parameter under user control while fixing the second changed stimulation parameter;

generating another plurality of stimulation parameter sets from the varied first stimulation parameter and the fixed changed second stimulation parameter;

outputting the pulsed electrical waveform from the neurostimulation device between the plurality of electrodes in accordance with the other plurality of stimulation parameter sets to maintain the therapeutic effect while the neural tissue is neurologically accommodated.

2. The method of claim 1, further comprising programming the neurostimulation device with a new set of stimulation parameters based on a result of the therapeutic effect.

3. The method of claim 1, wherein the first stimulation parameter is an electrode combination.

4. The method of claim 1, wherein the first stimulation parameter is a fractionalized electrode combination.

5. The method of claim 4, 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.

6. The method of claim 1, wherein the second stimulation parameter is automatically changed.

7. The method of claim 1, wherein the second stimulation parameter is a pulse rate.

8. The method of claim 1, wherein the second stimulation parameter is a pulse width.

9. The method of claim 1, wherein the second stimulation parameter is changed in accordance with a predetermined curve.

10. The method of claim 9, further comprising generating the predetermined curve based on data collected from patients that have undergone neurological accommodation.

11. The method of claim 9, further comprising:

generating a reference set of stimulation parameters from a first reference stimulation parameter of the same type as the first stimulation parameter, and a second stimulation parameter of the same type as the second stimulation parameter;

prior to allowing the neural tissue to undergo neurological accommodation, outputting the pulsed electrical waveform from the neurostimulation device between the electrodes in accordance with the reference stimulation parameter set, thereby stimulating the neural tissue to provide a reference therapeutic effect; and

after allowing the neural tissue to undergo neurological accommodation, outputting the pulsed electrical waveform from the neurostimulation device between the electrodes in accordance with the reference stimulation parameter set, thereby providing an effect different from the reference therapeutic effect, and varying the second reference stimulation parameter until the effect matches the reference therapeutic effect, wherein the varied second reference stimulation parameter is used as the changed second stimulation parameter.

12. The method of claim 1, wherein the neural tissue is spinal cord tissue, and the therapeutic effect is pain relief.

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

outputting a pulsed electrical waveform from the neurostimulation device between a plurality of electrodes in accordance with a specified pulse amplitude and a specified pulse width;

maintaining the pulsed electrical waveform between a first strength-duration curve for relatively large fibers of neural tissue and a second strength-duration curve for relatively small fibers of the neural tissue, whereby the relatively large fibers are stimulated and the relatively small fibers are not stimulated;

allowing the relatively large fibers of the neural tissue to neurological accommodate when the pulsed electrical waveform is between the first and second strength-duration curves; and

increasing one or both of the specified amplitude and the specified pulse width, such that the pulsed electrical waveform is on or above the second strength-duration curve, whereby the relatively small fibers are stimulated.

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 stimulation.

15. The method of claim 13, wherein the specified amplitude is increased.

16. The method of claim 13, wherein the specified pulse width is increased.

17. The method of claim 13, wherein the one or both of the specified amplitude and the specified pulse width is automatically increased.

18. The method of claim 13, wherein the one or both of the specified amplitude and the specified pulse width is increased at a predetermined period of time after the pulsed electrical waveform is initially output by the neurostimulation device.

19. The method of claim 13, wherein the neural tissue is spinal cord tissue.

20. The method of claim 13, further comprising varying a stimulation parameter under user control.

21. The method of claim 20, wherein the stimulation parameter is an electrode combination.

22. The method of claim 20, wherein the first stimulation parameter is a fractionalized electrode combination.

23. The method of claim 22, 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.

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

initially outputting a pulsed electrical waveform from the neurostimulation device between a plurality of electrodes, such that neural tissue of a patient is stimulated and undergoes neurological accommodation;

decreasing a pulse amplitude of the pulsed electrical waveform;

generating a plurality of stimulation parameter sets having the decreased amplitude;

outputting the pulsed electrical waveform with the decreased pulse amplitude in accordance with the stimulation parameter sets, such that the neural tissue is stimulated and remains neurologically accommodated; and

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

25. The method of claim 24, wherein the pulsed electrical waveform is initially output with the highest pulse amplitude tolerable for the patient.

26. The method of claim 24, wherein the neural tissue is spinal cord tissue.

27. The method of claim 24, further comprising varying a stimulation parameter under user control, wherein the plurality of stimulation parameter sets are generated from the varied stimulation parameter.

28. The method of claim 24, wherein the stimulation parameter is an electrode combination.

29. The method of claim 24, wherein the first stimulation parameter is a fractionalized electrode combination.

30. The method of claim 29, 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.