System and method of rapid, comfortable parameter switching in spinal cord stimulation

• US 7,263,402 B2
• Filed: 08/05/2002
• Issued: 08/28/2007
• Est. Priority Date: 08/13/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Bradley, Kerry, Thacker, James R, King, John D
• Primary Examiner(s): Evanisko; George R.
• Assistant Examiner(s): FILOSI, TERRI LYNN
• Application Number:
  US10/212,585
• Publication Number:
  US 20030032992A1
• Time in Patent Office: 1,849 Days
• Field of Search: 607/46, 607/117, 607/43
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A system and method for rapidly switching stimulation parameters of a Spinal Cord Stimulation (SCS) system increases the number of stimulation parameter sets that may be tested during a fitting procedure, or alternatively, reduces the time required for the fitting procedure. The switching method comprises selecting a new stimulation parameter set, and setting the initial stimulation levels to levels at or just below an estimated perception threshold of the patient. The estimated perception level is based on previous stimulation results. The stimulation level is then increased to determine a minimum stimulation level for effective stimulation, and/or an optimal stimulation level, and/or a maximum stimulation level, based on patient perception.

Claims

1. A method for switching between stimulation parameter sets applied to a patient, comprising:

selecting a new stimulation parameter set with a new combination of electrodes or electrode polarity;

selecting an initial stimulation level for the new stimulation parameter set, wherein the initial stimulation level is selected to be a non-zero value not to exceed an estimated perception threshold of the patient for the new stimulation parameter set;

activating stimulation with the new stimulation parameter set at the selected initial stimulation level; and

increasing the stimulation level.

2. The method of claim 1 wherein selecting the new stimulation parameter set comprises selecting the new stimulation parameter set of a Spinal Cord Stimulation (SCS) system.

3. The method of claim 1 further including recording the effect of the stimulation.

4. The method of claim 3 wherein recording the effect of the stimulation comprises recording a perception threshold for the new stimulation parameter set.

5. The method of claim 3 wherein recording the effect of the stimulation comprises recording an optimal stimulation level for the new stimulation parameter set.

6. The method of claim 3 wherein recording the effect of the stimulation comprises recording a discomfort threshold for the new stimulation parameter set.

7. The method of claim 3 wherein recording the effect of the stimulation comprises measuring an energy consumption required for effective stimulation for the new stimulation parameter set.

8. The method of claim 3 wherein recording the effect of the stimulation includes:

measuring at least one of a set consisting of a perception threshold, an optimal stimulation level, a discomfort threshold, and an energy consumption required for effective stimulation; and

varying the stimulation level around an initial measurement to improve the measurement.

9. The method of claim 1 further including holding the stimulation level at a fixed stimulation level to characterize the effect of stimulation at the fixed stimulation level for a short period of time.

10. The method of claim 1 further including performing the following steps for a second new stimulation parameter set:

selecting the second new stimulation parameter set;

selecting an initial stimulation lead level for the second new stimulation parameter set, wherein the initial stimulation level is selected so as to be a non-zero value not to exceed an estimated perception threshold of the patient for the second new stimulation parameter set;

activating stimulation with the second new stimulation parameter set at the selected initial stimulation level; and

increasing the stimulation level.

11. The method of claim 1 further including:

collecting perception level data for a subset of a multiplicity of stimulation parameter sets; and

using the collected perception level data to estimate the perception level for untested stimulation parameter sets.

12. The method of claim 1, wherein the non-zero value is a value at or just below the estimated perception threshold of the patient for the new stimulation parameter set.

13. The method of claim 1, wherein the new combination of electrodes or electrode polarity comprises a new subset of electrodes.

14. The method of claim 1, wherein the new combination of electrodes are arranged in a single in-line electrode array.

15. The method of claim 14, wherein the initial stimulation level is an energy level supplied to the electrodes of the single in-line electrode array.

16. The method of claim 1, wherein the new combination of electrodes are arranged in multiple in-line electrode arrays.

17. The method of claim 16, wherein the initial stimulation level is an energy level supplied to the electrodes of the multiple in-line electrode arrays.

18. A method for selecting a preferred stimulation parameter set from a group of candidate stimulation parameter sets, for stimulating a patient, comprising:

performing the following steps for each candidate stimulation parameter set;

selecting a trial stimulation parameter set with a new combination of

electrodes or electrode polarity;

selecting an initial stimulation level for the trial stimulation parameter set,

wherein the initial stimulation level is selected to be a non-zero value not to exceed an estimated perception threshold of the patient for the trial stimulation parameter set;

activating stimulation with the trial stimulation parameter set at the initial stimulation level

increasing the stimulation level; and

measuring the effectiveness of the stimulation parameter set;

selecting the preferred stimulation parameter set based on measured effectiveness.

19. The method of claim 18 wherein measuring the effectiveness of the stimulation parameter set comprises recording observations made by the patient on the effect of the stimulation.

20. The method of claim 18, wherein measuring the effectiveness of the stimulation parameter set comprises measuring at least one of a set consisting of a perception level, an optimal stimulation level, a discomfort threshold, and an energy consumption required for effective stimulation, wherein the measuring is based on observations made by the patient on the effect of the stimulation.

21. The method of claim 18 wherein selecting the stimulation parameter set with the preferred effectiveness includes retesting at least two previously tested stimulation parameter sets to compare the effectiveness of each of the at least two previously tested stimulation parameter sets to the effectiveness of others of the at least two previously tested stimulation parameter sets, wherein each stimulation parameter set is initiated at a stimulation level selected to be a non-zero value not to exceed the perception threshold of the patient, and then the stimulation level is increased to a level the comparison is to be made at.

22. The method of claim 18 wherein selecting a preferred stimulation parameter set, comprises selecting a preferred stimulation parameter set for a Spinal Cord Stimulation (SCS) system.

23. The method of claim 18 further including, after measuring the effectiveness of the stimulation parameter set, using the measurement of the perception threshold obtained for the tested stimulation parameter set to improve the estimated perception threshold for untested stimulation parameter sets.

24. The method of claim 18, wherein the non-zero value is a value at or just below the estimated perception threshold of the patient for the new stimulation parameter set.

25. The method of claim 18, wherein the new combination of electrodes or electrode polarity comprises a new subset of electrodes.

26. The method of claim 18, wherein the new combination of electrodes are arranged in a single in-line electrode array.

27. The method of claim 26, wherein the initial stimulation level is an energy level supplied to the electrodes of the single in-line electrode array.

28. The method of claim 18, wherein the new combination of electrodes are arranged in multiple in-line electrode arrays.

29. The method of claim 28, wherein the initial stimulation level is an energy level supplied to the electrodes of the multiple in-line electrode arrays.