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

• US 20030032992A1
• Filed: 08/05/2002
• Published: 02/13/2003
• Est. Priority Date: 08/13/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: King, John D.H., Thacker, James R., Bradley, Kerry
• Granted Patent: US 7,263,402 B2
• Time in Patent Office: Days
• US Class Current: 607/43
• 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;

selecting an initial stimulation level for the new stimulation parameter set, wherein the initial stimulation level is selected so as to not 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 a new stimulation parameter set comprises selecting a 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 repeating the above steps for a second new stimulation parameter set.

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. 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;

selecting an initial stimulation level for the trial stimulation parameter set, wherein the initial stimulation level is selected to not 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.

13. The method of claim 12 wherein measuring the effectiveness of the stimulation parameter set comprises recording observations made by the patient on the effect of the stimulation.

14. The method of claim 12, 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 determining is based on observations made by the patient on the effect of the stimulation.

15. The method of claim 12 wherein selecting the stimulation parameter set with the best 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 not exceed the perception threshold of the patient, and then the stimulation level is increased to the level the comparison is to be made at.

16. The method of claim 12 wherein selecting a preferred stimulation parameter set, comprises selecting a preferred stimulation parameter set for a Spinal Cord Stimulation (SCS) system.

17. The method of claim 12 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.

18. A stimulation system fitting suite comprising:

a pulse generator adapted to generate stimulation pulses according to stimulation commands;

a lead connected to the pulse generator, wherein the lead is adapted to carry the stimulation pulses;

an electrode array connected to the lead, wherein the electrode array is adapted to receive the stimulation pulses from the lead; and

a programming computer adapted to provide the stimulation commands to the pulse generator, wherein the programming computer includes;

a multiplicity of candidate stimulation parameter sets;

means for selecting a trial stimulation parameter set from the candidate stimulation parameter sets;

means for selecting an initial stimulation level for the trial stimulation parameter set, wherein the initial stimulation level is selected so as to not exceed an estimated perception threshold of the patient for the trial stimulation parameter set;

means for generating the stimulating commands based on the trial stimulation parameter set and the selected initial stimulation level; and

means for generating new stimulation commands with increased the stimulation level.

19. The system of claim 18 wherein the multiplicity of candidate stimulation parameter sets comprise a multiplicity of candidate Spinal Cord Stimulation (SCS) system stimulation parameter sets.

20. The method of claim 18 further including means for recording the effect of the stimulation for the trial stimulation parameter set.

21. The method of claim 20 further including means for varying the stimulation level to improve the recorded effect of the stimulation.

22. The method of claim 18 further including means for 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.

23. The method of claim 18 further including means for repeating the above steps for a second trial stimulation parameter set.

24. The method of claim 18 further including:

means for collecting perception level data for a subset of the candidate stimulation parameter sets; and

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

25. A stimulation system including a pulse generator, a lead connected to the pulse generator, at least one electrode connected to the lead, and at least one stimulation parameter set for specifying stimulation provided by the stimulation system, the stimulation parameter set selected by a process comprising:

operatively connecting a programming computer to the pulse generator;

repeating the following for a multiplicity of candidate stimulation parameter sets;

selecting one of the candidate stimulation parameter sets as a trial stimulation parameter set;

selecting an initial stimulation level for the trial stimulation parameter set, wherein the initial stimulation level is selected so as to not exceed an estimated perception threshold of the patient for the trial stimulation parameter set;

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

increasing the stimulation level; and

measuring the effectiveness of the trial stimulation parameter set;

selecting at least one candidate stimulation parameter set to use as the stimulation parameter set based on the effectiveness of the candidate stimulation parameter sets.

26. The system of claim 25 wherein measuring the effectiveness of the trial stimulation parameter set comprises measuring the optimum stimulation level for the trial stimulation parameter set.

27. The system of claim 25 wherein selecting the most effective candidate stimulation parameter set comprises selecting the candidate stimulation parameter set providing effective stimulation at a low energy consumption level.

28. The system of claim 25 wherein selecting an initial stimulation level further comprises selecting an initial stimulation level near the estimated perception threshold.

29. The system of claim 25 wherein the stimulation system is a Spinal Cord Stimulation (SCS) system.

30. The system of claim 25 wherein the process further includes:

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

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