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

• US 7,571,001 B2
• Filed: 07/27/2007
• Issued: 08/04/2009
• 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
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/829,742
• Publication Number:
  US 20080021513A1
• Time in Patent Office: 739 Days
• Field of Search: 607/43, 607/46, 607/117
• 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 stimulation system fitting suite, comprising:

a pulse generator configured for generating stimulation pulses according to stimulation commands;

a lead connected to the pulse generator, wherein the lead is configured for carrying the stimulation pulses;

an electrode array carried by the lead, wherein the electrode array is configured for receiving the stimulation pulses from the lead;

a programming computer configured for;

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 a patient for the new stimulation parameter set;

generating initial stimulation commands based on the new stimulation parameter set and the selected initial stimulation level;

generating new stimulation commands based on the new stimulation parameter set and an increased stimulation level; and

providing the initial stimulation commands and the new stimulation commands to the pulse generator.

2. The stimulation system fitting suite of claim 1, wherein the programming computer is configured for estimating the perception threshold of the patient.

3. The stimulation system fitting suite of claim 2, wherein the programming computer is configured for estimating the perception threshold of the patient based on a previously recorded effect of stimulation pulses on the patient.

4. The stimulation system fitting suite 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.

5. The stimulation system fitting suite of claim 1, wherein the new combination of electrodes or electrode polarity comprises a new subset of electrodes.

6. The stimulation system fitting suite of claim 1, wherein the programming computer is configured for recording the effect of the stimulation pulses on the patient.

7. The stimulation system fitting suite of claim 6, wherein the programming computer is configured for recording the effect of the stimulation pulses on the patient by recording a perception threshold for the new stimulation parameter set.

8. The stimulation system fitting suite of claim 6, wherein the programming computer is configured for recording the effect of the stimulation pulses on the patient by recording an optimal stimulation level for the new stimulation parameter set.

9. The stimulation system fitting suite of claim 6, wherein the programming computer is configured for recording the effect of the stimulation pulses on the patient by recording a discomfort threshold for the new stimulation parameter set.

10. The stimulation system fitting suite of claim 6, wherein the programming computer is configured for recording the effect of the stimulation pulses on the patient by measuring an energy consumption required for effective stimulation for the new stimulation parameter set.

11. The stimulation system fitting suite of claim 6, wherein the programming computer is configured for recording the effect of the stimulation pulses on the patient by:

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.

12. The stimulation system fitting suite of claim 1, wherein the programming computer is configured for holding the stimulation level at a fixed stimulation level to characterize the effect of stimulation pulses on the patient at the fixed stimulation level for a short period of time.

13. The stimulation system fitting suite of claim 1, wherein the programming computer is further configured for:

selecting a 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;

generating initial stimulation commands based on the second new stimulation parameter set and the selected initial stimulation level;

generating second new stimulation commands based on the second new stimulation parameter set and an increased stimulation level; and

providing the second new stimulation commands to the pulse generator.

14. The stimulation system fitting suite of claim 1, wherein the programming computer is further configured for:

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.

15. A stimulation system fitting suite, comprising:

a pulse generator configured for generating stimulation pulses according to stimulation commands;

a lead connected to the pulse generator, wherein the lead is configured for carrying the stimulation pulses;

an electrode array carried by the lead, wherein the electrode array is configured for receiving the stimulation pulses from the lead;

a programming computer, for each of a group of candidate stimulation parameter sets, configured for;

selecting a trial stimulation parameter set with a new combination of electrodes or electrode polarity from a group of candidate stimulation parameter sets;

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 a patient for the trial stimulation parameter set;

generating initial stimulation commands based on the new stimulation parameter set and the selected initial stimulation level;

generating new stimulation commands based on the new stimulation parameter set and an increased stimulation level;

providing the initial stimulation commands and the new stimulation commands to the pulse generator; and

measuring the effectiveness-of the stimulation pulses on the patient; and

selecting the preferred stimulation parameter set based on measured effectiveness.

16. The stimulation system fitting suite of claim 15, wherein the programming computer is configured for estimating the perception threshold of the patient.

17. The stimulation system fitting suite of claim 15, wherein the programming computer is configured for measuring the effectiveness of the stimulation parameter set comprises recording observations made by the patient on the effect of the stimulation pulses.

18. The stimulation system fitting suite of claim 15, wherein the programming computer is configured for measuring the effectiveness of the stimulation parameter set by 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 pulses.

19. The stimulation system fitting suite of claim 15, wherein the programming computer is configured for selecting the stimulation parameter set with the preferred effectiveness by 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.

20. The stimulation system fitting suite of claim 15, wherein the programming computer is configured for, 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.