Techniques for confirming a volume of effect of sub-perception threshold stimulation therapy

• US 8,751,009 B2
• Filed: 03/14/2013
• Issued: 06/10/2014
• Est. Priority Date: 04/24/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wacnik, Paul W.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/826,919
• Publication Number:
  US 20130282078A1
• Time in Patent Office: 453 Days
• Field of Search: 607/46, 607/59
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

A system may include a therapy delivery module configured to deliver electrical stimulation therapy to a tissue of a patient in accordance with a first stimulation therapy program. The first stimulation therapy program may define a first stimulation intensity below a perception threshold stimulation intensity of the patient. The therapy delivery module also may be configured to deliver electrical stimulation therapy to the tissue of the patient in accordance with a second stimulation therapy program. The second stimulation therapy program may define a second stimulation intensity at or above the perception threshold stimulation intensity. The system also may include a processor configured to determine stimulation parameter values for the first stimulation therapy program that result in a first volume of effect and determine stimulation parameter values for the second stimulation therapy program that result in a second volume of effect substantially the same as the first volume of effect.

Claims

1. A system comprising:

a therapy delivery module configured to;

deliver, via one or more electrodes of a plurality of implantable electrodes, electrical stimulation therapy to a tissue of a patient in accordance with a first stimulation therapy program, wherein the first stimulation therapy program defines a first stimulation intensity below a perception threshold stimulation intensity of the patient; and

deliver, via one or more electrodes of the plurality of implantable electrodes, stimulation therapy to the tissue of the patient in accordance with a second stimulation therapy program, wherein the second stimulation therapy program defines a second stimulation intensity at or above the perception threshold stimulation intensity; and

a processor configured to;

determine stimulation parameter values for the second stimulation therapy program that result in a second volume of effect within the patient; and

determine stimulation parameter values for the first stimulation therapy program that result in a first volume of effect within the patient that is substantially the same as the second volume of effect, wherein the first volume of effect represents a first volume of tissue in which a therapeutic effect is produced, and wherein the second volume of effect represents a second volume of tissue in which stimulation therapy is perceivable by the patient.

2. The system of claim 1, wherein the processor is configured to determine, using a neuron model and a generated stimulation field model, the stimulation parameter values for at least one of the first stimulation therapy program or the second stimulation therapy program.

3. The system of claim 2, wherein the processor is configured to determine, using the neuron model and the generated stimulation field model, at least one of the first volume of effect and the second volume of effect.

4. The system of claim 1, wherein the processor is configured to determine the stimulation parameter values for at least one of the first stimulation therapy program and the second stimulation therapy program by controlling the therapy module to deliver electrical stimulation therapy in accordance with a set of stimulation parameter values and receiving a signal representing an input from a user related to a third volume of effect of the stimulation therapy delivered by the therapy module in accordance with the set of stimulation parameter values.

5. The system of claim 1, wherein the processor is configured to determine at least one of the first volume of effect and the second volume of effect.

6. The system of claim 5, wherein the processor is configured to determine the first volume of effect by controlling the therapy module to deliver electrical stimulation therapy at a third stimulation intensity substantially equal to the perception threshold stimulation intensity and receiving a signal representing an input from a user related to a third volume of effect of the stimulation therapy delivered at the third stimulation intensity.

7. The system of claim 1, wherein the processor is configured to determine the stimulation parameter values of the first stimulation therapy program by:

controlling the therapy module to deliver electrical stimulation therapy at a third stimulation intensity at or above the perception threshold stimulation intensity;

receiving a first signal representing an input from a user related to a third volume of effect of the stimulation therapy delivered at the third stimulation intensity;

controlling the therapy module to deliver electrical stimulation therapy at a fourth stimulation intensity at or above the perception threshold stimulation intensity;

receiving a second signal representing an input from the user related to a fourth volume of effect of the stimulation therapy delivered at the fourth stimulation intensity;

controlling the therapy module to deliver electrical stimulation therapy at a fifth stimulation intensity at or above the perception threshold stimulation intensity;

receiving a third signal representing an input from the user related to a fifth volume of effect of the stimulation therapy delivered at the fifth stimulation intensity;

determining an equation describing a correlation between stimulation intensity and volume of effect based on the first, second, and third signals and the third, fourth, and fifth stimulation intensities; and

determining, using the equation describing the correlation between stimulation intensity and volume of effect, the stimulation parameter values for the first stimulation therapy program.

8. The system of claim 7, wherein the processor is configured to determine, using the equation describing the correlation between stimulation intensity and volume of effect, the first volume of effect.

9. The system of claim 1, wherein the first stimulation therapy program comprises a first pulse frequency, and wherein the second stimulation therapy program comprises a second pulse frequency different than the first pulse frequency.

10. The system of claim 1, further comprising an implantable medical device that comprises the therapy delivery module and the processor.

11. The system of claim 1, further comprising:

an implantable medical device that comprises the therapy delivery module; and

an external programmer that comprises the processor.

12. A method comprising:

delivering, by a therapy delivery module and via one or more electrodes of a plurality of implantable electrodes, electrical stimulation therapy to a tissue of a patient in accordance with a first stimulation therapy program, wherein the first stimulation therapy program defines a first stimulation intensity below a perception threshold stimulation intensity of the patient;

delivering, by the therapy delivery module and via one or more electrodes of the plurality of implantable electrodes, electrical stimulation therapy to the tissue of the patient in accordance with a second stimulation therapy program, wherein the second stimulation therapy program defines a second stimulation intensity at or above the perception threshold stimulation intensity;

determining, by a processor, stimulation parameter values for the second stimulation therapy program that result in a second volume of effect within the patient; and

determining, by the processor, stimulation parameter values for the first stimulation therapy program that result in a first volume of effect within the patient that is substantially the same as the second volume of effect, wherein the first volume of effect represents a first volume of tissue in which a therapeutic effect is produced, and wherein the second volume of effect represents a second volume of tissue in which stimulation therapy is perceivable by the patient.

13. The method of claim 12, wherein at least one of determining stimulation parameter values for the first stimulation therapy program and determining stimulation parameter values for the second stimulation therapy program comprises determining, using a neuron model and a generated stimulation field model, the stimulation parameter values for the respective stimulation therapy program.

14. The method of claim 13, further comprising determining, using the neuron model and the generated stimulation field model, at least one of the first volume of effect or the second volume of effect.

15. The method of claim 12, wherein at least one of determining stimulation parameter values for the first stimulation therapy program and determining stimulation parameter values for the second stimulation therapy program comprises:

delivering, by the therapy module, stimulation therapy in accordance with a set of stimulation parameter values; and

receiving a signal representing an input from a user related to a third volume of effect of the stimulation therapy delivered by the therapy module in accordance with a set of stimulation parameter values.

16. The method of claim 12, further comprising determining, by the processor, at least one of the first volume of effect or the second volume of effect.

17. The method of claim 16, wherein determining at least one of the first volume of effect of the second volume of effect comprises:

delivering, by the therapy module, stimulation therapy at a third stimulation intensity substantially equal to the perception threshold stimulation intensity; and

receiving a signal representing an input from a user related to a third volume of effect of the stimulation therapy delivered at the third stimulation intensity; and

using, by the processor, the volume of effect of the stimulation therapy delivered at the third stimulation intensity as the first volume of effect.

18. The method of claim 12, wherein determining the stimulation parameter values of the first stimulation therapy program comprises:

delivering, by the therapy module, electrical stimulation therapy at a third stimulation intensity at or above the perception threshold stimulation intensity;

receiving, by the processor, a first signal representing an input from a user related to a third volume of effect of the stimulation therapy delivered at the third stimulation intensity;

delivering, by the therapy module, electrical stimulation therapy at a fourth stimulation intensity at or above the perception threshold stimulation intensity;

receiving, by the processor, a second signal representing an input from the user related to a fourth volume of effect of the stimulation therapy delivered at the fourth stimulation intensity;

delivering, by the therapy module, electrical stimulation therapy at a fifth stimulation intensity at or above the perception threshold stimulation intensity;

receiving, by the processor, a third signal representing an input from the user related to a fifth volume of effect of the stimulation therapy delivered at the fifth stimulation intensity;

determining, by the processor, an equation describing the correlation between stimulation intensity and volume of effect based on the first, second, and third signals and the third, fourth, and fifth stimulation intensities; and

determining, by the processor and using the equation describing the correlation between stimulation intensity and volume of effect, the stimulation parameter values for the first stimulation therapy program.

19. The method of claim 18, further comprising determining, by the processor and using the equation describing the correlation between stimulation intensity and volume of effect, the first volume of effect.

20. The method of claim 12, wherein the first stimulation therapy program comprises a first pulse frequency, and wherein the second stimulation therapy program comprises a second pulse frequency different than the first pulse frequency.

21. The method of claim 12, wherein an implantable medical device comprises the therapy delivery module and the processor.

22. The method of claim 12, wherein an implantable medical device comprises the therapy delivery module and an external programmer comprises the processor.

23. A system comprising:

means for delivering, via one or more electrodes of a plurality of implantable electrodes, electrical stimulation therapy to a tissue of a patient in accordance with a first stimulation therapy program, wherein the first stimulation therapy program defines a first stimulation intensity below a perception threshold stimulation intensity of the patient;

means for delivering, via one or more electrodes of the plurality of implantable electrodes, electrical stimulation therapy to the tissue of the patient in accordance with a second stimulation therapy program, wherein the second stimulation therapy program defines a second stimulation intensity at or above the perception threshold stimulation intensity;

means for determining stimulation parameter values for the second stimulation therapy program that result in a second volume of effect within the patient; and

means for determining stimulation parameter values for the first stimulation therapy program that result in a first volume of effect within the patient that is substantially the same as the second volume of effect, wherein the first volume of effect represents a first volume of tissue in which a therapeutic effect is produced, and wherein the second volume of effect represents a second volume of tissue in which stimulation therapy is perceivable by the patient.

24. The system of claim 23, further comprising:

means for determining the first volume of effect; and

means for determining the second volume of effect.

25. A non-transitory computer-readable storage medium comprising instructions that, when executed by at least one processor, cause the at least one processor to:

control a therapy delivery module to deliver, via one or more electrodes of a plurality of implantable electrodes, electrical stimulation therapy to a tissue of a patient in accordance with a first stimulation therapy program, wherein the first stimulation therapy program defines a first stimulation intensity below a perception threshold stimulation intensity of the patient;

control the therapy delivery module to deliver, via one or more electrodes of the plurality of implantable electrodes, electrical stimulation therapy to the tissue of the patient in accordance with a second stimulation therapy program, wherein the second stimulation therapy program defines a second stimulation intensity at or above the perception threshold stimulation intensity;

determine stimulation parameter values for the second stimulation therapy program that result in a second volume of effect within the patient; and

determine stimulation parameter values for the first stimulation therapy program that result in a first volume of effect within the patient that is substantially the same as the second volume of effect, wherein the first volume of effect represents a first volume of tissue in which a therapeutic effect is produced, and wherein the second volume of effect represents a second volume of tissue in which stimulation therapy is perceivable by the patient.

26. The non-transitory computer-readable storage medium of claim 25, further comprising instructions that cause the at least one processor to:

determine the first volume of effect; and

determine the second volume of effect.