Peripheral nerve field stimulation control

• US 8,805,518 B2
• Filed: 01/23/2009
• Issued: 08/12/2014
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: King, Gary W., Goetz, Steven M., Houchins, Andrew H., Keacher, Jeffrey T., Greenberg, Jordan J., Heruth, Kenneth T., Lent, Mark S., Wacnik, Paul W.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): ALTER MORSCHAUSER, ALYSSA MARGO
• Application Number:
  US12/359,001
• Publication Number:
  US 20090281594A1
• Time in Patent Office: 2,027 Days
• Field of Search: 607/46, 607/118
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Peripheral nerve field stimulation (PNFS) may be controlled based on detected physiological effects of the PNFS, which may be an efferent response to the PNFS. In some examples, a closed-loop therapy system may include a sensing module that senses a physiological parameter of the patient, which may be indicative of the patient'"'"'s response to the PNFS. Based on a signal generated by the sensing module, the PNFS may be activated, deactivated or modified. Example physiological parameters of the patient include heart rate, respiratory rate, electrodermal activity, muscle activity, blood flow rate, sweat gland activity, pilomotor reflex, or thermal activity of the patient'"'"'s body. In some examples, a patient pain state may be detected based on a signal generated by the sensing module, and therapy may be controlled based on the detection of the pain state.

Claims

1. A method comprising:

controlling a medical device to deliver peripheral nerve field stimulation to a region of a body of a patient in which the patient experiences pain via at least one electrode implanted in the region;

receiving, with a processor, a first signal indicative of a physiological parameter of the patient in the region of the body in which the patient experiences pain, wherein the signal is generated by a sensing module, and wherein the signal indicates a response of the patient to the peripheral nerve field stimulation;

receiving, with the processor, a control physiological signal indicative of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain, wherein the control physiological signal changes as a function of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain;

comparing, with the processor, the first signal to the control physiological signal; and

controlling, with the processor, the delivery of the peripheral nerve field stimulation by the medical device based on the comparison of the first signal and the control physiological signal.

2. The method of claim 1, wherein delivering peripheral nerve field stimulation comprises delivering electrical stimulation therapy to activate sensory afferent nerve fibers of the patient.

3. The method of claim 1, wherein the response comprises an efferent response.

4. The method of claim 1, wherein receiving the first signal comprises receiving the first signal that is indicative of a motor response of the patient to the peripheral nerve field stimulation, wherein the first signal is indicative of at least one of muscle activity or sweat gland activity of the patient.

5. The method of claim 1, wherein delivering peripheral nerve field stimulation comprises delivering peripheral nerve field stimulation according to a therapy program defining values for a plurality of therapy parameters, and controlling the delivery of peripheral nerve field stimulation comprises automatically modifying a value of at least one of the therapy parameters.

6. The method of claim 1, wherein delivering peripheral nerve field stimulation comprises delivering peripheral nerve field stimulation according to a first therapy program, and controlling the delivery of peripheral nerve field stimulation comprises selecting a second therapy program and initiating the delivery of peripheral nerve field stimulation according to the second therapy program.

7. The method of claim 1, wherein controlling the delivery of the peripheral nerve field stimulation comprises deactivating the delivery of the peripheral nerve field stimulation.

8. The method of claim 1, wherein controlling the delivery of the peripheral nerve field stimulation comprises initiating the delivery of the peripheral nerve field stimulation.

9. The method of claim 1, wherein controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first signal and the control physiological signal comprises controlling the delivery of the peripheral nerve field stimulation to maintain, in the region in which the patient feels pain, a physiological state that is indicated by the control physiological signal.

10. The method of claim 1, wherein receiving the control physiological signal comprises receiving the control physiological signal substantially in real-time.

11. The method of claim 1, wherein comparing the first signal to the control physiological signal comprises comparing a first characteristic of the first signal to a second characteristic of the second signal, and wherein controlling the delivery of the peripheral nerve field stimulation comprises controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics.

12. The method of claim 11, wherein controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics comprises:

controlling the medical device to deliver the peripheral nerve field stimulation;

while the medical device is delivering the peripheral nerve field stimulation, determining whether the first characteristic substantially matches the second characteristic; and

in response to determining the first characteristic substantially matches the second characteristic, controlling the medical device to at least one of deactivate the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences pain or decrease an intensity of the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences pain.

13. The method of claim 12, further comprising:

in response to determining the first characteristic does not substantially match the second characteristic, controlling the medical device to adjust at least one stimulation parameter value; and

controlling the medical device to deliver the peripheral nerve field stimulation to the region of the body of the patient in which the patient experiences pain with the adjusted at least one stimulation parameter value.

14. The method of claim 11, wherein the first and second characteristics each comprises at least one of an amplitude value, an energy level within a frequency band of the respective first or second signals or a pattern in a waveform of the respective first or control physiological signals.

15. The method of claim 1, wherein the first signal is indicative of at least one of a heart rate, respiratory rate, electrodermal activity, muscle activity, blood flow rate, sweat gland activity, pilomotor reflex or thermal activity of the patient.

16. A system comprising:

a sensing module that generates a first signal indicative of a physiological parameter of a patient in a region of a body of the patient in which the patient experiences pain and a control physiological signal indicative of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain, wherein the control physiological signal changes as a function of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain;

a medical device that delivers peripheral nerve field stimulation to the region of the body of the patient in which the patient experiences pain via at least one electrode implanted in the region; and

a processor that receives the first signal and the control physiological signal from the sensing module, compares first signal to the control physiological signal, and controls the delivery of the peripheral nerve field stimulation by the medical device based on the comparison of the first signal and the control physiological signal, wherein the first signal indicates a response of the patient to the peripheral nerve field stimulation.

17. The system of claim 16, wherein the first signal indicates a motor response of the patient to the peripheral nerve field stimulation and the physiological parameter comprises at least one of muscle activity or sweat gland activity of the patient.

18. The system of claim 16, wherein the medical device includes the sensing module.

19. The system of claim 16, wherein the sensing module is physically separate from the medical device.

20. The system of claim 16, wherein the first signal indicates an efferent response of the patient to the peripheral nerve field stimulation.

21. The system of claim 16, wherein the medical device delivers peripheral nerve field stimulation according to a therapy program, and the processor controls the delivery of peripheral nerve field stimulation by automatically modifying the therapy program.

22. The system of claim 16, wherein the processor controls the delivery of peripheral nerve field stimulation by at least one of deactivating or initiating delivery of peripheral nerve field stimulation to the patient by the medical device.

23. The system of claim 16, wherein the sensing module comprises a first sensing module that generates the first signal that indicates a response of the patient to the peripheral nerve field stimulation and a second sensing module that generates the control physiological signal.

24. The system of claim 16, wherein the control physiological signal does not indicate any response of the patient to the peripheral nerve field stimulation.

25. The system of claim 16, wherein the processor compares the first signal to the control physiological signal by at least comparing a first characteristic of the first signal to a second characteristic of the second signal, and wherein the processor controls the delivery of the peripheral nerve field stimulation by at least controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics.

26. The system of claim 25, wherein the processor controls the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics by at least controlling the medical device to deliver the peripheral nerve field stimulation, determining, while the medical device is delivering the peripheral nerve field stimulation, whether the first characteristic substantially matches the second characteristic, and, in response to determining the first characteristic substantially matches the second characteristic, controlling the medical device to at least one of deactivate the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences or decrease an intensity of the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences pain.

27. The system of claim 26, wherein, in response to determining the first characteristic does not substantially match the second characteristic, the processor controls the medical device to adjust at least one stimulation parameter value and deliver the peripheral nerve field stimulation to the region of the body of the patient in which the patient experiences pain with the adjusted at least one stimulation parameter value.

28. The system of claim 16, wherein the physiological parameter comprises at least one of a heart rate, respiratory rate, electrodermal activity, muscle activity, blood flow rate, sweat gland activity, pilomotor reflex or thermal activity of the patient.

29. The system of claim 25, wherein the processor determines the first characteristic and the second characteristic, the first and second characteristics comprising at least one of an amplitude value, an energy level within a frequency band of the respective first or second signals or a pattern in a waveform of the respective first or second signals.

30. The system of claim 16, wherein the processor controls the delivery of the peripheral nerve field stimulation based on the comparison of the first signal and the control physiological signal to maintain, in the region in which the patient feels pain, a physiological state that is indicated by the control physiological signal.

31. A system comprising:

means for delivering peripheral nerve field stimulation to a region of a body of a patient in which the patient experiences pain via at least one electrode implanted in the region;

means for receiving a first signal indicative of a physiological parameter of the patient in the region of the body in which the patient experiences pain, wherein the first signal is generated by means for sensing the physiological parameter, and wherein the first signal indicates a response of the patient to the peripheral nerve field stimulation;

means for receiving a control physiological signal indicative of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain, wherein the control physiological signal changes as a function of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain;

means for comparing the first signal to the control physiological signal; and

means for controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first signal and the control physiological signal.

32. The system of claim 31, wherein the first signal indicates a motor response of the patient to the peripheral nerve field stimulation, the system further comprising the means for sensing the physiological parameter, wherein the means for sensing the physiological parameter generates the first signal indicative of at least one of muscle activity or sweat gland activity of the patient.

33. The system of claim 31, wherein the control physiological signal does not indicate any response of the patient to the peripheral nerve field stimulation.

34. The system of claim 31, wherein the means for comparing the first signal to the control physiological signal comprises means for comparing a first characteristic of the first signal to a second characteristic of the second signal, and wherein the means for controlling the delivery of the peripheral nerve field stimulation controls the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics.

35. The system of claim 34, wherein the means for controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics comprises:

means for determining, while the means for delivering peripheral nerve field stimulation is delivering the peripheral nerve field stimulation to the region of the body of the patient in which the patient experiences pain, whether the first characteristic substantially matches the second characteristic; and

means for controlling the means for delivering peripheral nerve field stimulation to at least one of deactivate the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences or decrease an intensity of the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences pain in response to determining the first characteristic substantially matches the second characteristic.

36. The system of claim 35, further comprising means for controlling the means for delivering peripheral nerve field stimulation to adjust at least one stimulation parameter value in response to determining the first characteristic does not substantially match the second characteristic and deliver the peripheral nerve field stimulation to the region of the body of the patient in which the patient experiences pain with the adjusted at least one stimulation parameter value.

37. The system of claim 31, wherein the first signal is indicative of at least one of a heart rate, respiratory rate, electrodermal activity, muscle activity, blood flow rate, sweat gland activity, pilomotor reflex or thermal activity of the patient.

38. The system of claim 31, wherein the means for controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first signal and the control physiological signal controls the delivery of the peripheral nerve field stimulation to maintain, in the region in which the patient feels pain, a physiological state that is indicated by the control physiological signal.

39. A computer-readable storage medium comprising instructions that, when executed by a processor, cause the processor to:

control a medical device to deliver peripheral nerve field stimulation to a region of a body of a patient in which the patient experiences pain via at least one electrode implanted in the region;

receive a first signal indicative of a physiological parameter of the patient in the region of the body in which the patient experiences pain, wherein the first signal is generated by a sensing module, and wherein the first signal indicates a response of the patient to the peripheral nerve field stimulation;

receive a control physiological signal indicative of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain, wherein the control physiological signal changes as a function of the physiological parameter of the patient outside of the region of the body in which the patient experiences pain;

compare the first signal to the control physiological signal; and

control the delivery of the peripheral nerve field stimulation based on the comparison of the first signal and the control physiological signal.

40. The computer-readable storage medium of claim 39, wherein the instructions cause the processor to control the delivery of the peripheral nerve field stimulation based on the comparison of the first signal and the control physiological signal by at least controlling the delivery of the peripheral nerve field stimulation to maintain, in the region in which the patient feels pain, a physiological state that is indicated by the control physiological signal.

41. The computer-readable storage medium of claim 39, wherein the instructions cause the processor to compare the first signal to the control physiological signal by at least comparing a first characteristic of the first signal to a second characteristic of the second signal, and wherein the instructions cause the processor to control the delivery of the peripheral nerve field stimulation by at least controlling the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics.

42. The computer-readable storage medium of claim 41, wherein the instructions cause the processor to control the delivery of the peripheral nerve field stimulation based on the comparison of the first and second characteristics by at least:

controlling the medical device to deliver the peripheral nerve field stimulation;

while the medical device is delivering the peripheral nerve field stimulation, determining whether the first characteristic substantially matches the second characteristic; and

in response to determining the first characteristic substantially matches the second characteristic, controlling the medical device to at least one of deactivate the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences pain or decrease an intensity of the peripheral nerve field stimulation delivered to the region of the body of the patient in which the patient experiences pain.

43. The computer-readable storage medium of claim 42, further comprising instructions that cause the programmable processor to, in response to determining the first characteristic does not substantially match the second characteristic, control the medical device to adjust at least one stimulation parameter value and deliver the peripheral nerve field stimulation to the region of the body of the patient in which the patient experiences pain with the adjusted at least one stimulation parameter value.