Medical device configuration based on sensed brain signals

• US 7,983,757 B2
• Filed: 06/05/2008
• Issued: 07/19/2011
• Est. Priority Date: 10/26/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miyazawa, Gabriela C., Molnar, Gregory F.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US12/133,999
• Publication Number:
  US 20090112281A1
• Time in Patent Office: 1,139 Days
• Field of Search: 382/132, 600/378, 607/2, 607/3, 607/42, 607/45, 607/46, 607/60
• US Class Current: 607/45
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61N 1/36071 Pain

Abstract

The invention is directed to techniques and systems in which external brain monitoring is used to facilitate implantation and configuration of an implantable medical device. The techniques may create an open loop or closed loop system in which brain signals quantify the efficacy of electrical logical stimulation (or drug therapy via an implantable drug pump) at locations outside of the brain. The techniques may be used to improve placement of leads and electrodes during an implantation procedure, and/or to select or adjust stimulation parameters either during the implantation procedure or possibly following implantation of an implantable medical device. The described techniques have applications for the alleviation of pain, but may find other applications where EEG signals can quantify the efficacy of treatment via an implantable medical device.

Claims

1. A method comprising:

monitoring brain signals of a brain, in a frequency band, of a patient via an external device that includes external electrodes disposed at one or more external locations on a head of the patient; and

adjusting electrical stimulation delivered via one or more implanted electrodes to one or more locations outside of the brain based on the brain signals to affect the brain signals in another frequency band.

2. The method of claim 1, wherein the electrical stimulation comprises neurostimulation.

3. The method of claim 1, wherein the one or more implanted electrodes are disposed on one or more implanted medical leads.

4. The method of claim 1, wherein the electrical stimulation is formulated to alleviate pain, the method further comprising:

adjusting the electrical stimulation to affect the brain signals in the frequency band.

5. The method of claim 4, wherein adjusting the electrical stimulation to affect the brain signals in the frequency band comprises adjusting the electrical stimulation to reduce the brain signals in the frequency band.

6. The method of claim 1, wherein the electrical stimulation is formulated to alleviate pain, the method further comprising:

monitoring the brain signals in the other frequency band;

determining a ratio of the brain signals in the frequency band and the other frequency band;

adjusting the electrical stimulation to adjust the ratio in a manner that alleviates pain;

determining a rate of change of the brain signals in response to the adjustment to the electrical stimulation; and

further adjusting the electrical stimulation based on the determined rate of change.

7. The method of claim 6, wherein adjusting the electrical stimulation to affect the brain signals in another frequency band comprises adjusting the electrical stimulation to increase the brain signals in the other frequency band.

8. The method of claim 1, wherein the electrical stimulation is formulated to alleviate pain, the method further comprising:

monitoring the brain signals in two different frequency bands;

determining a ratio of the brain signals in two different frequency bands; and

adjusting the electrical stimulation to adjust the ratio in a manner that alleviates the pain.

9. The method of claim 1, wherein the electrical stimulation is formulated to alleviate pain, the method further comprising:

monitoring the brain signals in one or more frequency bands;

adjusting the electrical stimulation to adjust the brain signals;

determining a rate of change of the brain signals in response to the adjustments to the electrical stimulation; and

further adjusting the electrical stimulation based on the determined rate of change.

10. The method of claim 1, wherein adjusting the electrical stimulation comprises adjusting an implantation location of the one or more electrodes.

11. The method of claim 1, wherein adjusting the electrical stimulation comprises selecting different electrodes to be active on one or more implanted medical leads.

12. The method of claim 1, wherein the electrical stimulation comprises stimulation pulses, and adjusting the electrical stimulation comprises adjusting one or more stimulation parameters selected from a group consisting of:

pulse polarity;

pulse voltage amplitude;

pulse current amplitude;

pulse rate;

pulse pattern;

waveform shape; and

pulse width.

13. The method of claim 1, further comprising:

measuring the brain signals via a brain measuring device positioned on or attached to a head of a patient;

monitoring the brain signals via the external device coupled to the brain measuring device; and

adjusting the electrical stimulation delivered via the one or more implanted electrodes based on the brain signals via an external stimulator coupled to the brain measuring device during implantation of the one or more implanted electrodes.

14. The method of claim 1, further comprising:

measuring the brain signals via a brain measuring device positioned on or attached to a head of a patient;

monitoring the brain signals via the external device coupled to the brain measuring device; and

adjusting the electrical stimulation delivered by an implanted medical device via the one or more implanted electrodes based on the brain signals via a programmer coupled to the brain measuring device, wherein the programmer telemetrically communicates with the implanted medical device.

15. The method of claim 1, further comprising:

measuring and monitoring the brain signals via a brain measuring and monitoring device positioned on or attached to a head of a patient, wherein the brain measuring and monitoring device is the external device; and

adjusting the electrical stimulation delivered by an implanted medical device via the one or more implanted electrodes based on the brain signals via a programmer coupled to the brain measuring and monitoring device, wherein the programmer telemetrically communicates with the implanted medical device.

16. The method of claim 1, further comprising:

adjusting drug delivery via an implanted drug pump based on the brain signals.

17. The method of claim 1, wherein the method is executed in an automated closed loop fashion in which the electrical stimulation is adjusted automatically based on the brain signals.

18. The method of claim 1, wherein the electrical stimulation is formulated to alleviate pain.

19. A method comprising:

monitoring brain signals in a frequency band via an external device that includes external electrodes disposed at one or more external locations on a head of the patient; and

adjusting drug delivery to one or more locations outside of the brain based on the brain signals and to affect the brain signals in another frequency band.

20. The method of claim 19, wherein adjusting the drug delivery comprise adjusting the drug delivery to alleviate pain of the patient based on the monitored brain signals.

21. A system comprising:

an external device that includes external electrodes configured to be disposed at one or more external locations on a head of a patient, wherein the external device externally monitors brain signals, in a specific frequency band, of a brain of a patient;

one or more implantable electrodes configured to deliver electrical stimulation to one or more locations within the patient outside of the brain; and

a stimulator device that generates the electrical stimulation delivered by the one or more implantable electrodes, wherein the stimulator device adjusts the electrical stimulation based on the brain signals monitored by the external device and to affect the brain signals in another frequency band.

22. The system of claim 21, wherein the electrical stimulation comprises neurostimulation.

23. The system of claim 21, further comprising one or more implantable medical leads, wherein the one or more implanted electrodes are disposed on the one or more implanted medical leads and the electrical stimulation is delivered from the stimulator device to the one or more implantable electrodes via the one or more implantable leads.

24. The system of claim 21, wherein the electrical stimulation is formulated to alleviate pain, wherein:

the stimulator device adjusts the electrical stimulation to affect the brain signals in the specific frequency band.

25. The system of claim 24 wherein the stimulator device adjusts the electrical stimulation to reduce the brain signals in the specific frequency band.

26. The system of claim 21, wherein the electrical stimulation is formulated to alleviate pain.

27. The system of claim 26, wherein the stimulator device adjusts the electrical stimulation to increase the brain signals in the another frequency band.

28. The system of claim 21, wherein the electrical stimulation is formulated to alleviate pain, wherein:

the external device monitors the brain signals in two different frequency bands, and determines a ratio of the signals in two different frequency bands; and

the stimulator device adjusts the electrical stimulation to adjust the ratio.

29. The system of claim 21, wherein the external device comprises:

a brain measuring device configured to be positioned on or attached to a head of the patient, and

wherein the stimulator device comprises an external stimulator coupled to the brain measuring device.

30. The system of claim 21, wherein the external device comprises:

a brain measuring device configured to be positioned on or attached to a head of the patient and an external brain activity monitoring device coupled to the brain measuring device,

wherein the system further comprises a programmer,

wherein the stimulator device comprises an implantable medical device, and

wherein the programmer is coupled to the external brain activity monitoring device and telemetrically communicates with the implantable medical device.

31. The system of claim 21, further comprising a programmer,

wherein the external device comprises a brain measuring and monitoring device positioned on or attached to a head of a patient,

wherein the stimulator device comprises an implantable medical device, and

wherein the programmer is coupled to the brain measuring and monitoring device and telemetrically communicates with the implantable medical device.

32. The system of claim 21, further comprising:

an implantable drug pump that adjusts drug delivery based on the brain signals.

33. The system of claim 21, wherein the system forms an automated closed loop system in which the stimulator device automatically adjusts the electrical stimulation based on the sensed brain signals.

34. A system comprising:

an external device that includes external electrodes configured to be disposed at one or more external locations on a head of a patient, wherein the external device externally monitors brain signals, in a frequency band, of a brain of the patient; and

an implantable drug pump that delivers drugs to a location outside of the brain, and adjusts drug delivery based on the brain signals monitored by the external device and to affect the brain signals in another frequency band.

35. The system of claim 34, wherein the system forms an automated closed loop system in which the implantable drug pump automatically adjusts drug delivery based on the brain signals.

36. The system of claim 34, wherein the delivery of drugs is formulated based on the brain signals to alleviate pain.

37. A method comprising:

monitoring brain signals of a brain in two different frequency bands;

determining a ratio of the brain signals in two different frequency bands; and

adjusting electrical stimulation delivered via one or more implanted electrodes based on the brain signals so as to adjust the ratio in a manner that alleviates pain to a patient.

38. The method of claim 37, wherein the electrical stimulation comprises spinal cord stimulation (SCS) provided to one or more locations outside of the brain.

39. The method of claim 37, wherein monitoring the brain comprises monitoring the brain via an external brain activity monitoring device.

40. The method of claim 37, wherein monitoring the brain comprises monitoring the brain via an implanted sensor positioned on or in the brain.

41. A system comprising:

means for monitoring brain signals, in a specific frequency band, of a brain of a patient via an external device that includes external electrodes configured to be disposed at one or more external locations on a head of the patient; and

means for adjusting electrical stimulation delivered via one or more implantable electrodes to one or more locations outside of the brain based on the brain signals and to affect the brain signals of another frequency band.

42. The system of claim 41, wherein the electrical stimulation comprises neurostimulation.

43. The system of claim 41, wherein the one or more implantable electrodes are disposed on one or more implantable medical leads.

44. The system of claim 41, wherein the electrical stimulation is formulated to alleviate pain, the system further comprising:

means for adjusting the electrical stimulation to affect the brain signals in the specific frequency band.

45. The system of claim 44, wherein means for adjusting the electrical stimulation to affect the brain signals in the frequency band comprises means for adjusting the electrical stimulation to reduce the brain signals in the specific frequency band.

46. The system of claim 41, wherein the electrical stimulation is formulated to alleviate pain, the system further comprising

means for monitoring the brain signals in the other frequency band;

means for determining a ratio of the brain signals of the specific frequency band and the other frequency band;

means for adjusting the electrical stimulation to adjust the ratio in a manner that alleviates pain;

means for determining a rate of change of the brain signals in response to the adjustment to the electrical stimulation; and

means for further adjusting-the electrical stimulation based on the determined rate of change.

47. The system of claim 46, wherein means for adjusting the electrical stimulation to affect the brain signals in another frequency band comprises means for adjusting the electrical stimulation to increase the brain signals in the another frequency band.

48. The system of claim 41, wherein the electrical stimulation is formulated to alleviate pain, the system further comprising:

means for monitoring the brain signals in two different frequency bands;

means for determining a ratio of the brain signals in two different frequency bands; and

means for adjusting the electrical stimulation to adjust the ratio in a manner that alleviates the pain.

49. The system of claim 41, wherein the electrical stimulation is formulated to alleviate pain, the system further comprising:

means for monitoring the brain signals in one or more frequency bands;

means for adjusting the electrical stimulation to adjust the brain signals;

means for determining a rate of change of the brain signals in response to the adjustments to the electrical stimulation; and

means for further adjusting the electrical stimulation based on the determined rate of change.

50. The system of claim 41, wherein means for adjusting the electrical stimulation comprises means for adjusting an implantation location of the one or more electrodes.

51. The system of claim 41, wherein means for adjusting the electrical stimulation comprises means for selecting different electrodes to be active on one or more implantable medical leads.

52. The system of claim 41, wherein means for adjusting the electrical stimulation comprises means for adjusting one or more stimulation parameters selected from a group consisting of:

pulse polarity;

pulse voltage amplitude;

pulse current amplitude;

pulse rate;

pulse pattern;

waveform shape; and

pulse width.

53. The system of claim 41, further comprising:

means for measuring the brain signals via a brain measuring device positioned on or attached to a head of a patient;

means for monitoring the brain signals via the external device coupled to the brain measuring device; and

means for adjusting the electrical stimulation delivered via the one or more implantable electrodes based on the brain signals via an external stimulator coupled to the brain measuring device during implantation of the one or more implantable electrodes.

54. The system of claim 41, further comprising:

means for measuring the brain signals via a brain measuring device positioned on or attached to a head of a patient;

means for monitoring the brain signals via the external device coupled to the brain measuring device; and

means for adjusting the electrical stimulation delivered by an implantable medical device via the one or more implantable electrodes based on the brain signals via a programmer coupled to the brain measuring device, wherein the programmer telemetrically communicates with the implantable medical device.

55. The system of claim 41, further comprising:

means for measuring and monitoring the brain signals via a brain measuring and monitoring device positioned on or attached to a head of a patient, wherein the brain measuring and monitoring device is the external device; and

means for adjusting the electrical stimulation delivered by an implantable medical device via the one or more implantable electrodes based on the brain signals via a programmer coupled to the brain measuring and monitoring device, wherein the programmer telemetrically communicates with the implantable medical device.

56. The system of claim 41, further comprising:

means for adjusting drug delivery via an implantable drug pump based on the brain signals.

57. The system of claim 41, wherein the system forms an automated closed loop in which the electrical stimulation is adjusted automatically based on the brain signals.

58. The system of claim 41, wherein the electrical stimulation is formulated to alleviate pain.

59. A system comprising:

means for monitoring brain signals in a frequency band via an external device that includes external electrodes configured to be disposed at one or more external locations on a head of the patient; and

means for adjusting drug delivery to one or more locations outside of the brain based on the brain signals so as to affect the brain signals of another frequency band.

60. The method of claim 59, wherein means for adjusting the drug delivery comprises means for adjusting the drug delivery to alleviate pain of the patient based on the monitored brain signals.

61. A method comprising:

monitoring brain signals of brains of patients via one or more external devices that include external electrodes disposed at one or more external locations on heads of the patients;

adjusting therapy delivered to one or more locations outside of the brains of the patients based on the brain signals; and

selecting a specific patient for treatment via an implantable medical device based on a brain response to the therapy for that specific patient.

62. The method of claim 61, wherein adjusting therapy comprises adjusting electrical stimulation delivered during a trial, and wherein selecting the specific patient for treatment via an implantable medical device based on brain response to the therapy comprises selecting the specific patient for treatment via an implantable stimulator device when the brain response for the specific patient demonstrates efficacy in pain reduction in the specific patient.