Medical device configuration based on sensed brain signals

• US 8,185,207 B2
• Filed: 06/24/2011
• Issued: 05/22/2012
• Est. Priority Date: 10/26/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Molnar, Gabriela C., Molnar, Gregory F.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert
• Application Number:
  US13/167,754
• Publication Number:
  US 20110251583A1
• Time in Patent Office: 333 Days
• Field of Search: 600/132, 600/345, 600/378, 600/544, 607/2, 607/42, 607/45, 607/46
• 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:

delivering electrical stimulation to a patient via one or more electrodes of a medical device, wherein the one or more electrodes are positioned proximate to a spinal cord of the patient and the electrical stimulation is formulated to alleviate pain in the patient;

monitoring brain signals of a brain of the patient in a gamma frequency band via an external brain activity monitoring device; and

adjusting the electrical stimulation delivered via the one or more electrodes based on the brain signals.

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

3. The method of claim 1, the method further comprising:

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

4. The method of claim 3, wherein adjusting the electrical stimulation to affect the brain signals in the gamma frequency band comprises adjusting the electrical stimulation to reduce the brain signals in the gamma frequency band.

5. The method of claim 1, the method further comprising:

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

6. The method of claim 5, 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 another frequency band.

9. The method of claim 1, wherein adjusting the electrical stimulation comprises adjusting an implantation location of the one or more electrodes based on the brain signals.

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

11. The method of claim 1, wherein 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.

12. The method of claim 1, wherein the medical device comprises an external stimulator, the method 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 brain activity monitoring device coupled to the brain measuring device; and

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

13. The method of claim 1, wherein the medical device comprises an implantable medical device (IMD), the method 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 brain activity monitoring device coupled to the brain measuring device; and

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

14. The method of claim 1, wherein the medical device comprises an implantable medical device (IMD), the method 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; and

adjusting the electrical stimulation delivered by the IMD 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 IMD.

15. The method of claim 1, further comprising:

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

16. 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.

52. The method of claim 1, wherein the gamma frequency band is at least one of a low gamma frequency band from approximately 30 hertz (Hz) to approximately 60 Hz, a medium frequency gamma band from approximately 60 Hz to approximately 90 Hz, or a high frequency band from approximately 90 Hz to approximately 300 Hz.

7. A method comprising:

delivering electrical stimulation to a patient via one or more electrodes of a medical device, wherein the one or more electrodes are positioned proximate to a spinal cord of the patient and the electrical stimulation is formulated to alleviate pain in the patient;

monitoring brain signals of a brain of the patient in two different frequency bands via an external brain activity monitoring device;

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

adjusting the electrical stimulation delivered via one or more electrodes to adjust the ratio in a manner that alleviates the pain.

8. A method comprising:

delivering electrical stimulation to a patient via one or more electrodes of a medical device, wherein the one or more electrodes are positioned proximate to a spinal cord of the patient and the electrical stimulation is formulated to alleviate pain in the patient;

monitoring brain signals of a brain of the patient 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.

17. A method comprising:

delivering one or more drugs to a spinal cord of a patient via a drug pump of a medical device, wherein the drugs alleviate pain in the patient;

monitoring brain signals in a gamma frequency band via an external brain activity monitoring device; and

adjusting the drug delivery based on the brain signals.

18. A system comprising:

an external brain activity monitoring device that monitors brain signals of a brain of a patient in a gamma frequency band;

one or more electrodes that deliver electrical stimulation to a patient, wherein the one or more electrodes are positioned proximate to the spinal cord of the patient and the electrical stimulation is formulated to alleviate pain in the patient; and

a stimulator device that generates the electrical stimulation delivered by the one or more electrodes, wherein the stimulator device adjusts the electrical stimulation based on the brain signals.

19. The system of claim 18, 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 electrodes via the one or more implantable leads.

20. The system of claim 18, wherein:

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

21. The system of claim 20, wherein the stimulator device adjusts the electrical stimulation to reduce the brain signals in the gamma frequency band.

22. The system of claim 18, wherein:

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

23. The system of claim 22, wherein the stimulator device adjusts the electrical stimulation to increase the brain signals in the another frequency band.

25. The system of claim 18, further comprising:

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

wherein the external brain activity monitoring device is coupled to the brain measuring device, and

wherein the stimulator device comprises an external stimulator coupled to the brain measuring device during implantation of the one or more implantable electrodes.

26. The system of claim 18, further comprising:

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

a programmer,

wherein the external brain activity monitoring device is coupled to the brain measuring device,

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.

27. The system of claim 18, further comprising a programmer,

wherein the external brain activity monitoring 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.

28. The system of claim 18, further comprising:

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

29. The system of claim 18, 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.

24. A system comprising:

an external brain activity monitoring device that monitors brain signals of a brain of a patient in two different frequency bands, and determines a ratio of the signals in the two different frequency bands;

one or more electrodes that delivery electrical stimulation to a patient, wherein the one or more electrodes are positioned proximate to the spinal cord of the patient and the electrical stimulation is formulated to alleviate pain in the patient; and

a stimulator device that generates the electrical stimulation delivered by the one or more electrodes and adjusts the electrical stimulation to adjust the ratio, wherein the stimulator device adjusts the electrical stimulation based on the brain signals.

30. A system comprising:

an external brain activity monitoring device that monitors brain signals of a brain of a patient in a gamma frequency band; and

an implantable drug pump that delivers drugs to a spinal cord of the patient, and adjusts drug delivery based on the brain signals, wherein the drugs alleviate pain in the patient.

31. The system of claim 30, wherein the system forms an automated closed loop system in which the implantable drug pump automatically adjusts drug delivery based on the brain signals.

32. A system comprising:

means for delivering electrical stimulation to a patient via one or more electrodes of a medical device, wherein the one or more electrodes are positioned proximate to a spinal cord of the patient and the electrical stimulation is formulated to alleviate pain in the patient;

means for monitoring brain signals of a brain of the patient in a gamma frequency band via an external brain activity monitoring device; and

means for adjusting the electrical stimulation delivered via the one or more electrodes based on the brain signals.

33. The system of claim 32, wherein the one or more electrodes are disposed on one or more implanted medical leads.

34. The system of claim 32, wherein:

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

35. The system of claim 34, wherein the means for adjusting the electrical stimulation to affect the brain signals in the gamma frequency band comprises means for adjusting the electrical stimulation to reduce the brain signals in the gamma frequency band.

36. The system of claim 32, wherein:

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

37. The system of claim 36, wherein the means for adjusting adjusts the electrical stimulation to increase the brain signals in the another frequency band.

38. The system of claim 32, wherein:

the means for monitoring monitors the brain signals in two different frequency bands, and determines a ratio of the brain signals in the two different frequency bands; and

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

39. The system of claim 32, wherein:

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

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

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

40. The system of claim 32, wherein the means for adjusting the electrical stimulation comprises means for adjusting an implantation location of the one or more electrodes based on the brain signals.

41. The system of claim 32, wherein the means for adjusting the electrical stimulation comprises means for selecting different electrodes to be active on one or more implanted medical leads based on the brain signals.

42. The system of claim 32, wherein the means for adjusting the electrical stimulation adjusts 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.

43. The system of claim 32, wherein the means for delivering comprises an external stimulator, the system further comprising:

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

wherein the means for monitoring the brain signals is coupled to the brain measuring device, and

wherein the means for adjusting the electrical stimulation is coupled to the brain measuring device during implantation of the one or more electrodes.

44. The system of claim 32, wherein the means for delivering comprises an implantable medical device (IMD), the system further comprising:

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

wherein the means for monitoring the brain signals is coupled to the brain measuring device, and

wherein the means for adjusting the electrical stimulation comprises a programmer coupled to the brain measuring device, wherein the programmer telemetrically communicates with the IMD.

45. The method of claim 32, wherein the means for delivering comprises an implantable medical device (IMD), wherein:

the means for monitoring comprises means for measuring and monitoring the brain signals; and

wherein the means for adjusting comprises a programmer coupled to the means for measuring and monitoring, wherein the programmer telemetrically communicates with the IMD.

46. The system of claim 32, further comprising:

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

47. The system of claim 32, wherein the system operates in an automated closed loop fashion in which the electrical stimulation is adjusted automatically based on the brain signals.

48. A system comprising:

means for delivering one or more drugs to a spinal cord of a patient via a drug pump of a medical device, wherein the drugs alleviate pain in the patient;

means for monitoring brain signals in a gamma frequency band via an external brain activity monitoring device; and

means for adjusting the drug delivery based on the brain signals.

49. A method comprising:

delivering electrical stimulation to a patient via one or more electrodes disposed on percutaneously implanted leads of an external medical device, wherein the one or more electrodes are positioned proximate to a spinal cord of a patient and the electrical stimulation is formulated to alleviate pain in the patient;

monitoring brain signals of a brain of the patient in a gamma frequency band via an external brain activity monitoring device;

adjusting the electrical stimulation delivered via the one or more electrodes based on the brain signals; and

determining whether to select the patient for treatment via an implantable medical device based on brain response to the therapy.

50. The method of claim 49, wherein adjusting the electrical stimulation comprises adjusting electrical stimulation delivered during a trial, and wherein determining whether to select the patient for treatment via an implantable medical device based on brain response to the therapy comprises determining whether to select the patient for treatment via an implantable stimulator device when the brain response demonstrates efficacy in pain reduction in the patient.

51. The method of claim 49, further comprising:

implanting the implantable medical device in the patient for spinal cord stimulation (SCS) when the brain response to the therapy demonstrates efficacy of the electrical stimulation in treating pain in the patient.

53. The system of 18, wherein the gamma frequency band is at least one of a low gamma frequency band from approximately 30 hertz (Hz) to approximately 60 Hz, a medium frequency gamma band from approximately 60 Hz to approximately 90 Hz, or a high frequency band from approximately 90 Hz to approximately 300 Hz.