Apparatus and method for closed-loop intracranial stimulation for optimal control of neurological disease

• US 20070073355A1
• Filed: 11/15/2006
• Published: 03/29/2007
• Est. Priority Date: 08/05/1998
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Bioneuronics Corporation
• Inventors: Dilorenzo, Daniel
• Granted Patent: US 9,421,373 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A neurological control system for modulating activity of any component or structure comprising the entirety or portion of the nervous system, or any structure interfaced thereto, generally referred to herein as a “nervous system component.” The neurological control system generates neural modulation signals delivered to a nervous system component through one or more intracranial (IC) stimulating electrodes in accordance with treatment parameters. Such treatment parameters may be derived from a neural response to previously delivered neural modulation signals sensed by one or more sensors, each configured to sense a particular characteristic indicative of a neurological or psychiatric condition.

Claims

1-20. -20. (canceled)

21. A method of managing a neurological or psychiatric disease state, the method comprising:

measuring one or more signals from a patient;

extracting one or more parameters from the one or more signals that are predictive of future symptomatology of a neurological or psychiatric disease;

initiating delivery of a neural modulation signal to the patient when the one or more extracted parameters predict the future symptomatology;

automatically monitoring the patient'"'"'s response to the delivered neural modulation signal; and

initiating delivery of a subsequent neural modulation signal if the response to the delivered neural modulation signal indicates that the subsequent neural modulation signal is needed.

22. The method of claim 21 wherein the neurological disease state comprises epilepsy and the future symptomatology comprises an impending seizure.

23. The method of claim 21, further comprising storing data in a memory implanted in the patient, wherein the data is reflective of the one or more extracted parameters and/or the one or more measured signals from the patient.

24. The method of claim 23, comprising transcutaneously transmitting the stored data from the memory implanted in the patient to a communication module that is external to the patient'"'"'s body.

25. The method of claim 21, wherein the one or more signals comprise brain activity signals and wherein the patient'"'"'s response comprises a brain activity response.

26. The method of claim 25, wherein monitoring the patient'"'"'s response comprises extracting the at least one parameter that is predictive of the future symptomatology from the brain activity response and comparing the extracted at least one brain activity response parameter to at least one clinician programmed reference parameter that is stored in a memory implanted in the patient.

27. The method of claim 26, wherein extracting the at least one parameter and comparing the at least one brain activity response parameter to the at least one clinician programmed reference parameter are performed in a unit that is implanted in the patient.

28. The method of claim 27, wherein the unit is implanted intracranially in the patient'"'"'s body.

29. The method of claim 21, wherein the one or more signals comprise one or more EEG signals, wherein the one or more extracted parameter comprises at least one of a peak-to-valley times, valley-to-peak times, positive phase amplitudes, and negative phase amplitudes of the EEG signal.

30. The method of claim 29, wherein the at least one extracted parameter comprises each of the peak-to-valley times, the valley-to-peak times, the positive phase amplitudes, and the negative phase amplitudes of the EEG signal.

31. The method of claim 21, wherein the subsequent neural modulation signal is needed if a desired change in brain activity is not achieved with the delivered neural modulation signal.

32. The method of claim 21, wherein at least one of the neural modulation signal and subsequent neural modulation signals comprise a pulse train of waveforms that include one or more bursts of waveforms.

33. The method of claim 32, wherein the one or more bursts each comprise one or more charge-balanced biphasic stimulus pulses.

34. The method of claim 33 wherein an anodic phase and a cathodic phase of the charge balanced biphasic stimulus pulses are asymmetrical.

35. The method of claim 21 wherein the neural modulation signal and subsequent neural modulation signal comprises delivery of a medication.

36. The method of claim 21 wherein the neural modulation signal and subsequent neural modulation signal comprises electrical stimulation of a nervous system component.

37. A method of managing a neurological or psychiatric disease state, the method comprising:

measuring one or more signals from a patient;

extracting one or more parameters from the one or more signals that are predictive of future symptomatology of a neurological or psychiatric disease;

initiating delivery of a neural modulation signal to the patient when the one or more signals predict an onset of the symptomatology;

monitoring the patient'"'"'s response to the neural modulation signal; and

initiating delivery of a subsequent neural modulation signal to the patient if the response to the neural modulation signal continues to predict an onset of the symptomatology.

38. The method of claim 37 wherein the neurological disease state comprises epilepsy and the symptomatology comprises a seizure.

39. The method of claim 37, further comprising storing data in a memory implanted in the patient wherein the data is reflective of the one or more extracted parameters and/or the one or more measured signals from the patient.

40. The method of claim 39, comprising transcutaneously transmitting the stored data from the memory that is implanted in the patient to a communication module that is external to the patient'"'"'s body.

41. The method of claim 37, wherein the one or more signals comprise brain activity signals and wherein the patient'"'"'s response comprises a brain activity response.

42. The method of claim 41, wherein monitoring the patient'"'"'s response comprises extracting the at least one parameter that is predictive of the future symptomatology from the brain activity response and comparing the extracted at least one brain activity response parameter to at least one clinician programmed reference parameter that is stored in a memory implanted in the patient.

43. The method of claim 42, wherein extracting the at least one parameter and comparing the at least one brain activity response parameter to the at least one clinician programmed reference parameter are performed in a unit that is implanted in the patient.

44. The method of claim 43, wherein the unit is implanted intracranially in the patient'"'"'s body.

45. The method of claim 37, wherein the one or more signals comprise one or more EEG signals, wherein the one or more extracted parameter comprises at least one of a peak-to-valley times, valley-to-peak times, positive phase amplitudes, and negative phase amplitudes of the EEG signal.

46. The method of claim 45, wherein the at least one extracted parameter comprises each of the peak-to-valley times, the valley-to-peak times, the positive phase amplitudes, and the negative phase amplitudes of the EEG signal.

47. The method of claim 37, wherein monitoring the patient'"'"'s response to the delivered neural modulation signal comprises determining if undesirable brain activity is present.

48. The method of claim 37, wherein the subsequent neural modulation signal is needed if a desired change in brain activity is not achieved with the neural modulation signal.

49. The method of claim 37, wherein at least one of the neural modulation signal and subsequent neural modulation signals comprise a pulse train of waveforms that include one or more bursts of waveforms.

50. The method of claim 49, wherein the one or more bursts each comprise one or more charge-balanced biphasic stimulus pulses.

51. The method of claim 50 wherein an anodic phase and a cathodic phase of the charge balanced biphasic stimulus pulses are asymmetrical.

52. The method of claim 37 wherein the neural modulation signal and subsequent neural modulation signal comprises delivery of a medication.

53. The method of claim 37 wherein the neural modulation signal and subsequent neural modulation signal comprises electrical stimulation of a nervous system component.

54. A method of managing epilepsy, the method comprising:

initiating delivery of a first neuromodulation signal to the patient when a patient'"'"'s brain activity is predictive of an onset of a future seizure;

automatically monitoring a patient'"'"'s brain activity response after delivering the first neural modulation signal; and

initiating delivery of a second neuromodulation signal to the patient if the monitored brain activity response continues to be predictive of the onset of the future seizure.

55. The method of claim 54 further comprising:

monitoring one or more EEG signals from a patient; and

extracting parameters from the one or more EEG signals that are predictive; and

analyzing trending and/or a temporal pattern of the extracted parameters to predict the onset of the future seizure.

56. The method of claim 55, wherein the one or more extracted parameter comprises at least one of a peak-to-valley times, valley-to-peak times, positive phase amplitudes, and negative phase amplitudes of the EEG signal.

57. The method of claim 55, further comprising storing the monitored EEG signals and/or the patient'"'"'s response to the first neural modulation signal in a memory device.

58. The method of claim 54, wherein the first and second neural modulation signals comprise electrical stimulation that is delivered directly to a patient'"'"'s brain with intracranial electrodes.

59. The method of claim 54, wherein at least one of the first and second neural modulation signals is delivered to a peripheral nerve.

60. The method of claim 54 wherein first neural modulation signal and the second neural modulation comprise medication.

61. The method of claim 54 wherein the first neural modulation signal and the second neural modulation signal comprise electrical stimulation, wherein the first neural modulation signal and the second neural modulation comprise at least one different parameter.

62. The method of claim 54 wherein the first neural modulation signal and the second neural modulation comprise electrical stimulation and the first neural modulation signal and the second neural modulation comprise same parameters.