Intelligent brain pacemaker for real-time monitoring and controlling of epileptic seizures

• US 20030083716A1
• Filed: 10/23/2001
• Published: 05/01/2003
• Est. Priority Date: 10/23/2001
• Status: Abandoned Application

• Current Assignee: Duke University
• Original Assignee: Duke University
• Inventors: Fanselow, Erika E., Reid, Ashlan P., Nicolelis, Miguel A.L.
• Application Number:
  US10/004,457
• Publication Number:
  US 20030083716A1
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

An intelligent brain pace maker for detecting and ameliorating epileptic seizures is disclosed. A method for detecting and ameliorating epileptic seizures is also disclosed. Further, a method of increasing the time interval between epileptic seizures is disclosed.

Claims

1. An intelligent brain pacemaker for a mammal having a cranial nerve not associated with an autonomic function comprising:

(a) one or more electrodes adapted to acquire field potential measurements indicative of a mammal'"'"'s brain activity in real-time;

(b) a seizure detector adapted to detect seizure-related brain activity of a mammal in real-time, the seizure detector being electrically connected to the one or more electrodes;

(c) one or more nerve stimulators adapted to provide electrical stimulation to a mammal'"'"'s cranial nerve not associated with an autonomic function, to terminate or ameliorate the seizure, the one or more nerve simulators being electrically connected to the seizure detector; and

(d) a power source for providing power to the intelligent brain pacemaker.

2. The apparatus of claim 1, wherein the one or more electrodes comprise one or more microwire arrays comprising TEFLON®

-coated stainless steel wires.

3. The apparatus of claim 2, wherein the stainless steel wires are about 50 μ

m in diameter.

4. The apparatus of claim 2, wherein the one or more microwire arrays comprise 8 or more TEFLON®

-coated stainless steel wires.

5. The apparatus of claim 2, wherein the one or more microwire arrays comprise a bundle of 8 or more TEFLON®

-coated stainless steel microwires.

6. The apparatus of claim 1, wherein the one or more electrodes comprise one or more microwire arrays comprising TEFLON®

-coated tungsten wires.

7. The apparatus of claim 6, wherein the tungsten wires are about 50 μ

m in diameter.

8. The apparatus of claim 6, wherein the one or more microwire arrays comprise 8 or more TEFLON®

coated tungsten wires.

9. The apparatus of claim 6, wherein the one or more microwire arrays comprise a bundle of 8 or more TEFLON®

-coated tungsten microwires.

10. The apparatus of claim 1, wherein the one or more electrodes are adapted to be affixed to an exterior surface of a subject'"'"'s body.

11. The apparatus of claim 1, wherein each of the one or more electrodes is separately monitored.

12. The apparatus of claim 1, wherein the field potential measurements indicative of a subject'"'"'s brain activity are acquired continuously.

13. The apparatus of claim 1, wherein the seizure-related brain activity of a subject is detected continuously.

14. The apparatus of claim 1, wherein the seizure detector is adapted to:

(a) determine if any field potential measurement matches a predetermined known pattern of epileptic brain activity;

(b) send a signal to a stimulator if a field potential measurement matches a predetermined known pattern of epileptic brain activity;

(c) continue sending a signal to the stimulator for as long as the a field potential matches a predetermined known pattern of

(d) epileptic brain activity; and

(d) stop sending a signal to the stimulator when field potential measurements do not match a predetermined known pattern of epileptic brain activity.

15. The apparatus of claim 14, wherein the predetermined known pattern of epileptic brain activity is indicative of seizure activity.

16. The apparatus of claim 14, wherein the predetermined known pattern of epileptic brain activity comprises a field potential surpassing a threshold voltage value.

17. The apparatus of claim 1, wherein the seizure detector comprises a seizure detection algorithm running on a computer microchip.

18. The apparatus of claim 17, wherein the seizure detector is disposed on a computer.

19. The apparatus of claim 1, wherein the one or more nerve stimulators comprise a nerve cuff electrode.

20. The nerve cuff electrode of claim 19, wherein the nerve cuff electrode comprises one or more bands comprising a conductive material, every band being in electrical connection with every other band.

21. The apparatus of claim 1, wherein the one or more nerve stimulators comprise a device adapted to provide electrical stimulation when triggered.

22. The apparatus of claim 1, wherein the electrical stimulation is provided in the form of a pulse train.

23. The apparatus of claim 1, wherein the cranial nerve not associated with an autonomic function is a trigeminal nerve.

24. The apparatus of claim 23, wherein a branch of the trigeminal nerve is electrically stimulated.

25. The apparatus of claim 1, wherein the power source is a lithium battery.

26. The apparatus of claim 1, wherein the apparatus is adapted to be implanted in the brain tissue of a subject.

27. The apparatus of claim 1, wherein the apparatus is adapted to be implanted in the body of a subject.

28. The apparatus of claim 1, further comprising an operatively connected computer adapted to provide a visualization of the field potential data.

29. The apparatus of claim 28, wherein the computer is a handheld computer.

30. The apparatus of claim 1, further comprising circuitry adapted to transmit information by radio telemetry.

31. The apparatus of claim 30, wherein the information transmitted is selected from the group consisting of field potential information and seizure-related information.

32. A method of detecting and ameliorating a seizure, in a mammal having a cranial nerve not associated with an autonomic function, the method comprising:

(a) acquiring field potential data indicative of a subject'"'"'s electrical brain activity in real-time;

(b) analyzing the field potential data to identify seizure-related brain activity;

(c) electrically stimulating a cranial nerve not associated with an autonomic function of the subject, if seizure-related brain activity is identified; and

(d) removing the stimulation when seizure-related brain activity is not detected, whereby a seizure is detected and ameliorated.

33. The method of claim 32, wherein the method is performed without generating a detectable cardiovascular side effect.

34. The method of claim 32, wherein the field potential data is acquired continuously.

35. The method of claim 32, wherein the field potential data is acquired via one or more microelectrode arrays comprising a plurality of microwires.

36. The method of claim 35, wherein the field potential data from each microwire of the microwire array is separately recorded.

37. The method of claim 35, wherein the one or more microwire arrays comprises one or more bundles of TEFLON®

-coated stainless steel microwires.

38. The method of claim 35, wherein the one or more microwire arrays comprises one or more bundles of TEFLON®

-coated tungsten microwires.

39. The method of claim 32, wherein the field potential data is acquired at a sampling rate of between 128 and 1024 Hz.

40. The method of claim 39, wherein the field potential data is acquired at a sampling rate of between 500 and 1024 Hz.

41. The method of claim 32, wherein the analyzing comprises the steps of:

(a) band-pass filtering the acquired field potential data;

(b) comparing the field potential data to a predetermined known pattern of epileptic brain activity; and

(c) determining if any of the field potential data exceeds the predetermined known pattern of epileptic brain activity.

42. The method of claim 41, wherein the band-pass filtering is at a frequency between 1 and 100 Hz.

43. The method of claim 41, wherein the band-pass filtering is at a frequency of 30 Hz.

44. The method of claim 41, wherein the band-pass filtering comprises employing a notch filter at 60 Hz.

45. The method of claim 41, wherein the predetermined known pattern of epileptic brain activity is indicative of one of:

seizure-related brain activity and brain activity predictive of oncoming seizure activity.

46. The method of claim 32, wherein the electrical stimulation is automatically triggered if seizure-related brain activity is identified.

47. The method of claim 32, wherein the electrical stimulation is stopped when seizure-related brain activity is absent.

48. The method of claim 32, wherein the electrical stimulation of the cranial nerve not associated with an autonomic function is delivered by a nerve cuff electrode.

49. The method of claim 48, wherein the nerve cuff electrode comprises one or more conducting bands.

50. The method of claim 48, wherein the electrical stimulation is delivered as a train of electrical pulses.

51. The method of claim 50, wherein the train of electrical pulses comprises a 0.5 second train of 500 μ

s pulses at a frequency value of between 1 and 333 Hz.

52. The method of claim 50, wherein the train of electrical pulses comprises a 0.5 second train of 500 μ

s pulses at a current value of between 3 and 11 mA.

53. The method of claim 32, wherein the cranial nerve not associated with an autonomic function is a trigeminal nerve.

54. The method of claim 53, wherein a branch of the trigeminal nerve is electrically stimulated.

55. The method of claim 54, wherein a branch of the trigeminal nerve is unilaterally electrically stimulated.

56. The method of claim 54, wherein a branch of the trigeminal nerve is bilaterally electrically stimulated.

57. The method of claim 32, wherein the cranial nerve not associated with an autonomic function and one or more locations on a subject'"'"'s body distinct from the cranial nerve not associated with an autonomic function are electrically stimulated.

58. The method of claim 57, wherein the one or more locations is selected from the group consisting of cranial nerves and brain tissue.

59. The method of claim 32, wherein steps (a) through (d) are repeated continuously.

60. The method of claim 32, wherein steps (a) through (d) are performed within the body of a subject.

61. A method of increasing the time between epileptic seizures, the method comprising:

(a) acquiring field potential data from the brain of a subject;

(b) analyzing the field potential data to identify the presence of an epileptic seizure in a subject;

(c) electrically stimulating a cranial nerve not associated with an autonomic function of the subject when an epileptic seizure is identified; and

(d) repeating steps (a) through (c), whereby the time between seizures is increased.

62. The method of claim 61, wherein the method is performed without generating a detectable cardiovascular side effect.

63. The method of claim 61, wherein the field potential data is acquired continuously.

64. The method of claim 61, wherein the field potential data is acquired from one or more microwire arrays.

65. The method of claim 64, wherein the field potential data from each microwire of the microwire array is separately recorded.

66. The method of claim 64, wherein the one or more microwire arrays comprises one or more bundles of TEFLON®

-coated stainless steel microwires.

67. The method of claim 64, wherein the one or more microwire arrays comprises one or more bundles of TEFLON®

-coated tungsten microwires.

68. The method of claim 61, wherein the field potential data is acquired at a sampling rate of between 128 and 1024 Hz.

69. The method of claim 68, wherein the field potential data is acquired at a sampling rate of between 500 and 1024 Hz.

70. The method of claim 61, wherein the analyzing comprises the steps of:

(a) band-pass filtering the acquired field potential data;

(b) comparing the field potential data to a predetermined known pattern of epileptic brain activity; and

(c) determining if any of the field potential data matches the predetermined known pattern of epileptic brain activity.

71. The method of claim 70, wherein the band-pass filtering is at a frequency between 1 and 100 Hz.

72. The method of claim 71, wherein the band-pass filtering is at a frequency of 30 Hz.

73. The method of claim 70, wherein the band-pass filtering comprises a notch filter at 60 Hz.

74. The method of claim 70, wherein the predetermined known pattern of epileptic brain activity is indicative of one of:

seizure-related brain activity and brain activity predictive of oncoming seizure activity.

75. The method of claim 70, wherein the predetermined known pattern of epileptic brain activity comprises a field potential that exceeds a predetermined threshold value.

76. The method of claim 61, wherein the electrical stimulation is automatically triggered if seizure-related brain activity is identified.

77. The method of claim 61, wherein the electrical stimulation of the trigeminal nerve is delivered by a nerve cuff electrode.

78. The method of claim 77, wherein the nerve cuff electrode comprises a plurality of conducting bands.

79. The method of claim 61, wherein the electrical stimulation is delivered as a train of electrical pulses.

80. The method of claim 79, wherein the train of electrical pulses comprises a 0.5 second train of 500 μ

s pulses at a frequency value of between 1 and 333 Hz.

81. The method of claim 79, wherein the train of electrical pulses comprises a 0.5 second train of 500 μ

s pulses at a current value of between 3 and 11 mA.

82. The method of claim 61, wherein the cranial nerve not associated with an autonomic function and one or more distinct locations on a subject'"'"'s body are electrically stimulated.

83. The method of claim 82, wherein the one or more distinct locations is selected from the group consisting of cranial nerves and brain tissue.

84. The method of claim 61, wherein the cranial nerve not associated with an autonomic function is a trigeminal nerve.

85. The method of claim 61 or 84, wherein the cranial nerve not associated with an autonomic function is unilaterally electrically stimulated.

86. The method of claim 61 or 84, wherein the cranial nerve not associated with an autonomic function is bilaterally electrically stimulated.

87. The method of claim 61, wherein steps (a) through (d) are performed within the body of a subject.