Treatment of neurological disorders via electrical stimulation, and methods related thereto

• US 20110137381A1
• Filed: 01/02/2009
• Published: 06/09/2011
• Est. Priority Date: 07/05/2006
• Status: Active Grant

• Current Assignee: Precisis US, Inc.
• Original Assignee: Precisis US, Inc.
• Inventors: Cohen, Richard, Foreman, Allan, Lee, Harry, Gotman, Jean, Cole, Andrew James, Daum, Wolfgang
• Granted Patent: US 9,381,346 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Disclosed are medical devices for the prevention and/or treatment of neurological disorders via electrical stimulation, and methods related thereto. The devices may also be utilized to detect disorders before the prevention or treatment of a neurological disorder. These devices are minimally or non-invasive. The present medical devices comprise various components, which include electrodes and control electronics. The electrodes are targeting electrodes constructed from ring type structures or virtually connected disc type arrays. The electrodes are located entirely outside the skull. The present medical devices also comprise one or more subsystems, a control system, a battery unit, and wires connecting the one or more subsystems. These devices may also be used for acute seizure control.

Claims

1. A system for delivering an electrical stimulation into the brain of a patient, comprising:

a) at least one electrode adapted for placement between a patient'"'"'s scalp and cranium to monitor electrical activity in the patient'"'"'s brain; and

b) a control module operatively coupled to the at least one electrode, the control module including;

1) a detection sub-system for detecting abnormal electrical activity within the brain;

2) a responsive analysis sub-system for analyzing the abnormal electrical activity within the brain;

3) a responsive stimulation sub-system operatively controlled by the control module to deliver an electrical responsive stimulation into the patient'"'"'s brain in response to the responsive analysis sub-system;

4) a preventive stimulation sub-system operatively controlled by the control module to deliver an electrical preventive stimulation into the patient'"'"'s brain independent of the responsive analysis sub-system to alter the onset of abnormal electrical activity within the patient'"'"'s brain.

2. The system according to claim 1 further comprising a localizing sub-system for determining the location of the abnormal electrical activity within the brain.

3. The system according to claim 2 further comprising a targeting sub-system for directing responsive stimulation to the location of the abnormal electrical activity.

4. The system according to claim 3 wherein the preventive stimulation is delivered into the patient'"'"'s brain independent of the targeting sub-system.

5. The system according to claim 3 further comprising a preventive analysis sub-system for analyzing the electrical activity within the patient'"'"'s brain to determine if the patient is treatable with said preventive stimulation.

6. The system according to claim 1 wherein the preventive stimulation is direct current.

7. The system according to claim 1 wherein the preventive stimulation is cathodal direct current.

8. The system according to claim 1 wherein the preventive stimulation is biphasic alternating current.

9. The system according to claim 1 wherein the preventive stimulation is monophasic alternating current.

10. The system according to claim 1 wherein the preventive stimulation is delivered constantly.

11. The system according to claim 1 wherein the preventive stimulation is delivered recurrently.

12. The system according to claim 1 wherein the preventive stimulation is delivered in time segment episodes.

13. The system according to claim 1 wherein the preventive stimulation is delivered in time segments preferably ranging between about 10 seconds and about 60 minutes, and preferably between about 1 minute and about 20 minutes.

14. The system according to claim 1 wherein the preventive stimulation has a frequency of about 0.1 Hz to about 2500 Hz.

15. The system according to claim 3 wherein the preventive stimulation is cathodal direct current delivered into the patient'"'"'s brain by the targeting sub-system to a location adjacent the abnormal electrical activity.

16. The system according to claim 1 wherein the at least one electrode comprises an array of electrodes.

17. The system according to claim 1 wherein the at least one electrode has at least one outer conductive element and a central conductive element with the at least one outer conductive element forming a concentric configuration about the central conductive element.

18. The system according to claim 1 wherein the responsive stimulation has a frequency of about 0.1 Hz to about 2500 Hz

19. The system according to claim 1 wherein the preventive stimulation has a first frequency and the responsive stimulation has a second frequency.

46. The system according to claim 1 wherein the at least one electrode is located beneath the patient'"'"'s scalp.

47. The system according to claim 1 wherein the control module is carried by a container of conductive material, implantable in a patient'"'"'s body.

48. The system according to claim 47 wherein the at least one electrode is located beneath the patient'"'"'s scalp.

20. A method for treating neurological disorders in a patient, comprising the steps of

positioning at least one electrode outside the patient'"'"'s brain;

detecting electrical activity within the brain consistent with a neurological event;

analyzing the neurological event to determine whether the neurological event is abnormal;

delivering an electrical responsive stimulation into the patient'"'"'s brain through the at least one electrode in response to an abnormal neurological event; and

delivering an electrical preventive stimulation into the patient'"'"'s brain, independent of analyzing the neurological event, so as to alter the onset of the neurological event within the patient'"'"'s brain.

21. The method of claim 20 further comprising the step of localizing the location of the neurological event within the brain of the patient.

22. The method of claim 21 further comprising the step of targeting the location of the neurological event for electrical responsive stimulation by the at least one electrode.

23. The method of claim 21 further comprising the step of targeting the location of the neurological event for electrical preventive stimulation by the at least one electrode.

24. The method of claim 23 wherein the electrical preventive stimulation comprises cathodal direct current.

25. The method of claim 20 further comprising the step of analyzing electrical activity within the brain to determine if the patient is treatable with said preventive stimulation.

26. The method of claim 20 wherein the electrical preventive stimulation comprises direct current.

27. The method of claim 20 wherein the electrical preventive stimulation comprises biphasic alternating current.

28. The method of claim 20 wherein the electrical preventive stimulation comprises monophasic alternating current.

29. The method of claim 20 wherein the electrical preventive stimulation is delivered constantly.

30. The method of claim 20 wherein the electrical preventive stimulation is delivered recurrently.

31. The method of claim 20 wherein the electrical preventive stimulation is delivered in time segment episodes.

32. The method of claim 20 wherein the electrical preventive stimulation is delivered in time segments preferably ranging between about 10 seconds and about 60 minutes, and more preferably between about 1 minute and about 20 minutes.

33. The method of claim 20 wherein the electrical preventive stimulation has a frequency of about 0.1 Hz to about 2500 Hz.

34. The method of claim 20 wherein the electrical responsive stimulation comprises anodal direct current.

35. The method of claim 20 wherein the electrical preventive stimulation comprises cathodal direct current.

36. A system for the treatment of neurological disorder in a patient, comprising:

a plurality of electrodes arranged in an array adapted for placement outside the brain of a patient to sense the patient'"'"'s electrical brain activity;

a power supply;

a control module operatively coupled to the power supply and including a switching sub-system operatively coupling the control module to the plurality of electrodes;

the switching module selecting electrodes among the plurality of electrodes so as to switch selected electrodes between first and second patterns about the patient'"'"'s brain without altering the placement of the plurality of electrodes; and

the control module further including an analysis sub-system to analyze the electrical activity sensed by the selected electrodes.

37. The system according to claim 36 wherein the control module further comprises a stimulation sub-system operatively controlled by the control module to deliver an electrical stimulation into the patient'"'"'s brain through the selected electrodes.

38. The system according to claim 36 wherein the control module further comprises a localizing sub-system to localize the source of the electrical activity.

39. The system according to claim 37 wherein the control module further includes a targeting sub-system for targeting electrical stimulation for delivery into a selected area of the brain.

40. The system according to claim 39 wherein the stimulation sub-system responds to the targeting sub-system to deliver targeted electrical stimulation into a selected area of the brain.

41. A method for treating neurological disorders in a patient, comprising the steps of:

positioning a plurality of electrodes arranged in an array, outside the patient'"'"'s brain;

detecting electrical activity within the brain;

providing a power supply;

operatively coupling a control module to the power supply;

coupling the control module to the plurality of electrodes through a switching sub-system;

selecting electrodes among the plurality of electrodes with the switching module;

switching the selected electrodes with the switching module between first and second preselected patterns about the patient'"'"'s brain, without altering the placement of the plurality of electrodes; and

analyzing the electrical activity sensed by the selected electrodes.

42. The method according to claim 41 further comprising the step of localizing the source of the electrical activity.

43. The method according to claim 42 further comprising the step of delivering an electrical stimulation into the patient'"'"'s brain through the selected electrodes.

44. The method according to claim 42 further comprising the step of targeting stimulation for delivery to the patient'"'"'s brain adjacent the source of the electrical activity.

45. The method according to claim 44 further comprising the step of delivering targeted electrical stimulation into a selected area of the patient'"'"'s brain.