Method for the detection and treatment of aberrant neural-electric activity

• US 8,467,877 B2
• Filed: 11/21/2011
• Issued: 06/18/2013
• Est. Priority Date: 01/26/2009
• Status: Expired due to Fees

• Current Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Original Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Inventors: Imran, Mir
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US13/301,584
• Publication Number:
  US 20120157963A1
• Time in Patent Office: 575 Days
• Field of Search: 607/3, 607/45
• US Class Current: 607/45
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• 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 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

An apparatus for detection of ANEA comprising an introducer having at least one lumen. The introducer is introduced into brain tissue through an opening in the skull. A reference electrode is positioned at an introducer distal portion. A plurality of electrode members are advanceable within the at least one lumen with each member having an insulated portion and an exposed distal portion. The members have a non-deployed state in the introducer and a deployed state when outwardly advanced out of the introducer. In the deployed state, the members are substantially orthogonal to each other with the exposed distal portions defining a detection volume capable of determining an electric field vector produced by the ANEA and the direction of foci of the ANEA.

Claims

1. A method for detecting and treating aberrant neural-electric activity (ANEA) in a brain of a patient causing an epileptic pre-seizure event or a seizure event, the method comprising:

positioning, at least partially in the brain or skull, three electrode members, wherein each electrode member defines a different orthogonal axis of a Cartesian coordinate system;

detecting, from inside the brain or skull, an electric field caused by ANEA in the brain wherein the electric field is detected using the Cartesian coordinate system defined by the three electrode members;

determining an electric field vector characteristic from the detected electric field;

interpreting the electric field vector characteristic as being a marker to the epileptic pre-seizure event or seizure event; and

delivering a dose of anti-seizure medication to the patient'"'"'s brain in response to the interpreted marker to the epileptic pre-seizure event or seizure event.

2. The method of claim 1, wherein the delivered medication is in a solid form.

3. The method of claim 1, wherein the medication is delivered to prevent an onset of a seizure.

4. The method of claim 1, wherein the medication is delivered to stop or reduce a duration of a seizure in process.

5. The method of claim 1, wherein the medication is delivered intracranially.

6. The method of claim 5, wherein the medication is delivered through an opening in the skull.

7. The method of claim 6, wherein the medication is delivered through a burr hole opening in the skull.

8. The method of claim 5, wherein the medication is delivered from a drug delivery device positioned outside of the skull.

9. The method of claim 1, wherein the medication comprises a loop diuretic.

10. The method of claim 9, wherein the loop diuretic comprises furosemide.

11. The method of claim 1, wherein the medication comprises phenytoin sodium.

12. The method of claim 1, wherein the dose of medication is titrated based on the type of event interpreted from the electric field vector characteristic.

13. The method of claim 1, wherein the dose of medication is titrated based on at least one of a patient'"'"'s weight, age or type of epilepsy.

14. The method of claim 1, wherein a medication dosing regimen is selected based on a type of event interpreted from the electric field vector.

15. The method of claim 14, wherein the type of event is a pre-seizure event and a bolus dose of medication is given.

16. The method of claim 14, wherein the type of event is a seizure event and a bolus dose of medication is given followed by a maintenance dose.

17. The method of claim 16, wherein the bolus dose is given intracranially.

18. The method of claim 16, wherein the maintenance dose is given intravenously.

19. The method of claim 1, wherein the electric field vector characteristic is assigned a score predictive of a pre-seizure or seizure event.

20. The method of claim 19, wherein the dose of anti-seizure medication is titrated based on the assigned score.

21. The method of claim 19, wherein a medication dosing regimen is selected based on the assigned score.

22. The method of claim 21, wherein a plurality of assigned scores are determined over a period of time and the medication dosing regimen is based on the plurality of assigned scores.

23. The method of claim 1, further comprising:

monitoring the patient'"'"'s brain activity after the delivery of a dose of anti-seizure medication to determine if the pre-seizure event or seizure event has subsided.

24. The method of claim 23, further comprising:

administering another dose of anti-seizure medication based on the monitored brain activity.

25. The method of claim 24, wherein the subsequent dose of anti-seizure medication is titrated based on the monitored brain activity.

26. The method of claim 1, further comprising:

in response to the detected marker, delivering an electrical inhibitory signal to the brain to prevent an occurrence of a seizure or shorten its duration.

27. The method of claim 26, wherein the electrical inhibitory signal is delivered before the delivery of the anti-seizure medication.

28. The method of claim 1, wherein the electric field is detected by measuring voltages in the brain produced by the electric field.

29. The method of claim 1, wherein detecting the electric field includes deploying a plurality of electrodes into the brain in an orientation that defines a span or volume in which the electric field is monitored.

30. The method of claim 29, wherein deploying a plurality of electrodes includes deploying at least three electrodes.

31. The method of claim 30, wherein the at least three electrodes have a substantially orthogonal orientation with respect to a longitudinal axis of each electrode.

32. The method of claim 1, wherein the electric field vector characteristic is a dwelling of a direction of the vector characteristic in a directional region for an extended period of time.

33. The method of claim 32, wherein the period of time is from about 0.1 to 2 seconds.

34. The method of claim 1, wherein the electric field vector characteristic is a magnitude or time averaged magnitude of the electric field vector characteristic exceeding a threshold for an extended period of time.

35. The method of claim 34, wherein the extended period of time is from about 0.1 to 2 seconds.

36. The method of claim 34, wherein the threshold includes a first threshold for the pre-seizure event and a second threshold for the seizure event.

37. The method of claim 1, wherein the electric field vector characteristic is a combination of a dwelling of the direction of the vector in a directional region for an extended period of time and a magnitude of the vector exceeding a threshold for an extended period of time.