Minimally Invasive Subgaleal Extra-Cranial Electroencephalography EEG Monitoring Device

• US 20180117331A1
• Filed: 11/03/2016
• Published: 05/03/2018
• Est. Priority Date: 11/03/2016
• Status: Active Application

• Current Assignee: New York University
• Original Assignee: New York University
• Inventors: KUZNIECKY, Ruben I., Doyle, Werner K., Pacia, Steve, Friedman, Daniel
• Application Number:
  US15/342,873
• Publication Number:
  US 20180117331A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• 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 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/37514 Brain implants

Abstract

A system includes an implantable body configured for implantation in a subgaleal extracranial position, the implantable body including a first electrode array including a first elongated body comprising first and second electrode contacts separated from one another by a distance selected to facilitate the detection of brain electrical activity and a unit coupled to the first electrode array. The unit includes a processor analyzing the detected brain electrical activity to determine whether an epileptic event has occurred and generating epileptic event data based on this determination and a transceiver controlled by the processor to wirelessly transmit epileptic event data to and from a remote computing device.

Claims

1. A unitary implantable device comprising:

an elongated implantable body configured for implantation at or near a cranial vertex in a subgaleal extracranial space of a patient;

a first and a second electrode contacts separated from one another by a distance selected to form a single channel for detection of brain electrical activity;

a processor analyzing the detected brain electrical activity to determine whether a change in brain state has occurred and generating brain state data based on this determination; and

a transceiver controlled by the processor to wirelessly transmit epileptic event data to and from a remote computer.

2. The device of claim 1, wherein the processor is configured to continuously analyze the brain electrical activity.

3. The device of claim 1, wherein the change in brain state is an epileptic event, and the brain state data comprises epileptic event data.

4. The device of claim 1, wherein the implantable body includes a central axis bisecting the length of the implantable body, the first electrode contact being positioned proximal of the central axis and the second electrode contact being positioned distal of the central axis.

5. The device of claim 3, wherein the first and second electrode contacts are separated by a distance selected to form a single channel for detection of ictal activity with a signal to noise ratio of at least 1.1 to 1.

6. The device of claim 1, wherein the first and second electrode contacts are separated by a distance from about 1 cm to about 10 cm.

7. The device of claim 1, further comprising a memory coupled to the processor, the memory configured to store brain state data.

8. The device of claim 1, wherein the implantable body further comprises a battery.

9. The device of claim 1, wherein the device is configured for implantation in vivo for a period of at least 3 days

10. The device of claim 1, wherein the elongated implantable body comprises a housing hermetically sealed around the device.

11. The device of claim 1, wherein the implantable body includes a reinforced portion.

12. The device of claim 11, wherein the implantable body has a curved shape corresponding to a mean curvature of a human skull.

13. A method for capturing brain wave data, comprising:

inserting, using a minimally invasive surgical technique, an implantable body into a subgaleal extracranial position at or near a cranial vertex of a patient, the implantable body positioned along a cranial surface at least 1 cm away from the temporalis muscles of the patient, and so that first and second electrode contacts of a first electrode array of the implantable body face the cranium;

detecting brain electrical activity via a single channel formed by the first and second electrode contacts;

monitoring and analyzing, via a processor, the brain electrical activity to detect epileptic events; and

transmitting epileptic event data corresponding to a detected epileptic event to one of a remote computer, local computer, local base station, cellular phone, portable tablet, personal computing device and cloud storage.

14. The method of claim 13, wherein the change in brain state is an epileptic event, and the brain state data comprises epileptic event data.

15. The method of claim 13, wherein the incision is less than 5 cm.

16. The method of claim 13, wherein the implantable body is inserted at an angle between 0 to 90°

to the anterior posterior head axis of the patient.

17. The method of claim 13, wherein the implantable body includes a central axis bisecting the length of the implantable body, the first electrode contact being positioned proximal of the central axis and the second electrode contact being positioned distal of the central axis.

18. The method of claim 14, wherein the first and second electrode contacts are separated by a distance selected to form a single channel for detection of ictal activity with a signal to noise ration of at least 1.1 to 1.

19. The method of claim 14, further comprising:

administering an anti-seizure treatment to the patient when the processor detects ictal activity.

20. The method of claim 14, wherein the implantable body remains in vivo for a period of at least 3 days.