EEG kit

• US 9,408,575 B2
• Filed: 10/29/2011
• Issued: 08/09/2016
• Est. Priority Date: 04/29/2009
• Status: Active Grant

• Current Assignee: BSG Corp.
• Original Assignee: Bio-Signal Group Corp.
• Inventors: Bordoley, Mordechai, Chudy, Paul A., Donnett, James G., Omurtag, Ahmet, Abdel Baki, Samah G., Fenton, Andre A.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TRAN, THO Q
• Application Number:
  US13/284,886
• Publication Number:
  US 20120143020A1
• Time in Patent Office: 1,746 Days
• Field of Search: 600/544, 600/545
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/01 Emergency care
• CPC Class Codes: A61B 2560/0285 Apparatus for single use
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/1114 Tracking parts of the body
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period

Abstract

An EEG kit can be thought of as “EEG In a Bag” (“EEG-IAB”). The EEG kit can provide a complete, disposable, fast, and easily-used platform to record EEG to measure brain activity. Other physiological information (e.g., oxygen saturation, ECG or EKG, etc.) or other information (e.g., local electrode motion) can also be recorded, such as in time-concordance with the recorded EEG signals. The recorded EEG and other information can be uplinked to a local or remote user interface. A local or remote neurologist can use the EEG information to render a diagnosis in tens of minutes, wherein such information can currently be unavailable, or can require a number of hours to obtain and diagnose. The EEG kit can be very convenient, and can be used in a hospital emergency department (ED), an intensive care unit (ICU), by a first responder, or can be deployed for emergency or disaster preparedness.

Claims

1. An apparatus comprising an electroencephalographic (EEG) monitoring kit comprising a kit package comprising:

an EEG recording module, configured to be worn on a head of a patient, the EEG recording module comprising a memory configured for recording a plurality of EEG signals from the patient;

a headpiece, sized and shaped to be worn on the head of the patient, the headpiece comprising a plurality of non-surgically implanted scalp-wearable electrode assemblies that are configured to be electrically connected to the EEG recording module;

an electrical connector cable, having a length that is less than 50 centimeters, the cable configured to couple the EEG recording module to the headpiece, when both the EEG recording module and the headpiece are worn on the head of the patient, to communicate the EEG signals from the electrode assemblies to the EEG recording module; and

a fluid-impervious single-use cover, configured to be directly or indirectly mounted to the headpiece or to the head of the patient, the cover sized or shaped to carry the EEG recording module within the cover and configured to permit the cable to extend Out from the cover to the headpiece, wherein the cover comprises a flexible plastic pouch comprising an adhesive seal, configured to seal the EEG recording module within the pouch with the cable extending out from the pouch, and wherein the pouch is configured with a tear strength that is less than an adhesion strength of the adhesive seal such that opening the sealed pouch to remove the EEG recording module from the pouch requires tearing of the pouch and thereby renders the pouch unsuitable for subsequent use with the EEG recording module.

2. The apparatus of claim 1, wherein the cover comprises a pouch that comprises a mount, configured to directly or indirectly mount the pouch to the headpiece or the head of the patient.

3. The apparatus of claim 2, wherein the EEG kit package comprises a headband, sized or shaped to be worn directly or indirectly about the head of the patient, and wherein the pouch comprises the mount including a sleeve that is sized or shaped to pass the headband through the sleeve for mounting the pouch for being worn directly or indirectly about the head of the patient.

4. The apparatus of claim 3, wherein the headband includes an elastic portion to allow stretching of the headband.

5. The apparatus of claim 4, wherein the headband further includes an additional length adjustment feature beyond the stretching.

6. The apparatus of claim 5, wherein the additional length adjustment feature includes a series of spaced-apart affixation tabs located on the headband.

7. The apparatus of claim 1, wherein the headpiece comprises a head-receiving configuration of support members, the configuration of support members carrying a plurality of electrode assemblies that are electrically connected to the EEG recording module and that respectively ride along a respective position adjustment track so as to be capable of being individually relocated by a user from a first location on the patient'"'"'s head to a different second location on the patient'"'"'s head while the headpiece is in place on the patient'"'"'s head.

8. The apparatus of claim 1, wherein at least one of the electrode assemblies comprises a plunger, configured to allow user-adjustment of an electrode toward a scalp of the patient, and wherein the plunger is configured to rupture a seal to allow user-actuated release of an at least somewhat flowable conductive substance toward a skin-electrode interface to assist in obtaining electrical conduction at the skin-electrode interface.

9. The apparatus of claim 1, wherein each one of the electrode assemblies comprises a respective accelerometer attached to that one of the electrode assemblies and wherein the EEG recording module further comprises a signal processor circuit coupled to the accelerometers, the signal processor configured to permit detecting relative movement of that particular one of the electrode assemblies beyond global motion of the patient'"'"'s head or body.

10. The apparatus of claim 1, wherein the EEG recording module comprises an impedance test circuit, configured to measure a skin-electrode impedance of an individual electrode configured to provide an EEG signal.

11. The apparatus of claim 1, comprising a user interface, configured to be capable of being communicatively coupled to the memory of the EEG recording module and configured to receive information from the recorded plurality of EEG signals, and wherein the user interface includes or is configured to be coupled to a camera to obtain images of the patient to be stored in concordance with the plurality of EEG signals.

12. The apparatus of claim 1, wherein the EEG recording module includes a non-EEG physiological sensor interface configured to receive at least one non-EEG physiological signal, and wherein the EEG recording module is configured to record the non-EEG physiological signal in concordance with the plurality of EEG signals.

13. The apparatus of claim 1, wherein the headpiece includes a local position monitor configured to monitor the position of at least one of the electrode assemblies and to provide an indication of the position of the monitored at least one electrode assembly to the memory of the EEG recording module for recording.

14. The apparatus of claim 1, further comprising an adjunct computing device, capable of being communicatively coupled to the memory of the EEG recording module and configured to receive information from the recorded plurality of EEG signals, and wherein the adjunct computing device includes or is configured to be coupled to processor configured to perform seizure detection using information from the recorded plurality of EEG signals.

15. The apparatus of claim 14, wherein the adjunct computing device is configured to be communicatively coupled to a plurality of EEG recording modules.

16. The apparatus of claim 15, wherein the adjunct computing device includes or is coupled to a memory circuit including instructions that, when performed by a processor circuit of the adjunct computing device, analyzes EEG signals from the plurality of EEG recording modules associated with different patients to permit prioritizing patients for further attention.

17. The apparatus of claim 14, wherein the adjunct computing device includes or is coupled to a memory circuit that is configured to record a measure of performance of a plurality of human reviewers.

20. The apparatus of claim 1, wherein the flexible plastic pouch comprises a polyethylene bag.

21. The apparatus of claim 1, wherein the flexible plastic pouch comprises a single-use transfer adhesive seal.

22. The apparatus of claim 21, wherein the single-use transfer adhesive seal includes a peel-away liner configured to be removed by an end-user to expose the adhesive of the adhesive seal.

23. The apparatus of claim 22, wherein the adhesive material includes an adhesion characteristic that prevents re-sealing after unsealing.

24. The apparatus of claim 1, wherein the pouch is flexible enough to allow insertion of the electronics unit into the pouch through an open end of the pouch that is capable of then being closed and sealed using the adhesive seal.

18. An apparatus comprising an electroencephalographic (EEG) monitoring kit comprising a kit package comprising:

an EEG recording module, configured to be worn on a head of a patient, the EEG recording module comprising a memory configured for recording a plurality of EEG signals from the patient;

a headpiece, sized and shaped to be worn on the head of the patient, the headpiece comprising a plurality of non-surgically implanted scalp-wearable electrode assemblies that are configured to be electrically connected to the EEG recording module;

an electrical connector cable, having a length that is less than 50 centimeters, the cable configured to couple the EEG recording module to the headpiece, when both are worn on the head of the patient, to communicate the EEG signals from the electrode assemblies to the EEG recording module;

a fluid-impervious single-use cover, configured to be directly or indirectly mounted to the headpiece or to the head of the patient, the cover sized or shaped to carry the EEG recording module within the cover and configured to permit the cable to extend out from the cover to the headpiece, wherein the cover comprises a flexible plastic pouch comprising an adhesive seal, configured to seal the EEG recording module within the pouch with the cable extending out from the pouch, wherein the pouch is configured with a tear strength that is less than an adhesion strength of the adhesive seal such that opening the sealed pouch to remove the EEG recording module from the pouch requires tearing of the pouch and thereby renders the pouch unsuitable for subsequent use with the EEG recording module, wherein the pouch comprises a mounting sleeve, configured to directly or indirectly mount the pouch to the headpiece or the head of the patient; and

a headband, including a stretchable elastic portion, the headband sized or shaped to be worn directly or indirectly about the head of the patient, and wherein the mounting sleeve of the pouch is sized or shaped to pass the headband through the sleeve for mounting the pouch for being worn directly or indirectly about the head of the patient.

19. The apparatus of claim 18, wherein each one of the electrode assemblies comprises a respective accelerometer attached to that one of the electrode assemblies and wherein the EEG recording module further comprises a signal processor circuit coupled to the accelerometers, the signal processor configured to permit detecting relative movement of that particular one of the electrode assemblies beyond global motion of the patient'"'"'s head or body;

and

wherein the EEG recording module comprises an impedance test circuit, configured to measure a skin-electrode impedance of an individual electrode configured to provide an EEG signal.