EEG electrode and EEG electrode locator assembly

Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...

Reexamination Certificate

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C600S393000, C600S397000, C607S139000, C607S153000

Reexamination Certificate

active

06640122

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to devices for the acquisition of electroencephalographic (EEG) signals, and more particularly concerns an EEG electrode and an EEG electrode locator assembly that can be applied by a user in combination with an EEG electrode locator headgear without assistance, for acquiring high quality EEG signals.
2. Description of Related Art
Advances in detection and characterization of electroencephalographic (EEG) signals from the brain have allowed EEG monitoring to be useful in analysis of neurological and sleep disorders, and laboratory studies of vigilance. Recent advances have, for example, provided much information about the correlation between EEG signals and an individual's level of arousal, in a continuum from vigilance to drowsiness, and sleep onset. Shifts in EEG signals have been directly correlated with changes in performance, particularly during tasks which require sustained attention over prolonged periods of time. Devices for monitoring EEG signals are typically used in a laboratory environment or in a home for sleep studies, but are typically set up and operated by trained technicians. However, application of EEG monitoring to environments for study and monitoring of brain performance, such as for monitoring brain activity in the home, office, aircraft cockpit, and train or truck operations cabins, for example, has been severely hampered by cumbersome detection and recording equipment, and the need for the assistance of a technician typically required to obtain high quality data.
In fitting EEG electrodes to the scalp of a subject being monitored, an EEG technician will typically first measure the distances between the nasium and the occipital bone, and between the mastoid processes, to identify the top center (Cz) of the head, and will then position all other electrodes relative to these landmarks to comply with the International 10/20 System that is well known in the art as the standard for positioning of EEG electrodes. The technician will then part the hair of the scalp of the subject at the intended electrode sites, clean the electrode sites to remove dirt, hair oil, and the like, and prepare the scalp to remove the top layer of dead skin, to ensure that scalp-electrode impedance values of less than 5 k&OHgr; are obtained. The minimum level of impedance needed to minimize EEG artifact is dependent, in part, on the quality of the EEG amplifiers. Filtering certain environmental noises, such as 60 Hz interference, allows acceptable EEG signals to be acquired with impedance levels up to 100 k&OHgr;. Other artifacts are magnified as the impedances increase unless the signal acquisition equipment has been designed to minimize these effects. For example, replacing a conventional EEG system which uses wires to transmit non-amplified EEG to the data acquisition/storage unit with a system that amplifies and digitizes the signals on the head will help to reduce movement artifacts. Maintaining sufficient downward pressure on an electrode with higher impedance values will minimize the contribution of artifacts resulting from the electrode sliding across hair or the scalp.
Conventionally, after preparation of the intended electrode sites on the scalp, electrodes are glued to the scalp with collodion, typically a viscous solution of pyroxilin, a commercially available nitrocellulose, in ether and alcohol, that is a particularly noxious preparation that can bond with the scalp and hair, to provide a stable scalp-electrode interface, until dissolved by a solvent such as acetone, or a non-acetone, oil based collodion remover.
A variety of hats, caps, helmets and headgear are known that have been developed to position EEG electrodes according to the International 10/20 System and provide a scalp-electrode interface without the use of an adhesive such as collodion. However, these types of devices still require technician assistance in the preparation of the electrode site, and are commonly uncomfortable and unacceptable for use during activities of work and daily living. One such sleep monitoring headgear utilizes a circumferential elastic headband to generate an electrode seating pressure for a single electrode located at the top center of the head of a subject. It has been found, however, that when such a circumferential elastic headband is utilized to seat multiple electrodes, the headband slides up and posteriorly on the forehead.
Such conventional hats, caps, helmets and headgear also typically make it difficult for a user to part the hair or abrade their scalp at the electrode site without assistance. For example, most of the electrode caps require a technician to abrade the scalp with a blunt tipped syringe and then inject conductive gel into the electrode embedded into the cap. Another conventional device requires the technician to lift or turn a disposable electrode on its side after a conductive gel on the electrode has made contact with the hair of the scalp, in order to part the hair at the intended area of the scalp for placement of the electrode. Several systems intended for use in the laboratory for non-ambulatory EEG monitoring dispense electrode gel to the electrode, but would make an EEG electrode locator headgear uncomfortably heavy and inconvenient for ambulatory use outside a laboratory environment. Another type of device utilizes sharp tipped metal points to penetrate the dead layer of skin. However, such sharp metal points can pose a medical danger due to the potential for infection, particularly with repeated abrasions, and the possibility of penetration of the skull if the device were to be struck accidentally during ambulatory activity, or other activities during daily living.
It would therefore be desirable to provide an EEG electrode and an EEG electrode locator assembly for use in combination with an EEG electrode locator headgear that allows the user to apply the electrodes at the electrode sites, permitting conventional scalp preparation techniques to be applied by the user without technical assistance. The present invention meets these needs.
SUMMARY OF THE INVENTION
Briefly, and in general terms, the present invention provides for an EEG electrode and an EEG electrode assembly for use in combination with an EEG electrode locator headgear for a user that allows the user to locate and apply the EEG electrodes accurately according to the International 10/20 System without technical assistance, to allow the acquisition of high quality EEG signals. The EEG electrode locator headgear is of the type that is portable and comfortable, allowing it to be worn by the user during daily activities as one would a cap or visor. The EEG locator headgear typically includes a plurality of locator straps connectable to one or more of the EEG electrode locators that form an electrode locator assembly with the EEG electrode for accurately positioning one or more of the EEG electrodes relative to the user's scalp, and for biasing the plurality of electrodes toward the user's scalp. Each EEG electrode is adapted to be received in and cooperate with a corresponding EEG electrode locator ring. Each EEG electrode includes a dispenser assembly adapted to dispense an electrically conductive gel through the user's hair onto the user's scalp. The dispenser assembly includes a base member for conducting EEG signals from the scalp of the user to a corresponding electrode locator ring for signal transmission to an EEG monitor.
The invention accordingly provides for an electroencephalograph (EEG) electrode locator assembly for use in combination with an EEG electrode locator headgear for accurate positioning of the EEG electrode locator assembly on the scalp of a user. In a presently preferred embodiment, the EEG electrode assembly comprises an EEG electrode locator member adapted to be mounted to EEG electrode locator headgear; and an EEG electrode received in and removably electrically coupled to the EEG electrode locator headgear. The EEG electrode includes an electricall

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