Methods And Apparatus For Electrode Placement And Tracking

Patent No. US12336826 (titled "Methods And Apparatus For Electrode Placement And Tracking") was filed by Ceribell Inc on Dec 28, 2021.

What is this patent about?

’826 is related to the field of electroencephalography (EEG) and more specifically to electrode placement systems. The patent addresses the problem of efficiently and reliably placing EEG electrodes on a patient's scalp, particularly in the presence of hair, without requiring extensive skin preparation or specialized training. Traditional EEG electrode placement can be time-consuming and require conductive gels, which can be messy and ineffective when hair is present.

The underlying idea behind ’826 is to provide an electrode carrier system, such as a headband, with integrated electrodes that can deliver a conductive fluid or gel through tubular members directly to the scalp. These tubular members are designed to penetrate hair and make contact with the skin. The system also incorporates features like reservoirs for the conductive fluid, and in some embodiments, mechanisms for abrading the skin to improve electrical contact.

The claims of ’826 focus on a headband with multiple electrode assemblies. Some of these assemblies have an upper part with a reservoir of conductive gel and a lower part that can rotate. This lower part has at least one elongated piece with a surface that touches the skin, a hole at the end, a hollow space, and a skin preparation surface. The electrode is designed to release the conductive gel from the reservoir through the hole and the hollow space. Other electrode assemblies on the headband do not have an elongated piece.

In practice, the headband is placed on the patient's head, and the tubular members of the electrode assemblies penetrate the hair to contact the scalp. The user can then press a plunger or otherwise actuate the reservoir to dispense the conductive fluid or gel through the tubular members, establishing an electrical connection between the scalp and the electrode. The ability to rotate the electrode assemblies allows for gentle abrasion of the skin, further enhancing contact.

’826 differentiates itself from prior approaches by integrating the electrode, conductive gel reservoir, and delivery mechanism into a single unit, often mounted on a headband. This allows for faster and easier electrode placement compared to traditional methods that require manual application of conductive gels. The use of tubular members facilitates contact through hair, eliminating the need for shaving or extensive hair removal. The optional skin abrasion feature further improves the reliability of the electrical connection.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’826 was filed, EEG systems were typically implemented using wired connections to external processing units. At a time when hardware or software constraints made real-time signal processing on low-power wearable devices non-trivial, systems commonly relied on off-line analysis or tethered processing units rather than fully integrated, wireless solutions. The application of conductive gels to ensure adequate electrical contact between electrodes and the scalp was a standard practice, but also a time-consuming and skill-dependent process.

Novelty and Inventive Step

The examiner allowed the claims because prior art references such as Levendowski, Bordoley, Manoli, and Dickson, failed to teach a specific combination of features. Specifically, these references did not disclose an electrode assembly with both an upper body portion containing a conductive fluid reservoir and a lower body portion that is rotatably mounted to a backing, includes an elongate member with a tissue-contacting surface, a lumen with a distal opening, a recess, and a skin preparation surface. Furthermore, these references did not disclose an electrode assembly configured to deliver conductive fluid from the reservoir through the lumen, recess, and distal opening, while also having another electrode assembly without an elongate member. The examiner found no motivation to combine the prior art references to arrive at the claimed invention.

Claims

This patent contains 18 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a headband with electrode assemblies for placement on a patient's head, where some electrode assemblies have an elongate member with a lumen for delivering conductive fluid or gel, and others do not. The dependent claims generally elaborate on the features of the headband and its components, such as the dimensions, materials, shape, and surface properties of the elongate member, as well as the inclusion of conductive wires and a controller for recording EEG signals.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Electrically conductive fluid or gel
(Claim 1)
“The reservoir in the electrode body which contains the conductive fluid or gel will preferably be sealed to preserve the fluid or gel and allow the long-term storage of an electrode assembly which has been pre-filled with the electrically conductive fluid or gel. In specific embodiments, the reservoir will have a sealed dispensing container within the reservoir which may be incorporated into the electrode assembly during the initial manufacture thereof. For example, the sealed dispensing container may comprise a sealed dispensing container, e.g. a packet, which is constrained within a chamber in the electrode body, where the electrode body comprises a plunger configured to be manually pressed against the sealed dispensing container to deliver the electrically conductive fluid or gel from the sealed dispensing container through the lumen(s) and out of the distal opening(s) of the tubular member(s).”A fluid or gel contained within a reservoir in the upper body portion of the electrode assembly, capable of conducting electrical signals. It is delivered through the lumen and distal opening of the elongate member to establish electrical contact with the patient's skin.
Elongate member
(Claim 1)
“As further used herein, the phrase “tubular member” will mean a generally elongated structure, i.e. having a length extending away from the bottom of the electrode body greater than its width parallel to the bottom of the electrode body, where the width is measured at its narrowest point. Usually, the length will be at least twice the width, frequently being at least three times the width. Exemplary tubular members may have generally circular horizontal peripheries (in a plane parallel to the bottom of the electrode body) making them generally cylindrical along a vertical axis.”A structure extending from the lower body portion of the electrode assembly, having a lumen with a distal opening. It facilitates the delivery of conductive fluid or gel to the skin and penetrates hair.
Rotatably mounted
(Claim 1)
“The systems of the present invention may further comprise the controller and/or output device configured to receive the low current biological signal from the electrode assemblies. Additionally, the controller may be configured to output a response corresponding to the electrical signals from the electrode assemblies. In preferred embodiments, the distal tips of at least some of the tubular members will define a tissue-roughening or other skin preparation surface and at least some of the electrode assemblies will be movably, e.g. rotatably, mounted on the elongated backing to allow a user to sweep or scrub the tissue-engaging surfaces of the assemblies over target tissue surface(s) to a abrade the tissue surface to enhance electrical contact.”The lower body portion of the electrode assembly is attached to the backing in a manner that allows it to rotate, enabling the tissue-contacting surface to be swept or scrubbed over the skin.
Skin preparation surface
(Claim 1)
“In other specific embodiments of the present invention, the distal tips of at least some of the tubular members will have a skin preparation, e.g. tissue-roughening, surface. For example, the tissue-roughening surface may comprise an abrasive material, such as a grit or other abrasive particles, formed over at least a portion of the distal tip of the tubular member. In other instances, the surface-roughening may comprise surface features, such as ridges, bumps, grooves, and the like, formed over at least a portion of the distal tip which contacts the patient's skin.”A feature on the tissue-contacting surface of the elongate member designed to improve electrical contact with the skin, potentially through abrasion or chemical treatment.
Tissue-contacting surface
(Claim 1)
“In particular, a distal skin-contacting surface of the electrode assembly may be modified to prepare the skin surface to enhance electrical conductance (i.e. lower electrical resistance) between an electrically conductive portion of the electrode assembly and the skin when that electrically conductive portion is in physical contact with the skin. For example, the tissue-contacting surface(s) of the electrode assembly may be modified to have an abrasive surface, e.g. by coating with abrasive particulate; may be formed or molded to have protruding rigid features, e.g. bumps, ridges, or the like; and/or may be coated with a material that lowers the electrode connection impedance. Such sweeping and/or chemical coating of the tissue-contacting surface(s) of the electrode assembly over the target tissue location could scrub, dissolve and/or otherwise disrupt dead tissue and break-up scalp oil.”The surface of the elongate member that comes into direct contact with the patient's tissue (e.g., scalp). It includes a recess and a skin preparation surface to enhance electrical conductance.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00832Jul 7, 2025Ceribell, Inc. V. Natus Medical Incorporated

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US12336826

CERIBELL INC
Application Number
US17564135
Filing Date
Dec 28, 2021
Status
Granted
Expiry Date
Feb 22, 2037
External Links
Slate, USPTO, Google Patents