Patent No. US12336826 (titled "Methods And Apparatus For Electrode Placement And Tracking") was filed by Ceribell Inc on Dec 28, 2021.
’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.
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.
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.
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.
Definitions of key terms used in the patent claims.
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