Electrode-based systems and devices for interfacing with biological tissue and related methods
Inventors
Clements, Isaac Perry • Harrison, Anna • Brown, Edgar • Preyer, Amanda • Ross, James David • Willsie, Andrew • Sonntag, Maximilian
Assignees
Publication Number
US-11612344-B2
Publication Date
2023-03-28
Expiration Date
2039-11-04
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Abstract
Systems, devices, and methods for interfacing with biological tissue are described herein. An example electrode patch as described herein includes a flexible substrate and an electrode array arranged on the flexible substrate. The electrode array includes a plurality of electrodes, where each of the plurality of electrodes is formed of a hydrogel. Additionally, each of the plurality of electrodes defines a raised geometry. Additionally, an example system includes the electrode patch, which is configured to interface with a subject's skin, and an electronics module operably coupled to the electrode array.
Core Innovation
The invention provides systems, devices, and methods for interfacing with biological tissue, specifically featuring an electrode patch comprised of a flexible substrate and an electrode array. The electrode array consists of multiple independently addressable electrodes, each formed at least partially from a hydrogel and defining a raised geometry that is configured to closely contact or push into a patient's skin. The electrodes extend beyond the outermost plane of the patch such that the hydrogel is in direct and uninterrupted contact with the skin, with no material interposed.
The problem addressed by the invention is the challenge of accurately and reproducibly positioning electrodes for the stimulation and recording of electrical activity from electroactive tissues, such as nerves and muscles. Traditional methods rely on flat metal or gel disc electrodes, which make accurate placement difficult due to anatomical variability, often resulting in inadvertent stimulation or measurement of non-target tissues, increased patient discomfort, signal artifacts, and reduced selectivity and sensitivity.
The raised hydrogel electrodes, attached and bonded during manufacture to the flexible substrate, are arranged in various grid or non-uniform patterns and can include features such as cutouts or grooves for increased flexibility and visibility. The system may include an adhesive layer with openings for the electrodes and optional intermediate layers for comfort and conformity. A compression pad with rigid members can be added to enhance electrode-skin contact. The electrode patch interfaces with an electronics module capable of delivering stimulation and recording electrical responses, supporting applications like nerve conduction studies or functional nerve imaging.
Claims Coverage
The patent includes two independent claims covering core inventive features relating to the electrode patch as a device and a system incorporating the patch with electronics. The main inventive features are outlined below.
Electrode patch with hydrogel electrodes in raised geometry
An electrode patch comprising: - A flexible substrate. - An adhesive layer with openings arranged on at least a portion of the flexible substrate. - An electrode array on the flexible substrate comprising three or more independently addressable electrodes arranged in a grid pattern. - Each electrode comprises a hydrogel defining a raised geometry configured to push into a patient’s skin due to the adhesive layer, such that the hydrogel extends beyond the distal-most plane of the patch and is in direct and uninterrupted contact with the skin. - The adhesive layer has openings through which the raised geometry of each electrode extends. - A plurality of traces, each trace electrically connecting an electrode to a peripheral region of the patch.
System comprising the electrode patch and electronics circuitry
A system comprising: - The electrode patch as described above. - An electronics circuitry operably coupled to the electrode array. - The electronics circuitry is configured to deliver a stimulus to an electroactive tissue via the electrode array, or to record an evoked electrical response from the electroactive tissue via the electrode array.
The inventive features focus on a flexible electrode patch with independently addressable, raised hydrogel electrodes designed for direct skin contact, and a system combining this patch with electronics for targeted tissue stimulation and recording.
Stated Advantages
The raised geometry of the hydrogel electrodes provides an intimate, stable interface with the skin, improving stimulation and recording characteristics.
Direct contact of the hydrogel with the skin can reduce motion artifacts during measurements.
The patch design improves spatial resolution, allowing mapping of underlying tissue activity and enabling higher sensitivity and data fidelity.
The array allows for a higher margin of error in electrode placement and increases selectivity in current delivery to target tissues.
Individually addressable electrodes enable automatic or manual selection for optimal stimulation/recording, reducing the need for electrode repositioning and operator guesswork.
Built-in electronics configurations minimize noise and stimulation artifact, enabling reliable functional nerve imaging and quantitative nerve conduction studies.
The system's design is cost-effective, supports automation, and is suitable for both clinical and at-home use, enhancing accessibility and ease of use.
Longitudinal tracking is facilitated by replicable placement and recording, allowing clinicians to monitor changes in nerve or muscle health over time.
Documented Applications
Nerve conduction studies and functional nerve imaging for the diagnosis and monitoring of conditions like peripheral neuropathy and carpal tunnel syndrome.
Quantitative assessment of nerve or muscle function to inform optimal treatment strategies, including monitoring surgical recovery or therapy effectiveness.
Measurement and imaging of nerve fiber conduction velocities and spatial mapping of neural activity.
Intra-operative neural monitoring (IONM) during procedures involving the brain, nerves, and spinal cord, including Somatosensory Evoked Potentials (SSEP), Transcranial Motor-Evoked Potentials (TcMEP), and Electromyography (EMG).
Targeted electrical stimulation for therapeutic purposes, including transcutaneous electrical nerve stimulation (TENS), pain reduction, and neuromodulation.
Non-invasive monitoring and feedback for implanted nerve stimulators, such as evaluating vagus nerve stimulation.
Assessment and monitoring of changes in sympathetic nerve activity and other physiological metrics using high-resolution, array-based electrodes.
Replicable and sensitive longitudinal monitoring of nerve regeneration, disease progression, or recovery following injury or surgery.
Use in clinical and at-home settings for automated or semi-automated screening, diagnostics, or therapy administration, even by non-specialist operators.
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