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-12295733-B2
Publication Date
2025-05-13
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 using an electrode patch that includes a flexible substrate and an electrode array arranged on the flexible substrate. Each electrode in the array is formed of a hydrogel and defines a raised geometry, which is designed to closely contact or push into a subject's skin, ensuring intimate and stable electrical interfacing for stimulation and recording applications.
The electrode array may contain a plurality of independently addressable electrodes, arranged in various spatial patterns, such as grids, circles, semi-circular, or arc configurations, and can include groups configured for different functions, such as stimulation or recording. The electrode patch can include additional features, such as an adhesive or intermediate layer to enhance skin contact, as well as a compression pad to apply pressure for optimal electrode–skin interaction. There are also mechanical and electrical connectors to integrate the electrode patch with external electronics.
The invention addresses problems present in conventional nerve conduction studies and electrodiagnostic tests, where flat metal or gel disc electrodes are difficult to position precisely due to anatomic variability. This can result in poor signal quality, increased current requirements, patient discomfort, and the need for skilled operators to optimize electrode positioning. By providing an array of hydrogel-based, raised-geometry electrodes that can be precisely and securely interfaced with the skin, and paired with advanced electronics for noise and artifact reduction, the system facilitates more robust, high-resolution, and user-friendly stimulation and recording of electroactive tissues.
Claims Coverage
The patent contains five independent claim sets, covering a total of five primary inventive features: systems for electrode-based interfacing with biological tissue, systems using multiple electrode patches, systems synchronized via a single clock, electronic noise reduction strategies, and high-precision timing in stimulation and recording.
System for electrode-based interface using precise stimulation, recording, and noise removal
A system comprising at least one electrode patch configured to be removably secured to a subject's skin for delivering a stimulus to, or recording an evoked electrical response from, electroactive tissue. The system includes electronic circuitry operably coupled to the electrode patch and configured to: - Deliver via the electrode patch successive stimuli to the electroactive tissue with precise timing. - Record via the electrode patch the evoked electrical response from the electroactive tissue. - Remove noise at a given frequency by averaging successive samples of the evoked response corresponding to the stimuli, where one or more stimuli are delivered in-phase and one or more out-of-phase with the noise frequency, averaging the results to suppress noise.
Electrode patches with independently addressable arrays and pressure application
A system where the electrode patch comprises a plurality of independently addressable electrodes arranged in a grid. Each electrode may comprise a hydrogel with a raised geometry extending beyond the patch for direct skin contact. The system can further include a compression pad with rigid members aligned to focus pressure onto respective electrodes.
Electronic circuitry integrating precise synchronization and advanced common-mode noise suppression
Electronic circuitry equipped for synchronized delivery and recording of stimuli/responses using a single clock, achieving synchronization within one clock cycle. The circuitry may include a driven right-leg circuit to measure and force ground to the subject's common-mode, and/or multiple processing chips configured to record evoked responses with a half-sample delay to increase effective sampling rate.
Support for multiple electrode patches and modular interfacing
A system comprising a plurality of electrode patches, each removably secured to the skin and operably coupled to electronic circuitry. The circuitry is configured for: - Delivering successive stimuli to electroactive tissue with precise timing (via one or more of the patches). - Recording evoked electrical responses (via one or more patches). - Removing noise by averaging phase-shifted response samples. This feature supports modular expansion and high-resolution multi-site measurements.
Synchronization of stimulation and recording events using a single synchronization clock
A system comprising at least one or a plurality of electrode patches, with electronic circuitry containing a single synchronization clock. The system delivers successive stimuli with precise timing and records evoked responses, with all delivery and recording events synchronized within one cycle of the synchronization clock, enabling reliable, artifact-robust data acquisition and noise removal.
Collectively, the inventive features define systems for high-resolution, robust bio-interface using hydrogel-array patches, precise stimulus/record timing, electronic noise artifact suppression, and modular multi-patch configurations leveraging synchronized electronics.
Stated Advantages
Provides high spatial resolution and repeatability for nerve and muscle diagnostic and therapeutic measurements.
Reduces operator error and removes guesswork in electrode placement due to anatomical variations.
Allows for automation and reduces the time required to perform experiments or diagnostic tests.
Eliminates the need for skill-based ‘hunt-and-peck’ placement, making procedures more accessible and efficient.
Reduces stimulation artifact and electrical noise through advanced electronic circuitry (including a driven right leg circuit and phase-synchronized noise averaging).
Improves patient comfort by minimizing needed stimulation current and unintentional adjacent nerve activation.
Enables clinicians to measure, visualize, and analyze neural and muscular conduction with higher sensitivity and quantitative assessment.
Facilitates more sensitive and earlier detection of disease progression and recovery in clinical and at-home settings.
Enables longitudinal tracking of nerve or muscle health with replicable, comparable data across sessions owing to array-based precision.
Allows non-expert health care providers or patients to effectively use the system due to feedback, automation, and robust design.
Documented Applications
Functional nerve imaging, including visualization of nerve conduction and nerve branch assessment.
High-resolution nerve and muscle diagnostics in neurology or physiatry, including measurement of local conduction velocities and disease screening.
Detection and diagnosis of carpal tunnel syndrome, including simultaneous recording from median and ulnar nerves.
Differentiation among various nerve fiber types using high-resolution array and conduction velocity mapping.
Tracking nerve regeneration and axon growth after nerve injury or surgery.
Longitudinal monitoring and tracking of neuromuscular recovery and disease progression.
Assessment and monitoring of muscle and nerve health post-surgery, including evaluation of reinnervation.
Supporting intra-operative neural monitoring (IONM) during sensitive or invasive procedures involving the brain, nerves, or spinal cord.
Therapeutic nerve stimulation including transcutaneous electrical nerve stimulation (TENS) and high-frequency stimulation for pain reduction.
Feedback and efficacy assessment for neuromodulation, bioelectronic medicine, and implanted nerve stimulators.
Quantitative assessment of nerve or muscle function for informing optimal surgical or non-surgical treatments (e.g., comparing carpal tunnel release procedures).
Screening and endpoint assessment of drugs for neuropathy and measurement at autonomic innervation sites.
Measurement and analysis of skin sympathetic nerve activity (SKNA) as a predictive physiological metric.
Facilitating at-home nerve and muscle monitoring for patients without a trained operator present.
Supporting automated and semi-automated diagnostic and therapeutic protocols in clinical and home settings.
Enabling sensitive measurement and tracking of small or epidermal nerves in diagnostic testing.
Detection and spatial localization of focal nerve dysfunction, including applications in Multiple Sclerosis (MS) diagnosis or treatment.
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