Modular physiologic monitoring systems, kits, and methods
Inventors
Toth, Landy • Schwartz, Robert
Assignees
Publication Number
US-12193842-B2
Publication Date
2025-01-14
Expiration Date
2034-06-06
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Abstract
Systems, devices, methods, and kits for monitoring one or more physiologic and/or physical signals from a subject are disclosed. A system including patches and corresponding modules for wirelessly monitoring physiologic and/or physical signals is disclosed. A service system for managing the collection of physiologic data from a customer is disclosed. An isolating patch for providing a barrier between a handheld monitoring device with a plurality of contact pads and a subject is disclosed.
Core Innovation
The invention provides modular systems, devices, methods, and kits for monitoring physiologic and/or physical signals from a subject. In particular, it discloses a system including skin-attachable patches and corresponding modules for wirelessly measuring physiologic signals such as skin neural activity, employing both microelectrodes for spatial neural mapping and macroelectrodes for artifact reference and comparison. The patches and modules are designed to be unobtrusive, comfortable, and suitable for prolonged or ambulatory use, and may be hot-swappable to enable nearly continuous operation.
The modular design allows patches containing sensors and electrodes to couple with reusable modules containing communication and processing circuitry. The modules wirelessly transmit data to host devices for analysis, coordination, and user feedback. The system further enables spatial mapping of neural signals by comparing microelectrode data to macroelectrode baselines, thereby identifying clusters of increased neural activity. The invention emphasizes stretchable, thin, and physically frail patch substrates to maximize comfort and compliance.
The problem addressed is the lack of reliable, comfortable, cable-free, and user-friendly physiologic monitoring solutions suitable for remote or mobile contexts. Current technologies suffer from false alarms, unreliable and cumbersome interfaces, interference issues, and poor patient compliance due to discomfort or difficulty in use. The invention aims to solve these shortcomings by providing more reliable, redundant, comfortable, and simplified monitoring tools capable of operation with limited supervision, enhancing both patient and practitioner experience.
Claims Coverage
There are two primary independent inventive features described in the claims: one directed to the patch interface and the other to the module.
Patch interface with spatial neural activity mapping via microelectrode and macroelectrode comparison
A patch interface comprising: - A substrate with a surface and adhesive for skin attachment. - An interconnect to attach the patch interface to a microcircuit. - A plurality of microelectrodes attached or embedded, electrically coupled via the interconnect. - One or more macroelectrodes also coupled via the interconnect. - A microcircuit configured to: - Obtain spatial readings of skin neural activity from each of a plurality of monitoring sites using signals from the microelectrodes. - Determine which monitoring sites have spatial readings exceeding a baseline by comparing microelectrode signals to those from at least one macroelectrode. - Identify one or more clusters of monitoring sites with readings exceeding the baseline. This setup enables the patch to spatially map skin neural activity, filter out artifacts, and identify significant clusters of neural activation by referencing macroelectrode data.
Module for spatial neural activity mapping with patch interface integration and artifact referencing
A module including: - A housing and a circuit board with one or more microcircuits, - One or more module interconnects configured for coupling the module onto a patch interface, - Microcircuits configured to: - Obtain spatial readings of skin neural activity at monitoring sites from microelectrode signals via the patch interface, - Compare these microelectrode signals with at least one macroelectrode signal received via patch interconnects to determine which sites have readings exceeding a baseline, - Identify one or more clusters of monitoring sites exceeding the baseline. The module may also be hermetically sealed and equipped with multiple processing banks for handling different neural regions or structures, enabling robust acquisition, reference, and identification of neural activity clusters.
The inventive features cover a modular physiologic monitoring system with patch interfaces and modules designed for spatial neural activity sensing. Core claim coverage includes spatial mapping of neural signals using arrays of microelectrodes benchmarked by macroelectrodes, integrated artifact filtering, and identification of neural activity clusters. The architecture enables simplified attachment, comfort, and reliable wireless operation.
Stated Advantages
The system enables reliable, redundant, and user-friendly monitoring of physiologic parameters, even with limited supervision or user manipulation.
Comfortable long-term wearable design facilitates subject compliance and unobtrusive monitoring.
Simplifies the monitoring process with cable-free, hot-swappable modules, and stretchable, breathable, and hypoallergenic skin interfaces.
Reduces false alarms and data loss by incorporating artifact rejection, redundancy, and robust signal quality assessment.
Enhances user and practitioner satisfaction through comfort and the minimization of usage-related failures.
Documented Applications
Monitoring electrocardiograms (EKG/ECG) including multi-lead and standard configurations for cardiovascular assessment.
Spatial mapping and assessment of skin-based neural activity for determining autonomic neural state and identifying clusters of increased neural activation.
Sleep state assessment, including capture of EMG/EOG, snoring, sleep apnea, bruxism, REM detection, and other sleep-related events.
Gait and muscle movement analysis through synchronized EMG and kinematic sensing for biomechanics, rehabilitation, or sports training.
Ambulatory and cuffless blood pressure monitoring via multimodal signal analysis including EKG and pulse time-of-flight.
Traumatic brain injury analysis using combined EEG and impact/kinematic sensors pre- and post-impact.
Assessment and follow-up for neuromodulation or ablation procedures (e.g., renal denervation), including feedback on procedure completion and autonomic response.
Biofeedback, stress management, and relaxation training via real-time physiologic monitoring and interactive feedback mechanisms.
Remote, hospital, or home monitoring of patients with chronic diseases, for prevention, treatment, or compliance tracking.
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