Modular physiologic monitoring systems, kits, and methods
Inventors
Toth, Landy • Schwartz, Robert • Pulling, Chris • Martin, Roy
Assignees
Publication Number
US-11284831-B2
Publication Date
2022-03-29
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, kits, and methods for monitoring physiologic and/or physical signals from a subject using patches and corresponding modules. These patches are designed for attachment to a subject and include sensors or electrodes embedded within a flexible, stretchable substrate, which interfaces with modules comprising microcircuitry for signal processing and wireless communication. The modular design allows the patch to serve as a single-use, comfortable, and unobtrusive interface, while the module is reusable and provides necessary electronic functions.
A key aspect of the system is the patch interface, which incorporates an adhesive for secure attachment to the skin, stretchable electrically conducting traces for durability during movement, and interconnects to physically and electrically couple with the module. The system ensures comfort through properties such as high tear strength, breathability, and moisture permeability, with moisture vapor transmission rates specified to enhance long-term wearability. The transparent areas of the patch and adhesive further permit optical or radiation-based signal transmission between the module and the subject.
The background outlines the need for reliable, simple, cable-free measurement of physiologic parameters, especially as mobile and remote healthcare becomes more prominent. Current systems are hampered by false alarms, unreliable interfaces, and discomfort, leading to inferior patient compliance. This invention addresses these issues by providing a user-friendly, robust, and wearable solution for continuous or ambulatory monitoring in hospital, home, and uncontrolled environments, aiming to improve patient outcomes and data reliability.
Claims Coverage
There are three independent claims in this patent, each describing inventive features of the patch interface for physiologic monitoring.
Patch interface with embedded conducting traces and partial transparency to radiation
The patch interface includes: - A substrate with first and second surfaces. - An adhesive with first and second surfaces, coupled to the substrate and formulated for skin attachment. - One or more patch interconnects coupled to the substrate, providing an electrically conducting interface for module attachment. - One or more electrically conducting traces (comprising electrically conducting ink) arranged between the substrate and the adhesive. - At least one sensor or electrode, embedded in the substrate or attached to the substrate's surface. - The electrically conducting traces couple at least one of the sensors or electrodes to a patch interconnect. - At least a portion of either the substrate or adhesive is at least partially transparent to radiation transmitted from the module to the subject or vice versa.
Patch interface with stretchable interconnects and traces
The patch interface includes: - A substrate and adhesive as previously described, arranged for attachment to skin. - One or more patch interconnects and one or more electrically conducting traces, wherein both the interconnects and conducting traces are stretchable. - At least one sensor or electrode embedded in or attached to the substrate. - The conducting traces couple at least one sensor or electrode to a patch interconnect. - At least a portion of the substrate or adhesive is at least partially transparent to radiation transmitted from the module to the subject or from the subject to the module.
Patch interface with embedded patch interconnects sealed between module and substrate
The patch interface includes: - A substrate and adhesive configured for skin attachment. - Patch interconnects embedded in the substrate, configured for attachment to a module that comprises one or more microcircuits. - Electrically conducting traces arranged between the substrate and adhesive, coupling sensors or electrodes with the patch interconnects. - At least one sensor or electrode embedded in or attached to the substrate. - The patch interconnects are sealed between the module and substrate when attached to the module. - At least a portion of the substrate or adhesive is at least partially transparent to radiation transmitted from the module to the subject or vice versa.
The inventive features cover a wearable patch interface for physiologic monitoring with stretchable, embedded conducting traces and interconnects, integration of sensors or electrodes, and transparency for radiation transmission, enabling versatile and comfortable subject-module interfacing.
Stated Advantages
Provides reliable, simplified, and cable-free measurement of physiologic parameters from a subject.
Enables comfortable, long-term wearable monitoring through the use of stretchable, breathable, and hypoallergenic materials.
Reduces false alarms, usage-related failures, and user/system interface issues associated with existing systems.
Facilitates modular, redundant, and user-friendly physiologic monitoring suitable for use with limited supervision or expertise.
Enhances patient compliance due to unobtrusive and comfortable design characteristics.
Documented Applications
Electrocardiography monitoring, including multi-lead and spatially distributed EKG signals.
Sleep assessment, including detection of sleep states, sleep apnea, bruxism, REM, sleep walking, nightmares, and waking events.
Traumatic brain injury and impact assessment, capturing both electrophysiological and kinetic signals.
Biofeedback, stress management, relaxation, and physiotherapy.
Stroke or surgical recovery monitoring, including hydration and tissue assessment.
Blood pressure monitoring in an ambulatory setting utilizing EKG and pulse measurements.
Muscle movement and gait assessment through EMG signals and kinetic/kinematic analysis.
Heart rate and heart rate variability monitoring for training, recovery, and assessment of emotional or sympathetic nervous system state.
Remote and home-based patient monitoring for a range of chronic conditions (cardiovascular, diabetes, COPD, obesity, neurological disorders).
Hospital-based patient monitoring to alleviate alarm fatigue and improve productivity.
Interfacing handheld monitoring devices with the subject using an isolating patch.
Entertainment and product feedback (e.g., amusement park or gaming applications) by capturing physiological responses.
Veterinary applications for animal physiologic monitoring.
Bioimpedance-based fluid and hydration monitoring, including edema and blood clot detection.
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