Physiological monitoring device
Inventors
Bahney, Timothy J. • Ho, Hung H. • Park, Shena H. • Sepulveda, Genaro S. • Day, Mark J. • Tamura, Yuriko
Assignees
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Publication Number
US-12245860-B2
Publication Date
2025-03-11
Expiration Date
Abstract
The present invention relates to a physiological monitoring device. Some embodiments of the invention allow for long-term monitoring of physiological signals. Further embodiments may also allow for the monitoring of secondary signals such as motion.
Core Innovation
The invention relates to a physiological monitoring device configured to monitor cardiac rhythm data of a patient. The device includes a rigid watertight housing portion that houses a circuit board assembly and an electrode system carried on flexible, conformal wings. The flexible portions include embedded electrodes and thin electrode traces coupled to the circuit board assembly to obtain the cardiac rhythm data while the device is worn for extended periods.
A key mechanical aspect is the integration of a patient event trigger into the rigid watertight housing. The trigger is implemented as a concave, recessed trigger surface of the rigid housing to minimize motion artifacts, and the force from interaction with the trigger is transmitted to a support post such that no bending moment is created. The housing portions are sealed using watertight upper and lower gaskets, and hinge portions allow the device to float off the skin during flexing.
The flexible substrate is formed as a multi-layer structure with a first layer and a second layer, where the first layer extends beyond the second layer to create an edge that is thinner than an inner portion of the flexible substrate. The electrode system is embedded in a flexible substrate/adhesive/electrode construction to support long-term wear, including showering, and the device includes an adhesive layer that adheres to a patient’s skin for at least 7 days.
The invention also describes secondary sensing for motion/artefact identification, including a 3-axis accelerometer and motion/artefact detection based on frequency-spectrum comparison, with support for event marking such as sleep and fainting indicators.
Claims Coverage
The partial claim set includes one independent claim that covers a physiological monitoring device for monitoring a patient’s cardiac rhythm data, with eight inventive features including spring-powered electrical coupling, a multi-layer flexible substrate with an edge-thinning geometry, flexible electrode traces electrically coupled via spring contacts, a support post designed to transmit force from trigger interaction, and watertight sealing with an adhesive layer for extended monitoring.
Spring contact coupling battery to circuit board assembly
A spring contact configured to electrically couple a battery to a circuit board assembly housed within a first housing portion.
Multi-layer flexible substrate with edge thinner than inner portion
A flexible substrate coupled to a second housing portion, wherein the flexible substrate comprises a first layer and a second layer, and wherein the first layer extends beyond the second layer creating an edge to the flexible substrate that is thinner than an inner portion of the flexible substrate.
Electrode coupled to flexible substrate to detect physiological signals
An electrode coupled to the flexible substrate and configured to detect physiological signals of the patient to obtain the cardiac rhythm data.
Support post transmitting trigger interaction force
A support post configured such that force from interaction with a trigger is transmitted to the support post.
Flexible electrode trace electrically coupled to circuit board assembly via spring contacts
A flexible electrode trace coupled to the flexible substrate and configured to electrically couple the electrode to the circuit board assembly, wherein at least a portion of the flexible electrode trace is in electrical contact with a second spring contact, and wherein the second spring contact is further configured to electrically couple the flexible electrode trace to the circuit board assembly.
No bending moment in force transmission to support post
The physiological monitoring device wherein force from interaction with a trigger is transmitted to the support post such that no bending moment is created.
Gasket sealing the housing to make it watertight
The physiological monitoring device further includes a gasket configured to seal the housing formed by the first and second housing portions to make it watertight.
Adhesive layer adhering to skin for at least 7 days
The physiological monitoring device includes an adhesive layer that adheres to a patient’s skin for at least 7 days so the device can monitor the patient’s cardiac rhythm data for at least 7 days.
Overall, the claim coverage centers on an ECG-capable physiological monitoring device that electrically couples power and electrode traces to a circuit board assembly using spring contacts, while mechanically supporting a trigger with a force-transmitting support post and reducing interface issues using a multi-layer flexible substrate with a thinner edge, sealed watertight housing gaskets, and a skin-adhering adhesive layer for extended monitoring.
Stated Advantages
Improves comfort and signal quality during long-term wear by using a reduced edge-lift flexible substrate border.
Minimizes motion artifacts by using a concave, recessed trigger surface in the rigid housing.
Enables watertight operation of the device by sealing the housing with watertight upper and lower gaskets.
Supports long-term monitoring wear, including showering, enabled by the flexible substrate/adhesive/electrode construction and an adhesive layer configured for at least 7 days.
Documented Applications
Long-term wearable physiological monitoring of cardiac rhythm data, including extended wear such as showering.
Event marking supported by secondary sensing, including sleep indicator and fainting/syncope (free-fall) detection.
Motion/artefact identification using frequency-spectrum comparison based on motion sensing (e.g., 3-axis accelerometer) to support interpretation of events.
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