Ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation
First Claim
1. An ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation, comprising:
- a disposable extended wear electrode patch comprising;
a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief;
a pair of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along the midline of a sternum for capturing action potential propagation;
a non-conductive receptacle affixed to a non-contacting surface of the flexible backing;
a docking interface positioned on the non-conductive receptacle and comprising electrical contact mating pads;
a battery compartment formed on a bottom surface of the non-conductive receptacle;
a battery within the battery compartment electrically interfaced to a set of the electrical contact mating pads; and
a flexible circuit comprising a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to one of a second set of the electrical contact mating pads of the docking interface, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection and to define a torsional and tensile strain relief that facilitates longitudinal extension and twisting of the flexible circuit in response to tensile and torsional forces, the torsional and tensile strain relief comprising a pair of strain relief cutouts that each face towards the other strain relief cutout; and
an ambulatory electrocardiography monitor recorder comprising;
a wearable housing adapted to securely fit into the non-conductive receptacle;
an external connector comprising a set of electrical contacts protruding from a surface of the wearable housing that fits within the non-conductive receptacle, the set of contacts electrically and mechanically contacting the first set of the electrical contact mating pads of the docking interface and the second set of the electrical contact mating pads of the docking interface; and
electronic circuitry provided within the wearable housing and removably connected via the external connector to the electrocardiographic electrodes via the second set of the electrical contact mating pads on the docking interface, and to the battery via the second set of the electrical contact mating pads, the electronic circuitry further comprising;
a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and to draw power from the battery via the external connector;
an electrocardiographic front end circuit under the control of the microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation; and
non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals throughout the extended period and to draw power from the battery via the external connector.
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Accused Products
Abstract
Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally on the patient'"'"'s chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.
389 Citations
20 Claims
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1. An ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation, comprising:
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a disposable extended wear electrode patch comprising; a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief; a pair of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along the midline of a sternum for capturing action potential propagation; a non-conductive receptacle affixed to a non-contacting surface of the flexible backing; a docking interface positioned on the non-conductive receptacle and comprising electrical contact mating pads; a battery compartment formed on a bottom surface of the non-conductive receptacle; a battery within the battery compartment electrically interfaced to a set of the electrical contact mating pads; and a flexible circuit comprising a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to one of a second set of the electrical contact mating pads of the docking interface, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection and to define a torsional and tensile strain relief that facilitates longitudinal extension and twisting of the flexible circuit in response to tensile and torsional forces, the torsional and tensile strain relief comprising a pair of strain relief cutouts that each face towards the other strain relief cutout; and an ambulatory electrocardiography monitor recorder comprising; a wearable housing adapted to securely fit into the non-conductive receptacle; an external connector comprising a set of electrical contacts protruding from a surface of the wearable housing that fits within the non-conductive receptacle, the set of contacts electrically and mechanically contacting the first set of the electrical contact mating pads of the docking interface and the second set of the electrical contact mating pads of the docking interface; and electronic circuitry provided within the wearable housing and removably connected via the external connector to the electrocardiographic electrodes via the second set of the electrical contact mating pads on the docking interface, and to the battery via the second set of the electrical contact mating pads, the electronic circuitry further comprising; a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and to draw power from the battery via the external connector; an electrocardiographic front end circuit under the control of the microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation; and non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals throughout the extended period and to draw power from the battery via the external connector. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. An ambulatory electrocardiography monitor optimized for capturing low amplitude cardiac action potential propagation, comprising:
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a disposable extended wear electrode patch comprising; a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief; a pair of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along the midline of a sternum for capturing action potential propagation; a non-conductive receptacle affixed to a non-contacting surface of the flexible backing; a docking interface positioned on the non-conductive receptacle and comprising electrical contact mating pads; a battery compartment formed on a bottom surface of the non-conductive receptacle; a battery within the battery compartment electrically interfaced to a first set of the electrical contact mating pads; and a flexible circuit comprising a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to one of a second set of the electrical contact mating pads of the docking interface, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection; and an ambulatory electrocardiography monitor recorder comprising; a wearable housing adapted to securely fit into the receptacle; an external connector comprising a set of electrical contacts protruding from a surface of the wearable housing that fits within the receptacle, the set of contacts electrically and mechanically contacting the first set of the electrical contact mating pads of the docking interface and the second set of the electrical contact mating pads of the docking interface; and electronic circuitry provided within the wearable housing and removably connected via the external connector to the electrocardiographic electrodes via the second set of the electrical contact mating pads on the docking interface, and to the battery via the first set of the electrical contact mating pads, further comprising; a low power microcontroller operable to execute over an extended period under modular micro program control as specified in a firmware and to draw power from the battery via the external connector; an electrocardiographic front end circuit under the control of the microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation; and non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals throughout the extended period and to draw power from the battery via the external connector. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification