Computer-implemented system for secure physiological data collection and processing
First Claim
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1. A computer-implemented system for secure physiological data collection and processing, comprising:
- an extended wear electrocardiography and physiological sensor monitor recorder, comprising;
a sealed housing adapted to be removably secured into a non-conductive receptacle on a disposable extended wear electrode patch, wherein an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch are stored on the patch; and
an electronic circuitry comprised within the sealed housing, comprising;
an electrocardiographic front end circuit electrically interfaced to an externally-powered micro-controller and operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch when the sealed housing is secured within the non-conductive receptacle of the patch, wherein each of the electrocardiographic electrodes are adapted to be positioned axially along the midline of a sternum for capturing action potential propagation;
the externally-powered micro-controller electrically interfaced to the front end and operable to execute under micro programmable control through firmware that is stored in a program memory unit of the micro-controller, the micro-controller operable to retrieve the password and the identifier from the patch when the sealed housing is secured within the non-conductive receptacle of the patch; and
an externally-powered flash memory electrically interfaced with the micro-controller and operable to store together the password, the identifier, and samples of the electrocardiographic signals, the micro-controller further configured to offload the stored samples of the electrocardiographic signals from the memory together with the stored password and identifier.
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Abstract
The electrode patch can store an identifier, such as a serial number, and a password associated with the identifier. The password can include a cryptographic hash of the identifier. The password and the identifier are coupled to the data collected using the patch and the data can be stored as electronic medical records (EMR) in a database based on the identifier. A patient or another authorized party can access the data using the identifier and the password. The EMRs can also include results of analysis of data received from the monitor, such as an automated over-read of an ECG trace based on the received data.
359 Citations
20 Claims
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1. A computer-implemented system for secure physiological data collection and processing, comprising:
an extended wear electrocardiography and physiological sensor monitor recorder, comprising; a sealed housing adapted to be removably secured into a non-conductive receptacle on a disposable extended wear electrode patch, wherein an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch are stored on the patch; and an electronic circuitry comprised within the sealed housing, comprising; an electrocardiographic front end circuit electrically interfaced to an externally-powered micro-controller and operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch when the sealed housing is secured within the non-conductive receptacle of the patch, wherein each of the electrocardiographic electrodes are adapted to be positioned axially along the midline of a sternum for capturing action potential propagation; the externally-powered micro-controller electrically interfaced to the front end and operable to execute under micro programmable control through firmware that is stored in a program memory unit of the micro-controller, the micro-controller operable to retrieve the password and the identifier from the patch when the sealed housing is secured within the non-conductive receptacle of the patch; and an externally-powered flash memory electrically interfaced with the micro-controller and operable to store together the password, the identifier, and samples of the electrocardiographic signals, the micro-controller further configured to offload the stored samples of the electrocardiographic signals from the memory together with the stored password and identifier. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A computer-implemented system for secure low amplitude cardiac action potential data collection and processing, 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 and comprising an electro mechanical docking interface; 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 the docking interface, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as a strain relief; and a circuit operable to store an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch; and an ambulatory electrocardiography monitor comprising; a wearable housing adapted to securely fit into the receptacle; and electronic circuitry provided within the wearable housing and comprising an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface, further comprising; a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and further operable to retrieve the identifier and the password from the circuit when the wearable housing is secured within the non-conductive receptacle of the patch; 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 a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals collected throughout the extended period together with the retrieved password and identifier, the micro-controller is further configured to offload the stored samples of the electrocardiographic signals from the memory together with the stored password and identifier. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification