Contact-activated extended wear electrocardiography and physiological sensor monitor recorder

• US 10,667,711 B1
• Filed: 03/12/2015
• Issued: 06/02/2020
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Felix, Jason, Bishay, Jon Mikalson, Bardy, Gust H.
• Primary Examiner(s): Patel, Niketa I
• Assistant Examiner(s): Baldwin, Nathan A
• Application Number:
  US14/656,615
• Time in Patent Office: 1,909 Days
• Field of Search: 600391
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. 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 (or immediately to either side of the sternum) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. The wearable monitor can interoperate wirelessly with other physiology and activity sensors and mobile devices, and can include cellular phone capabilities. The power usage of the wireless communication can be reduced by using a low energy wireless transceiver in the monitor. The monitor detects that the monitor has been adhered to the patient and begin collecting physiological data after such detection, preserving battery power.

Claims

1. A contact-activated 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; and

an electronic circuitry comprised within the sealed housing, comprising;

an electrocardiographic front end circuit electrically interfaced to an externally-powered microcontroller and operable to sense voltage comprising electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch once a removable release liner is removed from the electrocardiographic electrodes, each of the electrocardiographic electrodes adapted to be positioned axially along the midline of the sternum for capturing action potential propagation;

an actigraphy sensor electrically interfaced with the externally-powered microcontroller, the actitgraphy sensor operable to collect movement data when the sealed housing is worn by the patient and to provide the movement data collected when the sealed housing is worn by the patient to the externally-powered micro-controller;

a timer operable to measure one or more time intervals following an execution of a power-up sequence by the externally-powered microcontroller and a receipt of the movement data collected when the sealed housing is worn by the patient by the externally-powered microcontroller;

the externally-powered microcontroller electrically interfaced to the electrographic front end circuit and operable to execute under micro programmable control through firmware that is stored in a program memory unit of the microcontroller, the microcontroller operable to execute the power-up sequence upon the sealed housing being secured into the non-conductive receptacle, to receive the movement data collected when the sealed housing is worn by the patient, to measure the voltage via the front end following an expiration of each of the time intervals and to process the sensed voltage following the measurement, determine the sensed voltage to be representative of one of the portion of the electrocardiographic waveform and the release liner being attached to the electrocardiographic electrodes during the processing, to detect an adherence of the electrodes to a patient upon determining the sensed voltage to be representative of the at least the portion of the electrocardiographic waveform and not the release liner being attached to the electrocardiographic electrodes, and to start for a first time during a monitoring period an execution of a monitoring sequence stored as part of the firmware upon detecting the adherence, the monitoring sequence comprising sampling the electrocardiographic signals over the monitoring period and storing all of the sampled electrocardiographic signals, wherein the timer initiates the measurement of another one of the time intervals upon the determination of the sensed voltage being representative of the release liner being attached to the electrocardiographic electrodes;

an externally-powered flash memory electrically interfaced with the microcontroller and operable to store the samples of the electrocardiographic signals collected during the execution of the monitoring sequence; and

a wireless transceiver interfaced with the externally-powered microcontroller and the externally-powered flash memory, the wireless transceiver comprising a cellular chipset operable to receive additional data associated with the patient from one or more cellular phones over a cellular network and to transmit the stored samples of the electrocardiographic signals and the additional data over the cellular network.

2. A contact-activated extended wear electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the wireless transceiver is further operable to wirelessly interface with one or more further external wireless-enabled devices.

3. A contact-activated extended wear electrocardiography and physiological sensor monitor recorder according to claim 2, wherein the wireless transceiver communicates to the one or more further external wireless-enabled devices an alert generated based on the samples.

4. A contact-activated extended wear electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the patient is referred for medical care based on the transmitted samples.

5. A contact-activated extended wear electrocardiography and physiological sensor monitor recorder according to claim 1, the disposable extended wear electrode patch further comprising:

a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection and, on each end, a contact surface at least partially coated with an adhesive dressing provided as a crimp relief;

the pair of the electrocardiographic electrodes conductively exposed on the contact surface of each end of the elongated strip;

a non-conductive receptacle adhered to an outward-facing surface of the elongated strip and comprising electrical pads; and

a flexible circuit affixed on each end of the elongated strip as a strain relief and comprising a pair of circuit traces electrically coupled to the pair of electrocardiographic electrodes and a pair of the electrical pads, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as the strain relief.

6. A contact-activated extended wear electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the timer is one of interfaced to the externally-powered micro-controller or implemented by the externally-powered microcontroller.

7. A contact-activated ambulatory electrocardiography monitor 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 the sternum for capturing action potential propagation;

a release liner removably attached to the electrocardiographic electrodes;

a non-conductive receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro mechanical docking interface; and

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

an ambulatory electrocardiography monitor recorder 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;

an electrocardiographic front end circuit adapted to sense voltage comprising cardiac electrical potential differentials through the electrocardiographic electrodes when the release liner is removed from the electrocardiographic electrodes;

an actigraphy sensor electrically interfaced with a low-power microcontroller, the actitgraphy sensor operable to collect movement data when the sealed housing is worn by the patient and to provide the movement data collected when the sealed housing is worn by the patient to the micro-controller;

a timer operable to measure one or more time intervals following an execution of a power-up sequence by the low-power microcontroller and a receipt of the movement data collected when the sealed housing is worn by the patient by the low-power microcontroller;

the low power microcontroller in control of the electrographic front end circuit and operable to execute over an extended monitoring period under modular micro program control as specified in firmware, the microcontroller further operable to execute the power-up sequence upon the sealed housing being secured into the non-conductive receptacle, to receive the movement data collected when the sealed housing is worn by the patient, to measure the voltage via the electrocardiographic front end following an expiration of each of the time intervals, to process the sensed voltage, to determine the sensed voltage to be representative of one of the portion of the electrocardiographic waveform and the release liner being attached to the electrocardiographic electrodes during the processing, to detect an adherence of the electrodes to a patient upon the determination that the sensed voltage represents the at least the portion of the electrocardiographic waveform and not the release liner being attached to the electrocardiographic electrodes, and to start for a first time during the extended monitoring period an execution of a monitoring sequence stored as part of the firmware upon detecting the adherence, the monitoring sequence comprising sampling the electrocardiographic signals over the extended monitoring period and storing all of the sampled electrocardiographic signals, wherein the timer initiates the measurement of another one of the time intervals upon the determination of the sensed voltage being representative of the release liner being attached to the electrocardiographic electrodes;

a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store the samples of the electrocardiographic signals collected during the execution of the monitoring sequence throughout the extended monitoring period; and

a wireless transceiver interfaced with the low power microcontroller and the non-volatile memory, the wireless transceiver comprising a cellular chipset configured to receive additional data associated with the patient from one or more cellular phones over a cellular network and to transmit the stored samples of the electrocardiographic signals and the additional data over the cellular network.

8. A contact-activated ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation according to claim 7, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

9. A contact-activated ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation according to claim 7, wherein the wireless transceiver is further operable to wirelessly interface with one or more further external wireless-enabled devices.

10. A contact-activated ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation according to claim 9, wherein the wireless transceiver communicates to the one or more further external wireless-enabled devices an alert generated based on the samples.

11. A contact-activated ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation according to claim 7, wherein the patient is referred for medical care based on the transmitted samples.

12. A contact-activated ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation according to claim 7, wherein the timer is one of interfaced to the low-power microcontroller or implemented by the low-power microcontroller.