Ambulatory electrocardiography monitor optimized for capturing low amplitude cardiac action potential propagation

• US 10,278,606 B2
• Filed: 10/29/2018
• Issued: 05/07/2019
• 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: Bishay, Jon Mikalson, Felix, Jason, Bardy, Gust H.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US16/174,122
• Publication Number:
  US 20190059768A1
• Time in Patent Office: 190 Days
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• 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

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.

Claims

1. An ambulatory electrocardiography monitor optimized for capturing low amplitude cardiac action potential propagation, comprising:

a disposable extended wear electrode patch, comprising;

a flexible backing comprising two adhesive contact surfaces;

a pair of electrocardiographic electrodes, each comprised on one of the adhesive contact surfaces, each electrocardiographic electrode conductively exposed for dermal adhesion;

a receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro-mechanical docking interface, the docking interface comprising a first set of electrical contact mating pads and a second set of electrical contact mating pads;

a battery within a compartment on a bottom surface of the receptacle and electrically interfaced to the first set of the electrical contact mating pads of the docking interface; and

a 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 the electrical contact mating pads of the second set of the electrical contact mating pads of the docking interface; 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 electrical 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, wherein the electrical contacts are arranged in alignment with the first set of electrical contact mating pads and the second set of electrical contact mating pads when the wearable housing is securely fitted within the receptacle; 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 of the docking interface and to the battery via the first set of the electrical contact mating pads of the docking interface, the electronic circuitry further comprising;

a low power micro-controller 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 micro-controller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the micro-controller as electrocardiographic signals representative of amplitudes of the action potential propagation; and

a non-volatile memory electrically interfaced with the micro-controller and operable to continuously store samples of the electrocardiographic signals throughout the extended period.

2. A monitor in accordance with claim 1, wherein the external connector is configured to mechanically and electrically interface with a download station and the download station is configured to retrieve the stored samples of the electrocardiographic signals via the external connector.

3. A monitor in accordance with claim 1, further comprising:

the micro-controller further operable to buffer each of the electrocardiographic signal samples, to compress each of the buffered electrocardiographic signal samples, to buffer each of the compressed electrocardiographic signal samples, and to write the buffered compressed electrocardiographic signal samples into the non-volatile memory.

4. A monitor in accordance with claim 1, further comprising:

an actigraphy sensor comprised within the ambulatory electrocardiography monitor recorder and operable to detect actigraphy events, the actigraphy sensor configured to provide to the micro-controller an interrupt signal upon detection of one of the actigraphy events;

the microcontroller further configured to sample the one actigraphy event upon receipt of the interrupt signal and to store the actigraphy event sample within the non-volatile memory.

5. A monitor in accordance with claim 4, wherein each of the actigraphy events comprise a wake up event or a free fall event.

6. A monitor in accordance with claim 4, wherein the actigraphy sensor is configured so that an orientation of the monitor recorder is compensated if installed upside down.

7. A system for ambulatory electrocardiography monitoring and capturing low amplitude cardiac action potential propagation, comprising:

an ambulatory electrocardiography monitor, comprising;

a disposable extended wear electrode patch, comprising;

a flexible backing comprising two adhesive contact surfaces;

a pair of electrocardiographic electrodes, each comprised on one of the adhesive contact surfaces, each electrocardiographic electrode conductively exposed for dermal adhesion;

a receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro-mechanical docking interface, the docking interface comprising a first set of electrical contact mating pads and a second set of electrical contact mating pads;

a battery within a compartment on a bottom surface of the receptacle and electrically interfaced to the first set of the electrical contact mating pads of the docking interface; and

a 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 the electrical contact mating pads of the second set of the electrical contact mating pads of the docking interface;

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 electrical 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 of the docking interface and to the battery via the first set of the electrical contact mating pads of the docking interface, the electronic circuitry further comprising;

a low power micro-controller 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 micro-controller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the micro-controller as electrocardiographic signals representative of amplitudes of the action potential propagation; and

a non-volatile memory electrically interfaced with the micro-controller and operable to continuously store samples of the electrocardiographic signals throughout the extended period; and

a download station configured to retrieve the stored samples of the electrocardiographic signals from the non-volatile memory.

8. A system in accordance with claim 7, wherein the electrical contacts are arranged in alignment with the first set of electrical contact mating pads and the second set of electrical contact mating pads when the wearable housing is securely fitted within the receptacle.

9. A system in accordance with claim 7, wherein the external connector is configured to mechanically and electrically interface with the download station.

10. A system in accordance with claim 7, further comprising:

the micro-controller further operable to buffer each of the electrocardiographic signal samples, to compress each of the buffered electrocardiographic signal samples, to buffer each of the compressed electrocardiographic signal samples, and to write the buffered compressed electrocardiographic signal samples into the non-volatile memory.

11. A system in accordance with claim 7, further comprising:

an actigraphy sensor comprised within the ambulatory electrocardiography monitor recorder and operable to detect actigraphy events, the actigraphy sensor configured to provide to the micro-controller an interrupt signal upon detection of one of the actigraphy events;

the microcontroller further configured to sample the one actigraphy event upon receipt of the interrupt signal and to store the actigraphy event sample within the non-volatile memory.

12. A system in accordance with claim 11, wherein each of the actigraphy events comprise a wake up event or a free fall event.

13. A system in accordance with claim 11, wherein the actigraphy sensor is configured so that an orientation of the monitor recorder is compensated if installed upside down.

14. A system in accordance with claim 11, the download station further comprising:

an electro mechanical docking interface; and

a download station controller configured to be removably connected to the electronic circuitry via the docking interface and operable to execute under programmable control as specified in software, the software comprising;

a data storage module configured to store the retrieved samples of the electrocardiographic signals into local storage.

15. A system in accordance with claim 14, the software further comprising:

a software-implemented P-wave base boost response filter adapted to restore missing frequency content in the retrieved samples of the electrocardiographic signals.

16. A system in accordance with claim 14, wherein:

the micro-controller further comprising;

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of cardiac activation wave front amplitudes;

at least one low pass filter comprised in the firmware; and

at least one high pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the at least one low pass filter and the at least one high pass filter following conversion into the digital representations; and

the software further comprising;

at least one software-implemented low pass filter that corresponds to the at least one low pass filter comprised in the firmware;

at least one software-implemented high pass filter that corresponds to the at least one high pass filter comprised in the firmware; and

a phase distortion correction module configured to run the retrieved samples of the electrocardiographic signals through each of the at least one software-implemented low pass filter and the at least one software-implemented high pass filter in a direction reversed respectively from the at least one low pass filter comprised in the firmware and the at least one high pass filter comprised in the firmware.

17. A system in accordance with claim 14, the software further comprising:

a software-implemented bidirectional impulse infinite response (IIR) high pass filter; and

a phase distortion correction module configured to run the retrieved samples of the electrocardiographic signals through the IIR high pass filter first in a forward direction and then in a reverse direction.

18. A system in accordance with claim 7, the micro-controller further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of cardiac activation wave front amplitudes;

at least one low pass filter comprised in the firmware; and

at least one high pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the at least one low pass filter and the at least one high pass filter following conversion into the digital representations.

19. A system in accordance with claim 7, wherein the ambulatory electrocardiography monitor is wirelessly interfaced to the download station.