Ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation

• US 9,700,227 B2
• Filed: 09/16/2014
• Issued: 07/11/2017
• 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:
  US14/488,230
• Publication Number:
  US 20160007872A1
• Time in Patent Office: 1,029 Days
• Field of Search: 600382, 600391-393, 600509
• 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 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.

2. An electrocardiography monitoring patch in accordance with claim 1, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

3. An electrocardiography monitoring patch in accordance with claim 1, wherein the disposable extended wear electrode patch is disposed for being adhered to a patient'"'"'s chest positioned axially along the midline of the sternum with one of the electrocardiographic electrodes overlying a region of the manubrium and one of the electrocardiographic electrodes overlying a region of the lower sternum.

4. An electrocardiography monitoring patch in accordance with claim 1, wherein the electronic circuitry is configured so that an orientation of the monitor recorder is compensated if installed upside down.

5. An electrocardiography monitoring patch in accordance with claim 1, the microcontroller further comprising:

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

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

at least one high pass filter comprised in the firmware,

wherein the 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.

6. An electrocardiography monitoring patch in accordance with claim 5, the microcontroller further comprising:

a compression algorithm comprised in the firmware,

wherein the amplitudes are compressed with the compression algorithm into compressed digital representations prior to being stored in the non-volatile memory.

7. An electrocardiography monitoring patch in accordance with claim 1,

wherein each strain relief cutout is partially extending transversely from and continuing longitudinally to a side of the flexible circuit different than the other strain relief cutout, one of the pair of circuit traces following a path formed on the flexible circuit between the pair of strain relief cutouts.

8. 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 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.

9. An electrocardiography monitor in accordance with claim 8, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

10. An electrocardiography monitor in accordance with claim 8, wherein the disposable extended wear electrode patch is disposed for being adhered to a patient'"'"'s chest positioned axially along the midline of the sternum with one of the electrocardiographic electrodes overlying a region of the manubrium and one of the electrocardiographic electrodes overlying a region of the lower sternum.

11. An electrocardiography monitor in accordance with claim 8, wherein the electronic circuitry is configured so that an orientation of the monitor recorder is compensated if installed upside down.

12. An electrocardiography monitor in accordance with claim 8, the microcontroller further comprising:

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

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

at least one high pass filter comprised in the firmware,

wherein the 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.

13. An electrocardiography monitor in accordance with claim 12, the microcontroller further comprising:

a compression algorithm comprised in the firmware,

wherein the amplitudes are compressed with the compression algorithm into compressed digital representations prior to being stored in the non-volatile memory.

14. An electrocardiography monitor in accordance with claim 8, further comprising:

a non-irritating adhesive dressing at least partially coated on each end of the elongated strip on the contact surface.

15. An electrocardiography monitor in accordance with claim 8, further comprising:

an actigraphy sensor comprised within the ambulatory electrocardiography monitor recorder and operable to detect movement, the actigraphy sensor electrically interfaced with the micro-controller; and

the non-volatile memory further operable to store samples of the movement detected by the actigraphy sensor.

16. An electrocardiography monitor recorder in accordance with claim 8, further comprising:

a transceiver provided with the wearable housing and operable to provide remote control over the microcontroller.

17. An electrocardiography monitor according to claim 8, further comprising:

an expansion port comprised in the micro-controller and electrically coupled to at least one of the electrical contact mating pads;

a physiology sensor comprised within the disposable extended wear electrode patch and operable to sense physiology and to draw power from the battery, the physiology sensor electrically interfaced to the expansion port; and

the non-volatile memory further operable through the expansion port to store samples of the physiology sensed by the physiology sensor.

18. An electrocardiography and physiological sensor monitor according to claim 17, wherein the physiology sensor is selected from the group consisting of an SpO₂ sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

19. An electrocardiography monitor according to claim 8, further comprising:

an expansion port comprised in the micro-controller;

a physiology sensor comprised within the ambulatory electrocardiography monitor recorder and operable to sense physiology and to draw power from the battery, the physiology sensor electrically interfaced to the expansion port; and

the non-volatile memory further operable through the expansion port to store samples of the physiology sensed by the physiology sensor.

20. An electrocardiography and physiological sensor monitor according to claim 19, wherein the physiology sensor is selected from the group consisting of an SpO₂ sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.