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

• US 9,615,763 B2
• Filed: 09/16/2014
• Issued: 04/11/2017
• 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: Felix, Jason, Bishay, Jon Mikalson, Bardy, Gust H.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/488,247
• Publication Number:
  US 20160007877A1
• Time in Patent Office: 938 Days
• Field of Search: 600509, 600382, 600391-393
• 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 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• 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 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/725 using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence

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 (in the midline) 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, to a lesser extent, the QRS interval signals indicating ventricular activity in the ECG waveforms. Additionally, the monitor recorder includes an ECG sensing circuit that measures raw cutaneous electrical signals using a driven reference containing power supply noise and system noise to the reference lead, which is critical to preserving the characteristics of low amplitude cardiac action potentials, particularly P-waves.

Claims

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

a wearable housing adapted to be coupled to a pair of electrocardiographic electrodes that are fitted for dermal placement along a sternal midline; and

electronic circuitry provided within the wearable housing and comprising;

a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware stored in a program memory unit;

an electrocardiographic front end circuit interfaced to the microcontroller and configured to output electrocardiographic signals representative of cardiac activation wave front amplitudes, comprising;

a signal lead operable to sense cardiac electrical potentials dermally through one of the electrocardiographic electrodes;

a reference lead operable to sense the cardiac electrical potentials dermally through the other of the electrocardiographic electrodes; and

a reference generator comprising a pair of resistors configured to inject a driven reference containing power supply noise and system noise to the reference lead, the signal lead further comprising a coupling capacitor and a protection resistor associated with thermal noise and comprised inline with the electrocardiographic electrode, wherein the thermal noise is not contained in the driven reference, the pair of the resistors connected to a DC power source by a pair of connections through which the pair of the resistors receive the system noise and the power noise comprised in the driven reference; and

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

2. An electrocardiography monitor recorder 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 monitor recorder 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 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.

4. An electrocardiography monitor recorder in accordance with claim 3, further comprising:

the electronic circuitry further comprising an external interface; and

a download station 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 retrieval module configured to retrieve the samples of the electrocardiographic signals from the non-volatile memory; and

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

5. An electrocardiography monitor recorder in accordance with claim 4, 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.

6. An electrocardiography monitor recorder in accordance with claim 4, 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.

7. An electrocardiography monitor recorder in accordance with claim 4, 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.

8. An electrocardiography monitor recorder in accordance with claim 3, the microcontroller further comprising:

a compression algorithm comprised in the firmware,

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

9. An electrocardiography monitor recorder in accordance with claim 1, wherein the DC power source comprises a direct current power cell comprised external to the wearable housing and adapted to be removably and electronically coupled to the electronic circuitry.

10. An electrocardiography monitor recorder in accordance with claim 9, further comprising:

a power up sequence stored as part of the firmware in the program memory unit, wherein the microcontroller is operable to execute the power up sequence upon the power cell being electronically coupled to the electronic circuitry.

11. An electrocardiography monitor recorder according to claim 10, the power up sequence comprising one or more of a power cell voltage checking procedure, a flash memory state checking procedure, and a micro-controller diagnostic procedure.

12. An electrocardiography monitor recorder in accordance with claim 9, further comprising:

a power up sequence stored as part of the firmware in the program memory unit; and

a control switch external to the wearable housing and operatively coupled to the electronic circuitry, wherein the microcontroller is operable to execute the power up sequence when the switch is in an on state.

13. An electrocardiography monitor recorder in accordance with claim 9, further comprising:

a power up sequence stored as part of the firmware in the program memory unit; and

a transreceiver provided with the wearable housing and operable to provide remote control over the microcontroller, wherein the microcontroller is operable to execute the power up sequence upon the transreceiver receiving a power up signal.

14. An electrocardiography monitor recorder according to claim 9, further comprising:

a disposable extended wear electrode patch comprising the pair of the electrocardiographic electrodes;

a cryptographic circuit external to the wearable housing; and

an authentication procedure stored as part of the firmware in the program memory unit, wherein the microcontroller is operable to securely authenticate and validate the disposable extended wear electrode patch through the cryptographic circuit upon the power cell being coupled to the electronic circuitry, the microcontroller further operable to cease execution upon failure of the authentication procedure.

15. An electrocardiography monitor recorder according to claim 1, further comprising:

a disposable extended wear electrode patch comprising the pair of the electrocardiographic electrodes;

a pair of electrical contacts external to the wearable housing and electrically connected to the microcontroller; and

a pair of electrical pads external to the disposable extended wear electrode patch and disposed to operatively couple with the pair of the electrical contacts, the electrical pads further electrically interfaced via power cell leads to a power cell.

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

a wearable housing adapted to be coupled to a pair of electrocardiographic electrodes that are fitted for dermal placement along a sternal midline; and

electronic circuitry provided within the wearable housing and comprising;

a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware stored in a program memory unit;

an electrocardiographic front end circuit interfaced to the microcontroller and configured to output electrocardiographic signals representative of cardiac activation wave front amplitudes, comprising;

a signal lead operable to sense cardiac electrical potentials dermally through one of the electrocardiographic electrodes and comprising a coupling capacitor and a protection resistor comprised inline with the electrocardiographic electrode;

a reference lead operable to sense the cardiac electrical potentials dermally through the other of the electrocardiographic electrodes; and

a reference generator comprising a pair of resistors configured to inject a driven reference containing power supply noise and system noise to the reference lead, the pair of the resistors connected to a DC power source by a pair of connections through which the pair of the resistors receive the system noise and the power noise comprised in the driven reference; and

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

17. An electrocardiography monitor recorder in accordance with claim 16, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

18. An electrocardiography monitor recorder in accordance with claim 16, the microcontroller further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of the 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. An electrocardiography monitor recorder in accordance with claim 18, further comprising:

the electronic circuitry further comprising an external interface; and

a download station 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 retrieval module configured to retrieve the samples of the electrocardiographic signals from the non-volatile memory; and

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

20. An electrocardiography monitor recorder in accordance with claim 19, 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.