Monitor recorder optimized for electrocardiographic potential processing

• US 10,561,326 B2
• Filed: 04/29/2019
• Issued: 02/18/2020
• 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): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US16/397,091
• Publication Number:
  US 20190254553A1
• Time in Patent Office: 295 Days
• 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 and performs signal processing prior to outputting the processed signals for sampling and storage.

Claims

1. A monitor recorder optimized for electrocardiographic potential processing, comprising:

a housing adapted to be coupled to at least one electrocardiographic electrode; and

an electronic circuitry provided within the housing and comprising;

an electrocardiographic front end circuit under the control of a low-power microcontroller and configured to sense electrocardiographic potentials through the at least one electrocardiographic electrode and to output electrocardiographic signals representative of cardiac activation wave front amplitudes, the electrocardiographic front end circuit comprising an operational amplifier and an AC coupling capacitor through which a current of the sensed electrocardiographic potentials passes in a direct sequence, wherein the operational amplifier amplifies the current;

the low-power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and further operable to acquire samples of the output electrocardiographic signals; and

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

2. A monitor recorder in accordance with claim 1, wherein the AC coupling capacitor applies a high-pass filter on the current.

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

a further operational amplifier through which the current passes after passing through the AC coupling capacitor.

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

a resistor and a capacitor through which the current sequentially passes after passing through the further operational amplifier.

5. A monitor recorder in accordance with claim 4, wherein the resistor and the capacitor apply an anti-aliasing low pass filter to the current.

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

a protection resistor through which the current passes prior to passing through the operational amplifier.

7. A monitor recorder in accordance with claim 6, further comprising:

an additional AC coupling capacitor, a termination resistor, and a filter capacitor through which the current passes after passing through the protection resistor and prior to passing through the operational amplifier.

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

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

one or more low pass filters comprised in the firmware; and

one or more high pass filters comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the one or more of the low pass filters and the one or more of the high pass filters following conversion into the digital representations.

9. A monitor recorder in accordance with claim 8, wherein the firmware comprises three of the low pass filters.

10. A monitor recorder in accordance with claim 8, wherein the firmware comprises two of the high pass filters.

11. A monitor optimized for electrocardiographic potential processing, comprising:

a disposable extended wear electrode patch, comprising;

a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection;

a pair of electrocardiographic electrodes comprised on a contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along a 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; 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; and

an electrocardiography monitor recorder, comprising;

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

an electronic circuitry provided within the wearable housing and comprising;

an electrocardiographic front end circuit under the control of a low-power microcontroller and configured to sense electrocardiographic potentials through the electrocardiographic electrodes and to output electrocardiographic signals representative of cardiac activation wave front amplitudes, the electrocardiographic front end circuit comprising an operational amplifier and an AC coupling capacitor through which a current of the sensed electrocardiographic potentials passes in a direct sequence, wherein the operational amplifier amplifies the current;

the low-power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and further operable to acquire samples of the output electrocardiographic signals; and

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

12. A monitor in accordance with claim 11, wherein the AC coupling capacitor applies a high-pass filter on the current.

13. A monitor in accordance with claim 11, further comprising:

a further operational amplifier through which the current passes after passing through the AC coupling capacitor.

14. A monitor in accordance with claim 13, further comprising:

a resistor and a capacitor through which the current sequentially passes after passing through the further operational amplifier.

15. A monitor in accordance with claim 14, wherein the resistor and the capacitor apply an anti-aliasing low pass filter to the current.

16. A monitor in accordance with claim 11, further comprising:

a protection resistor through which the current passes prior to passing through the operational amplifier.

17. A monitor in accordance with claim 16, further comprising:

an additional AC coupling capacitor, a termination resistor, and a filter capacitor through which the current passes after passing through the protection resistor and prior to passing through the operational amplifier.

18. A monitor in accordance with claim 11, further comprising:

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

one or more low pass filters comprised in the firmware; and

one or more high pass filters comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the one or more of the low pass filters and the one or more of the high pass filters following conversion into the digital representations.

19. A monitor in accordance with claim 18, wherein the firmware comprises three of the low pass filters.

20. A monitor in accordance with claim 18, wherein the firmware comprises two of the high pass filters.