IP Library Granted Patent US 11,660,037
Granted Patent B2
US 11,660,037 · App. 17/947,914 · Granted May 30, 2023

System for electrocardiographic signal acquisition and processing

Inventors: Jason Felix (Vashon Island, WA); Jon Mikalson Bishay (Lexington, KY); Gust H. Bardy (Carnation, WA)
Assignee: BARDY DIAGNOSTICS, INC.
A61B5/335A61B5/259A61B5/282A61B5/332A61B5/349A61B5/6823A61B5/725A61B5/7232
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Quick Facts
Patent No.
US 11,660,037
App. No.
17/947,914
Granted
May 30, 2023
Kind
B2
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 (46)

1. A system for electrocardiographic signal acquisition and processing, comprising:

a monitor, comprising:

a housing adapted to interface to two electrocardiographic electrodes;

the two electrocardiographic electrodes, one of the electrocardiographic electrodes comprising an inline resistor;

an electrocardiographic front end circuit under a control of a microcontroller and configured to sense cardiac action potentials through the two electrocardiographic electrodes and to output an analog electrocardiographic signal, the electrocardiographic front end circuit further comprising:

two leads configured to sense the potentials through the ECG sensing electrodes;

at least a portion of a passive input filter stage, the at least the portion of the stage comprising a coupling capacitor, a termination resistor, and filter capacitor through which at least some of a current of the sensed electrocardiographic potentials passes in a direct sequence prior to reaching an operational amplifier comprised in a further portion of the electrocardiographic front end circuit;

the microcontroller operable to execute under modular micro program control as specified in firmware and further operable to acquire samples of the output analog electrocardiographic signal; and

a memory electrically interfaced with the microcontroller and operable to store the samples.

2. The system according to claim 1 , wherein the passive input filter stage shifts frequency response poles downward when there is a high electrode impedance from a patient on the two leads, which reduces high frequency noise.

3. The system according to claim 2 , wherein the inline resistor protects the patient from at least a portion of leakage current in case of a failure of the electrocardiographic front end circuit.

4. A system according to claim 1 , further comprising:

an external connector comprising a plurality of electrical contacts, wherein the two leads interface to the two electrocardiographic electrodes through the external connector.

5. A system according to claim 4 , wherein the electrical contacts protrude from a surface of the housing.

6. A system according to claim 4 , wherein the microcontroller and the memory receive power via the external connector.

7. The system according to claim 4 , further comprising:

a download station configured to interface to the monitor via the external connector when the housing is not interfaced to the electrodes and to receive the samples from the memory.

8. The system according to claim 7 , wherein the samples are compressed prior to being stored in the memory and the download station decompresses the samples.

9. The system according to claim 7 , wherein the download station comprises an electromechanical docking interface configured to connect to the external connector.

10. The system according to claim 4 , further comprising:

a physiology sensor configured to sense physiological data, wherein the physiological data is stored in the memory via the external connector.

11. A multi-part system for electrocardiographic data acquisition and processing, comprising:

an 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, one of the electrocardiographic electrodes comprising an inline resistor;

a 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

a monitor recorder, comprising:

a housing adapted to be coupled to the pair of the electrocardiographic electrodes via the electromechanical docking interface;

an electrocardiographic front end circuit under a control of a microcontroller and configured to sense cardiac action potentials through the pair of the electrocardiographic electrodes and to output an analog electrocardiographic signal, the electrocardiographic front end circuit further comprising:

two leads configured to sense the potentials through the ECG sensing electrodes;

at least a portion of a passive input filter stage, the at least the portion of the stage comprising a coupling capacitor, a termination resistor, and filter capacitor through which at least some of a current of the sensed electrocardiographic potentials passes in a direct sequence prior to reaching an operational amplifier comprised in a further portion of the electrocardiographic front end circuit;

the microcontroller operable to execute under modular micro program control as specified in firmware and further operable to acquire samples of the output analog electrocardiographic signal; and

a memory electrically interfaced with the microcontroller and operable to store the samples.

12. The system according to claim 11 , wherein the passive input filter stage shifts frequency response poles downward when there is a high electrode impedance from a patient on the two leads, which reduces high frequency noise.

13. The system according to claim 12 , wherein the inline resistor protects the patient from at least a portion of leakage current in case of a failure of the electrocardiographic front end circuit.

14. A system according to claim 11 , further comprising:

an external connector comprising a plurality of electrical contacts, wherein the two leads interface to the two electrocardiographic electrodes through the external connector.

15. The system according to claim 14 , wherein the electrical contacts protrude from a surface of the housing.

16. A system according to claim 14 , wherein the microcontroller and the memory receive power via the external connector.

17. The system according to claim 14 , further comprising:

a download station configured to interface to the monitor recorder via the external connector when the housing is not interfaced to the electrodes and to receive the samples from the memory.

18. The system according to claim 17 , wherein the samples are compressed prior to being stored in the memory and the download station decompresses the samples.

19. The system according to claim 17 , wherein the download station comprises an electromechanical docking interface configured to connect to the external connector.

20. The system according to claim 14 , further comprising:

a physiology sensor configured to sense physiological data, wherein the physiological data is stored in the memory via the external connector.

Continuity (8)
Continuation 16783072 · Feb 5, 2020
Continuation 16397091 · Apr 29, 2019
Continuation 15966910 · Apr 30, 2018
Continuation 15483142 · Apr 10, 2017
Continuation 14488247 · Sep 16, 2014
Continuation In Part 14080725 · Nov 14, 2013
Provisional Application 61882403 · Sep 25, 2013
Related Publication 20230017410A1 · Jan 19, 2023
Cited By (15)
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