IP Library Granted Patent US 11,653,869
Granted Patent B2
US 11,653,869 · App. 17/959,174 · Granted May 23, 2023

Multicomponent electrocardiography monitor

Inventors: Jon Mikalson Bishay (Lexington, KY); Jason Felix (Vashon Island, WA); Gust H. Bardy (Carnation, WA)
Assignee: BARDY DIAGNOSTICS, INC.
A61B5/349A61B5/0006A61B5/0205A61B5/259A61B5/282A61B5/6823A61B5/7225A61B2560/0406A61B2560/0443
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Quick Facts
Patent No.
US 11,653,869
App. No.
17/959,174
Granted
May 23, 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 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 (43)

1. A multicomponent electrocardiography monitor, comprising:

an electrocardiography monitor recorder comprising:

a wearable housing comprising a substantially trapezoidal cavity and a plurality of electrical contacts positioned on a same side of the wearable housing on which the substantially trapezoidal cavity is formed, wherein the plurality of the electrical contacts are closer to a proximal end of the wearable housing than the substantially trapezoidal cavity; and

electronic circuitry provided at least partially within the wearable housing, the electronic circuitry further comprising:

an electrocardiographic front end circuit under a control of a micro-controller adapted to sense cardiac electrical potential differentials through electrocardiographic electrodes via some of the electrical contacts, which are provided to the micro-controller as an analog signal; and

the micro-controller configured to sample the analog signal;

a memory electrically interfaced with the micro-controller and operable to store the samples; and

an extended wear electrode patch, comprising:

a flexible backing comprising a plurality of adhesive contact surfaces;

the electrocardiographic electrodes, each comprised on one of the adhesive contact surfaces;

a receptacle affixed to a non-contacting surface of the flexible backing into which the wearable housing can be removable secured, the receptacle comprising a protrusion that is at least partially aligned with the substantially trapezoidal cavity when the wearable housing is secured within the receptacle; and

a plurality of electrical pads positioned on the receptacle, each of the pads configured to interface with one of the electrical contacts when the wearable housing is secured within the receptacle, wherein the protrusion comprises a compartment within which a component of the patch interfaced to some of the electrical contacts through some of the pads is positioned.

2. A monitor according to claim 1 , wherein the protrusion is closer to a distal end of the patch than the pads.

3. A monitor according to claim 1 , wherein at least some of the corners of the substantially trapezoid cavity are rounded.

4. A monitor according to claim 1 , wherein the protrusion is shaped substantially as a trapezoid.

5. A monitor according to claim 4 , wherein at least some of the corners of the protrusion are rounded.

6. A monitor according to claim 4 , wherein the component is interfaced to different ones of the pads than the electrodes.

7. A monitor according to claim 6 , wherein the component comprises a battery.

8. A monitor according to claim 1 , further comprising:

the monitor recorder further comprising a seal coupling circumferentially surrounding the contacts and shaped to mate with a moisture resistant seal when the wearable housing is within the receptacle; and

the patch further comprising the moisture-resistant seal surrounding the pads.

9. A monitor according to claim 1 , wherein some of the pads are interfaced to the electrodes via a circuit trace.

10. An electrocardiography monitor with interfacing components, comprising:

an electrocardiography monitor recorder comprising:

a wearable housing comprising a substantially trapezoidal cavity at a distal portion of the housing and a plurality of electrical contacts positioned on a proximal portion of a same side of the wearable housing on which the substantially trapezoidal cavity is formed; and

an electronic circuitry provided at least partially within the wearable housing, the electronic circuitry further comprising:

an electrocardiographic front end circuit under a control of a micro-controller adapted to sense cardiac electrical potential differentials through electrocardiographic electrodes via some of the electrical contacts, which are provided to the micro-controller as an analog signal;

the micro-controller configured to sample the analog signal; and

a memory electrically interfaced with the micro-controller and operable to store the samples; and

an extended wear electrode patch, comprising:

a flexible backing comprising a plurality of adhesive contact surfaces;

the electrocardiographic electrodes, each comprised on one of the adhesive contact surfaces;

a receptacle affixed to a non-contacting surface of the flexible backing into which the wearable housing can be removable secured, the receptacle comprising a protrusion that is at least partially aligned with the substantially trapezoidal cavity when the wearable housing is secured into the receptacle; and

a plurality of electrical pads positioned on the receptacle, each of the pads configured to interface with one of the electrical contacts when the wearable housing is secured within the receptacle, wherein the protrusion is positioned on a distal portion of the receptacle and the pads are positioned on a proximal portion of the receptacle, wherein the protrusion comprises a compartment within which a battery is positioned.

11. A monitor according to claim 10 , wherein at least some of the corners of the substantially trapezoid cavity are rounded.

12. A monitor according to claim 10 , wherein the protrusion is shaped substantially as a trapezoid.

13. A monitor according to claim 12 , wherein at least some of the corners of the protrusion are rounded.

14. A monitor according to claim 10 , wherein the battery is interfaced to different ones of the pads than the electrodes.

15. A monitor according to claim 10 , further comprising:

the monitor recorder further comprising a seal coupling circumferentially surrounding the contacts and shaped to mate with a moisture resistant seal when the wearable housing is within the receptacle; and

the patch further comprising the moisture-resistant seal surrounding the pads.

16. A monitor according to claim 10 , wherein some of the pads are interfaced to the electrodes via a circuit trace.

17. A monitor according to claim 10 , wherein the micro-controller, the electrocardiographic front end circuit, and the memory each interface to at least some of the electrical contacts.

Continuity (8)
Continuation 16782951 · Feb 5, 2020
Continuation 16404562 · May 6, 2019
Continuation 16174122 · Oct 29, 2018
Continuation 15645708 · Jul 10, 2017
Continuation 14488230 · Sep 16, 2014
Continuation In Part 14080725 · Nov 14, 2013
Provisional Application 61882403 · Sep 25, 2013
Related Publication 20230029962A1 · Feb 2, 2023