IP Library › Granted Patent US 12,285,261
Granted Patent B2
US 12,285,261 · App. 18/318,641 · Granted Apr 29, 2025

Moisture-resistant electrocardiogramy monitor

Inventors: Jon Mikalson Bishay (Lexington, KY); Jason Felix (Vashon Island, WA); Gust H. Bardy (Carnation, WA)
A61B5/349A61B5/0006A61B5/0205A61B5/259A61B5/282A61B5/6823A61B5/7225A61B2560/0406A61B2560/0443
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Quick Facts
Patent No.
US 12,285,261
App. No.
18/318,641
Granted
Apr 29, 2025
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 (48)

1. A moisture-resistant electrocardiography monitor, comprising:

an electrocardiography monitor recorder, comprising:

a wearable housing molded out of one or more materials and sealed against moisture;

a plurality of electrical contacts protruding from the wearable housing;

a seal coupling positioned on the wearable housing and surrounding the electrical contacts; and

electronic circuitry provided within the wearable housing, the electronic circuitry further comprising:

an electrocardiographic front end circuit under a control of a micro-controller and 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 removably secured, the receptacle comprising a compartment within which a component interfaced to the electronic circuitry is positioned via some of the electrical contacts, wherein the component is a battery;

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; and

a moisture-resistant seal formed on the receptacle and surrounding the electrical pads, wherein the moisture-resistant seal mates the seal coupling when the wearable housing is secured within the receptacle.

2. A monitor according to claim 1 , wherein the one or more materials comprise at least one of polycarbonate and ABS.

3. A monitor according to claim 1 , wherein the one or more materials comprise an alloy of polycarbonate and ABS.

4. A monitor according to claim 1 , the housing further comprising a waterproof patient-operable tactile-feedback button.

5. A monitor according to claim 4 , wherein an outer surface of the button is molded out of a soft pliable material.

6. A monitor according to claim 5 , wherein the soft pliable material comprises silicon rubber.

7. A monitor according to claim 1 , wherein the seal coupling and the moisture resistant seal are circular.

8. A monitor according to claim 1 , wherein the battery is replaceable without opening the wearable housing.

9. A monitor according to claim 1 , wherein the compartment is formed on a bottom surface of the receptacle.

10. A moisture-resistant patient-interfacing electrocardiography monitor, comprising:

an electrocardiography monitor recorder, comprising:

a wearable housing molded out of one or more materials and sealed against moisture;

a waterproof patient-operable tactile feedback button positioned on an outside of the wearable housing;

a plurality of electrical contacts protruding the wearable housing;

a seal coupling positioned on the wearable housing and surrounding the electrical contacts; and

electronic circuitry provided within the wearable housing, the electronic circuitry further comprising:

an electrocardiographic front end circuit under a control of a micro-controller and 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 removably secured, the receptacle comprising a compartment within which a battery, wherein the electronic circuitry is powered by the battery via at least some of the electrical contacts;

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; and

a moisture-resistant seal formed on the receptacle and surrounding the electrical pads, wherein the moisture-resistant seal mates the seal coupling when the wearable housing is secured within the receptacle.

11. A monitor according to claim 10 , wherein the one or more materials comprise at least one of polycarbonate and ABS.

12. A monitor according to claim 10 , wherein the one or more materials comprise an alloy of polycarbonate and ABS.

13. A monitor according to claim 10 , wherein the waterproof patient-operable tactile feedback button is positioned on a side of the housing opposite to a further side on which the electrical contacts are positioned.

14. A monitor according to claim 13 , wherein an outer surface of the button is molded out of a soft pliable material.

15. A monitor according to claim 14 , wherein the soft pliable material comprises silicon rubber.

16. A monitor according to claim 10 , wherein the seal coupling and the moisture resistant seal are circular.

17. A monitor according to claim 10 , wherein the battery is one of a replaceable, rechargeable, and disposable battery.

18. A monitor according to claim 10 , wherein the compartment is formed on a bottom surface of the receptacle.

19. A monitor according to claim 10 , wherein the battery is replaceable without opening the wearable housing.

Continuity (9)
Continuation 17959174 · Oct 3, 2022
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 20230301576A1 · Sep 28, 2023
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[Corrected] Chart CC-2 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Patent No. by U.S. Pat. Pub. No. 2011/0077497 (“Oster”) and U.S. Pat. No. 11,116,447 (“Yang”); … [cited by applicant]
[Corrected] Chart C-2 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. Pub. No. 2011/0077497 (“Oster”) and U.S. Pat. No. 11,116,447 (“… [cited by applicant]
Chart AA-1 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by International Publication No. WO 2010/104952 to Mazar (“Mazar”) and U.S. Pat. No. 11… [cited by applicant]
Chart C-1 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by International Publication No. WO 2010/104952 to Mazar (“Mazar”) and U.S. Pat. No. 11,… [cited by applicant]
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Chart B-6 Invalidity Contentions: U.S. Pat. No. 11,051,743 and U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Hydrocolloid Adhesives on a Portion of the Backing; Oct. 25, 2023; 5 pages. [cited by applicant]
Chart B-5 Invalidity Contentions: U.S. Pat. No. 11,051,743 and U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Conversion of Electrocardiogramals From One Format to Another; Oct. 25, 2023; 6 pages. [cited by applicant]
Chart B-4 Invalidity Contentions: U.S. Pat. No. 11,051,743 and U.S. Pat. No. 11,445,967; The Case No. 22-351-CJB (Delaware); Rounded Outer Edge of Backing Ends; Oct. 25, 2023; 5 pages. [cited by applicant]
Chart B-3 Invalidity Contentions: U.S. Pat. No. 11,051,743 and U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Flexible Circuit Comprising a Pair of Circuit Traces to Couple Electrodes; Oct. 25, 2023; 8 pages. [cited by applicant]
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Chart AA-10 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by WO 2003/065926 (“Ozguz”); Oct. 25, 2023; 6 pages. [cited by applicant]
Chart AA-9 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by U.S. Pat. Pub. No. 2011/0009729 (“Shin”); Oct. 25, 2023; 6 pages. [cited by applicant]
Chart AA-8 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by WO 2008/005015 (“Shennib”); Oct. 25, 2023; 6 pages. [cited by applicant]
Chart AA-7 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by U.S. Pat. No. 7,206,630 (“Tarler”); Oct. 25, 2023; 7 pages. [cited by applicant]
Chart AA-6 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by U.S. Pat. No. 9,669,212 (“Mueller”); Oct. 25, 2023; 6 pages. [cited by applicant]
Chart AA-5 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by U.S. Pat. No. 10,413,251 (“Golda”); Oct. 25, 2023; 6 pages. [cited by applicant]
Chart A-4 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by U.S. Pat. Pub. No. 2011/0077497 (“Oster”); Oct. 25, 2023; 6 pages. [cited by applicant]
Chart A-3 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by U.S. Pat. No. 10,327,660 (“Gallego”); Oct. 25, 2023; 7 pages. [cited by applicant]
Chart AA-2 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by U.S. Pat. No. 11,116,447 (“Yang”); Oct. 25, 2023; 14 pages. [cited by applicant]
Chart AA-1 Invalidity Contentions: U.S. Pat. No. 11,445,967; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,445,967 by International Publication No. WO 2010/104952 to Mazar (“Mazar”); Oct. 25, 2023; 13 p… [cited by applicant]
Chart A-10 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by WO 2003/065926 (“Ozguz”); Oct. 25, 2023; 12 pages. [cited by applicant]
Chart A-9 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. Pub. No. 2011/0009729 (“Shin”); Oct. 25, 2023; 12 pages. [cited by applicant]
Chart A-8 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by WO 2008/005015 (“Shennib”); Oct. 25, 2023; 12 pages. [cited by applicant]
Chart A-7 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. No. 7,206,630 (“Tarler”); Oct. 25, 2023; 12 pages. [cited by applicant]
Chart A-6 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. No. 9,669,212 (“Mueller”); Oct. 25, 2023; 11 pages. [cited by applicant]
Chart A-5 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. No. 10,413,251 (“Golda”); Oct. 25, 2023; 11 pages. [cited by applicant]
Chart A-4 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. Pub. No. 2011/0077497 (“Oster”); Oct. 25, 2023; 11 pages. [cited by applicant]
Chart A-3 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. No. 10,327,660 (“Gallego”); Oct. 25, 2023; 12 pages. [cited by applicant]
Chart A-2 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by U.S. Pat. No. 11,116,447 (“Yang”); Oct. 25, 2023; 19 pages. [cited by applicant]
Chart A-1 Invalidity Contentions: U.S. Pat. No. 11,051,743; Case No. 22-351-CJB (Delaware); Invalidity of U.S. Pat. No. 11,051,743 by International Publication No. WO 2010/104952 to Mazar (“Mazar”); Oct. 25, 2023; 19 pa… [cited by applicant]
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