IP Library Granted Patent US 12,232,879
Granted Patent B2
US 12,232,879 · App. 17/390,780 · Granted Feb 25, 2025

Atrial fibrillation detection

Inventor: Joseph L. Sullivan (Kirkland, WA)
Assignee: West Affum Holdings DAC
A61B5/361A61B5/33A61B5/7217
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,232,879
App. No.
17/390,780
Granted
Feb 25, 2025
Kind
B2
Abstract

Embodiments of a wearable monitoring device system can include one or more dry ECG electrodes and a processor that can be configured with one or more algorithms for detecting atrial fibrillation (AF) from sensed ECG signals sensed by the one or more dry ECG electrodes, and optionally other signals. In some embodiments the algorithms include one or more AF detection algorithms and optionally a noise detection algorithm. In some embodiments the wearable monitoring device or a remote system that receives data from the wearable medical device may calculate and/or characterize AF burden from ECG signals sensed by the one or more dry ECG electrodes.

Claims (40)

1. A wearable medical device (WMD) system for detecting atrial fibrillation (AF) in a patient capable of being ambulatory while using the WMD system, the WMD system comprising:

a plurality of electrocardiogram (ECG) electrodes configured to sense a multichannel ECG signal while the patient is using the WMD system;

a support structure configured to position at least one of the plurality of ECG electrodes to contact a body of the patient while the support structure is worn by the patient;

one or more processors, communicatively coupled to the plurality of ECG electrodes, configured with:

a first AF detection module configured to analyze the multichannel ECG signal using a first algorithm and output first information, and

a second AF detection module configured to analyze the multichannel ECG signal using a second algorithm with a different noise tolerance from the first algorithm and output second information,

wherein, based at least in part on the first information and the second information, the one or more processors determine whether the multichannel ECG signal is indicative of AF; and

a communication module, communicatively coupled to the one or more processors, configured to:

responsive to a determination that the multichannel ECG signal is indicative of AF, provide a notification that the AF has been detected.

2. The WMD system of claim 1 , wherein the one or more processors are further configured with a noise detection module configured to analyze the multichannel ECG signal and output third information, and wherein the one or more processors determine whether the multichannel ECG signal is indicative of AF, based at least in part on the first information, the second information, and the third information.

3. The WMD system of claim 2 , wherein responsive to the third information provided by the noise detection module, the one or more processors determine whether the multichannel ECG signal is indicative of noise.

4. The WMD system of claim 3 , wherein the one or more processors analyze a plurality of multichannel ECG signals over a predetermined time period and determine AF burden over the predetermined time period without using ECG signals of the plurality of multichannel ECG signals that are determined to be indicative of noise.

5. The WMD system of claim 3 , wherein the one or more processors analyze a plurality of multichannel ECG signals over a predetermined time period and characterize AF burden over the predetermined time period by providing a metric corresponding to an amount of time during the predetermined time period in which one or more ECG signals of the plurality of multichannel ECG signals were determined to be indicative of noise.

6. The WMD system of claim 3 , wherein the one or more processors analyze a plurality of multichannel ECG signals over a predetermined time period and characterize AF burden over the predetermined time period by providing a metric corresponding to a first amount of time during the predetermined time period in which one or more ECG signals of the plurality of multichannel ECG signals were determined to be indicative of detected AF, and a metric corresponding to a second amount of time during the predetermined time period in which one or more ECG signals of the plurality of multichannel ECG signals were determined to be indicative of suspected AF.

7. The WMD system of claim 6 , wherein the first algorithm determines the detected AF and the second algorithm determines the suspected AF.

8. The WMD system of claim 2 , wherein the third information provided by the noise detection module includes information indicating one or more channels of the multichannel ECG signal meeting a noise criterion, and one or more channels of the multichannel ECG signal not meeting the noise criteria, and wherein the one or more processors use the first AF detection module to analyze the one or more channels that meet the noise criterion and the second AF detection module to analyze the one or more channels that do not meet the noise criterion.

9. The WMD system of claim 1 , wherein the one or more processors analyze a plurality of multichannel ECG signals over a predetermined time period and determine AF burden over the predetermined time period.

10. The WMD system of claim 1 , wherein the first algorithm comprises a high specificity AF algorithm and the second algorithm comprises a noise-tolerant AF algorithm with less specificity than the first algorithm.

11. The WMD system of claim 1 , wherein the WMD comprises an external defibrillator.

12. A wearable medical device (WMD) system for detecting atrial fibrillation (AF) in a patient capable of being ambulatory while using the WMD system, the WMD system comprising:

a plurality of electrocardiogram (ECG) electrodes configured to sense a multichannel ECG signal while the patient is using the WMD system;

a support structure configured to position at least one of the plurality of ECG electrodes to contact a body of the patient while the support structure is worn by the patient;

an AF detector, communicatively coupled to at least the plurality of ECG electrodes, configured to:

analyze, using a first algorithm, the multichannel ECG signal, wherein the first algorithm outputs first information,

analyze, using a second algorithm, the multichannel ECG signal, wherein the second algorithm has a different noise tolerance from the first algorithm and outputs second information,

determine whether the multichannel ECG signal is indicative of AF based at least in part on the first information and the second information, and

determine whether the multichannel ECG signal is indicative of suspected AF based at least in part on the first information and the second information; and

a communication module, communicatively coupled to at least the AF detector, configured to:

responsive to a determination that the multichannel ECG signal is indicative of AF, provide a notification that the AF has been detected, and

responsive to a determination that the multichannel ECG signal is indicative of suspected AF, provide a notification that the suspected AF has been detected.

13. The WMD system of claim 12 , wherein the AF detector is configured to analyze the multichannel ECG signal further using a noise detection algorithm, wherein the noise detection algorithm outputs noise analysis information, and wherein the AF detector is configured to determine whether the multichannel ECG signal is indicative of AF further based on the noise analysis information.

14. The WMD system of claim 13 , wherein the noise analysis information includes information indicating one or more channels of the multichannel ECG signal that exceeded a noise criterion and one or more channels of the multichannel ECG signal that did not exceed the noise criterion.

15. The WMD system of claim 14 , wherein the one or more channels that exceeded the noise criterion are analyzed using the first algorithm, and the one or more channels that did not exceed the noise criterion are analyzed using the second algorithm.

16. The WMD system of claim 14 , wherein the AF detector is further configured to determine an AF burden over a predetermined time period without using the one or more channels of the multichannel ECG signal that exceeded the noise criterion.

17. The WMD system of claim 14 , wherein the AF detector is further configured to:

determine a metric corresponding to a first amount of time over a predetermined time period in which the multichannel ECG signal was determined to be indicative of the detected AF, and

determine another metric corresponding to a second amount of time over the predetermined time period in which the multichannel ECG signal was determined to be indicative of the suspected AF.

18. The WMD system of claim 12 , wherein in response to a determination that the multichannel ECG signal is indicative of AF, the AF detector is further configured to determine an AF burden over a predetermined time period.

19. The WMD system of claim 12 , wherein the first algorithm is used to determine the detected AF and the second algorithm is used to determine the suspected AF.

20. The WMD system of claim 12 , wherein the first algorithm comprises a high specificity AF algorithm and the second algorithm comprises a noise-tolerant AF algorithm with less specificity than the first algorithm.

Assignments (4)
SECURITY AGREEMENT Recorded Oct 4, 2023
From: WEST AFFUM HOLDINGS DESIGNATED ACTIVITY COMPANY
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 065116/0049 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 15, 2022
From: WEST AFFUM HOLDINGS CORP.
To: WEST AFFUM HOLDINGS DAC
Reel/Frame 060389/0694 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 19, 2021
From: KESTRA MEDICAL TECHNOLOGIES, INC.
To: WEST AFFUM HOLDINGS CORP.
Reel/Frame 057836/0715 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2021
From: SULLIVAN, JOSEPH L.
To: KESTRA MEDICAL TECHNOLOGIES, INC.
Reel/Frame 057691/0516 →
Continuity (2)
Provisional Application 63216187 · Jun 29, 2021
Related Publication 20220409118A1 · Dec 29, 2022
References Cited (184)
US 3724355A · Busch et al. · 1973 [cited by applicant]
US 3724455A · Unger · 1973 [cited by applicant]
US 4583524A · Hutchins · 1986 [cited by applicant]
US 4619265A · Morgan et al. · 1986 [cited by applicant]
US 4666432A · McNeish et al. · 1987 [cited by applicant]
US 4698848A · Buckley · 1987 [cited by applicant]
US 4928690A · Heilman et al. · 1990 [cited by applicant]
US 4955381A · Way et al. · 1990 [cited by applicant]
US 5078134A · Heilman et al. · 1992 [cited by applicant]
US 5228449A · Christ et al. · 1993 [cited by applicant]
US 5348008A · Bornn et al. · 1994 [cited by applicant]
US 5353793A · Bornn · 1994 [cited by applicant]
US RE34800E · Hutchins · 1994 [cited by applicant]
US 5394892A · Kenny · 1995 [cited by applicant]
US 5405362A · Kramer et al. · 1995 [cited by applicant]
US 5429593A · Matory · 1995 [cited by applicant]
US 5474574A · Payne et al. · 1995 [cited by applicant]
US 5618208A · Crouse et al. · 1997 [cited by applicant]
US 5662690A · Cole et al. · 1997 [cited by applicant]
US 5708978A · Johnsrud · 1998 [cited by applicant]
US 5741306A · Glegyak et al. · 1998 [cited by applicant]
US 5782878A · Morgan et al. · 1998 [cited by applicant]
US 5792204A · Snell · 1998 [cited by applicant]
US 5902249A · Lyster · 1999 [cited by applicant]
US 5913685A · Hutchins · 1999 [cited by applicant]
US 5944669A · Kaib · 1999 [cited by applicant]
US 6047203A · Sackner et al. · 2000 [cited by applicant]
US 6065154A · Hulings et al. · 2000 [cited by applicant]
US 6108197A · Janik · 2000 [cited by applicant]
US 6148233A · Owen et al. · 2000 [cited by applicant]
US 6201992B1 · Freeman · 2001 [cited by applicant]
US 6263238B1 · Brewer et al. · 2001 [cited by applicant]
US 6280461B1 · Glegyak et al. · 2001 [cited by applicant]
US 6287328B1 · Snyder et al. · 2001 [cited by applicant]
US 6304780B1 · Owen et al. · 2001 [cited by applicant]
US 6319011B1 · Motti et al. · 2001 [cited by applicant]
US 6334070B1 · Nova et al. · 2001 [cited by applicant]
US 6356785B1 · Snyder · 2002 [cited by applicant]
US 6427083B1 · Owen et al. · 2002 [cited by applicant]
US 6437083B1 · Owen et al. · 2002 [cited by applicant]
US 6450942B1 · Lapanashvili et al. · 2002 [cited by applicant]
US 6529875B1 · Nakajima · 2003 [cited by applicant]
US 6546285B1 · Owen et al. · 2003 [cited by applicant]
US 6671545B2 · Fincke · 2003 [cited by applicant]
US 6681003B2 · Linder et al. · 2004 [cited by applicant]
US 6762917B1 · Verbiest et al. · 2004 [cited by applicant]
US 7065401B2 · Worden · 2006 [cited by applicant]
US 7099715B2 · Korzinov et al. · 2006 [cited by applicant]
US 7212850B2 · Prystowsky et al. · 2007 [cited by applicant]
US 7559902B2 · Ting et al. · 2009 [cited by applicant]
US 7587237B2 · Korzinov et al. · 2009 [cited by applicant]
US 7753759B2 · Pintor et al. · 2010 [cited by applicant]
US 7865238B2 · Brink · 2011 [cited by applicant]
US 7870761B2 · Valentine et al. · 2011 [cited by applicant]
US 7907996B2 · Prystowsky et al. · 2011 [cited by applicant]
US 7941207B2 · Korzinov · 2011 [cited by applicant]
US 7974689B2 · Volpe et al. · 2011 [cited by applicant]
US 8135462B2 · Owen et al. · 2012 [cited by applicant]
US 8140154B2 · Donnelly et al. · 2012 [cited by applicant]
US 8369944B2 · Macho et al. · 2013 [cited by applicant]
US 8527028B2 · Kurzweil et al. · 2013 [cited by applicant]
US 8548557B2 · Garstka et al. · 2013 [cited by applicant]
US 8560044B2 · Kurzweil et al. · 2013 [cited by applicant]
US 8615295B2 · Savage et al. · 2013 [cited by applicant]
US 8644925B2 · Volpe et al. · 2014 [cited by applicant]
US 8676313B2 · Volpe et al. · 2014 [cited by applicant]
US 8706255B2 · Phillips et al. · 2014 [cited by applicant]
US 8742349B2 · Urbon et al. · 2014 [cited by applicant]
US 8897860B2 · Volpe et al. · 2014 [cited by applicant]
US 8904214B2 · Volpe et al. · 2014 [cited by applicant]
US 8965500B2 · Macho et al. · 2015 [cited by applicant]
US 9008801B2 · Kaib et al. · 2015 [cited by applicant]
US 9084583B2 · Mazar et al. · 2015 [cited by applicant]
US 9089685B2 · Sullivan et al. · 2015 [cited by applicant]
US 9119547B2 · Cazares et al. · 2015 [cited by applicant]
US 9131901B2 · Volpe et al. · 2015 [cited by applicant]
US 9132267B2 · Kaib · 2015 [cited by applicant]
US 9265432B2 · Warren et al. · 2016 [cited by applicant]
US 9345898B2 · Piha et al. · 2016 [cited by applicant]
US 9408548B2 · Volpe et al. · 2016 [cited by applicant]
US 9445719B2 · Libbus et al. · 2016 [cited by applicant]
US 9454219B2 · Volpe et al. · 2016 [cited by applicant]
US 9579020B2 · Libbus et al. · 2017 [cited by applicant]
US 9592403B2 · Sullivan · 2017 [cited by applicant]
US 9598799B2 · Shoshani et al. · 2017 [cited by applicant]
US 9675804B2 · Whiting et al. · 2017 [cited by applicant]
US 9724008B2 · Sullivan et al. · 2017 [cited by applicant]
US 9878171B2 · Kaib · 2018 [cited by applicant]
US 9895105B2 · Romem · 2018 [cited by applicant]
US 9901741B2 · Chapman et al. · 2018 [cited by applicant]
US RE46926E · Bly et al. · 2018 [cited by applicant]
US 10016613B2 · Kavounas · 2018 [cited by applicant]
US 10076656B2 · Dar et al. · 2018 [cited by applicant]
US 10192387B2 · Brinig et al. · 2019 [cited by applicant]
US 10307133B2 · Kaib · 2019 [cited by applicant]
US 10463867B2 · Kaib et al. · 2019 [cited by applicant]
US 10589110B2 · Oskin et al. · 2020 [cited by applicant]
US 10599814B2 · Landrum et al. · 2020 [cited by applicant]
US 20020181680A1 · Linder et al. · 2002 [cited by applicant]
US 20030158593A1 · Heilman et al. · 2003 [cited by applicant]
US 20050107833A1 · Freeman et al. · 2005 [cited by applicant]
US 20050107834A1 · Freeman et al. · 2005 [cited by applicant]
US 20060173499A1 · Hampton et al. · 2006 [cited by applicant]
US 20080312709A1 · Volpe et al. · 2008 [cited by applicant]
US 20090005827A1 · Weintraub et al. · 2009 [cited by applicant]
US 20090171227A1 · Dziubinski · 2009 [cited by examiner]
US 20100007413A1 · Herleikson · 2010 [cited by applicant]
US 20100298899A1 · Donnelly et al. · 2010 [cited by applicant]
US 20110022105A9 · Owen et al. · 2011 [cited by applicant]
US 20110288604A1 · Kaib et al. · 2011 [cited by applicant]
US 20110288605A1 · Kaib et al. · 2011 [cited by applicant]
US 20120112903A1 · Kaib et al. · 2012 [cited by applicant]
US 20120144551A1 · Guldalian · 2012 [cited by applicant]
US 20120150008A1 · Kaib et al. · 2012 [cited by applicant]
US 20120158075A1 · Kaib et al. · 2012 [cited by applicant]
US 20120191476A1 · Reid et al. · 2012 [cited by applicant]
US 20120265265A1 · Razavi et al. · 2012 [cited by applicant]
US 20120283794A1 · Kaib et al. · 2012 [cited by applicant]
US 20120293323A1 · Kaib et al. · 2012 [cited by applicant]
US 20120302860A1 · Volpe et al. · 2012 [cited by applicant]
US 20120310315A1 · Savage et al. · 2012 [cited by applicant]
US 20130085538A1 · Volpe et al. · 2013 [cited by applicant]
US 20130144355A1 · Macho et al. · 2013 [cited by applicant]
US 20130231711A1 · Kaib · 2013 [cited by applicant]
US 20130245388A1 · Rafferty et al. · 2013 [cited by applicant]
US 20130274565A1 · Langer et al. · 2013 [cited by applicant]
US 20130317852A1 · Worrell et al. · 2013 [cited by applicant]
US 20130325078A1 · Whiting et al. · 2013 [cited by applicant]
US 20140012144A1 · Crone · 2014 [cited by applicant]
US 20140025131A1 · Sullivan et al. · 2014 [cited by applicant]
US 20140046391A1 · Cowan et al. · 2014 [cited by applicant]
US 20140070957A1 · Longinotti-Buitoni et al. · 2014 [cited by applicant]
US 20140114167A1 · Reaser, Jr. · 2014 [cited by examiner]
US 20140163663A1 · Poddar et al. · 2014 [cited by applicant]
US 20140324112A1 · Macho et al. · 2014 [cited by applicant]
US 20140378812A1 · Saroka et al. · 2014 [cited by applicant]
US 20150039053A1 · Kaib et al. · 2015 [cited by applicant]
US 20150161554A1 · Sweeney et al. · 2015 [cited by applicant]
US 20150297135A1 · Shoshani et al. · 2015 [cited by applicant]
US 20150328472A1 · Sullivan et al. · 2015 [cited by applicant]
US 20160004831A1 · Carlson et al. · 2016 [cited by applicant]
US 20160076175A1 · Rock et al. · 2016 [cited by applicant]
US 20160076176A1 · Rock et al. · 2016 [cited by applicant]
US 20160082277A1 · Foshee, Jr. et al. · 2016 [cited by applicant]
US 20160113581A1 · Amir et al. · 2016 [cited by applicant]
US 20160256104A1 · Romem et al. · 2016 [cited by applicant]
US 20160283900A1 · Johnson et al. · 2016 [cited by applicant]
US 20170014073A1 · Shoshani et al. · 2017 [cited by applicant]
US 20170027469A1 · Amir et al. · 2017 [cited by applicant]
US 20170036066A1 · Chahine · 2017 [cited by applicant]
US 20170040758A1 · Amir et al. · 2017 [cited by applicant]
US 20170162840A1 · Pendry · 2017 [cited by applicant]
US 20170319862A1 · Foshee, Jr. et al. · 2017 [cited by applicant]
US 20170367591A1 · Jorgensen · 2017 [cited by applicant]
US 20180116537A1 · Sullivan et al. · 2018 [cited by applicant]
US 20180117299A1 · Gustavson et al. · 2018 [cited by applicant]
US 20180184933A1 · Sullivan et al. · 2018 [cited by applicant]
US 20180185662A1 · Foshee, Jr. et al. · 2018 [cited by applicant]
US 20180243578A1 · Volosin · 2018 [cited by applicant]
US 20180361165A1 · Jaax et al. · 2018 [cited by applicant]
US 20190030352A1 · Sullivan et al. · 2019 [cited by applicant]
US 20190076666A1 · Medema · 2019 [cited by applicant]
US 20190116896A1 · Armour et al. · 2019 [cited by applicant]
US 20190321650A1 · Raymond et al. · 2019 [cited by applicant]
DE 102005060985A1 · 2007 [cited by applicant]
EP 2305110A1 · 2011 [cited by applicant]
EP 3380189B1 · 2018 [cited by applicant]
JP 4320257B2 · 2009 [cited by applicant]
JP 2014526282A · 2014 [cited by applicant]
JP 5963767B2 · 2016 [cited by applicant]
WO 1998039061A2 · 1998 [cited by applicant]
WO 2011146448A1 · 2011 [cited by applicant]
WO 2012064604A1 · 2012 [cited by applicant]
WO 2012151160A1 · 2012 [cited by applicant]
WO 2015056262A1 · 2015 [cited by applicant]
Klein, H. U., Goldenberg I., & Moss, A. J., Risk Stratification for Implantable Cardioverter Defibrillator Therapy: The Role of the Wearable Cardioverter-Defibrillator, Clinical update, European Heart Journal, May 31, 2… [cited by applicant]
Lifecor LifeVest System Model WCD 3100 Operator's Manual, 2006, PN 20B0040 Rev FI, Zoll Lifecor Corporation, Pittsburgh, PA. [cited by applicant]
LifeVest Model 4000 Patient Manual, Zoll, 2009, PN 20B0047 Rev B. [cited by applicant]
Heartstart MRx and XL AED Algorithm—Application Note, Jul. 2001, Edition 2 Philips Healthcare, USA. [cited by applicant]
The LifeVest Network/Patient Data Management System, Zoll, 2015, 20C0503 Rev A. [cited by applicant]
Metting Van Rijn, A. C., Peper A., & Grimbergen, C. A., High-Quality Recording of Bioelectric Events Part 1: Interference Reduction, Theory and Practice, Review, Medical & Biological Engineering & Computing, Sep. 1990, … [cited by applicant]
Pagan-Carlo, et al., “Encircling Overlapping Multipulse Shock Waveforms for Transthoracic Defibrillation,” JACC Journals, Dec. 1998, vol. 32 Issue 7, p. 2065-2071. [cited by applicant]
Zoll, LifeVest, Proven protection from Sudden Cardiac Death, 2017, 4 pages. Pittsburgh PA, USA. [cited by applicant]
International Search Report and Written Opinion for PCT Application No. PCT/US2015/051726, dated May 20, 2016, European Patent Office, Rijswijk, 11 pages. [cited by applicant]