IP Library Granted Patent US 12,708,315
Granted Patent B2
US 12,708,315 · App. 18/313,218 · Granted Aug 18, 2026

Arrhythmia detection in a wearable medical system

Inventor: Jaeho Kim (Kirkland, WA)
Assignee: West Affum Holdings DAC
A61B5/363A61B5/308A61B5/352A61B5/366A61N1/365A61N1/3904
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Quick Facts
Patent No.
US 12,708,315
App. No.
18/313,218
Filed
May 5, 2023
Granted
Aug 18, 2026
Kind
B2
Art Unit
3792
USPC
607/4
Abstract

A wearable medical system detects cardiac arrythmia condition of a patient. The wearable medical system comprises a support structure, a plurality of ECG electrodes to sense an ECG signal, and an energy output device to store an electrical charge. The wearable medical system further comprises an output circuit coupled to the energy output device, a plurality of therapy electrodes, and a processor. The plurality of therapy electrodes is coupled to the support structure and the output circuit and delivers therapy to the patient. The processor is coupled to the plurality of ECG electrodes and the output circuit. The processor comprises a QRS detector module that has a first threshold and a second threshold. The QRS detector module comprises first and second QRS detectors that analyze the ECG signals for the first and second thresholds, respectively. The first and second thresholds are configured to detect tachyarrhythmia and bradyarrhythmia, respectively.

Claims (64)

1 . A wearable medical system, comprising:

a support structure;

a plurality of electrocardiogram (ECG) electrodes to sense an ECG signal of a patient;

an energy output device to store an electrical charge;

an output circuit coupled to the energy output device;

a plurality of therapy electrodes, coupled to the support structure and the output circuit, wherein the plurality of therapy electrodes deliver therapy to the patient; and

a processor, coupled to the plurality of ECG electrodes and the output circuit, comprising:

a QRS detector module, wherein the QRS detector module has a first threshold and a second threshold, and configured to:

detect a sensed event responsive to the ECG signal exceeding at least one of the first threshold or the second threshold;

observe a refractory period after the sensed event is detected;

inhibit identification or detection of a new sensed event during the refractory period;

measure a maximum absolute ECG signal amplitude during the refractory period;

recalculate the first threshold and/or the second threshold based on the maximum absolute ECG signal amplitude during the refractory period;

detect a subsequent ECG signal after the refractory period using the plurality of ECG electrodes in contact with the patient; and

determine whether the subsequent ECG signal exceeds the recalculated first threshold or the recalculated second threshold.

2 . The wearable medical system of claim 1 , wherein the QRS detector module further comprises:

a first QRS detector, wherein the first QRS detector analyzes ECG signals for the first threshold; and

a second QRS detector, wherein the second QRS detector analyzes ECG signals for the second threshold.

3 . The wearable medical system of claim 1 , further comprising a user interface, wherein the user interface comprises audio and/or visual alarms.

4 . The wearable medical system of claim 1 , wherein the first threshold is configured to detect tachyarrhythmia and the second threshold is configured to detect bradyarrhythmia.

5 . The wearable medical system of claim 1 , wherein when the recalculated first or second threshold is exceeded, a heart rate is calculated; wherein the heart rate is used to determine the presence of tachyarrhythmia or bradyarrhythmia; and wherein a defibrillation shock is delivered to the patient by the plurality of therapy electrodes when the presence of tachyarrhythmia is determined, or a pacing pulse is delivered to the patient by the plurality of therapy electrodes when the presence of bradyarrhythmia is determined.

6 . The wearable medical system of claim 1 , further comprising a band pass filter for filtering ECG signals.

7 . A method for identifying a cardiac condition using a wearable medical system having a processor and a memory, the method comprising:

detecting an electrocardiogram (ECG) signal of a patient using a plurality of electrodes in contact with the patient;

determining whether the ECG signal exceeds a first threshold of a QRS detector module;

determining whether the ECG signal exceeds a second threshold of the QRS detector module;

identifying or detecting a sensed event responsive to the ECG signal exceeding at least one of the first threshold or the second threshold;

observing a refractory period after the sensed event is detected;

inhibiting identification or detection of a new sensed event during the refractory period;

measuring a maximum absolute ECG signal amplitude during the refractory period;

recalculating the first threshold and/or the second threshold based on the maximum absolute ECG signal amplitude during the refractory period;

detecting a subsequent ECG signal after the refractory period using the plurality of electrodes in contact with the patient;

determining whether the subsequent ECG signal exceeds the recalculated first threshold or the recalculated second threshold;

calculating, based on determination that the subsequent ECG signal exceeds the recalculated first threshold or the recalculated second threshold of the QRS detector module, a heart rate to determine the presence of tachyarrhythmia or bradyarrhythmia;

delivering a defibrillation shock to the patient when the presence of tachyarrhythmia is determined; and

delivering a pacing pulse to the patient when the presence of bradyarrhythmia is determined.

8 . The method of claim 7 , wherein the first threshold and/or the second threshold are recalculated by multiplying a start drop coefficient by the maximum absolute ECG signal amplitude.

9 . The method of claim 7 , further comprising decreasing at least one of the recalculated first threshold or the recalculated second threshold with time in an exponential manner.

10 . The method of claim 7 , wherein the recalculated first threshold and the recalculated second threshold stop decreasing when the recalculated first threshold and the recalculated second threshold reach a minimum threshold level.

11 . The method of claim 7 , wherein the heart rate is calculated using an inverse of an R-R interval of the ECG signals exceeding the first threshold and the recalculated first threshold or exceeding the second threshold and the recalculated second threshold.

12 . The method of claim 7 , wherein the first threshold is configured to identify tachyarrhythmia and the second threshold is configured to identify bradyarrhythmia.

13 . The method of claim 7 , wherein the QRS detector module comprises:

a first QRS detector, wherein the first QRS detector analyzes ECG signals for the first threshold; and

a second QRS detector, wherein the second QRS detector analyzes ECG signals for the second threshold.

14 . A non-transitory computer-readable medium encoded with QRS detection instructions stored thereon that, when executed by a computing device, cause the computing device to perform operations for identifying a cardiac condition in a patient, the operations comprising:

detecting an electrocardiogram (ECG) signal using one or more ECG electrodes;

activating a QRS detector module to:

analyze the ECG signal, wherein the QRS detector module has a first threshold and a second threshold;

determine whether the ECG signal exceeds the first threshold or the second threshold;

identify or detect a sensed event responsive to the ECG signal exceeding the first threshold or the second threshold;

observe a refractory period after the sensed event is detected;

inhibit identification or detection of a new sensed event during the refractory period;

measure a maximum absolute ECG signal amplitude during the refractory period;

recalculate the first threshold and/or the second threshold based on the maximum absolute ECG signal amplitude during the refractory period;

detecting a subsequent ECG signal after the refractory period using the one or more ECG electrodes;

reactivating the QRS detector module to determine whether the subsequent ECG signal exceeds the recalculated first threshold or the recalculated second threshold;

calculate, based on a determination that the subsequent ECG signal exceeds the recalculated first threshold or the recalculated second threshold, a heart rate to determine the presence of tachyarrhythmia or bradyarrhythmia; and

controlling an output circuit and an energy output device to:

deliver a defibrillation shock to the patient through a plurality of therapy electrodes when the presence of tachyarrhythmia is determined; and

deliver a pacing pulse to the patient through a plurality of therapy electrodes when the presence of bradyarrhythmia is determined.

15 . The non-transitory computer-readable medium of claim 14 , wherein the first threshold and/or the second threshold are recalculated by multiplying a start drop coefficient by the maximum absolute ECG signal amplitude.

16 . The non-transitory computer-readable medium of claim 14 , wherein the operations further include decreasing at least one of the recalculated first threshold or the recalculated second threshold with time in an exponential manner until the recalculated first threshold and/or the recalculated second threshold reach a minimum threshold level.

17 . The non-transitory computer-readable medium of claim 14 , wherein the heart rate is calculated using an inverse of an R-R interval of the ECG signals exceeding the first threshold and the recalculated first threshold or exceeding the second threshold and the recalculated second threshold.

18 . The non-transitory computer-readable medium of claim 14 , wherein the first threshold is configured to further detect tachyarrhythmia and the second threshold is configured to further detect bradyarrhythmia.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 11, 2024
From: WEST AFFUM HOLDINGS CORP.
To: WEST AFFUM HOLDINGS DAC
Reel/Frame 067969/0595 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 10, 2024
From: KESTRA MEDICAL TECHNOLOGIES, INC.
To: WEST AFFUM HOLDINGS CORP.
Reel/Frame 067947/0709 →
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 May 11, 2023
From: KIM, JAEHO
To: KESTRA MEDICAL TECHNOLOGIES, INC.
Reel/Frame 063617/0761 →
Continuity (2)
Provisional Application 63395282 · Aug 4, 2022
Related Publication 20240041381A1 · Feb 8, 2024
References Cited (186)
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 · Bomnn et al. · 1994 [cited by applicant]
US 5353793A · Bomn · 1994 [cited by applicant]
US RE34800E · Hutchins · 1994 [cited by applicant]
US 5394892A · Kenny et al. · 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 et al. · 2002 [cited by applicant]
US 6427083B1 · Owen et al. · 2002 [cited by applicant]
US 6437083B1 · Brack et al. · 2002 [cited by applicant]
US 6450942B1 · Apanashvili et al. · 2002 [cited by applicant]
US 6529875B1 · Nakajima et al. · 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 · 2006 [cited by applicant]
US 7212850B2 · Prystowsky · 2007 [cited by applicant]
US 7559902B2 · Ting et al. · 2009 [cited by applicant]
US 7587237B2 · Korzinov · 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 · 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 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 20080140159A1 · Bornhoft · 2008 [cited by examiner]
US 20080312709A1 · Vollpe et al. · 2008 [cited by applicant]
US 20090005827A1 · Weintraub et al. · 2009 [cited by applicant]
US 20100007413A1 · Herleikson et al. · 2010 [cited by applicant]
US 20100114213A1 · Doerr · 2010 [cited by examiner]
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 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 20170095175A1 · Allavatam · 2017 [cited by examiner]
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]
US 20190329052A1 · Kim · 2019 [cited by examiner]
US 20210178172A1 · Kim · 2021 [cited by examiner]
US 20230149258A1 · Kaufman · 2023 [cited by examiner]
US 20240374136A1 · Sørensen · 2024 [cited by examiner]
DE 102005060985A2 · 2007 [cited by applicant]
EP 2305110A1 · 2011 [cited by applicant]
JP 4320257B2 · 2009 [cited by applicant]
JP 2014526282A · 2014 [cited by applicant]
JP 5963767B2 · 2016 [cited by applicant]
WO 199839061A2 · 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]
Heartstart MRx and XL AED Algorithm—Application Note, Jul. 2001, Edition 2 Philips Healthcare, USA. [cited by applicant]
Klein et al., “Risk Stratification for Implantable Cardioverter Defibrillator Therapy: The Role of the Wearable Cardioverter-Defibrillator, Clinical update,” European Heart Journal, May 31, 2013, pp. 1-14, doi:10.1093/e… [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]
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]
The LifeVest Network/Patient Data Management System, Zoll, 2015, 2000503 Rev A. [cited by applicant]
Zoll, LifeVest, Proven protection from Sudden Cardiac Death, issued Mar. 27, 2018, 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]