# US 10,500,403 B2 · WCD system validating detected cardiac arrhythmias thoroughly so as to not sound loudly due to some quickly self-terminating cardiac arrhythmias

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- Number: US 10,500,403 B2
- Document ID: US10500403B2
- Status: Granted
- Kind: B2
- Application number: 15/647,524
- Filed: 2017-07-12
- Published: 2017-11-09
- Granted: 2019-12-10
- Earliest claimed: 2013-02-25
- Assignees: West Affum Holdings Corp.
- Applicants: West Affum Holdings Corp.
- Inventors: Phillip D. Foshee, Jr.; David P. Finch; Laura M. Gustavson; Nikolai Korsun; Joseph L. Sullivan
- Web page: https://patentgrep.com/patent/US10500403B2

## CPC

- A61N 1/3918: {characterised by shock pathway, e.g. by electrode configuration}
- A61B 5/318: Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/6805: {Vests, e.g. shirts or gowns}
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- A61N 1/0484: {Garment electrodes worn by the patient}
- A61N 1/39: Heart defibrillators
- A61N 1/3937: {Monitoring output parameters}
- A61N 1/3968: {Constructional arrangements, e.g. casings (A61N1/375 takes precedence)}
- A61N 1/3987: {characterised by the timing or triggering of the shock}
- A61N 1/3993: {User interfaces for automatic external defibrillators}
- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61N 1/046: {Specially adapted for shock therapy, e.g. defibrillation}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A wearable cardioverter defibrillator (“WCD”) system may output a loud sound after detecting and validating a shockable cardiac arrhythmia. In such embodiments, however, the WCD system might not sound a loud alarm before validating the arrhythmia thoroughly, i.e. for a longer time, thus giving the arrhythmia a further chance to self-terminate. The WCD system may thus detect more robustly the cardiac arrhythmias that do not self-terminate quickly. Such arrhythmias that self-terminate quickly may occur from likely harmless events occurring multiple times in the daily life of the patient, such as the patient becoming “winded” from climbing stairs. In embodiments the WCD system may notify the patient only discreetly, or even not at all. The lack of sounding such a loud alarm responsive to such events reduces the overall number of times in which the patient experiences unwanted attention by others, embarrassment, loss of privacy and dignity, and so on.

## Claims

### Claim 1

A wearable cardioverter defibrillator (“WCD”) system, comprising:
a support structure configured to be worn by a patient;
an energy storage module configured to store an electrical charge;
a discharge circuit coupled to the energy storage module, the discharge circuit controllable to discharge the stored electrical charge so as to cause a shock to be delivered to the patient while the support structure is worn by the patient;
a measurement circuit configured to render physiological inputs from an ElectroCardioGram (ECG) signal of the patient, wherein the physiological inputs comprise sections of a waveform of the ECG signal taken at different times;
a user interface that includes a speaker configured to output a sound; and
a processor configured to:
detect, from one of the physiological inputs, a cardiac arrhythmia of the patient,
then determine, from another one of the physiological inputs, whether or not the detected cardiac arrhythmia meets a validation criterion, the validation criterion including that the detected cardiac arrhythmia is maintained for a threshold validation time that lasts at least 25 sec
cause the speaker to output a sound that is no louder than 58 db as measured at a distance of 2′ from the speaker while the determination is being performed, and:
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then control the discharge circuit to not cause a shock to be delivered to the patient responsive to the detected cardiac arrhythmia,
else cause the speaker to output a sound louder than 62 db as measured at a distance of 2′ from the speaker, and control the discharge circuit to cause the shock to be delivered.

### Claim 2 (depends on 1)

The WCD system of claim 1, in which
the cardiac arrhythmia is a ventricular tachycardia.

### Claim 3 (depends on 1)

The WCD system of claim 1, in which
the threshold validation time lasts at least 35 sec.

### Claim 4 (depends on 1)

The WCD system of claim 1, in which
the speaker is caused to output no sound while the determination being performed.

### Claim 5 (depends on 1)

The WCD system of claim 1, in which
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then the speaker is caused to output no sound louder than 58 db as measured at a distance of 2′ from the speaker, for another 10 min after the determination has been performed.

### Claim 6 (depends on 1)

The WCD system of claim 1, in which
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then the speaker is caused to output no sound, for another 10 min after the determination has been performed.

### Claim 7 (depends on 1)

The WCD system of claim 1, in which
the user interface further includes an other speaker, and
the other speaker is caused to output no sound louder than 58 db as measured at a distance of 2′ from the other speaker, while the determination being performed.

### Claim 8 (depends on 1)

The WCD system of claim 1, in which
the user interface further includes an other speaker, and
the other speaker is caused to output no sound, while the determination being performed.

### Claim 9 (depends on 1)

The WCD system of claim 1, wherein the processor is to cause the speaker to output no sound louder than 40 db, 45 db, 50 db, or 55 db as measured at a distance of 3 feet in response to detection of the cardiac arrhythmia and prior to the detected cardiac arrhythmia being validated.

### Claim 10

A non-transitory computer-readable storage medium storing one or more programs which, when executed by at least one processor of a wearable cardioverter defibrillator (“WCD”) system, the WCD system further including a support structure configured to be worn by a patient, an energy storage module that can store an electrical charge, a discharge circuit coupled to the energy storage module, a measurement circuit configured to render physiological inputs from an ElectroCardioGram (ECG) signal of the patient, wherein the physiological inputs comprise sections of a waveform of the ECG signal taken at different times, and a user interface that includes a speaker, these one or more programs result in operations comprising:
detecting, from one of the physiological inputs, a cardiac arrhythmia of the patient;
then determining, from another one of the physiological inputs, whether or not the detected cardiac arrhythmia meets a validation criterion, the validation criterion including that the detected cardiac arrhythmia is maintained for a threshold validation time that lasts at least 25 sec,
causing the speaker to output a sound that is no louder than 58 db as measured at a distance of 2′ from the speaker while the determination is being performed; and:
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then controlling the discharge circuit to not discharge the stored electrical charge through the patient responsive to the detected cardiac arrhythmia,
else causing the speaker to output a sound louder than 62 db as measured at a distance of 2′ from the speaker, and controlling the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient.

### Claim 11 (depends on 10)

The medium of claim 10, in which
the cardiac arrhythmia is a ventricular tachycardia.

### Claim 12 (depends on 10)

The medium of claim 10, in which
the threshold validation time lasts at least 35 sec.

### Claim 13 (depends on 10)

The medium of claim 10, in which
the speaker is caused to output no sound while the determination being performed.

### Claim 14 (depends on 10)

The medium of claim 10, in which
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then the speaker is caused to output no sound louder than 58 db as measured at a distance of 2′ from the speaker, for another 10 min after the determination has been performed.

### Claim 15 (depends on 10)

The medium of claim 10, in which
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then the speaker is caused to output no sound, for another 10 min after the determination has been performed.

### Claim 16 (depends on 10)

The medium of claim 10, in which
the user interface further includes an other speaker, and
the other speaker is caused to output no sound louder than 58 db as measured at a distance of 2′ from the other speaker, while the determination being performed.

### Claim 17 (depends on 10)

The medium of claim 10, in which
the user interface further includes an other speaker, and
the other speaker is caused to output no sound, while the determination being performed.

### Claim 18 (depends on 10)

The medium of claim 10, wherein the one or more programs result in the speaker outputting no sound louder than 40 db, 45 db, 50 db, or 55db as measured at a distance of 3 feet in response to detection of the cardiac arrhythmia and prior to the detected cardiac arrhythmia being validated.

### Claim 19

A method for a wearable cardioverter defibrillator (“WCD”) system, the WCD system including a support structure worn by a patient, an energy storage module that can store an electrical charge, a discharge circuit coupled to the energy storage module, a measurement circuit, a processor and a user interface that includes a speaker, the method comprising:
rendering, by the measurement circuit physiological inputs from an ElectroCardioGram (ECG) signal of the patient, wherein the physiological inputs comprise sections of a waveform of the ECG signal taken at different times;
detecting, from one of the physiological inputs, a cardiac arrhythmia of the patient;
then determining, from another one of the physiological inputs, whether or not the detected cardiac arrhythmia meets a validation criterion, the validation criterion including that the detected cardiac arrhythmia is maintained for a threshold validation time that lasts at least 25 sec;
causing the speaker to output a sound that is no louder than 58 db as measured at a distance of 2′ from the speaker while the determination is being performed; and:
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then controlling the discharge circuit to not discharge the stored electrical charge through the patient responsive to the detected cardiac arrhythmia,
else causing the speaker to output a sound louder than 62 db as measured at a distance of 2′ from the speaker, and discharging by the discharge circuit the stored electrical charge through the patient while the support structure is worn by the patient.

### Claim 20 (depends on 19)

The method of claim 19, in which
the cardiac arrhythmia is a ventricular tachycardia.

### Claim 21 (depends on 19)

The method of claim 19, in which
the threshold validation time lasts at least 35 sec.

### Claim 22 (depends on 19)

The method of claim 19, in which
the speaker is caused to output no sound while the determination being performed.

### Claim 23 (depends on 19)

The method of claim 19, in which
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then the speaker is caused to output no sound louder than 58 db as measured at a distance of 2′ from the speaker, for another 10 min after the determination has been performed.

### Claim 24 (depends on 19)

The method of claim 19, in which
if it is determined that the detected cardiac arrhythmia does not meet the validation criterion, then the speaker is caused to output no sound, for another 10 min after the determination has been performed.

### Claim 25 (depends on 19)

The method of claim 19, in which
the user interface further includes an other speaker, and
the other speaker is caused to output no sound louder than 58 db as measured at a distance of 2′ from the other speaker, while the determination being performed.

### Claim 26 (depends on 19)

The method of claim 19, in which
the user interface further includes an other speaker, and
the other speaker is caused to output no sound, while the determination being performed.

### Claim 27 (depends on 19)

The method of claim 19, further comprising the processor is to cause the speaker to output no sound louder than 40 db, 45 db, 50 db, or 55 db as measured at a distance of 3 feet in response to detection of the cardiac arrhythmia and prior to the detected cardiac arrhythmia being validated.
