WCD system validating detected cardiac arrhythmias thoroughly so as to not sound loudly due to some quickly self-terminating cardiac arrhythmias

• US 10,500,403 B2
• Filed: 07/12/2017
• Issued: 12/10/2019
• Est. Priority Date: 02/25/2013
• Status: Active Grant

• Current Assignee: West Affum Holdings DAC
• Original Assignee: West Affum Holdings Corp
• Inventors: Foshee, Jr., Phillip D., Finch, David P., Gustavson, Laura M., Korsun, Nikolai, Sullivan, Joseph L.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US15/647,524
• Publication Number:
  US 20170319862A1
• Time in Patent Office: 881 Days
• Field of Search: 607 5
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/39 Heart defibrillators
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration
• CPC Class Codes: A61N 1/3937 Monitoring output parameters
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

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

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.

2. The WCD system of claim 1, in which

the cardiac arrhythmia is a ventricular tachycardia.

3. The WCD system of claim 1, in which

the threshold validation time lasts at least 35 sec.

4. The WCD system of claim 1, in which

the speaker is caused to output no sound while the determination being performed.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

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.

11. The medium of claim 10, in which

the cardiac arrhythmia is a ventricular tachycardia.

12. The medium of claim 10, in which

the threshold validation time lasts at least 35 sec.

13. The medium of claim 10, in which

the speaker is caused to output no sound while the determination being performed.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

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.

20. The method of claim 19, in which

the cardiac arrhythmia is a ventricular tachycardia.

21. The method of claim 19, in which

the threshold validation time lasts at least 35 sec.

22. The method of claim 19, in which

the speaker is caused to output no sound while the determination being performed.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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.