Wearable cardioverter defibrillator (WCD) system using sensor modules with reassurance code for confirmation before shock

• US 10,478,631 B2
• Filed: 02/26/2018
• Issued: 11/19/2019
• Est. Priority Date: 05/11/2015
• Status: Active Grant

• Current Assignee: West Affum Holdings DAC
• Original Assignee: West Affum Holdings Corp
• Inventors: Chapman, Fred William, Kavounas, Gregory T.
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US15/905,575
• Publication Number:
  US 20180289976A1
• Time in Patent Office: 631 Days
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/1032 Determining colour for diagnostic purposes measuring colour in general G01J3/46
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/4427 Device being portable or laptop-like
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• 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

Abstract

A wearable cardioverter defibrillator (“WCD”) system includes a support structure that can be worn by a patient, and a defibrillator coupled to the support structure. An ECG input, rendered from an ECG of the patient, may meet a primary shock criterion. One or more sensor modules are further provided, which are worn by the patient at different times. The sensor modules may monitor different physiological parameters of the patient, and transmit signals about them. The WCD system further has a multi-sensor interface to receive the transmitted signals, and a processor to determine from them whether a secondary shock criterion is met. If both the primary and the secondary shock criteria are met, the decision is to shock. The signals increase specificity of the detection, while the patient can wear different modules depending on context.

Claims

1. A wearable cardioverter defibrillator (WCD) system, comprising:

a support structure that may be worn by a patient;

a processor coupled to the support structure;

a discharge circuit configured to discharge a stored electrical charge through a body of the patient, the discharge circuit in communication with the processor;

at least two sensors in communication with the processor, the at least two sensors including at least a physiological sensor configured and positioned to detect a physiological parameter of the patient and a motion sensor configured and positioned to detect that the WCD is in motion;

the processor configured to;

determine from the physiological parameter whether or not a first shock criterion is met;

in response to the first shock criterion being met, determine, from an output of the motion sensor, whether the WCD is in motion;

in response to motion being detected, determine a second shock criterion is not satisfied; and

maintain an inactivate state of the discharge circuit.

2. The WCD system of claim 1, wherein the second shock criterion is a lack of sufficient movement of the patient.

3. The WCD system of claim 1, wherein the motion sensor comprises an accelerometer and the accelerometer is coupled to the support structure.

4. The WCD system of claim 1 wherein the motion sensor comprises an accelerometer and the accelerometer is coupled to the body of the patient and is in wireless communication with the processor.

5. The WCD system of claim 1, wherein the processor is further configured to:

receive an output from a third sensor remote from the WCD system;

analyze the output from the third sensor; and

activate the discharge circuit when the analyzed output of the third sensor satisfies the second shock criterion.

6. The WCD system of claim 1, wherein the processor is further configured to:

receive outputs from a multiple sensors separate from the WCD system;

analyze the outputs from the multiple sensors; and

compare the analyzed outputs to the second shock criterion.

7. The WCD system of claim 1, wherein the motion sensor is one of an accelerometer and a pressure sensor.

8. The WCD system of claim 1, wherein the processor is further configured to generate a polling signal to the motion sensor at a predetermined time interval.

9. The WCD system of claim 8, wherein the predetermined time interval is between 10 seconds and 60 seconds.

10. The WCD system of claim 8, wherein the processor is still further configured to cause the motion sensor to enter a rapid polling process.

11. The WCD system of claim 10, wherein the rapid polling process prompts the processor to continuously poll the motion sensor for a predetermined length of time.

12. The WCD system of claim 11;

wherein, when a detected motion does not satisfy the second shock criterion during the predetermined length of time, the processor is configured to activate the discharge circuit.

13. The WCD system of claim 11, wherein, when a detected motion does not satisfy the second shock criterion during the predetermined length of time, the processor is configured to activate an alarm of an impending electrical charge.

14. The WCD system of claim 1, wherein the processor further generates a reassurance code from the determination of the second shock criterion, and wherein the reassurance code inhibits the discharge circuit from emitting the stored electrical charge.

15. The WCD system of claim 1, further comprising:

an active visual indicator coupled to each of the at least two sensors, wherein the active visual indicator is configured to indicate each the at least two sensors is transmitting data to the processor.

16. A wearable cardioverter defibrillator system, comprising:

a support structure for wearing by a patient;

a defibrillator housing coupled to the support structure;

a discharge circuit in communication with the defibrillator housing;

the discharge circuit configured to discharge a stored electrical charge through a body of the patient,

a processor within the defibrillator housing, the processor in communication with the discharge circuit;

at least one physiological sensor in communication with the processor, the physiological sensor positioned to ECG parameter of the patient; and

at least one motion sensor in communication with the processor, the motion sensor positioned to detect movement of the patient;

the processor configured to;

determine from the ECG parameter whether or not a first shock criterion is met;

receive a second parameter from the at least one motion sensor;

determine, from the received signal, whether the patient is in motion; and

activate the discharge circuit to emit the stored electrical charge to the patient when the motion does not satisfy a second shock criterion.

17. The WCD system of claim 16, wherein the processor is further configured to:

generate an alarm to be dispatched to the patient when the second shock criterion is not satisfied;

determine when a response to the generated alarm is received; and

deactivate the discharge circuit when the response to the generated alarm is received.

18. The WCD system of claim 16, wherein the processor is further configured to:

receive data from at least one sensor external to the WCD system;

analyze data from the at least one sensor; and

compare the analyzed data to the first and second shock criterion.

19. The WCD system of claim 16, wherein the processor is further configured to:

receive data from multiple sensors external to the WCD system; and

determine from the multiple sensors when a secondary shock criterion is met.

20. A wearable cardioverter defibrillator system, comprising:

a support structure for wearing by a patient;

one or more electrodes for delivering a charge to the patient, while the patient is wearing the support structure;

a discharge circuit coupled to the electrodes, the discharge circuit configured to store an electrical charge;

a processor for activating the discharge circuit, the processor in communication with the discharge circuit;

at least one physiological sensor module in communication with the processor, the at least one physiological sensor module configured to monitor a physiological parameter of the patient while the patient wears the support structure and to transmit a first signal that communicates the physiological parameter; and

at least one motion sensor module in communication with the processor, the at least one motion sensor module configured to monitor a motion parameter of the patient while the patient wears the support structure and to transmit a second signal that communicates the motion parameter.

21. The WCD system of claim 20, in which

the at least one motion sensor module encodes a reassurance code generated from a value of the second signal.

22. The WCD system of claim 21, wherein the at least one motion sensor module is configured to communicate the reassurance code to the processor and the processor inhibits signals for shocking when the reassurance code is received.

23. The WCD system of claim 20, wherein the at least one motion sensor module further includes:

a sensor housing configured to be worn by the patient; and

a sensor coupled to the sensor housing and configured to monitor the motion parameter while the sensor housing is worn by the patient.

24. The WCD system of claim 20, in which the at least one motion sensor module includes a communication device configured to transmit the second signal to the processor.

25. The WCD system of claim 24, in which

the communication device is configured to transmit the second signal wirelessly.

26. The WCD system of claim 24, in which

the communication device is configured to transmit the second signal periodically within one hour.

27. The WCD system of claim 24, in which

the at least one motion sensor module is configured to receive a polling signal;

and

the communication device is configured to transmit the second signal responsive to the at least one motion sensor receiving the polling signal.

28. The WCD system of claim 27, wherein the at least one motion sensor module is configured to generate the second signal when the first signal transmits a shock code.

29. The WCD system of claim 28, in which

the second signal encodes a reassurance code generated from a value of the motion parameter.

30. The WCD system of claim 29, wherein the processor inhibits signals for shocking when the reassurance code is received from the at least one motion sensor module.