Wearable cardioverter defibrillator (WCD) causing patient's QRS width to be plotted against the heart rate

• US 10,105,547 B2
• Filed: 11/02/2016
• Issued: 10/23/2018
• Est. Priority Date: 11/02/2015
• Status: Active Grant

• Current Assignee: West Affum Holdings DAC
• Original Assignee: West Affum Holdings Corp
• Inventors: Gustavson, Laura M., Finch, David P., Sullivan, Joseph L.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US15/341,978
• Publication Number:
  US 20170128735A1
• Time in Patent Office: 720 Days
• CPC Class Codes: A61B 2505/01 Emergency care
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• 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 1/3904 : External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3925 : Monitoring; Protecting
• CPC Class Codes: A61N 1/3968 : Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3993 : User interfaces for automatic external defibrillators
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

A wearable cardioverter defibrillator (WCD) system includes a support structure that the patient may wear, and one or more sensors that may acquire patient physiological signals, such as ECG and others. A processor of the WCD system may determine diagnostics from the patient physiological signals. These diagnostics include a six-second ECG portion, heart rates as histograms, heart rates against QRS width, heart rate trends, clinical event counters, diagnostics relating to heart rate variability and about the atrial arrhythmia burden of the patient. In some embodiments, the WCD system includes a user interface with a screen that displays these diagnostics. In some embodiments, the WCD system exports these diagnostics for viewing by a different screen. When viewed, these diagnostics permit more detailed analysis of the state of the patient.

Claims

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

a support structure configured to be worn by a patient;

a power source;

an energy storage module configured to be coupled to the support structure, to receive an electric charge from the power source, and to store the received electric charge;

a discharge circuit coupled to the energy storage module, the discharge circuit controllable to discharge an electric charge stored in the energy storage module while the support structure is worn by the patient;

one or more sensors configured to acquire patient physiological signals during a time interval, the patient physiological signals including electrocardiogram (ECG) data of the patient;

a processor configured to select a plurality of aggregation periods within the time interval and, for each aggregation period, to;

a) identify one or more QRS complexes of the ECG data within the aggregation period, b) identify a representative width value for the identified one or more QRS complexes, and c) determine a representative heart rate value for the aggregation period;

a memory configured to store, for at least some of the aggregation periods during the time interval, the rendered representative width values in association with the determined representative heart rate values; and

wherein the processor is further configured to analyze a plurality of stored QRS width values in relation to their respective stored heart rate values and to determine a treatment to be provided to the patient based, at least in part, on that analysis.

2. The WCD system of claim 1, in which the time interval is one day or longer than one day.

3. The WCD system of claim 1, in which the time interval is one month or longer than one month.

4. The WCD system of claim 1, in which the aggregation period is 5 sec.

5. The WCD system of claim 1, in which the identified representative width value is a value of an average width of the identified QRS complexes within the aggregation period.

6. The WCD system of claim 1, in which the identified representative width value is a value of a width of one of the identified QRS complexes within the aggregation period.

7. The WCD system of claim 1, in which the representative heart rate value is determined as a statistic of determined heart rate values within the aggregation period.

8. The WCD system of claim 1, further comprising a communication interface which is configured to output the plurality of stored width values in relation to their respective stored heart rate values while the patient is wearing the support structure, and has been so wearing continuously since the patient physiological signals were acquired.

9. The WCD system of claim 1, further comprising a remote user interface that is configured to plot the plurality of stored width values in relation to their associated stored heart rate values.

10. The WCD system of claim 9, in which the remote user interface comprises a screen and is configured to be coupled to the support structure, and

the screen is configured to display the plot while the patient is wearing the support structure.

11. The WCD system of claim 9, in which different versions of the plot are thus displayed at different times, and

the memory is configured to store data files that encode the different versions of the plot.

12. The WCD system of claim 11, in which time stamps are further stored in the memory in association with the respective data files.

13. The WCD system of claim 11, in which an additional data file becomes thus stored after the passage of a preset aggregation time.

14. The WCD system of claim 11, in which an additional data file becomes thus stored after a preset number of representative heart rate values have been determined.

15. The WCD system of claim 11, further comprising:

an input device; and

in which

an additional data file becomes thus stored responsive to receiving a user input from the input device.

16. 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 also including:

a support structure, a power source, an energy storage module coupled to the support structure, a discharge circuit, one or more sensors, and a memory, these one or more programs result in operations comprising;

acquiring, by the one or more sensors, during a time interval, patient physiological signals that include electrocardiogram (ECG) data of the patient while the patient is wearing the support structure;

selecting a plurality of aggregation periods within the time interval and, for each aggregation period in the plurality;

a) identifying one or more QRS complexes of the ECG data within the aggregation period;

b) identifying a representative width value for the identified one or more QRS complexes; and

c) determining a representative heart rate value for the aggregation period;

storing, for at least some of the aggregation periods, the identified representative width values in association with the determined representative heart rate values;

determining whether an electric charge should be discharged based, at least in part, on an analysis of the stored width values in relation to their associated stored heart rate values;

receiving, in the energy storage module, the electric charge from the power source, and storing the received electric charge; and

discharging, by the discharge circuit, the electric charge stored in the energy storage module while the support structure is worn by the patient and when the analysis of the stored width values in relation to their associated stored heart rate values indicates that a defibrillation shock is necessary.

17. The medium of claim 16, in which the time interval is one day or longer than one day.

18. The medium of claim 16, in which the time interval is one month or longer than one month.

19. The medium of claim 16, in which the aggregation period is approximately 5 sec.

20. The medium of claim 16, in which the representative width value is a value of an average width of the identified QRS complexes within the aggregation period.

21. The medium of claim 16, in which the representative width value is a value of a width of one of the identified QRS complexes within the aggregation period.

22. The medium of claim 16, in which the representative heart rate value is determined as a statistic of determined heart rate values within the aggregation period.

23. The medium of claim 16, in which different versions of the stored width values in relation to their associated stored heart rate values are stored at different times, and the operations further comprise:

storing, in the memory, data files that encode the different versions.

24. The medium of claim 23, in which time stamps are further stored in the memory in association with the respective data files.

25. The medium of claim 23, in which an additional data file becomes thus stored after the passage of a preset aggregation time.

26. The medium of claim 23, in which an additional data file becomes thus stored after a preset number of representative heart rate values have been determined.

27. The medium of claim 23, in which the WCD system further includes an input device, and

an additional data file becomes thus stored responsive to a user input being received from the input device.

28. A method for using a wearable cardioverter defibrillator (WCD) system, the WCD system including:

a support structure, a power source, an energy storage module coupled to the support structure, a discharge circuit, one or more sensors, a processor, and a memory, the method comprising;

acquiring, by the one or more sensors, during a time interval patient physiological signals that include electrocardiogram (ECG) data of the patient while the patient is wearing the support structure;

selecting a plurality of aggregation periods within the time interval and, for each aggregation period in the plurality;

(a) identifying one or more QRS complexes of the ECG data within the aggregation period;

(b) determining a representative width value for the identified one or more QRS complexes; and

(c) determining a representative heart rate value for the aggregation period;

storing, for at least some of the aggregation periods, the identified representative width values in association with the determined representative heart rate values;

determining a treatment for the patient based on the stored width values in relation to their associated stored heart rate values;

receiving, in the energy storage module an electric charge from the power source, and storing the received electric charge; and

discharging, by the discharge circuit, the electric charge stored in the energy storage module while the support structure is worn by the patient and based on the determined treatment.

29. In combination, a wearable cardioverter defibrillator (WCD) system and a remote computer, the WCD system comprising:

a support structure configured to be worn by a patient;

a power source;

an energy storage module configured to be coupled to the support structure, to receive an electric charge from the power source, and to store the received electric charge;

a discharge circuit coupled to the energy storage module, the discharge circuit controllable to discharge an electric charge stored in the energy storage module while the support structure is worn by the patient;

one or more sensors configured to acquire patient physiological signals during a time interval, the patient physiological signals including electrocardiogram (ECG) data of the patient;

a local processor configured to perform the following local operations;

select a plurality of aggregation periods within the time interval and,

for each aggregation period, to;

a) identify one or more QRS complexes of the ECG data within the aggregation period, b) determine a representative width value for the identified one or more QRS complexes, and c) determine a representative heart rate value for the aggregation period;

a local memory configured to store data resulting from outcomes of the local operations;

a local communication module configured to transmit data stored in the local memory via a communications link,

while the remote computer comprises;

a remote communication module configured to receive from the communications link the transmitted data; and

a remote screen configured to display a plot of the stored width values versus their associated stored heart rate values.

30. In combination, a wearable cardioverter defibrillator (WCD) system and a remote computer, the WCD system comprising:

a support structure configured to be worn by a patient;

a power source;

an energy storage module configured to be coupled to the support structure, to receive an electric charge from the power source, and to store the received electric charge;

a discharge circuit coupled to the energy storage module, the discharge circuit controllable to discharge an electric charge stored in the energy storage module while the support structure is worn by the patient;

one or more sensors configured to acquire patient physiological signals during a time interval, the patient physiological signals including electrocardiogram (ECG) data of the patient;

a local processor configured to perform at least one of the following local operations;

select a plurality of aggregation periods within the time interval, and

for each aggregation period, to;

a) identify one or more QRS complexes of the ECG data within the aggregation period, b) render a representative width value for the identified one or more QRS complexes, and c) determine a representative heart rate value for the aggregation period;

a local memory configured to store data resulting from outcomes of the local operations;

a local communication module configured to transmit data stored in the local memory via a communications link,

while the remote computer comprises;

a remote communication module configured to receive from the communications link the transmitted data;

a remote memory configured to store the transmitted data;

a remote processor configured to perform whichever of the following remote operations that was not performed by the local processor;

select a plurality of aggregation periods within the time interval, and

for each aggregation period, to;

a) identify one or more QRS complexes of the ECG data within the aggregation period, b) render a representative width value for the identified one or more QRS complexes, and c) determine a representative heart rate value; and

a remote screen configured to display a plot of the stored width values versus their associated stored heart rate values.