Granted Patent B2

US 12,569,696 · App. 18/073,659 · Granted Mar 10, 2026

Inventors: Cameron G. Pollock (Kirkland, WA); Stacy Taylor (Kingston, WA); Kenneth F. Cowan (Everett, WA); Traci S. Umberger (Kirkland, WA); Gregory T. Kavounas (Bellevue, WA)

Assignee: West Affum Holdings DAC

A61N1/3993A61N1/3904

Abstract

Claims (61)

1 . A wearable medical system (WMS) for an ambulatory patient, comprising:

a support structure configured to be worn by the ambulatory patient;

a sensor configured to sense one or more parameters of the ambulatory patient;

a measurement circuit configured to render a patient input responsive to the sensed one or more parameters;

an energy storage module configured to store an electrical charge;

a therapy electrode coupled to the energy storage module and configured to be maintained on a body of the ambulatory patient when the support structure is worn by the ambulatory patient;

a microphone configured to output an audio signal responsive to ambient sounds, wherein the microphone is further configured to continuously record and discard audio data corresponding to the audio signal;

a memory;

a user trigger module configured to enable the ambulatory patient to generate a trigger input; and

one or more processors programmed to:

receive the patient input responsive to the sensed one or more parameters,

determine, based on the received patient input, whether a shock criterion is met, wherein the shock criterion is met when the one or more parameters cross a threshold value,

issue, responsive to the shock criterion being met, a prompt for a preset amount of time indicating the ambulatory patient to generate the trigger input within the preset amount of time,

detect the generated trigger input,

cause, responsive to the detected trigger input, the audio data to be recorded in the memory, wherein causing the audio data to be recorded stops the discarding of the audio data, wherein the audio data is recorded for a predetermined time interval, and wherein the memory is configured to retain audio recordings made prior to the detected trigger input; and

create an exportable computer file comprising the recorded audio data for clinical review.

2 . The WMS of claim 1 , in which:

the parameter includes an Electrocardiogram (ECG) signal of the patient,

the sensor includes sensing electrodes configured to sense the ECG signal,

and the patient input includes values for the ECG signal.

3 . The WMS of claim 1 , wherein:

the one or more processors are further programmed to:

stop the audio data recording in the memory, responsive to a stop audio recording event occurring, wherein the stop audio recording event occurs after the trigger input is generated.

4 . The WMS of claim 3 , in which:

the stop audio recording event is passage of a predetermined amount of time from when the generated trigger input was detected.

5 . The WMS of claim 3 , in which:

the stop audio recording event is the detection of another generated trigger input.

6 . The WMS of claim 1 , in which:

the user trigger module is a voice recognition module that is designed to:

receive the audio signal,

recognize, within the audio signal, a preset voice prompt, and

generate the trigger input responsive to thus recognizing the preset voice prompt.

7 . The WMS of claim 1 , further comprising:

an output device configured to output a human-perceptible warning prompt, wherein:

the one or more processors are further programmed to:

cause, responsive to the shock criterion being met, the output device to output a Human Perceptible Indication (HPI),

wait for the preset amount of time after the HPI is output, and

cause, responsive to the generated trigger input not being detected during the preset amount of time, at least some of the stored electrical charge to be thus discharged so as to deliver a shock to the ambulatory patient, and

responsive to the generated trigger input being detected during the preset amount of time, not cause any of the stored electrical charge to be thus discharged responsive to the shock criterion being met.

8 . The WMS of claim 1 , in which:

the energy storage module is provided within a unit, and

a peripheral device that is distinct from the unit is configured to be carried by the ambulatory patient, is configured to be in electronic communication with the unit, and includes the user trigger module.

9 . The WMS of claim 8 , in which: the peripheral device is part of the WMS.

10 . The WMS of claim 8 , in which: the user trigger module includes a touchscreen on the peripheral device.

11 . The WMS of claim 8 , in which:

the peripheral device includes the microphone, and

the user trigger module is a voice recognition module within the peripheral device, and which is designed to:

receive the audio signal,

recognize, within the audio signal, a preset voice prompt, and

generate the trigger input responsive to thus recognizing the preset voice prompt.

12 . The WMS of claim 1 , wherein the exportable computer file comprises at least electrocardiogram (ECG) signals and the audio data recorded during the predetermined time interval.

13 . The WMS of claim 1 , wherein the one or more processors are further programmed to cause, responsive to the shock criterion being met, at least some of the stored electrical charge to be discharged via the therapy electrode through the ambulatory patient while the support structure is worn by the ambulatory patient, to deliver a shock to the ambulatory patient.

14 . A method for a wearable medical system (WMS), the WMS including at least a support structure configured to be worn by an ambulatory patient, a sensor configured to sense one or more parameters of the ambulatory patient, a measurement circuit configured to render a patient input responsive to the sensed one or more parameters, an energy storage module configured to store an electrical charge, a therapy electrode coupled to the energy storage module and configured to be maintained on a body of the ambulatory patient when the support structure is worn by the ambulatory patient, a microphone configured to output an audio signal responsive to ambient sounds, wherein the microphone is further configured to continuously record and discard audio data corresponding to the audio signal, a memory, a user trigger module configured to enable the ambulatory patient to generate a trigger input, and one or more processors, the method comprising:

receiving the patient input responsive to the sensed one or more parameters;

determining, based on the received patient input, whether a shock criterion is met, wherein the shock criterion is met when the one or more parameters cross a threshold value;

issuing, responsive to the shock criterion met, a prompt for a preset amount of time indicating the ambulatory patient to generate the trigger input within the preset amount of time;

detecting the generated trigger input;

causing, responsive to the detected trigger input, the audio data to be recorded in the memory, wherein causing the audio data to be recorded stops the discarding of the audio data, wherein the audio data is recorded for a predetermined time interval, and wherein the audio recordings made prior to the detected trigger input are retained; and

creating an exportable computer file comprising the recorded audio data for clinical review.

15 . The method of claim 14 , further comprising:

stopping the audio data recording in the memory, responsive to a stop audio recording event occurring, wherein the stop audio recording event occurs after the trigger input is generated.

Assignments (5)

Continuity (2)

References Cited (186)