Systems and Methods for Testing a Medical Device

Patent metadata

Field	Value
Publication number	US-2016274162-A1
Application number	US-201615073923-A
Country	US
Kind code	A1
Filing date	Mar 18, 2016
Priority date	Mar 20, 2015
Publication date	Sep 22, 2016
Grant date	—

Abstract

An ambulatory medical device comprises: a sensing component to be disposed on a patient for detecting a physiological signal of the patient; and monitoring and self-test circuitry configured for detecting a triggering event and initiating one or more self-tests based on detection of the triggering event. The ambulatory medical device senses the physiological signal of the patient substantially continuously over an extended period of time.

First claim

What is claimed is:

1 . An ambulatory medical device, comprising:
a sensing component to be disposed on a patient for detecting a physiological signal of the patient; and monitoring and self-test circuitry configured for detecting a triggering event and initiating one or more self-tests based on detection of the triggering event, wherein the ambulatory medical device senses the physiological signal of the patient substantially continuously over an extended period of time.

2 . The ambulatory medical device of claim 1 , wherein the triggering event comprises at least one of an impact and a vibration event experienced by the ambulatory medical device.

3 . The ambulatory medical device of claim 2 , wherein the at least one of the impact and the vibration event experienced by the ambulatory medical device corresponds to one of an impact level that exceeds a predetermined impact level and a vibration level that exceeds a predetermined vibration level.

4 . The ambulatory medical device of claim 2 , wherein at least one of the impact and the vibration event experienced by the ambulatory medical device corresponds to an impact duration that exceeds a predetermined impact duration and a vibration duration that exceeds a predetermined vibration duration.

5 . The ambulatory medical device of claim 2 , further comprising an electromechanical switch for detecting the at least one of the impact and the vibration event experienced by the ambulatory medical device.

6 . The ambulatory medical device of claim 2 , further comprising at least one of a single axis accelerometer, a multi-axis accelerometer, and a piezoelectric transducer for detecting the at least one of the impact and the vibration event experienced by the ambulatory medical device.

7 . The ambulatory medical device of claim 2 , wherein the one or more self-tests comprise tests of at least one of a device, component, and subsystem of the ambulatory medical device to ensure that the at least one of the impact and the vibration event has not adversely affected the at least one of the device, component, and subsystem.

8 . The ambulatory medical device of claim 1 , wherein the triggering event comprises at least one of a software update, a device configuration update, and a patient parameter change.

9 . The ambulatory medical device of claim 8 , wherein the at least one of the software update, the device configuration update, and the patient parameter change is initiated remotely.

10 . The ambulatory medical device of claim 8 , wherein the device configuration update comprises an update to one or more device parameters set in the ambulatory medical device.

11 . The ambulatory medical device of claim 1 , wherein the triggering event is based on a user action or activity.

12 . The ambulatory medical device of claim 1 , wherein the triggering event is a wireless test signal.

13 . The ambulatory medical device of claim 12 , wherein the wireless test signal is initiated at a remote support center.

14 . The ambulatory medical device of claim 1 , wherein the triggering event is based on a detecting of at least one of battery replacement, battery removal, and battery ejection.

15 . The ambulatory medical device of claim 1 , wherein the triggering event is based on a battery level transgressing a predetermined battery charge threshold.

16 . The ambulatory medical device of claim 1 , wherein the triggering event is based on a signal indicating that one or more electrodes is making insufficient contact with the patient's skin.

17 . The ambulatory medical device of claim 1 , wherein the triggering event is in response to detecting moisture in excess of a predetermined moisture level.

18 . The ambulatory medical device of claim 1 , wherein the triggering event is in response to detecting strain on a device component in excess of a predetermined strain level.

19 . The ambulatory medical device of claim 1 , wherein the triggering event is in response to detecting a temperature of at least one of the device or a component of the device greater than a predetermined maximum temperature or less than a predetermined minimum temperature.

20 . The ambulatory medical device of claim 1 , wherein the triggering event is in response to detecting an operative connection between one or more electrodes and the medical device.

21 . The ambulatory medical device of claim 1 , wherein the triggering event comprises at least one of replacement of a garment that comprises the ambulatory medical device worn about a torso of the patient, replacement of a patient signal sensor, and a prompt for replacement of at least one of the garment and the patient signal sensor in response to wear of the at least one of the garment and the patient signal sensor over time due to use.

22 . The ambulatory medical device of claim 1 , wherein the one or more self-tests comprises one or more tests related to a type of the triggering event.

23 . The ambulatory medical device of claim 1 , wherein the triggering event is initiated by or within a device, component, or subsystem of the ambulatory medical device, and the one or more self-tests comprise one or more tests of the device, component, or subsystem of the ambulatory medical device that initiated or caused the triggering event.

24 . The ambulatory medical device of claim 1 , wherein the monitoring and self-test circuitry is configured to classify the triggering event and, based on the classification, determine whether to initiate a self-test of the continuous use medical device.

25 . The ambulatory medical device of claim 1 , wherein the monitoring and self-test circuitry is configured to store a flag in a memory of the ambulatory medical device indicating a status of the triggering event.

26 . The ambulatory medical device of claim 1 , wherein the monitoring and self-test circuitry is always operational for the monitoring whether a primary source of power is available in the ambulatory medical device.

27 . The ambulatory medical device of claim 26 , wherein the primary source of power is a main battery for use with the ambulatory medical device.

28 . The ambulatory medical device of claim 26 , wherein when the primary source of power is not able to or is not available to supply electrical power, a secondary source of power provides power to the monitoring and self-test circuitry.

29 . The ambulatory medical device of claim 28 , wherein the secondary source of power comprises at least one of a backup battery, a capacitor, an inductor, and a supercapacitor.

30 . The ambulatory medical device of claim 28 , wherein, responsive to the triggering event when the secondary source of power is providing power to the monitoring and self-test circuitry at least one of:
performing a subset of the one or more self-test with power from the secondary source of power, and delay performing the subset of the one or more self-test until the primary source of power is supplying electrical power to the monitoring and self-test circuitry.

31 . The ambulatory medical device of claim 28 , wherein the monitoring and self-test circuitry, operating with power from only the secondary source of power, is operational for monitoring during at least one of the following: replacement of the primary source of power;
at least one of remov

Assignees

• Zoll Medical Corp

Inventors

• Freeman Gary A
• Volpe Shane
• Stever Timothy F
• Kaib Thomas E

Classifications

• A61B5/0205 Primary

  Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition · CPC title

• A61N1/3904

  External heart defibrillators [EHD] · CPC title

• A61B5/7285

  for synchronizing or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal · CPC title

• A61B5/7282

  Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818) · CPC title

• A61B5/6805

  Vests, e.g. shirts or gowns · CPC title