| CPC A61N 1/0484 (2013.01) [A61N 1/0456 (2013.01); A61N 1/046 (2013.01); A61N 1/0476 (2013.01); A61N 1/3625 (2013.01); A61N 1/36585 (2013.01); A61N 1/3925 (2013.01); A61N 1/3968 (2013.01); A61N 1/3987 (2013.01); A41D 13/1281 (2013.01); A41D 31/102 (2019.02); A41D 31/12 (2019.02); A61B 5/021 (2013.01); A61B 5/0537 (2013.01); A61B 5/0816 (2013.01); A61B 5/1118 (2013.01); A61B 5/14542 (2013.01); A61B 5/4839 (2013.01); A61B 5/6804 (2013.01); A61B 5/6805 (2013.01); A61B 7/00 (2013.01); A61B 7/003 (2013.01)] | 55 Claims |
|
1. A wearable cardiac monitoring and treatment device with enhanced comfort for a patient at risk of life-threatening cardiac arrhythmias, comprising:
a garment configured to be worn around a torso of the patient, the garment comprising an outer fabric layer forming an exterior surface of the garment and an inner fabric layer forming an interior surface of the garment, wherein the exterior surface is configured to be water-resistant to substantially prevent an ingress of water and the interior surface is configured to substantially allow moisture vapor to be transferred away from the patient's skin and from the inner fabric layer towards the outer fabric layer;
a plurality of electrocardiogram (ECG) sensing electrodes permanently coupled at first predetermined locations on the garment, the plurality of ECG sensing electrodes configured to sense one or more ECG signals from the patient;
a ground electrode configured to sense a ground signal;
a plurality of wires or cables integrated into the garment and permanently disposed between the outer fabric layer and the inner fabric layer;
a waterproof or water-resistant low-voltage removable sensor interface module configured to operate below about 100 V and further configured to be disposed on the garment, wherein the low-voltage removable sensor interface module is further configured to receive the one or more ECG signals from the plurality of ECG sensing electrodes and the ground signal from the ground electrode via the plurality of wires or cables disposed between the outer fabric layer and the inner fabric layer;
a waterproof or water-resistant high-voltage therapy control module configured to operate between about 100 V and about 2000 V and further configured to be disposed on the garment, wherein the high-voltage therapy control module is further configured to control delivery of a therapeutic shock to the patient responsive to detection of a cardiac arrhythmia based on the sensed one or more ECG signals;
a waterproof or water-resistant plurality of capacitor modular components configured to store energy for the therapeutic shock and further configured to be distributed about and integrated into the garment, wherein each capacitor modular component comprises an enclosure and one or more capacitors adapted to be housed in the enclosure;
a waterproof or water-resistant user interface module configured to be disposed on the garment and comprising a speaker, a tactile vibrator, and at least one user response button; and
a plurality of therapy electrodes removably disposed in second predetermined locations on the garment, and configured to deliver the therapeutic shock to the patient;
wherein the low-voltage removable sensor interface module is further configured to
pre-treat and/or digitize the received one or more ECG signals, wherein pre-treating and/or digitizing the one or more ECG signals comprises reducing and/or removing common mode noise in the one or more ECG signals using the ground signal from the ground electrode, and
provide the pre-treated and/or digitized one or more ECG signals to another component of the wearable cardiac monitoring and treatment device;
wherein the high-voltage therapy control module is further configured to control characteristics of the therapeutic shock;
wherein the user interface module is further configured to
emit alarms to notify the patient of a detected cardiac arrhythmia via the speaker and the tactile vibrator, and
detect the at least one user response button being pressed to indicate that the patient is conscious;
wherein therapy delivery systems comprising at least the high-voltage therapy control module and the plurality of capacitor modular components are configured to be separable from monitoring systems comprising at least the plurality of ECG sensing electrodes, the ground electrode, and the sensor interface module such that the wearable cardiac monitoring and treatment device is re-configurable as a monitoring device configured to monitor a condition of the patient using the pre-treated and/or digitized one or more ECG signals; and
wherein the wearable cardiac monitoring and treatment device is configured to perform a self-test to check that the therapy delivery systems have been properly attached and electrically or otherwise coupled to other portions of the wearable cardiac monitoring and treatment device.
|