Garments for wearable medical devices

Inventors

Kaib, Thomas E. • Volpe, Shane S. • Frank, Gregory R. • Freeman, Gary A. • Owens, Mark Jerome

Assignees

Zoll Medical Corp

Abstract

According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes a garment worn about a torso of a patient, at least one sensing electrode to monitor cardiac activity of the patient, and a controller including a plurality of separate and distinct modules distributed about and/or integrated into the garment. The plurality of separate and distinct modules includes, for example, an operations module coupled to the at least one sensing electrode and configured to detect at least one cardiac condition of the patient and/or a communications module coupled to the operations module to communicate with an external device. In some examples, the wearable cardiac device may be configured as a treatment device and include an energy storage module coupled to at least one therapy electrode and configured to store energy for at least one therapeutic shock to be applied to the patient.

Core Innovation

The invention relates to a wearable cardiac monitoring and treatment device configured for enhanced comfort of a patient at risk of life-threatening cardiac arrhythmias. A garment is configured to be worn around a torso and includes an outer fabric layer forming an exterior surface and an inner fabric layer forming an interior surface. The exterior surface is configured to be water-resistant to substantially prevent ingress of water, while the interior surface is configured to substantially allow moisture vapor to be transferred away from the patient’s skin toward the outer fabric layer.

The garment includes permanently coupled ECG sensing electrodes at first predetermined locations and a ground electrode configured to sense a ground signal. Wires or cables are integrated into the garment and permanently disposed between the outer and inner fabric layers. A waterproof or water-resistant low-voltage removable sensor interface module operates below about 100 V and receives ECG signals and the ground signal via the integrated wires or cables, and is configured to pre-treat and/or digitize the ECG signals by reducing and/or removing common mode noise using the ground signal.

A waterproof or water-resistant high-voltage therapy control module operates between about 100 V and about 2000 V and controls delivery of a therapeutic shock responsive to detection of a cardiac arrhythmia based on the sensed ECG signals. Energy for the therapeutic shock is stored in waterproof or water-resistant capacitor modular components distributed and integrated into the garment, each capacitor modular component including an enclosure and one or more capacitors. Therapy electrodes are removably disposed at second predetermined locations to deliver the therapeutic shock, while a waterproof or water-resistant user interface module includes a speaker, a tactile vibrator, and at least one user response button to emit alarms and detect whether the patient is conscious.

Therapy delivery systems including the high-voltage therapy control module and capacitor modular components are separable from monitoring systems including at least the ECG sensing electrodes, the ground electrode, and the sensor interface module, such that the device is re-configurable as a monitoring device. The wearable device performs 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.

Claims Coverage

Independent claim clm-00001 covers one integrated wearable device architecture and connectivity scheme, including nine inventive features spanning garment comfort, removable low-voltage sensing electronics, high-voltage therapy control, distributed capacitor energy storage, user notification and consciousness detection, and separable reconfiguration with self-test. The claim further specifies quantitative operating ranges for the low-voltage module and therapy control module, and defines signal pre-treatment using ground-based common mode noise reduction.

Across the independent claim, the invention combines a comfort-oriented torso garment with permanently coupled ECG sensing and ground, a waterproof low-voltage removable sensor interface that pre-treats and/or digitizes ECG signals using ground-based common mode noise reduction, and a waterproof high-voltage therapy control module for arrhythmia-responsive therapeutic shock. Energy storage is provided by distributed garment-integrated capacitor modular components, and therapy delivery is removably separable to enable monitoring-only reconfiguration with an associated self-test of proper attachment and coupling.

Stated Advantages

Documented Applications

No documented applications found