Patient Wearable Arrhythmia Monitoring and Disposal Device

Abstract

The present invention relates to a patient-wearable arrhythmia monitoring and treatment device. The patient-wearable arrhythmia monitoring and treatment device weighing from 250 grams to 2500 grams comprises: at least one conformable pad configured to be attached and coupled to a patient's torso; a plurality of treatment electrodes, at least one of which is integrated with at least one conformable pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with at least one conformable pad. At least one housing configured to form a watertight seal with at least one conformable pad extends from the conformable pad by no more than 5 cm. A processor disposed within the housing is coupled to a treatment delivery circuit and is configured to detect one or more treatable arrhythmias based on at least one ECG signal and cause the treatment delivery circuit to deliver at least one defibrillation pulse when one or more treatable arrhythmias are detected.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 738,113, filed on September 28, 2018, titled "Adhesively Coupled Wearable Medical Device", which is hereby incorporated by reference in its entirety. Background Art

[0003] In one example, a patient - wearable arrhythmia monitoring and treatment device includes: at least one conformable pad configured to be adhesively coupled to a patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the conformable pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the conformable pad. At least one housing is configured to form a watertight seal with the conformable pad and extends from the surface of the conformable pad by no more than 5 cm. An ECG acquisition and conditioning circuit may be disposed within the at least one housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal of the patient, and a treatment delivery circuit may be disposed within the at least one housing. The treatment delivery circuit may be configured to deliver one or more treatment pulses to the patient through the plurality of treatment electrodes. In the example, a processor is disposed within the at least one housing and coupled to the treatment delivery circuit, and is configured to analyze at least one ECG signal of the patient, detect one or more treatable arrhythmias based on the at least one ECG signal, and cause the treatment delivery circuit to deliver at least one defibrillation pulse to the patient when one or more treatable arrhythmias are detected. In the example, the patient - wearable monitoring and treatment device has a weight of 250 grams to 2500 grams.

[0004] The implementation of the device may include one or more of the following features.

[0005] In the example, the at least one housing is configured to extend from the surface of the at least one conformable pad by 1 cm to 5 cm.

[0006] In the example, the at least one housing is configured to extend from the surface of the at least one conformable pad by 1 cm to 4 cm.

[0007] In the example, the at least one housing is configured to extend from the surface of the at least one conformable pad by 1 cm to 3 cm.

[0008] In the example, the delivery of at least one defibrillation pulse includes the delivery of no more than one defibrillation pulse.

[0009] In the example, the plurality of ECG sensing electrodes are dry ECG electrodes configured to contact the patient's skin. In the example, the plurality of ECG sensing electrodes are conductive electrodes. In the example, the plurality of ECG sensing electrodes are non - polarizable electrodes configured to contact the patient's skin.

[0010] In an example, one or more arrhythmias that can be treated include shockable ventricular tachycardia and ventricular fibrillation, and the therapy delivery circuit is also configured to deliver one or more pacing pulses. In an example, one or more arrhythmias that can be treated include tachycardia and bradycardia.

[0011] In an example, the conformable pad is configured to attach to and couple with a patient for a short duration. In an example, the short duration is a duration that is at least one of up to about 24 hours, about 48 hours, about 4 days, about 1 week, and about 2 weeks. In an example, the weight of the patient-wearable monitoring and treatment device is at least one of 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

[0012] In an example, the conformable pad includes a flexible material configured to conform to the curvature of a region of the torso. In an example, the conformable pad includes a plurality of sections separated by the flexible material to conform to the curvature of a region of the torso. In an example, at least one housing includes a plurality of housings, where each of the plurality of housings is disposed on a respective one of the plurality of sections. The plurality of housings may each be configured to house one or more of a therapy delivery circuit, an ECG acquisition and conditioning circuit, a processor, at least one capacitor, and at least one power source.

[0013] In an example, the electronics are disposed within at least one housing. The electronics may include one or more of a therapy delivery circuit, an ECG acquisition and conditioning circuit, a processor, at least one capacitor, and at least one power source. One or more of the therapy delivery circuit, the ECG acquisition and conditioning circuit, the processor, at least one capacitor, and at least one power source may each be within a separate enclosure.

[0014] In an example, the conformable pad, the at least one housing, and the electronics are assembled into a component such that when the device is mounted on a patient, the center of mass of the component is below the center of volume of the component.

[0015] In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing to the distance between the center of volume and the lower edge line is in the range of at least one of 1% to 90%, 5% to 80%, and 10% to 70%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing to the distance between the center of volume and the lower edge line is in the range of 1% to 90%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing to the distance between the center of volume and the lower edge line is in the range of 5% to 80%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing to the distance between the center of volume and the lower edge line is in the range of 10% to 70%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of at least one contour pad to the lateral distance between the center of volume and the patient-facing surface of at least one contour pad is in the range of at least one of 1% to 90%, 5% to 80%, and 10% to 70%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad to the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 1% to 90%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad to the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 5% to 80%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad to the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 10% to 70%.

[0016] In an example, the rotational torque at the centroid of the assembly is in the range of 0.15 to 1.0 lbf ft.

[0017] In an example, at least one capacitor included in the electronic device is a thin film capacitor. The at least one capacitor may have an envelope volume ranging from about 10 cm 2 to 15 cm 2 The at least one capacitor has a capacitance of 140 microfarads and a rated voltage of at least 1600 V.

[0018] In an example, at least one power source included in the electronic device includes one or more batteries, where the batteries have a combined envelope volume not exceeding one quarter of the volume of at least one housing and have a capacity of 1200 mAh to 8000 mAh. In an example, at least one power source includes at least one lithium ion battery. The one or more batteries may be a flat-packaged lithium polymer battery. In an example, the one or more batteries may have a combined volume ranging from about 1 cm 2 to 7 cm 2 The combined volume of.

[0019] In an example, the device includes an active thermal management system disposed within at least one housing. The active thermal management system can include a thermoelectric cooling device. The active thermal management system can include a low-profile fan.

[0020] In an example, the device includes a passive thermal management system disposed within at least one housing. The passive thermal management system can include a removably insertable cooling pack. The passive thermal management system can include a metal heat dissipation layer disposed on one or more of a plurality of ECG sensing electrodes and / or a plurality of treatment electrodes. The passive thermal management system can include one or more through-holes extending between an interface between a conformable pad and a patient's torso and an outer surface of at least one housing.

[0021] In an example, at least one conformable pad includes a second pad configured to attachably couple to a patient's torso. In an example, the second pad is configured to have a certain shape. A wireless transceiver can be integrated with the second pad to be configured to communicate with a treatment delivery circuit, and a second treatment electrode of the plurality of treatment electrodes can be integrated with the second pad and communicate wirelessly with the treatment delivery circuit.

[0022] In an example, at least one conformable pad includes a second pad configured to attachably couple to a patient's torso. In an example, the second pad is configured to have a certain shape. A second treatment electrode of the plurality of treatment electrodes can be integrated with the second pad and communicate wiredly with the treatment delivery circuit.

[0023] In an example, at least one conformable pad includes a third pad configured to attachably couple to a patient's torso. In an example, the third pad is configured to have a certain shape. The third pad can include a transceiver integrated with the third pad, where the transceiver is configured to communicate with a treatment delivery circuit. A third treatment electrode of the plurality of treatment electrodes can be integrated with the third pad and communicate wiredly with the treatment delivery circuit. In an example, the third pad is configured to attachably couple to the torso adjacent to the atrium.

[0024] In an example, at least one conformable pad has an area occupancy of from about 200 square centimeters to about 300 square centimeters.

[0025] In an example, the ratio of the weight of the patient-wearable monitoring and treatment device to the area occupancy of at least one conformable pad ranges from about 10 kg / m 2 to 100 kg / m 2 .

[0026] In an example, the device includes a breathable anisotropic conductive gel disposed between at least one contoured pad and the torso and configured to be placed along at least one of a plurality of treatment electrodes. In an example, the ratio of the area occupied by the region of the breathable anisotropic conductive gel to the area occupied by the region of at least one contoured pad ranges from about 0.30 to 0.75. A breathable adhesive may be disposed between at least one contoured pad and the torso, wherein the ratio of the area occupied by the region of the breathable adhesive to the area occupied by the region of at least one contoured pad ranges from about 0.05 to 0.25.

[0027] In an example, at least one contoured pad includes one or more receptacles for receiving at least one housing in a watertight fit. The one or more receptacles may include a sealing lip. The sealing lip may include an elastomeric waterproof material and engage the upper surface of at least one housing. At least one housing may include a peripheral flange, and the sealing lip receives the peripheral flange.

[0028] The present invention relates to a wearable cardiac monitoring and treatment device.

[0029] Patients with heart failure experience symptoms caused by a weak or impaired heart that is inefficient at contracting and pumping oxygenated blood effectively through the body. The heart may be weakened due to, for example, abnormal heart rhythms (e.g., arrhythmias), high blood pressure, coronary artery disease, myocardial infarction, and myocarditis.

[0030] If left untreated, heart failure can lead to certain life-threatening arrhythmias. Both atrial and ventricular arrhythmias are common in patients with heart failure. One of the most deadly arrhythmias is ventricular fibrillation, which occurs when normal regular electrical impulses are replaced by irregular and rapid impulses, causing the myocardium to stop contracting normally. Since there is no perceivable warning of an impending fibrillation for the victim, death often occurs before necessary medical assistance can arrive. Other arrhythmias can include a slow heart rate known as bradycardia or a fast heart rate known as tachycardia.

[0031] Cardiac arrest can occur when various arrhythmias of the heart, such as ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA), and asystole (when the heart stops all electrical activity), result in an insufficient level of blood flow from the heart to the brain and other vital organs for maintaining life. Monitoring heart failure patients to assess heart failure symptoms early and provide intervention as soon as possible is generally useful.

[0032] A wearable cardiac monitoring and treatment device is provided to monitor such arrhythmias and provide treatment when a life-threatening arrhythmia is detected. The patient wears the device continuously to provide constant protection. As such, the device needs to be designed to be comfortable and easy to use. Summary of the Invention

[0033] In one example, a patient-wearable arrhythmia monitoring and treatment device includes: at least one conformable pad configured to be attached and coupled to a patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the conformable pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the conformable pad. At least one housing is configured to form a watertight seal with the conformable pad and extends no more than 5 cm from the surface of the conformable pad. An ECG acquisition and conditioning circuit may be disposed within the at least one housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal of the patient, and a treatment delivery circuit may be disposed within the at least one housing. The treatment delivery circuit may be configured to deliver one or more treatment pulses to the patient via the plurality of treatment electrodes. In an example, a processor is disposed within the at least one housing and coupled to the treatment delivery circuit and is configured to analyze at least one ECG signal of the patient, detect one or more treatable arrhythmias based on the at least one ECG signal, and cause the treatment delivery circuit to deliver at least one defibrillation pulse to the patient when one or more treatable arrhythmias are detected. In an example, the patient-wearable monitoring and treatment device has a weight of 250 grams to 2500 grams.

[0034] A patient-wearable arrhythmia monitoring and treatment device includes: at least one assembly of lighter components, the at least one assembly including: at least one treatment electrode configured to deliver a treatment pulse, at least one of the at least one treatment electrode being configured to be disposed on an attachment pad; at least one ECG sensing electrode configured to sense an ECG signal of the patient, the at least one ECG sensing electrode being attached and coupled to the torso; and at least one assembly of heavier components disposed on a wearable support, the at least one assembly including: a device controller including: at least one capacitor configured to provide energy for the treatment pulse, at least one rechargeable battery for powering the at least one capacitor, at least one processor including a circuit board, and a user interface.

[0035] The implementation of the device may include one or more of the following features.

[0036] In an example, at least one housing is configured to extend from the surface of at least one conformable pad by 1 cm to 5 cm.

[0037] In an example, at least one housing is configured to extend from the surface of at least one conformable pad by 1 cm to 4 cm.

[0038] In an example, at least one housing is configured to extend from the surface of at least one conformable pad by 1 cm to 3 cm.

[0039] In an example, delivery of at least one defibrillation pulse includes delivery of no more than one defibrillation pulse.

[0040] In an example, the plurality of ECG sensing electrodes are dry ECG electrodes configured to contact the patient's skin. In an example, the plurality of ECG sensing electrodes are conductive electrodes. In an example, the plurality of ECG sensing electrodes are non-polarizable electrodes configured to contact the patient's skin.

[0041] In an example, one or more treatable arrhythmias include shockable ventricular tachycardia and ventricular fibrillation, and the therapy delivery circuit is further configured to deliver one or more pacing pulses. In an example, one or more treatable arrhythmias include tachycardia and bradycardia.

[0042] In an example, the conformable pad is configured to attach and couple to the patient for a short duration. In an example, the short duration is a duration of at least one of up to about 24 hours, about 48 hours, about 4 days, about 1 week, and about 2 weeks. In an example, the patient-wearable monitoring and treatment device weighs at least one of 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

[0043] In an example, the conformable pad includes a flexible material configured to conform to the curvature of a region of the torso. In an example, the conformable pad includes a plurality of sections separated by the flexible material to conform to the curvature of a region of the torso. In an example, the at least one housing includes a plurality of housings, wherein each of the plurality of housings is disposed on a respective one of the plurality of sections. The plurality of housings may each be configured to house one or more of a therapy delivery circuit, an ECG acquisition and conditioning circuit, a processor, at least one capacitor, and at least one power source.

[0044] In an example, the electronics are disposed within the at least one housing. The electronics may include one or more of a therapy delivery circuit, an ECG acquisition and conditioning circuit, a processor, at least one capacitor, and at least one power source. One or more of the therapy delivery circuit, the ECG acquisition and conditioning circuit, the processor, at least one capacitor, and at least one power source may each be within a separate enclosure.

[0045] In an example, the conformable pad, the at least one housing, and the electronics are assembled into an assembly such that when the device is mounted on the patient, the center of mass of the assembly is below the center of volume of the assembly.

[0046] In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing divided by the distance between the center of volume and the lower edge line is in the range of at least one of 1% to 90%, 5% to 80%, and 10% to 70%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing divided by the distance between the center of volume and the lower edge line is in the range of 1% to 90%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing divided by the distance between the center of volume and the lower edge line is in the range of 5% to 80%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing divided by the distance between the center of volume and the lower edge line is in the range of 10% to 70%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of at least one contour pad divided by the lateral distance between the center of volume and the patient-facing surface of at least one contour pad is in the range of at least one of 1% to 90%, 5% to 80%, and 10% to 70%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad divided by the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 1% to 90%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad divided by the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 5% to 80%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad divided by the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 10% to 70%.

[0047] In an example, the rotational torque at the centroid of the assembly is in the range of 0.15 to 1.0 lbf ft.

[0048] In an example, at least one capacitor included in the electronic device is a thin film capacitor. The at least one capacitor may have an envelope volume ranging from about 10 cm 2 to 15 cm 2 The at least one capacitor has a capacitance of 140 microfarads and a rated voltage of at least 1600 V.

[0049] In an example, at least one power source included in the electronic device includes one or more batteries, where the batteries have a combined envelope volume not exceeding one quarter of the volume of at least one housing and have a capacity of 1200 mAh to 8000 mAh. In an example, at least one power source includes at least one lithium ion battery. The one or more batteries may be flat-packaged lithium polymer batteries. In an example, the one or more batteries may have a combined volume ranging from about 1 cm 2 to 7 cm 2 The combined volume of the one or more batteries may be in the range of 1 cm to 7 cm.

[0050] In an example, the device includes an active thermal management system disposed within at least one housing. The active thermal management system can include a thermoelectric cooling device. The active thermal management system can include a low-profile fan.

[0051] In an example, the device includes a passive thermal management system disposed within at least one housing. The passive thermal management system can include a removably insertable cooling pack. The passive thermal management system can include a metallic heat dissipation layer disposed on one or more of a plurality of ECG sensing electrodes and / or a plurality of treatment electrodes. The passive thermal management system can include one or more through-holes extending between an interface between a conformable pad and a patient's torso and an outer surface of at least one housing.

[0052] In an example, at least one conformable pad includes a second pad configured to be attached and coupled to a patient's torso. In an example, the second pad is configured in a certain shape. A wireless transceiver can be integrated with the second pad to be configured to communicate with a treatment delivery circuit, and a second treatment electrode of the plurality of treatment electrodes can be integrated with the second pad and communicate wirelessly with the treatment delivery circuit.

[0053] In an example, at least one conformable pad includes a second pad configured to be attached and coupled to a patient's torso. In an example, the second pad is configured in a certain shape. A second treatment electrode of the plurality of treatment electrodes can be integrated with the second pad and communicate wiredly with the treatment delivery circuit.

[0054] In an example, at least one conformable pad includes a third pad configured to be attached and coupled to a patient's torso. In an example, the third pad is configured in a certain shape. The third pad can include a transceiver integrated with the third pad, wherein the transceiver is configured to communicate with a treatment delivery circuit. A third treatment electrode of the plurality of treatment electrodes can be integrated with the third pad and communicate wiredly with the treatment delivery circuit. In an example, the third pad is configured to be attached and coupled to the torso adjacent to the atrium.

[0055] In an example, at least one conformable pad has an area occupancy of from about 200 square centimeters to about 300 square centimeters.

[0056] In an example, the ratio of the weight of the patient-wearable monitoring and treatment device to the area occupancy of at least one conformable pad ranges from about 10 kg / m 2 to 100 kg / m 2 .

[0057] In an example, the device includes a breathable anisotropic conductive gel disposed between at least one conformable pad and the torso and configured to be placed along at least one of a plurality of treatment electrodes. In an example, the ratio of the area occupied by the breathable anisotropic conductive gel to the area occupied by the at least one conformable pad ranges from about 0.30 to 0.75. A breathable adhesive may be disposed between the at least one conformable pad and the torso, where the ratio of the area occupied by the breathable adhesive to the area occupied by the at least one conformable pad ranges from about 0.05 to 0.25.

[0058] In an example, the at least one conformable pad includes one or more receptacles for receiving at least one housing in a watertight fit. The one or more receptacles may include a sealing lip. The sealing lip may include an elastomeric waterproof material and engage the upper surface of the at least one housing. The at least one housing may include a peripheral flange, and the sealing lip receives the peripheral flange.

[0059] In one example, a patient-wearable arrhythmia monitoring and treatment device includes: at least one conformable pad configured to be attached to a patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the conformable pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the conformable pad. At least one housing is configured to form a watertight seal with the conformable pad, and the at least one housing extends from the surface of the conformable pad by about 1 cm to 5 cm. ECG acquisition and conditioning circuitry may be disposed within the at least one housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal of the patient, and treatment delivery circuitry may be disposed within the at least one housing. The treatment delivery circuitry may be configured to deliver one or more treatment pulses to the patient through the plurality of treatment electrodes. In an example, a processor is disposed within the at least one housing and coupled to the treatment delivery circuitry, and is configured to analyze at least one ECG signal of the patient, detect one or more treatable arrhythmias based on the at least one ECG signal, and cause the treatment delivery circuitry to deliver at least one defibrillation pulse to the patient when one or more treatable arrhythmias are detected. In an example, the patient-wearable monitoring and treatment device has a weight of 250 grams to 2500 grams.

[0060] Implementations of the device may include one or more of the following features.

[0061] In an example, the delivery of at least one defibrillation pulse includes the delivery of one defibrillation pulse.

[0062] In an example, the plurality of ECG sensing electrodes are dry ECG electrodes configured to contact the patient's skin. In an example, the plurality of ECG sensing electrodes are conductive electrodes. In an example, the plurality of ECG sensing electrodes are non-polarizable electrodes configured to contact the patient's skin.

[0063] In an example, one or more arrhythmias treatable include shockable ventricular tachycardia and ventricular fibrillation, and the therapy delivery circuit is also configured to deliver one or more pacing pulses. In an example, one or more arrhythmias treatable include tachycardia and bradycardia.

[0064] In an example, the conformable pad is configured to attach and couple to a patient for a short duration. In an example, the short duration is a duration of at least one of up to about 24 hours, about 48 hours, about 4 days, about 1 week, and about 2 weeks. In an example, the weight of the patient-wearable monitoring and treatment device is from 250 grams to 1250 grams. In an example, the weight of the patient-wearable monitoring and treatment device is from 500 grams to 1000 grams. In an example, the weight of the patient-wearable monitoring and treatment device is from 750 grams to 900 grams.

[0065] In an example, the conformable pad includes a flexible material configured to conform to the curvature of an area of the torso. In an example, the conformable pad includes a plurality of sections separated by the flexible material to conform to the curvature of an area of the torso. In an example, the at least one housing includes a plurality of housings, wherein each of the plurality of housings is disposed on a respective one of the plurality of sections. The plurality of housings may each be configured to house one or more of a therapy delivery circuit, an ECG acquisition and conditioning circuit, a processor, at least one capacitor, and at least one power source.

[0066] In an example, the electronics are disposed within the at least one housing. The electronics may include one or more of a therapy delivery circuit, an ECG acquisition and conditioning circuit, a processor, at least one capacitor, and at least one power source. One or more of the therapy delivery circuit, the ECG acquisition and conditioning circuit, the processor, at least one capacitor, and at least one power source may each be within a separate enclosure.

[0067] In an example, the conformable pad, the at least one housing, and the electronics are assembled as a component such that when the device is mounted on a patient, the center of mass of the component is below the center of volume of the component.

[0068] In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing divided by the distance between the center of volume and the lower edge line is in the range of 1% to 90%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing divided by the distance between the center of volume and the lower edge line is in the range of 5% to 80%. In an example, the ratio of the distance between the centroid and the lower edge line of at least one housing divided by the distance between the center of volume and the lower edge line is in the range of 10% to 70%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad divided by the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 1% to 90%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad divided by the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 5% to 80%. In an example, the ratio of the lateral distance between the centroid and the patient-facing surface of the contour pad divided by the lateral distance between the center of volume and the patient-facing surface of the contour pad is in the range of 10% to 70%.

[0069] In an example, the rotational torque at the centroid of the assembly is in the range of 0.15 to 1.0 lbf ft.

[0070] In an example, at least one capacitor included in the electronic device is a thin-film capacitor. The at least one capacitor may have an envelope volume ranging from about 10 cm 2 to 15 cm 2 The at least one capacitor has a capacitance of 140 microfarads and a rated voltage of at least 1600 V.

[0071] In an example, at least one power source included in the electronic device includes one or more batteries, where the batteries have a combined envelope volume not exceeding one quarter of the volume of at least one housing and have a capacity of 1200 mAh to 8000 mAh. In an example, at least one power source includes at least one lithium-ion battery. The one or more batteries may be a flat-pack lithium polymer battery. In an example, the one or more batteries may have a combined volume ranging from about 1 cm 2 to 7 cm 2 The combined volume.

[0072] In an example, the device includes an active thermal management system disposed within at least one housing. The active thermal management system may include a thermoelectric cooling device. The active thermal management system may include a low-profile fan.

[0073] In an example, the device includes a passive thermal management system disposed within at least one housing. The passive thermal management system can include a removably insertable cooling pack. The passive thermal management system can include a metallic heat dissipation layer disposed on one or more of a plurality of ECG sensing electrodes and / or a plurality of treatment electrodes. The passive thermal management system can include one or more through-holes extending between an interface between a conformable pad and a patient's torso and an outer surface of at least one housing.

[0074] In an example, at least one conformable pad includes a second conformable pad configured to be adhesively coupled to a patient's torso. A wireless transceiver can be integrated with the second conformable pad and configured to communicate with a treatment delivery circuit, and a second treatment electrode of the plurality of treatment electrodes can be integrated with the second conformable pad and communicate wirelessly with the treatment delivery circuit.

[0075] In an example, at least one conformable pad includes a second conformable pad configured to be adhesively coupled to a patient's torso. A second treatment electrode of the plurality of treatment electrodes can be integrated with the second conformable pad and communicate wiredly with the treatment delivery circuit.

[0076] In an example, at least one conformable pad includes a third conformable pad configured to be adhesively coupled to a patient's torso. The third conformable pad can include a transceiver integrated with the third conformable pad, wherein the transceiver is configured to communicate with a treatment delivery circuit. A third treatment electrode of the plurality of treatment electrodes can be integrated with the third conformable pad and communicate wiredly with the treatment delivery circuit. In an example, the third conformable pad is configured to be adhesively coupled to a torso adjacent to the atrium.

[0077] In an example, at least one conformable pad has an area occupancy of from about 200 square centimeters to about 300 square centimeters.

[0078] In an example, the ratio of the weight of the patient-wearable monitoring and treatment device to the area occupancy of at least one conformable pad ranges from about 10 kg / m 2 to 100 kg / m 2 .

[0079] In an example, the device includes a breathable anisotropic conductive gel disposed between at least one conformable pad and a torso and configured to be placed along at least one of the plurality of treatment electrodes. In an example, the ratio of the area occupancy of the breathable anisotropic conductive gel to the area occupancy of at least one conformable pad ranges from about 0.30 to 0.75. A breathable adhesive can be disposed between at least one conformable pad and a torso, wherein the ratio of the area occupancy of the breathable adhesive to the area occupancy of at least one conformable pad ranges from about 0.05 to 0.25.

[0080] In an example, at least one profile pad includes one or more receivers for receiving at least one housing in a watertight fit. The one or more receivers may include a sealing lip. The sealing lip may include an elastic waterproof material and engage the upper surface of the at least one housing. The at least one housing may include a peripheral flange, and the sealing lip receives the peripheral flange.

[0081] In one example, a patient-wearable arrhythmia monitoring and treatment device includes: an anterior attachment coupling pad configured to attach in an upper anterior region of a patient's torso, where the anterior attachment coupling pad has a weight in the range of 0.05 to 1.0 kg; and a posterior attachment coupling pad electrically connected to the anterior attachment coupling pad. The posterior attachment coupling pad may be configured to attach in a posterior region of the torso, where the posterior attachment coupling pad has a weight in the range of 0.05 to 1.0 kg. The device includes a wearable support, where the wearable support is integrated with the anterior attachment coupling pad and the posterior attachment coupling pad and at least partially traces a path from the upper anterior region of the torso, over the patient's shoulder, and terminating in the posterior region of the torso. The wearable support may be configured to carry at least a portion of the weight of at least one of the anterior attachment coupling pad and the posterior attachment coupling pad. The device includes a pair of treatment electrodes configured to contact the patient's torso and deliver one or more treatment pulses. One of the pair of treatment electrodes may be integrated within the anterior attachment coupling pad, and the other of the pair of treatment electrodes may be integrated within the posterior attachment coupling pad. A plurality of ECG sensing electrodes may be integrated with the anterior attachment coupling pad and the posterior attachment coupling pad and configured to contact the patient's torso. A first housing may be configured to form a watertight seal with the anterior attachment coupling pad, and a second housing may be configured to form a watertight seal with the posterior attachment coupling pad. An ECG acquisition and conditioning circuit may be disposed within the first housing or the second housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal of the patient, and a treatment delivery circuit may be disposed within the first housing or the second housing and configured to deliver one or more treatment pulses to the patient through an electrical connection with the pair of treatment electrodes. A processor may be disposed within the first housing or the second housing and coupled to the treatment delivery circuit. In an example, the processor is configured to analyze at least one ECG signal of the patient and detect one or more treatable arrhythmias based on the at least one ECG signal. The processor may be configured to cause the treatment delivery circuit to deliver up to five treatment pulses to the patient when one or more treatable arrhythmias are detected. In an example, at least one power source is disposed within the first housing or the second housing and coupled to the treatment delivery circuit and the pair of treatment electrodes.

[0082] Implementation of the device may include one or more of the following features.

[0083] In an example, a breathable adhesive is disposed between at least a portion of the wearable support and the patient's shoulder.

[0084] In an example, the wearable support is a garment. In an example, the wearable support is at least one of a vest, a shirt, a sash, a strap, a belt, and a shoulder harness. The shoulder harness can be made of a non-adhesive stretchable fabric. In an example, the non-adhesive stretchable fabric includes conductive wires communicating with a front-side attachment coupling pad and a rear-side attachment coupling pad. In an example, the tensile strength of the shoulder harness is greater than at least 10% of the load applied by at least one of the front-side attachment coupling pad and the rear-side attachment coupling pad and does not exceed 10 times the load applied by at least one of the front-side attachment coupling pad and the rear-side attachment coupling pad. In an example, the shoulder harness has an elongation percentage of about 10% to 200%. In an example, the elasticity of the shoulder harness along the long axis of the shoulder harness is relatively lower than the elasticity along the short axis of the shoulder harness.

[0085] In an example, the shoulder strap has a curvature that conforms to the shape of the patient's body. The shoulder harness can be designed to match the shape of the patient's body by at least one of molding, 3D printing, and knitting.

[0086] In an example, the shoulder harness is integrally formed with at least one of the front-side attachment coupling pad and the rear-side attachment coupling pad. The shoulder harness can be designed to match the shape of the receiving portion of the patient's body by at least one of molding, 3D printing, and knitting.

[0087] In an example, the shoulder harness has a greater tensile strength and a lower stiffness coefficient compared to either of the front-side attachment coupling pad and the rear-side attachment coupling pad.

[0088] In an example, the shoulder harness further includes at least one length adjuster configured to tension the shoulder harness. The at least one length adjuster can be at least one of a drawstring, a belly band, a lockable elastic drawstring, a zipper, a spring-loaded toggle stop, a ratchet strap, an adjustable buckle, an extendable and movable hook-and-loop strap, a lace, a snap, and a button.

[0089] In an example, the shoulder harness supports at least 1.0 lbf ft of torque at at least one end.

[0090] In an example, when a 22 lbf force is applied, the shoulder harness stretches no more than 1 inch.

[0091] In an example, when a 30 lbf force is applied, the shoulder harness stretches no more than 2 inches.

[0092] In an example, with a force of 30 lbf applied, the shoulder strap stretches 0.5 to 3 inches.

[0093] In an example, the shoulder strap has a higher MVTR than either or both of the front attachment coupling pad and the rear attachment coupling pad. The shoulder strap can have an MVTR in the range of at least about 1200 to 2500 g / m 2 / 24 hours, and the front attachment coupling pad and the rear attachment coupling pad have an MVTR in the range of about 50 to 1000 g / m 2 / 24 hours.

[0094] In an example, the front attachment coupling pad and the rear attachment coupling pad are configured to adhere to the torso for a long duration. The long duration can be a duration that includes and is up to at least one of about 2 weeks, about 1 month, about 6 weeks, about 8 weeks, and about 2 months. In an example, the long duration includes and is up to at least one of about 6 months, about 1 year, and about 2 years.

[0095] In an example, 50 to 75% of the area occupied by the front attachment coupling pad has an MVTR in the range of about 500 to 1200 g / m 2 / day, and 25 to 50% of the area occupied by the front attachment coupling pad has an MVTR in the range of about 250 to 500 g / m 2 / day.

[0096] In an example, 50 to 75% of the area occupied by the rear attachment coupling pad has an MVTR in the range of about 500 to 1200 g / m 2 / day, and 25 to 50% of the area occupied by the rear attachment coupling pad has an MVTR in the range of about 250 to 500 g / m2 / day.

[0097] In an example, the water vapor permeability of the device is 100 g / m2 / 24 hours.

[0098] In an example, the ratio of the weight of the device to the area occupied by the device ranges from about 0.008 to 0.030 lb / in 2 。

[0099] In an example, the device includes a breathable anisotropic conductive gel disposed between the rear attachment coupling pad and the torso. In an example, the ratio of the area occupied by the breathable anisotropic gel to the area occupied by the rear attachment coupling pad ranges from about 0.30 to 0.75. In an example, the ratio of the area occupied by the adhesive to the area occupied by the rear attachment coupling pad ranges from about 0.05 to 0.25.

[0100] In one example, a patient-wearable arrhythmia monitoring and treatment device includes: a contour pad configured to attach and couple to a patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the contour pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the contour pad. The plurality of ECG sensing electrodes are configured to contact the patient's skin. In the example, the device includes at least one housing configured to form a watertight seal with the contour pad. In the example, the device includes an ECG acquisition and conditioning circuit disposed within the at least one housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal of the patient, and a treatment delivery circuit disposed within the at least one housing and configured to deliver one or more treatment pulses to the patient through the plurality of treatment electrodes. In the example, a processor is disposed within the at least one housing and coupled to the treatment delivery circuit. In the example, the processor is configured to analyze at least one ECG signal of the patient, detect one or more treatable arrhythmias based on the at least one ECG signal, and cause the treatment delivery circuit to deliver treatment to the patient when one or more treatable arrhythmias are detected.

[0101] The implementation of the device may include one or more of the following features.

[0102] In the example, the at least one housing extends from the surface of the contour pad by about 1 cm to 5 cm.

[0103] In the example, the device has a weight of about 500 g to 2500 g.

[0104] In the example, the treatment includes delivering up to two defibrillation pulses. The treatment may include delivering no more than one defibrillation pulse.

[0105] In the example, the plurality of ECG sensing electrodes are dry electrodes configured to contact the patient's skin. The plurality of ECG sensing electrodes may be conductive electrodes. The plurality of ECG sensing electrodes may be non-polarizable electrodes configured to contact the patient's skin.

[0106] In the example, the contour pad is configured to attach and couple to the patient for a short duration. The short duration may be a duration of at least one of up to about 24 hours, about 48 hours, about 4 days, about 1 week, and about 2 weeks.

[0107] In one example, a patient-wearable arrhythmia monitoring and treatment device includes: a first conformable pad configured to attach and couple to a patient's torso to support a first component; a second conformable pad coupled to the first conformable pad, the second conformable pad configured to attach and couple to the patient's torso to support a second component; and a wearable support integrated with at least one of the first attachment and coupling pad and the second attachment and coupling pad, wherein the wearable support is configured to carry at least a portion of the weight of at least one of the first component and the second component. In the example, the first component includes: a plurality of treatment electrodes, at least one of which is integrated with the conformable pad; a plurality of ECG sensing electrodes, at least one of which is integrated with the conformable pad; at least one housing configured to form a watertight seal with the conformable pad, the at least one housing extending from the surface of the conformable pad by about 1 cm to 5 cm; an ECG acquisition and conditioning circuit disposed within the at least one housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal of the patient; a treatment delivery circuit disposed within the at least one housing and configured to deliver one or more treatment pulses to the patient through the plurality of treatment electrodes; and a processor disposed within the at least one housing and coupled to the treatment delivery circuit. In the example, the processor is configured to analyze at least one ECG signal of the patient, detect one or more treatable arrhythmias based on the at least one ECG signal, and cause the treatment delivery circuit to deliver at least one defibrillation pulse to the patient when one or more treatable arrhythmias are detected.

[0108] Implementations of the device may include one or more of the following features.

[0109] In the example, the weight of the patient-wearable monitoring and treatment device is between 500 grams and 10 kilograms. The weight of the patient-wearable monitoring and treatment device may be between 1000 grams and 8000 grams. The weight of the patient-wearable monitoring and treatment device may be between 2500 grams and 6000 grams. BRIEF DESCRIPTION OF THE DRAWINGS

[0110] Figure 1 A schematic diagram depicting an exemplary wearable cardiac monitoring and treatment device including a wearable support.

[0111] Figure 2 A schematic diagram depicting an exemplary wearable cardiac monitoring and treatment device including a wearable support and an attachment and coupling portion.

[0112] Figure 3A A schematic diagram depicting an exemplary wearable cardiac monitoring and treatment device including a wearable support and an attachment and coupling portion.

[0113] Figure 3B Depicts Figure 3AA plan view schematic of a part of an exemplary wearable cardiac monitoring and treatment device.

[0114] Figure 3C Depicts Figure 3B A side cross-sectional view of a part of an exemplary wearable cardiac monitoring and treatment device.

[0115] Figure 4A A schematic diagram of an exemplary wearable cardiac monitoring and treatment device including a wearable support for wired communication and an attachment coupling part.

[0116] Figure 4B A schematic diagram of an exemplary wearable cardiac monitoring and treatment device including a wearable support for wireless communication and an attachment coupling part.

[0117] Figure 4C A schematic diagram of an exemplary wearable cardiac monitoring and treatment device including a wearable support and at least one attachment coupling part disposed between the wearable support and the patient's torso.

[0118] Figure 4D A schematic diagram of an exemplary wearable cardiac monitoring and treatment device including a wearable support and an attachment coupling part disposed between the wearable support and the patient's torso.

[0119] Figure 5A A schematic diagram of an exemplary attachable and coupled wearable cardiac monitoring and treatment device including a first component and a second component mounted on the front side.

[0120] Figure 5B A schematic diagram of an exemplary attachable and coupled wearable cardiac monitoring and treatment device including a first component mounted on the rear side and a second component mounted on the front side.

[0121] Figure 5C Depicts Figure 5A And 5B A schematic diagram of an example of a part of an attachable and coupled wearable cardiac monitoring and treatment device.

[0122] Figure 6 A side cross-sectional schematic diagram of an exemplary wearable cardiac monitoring and treatment device.

[0123] Figure 7 A schematic diagram of an exemplary electrical connection component of a wearable cardiac monitoring and treatment device.

[0124] Figure 8 A side cross-sectional schematic diagram of an exemplary wearable cardiac monitoring and treatment device.

[0125] Figure 9A A side cross-sectional schematic view of an exemplary attachment pad assembly of an exemplary wearable cardiac monitoring and treatment device is depicted.

[0126] Figure 9B A side cross-sectional schematic view of an exemplary attachment pad assembly of an exemplary wearable cardiac monitoring and treatment device including an air flow channel is depicted.

[0127] Figure 10A An exemplary schematic view of a skin interface surface of an exemplary wearable cardiac monitoring and treatment device including a continuous attachment ring and a centrifugal conductive gel patch is depicted.

[0128] Figure 10B An exemplary schematic view of a skin interface surface of an exemplary wearable cardiac monitoring and treatment device including a continuous attachment ring and a centrifugal conductive gel patch is depicted.

[0129] Figure 10C An exemplary schematic view of a skin interface surface of an exemplary wearable cardiac monitoring and treatment device including a discontinuous attachment ring and a conductive gel patch is depicted.

[0130] Figure 10D An exemplary schematic view of a skin interface surface of an exemplary wearable cardiac monitoring and treatment device including a continuous attachment ring and a conductive gel patch (which includes a plurality of perforations) is depicted.

[0131] Figure 11A A plan view schematic of a first component of an exemplary attachably coupled wearable cardiac monitoring and treatment device is depicted.

[0132] Figure 11B A plan view schematic of a second component of an exemplary attachably coupled wearable cardiac monitoring and treatment device is depicted.

[0133] Figure 12A A rear perspective view of an example of an attachably coupled wearable cardiac monitoring and treatment device including a wearable support is depicted.

[0134] Figure 12B Depicts Figure 12A A front perspective view of an exemplary attachably coupled wearable cardiac monitoring and treatment device.

[0135] Figure 13A An example of an attachably coupled wearable cardiac monitoring and treatment device including a shoulder-mounted support terminating in a first attachment coupling pad and a second attachment coupling pad is depicted.

[0136] Figure 13B An example of an attachably coupled wearable cardiac monitoring and treatment device including a shoulder-mounted support terminating in a first attachment coupling pad and a second attachment coupling pad is depicted.

[0137] Figure 13C Depicts an example of an attachment-coupled wearable cardiac monitoring and treatment device including three attachment pads and a wearable support.

[0138] Figure 14 Depicts an exemplary system including a user interface and an attachment-coupled wearable cardiac monitoring and treatment device.

[0139] Figure 15 Is a schematic diagram of an exemplary method of using an attachment-coupled wearable cardiac monitoring and treatment device.

[0140] Figure 16 Depicts a schematic diagram of an embodiment of an attachment-coupled wearable cardiac monitoring and treatment device.

[0141] Figure 17 Depicts a schematic diagram of an embodiment of the electrical components of an attachment-coupled wearable cardiac monitoring and treatment device. DETAILED DESCRIPTION

[0142] The present invention relates to a patient-wearable attachment-coupled cardiac monitoring and treatment device for detecting one or more treatable arrhythmias based on physiological signals from a patient. Treatable arrhythmias include arrhythmias that can be treated by defibrillation pulses (such as ventricular fibrillation (VF) and shockable ventricular tachycardia (VT), etc.), or arrhythmias that can be treated by one or more pacing pulses (such as bradycardia, tachycardia, and cardiac arrest, etc.). The wearable medical device as disclosed herein is attachment-coupled to the patient, monitors the patient's physiological condition (e.g., cardiac signals, respiratory parameters, and patient activity), and delivers life-saving treatment to the patient. Embodiments of the patient-wearable attachment-coupled cardiac monitoring and treatment device may include a garment or wearable support for supporting one or more components on the patient's torso, a component attached to the patient's torso, or some combination of the garment or wearable support and the attachment component.

[0143] As described in U.S. Patent 8,983,597, titled "MEDICAL MONITORING AND TREATMENT DEVICE WITH EXTERNAL PACING," issued on March 17, 2015 (hereinafter the "'597 patent," which is incorporated herein by reference in its entirety), an exemplary patient-wearable cardiac monitoring and treatment device can be, for example, a mobile medical device capable of and designed to move with the patient as the patient goes about his or her daily affairs. For example, as Figure 1As shown, the mobile medical device 10A can be a wearable cardioverter defibrillator (WCD) and can include one or more of the following: clothing 11, one or more physiological sensors 12 (e.g., ECG electrodes, heart rate sensors, vibration sensors, and / or other physiological sensors), one or more therapy electrodes 14a and 14b (collectively referred to herein as therapy electrodes 14), a medical device controller 20, a connection box 30, a patient interface box 40, a belt 50 around the patient's torso to support one or more components, or any combination of these. In some examples, at least some components of the medical device 10A can be configured to be attached to a garment 11 that can be worn around the patient's torso 5 (or in some examples, permanently integrated into the garment 11).

[0144] The medical device controller 20 may be operably coupled to the physiological sensor 12, wherein the physiological sensor 12 may be attached to the garment 11 (e.g., assembled into the garment 11 or removably attached to the garment 11), for example, using hook and loop fasteners. In some implementations, the physiological sensor 12 may be permanently integrated into the garment 11. The medical device controller 20 may be operably coupled to the therapy electrode 14. For example, the therapy electrode 14 may also be assembled into the garment 11, or in some implementations, the therapy electrode 14 may be permanently integrated into the garment 11.

[0145] In an embodiment according to the present invention (such as Figures 2 to 4D In the embodiment of Figure 1 One or more portions of the garment 11 in the device 10A of the device 10B to G, such as a leather case portion and the remaining portion combined with other attachment mechanisms. In an embodiment, eliminating one or more portions of the garment 11 results in leaving a wearable support configured with a relatively small surface area. Such a wearable support can be, for example, a shoulder strap, a vest, a belt, a strap, a bandeau and / or a ribbon. In an implementation, the wearable support can be mounted on the body as a lightweight, retractable support garment or other structure for supporting the heavier components of the devices 10B to G. In one example, the wearable support can be a belt 50 or a ribbon 53, such as Figures 2 to 4D The strap 50 or ribbon 53 is configured to support the heavy components of the apparatus 10B to 10G, while other components such as the therapy electrodes 14 and the sensor 12 (eg, an ECG sensor) may be adherently attached to the patient's torso 5 .

[0146] In one example, if Figure 2As shown, the treatment electrode 14b placed on the posterior side can be integrated and / or adhered to the patient's skin through the attachment patch 15 that surrounds some or all of the treatment electrode 14b. The patch can provide an attachment boundary for attaching one or more treatment electrodes 14b that are covered and / or integrated to the patient's torso 5. The heavier components disposed on the wearable support (strap 50) can include a medical device controller 20, where the medical device controller 20 includes high-voltage components such as one or more batteries, one or more capacitors, one or more circuit boards, one or more controllers, and one or more user interfaces, etc. In this example, the treatment electrode 14a placed on the anterior side can also be integrated or attached to the strap 50. By providing support in the form of, for example, the strap 50, the device 10B can hold the heavier components in a body area on the patient's lower torso that is more capable of supporting additional weight without disrupting the patient's balance or causing soreness in the muscle tissue of the upper torso. When distributing the weight in this way, the device 10B thus encourages patient compliance with the prescribed wearing duration by avoiding weight-related discomfort.

[0147] This compliance can be further encouraged by minimizing the volume and weight of one or more components to minimize or eliminate any skin irritation associated with surface area contact and / or weight-based forces. For example, as Figures 3A to 3C shown, in an embodiment, the device 10C includes a first assembly 102 fixed to the lower left anterior position of the torso 5 by a strap 50, and a second assembly 107 that is wired to the first assembly 102. The second assembly 107 can be attached and fixed to the posterior upper torso position, generally between the patient's shoulder blades. As Figure 3B and 3C shown, the first assembly can include a first contoured pad 105 and one or more treatment electrodes 110 and / or multiple ECG sensing electrodes 115 integrated with the contoured pad 105. The first assembly can include a plurality of housings 120a, 120b, 120c (collectively referred to as housings 120). Each housing 120 is configured to form a watertight seal with the contoured pad 105. In a particular implementation, the housing 120 can extend from the surface of the contoured pad 105 by about 1 cm to 5 cm. The housing 120 can at least include an ECG acquisition and conditioning circuit, a treatment delivery circuit, a processor 118, one or more capacitors 135, and one or more batteries 140. In an implementation, the second assembly 107 can only include components that are relatively lighter compared to the first assembly 102 (e.g., a second assembly weighing about 10 to 500 grams), such as one or more treatment electrodes 110 and / or one or more ECG sensing electrodes 115.

[0148] In an embodiment (such as Figure 4AIn embodiments from A to D, the first component and the second component can both be placed on the front side portion of the torso 5. The second component 107 of the device 10D can be placed above the right nipple of the patient's torso 5, and the first component 102 is placed on the left side of the patient's torso 5 opposite to the placement of the second component 107. As Figure 4A , 4C and as shown in 4D, in an embodiment, the device 10D includes a first component 102 and a second component 107 that are connected by wire. Optionally, as Figure 4B shown, in an embodiment, for example when the device is used to monitor a cardiac condition, the devices 10D, 10F, 10G include a first component 102 and a second component 107 that communicate wirelessly. In some examples, the wiring 116 can be detachable, and when the device 10E detects a cardiac condition that requires treatment, the device 10E can prompt the patient to attach the wiring 116 to the first component 102 and the second component 107.

[0149] In Figure 4A embodiments from A to B, the wearable support can be a belt 50 or a corset configured to support the first component 102 and the relatively heavy components included therein (e.g., the first component weighing about 500 grams to 10 kg). In implementation, the belt 50 can include a tensioner 52 for tightening and / or loosening the belt 50 with respect to the patient's torso 5. In implementation, the tensioner 52 can also fasten the belt 50 with respect to the patient's torso 5, such as a hook-and-loop fastener system or a ratchet belt and buckle assembly. In an embodiment, the first component 102 can be disposed on or integrated with the wearable support. For example, in Figure 4A to B, the first component 102 can form a linking portion of the belt 50 such that the sensors integrated with the profile pad 105 are in contact with the patient's skin. In some embodiments, the first component 102 and / or the second component 107 can be covered by the wearable support. For example, as Figure 4C shown by the dashed lines in A to D, the support garment can be a belt 51 located in the lower torso region, or a sash 53 that extends diagonally across the torso 5 and covers the first component 102 and / or the second component 107. In an embodiment, the belt 51 and the sash 53 can include a tensioner 52 configured to tighten the wearable support with respect to the torso 5, increase the compressive force on the first component 102 and / or the second component 107, and help maintain the contact between the first component 102 and the second component 107 and the torso 5.

[0150] As described above, in some examples, the second component 107 may include only relatively light components, such as one or more therapy electrodes 110 and / or one or more ECG sensing electrodes 115. In an alternative implementation, the second component 107 may include one or more components that are heavier compared to the first component 102 (e.g., a second component weighing about 500 grams to 10 kg), such as one or more capacitors, batteries, and / or therapy circuits. Providing an additional wearable support (such as Figure 4D the strap 53 shown) may, for example, help hold the relatively heavy second component 107, which includes the heavier components, on the upper region of the torso 5. Providing such an additional wearable support helps prevent the second component 107 from pulling on the patient's skin while being adhesively attached.

[0151] In an example that will be described in further detail later with respect to Figures 5A to 5C the device 100 may include the adhesively attached first component 102 and the adhesively attached second component 107 without a wearable support and / or a garment-based support.

[0152] The attachment coupling devices described herein may be configured for short-term or long-term use. For example, a short-term device may be prescribed for a patient for the duration from discharge or an outpatient clinical visit to a subsequent medical appointment. In this regard, a short-term wear duration may include a time period of less than one hour (e.g., 10 minutes to about 60 minutes in a medical waiting room), or a time period of 1 hour to about 24 hours, 1 hour to about 48 hours, 1 hour to about 72 hours, 1 hour to about 4 days, 1 hour to about one week, and 1 hour to about two weeks. In an example, a short-term wear duration may, for example, include a duration of up to and including about 14 days, or a duration of up to and including about 30 days.

[0153] In another exemplary scenario, a long-term device may be prescribed for a patient after a medical appointment to protect the patient from life-threatening arrhythmias while also collecting diagnostic information for additional, potentially more invasive procedures. In this scenario, such a device may be designed to be used by the patient for an extended period of time, where the time period may be greater than the short-term durations described above. For example, a long-term wear duration may include a time period of about 1 month to about 3 months, or about 3 months to about 6 months. Thus, the advantages of the configurations herein include providing additional diagnostic and treatment options for physicians and caregivers in treating the patients in their care.

[0154] Because these devices are intended for continuous operation and are to be worn by the patient to whom they are prescribed, the advantages of the implementations herein include the use of a comfortable, non-irritating, biocompatible adhesive and construction materials, and features designed to enhance patient compliance. Such compliance-inducing design features include, for example, device ergonomics, the weight and / or distribution of weight of the components, the overall device shape, and an unobtrusive appearance when worn under outer clothing, among others.

[0155] The exemplary devices described herein are intended for continuous wear and typically for a prescribed duration. For example, the prescribed duration can be the duration that a caregiver instructs the patient to comply with the device usage instructions to wear the device. As described above, the prescribed duration can be a short period (e.g., 1 hour to about 24 hours, 1 day to about 14 days, or 14 days to about 1 month) until a subsequent medical appointment, or a longer period (e.g., 1 month to about 3 months), during which diagnostic information related to the patient is collected while protecting the patient from arrhythmias. The prescribed use can be uninterrupted until a physician or other caregiver provides a specific prescription to the patient to stop using the wearable medical device. For example, the wearable medical device can be prescribed for a period of at least one week for the patient. In an example, the wearable medical device can be prescribed for a period of at least 30 days for the patient. In an example, the wearable medical device can be prescribed for a period of at least one month for the patient. In an example, the wearable medical device can be prescribed for a period of at least two months for the patient. In an example, the wearable medical device can be prescribed for a period of at least three months for the patient. In an example, the wearable medical device can be prescribed for a period of at least six months for the patient. In an example, the wearable medical device can be prescribed for an extended period of at least one year for the patient.

[0156] Sudden cardiac arrest or other arrhythmia conditions can occur at any time and with little warning. Each patient is encouraged to comply with the device usage guidelines, including wearing the device at all times during the prescribed duration, including during showering or sleeping. To improve patient compliance with these guidelines, the devices described herein are lightweight, comfortable, and compact so that they can be hidden under the patient's clothing. Additionally, the devices are configured to allow for uncomplicated application and adhesion to the skin of the patient's body. In some of the implementations described herein, the devices include various features that promote comfort while continuing to protect the patient from adverse cardiac events. These features can be customized according to the patient's comfort preferences and can include durable adhesion, ease of application and removal, and an unobtrusive appearance.

[0157] The device herein is configured to attach to a patient's torso for short-term and long-term durations. The device includes a biocompatible adhesive, such as a pressure-sensitive adhesive having tacky, adherent, and bonding properties, which is suitable for use with medical devices applied to the skin for short-term and long-term durations. These pressure-sensitive adhesives can include polymers having high initial tack to adhere to the skin, such as acrylic resins, rubbers, silicones, and polyurethanes. These pressure-sensitive adhesives also remain adherent during showers or when the patient sweats. The adhesive is also capable of being removed without leaving a discomforting residue. For example, such an adhesive can be a rubber mixed with a tackifier.

[0158] In any of the previously proposed or foregoing examples, the device herein includes an adhesive with low skin irritation. In an embodiment, the device can be continuously worn by the patient for a long-term duration (e.g., a duration of at least one week, at least 30 days, at least one month, at least two months, at least three months, at least six months, and at least one year), and the patient does not experience significant skin irritation. For example, the measure of skin irritation can be based on one or more skin irritation gradings set forth in Table C.1 of Appendix C of American National Standard ANSI / AAMI / ISO 10993-10:2010, where Table C.1 is reproduced in its entirety herein:

[0159] Table C.1 – Human Skin Irritation Test, Grading Scale

[0160]

[0161] Table 1

[0162] A skin irritation grading of 1 represents a weak positive reaction, typically characterized by mild erythema and / or dryness at most treatment sites. In one implementation, the measure of skin irritation can be determined by testing a human subject according to the method set forth in American National Standard ANSI / AAMI / ISO 10993-10:2010, where the method applies a sample patch of the attachment device to the treatment site for up to 4 hours and then applies the sample patch to the treatment site for up to 24 hours in the absence of skin irritation. The treatment site is examined for signs of skin irritation, and the response is scored immediately after removing the patch and at time intervals of (1 ± 0.1) hours to (2 ± 1) hours, (24 ± 2) hours, (48 ± 2) hours, and (72 ± 2) hours after removing the patch. In another implementation, the patient can wear the attachment device for a duration of (24 ± 2) hours as directed, and if the patient's skin shows no reaction at the end of that duration, the attachment device is rated as skin irritation grading "zero".

[0163] In addition to the biocompatible adhesive, the short-term and long-term wearable devices include a plurality of sensing electrodes that are disposed on a patient's body and configured to monitor cardiac signals such as electrocardiogram (ECG) signals. Thus, prior to delivering treatment to a patient, the device determines an appropriate disposition for the patient based on the detected cardiac signals and / or other physiological parameters. The device then causes one or more therapeutic shocks (e.g., defibrillation shocks and / or pacing shocks) to be delivered to the patient's body. The wearable medical device includes a plurality of treatment electrodes, at least one of which is integrated with the conformable pad described in detail herein. The plurality of treatment electrodes are disposed on the patient's body and configured to deliver therapeutic shocks. In some implementations, the device may also be configured to allow a patient to report his / her symptoms, including one or more skipped beats, shortness of breath, dizziness, rapid heartbeat, fatigue, fainting, and chest discomfort. Device implementations and exemplary features are disclosed herein to improve the ergonomics of such wearable medical devices.

[0164] In an implementation, the device includes one or more conformable pads configured to attach and secure to a patient's torso. One or more energy storage units are operably connected to the treatment delivery circuit. The energy storage unit and the treatment delivery circuit are housed in at least one housing configured to form a watertight seal with the conformable pad. In some implementations, a plurality of housings may be disposed on a plurality of sections of the conformable pad. Each of the plurality of housings may include a different portion of the device circuitry, such as an ECG acquisition and conditioning circuit, a treatment delivery circuit, an energy storage unit, a processor, and a power source, among others. The energy storage unit is configured to store the energy of at least one therapeutic pulse (e.g., a defibrillation pulse). The treatment delivery circuit is configured to cause the delivery of at least one therapeutic pulse via the plurality of treatment electrodes. In an implementation, the energy storage unit is electrically coupled (e.g., via printed circuit board traces, flexible circuits, or direct contact connections) to the plurality of treatment electrodes.

[0165] As described above, the implementation of the wearable medical device described herein can be continuously used by a patient during a short-term or long-term wearing duration. This continuous use can be substantially continuous or nearly continuous in nature. During substantially continuous or nearly continuous use, the wearable medical device can be continuously used except for sporadic time periods when use is temporarily stopped (e.g., when the patient re-assembles a new and / or different device, when the battery is charged and / or replaced, etc.). However, such substantially continuous or nearly continuous use as described herein can still be considered continuous use. For example, continuous use can include continuously wearing or attaching the wearable medical device to the patient. In an implementation, one or more electrodes are continuously attached to the patient as described herein during a monitoring time period and during time periods when the device may not be actively monitoring the patient but is still otherwise worn by the patient or otherwise attached to the patient. Continuous use can include continuously monitoring the patient for cardiac-related information (e.g., electrocardiogram (ECG) information, including arrhythmia information, cardiac vibrations, etc.) and / or non-cardiac information (e.g., blood oxygen, patient's body temperature, glucose level, interstitial fluid level, and / or lung vibrations) while the patient is wearing the device. For example, the wearable medical device can perform its continuous monitoring and / or recording at periodic or aperiodic time intervals or times (e.g., every few minutes, every few hours, once a day, once a week, or other intervals set by a technician or prescribed by a caregiver). Optionally or additionally, the monitoring and / or recording during an interval or time can be triggered by a user action or other event.

[0166] As described above, the wearable medical device can be configured to monitor other physiological parameters of the patient in addition to cardiac-related parameters. For example, the wearable medical device can be configured to monitor, for example, lung vibrations (e.g., using a microphone and / or accelerometer), respiratory vibrations, sleep-related parameters (e.g., snoring, sleep apnea), and interstitial fluid (e.g., using a radio frequency transmitter and sensor), etc.

[0167] As will be described in detail below, Figure 5A Figures 8A to C depict an exemplary monitoring and treatment device 100 that is held on the patient's torso only by an attachment coupling, and Figure 4A Figures 10D to G, 800A to D, 1000 relate to attachment coupling monitoring and treatment devices 10D to G, 800A to D, 1000 that include one or more wearable supports.

[0168] Figure 5AExemplary attachment coupling monitoring and treatment device 100 is shown in FIGS. A through B. As shown, device 100 is external, mobile, and attached to a patient. Medical device 100 is an external or non-invasive medical device that is, for example, located outside the patient's body and configured to provide transcutaneous treatment to the body. Device 100 is a mobile medical device that is, for example, capable and designed to move with the patient as the patient goes about his or her daily business. Device 100 includes a first assembly 102, where the first assembly 102 includes a conformable pad 105 configured to attach to the patient's torso 5. In implementations, multiple treatment electrodes and / or multiple ECG sensing electrodes may be integrated with the conformable pad. Additionally, as Figure 6 shown, device 100 may include a housing 120 configured to form a watertight seal with conformable pad 105. In a particular implementation, housing 120 may extend from the surface of the conformable pad by about 1 cm to 5 cm. The housing may include at least an ECG acquisition and conditioning circuit, a treatment delivery circuit, and a processor. For example, the processor may analyze the patient's ECG signals received and conditioned via the ECG acquisition and conditioning circuit and detect one or more treatable arrhythmias. The processor may cause the treatment delivery circuit to deliver at least one defibrillation pulse to the patient when one or more treatable arrhythmias are detected. As described in further detail below, device 100 includes components having specific physical dimensions, weights, and functional attributes, where these components are combined such that the total weight of device 100 is in the range of 250 grams to 2500 grams while enabling device 100 to function as a monitoring and treatment device.

[0169] In an example, as Figure 5A shown in FIGS. A through B and as will be described in further detail subsequently, first assembly 102 may be coupled to a second assembly 107 that includes a different second conformable pad 109. For example, as Figure 5A shown, second assembly 107 may be configured to be located at the upper right front side of patient's torso 5. In other examples, as Figure 5B shown, second assembly 107 may be configured to be located at the upper rear side of patient's torso 5, such as the upper right rear side, etc. Although Figure 5A and 5B 's implementations depict first assembly 102 having a substantially rectangular shape and second assembly having a triangular shape, the shapes of the first and second assemblies may be any shape, including, for example, polygons, squares, circles, ellipses, octagons, trefoils, trapezoids, or polygon or non-polygon shapes customized to the patient's form and / or preferences. In an implementation, second assembly 107 may include one or more of the components and / or materials described for the implementation of first assembly 102, such as the components and materials described for Figures 6 to 8 's implementation, etc.

[0170] The contoured pad 105 is configured to be attached and coupled to the patient's torso 5. The contoured pad 105 is formed of a flexible material and is configured to conform to the unique curvature of the region of the patient's torso 5. Additionally or alternatively, as Figure 3C schematically illustrated, the contoured pad 105 may include a plurality of sections separated by a flexible material to conform the contoured pad 105 to the curvature of the region of the torso 5 to which it is applied. The contoured pad 105 may be configured to conform to the curvature of a portion of the patient's torso 5, such as the lower portion of the torso, the upper anterior portion of the torso, the upper posterior portion of the torso, or one or more lateral portions of the torso, etc. In implementations including the contoured pad 105 formed of a conformable material and / or sections, the contoured pad may accommodate various body shapes and sizes as well as shape changes associated with movement of the patient's body. For example, the contoured pad 105 may accommodate stretching, expansion, and contraction of the lower region of the torso 5 when the patient is standing, walking, sitting, or lying prone.

[0171] In an implementation, the size of the contoured pad 105 may be designed to accommodate various body sizes. In some implementations, the contoured pad 105 may be manufactured in various sizes to accommodate a range of body sizes. The specific shape and size of the contoured pad 105 may be pre-configured or uniquely customized for the patient. For example, various body size measurements and / or contour mappings may be obtained from the patient, and a uniquely customized contoured pad 105 may be 3D printed, for example, from any suitable thermoplastic (e.g., ABS plastic). Thus, the contoured pad 105 accommodates variable patient sizes and / or contours, and / or some or all portions of the contoured pad may be customized to fit the specific body size and contour of the patient.

[0172] In an example, the patient can apply the contour pad 105 in a unique and preferred orientation and position. By consulting with a caregiver, the patient is enabled to place the device 100 in a comfortable position and orientation, which encourages the patient to comply with continuous wear throughout the prescribed wear duration. For example, at the start of the prescribed wear duration, a caregiver or physician can position the pad 105 at a first position on the patient's torso 5. At least one of the patient, caregiver, and physician can reposition the contour pad 105 to a second position that overlaps, is tangent to, is adjacent to, or is away from the first position, but within the prescribed torso region. For example, the first assembly 102 can initially be placed in the lower anterior region of the torso along a line at the bottom of the patient's chest cavity to seek comfort and minimize any bulging appearance in the clothing worn over the device 100. The patient, caregiver, or physician can remove the contour pad 105 and re-adhere a one-inch portion of the contour pad 105, for example, in any lateral and / or rotational direction. This provides an opportunity for the patient's skin to breathe and regenerate (e.g., shed) and reduces the effects of skin irritation that may be caused by the adhesive. By keeping the contour pad within the initially applied area, the first assembly 102 of the device 100 continues to operate in concert with the second assembly 107, where the second assembly 107 is positioned relative to the first assembly and particular attention is paid to the shock vector that travels between and through the heart between the assemblies 102, 107.

[0173] In an embodiment, the contour pad 105 is designed to be durable, flexible, and breathable to allow sweat evaporation. In an embodiment, the contour pad 105 is non-irritating when in contact with the skin, as described in the skin irritation grading set forth in Table C.1 of Appendix C of the previously proposed American National Standard ANSI / AAMI / ISO 10993-10:2010, as above. In an example, the contour pad 105 is generally non-conductive, flexible, water vapor permeable, and substantially liquid impermeable or waterproof. The non-conductive, flexible, water vapor permeable contour pad 105 can include or be composed of polyurethane, such as a TEGADERM polyurethane film (available from 3M), an OPSITE polyurethane film (available from Smith & Nephew, London, United Kingdom), or a HYDROFILM polyurethane film (available from Hartman USA, Rock Hill, SC), among others. In other examples, the contour pad 105 can include or be composed of at least one of neoprene, thermoplastic, or injection molded rubber or plastic (such as silicone or other biocompatible synthetic rubbers, etc.). In an example, the contour pad 105 is a laminated pad that includes a waterproof or water resistant layer applied to a relatively more rigid plastic or rubber layer, where the relatively more rigid plastic or rubber layer is configured to provide structural support for the housing and the electronic components disposed therein. In an example, the contour pad 105 is perforated to facilitate the evaporation of water vapor from the skin.

[0174] In an embodiment, as Figure 6 shown, device 100 may include a conductive adhesive layer 138. As described in U.S. Patent No. 9,867,976, titled "LONG-TERM WEAR ELECTRODE," issued on January 16, 2018 (hereinafter referred to as the "'976 patent," which is hereby incorporated by reference in its entirety), the water vapor permeable conductive adhesive material may be, for example, flexible, water vapor permeable, and the conductive adhesive material may include a material selected from the group consisting of: electrospun polyurethane adhesives, polymeric microemulsion pressure-sensitive adhesives, organic conductive polymers, organic semiconductor conductive polymers, organic conductive compounds and semiconductor conductive compounds, and combinations thereof. In an example, the thickness of the flexible, water vapor permeable conductive adhesive material may be between 0.25 and 100 mils. In another example, the water vapor permeable conductive adhesive material may include conductive particles. In an implementation, the conductive particles may be microscopic or nanoscale particles or fibers of the material, including but not limited to carbon black, silver, nickel, graphene, graphite, carbon nanotubes, and / or one or more of other conductive biocompatible metals such as aluminum, copper, gold, and / or platinum.

[0175] Figure 6 depicts a first component 102 that is part of device 100. Device 100 includes a profile pad 105 and a housing 120 configured to form a watertight seal with the profile pad 105. Now referring to Figure 6 , device 100 includes at least one of a plurality of treatment electrodes 110 integrated with the profile pad 105. Exemplary treatment electrodes 110 include, for example, conductive metal electrodes, such as conductive metal electrodes made of stainless steel, tin, or aluminum, conductive ink, or conductive polymers. Device 100 may also include at least one of a plurality of ECG sensors 115 integrated with the profile pad 105. In Figure 6In the implementation, two ECG sensors 115a and 115b are shown integrated with the conformable pad 105. In the example, the ECG sensors 115 monitor the patient's ECG information. As will be described in detail in subsequent examples, the ECG sensors 115 can be non-polarizable ECG electrodes (e.g., clinical-grade Ag / AgCl electrodes) or polarizable electrodes (e.g., electrodes with a metal substrate having an oxide layer including, such as a Ta2O5 coating) configured to measure changes in the patient's electrophysiological phenomena to measure the patient's ECG information. For example, as described in U.S. Patent 6,253,099 titled "Cardiac Monitoring Electrode Apparatus and Method", the exemplary ECG sensors 115 include tantalum pentoxide electrodes, and the entire content of the above-mentioned document is incorporated herein by reference. In the implementation, the ECG sensors 115 can be made of a core plastic or a metal substrate element, where the core plastic or metal substrate element is coated with a thick-film polymeric compound filled with conductive Ag / Ag / Cl metal filler.

[0176] In some examples, as Figure 6 shown, at least one therapy electrode 110 and one or more ECG sensors 115 are formed within the conformable pad 105 such that the skin contact surfaces of the respective components are coplanar with or protrude from the patient contact surface of the conformable pad 105. In the example, the therapy electrodes 110 and the ECG sensors 115 are disposed on the patient contact surface of the conformable pad 105. In some implementations, the therapy electrodes 114 and the ECG sensors 115 are metal plates (e.g., stainless steel) or substrates formed as a permanent part of the device 100. The metal plates or substrates can be adhered to the conformable pad 105, for example, by a polyurethane adhesive or a polymer dispersion adhesive (such as a polyvinyl acetate (PVAc)-based adhesive or other such adhesives). In the example, the multiple ECG sensors 115 are multiple dry ECG sensing electrodes. In the example, the ECG sensors 115 are flexible dry surface electrodes, such as conductive polymer-coated nanoparticle-loaded polysiloxane electrodes mounted to the conformable pad 105, etc. In some examples, the ECG sensors 115 are flexible dry surface electrodes, such as silver-coated conductive polymer foam soft electrodes mounted to the conformable pad 105. In the example, the ECG sensors 115 are screen-printed onto the conformable pad 105 with a metal ink (such as a silver-based ink, etc.). In the implementation, each of the therapy electrodes 110 has a conductive surface adapted to be placed adjacent to the patient's skin. In some implementations, the therapy electrodes 110 can include impedance-reducing materials and / or mechanisms as described subsequently.

[0177] In an implementation, at least one therapy electrode 110 and at least one ECG sensor 115 are fabricated as integral components of the conformable pad 105. For example, the therapy electrode 110 and / or the ECG sensor 115 can be formed from the warp and weft threads of the fabric that forms at least one layer of the conformable pad 105. In an implementation, the therapy electrode 110 and / or the ECG sensor 115 are formed from conductive fibers interwoven with non-conductive fibers of the fabric.

[0178] The device 100 includes an ECG acquisition and conditioning circuit 125 that is disposed within at least one housing 120 and electrically coupled to a plurality of ECG sensors 115 to provide at least one ECG signal of a patient. In an example, the ECG acquisition and conditioning circuit 125 includes a signal processor configured to amplify, filter, and digitize cardiac signals before sending the cardiac signals to a processor 118 of the device 100. Accordingly, the ECG sensors 115 can send information describing the ECG signals via the ECG acquisition and conditioning circuit 125 to a sensor interface for subsequent analysis.

[0179] In an example, as Figure 6 shown, a therapy delivery circuit 130 is disposed within at least one housing 120 and is configured to deliver one or more therapy pulses to a patient via a plurality of therapy electrodes 110 of the device 100. In an example, the processor 118 is disposed within at least one housing 120 and is coupled to the therapy delivery circuit 130. The processor 118 is configured to analyze the ECG signals of the patient and detect one or more treatable arrhythmias based on at least one ECG signal. The processor 118 is configured to cause the therapy delivery circuit 130 to deliver at least one defibrillation pulse to the patient when one or more treatable arrhythmias are detected.

[0180] In an example, one or more printed circuit boards 145 connect the various circuits and hardware components of the first assembly 102 (e.g., the processor 118, the therapy delivery circuit 130, the therapy electrodes 110, the ECG acquisition and conditioning circuit 125, the ECG sensing electrodes 115, etc.). For example, as Figure 7 shown in the schematic diagram of, the printed circuit board 145 can route signals between the therapy delivery circuit 130 and the therapy electrodes 110 and between the ECG acquisition and conditioning circuit 125 and the ECG sensing electrodes 115. In an implementation of the conformable pad 105 that includes a plurality of sections separated by a flexible material, one or more circuit boards 145 can be distributed among some or all of the plurality of sections and can be electrically interconnected in an example by one or more wiring and / or flexible traces or cables.

[0181] Continuing the description of the implementation of the device 100 of FIGS. 5-6, in the implementation, the therapy delivery circuit 130 is operably connected to one or more capacitors 135. In the implementation, the one or more capacitors 135 are a plurality of capacitors (e.g., three, four, or more capacitors) that can be switched to a series connection during defibrillation pulse discharge. For example, four capacitors of about 650 μF can be used. In one implementation, the capacitors can have a surge rating of 200 to 2500 volts and can be charged by the battery 140 in about 5 to 30 seconds depending on the amount of energy to be delivered to the patient. Additional implementations of the capacitor properties and arrangements within the device 100 are provided in subsequent sections herein.

[0182] For example, each defibrillation pulse can deliver an energy of 60 to 400 joules (J). In some implementations, the defibrillation pulse can be a biphasic truncated exponential waveform, whereby the signal can switch between a positive portion and a negative portion (e.g., the charging direction). The amplitudes and widths of the two phases of the energy waveform can be automatically adjusted to deliver a predetermined amount of energy.

[0183] In the implementation, the therapy delivery circuit 130 includes or is operably connected to circuit components configured to generate and provide a therapeutic shock. As will be described in detail subsequently regarding the implementation of the device 100, the circuit components include, for example, resistors, one or more capacitors 135, relays and / or switches, a bridge such as an H-bridge (e.g., an H-bridge circuit including a plurality of switches (e.g., insulated gate bipolar transistors (or IGBTs), silicon carbide field effect transistors (SiC FETs), metal oxide semiconductor field effect transistors (MOSFETs), silicon controlled rectifiers (SCRs), or other high-current switching devices, etc.)), voltage and / or current measurement components, and other similar circuit components, where these similar circuit components are arranged and connected such that these circuit components work in cooperation with the therapy delivery circuit 130 and under the control of one or more processors (e.g., the processor 118) to provide, for example, one or more pacing or defibrillation therapy pulses.

[0184] As previously introduced, at least one housing 120 forms a watertight seal together with the profile pad 105. In examples (such as Figure 6 examples, etc.), various circuit and hardware components (e.g., the processor 118, the therapy delivery circuit 130, the therapy electrodes 110, the ECG acquisition and conditioning circuit 125, the ECG sensing electrodes 115, the PCB 145, etc.) are located within a compartment defined by at least one housing 120 and the profile pad 105. The housing 120 protects the components thereunder from the external environment (e.g., damage associated with water ingress). Preventing such ingress protects the electronic components of the device 100 from, for example, short-circuiting or corrosion of moisture-sensitive electronics in the case where the patient wears the device while showering. These features can also protect against the entry of other liquids and solid particles.

[0185] In an example, the outer shape pad 105 includes one or more receivers for receiving at least one housing 120 in a watertight fit. In examples (such as Figure 9A the example of etc.), the one or more receivers include a sealing lip 106, and the sealing lip 106 can engage with the upper surface of at least one housing 120. In an implementation, the sealing lip 106 includes an elastic waterproof material. For example, the one or more receivers can include a rubber or silicone sealing lip 106 integrally formed with the outer shape pad 105 for receiving the flange of the housing in a press-fit seal manner. For example, the sealing lip 106 and the outer shape pad 105 can be injection-molded into an integral structure. In an example, at least one housing 120 can also include a peripheral flange 121, and the sealing lip 106 fixedly receives the peripheral flange 121 in a watertight fit structure. In an example, one or more of the housing 120 or a plurality of housings are removable and / or replaceable. When the housing 120 is pulled away from the outer shape pad 105, the sealing lip 106 expands and contracts, thereby allowing the housing 120 to be pulled away from the sealing lip 106. Since the sealing lip 106 is elastic, the deformation is not permanent, and the sealing lip 106 retracts to a stationary state to receive the housing 120 and / or a plurality of housings in a sealed structure again. In other implementations, the housing 120 can be thermally welded to the outer shape pad 105. In other implementations, the housing 120 can be locked to the outer shape pad 105 and held in compression by a spring-loaded clamp. In some or all implementations, the housing and / or the outer shape pad can include a deformable waterproof grommet therebetween, such as an elastic silicone seal around the perimeter of the interface between the housing and the outer shape pad 105, etc.

[0186] In addition to forming a watertight seal with the outer shape pad, in some examples, at least one housing 120 is water-resistant and / or coated with a water-resistant coating (e.g., an epoxy coating). Thus, the device 100 can be worn during a shower without damaging the electrical components disposed within the housing 120. Additionally or alternatively, in an implementation, at least one of the plurality of ECG sensors 115, the plurality of therapy electrodes 110, and one or more electrical components of the device (e.g., the capacitor 135, the therapy delivery circuit 130, the processor 118) is housed within one or more water-resistant housings 120 or enclosures.

[0187] According to one or more scenarios set forth in Table 2, exemplary protection of the water-resistant housing 120 from liquid ingress:

[0188]

[0189] Table 2

[0190] In some implementations, at least one housing 120 is water resistant and has a predetermined ingress protection rating that complies with one or more rating levels set forth in IEC standard 60529. The liquid ingress protection rating can be any one or more of the levels in the standard that specify the rating compliance tests (e.g., levels 3 through 9). For example, to have a liquid ingress protection rating of 6, at least one housing 120 of device 100 will protect against the ingress of water provided by a powerful water jet. The powerful water jet test requires spraying the housing 120 from all possible directions with a water stream from a test nozzle having a 12.5 mm diameter. The water is sprayed at a rate of 100 liters per minute (+ / - 5%) for 1 minute per square meter for at least 3 minutes such that the core of the water stream is in a circle with a diameter of approximately 120 mm at a distance of 2.5 meters from the nozzle. For example, to have a rating level of 7, when the housing 120 is fully immersed in water with a depth between 0.15 m and 1 m, water cannot enter such that the lowest point of the housing 120 that is less than 850 mm in height is 1000 mm below the water surface and the highest point of the housing that is less than 850 mm in height is 150 mm below the water surface. The housing 120 is immersed for a duration of up to 30 minutes and the water temperature differs from the temperature of the housing by no more than 5 K. Table 3 provides the rating levels and tests for liquid ingress protection according to IEC standard 60529:

[0191]

[0192]

[0193]

[0194] Table 3

[0195] For example, the housing 120 can be constructed to be water resistant and thus tested for ingress protection according to IEC 60529 standard. For example, one or more housings 120 of the device can be configured to have a rating level of 7, thus protecting against the effects of being immersed in water up to a depth of 1 meter for up to 30 minutes. This enables a patient to wear device 100 in a bathtub or shower for continuous use without interruption. In an implementation, one or more housings 120 of device 100 can be multi-coded, including two or more levels. For example, the housing 120 of device 100 can maintain a liquid ingress protection level of 7 that protects against the effects of temporary immersion and a liquid ingress protection level of 5 that protects against the effects of water jets.

[0196] As described above, at least one housing 120 shields one or more of the therapy delivery circuitry, the ECG acquisition and conditioning circuitry 125, the processor 118, at least one capacitor 135, and at least one power source (e.g., battery 140) from the environment. The housing 120 covers and / or encloses the hardware components therein, thereby protecting them from wear and tear and protecting the patient from contact with high voltage components. For example, during a patient shower, the housing 120 protects the components from liquid ingress.

[0197] As described above with respect to the conformable pad 105, the housing 120 is non-conductive, vapor permeable, and substantially liquid impermeable or waterproof. The housing 120 may comprise or be formed of polyurethane, such as a Tegaderm polyurethane film (available from 3M), an Opsite polyurethane film (available from Smith & Nephew), or a Hydrofilm polyurethane film (available from Hartman USA), among others. In other examples, the conformable pad 105 may comprise or be formed of at least one of neoprene, thermoformed plastic, or injection molded rubber or plastic (such as silicone or other biocompatible synthetic rubber). In an example, the housing 120 may comprise a nonwoven laminate, such as at least one of spandex, nylon-spandex, and nylon-Lycra. In an example, the housing 120 may comprise a thermoformed layer coated with a waterproof or hydrophobic layer, such as a nonwoven polyurethane fabric material layer. One or more vapor release valves or through-holes may be formed into or provided through the housing to vent sweat out of the housing 120. In other examples, the housing 120 may comprise or be formed of a fabric having a biocompatible surface treatment to render the fabric water resistant and / or waterproof. For example, the fabric may be enhanced by immersion in a fluorocarbon bath such as Teflon or fluorinated decyl polyhedral oligomeric silsesquioxane (F-POSS).

[0198] In addition to the water resistant and / or waterproof characteristics, the form factor dimensions of the attachment coupling device 100 are designed for patient comfort. In an example, the patient-worn monitoring and treatment device 100 has a weight of from 250 grams to 2500 grams. For example, the device 100 may have a weight within at least one of three ranges: from 250 grams to 1250 grams, from 500 grams to 1000 grams, and from 750 grams to 900 grams. Maintaining the weight within such an exemplary range improves patient comfort. Since the device 100 adheres to the skin of the patient's torso 5, examples of the device 100 include weight distribution and attachment features for encouraging patient compliance by improving comfort and maintaining attachment throughout a prescribed duration.

[0199] In implementations where the outer form pad 105 includes multiple sections, the housing 120 can include multiple housings, and one or more of the therapy delivery circuit 130, the ECG acquisition and conditioning circuit 125, the processor 118, at least one capacitor 135, and at least one power source (e.g., the battery 140) can each be located in a separate housing disposed on a respective one of the multiple sections. By distributing components in separate housings, the device 100 can be modular in implementation. This modularity allows one or more components to be removed for repair or replacement. For example, the housing of the battery can be releasably sealed around the rechargeable battery so that a patient or caregiver can recharge and replace the battery 140 periodically during a prescribed wear duration. As previously described, in an example, the outer form pad 105 can include a sealing lip formed of an elastomeric material, where the sealing lip expands and contracts when the housing 120 or one of the multiple housings 120 is pulled away from the outer form pad 105, thereby allowing one or more of the housing or multiple housings 120 to be pulled away from the sealing lip. Since the sealing lip is elastic, the deformation is not permanent, and the sealing lip retracts to a rest state to again receive the housing 120 or one of the multiple housings 120 in a sealed configuration.

[0200] Regardless of whether the at least one housing is a single enclosure or multiple enclosures, the components of the device 100 can be distributed to be comfortable for the patient. In an example (such as Figure 8 the example, etc.), the outer form pad 105, the housing 120, and the electronics (e.g., the EGC acquisition and conditioning circuit 125, the processor 118, the therapy delivery circuit 130, the capacitor 135, the battery 140, and the PCB 145) are assembled into an assembly such that when the first assembly 102 is mounted on the patient's torso 5, the centroid 147 of the assembly is below the volume center 150 (e.g., the centroid of the volume) of the assembly. As previously described, in an example, the first assembly 102 and the second assembly 107 of the device 100 are attached and coupled to the patient's torso 5.

[0201] Referring to Figure 5A 、 5B and 6, when the patient is standing or sitting, and when the attached and coupled assemblies are applied to the patient in accordance with the medical instructions for application and use, the vertical axis 137 of the first assembly 102 and the second assembly 107 is antiparallel to gravity.

[0202] Many forces applied to the attachment joint can cause the attachment joint to fail prematurely. These forces include one or more of the following forces:

[0203] 1) Tensile force is a pulling force evenly applied across the joint. Under the action of the tensile force on the attachment joint, the pulling direction is orthogonal to the attachment joint;

[0204] 2) The shear force on the attachment joint is a tensile force that is directed parallel to the attachment joint and passes through the adhesive, and is used to force the substrates to slide relative to each other;

[0205] 3) The cleavage force is a tensile force concentrated at one edge of the attachment joint and is used to apply a prying force on the joint. The other edge of the joint is theoretically under the action of zero stress; and / or

[0206] 4) The peeling force is concentrated along a thin line at the edge of the joint, where one substrate is flexible. If the flexible surface is peeled from its mating surface, the line is the exact point where the adhesive separates. Once peeling begins, the stress line remains before the advancing joint separation.

[0207] The lever effect of the cleavage force and the peeling force concentrates the stress in a smaller joint area, resulting in failure at a lower force level than that observed in tension and shear. By taking advantage of the non-uniformity of the relative component density (such as by placing components within a housing, etc.) and distributing the electronic components such that the centroid or center of gravity 147 of the housing 120 is lower than the volume center 150 of the housing 120 in terms of its position along the vertical axis 137, the delamination forces (such as cleavage and peeling, etc.) can be minimized. This helps to fix the first component 102 to the patient while minimizing any undesired partial or complete separation of the device 100 from the patient's skin during the specified wearing duration. If the profile pad 105 is pulled away from the patient's skin, the treatment electrode 110 and the ECG sensor 115 may lose contact with the skin, thus hindering the proper monitoring of the patient.

[0208] In an implementation, as Figure 6 shown, the centroid or center of gravity 147 of the housing 120 is located below the volume center 150 of the housing 120 relative to the vertical axis 137, such that the ratio of the distance V1 between the centroid or center of gravity 147 of the housing 120 and the lower edge line 136 to the distance V2 between the volume center 150 and the lower edge line 136 is less than 90%. As Figure 6 the example of shows, the lower edge line 136 is a line (or plane) tangent to the bottom end 123 of the housing 120. In other implementations, the ratio of the distances V1 / V2 can be less than 80%. In other implementations, the ratio of the distances V1 / V2 can be less than 75%. In other implementations, the ratio of the distances V1 / V2 can be less than 70%. In other implementations, the ratio of the distances V1 / V2 can be less than 50%. In other implementations, the ratio of the distances V1 / V2 can be less than 30%. In other implementations, the ratio of the distances V1 / V2 can be less than 20%. In an implementation, the ratio of the distances V1 / V2 can be in the range of 1% to 90%. In an implementation, the ratio of the distances V1 / V2 can be in the range of 5% to 80%. In an implementation, the ratio of the distances V1 / V2 can be in the range of 10% to 70%

[0209] In other implementations, such as Figure 8 shown, a second axis can be selected to determine a distance ratio, such as the horizontal axis H for measuring proximity to the patient's skin. In these implementations, the ratio of the lateral distance H1 between the centroid or center of gravity 147 and the patient-facing surface of the contour pad 105 to the lateral distance H2 between the center of volume 150 and the patient-facing surface of the contour pad 105 is less than 90%. In other implementations, the ratio of the lateral distances H1 / H2 can be less than 80%. In other implementations, the ratio of the lateral distances can be less than 70%. In other implementations, the ratio of the lateral distances H1 / H2 can be less than 50%. In other implementations, the ratio of the lateral distances H1 / H2 can be less than 30%. In other implementations, the ratio of the lateral distances H1 / H2 can be less than 20%. In an implementation, the ratio of the lateral distances H1 / H2 can be in the range of 1% to 90%. In an implementation, the ratio of the lateral distances H1 / H2 can be in the range of 5% to 80%. In an implementation, the ratio of the lateral distances H1 / H2 can be in the range of 10% to 70%.

[0210] In some implementations, more than one vertical axis 137 can be defined, such as a vertical axis oriented based on the patient being awake and standing, and a second vertical axis based on the patient lying flat for sleep. To meet the above criteria for the distance ratio for the two orientations, the center of gravity or centroid 147 is located in the lower rear quadrant of the housing 120.

[0211] In an example, the heaviest electrical components (e.g., at least one capacitor 135 and battery 140) are disposed below the center of volume 150 of the first assembly 102. Optionally or additionally, the heaviest electrical components are positioned close to the contour pad 105. For example, as Figure 8 shown, both the capacitor 135 and the battery 140 have a flat geometry such that they can be stacked at one end of the first assembly 102 that is below the center of volume 150. Relatively lighter electrical components, such as integrated circuits or systems-on-chip (SoCs) (such as the therapy delivery circuit 130 and the ECG acquisition and conditioning circuit 125, etc.), are disposed above the center of volume 150 within the housing 120. Since the centroid 147 of the first assembly 102 is below the center of volume 150, when the patient moves, the contour pad 105 is less likely to peel away from the patient's torso 5 under the action of gravity and other forces acting on the device.

[0212] Additionally or optionally, in an example (such as the example of Figure 8 etc.), the first assembly 102 of the device 100 has an ergonomic profile. In an implementation, the housing 120 extends a distance D of about 1 cm to 5 cm from the surface of the contour pad 105. In Figure 8In an example (where the centroid 147 is below the center of volume 150 and the heavier and / or larger components are below the center of volume 150), the housing 120 can be ergonomically shaped to follow the general contour of the components contained therein. For example, the distance D that the housing 120 extends from the surface of the contour pad 105 can vary from the top end 122 to the bottom end 123 (e.g., the top end is oriented closer to the patient's head compared to the bottom end). In one example, the side profile has the appearance of a right triangle with rounded surfaces and edges, or an approximately teardrop shape. In Figure 8 the example, the distance D1 at the top end 122 of the first component 102 is shorter than the distance D2 at the middle, and the distance D2 at the middle is shorter than the distance D3 at the bottom end 123. Figure 8 The exemplary contour of the housing 120 of provides a comfortable weight distribution that reduces the pulling on the skin under the gravitational force of trying to rotate the top end 122 away from the torso 5. Thus, the teardrop-shaped cross-section of the first component counteracts the peeling force that tends to pull the contour pad 105 away from the torso. Additionally, the streamlined contour shape closely follows the contour of the lower front region of the torso 5, such that the device 100 is unobtrusive or very minimally protruding when worn under clothing. This comfortable and compact structure encourages patient compliance by maintaining the patient's privacy during the prescribed wear duration.

[0213] As previously described with respect to Figures 3A to 4D the example, the implementation of the attachable wearable device 100 can include additional wearable supports and / or support garments for counteracting one or more forces such as peeling, shear, cleavage, and tensile forces and keeping the wearable device 100 in contact with the patient's torso 5. In such an implementation, the wearable supports and / or support garments help prevent the device 100 from pulling on the patient's skin and thus increase and / or ensure patient comfort throughout the wear duration. Ensuring patient comfort removes an impediment to patient compliance for wearing the device throughout the prescribed duration. Such wearable supports and / or support garments are particularly beneficial during long-term prescribed wear durations.

[0214] As previously described and as Figure 10A the example from D shows, the device 100 can further include a breathable anisotropic conductive gel 660 that is disposed between the contour pad 105 and the torso 5 and is configured to be placed along at least one of the plurality of treatment electrodes 110. In an example, the ratio of the area occupied by the region of the breathable anisotropic conductive gel 660 (e.g., the surface area bounded by the perimeter) to the area occupied by the region of the contour pad 105 ranges from about 0.30 to 0.75. In an example, the ratio of the area occupied by the region of the breathable adhesive 665 to the area occupied by the region of the contour pad 105 ranges from about 0.05 to 0.25.

[0215] By limiting the area occupied by the adhesive 665 to only the area required to support the weight of the device 100 for a specified duration, the surface area of the skin contacted by the adhesive is limited to only a portion of the area occupied by the profile pad 105. This limits the likelihood of the adhesive irritating the skin and facilitates evaporation of moisture from the areas of the skin not contacted by the adhesive. In some implementations (such as Figure 10C implementations, etc.), the adhesive 665 is disposed only on a portion of the perimeter of the profile pad 105, thereby providing one or more outlets 670 that promote evaporation of moisture. Additionally or alternatively, in some examples (such as Figure 10D examples, etc.), the gel 660 includes a plurality of perforations 662 that promote evaporation of sweat at the device-skin interface.

[0216] Now returning to Figure 8 , as previously described, in an implementation, the housing extends a distance D of about 1 cm to 5 cm from the surface of the profile pad. For example, the housing can extend 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, and 5 cm from the profile pad. In addition to keeping the centroid 147 below the center of volume 150, the device 100 also maintains a low profile and is worn under the patient's clothing in an unobtrusive manner. The device does not protrude too much from the patient's skin to create one or more noticeable bulges under the clothing and thus more seamlessly integrates with the patient's lifestyle. Patients who are less likely to feel disturbed by wearing the device 100 are more likely to comply with wearing the device for a specified duration. In an example, the volume under the housing 120 and thus the distance of the housing from the surface of the profile pad depends on a combination of component dimensions, shapes, and relative placement.

[0217] In an example, at least one power source of device 100 includes one or more batteries 140, where these batteries 140 have a combined envelope volume that does not exceed one quarter of the volume of at least one housing 120 and have a capacity of not less than 1200 mAh. In an example, at least one power source includes one or more batteries, where these batteries have a combined envelope volume that does not exceed one quarter of the volume of at least one housing and have a capacity in the range of 1200 mAh to 8000 mAh. In an example, at least one battery 140 is configured to supply power to one or more components such as one or more capacitors 135. In an example, battery 140 may include a rechargeable battery or a multi-cell battery pack. In an example, battery 140 may include a non-rechargeable replaceable battery. In one exemplary implementation, battery 140 may include three or more 2200 mAh lithium-ion batteries for supplying power to other components within device 100. In an implementation, at least one power source includes at least one 3V lithium-ion battery with a capacity of 1470 mAh. In an example, battery 140 may include a plurality of button cells. In an example, one or more batteries are flat-packaged lithium polymer batteries. In an example, battery 140 may be a flat-packaged (e.g., prismatic) battery, such as a lithium-ion battery with a size range between, for example, 12 mm x 4 mm x 1 mm and 35 mm x 50 mm x 2 mm. In an example, at least one power source includes one or more batteries 140, where these batteries 140 have a combined volume in the range of about 1 cm 2 to 7 cm 2 and a weight between about 1 g and 70 g (e.g., 1 g, 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 40 g, 50 g, 55 g, 60 g, 65 g, 70 g). In an example, one or more batteries 140 are rechargeable and can provide a power output in the range of 20 mA to 3000 mA and support a runtime of 24 hours, 48 hours, 72 hours, or more between charges. In a particular implementation, the battery capacity, runtime, and type (e.g., lithium-ion, nickel-cadmium, or nickel-metal hydride) can be varied to best suit the specific application of device 100 (e.g., defibrillation, pacing, etc.).

[0218] It should be understood that the capacitor 135 of the device 100 can be constructed in various form factors. For example, the capacitor 135 can include an encapsulated rigid housing. In an implementation, the outer shape of the rigid housing can be designed to conform to the curvature of the patient's torso 5, thereby creating a comfortable fit when worn. For example, the housing can be constructed of a rigid plastic, where the rigid plastic includes, for example, acrylonitrile-butadiene-styrene (ABS) plastic having a contoured surface that conforms to the patient's body shape. For example, the contoured surface can be configured to conform to the curvature of a portion of the patient's torso, such as the lower part of the torso, the upper front side of the torso, the upper back side of the torso, one or more sides of the torso, etc. A specific shape of the contoured surface can be pre-configured for the patient or uniquely designed. For example, various body dimension measurements can be obtained from the patient, and a uniquely customized housing can be 3D printed, for example, from any suitable thermoplastic plastic (such as ABS plastic).

[0219] In some implementations, the capacitor 135 can be a compact thin-film capacitor, such as a small thin-film capacitor having a maximum thickness of 1 mm to 40 mm, a capacitance at 700 μF, and a rated breakdown voltage of 500 to 2500 volts, etc. In an example, the capacitor 135 has an envelope volume ranging from about 10 cm 2 to 15 cm 2 In an example, the capacitor 135 has a capacitance of 140 microfarads and a rated voltage of at least 1600 V. The thin-film capacitor 135 can be made of tightly wound dielectric layers, where these dielectric layers are compressed and molded to match the patient's body shape. For example, multiple capacitors can be configured to conform to the curvature of a portion of the patient's torso 5, such as the lower part of the torso, the upper front side of the torso, the upper back side of the torso, or one or more sides of the torso, etc. Shaping one or more thin-film capacitors 135 to fit one or more contoured regions of the patient's torso 5 increases the patient's comfort and minimizes the bulky volume associated with cylindrical or stacked capacitors. Thus, the amount by which the device 100 protrudes from the surface of the patient's skin may be less compared to a situation where the capacitor has a larger volume and / or a smaller conforming profile. Table 4 provides examples of the weights of various components of an implementation of the device 100:

[0220]

[0221] Table 4

[0222] The weights of various components can be selected for comfort, size, and performance characteristics. For example, as previously described, one or more batteries 140 can be rechargeable, non-rechargeable, cylindrical, prismatic, and sized to provide energy for one or more defibrillation or pacing charges. Tables 5 and 6 provide exemplary lithium-ion prismatic batteries or lithium-ion cylindrical batteries used in one or more implementations of short-term and long-term wear embodiments of the attachment coupling devices 10, 100, 800:

[0223] Examples of lithium-ion prismatic batteries:

[0224]

[0225]

[0226] Table 5 Examples of lithium-ion cylindrical batteries

[0227]

[0228]

[0229] Table 6

[0230] In another example, as previously described, in an embodiment, the capacitor 135 can be a ~140 microfarad, 1600V thin film capacitor weighing approximately 118 grams. Optionally, the capacitor 135 can be a 4-cell cylindrical electrolytic capacitor weighing approximately 400 grams with a discharge rating of 140 microfarads. Similarly, the size and shape of other hardware components can be designed to be compact and lightweight without sacrificing performance. For example, the H-bridge can be a compact, surface-mounted silicon carbide FET (SiC FET) instead of a 4-part IGBT configuration. The ECG acquisition and conditioning circuitry, processor, and therapy delivery circuitry can be included in one or more ASICs, or on one or more wire-bonded, epoxy-protected "chip-on-board" flip chips.

[0231] Other features of the profile pad 105 contribute to the stability of the device 100 over a specified wear duration. For example, the profile pad 105 is sized to accommodate components disposed within the housing 120 and / or integrated within the profile pad 105, while providing sufficient attachment surface area to secure the first assembly 102 of the device 100 to the patient's skin over a specified duration. In one example, as Figure 11AAs shown, the contour pad has a width W1 of 2 cm to 18 cm and a length L1 of 12 cm to 36 cm. In an implementation, the contour pad 105 defines an area (e.g., "area occupancy") in the range of approximately 200 to 300 square centimeters. In an implementation, the contour pad 105 has an area occupancy of approximately 230 square centimeters (e.g., 0.023 square meters). The components thereon and / or therein have a cumulative weight in the range of 0.25 kg to 2.25 kg. In this example, the first component 102 thus has a weight-to-area occupancy ratio of approximately 10 kg / m 2 to 100 kg / m 2 The following table 7 provides additional examples of the weight (kg) to area occupancy (m2) ratio of the first component 102. The weights shown below are examples. Other weights are possible depending on the choice and design of the components and whether a wearable support is used, including a range of approximately 2.25 kg to approximately 10 kg.

[0232]

[0233] Table 7

[0234] As previously described in the example regarding Figure 5A and B, the device 100 includes a first component 102 and a separate second component 107, where the second component 107 is coupled to the first component 102 and is configured to be attached to the patient's torso 5. The second component 107 can be coupled to the first component 102 using one or more electrical wires or wiring configured to deliver an electric current (such as a 360 J defibrillation pulse).

[0235] The second component 107 can include the breathable and non-irritating materials and adhesives as described above regarding the first component 102 and the contour pad 105. In an example, the second component 107 includes a second treatment electrode among a plurality of treatment electrodes 110 that is integrated with the pad 109 of the second component 107 and is in wired communication with the treatment delivery circuit 130. In an example, the second component 107 includes an ECG sensor 115. Since the first component 102 contains the treatment delivery circuit and various other electrical components, the second component 107 can be more compact than the first component. For example, the second component can be a low-profile attachment pad that includes the treatment electrode 110 and the ECG electrode 115 and has a pad thickness of approximately 0.1 cm to 2 cm. In one example, as Figure 11BAs shown, the profile pad 109 of the second component 107 has a width W2 of 1 cm to 4 cm and a length L2 of 2 cm to 10 cm. In one example, the profile pad 109 defines a patient skin area (e.g., "area occupancy area") of approximately 100 square centimeters (e.g., 0.01 square meters). The components thereon and / or therein have a cumulative weight ranging from 0.05 kg to 1.0 kg. In this example, the second component has a weight-to-area occupancy area ratio of about 5 kg / m 2 to 100 kg / m 2 Table 8 provides additional examples of the weight (kg) to area occupancy area (m2) ratio of the second component 107. The weights shown below are examples. Other weights are possible depending on the choice and design of the components and whether a wearable support is used, including a range of about 1 kg to about 10 kg.

[0236]

[0237] Table 8

[0238] In an example, as previously described with respect to the first component 102, the second component 107 is made of a water-resistant and / or waterproof material. One or more electrical wires or wiring used to couple the second component 107 to the first component 102 can be encapsulated in a waterproof layer. In an example, one or more electrical wires or wiring can be connected to and / or cooperate with the first component 102 and the second component 107 in a waterproof and / or watertight structure. For example, the first component 102 and the second component 107 can also include waterproof and / or watertight orifices or connectors for receiving one or more electrical wires or wiring.

[0239] In an embodiment, the profile pad 109 of the second component is designed to be durable, flexible, and breathable to allow sweat evaporation. In an embodiment, the profile pad 109 is non-irritating when in contact with the skin as described by the skin irritation grading set forth in Table C.1 of Appendix C of the previously proposed American National Standard ANSI / AAMI / ISO 10993-10:2010. In an example, the profile pad 109 is generally non-conductive, flexible, water vapor permeable, and substantially liquid impermeable or waterproof. The non-conductive, flexible, water vapor permeable profile pad 105 may comprise or consist of polyurethane, such as TEGADERM polyurethane film (available from 3M), OPSITE polyurethane film (available from Smith&Nephew), or HYDROFILM polyurethane film (available from Hartman USA), among others. In other embodiments, the profile pad 109 may comprise or consist of at least one of neoprene, thermoformed plastic, or injection molded rubber or plastic (such as silicone or other biocompatible synthetic rubber, etc.). In an example, the profile pad 109 is a laminated pad comprising a waterproof or water resistant layer applied to a relatively more rigid plastic or rubber layer, wherein the relatively more rigid plastic or rubber layer is configured to provide structural support for the housing and the electronic components disposed therein. In an example, the profile pad 109 is perforated to facilitate the evaporation of water vapor from the skin.

[0240] In an embodiment, the second component 107 may include a conductive adhesive layer. As described in the '976 patent, which is hereby incorporated by reference in its entirety, the water vapor permeable conductive adhesive material may be selected, for example, from the group consisting of poly(3,4-ethylenedioxythiophene), doped poly(styrenesulfonate) (PEDOT:PSS), poly(aniline) (PANI), poly(thiopropene), poly(9,9-dioctylfluorene co-dithiophene) (F8T2), and combinations thereof. Such polymers may be printed as a flexible, water vapor permeable conductive adhesive layer using methods such as inkjet printing, screen printing, offset printing, flexographic printing, and gravure printing. In an example, the thickness of the flexible, water vapor permeable conductive adhesive material may be between 0.25 and 50 mils. In another example, the water vapor permeable conductive adhesive material may include conductive particles. In an implementation, the conductive particles may be microscopic or nanoscale particles or fibers of the material, including but not limited to carbon black, silver, nickel, graphene, graphite, carbon nanotubes, and / or one or more of other conductive biocompatible metals such as aluminum, copper, gold, and / or platinum.

[0241] In an example, as Figure 3A and 5AAs shown in FIGS. A to B, the second assembly 107 includes at least one of a plurality of treatment electrodes 110 integrated with the profile pad 109. Exemplary treatment electrodes 110 include, for example, conductive metal electrodes such as those made of stainless steel, tin, or aluminum, conductive ink, or conductive polymers, and the like. In an example, the second assembly may further include at least one of a plurality of ECG sensors 115 integrated with the profile pad 109. As described with respect to the first assembly 102, the ECG sensors 115 of the second assembly 107 may be non-polarizable ECG electrodes (e.g., clinical-grade Ag / AgCl electrodes) or polarizable electrodes (e.g., electrodes having a metal substrate with an oxide layer including, for example, a Ta2O5 coating) configured to measure changes in the patient's electrophysiological phenomena to measure the patient's ECG information. For example, as described in U.S. Patent 6,253,099 titled "Cardiac Monitoring Electrode Apparatus and Method," the exemplary ECG sensors 115 include tantalum pentoxide electrodes, and the entire content of the above-mentioned document is incorporated herein by reference. In an implementation, the ECG sensors 115 may be made of a core plastic or a metal substrate element, where the core plastic or metal substrate element is coated with a thick-film polymeric compound filled with conductive Ag / Ag / Cl metal filler.

[0242] In some examples, at least one treatment electrode 110 and one or more ECG sensors 115 are formed within the profile pad 109 such that the skin contact surfaces of the respective components are coplanar with or protrude from the patient contact surface of the profile pad 105. In an example, the treatment electrodes 110 and the ECG sensors 115 are disposed on the patient contact surface of the profile pad 105. In some implementations, the treatment electrodes 114 and the ECG sensors 115 are metal plates (e.g., stainless steel) or substrates formed as a permanent part of the second assembly 107. The metal plate or substrate may be adhered to the profile pad 109, for example, by a polyurethane adhesive or a polymer dispersion adhesive (such as a polyvinyl acetate (PVAc)-based adhesive or other such adhesives). In an example, the ECG sensors 115 are flexible dry surface electrodes such as conductive polymer-coated nanoparticle-loaded polydimethylsiloxane electrodes mounted to the profile pad 109. In some examples, the ECG sensors 115 are flexible dry surface electrodes such as silver-coated conductive polymer foam soft electrodes mounted to the profile pad 109. In an example, the ECG sensors 115 are screen-printed onto the profile pad 109 with a metal ink (such as silver-based ink). In an implementation, each of the treatment electrodes 110 has a conductive surface adapted to be placed adjacent to the patient's skin. In some implementations, the treatment electrodes 110 may include impedance-reducing materials and / or mechanisms as described later.

[0243] In an implementation, at least one therapy electrode 110 and at least one ECG sensor 115 are fabricated as integrated components of the conformable pad 109. For example, the therapy electrode 110 and / or the ECG sensor 115 can be formed by the warp and weft threads of the fabric that at least forms one layer of the conformable pad 109. In an implementation, at least one of the therapy electrode 110 and the ECG sensor 115 is formed by conductive fibers interwoven with non-conductive fibers of the fabric.

[0244] In an example, the device 100 can include a third assembly configured to be attached and coupled to a patient's torso. The third pad can include one of a plurality of therapy electrodes 110 that is integrated with the pad of the third assembly and is in wired communication with the therapy delivery circuit 130. The third assembly can have characteristics similar to those described above with respect to the second assembly 107. In an example, the third pad can be configured to be attached to the posterior portion of the patient's torso 5 between the patient's shoulder blades, for example, while the first assembly 102 is positioned along the lower ridge of the thoracic cavity and the second assembly 107 is positioned on the upper anterior side of the torso 5 adjacent to the apex of the heart. In an example, the third assembly includes a portion configured to be attached and coupled to the patient's torso adjacent to the atria.

[0245] Now referring Figure 4A to FIGS. D, 12A - B, 13A - C, and 14, the wearable support medical devices 800, 1000 are external, mobile, and wearable by a patient, and are configured to implement one or more of the configurations described herein. In an implementation, the wearable support medical devices 800, 1000 are mobile medical devices that are, for example, capable of and designed to move with the patient as the patient conducts his or her daily affairs.

[0246] For example, as Figure 12A and 12B shown, the device 800 can include: one or more anterior attachment and coupling pads 807A, 807B configured to be attached in the anterior region of the patient's torso 5; and one or more posterior attachment and coupling pads 802A, 802B that are electrically connected to the one or more anterior attachment and coupling pads 807A, 807B and are configured to be attached in the posterior region of the torso 5. In an example (such as the examples in Figure 13A FIGS. to C, etc.), the posterior attachment and coupling pad 802 can adhere to the patient's torso 5 such that a portion or all of the posterior attachment and coupling pad 802 covers one side of the torso 5. This configuration provides accessibility to the pad 802 for the patient for removal or adjustment and other device interactions. This configuration also enables the device to be hidden between the patient's arm and the torso 5. Similarly, Figure 14The device 1000 is configured to be hidden by connecting the posterior attachment coupling pads 1002a, 1002b to the anterior pads via a connection portion 1005 located under the patient's arm. The connection portion 1005 may be attached to the patient's torso 5 to assist in supporting the monitoring and treatment components of the device 1000.

[0247] In implementations such as Figure 13A and 13B the implementation of, etc., the garment 805 integrated with the anterior attachment coupling pads and the posterior attachment coupling pads at least partially traces the path from the anterior attachment coupling pad 807 coupled to the upper anterior region of the torso 5, over the patient's shoulder, and terminating at the posterior attachment coupling pad 802 on the posterior region of the torso 5. In an example, the garment 805 is a wearable support including a shoulder strap 806, where the shoulder strap 806 is configured to carry at least a portion of the weight of at least one of the anterior attachment coupling pad 807 and the posterior attachment coupling pad 802. In an example, each of the anterior attachment coupling pad 807 and the posterior attachment coupling pad 802 weighs from 0.5 kg to 1 kg, and the shoulder strap 806 is configured to support at least a portion of the weight of the two attachment coupling pads 807, 802.

[0248] As described above with respect to Figure 6 , 8 and 9A, for example, the wearable support device 800 includes a plurality of treatment electrodes and / or a plurality of ECG sensing electrodes integrated with the anterior attachment coupling pad 807 and the posterior attachment coupling pad 802. The housings 820a to c together with each of the anterior attachment coupling pads 807a to b and the posterior attachment coupling pad 802 form a watertight seal. For example, as shown in Figure 13A to B, the first housing 820b is configured to form a watertight seal with the anterior attachment coupling pad 806, and the second housing is configured to form a watertight seal with the posterior attachment coupling pad 802. As described in the embodiment of the device 100 with respect to FIGS. 5 to 8, Figures 12A to 13C the embodiment of is water resistant and / or water repellent. At least one housing may at least hide the ECG acquisition and conditioning circuit, the treatment delivery circuit, and the processor. For example, the processor may analyze the patient's ECG signal, detect one or more treatable arrhythmias, and cause the treatment delivery circuit to deliver at least one defibrillation pulse to the patient when one or more treatable arrhythmias are detected. In an implementation, the ECG sensing electrodes, the ECG acquisition and conditioning circuit, the treatment electrodes, the treatment delivery circuit, and the processor operate as described in the embodiment above with respect to Figures 6 to 8 the embodiment of.

[0249] In an implementation, the processor is configured to cause the therapy delivery circuit to deliver up to five therapy pulses to a patient upon detection of one or more disposible arrhythmias. At least one power source is disposed within the first housing or the second housing and coupled to the therapy delivery circuit and the therapy electrode pair to energize up to five therapy pulses.

[0250] In an implementation, capacitor 135 can be one or more capacitors disposed on one or both of the front side attachment coupling pad 807 and the rear side attachment coupling pad 802. In some examples, one of the front side attachment coupling pad 807 and the rear side attachment coupling pad 802 contains all of the circuitry and power components. The other of the front side attachment coupling pad 807 and the rear side attachment coupling pad 802 includes at least one therapy electrode and at least one ECG sensor in electrical communication with the circuitry and power components. In an implementation, the wearable support 805 includes conductive wires in communication with the front side attachment coupling pad 807 and the rear side attachment coupling pad 802. In an implementation, the conductive wires can be integrated into the fabric of the wearable support 805. In an example, the conductive wires can be integrated in a zigzag or other folded pattern to straighten as the garment stretches. Thus, the zigzag or folded pattern accommodates garment stretch and patient movement while preventing the conductive wires from contacting the patient's skin. Integrating the conductive wires into the garment reduces and / or eliminates wiring or wires snagging on external objects. In other examples, the conductive wires can be routed on the outer surface of the wearable support 805 to avoid contact with the patient's skin and thus avoid irritation associated with such potential contact. In an implementation, the conductive wires can be routed on the outer surface of the garment and appropriately retained using loops, closable fabric retainers, or grommets.

[0251] In an embodiment, devices 800B - D also include a breathable adhesive disposed between at least a portion of the wearable support 805 and the patient's shoulder. The garment 805 can be at least one of a vest, shirt, sash, belt, and shoulder strap. For example, in an embodiment, the garment 805 is a wearable support including a shoulder strap 806 made of a non - adherent stretchable fabric, and the adhesive is applied along the length of the strap at least at the outer perimeter. In an implementation, the fabric is a biocompatible, non - irritating, latex - free fabric such as spandex fabric, nylon - spandex fabric, or nylon - LYCRA fabric, etc. The adhesive can be applied to, for example, 20 - 25%, 25 - 30%, 30 - 35%, 40 - 45%, 45% - 50%, 50 - 60%, 60 - 65%, 65 - 70%, 70 - 75%, 75% - 80%, 85% - 90%, 95% - 100% of the surface area of the garment 805. In some examples, the adhesive is applied only to the front side attachment coupling pad 807 and the rear side attachment coupling pad 802, and the shoulder strap 806 stretches and is appropriately retained on the patient's torso 5 via a compressive force. In an example (such as Figure 12AIn examples such as Example A to Example B, the garment 805 is a fully attached wearable support that is suitably held against the patient's torso 5 by adhesion.

[0252] As previously described, in the examples, one of the front attachment coupling pad 807 and the rear attachment coupling pad 802 includes a therapy delivery circuit, an ECG acquisition and conditioning circuit, a processor, and a PCB. The one of the front attachment coupling pad 807 and the rear attachment coupling pad 802 that includes the relatively heavier set of electronic components can be placed lower on the torso 5 than the other. The garment 805 is a wearable support configured to help comfortably support the weight of both the front attachment coupling pad 807 and the rear attachment coupling pad 802. In examples (such as Figure 13A In examples such as Example A to Example B, the garment 805 is a wearable support 805 that includes a shoulder strap 806, where the shoulder strap 806 traces a path between the front attachment coupling pad 807 and the rear attachment coupling pad 802 and over the patient's shoulders. In an implementation, the tensile strength of the shoulder strap 806 is greater than at least 10% of the load exerted by the un - attached coupling assembly 807 and no more than 10 times the load exerted by the un - attached coupling assembly 807. In some examples, the shoulder strap 806 has an elongation percentage of about 10% to 200%. Thus, the shoulder strap 806 helps maintain and support the weight of the device 800 on the patient's torso 5, which can be particularly beneficial during long wear durations. In other implementations, the elastic parameters (such as elongation percentage, tensile strength, or elastic modulus) can be anisotropic in at least a portion of the shoulder strap 802. For example, to better conform to the complex curvature of the shoulder and neck regions, the elasticity may be lower along the long axis of the shoulder strap 806 compared to the short axis of the shoulder strap 806. The anisotropy allows for more stretch along the shoulder and neck regions for greater comfort while carrying the load of the support housing 120.

[0253] In addition to counteracting and balancing the weight of the front attachment coupling pad 807 and the rear attachment coupling pad 802, the garment 805 can have a curvature that conforms to the shape of the patient's body. In an example, the garment 508 is a wearable support that includes a shoulder strap 806, where the shoulder strap 806 is designed in at least one of molding, 3D printing, and knitting to match the shape of the patient's body. Thus, the device 800 can be customized to fit the individual body shape of the patient, ensuring comfort and encouraging patient compliance with the wearing instructions.

[0254] In some examples, the garment 805 is a wearable support including a shoulder strap 806, and at least one of the front attachment coupling pad 807 and the rear attachment coupling pad 802 is integrally formed with the shoulder strap 806 of the wearable support garment 805. For example, the garment 805 is a wearable support designed to match the shape of the receiving portion of the patient's torso 5 in at least one of molding, 3D printing, die cutting, and knitting. At least one of the front attachment coupling pad 807 and the rear attachment coupling pad 802 may be formed as part of the wearable support 805. In an implementation where the garment 805 includes a shoulder strap 806, for example, the wearable support 805 may be a mold die cut from a single sample of fabric or a formed substrate and may include the front attachment coupling pad 807 and the rear attachment coupling pad 802 as terminal portions of the shoulder strap 806. In other examples, the wearable support 805 mates with a separately formed front attachment coupling pad 807 and a separately formed rear attachment coupling pad 802.

[0255] In examples, each of the front attachment coupling pad 807 and the rear attachment coupling pad 802 may include a loop or buckle configured to receive an end of, for example, a load bearing strap or the shoulder strap 806. In these examples, the shoulder strap 806 is adjustable in length to achieve a preferred patient comfort setting. Additionally, in these examples, the shoulder strap 806 is removable for cleaning without having to remove the front attachment coupling pad 807 and the rear attachment coupling pad 802, etc., so the removal does not interfere with the critical functions of the device 800. In these examples, the front attachment coupling pad 807 and the rear attachment coupling pad 802 may be interconnected by wiring releasably attaching the shoulder strap such that the two pads continue to communicate when the shoulder strap is temporarily removed.

[0256] In other examples, each of the front attachment coupling pad 807 and the rear attachment coupling pad 802 may include a connector for electrically connecting to a mating portion on either end of a replaceable strap in a watertight structure. The replaceable strap may include conductive wiring or conductive lines extending through or over the replaceable strap and terminating at a connector on either end of the shoulder strap. In these examples, the shoulder strap may be removed, cleaned, replaced, and / or discarded. Enabling the patient to clean, discard, and / or replace the shoulder strap without having to remove the front attachment coupling pad 807 and the rear attachment coupling pad 802 helps maintain a clean and comfortable wearable support garment 805 throughout the prescribed wear duration.

[0257] In an example, the garment 805 is a wearable support having a greater tensile strength and a lower stiffness coefficient than either the front attachment coupling pad 807 or the rear attachment coupling pad 802. This helps the garment 805 to be soft enough to conform to the shape of the patient's torso 5 while also being strong enough to hold the weight of the front attachment coupling pad 807 and the rear attachment coupling pad 802 without tearing. In an example, the garment 805 includes a shoulder strap 806 that supports a rotational torque of at least 1.0 lbf ft at least at one end. In an implementation, the garment 805 is a wearable support (e.g., the shoulder strap 806) that stretches no more than 1 inch when a force of 22 lbf is applied. In an implementation, the wearable support 805 stretches no more than 2 inches when a force of 30 lbf is applied. In an implementation, the wearable support 805 stretches from 0.5 to 3.0 inches when a force of 30 lbf is applied.

[0258] In some implementations, the garment 805 is a wearable support that further includes at least one length adjuster configured to tension the shoulder strap 806 to a desired comfort level for a patient of the wearable device 800. The length adjuster can include, for example, at least one of a drawstring, a belly band, a lockable elastic drawstring, a zipper and a spring-loaded toggle stop, a ratchet strap, an adjustable buckle, an extendable and movable hook-and-loop fastener strap, a lace, a snap, and a button. By enabling the patient to adjust the length of the garment 805, the device 800 provides a mechanism for increasing or decreasing the tensile force and thus increasing or decreasing the compressive force acting on the patient's torso 5. For example, a patient may prefer more or less tension when sitting, lying down, reclining, standing, walking, and / or exercising. In an example, the front attachment coupling pad 807 and the rear attachment coupling pad 802 can be positioned on the patient's torso 5 by a caregiver or physician at the start of a prescribed wear duration, and the patient can adjust the garment 805 extending between the first component 102 and the second component 107 throughout the wear duration to accommodate movement, positioning, fabric stretch, and / or weight gain or loss. By, for example, limiting the garment 805 to a single supportive shoulder strap 806, the device 800 only covers a portion of the torso 5, while the remainder of the torso is not covered by the device 800. This can help to maintain patient comfort during the wear duration by minimizing the skin surface area covered on the torso 5 and thus helping to allow natural biological processes such as water vapor evaporation and skin shedding.

[0259] In an example, as with Figures 10A to 10D the embodiment of the device 100 shown, Figures 12A to 13CThe wearable support devices 800A to D may include a breathable anisotropic conductive gel disposed between at least one therapeutic electrode of the rear attachment coupling pad 802 and the torso 5. Similar to the profile pad 105 of the device 100, in some examples, the ratio of the area occupied by the breathable anisotropic gel to the area occupied by the rear attachment coupling pad 802 ranges from about 0.30 to 0.75. Also similar to the profile pad 105 of the device 100, the ratio of the area occupied by the adhesive to the area occupied by the rear attachment coupling pad 802 ranges from about 0.05 to 0.25. In an implementation, each of the front attachment coupling pad 807 and the rear attachment coupling pad 802 includes a therapeutic electrode for providing a therapeutic pulse to the patient's torso 5. In an implementation, each of the front attachment coupling pad 807 and the rear attachment coupling pad 802 includes a breathable anisotropic conductive gel disposed between at least one therapeutic electrode of each pad 802, 807 and the torso 5.

[0260] As previously introduced, in an implementation, the devices 100, 800 may include an impedance reduction material and / or mechanism for reducing the impedance between the therapeutic electrode and the patient's skin 7. In an example, the device includes a conductive hydrogel layer disposed between the therapeutic electrode 110 and the patient's skin. In an implementation, the impedance reduction layer includes an anisotropic conductive gel such as a conductive hydrogel.

[0261] In an example, the conductive gel may be a conductive adhesive layer. The conductive adhesive layer may be a vapor-permeable conductive adhesive material. The flexible, vapor-permeable conductive adhesive material may include a material selected from the group consisting of: electrospun polyurethane adhesives, polymeric microemulsion pressure-sensitive adhesives, organic conductive polymers, organic semiconductor conductive polymers, organic conductive compounds and semiconductor conductive compounds, and combinations thereof. In one example, the thickness of the flexible, vapor-permeable conductive adhesive material may be between 0.25 and 100 mils. In another example, the vapor-permeable conductive adhesive material may include conductive particles. In an implementation, the conductive particles may be microscopic or nanoscale particles or fibers of the material, including but not limited to carbon black, silver, nickel, graphene, graphite, carbon nanotubes, and / or one or more of other conductive biocompatible metals such as aluminum, copper, gold, and / or platinum.

[0262] In an implementation, the devices 100, 800 may include a gel deployment circuit configured to cause delivery of a conductive gel substantially proximate to a treatment site (e.g., the surface of the patient's skin where the treatment electrode 114 makes contact) prior to delivering a therapeutic shock to the treatment site. As described in U.S. Patent No. 9,008,801, titled “WEARABLE THERAPUETIC DEVICE,” issued on April 14, 2015 (hereinafter referred to as the “’801 patent,” which is hereby incorporated by reference in its entirety), the gel deployment circuit may be configured to cause delivery of the conductive gel immediately prior to or within a short time interval prior to delivering a therapeutic shock to the treatment site (e.g., within about 1 second, 5 seconds, 10 seconds, 30 seconds, or one minute). Such a gel deployment circuit may be coupled to or integrated into the treatment electrode 110 or other treatment delivery device as a single unit. In the event that a treatable cardiac condition is detected and no patient response is received after a device prompt, the gel deployment circuit may be signaled to deploy the conductive gel. In some examples, the gel deployment circuit may be configured as one or more separate and independent gel deployment modules. These modules may be configured to receive removable and / or replaceable gel cartridges (e.g., cartridges containing one or more conductive gel reservoirs). As such, the gel deployment circuit may be permanently disposed in the device as part of the treatment delivery circuit 130, while the cartridge may be removable and / or replaceable. Such a gel deployment circuit may be coupled to or integrated into the first component 102, 802, second component 107, 807, and / or third component of the device.

[0263] In the event that a treatable cardiac condition is detected and no patient response is received after a device prompt, the gel deployment circuit may be signaled to deploy the conductive gel. In some examples, the gel deployment circuit may be configured as one or more separate and independent gel deployment modules. These modules may be configured to receive removable and / or replaceable gel cartridges (e.g., cartridges containing one or more conductive gel reservoirs). As such, the gel deployment circuit may be permanently disposed in the device as part of the treatment delivery system, while the cartridge may be removable and / or replaceable.

[0264] In some implementations, the gel deployment module may be implemented as a gel deployment pack and include at least a portion of the gel deployment circuit and one or more gel reservoirs within the gel deployment pack. In such an implementation, the gel deployment pack including the one or more gel reservoirs and the associated gel deployment circuit may be removable and / or replaceable. In some examples, the gel deployment pack including the one or more gel reservoirs and the associated gel deployment circuit and the treatment electrode may be integrated into a treatment electrode assembly, where the treatment electrode assembly may be removed and replaced as a single unit after use or in the event of damage or breakage.

[0265] In addition to including impedance reducing materials and / or mechanisms, the short-term and long-term wear implementations of devices 100, 800 also include materials and / or mechanisms of devices 10, 100, 800 for facilitating the passage of moisture vapor from the patient's skin through the material adhering to the patient's skin.

[0266] Implementations of devices 100, 800 according to the present invention may exhibit, for example, a moisture vapor transmission rate (MVTR) of from about 600 g / m 2 / day to about 1400 g / m 2 / day when worn by a subject in an environment at room temperature (e.g., about 25 °C) and a relative humidity of, for example, about 70%. The vapor permeability of devices 100, 800, as measured by the vapor transmission standard of ASTM E-96-80 (version E96 / E96M-13) using the "contact with water vapor" ("dry") or "contact with liquid" ("wet") method, is greater than 100 grams / m 2 / 24 hours. This test method is described in the '976 patent, the disclosure of which is incorporated herein by reference in its entirety.

[0267] In an implementation, the wearable support device 800 has a water vapor permeability of 100 g / m 2 / 24 hours. In an implementation, device 800 includes a shoulder strap 806 having a higher MVTR than either or both of the front attachment coupling pad 807 and the rear attachment coupling pad 802. In an implementation, the shoulder strap 806 has an MVTR in the range of at least about 1200 to 2500 g / m 2 / 24 hours, and the front attachment coupling pad 807 and the rear attachment coupling pad 802 have an MVTR in the range of about 50 to 1000 g / m 2 / 24 hours. In implementations of devices 100, 800, 50 to 75% of the area occupied by the front attachment coupling pad 807 has an MVTR in the range of about 500 to 1200 g / m 2 / day, and 25 to 50% of the area occupied by the front attachment coupling pad 807 has an MVTR in the range of about 250 to 500 g / m 2 / day. In an implementation, 50 to 75% of the area occupied by the rear attachment coupling pad 802 has an MVTR in the range of about 500 to 1200 g / m 2 / day, and 25 to 50% of the area occupied by the rear attachment coupling pad has an MVTR in the range of about 250 to 500 g / m 2 / day. In an implementation, the portion of the area occupied by the front attachment coupling pad 807 or the rear attachment coupling pad 802 having a lower MVTR is the portion to which one or more breathable adhesives and / or breathable conductive hydrogels are applied.

[0268] In addition to having one or more breathable adhesives and / or breathable conductive hydrogel layers disposed between the conformable pad and the patient's skin, the implementations of devices 100, 800 include one or more moisture and heat management systems. In an implementation, as previously described, devices 100, 800 include one or more vapor-permeable housings. As previously described, housings 120, 820 are non-conductive, water vapor-permeable, and substantially liquid-impermeable or waterproof. Housings 120, 820 may comprise or be made of polyurethane, such as a Tegaderm polyurethane film (available from 3M), an Opsite polyurethane film (available from Smith & Nephew), or a Hydrofilm polyurethane film (available from Hartman USA), etc. In an example, housings 120, 820 may comprise a nonwoven laminate, such as at least one spandex, nylon-spandex, and nylon-Lycra, etc. In an example, housing 120 may comprise a thermoformed layer coated with a waterproof or hydrophobic layer, such as a nonwoven polyurethane fabric material layer. In other examples, housing 120 may comprise or be made of a fabric having a biocompatible surface treatment, rendering the fabric water-resistant and / or waterproof. For example, the fabric may be enhanced by immersion in a fluorocarbon bath such as Teflon or fluorinated decyl polyhedral oligomeric silsesquioxane (F-POSS).

[0269] One or more vapor release valves or through-holes may be formed into or disposed through the conformable pad 105, and / or the treatment electrode 110, and / or the housing, to evaporate and discharge moisture generated due to sweating and moisture from the patient's skin out of housings 120, 820. As previously described, in an implementation, one or more vapor release valves (e.g., Figure 6 and 9A vapor release valves 149a to c in the implementation of Figure 6 may be formed into or disposed through housing 120 to discharge sweat out of housings 120, 820. As moisture from the skin dissipates through the breathable adhesive and the vapor-permeable conformable pad 105, the vapor pressure within housing 120 may increase. In some implementations, the vapor release valves are pressure-activated such that when the moisture within housings 120, 820 increases and the pressure within the housing increases to a threshold or trigger value, one or more of the vapor release valves 149a to c open, allowing the moisture to evaporate. When the moisture has evaporated sufficiently to reduce the pressure within the housing below the threshold, the vapor release valves close. In an implementation, the vapor release valves may communicate with a processor of the device (e.g., Figure 6 processor 118 of

[0270] In an example, the conformable pad 105, the treatment electrode 110, and / or the housing 120 may include perforations through which water vapor escapes. For example, the housing 120, 820 may include a non-woven laminate material having a plurality of micro-perforations that are etched through. The perforations form through-holes that are small enough to allow water vapor from inside the housing to evaporate and escape, but too small to allow water to enter. For example, the diameter of such through-holes may range from 0.02 microns to 250 microns (e.g., about 0.001 mil to 10 mil). In an implementation, the devices 100, 800 may include moisture-absorbing, vapor-permeable, and / or wicking materials in the conformable pads 105, 109, 802, 809 to assist in moving moisture from the patient's skin through the housing 120, 820 for discharge by evaporation.

[0271] In an implementation, the devices 10, 100, 800 may include one or more passive thermal management systems and / or one or more active thermal management systems. For example, in an implementation, the device may include one or more active thermal management systems disposed within at least one housing. In an implementation, the active thermal management system may include a thermoelectric cooling device (e.g., Figure 8 and 9B the thermoelectric cooling devices 143, 943) that communicates with the processor 118. In an implementation, the active thermal management system may include a low-profile fan (e.g., Figure 9A the fan 144 and Figure 9B the fan 944). Such a low-profile fan may improve air circulation within the housings 120, 820, 920 of the device and contribute to surface cooling at the device-skin interface. In an implementation, the fan 144 helps to draw moisture from the skin, through the breathable adhesive, and through the vapor-permeable conformable pad 105, and through the vapor-permeable housing 120. In an implementation, the fan 144 may be used in combination with one or more vapor transport features, such as one or more vapor release valves 149a-c (collectively referred to as the vapor release valve 149) as described below for an implementation for releasing vapor emitted from the skin into the housings 120, 820. In some implementations, the device includes one or more vapor release valves without the accompanying fan 144.

[0272] In an implementation (such as Figure 9B the implementation, etc.), the fan 944 may also draw air from the air inlet 945 of the housing 920 to create an air flow 950 within the housing. The air is then cooled by a cooling device 943, such as a thermoelectric cooling device or a cooling pack, and blown through one or more air channels 946 through the breathable conformable pad 905 and the patient's skin 7 to increase comfort. (For simplicity, in Figure 9BOnly a portion of the patient's skin 7 is shown to illustrate the relative position of the profile pad 905 on the skin 7 when attached by a breathable adhesive 938 such as a conductive breathable adhesive. In an implementation, the air inlet 945 is a passage or gap defined by the profile pad 905 on one side and the inner housing wall 921 on the other side. The inner housing wall 921 is shorter than the profile pad 105 such that a gap 948 is defined between the end of the inner housing wall 921 and the connecting portion 918 of the housing 120 that is anchored to the profile pad 905. In an implementation, the inner housing wall 921 includes one or more supports 923 for anchoring the housing 920 to the profile pad 905 at a distance that defines the width Wc of the passage. In an implementation, one or more supports 923 can be conductive connectors configured to engage one or more of the treatment electrodes 110 or ECG electrodes 115.

[0273] In an implementation, as Figure 6 , 8 and as shown in FIGS. 9A - B, the first assemblies 102, 802, 902 can include a passive thermal management system disposed within at least one housing. In an implementation, the passive thermal management system can include a cooling device 943 such as a removably insertable cooling pack. In an implementation, the passive thermal management system can include a metal heat sink layer 146 disposed within the housing adjacent to one or more of the plurality of ECG electrodes and / or the plurality of treatment electrodes. In some examples, the metal heat sink layer 146 can be, for example, one or more pieces of lightweight metal such as aluminum or stainless steel that are located within the housing and in contact with the profile pad as depicted in Figure 9A . In an implementation, the metal heating layer can be formed as part of a printed circuit board (such as the printed circuit board 145 of Figure 6 ).

[0274] In an implementation, the device can include a gel - based heat distribution system disposed within at least one housing. Similar to the metal heat sink layer 146 disposed within the housing, the gel - based heat distribution system is a gel layer for conducting heat away from one or more of the plurality of ECG electrodes and / or the plurality of treatment electrodes. The gel layer conducts heat from the patient's skin 7 into the housing for active or passive dissipation, for example, by evaporation via one or more through - holes and / or by fan - driven displacement through the housing 120.

[0275] As previously described, in an implementation, the passive thermal management system can include one or more through - holes (e.g., the through - hole 148 of Figure 6 ) that extend between the interface between the profile pad and the patient's torso and the outer surface of at least one housing 120. In an implementation, one or more vapor release valves (e.g., the vapor release valves of Figure 6 and 9AIn the implementation, the steam release valves 149a to c) can be formed into the housing 120 or arranged to pass through the housing 120 to discharge sweat from the housings 120, 820. As the moisture 903 from the patient's skin 7 dissipates through the breathable adhesive and the vapor-permeable conformable pad 105, the steam pressure inside the housing 120 can increase. In some implementations, the steam release valves are pressure-activated such that when the moisture increases within the housings 120, 820 and the pressure inside the housing increases to a threshold or trigger value, one or more of the steam release valves 149a-c open, allowing the water vapor to evaporate. When the water vapor has evaporated sufficiently to reduce the pressure inside the housing below the threshold, the steam release valve closes. In an implementation, the steam release valve can communicate with the processor of the device (e.g., Figure 6 the processor 118) and is electromechanically controlled.

[0276] In an implementation, one or more of the steam release valves 149 can be manually activated by the patient or caregiver by pressing a manual button, or tapping the device or providing an indication to the device 100, 800 from a remote device that communicates with the processor 118. For example, a remote watch or smartphone running an application can provide a user interface for the user to tap to request valve activation. In an implementation, the devices 100, 800 can include a humidity sensor inside the housings 120, 820. The humidity sensor can communicate with the processor 118 such that the processor automatically activates the steam release mechanism when the steam level inside the housing reaches a threshold. In an implementation, a threshold for automatically activating the steam release valve is preset on the devices 100, 800. In an implementation, the threshold for automatically activating the steam release valve can be configured by the patient, physician, or other caregiver representative to customize the frequency of steam release for a particular patient's sweating rate and comfort level. For example, when the patient is exercising, he or she can set the frequency of opening the steam release valve to once every 5 minutes, while when the patient is resting, he or she can set the frequency of opening the steam release valve to once per hour.

[0277] As described above, the teachings of the present invention can generally be applied to external medical monitoring and / or treatment devices (e.g., devices that are not fully implanted within the patient). External medical devices can include, for example, mobile medical devices that are capable of and designed to move with the patient as the patient goes about his or her daily activities. Exemplary mobile medical devices can be wearable medical devices such as wearable cardioverter defibrillators (WCDs), wearable cardiac monitoring devices, in-hospital devices such as in-hospital wearable defibrillators, short-term wearable cardiac monitoring and / or treatment devices, and other similar wearable medical devices.

[0278] A wearable medical cardiac monitoring device can be continuously used by a patient. Additionally, the wearable medical device can be configured as a medical device for long-term or extended use. Such a device can be designed to be used by a patient for a long period of time, such as a period of 24 hours or more, several days, weeks, months, or even years. Thus, the long-term use can be uninterrupted until a physician or other caregiver provides a specific prescription to the patient to stop using the wearable medical device. For example, the wearable medical device can be prescribed for a patient to use for a period of at least one week. In an example, the wearable medical device can be prescribed for a patient to use for a period of at least 30 days. In an example, the wearable medical device can be prescribed for a patient to use for a period of at least one month. In an example, the wearable medical device can be prescribed for a patient to use for a period of at least two months. In an example, the wearable medical device can be prescribed for a patient to use for a period of at least three months. In an example, the wearable medical device can be prescribed for a patient to use for a period of at least six months. In an example, the wearable medical device can be prescribed for a patient to use for a long period of at least one year. In some implementations, the extended use can be uninterrupted until a physician or other caregiver provides a specific prescription to the patient to stop using the wearable medical device.

[0279] Implementations of attaching and coupling the wearable device can include additional wearable supports and / or support garments for counteracting one or more forces such as peel forces, shear forces, cleavage forces, and tensile forces and for keeping the wearable device in contact with the patient's torso. In such implementations, the wearable supports and / or support garments help prevent the wearable device from pulling on the patient's skin and thus increase and / or ensure patient comfort throughout the wearing duration. Ensuring patient comfort removes an impediment to patient compliance in wearing the device throughout the prescribed duration. Such wearable supports and / or support garments are particularly beneficial during a long-term prescribed wearing duration.

[0280] Irrespective of the period of wear, the use of a wearable medical device can include continuous or nearly continuous wear of the patient as described above. For example, continuous use can include continuously wearing or attaching the wearable medical device to the patient. In an implementation, during a monitoring period and during a period when the device may not be monitoring the patient but is still otherwise worn by the patient or otherwise attached to the patient, as described herein, continuous attachment is via one or more electrodes. Continuous use can include continuously monitoring the patient to obtain cardiac-related information (e.g., electrocardiogram (ECG) information, including arrhythmia information, cardiac vibrations, etc.) and / or non-cardiac information (e.g., blood oxygen, patient's body temperature, glucose level, interstitial fluid level, and / or lung vibrations) while the patient is wearing the device. For example, the wearable medical device can perform its continuous monitoring and / or recording at periodic or aperiodic time intervals or times (e.g., every few minutes, hours, once a day, once a week, or other intervals set by a technician or prescribed by a caregiver). Optionally or additionally, the monitoring and / or recording during the interval or time can be triggered by a user action or other event.

[0281] As described above, the wearable medical device can be configured to monitor other physiological parameters of the patient in addition to cardiac-related parameters. For example, the wearable medical device can be configured to monitor, for example, lung vibrations (e.g., using a microphone and / or accelerometer), respiratory vibrations, sleep-related parameters (e.g., snoring, sleep apnea), interstitial fluid (e.g., using a radio frequency transmitter and sensor), etc.

[0282] In an implementation, the patient-wearable arrhythmia monitoring and treatment device 100, 800 also includes a patient notification output. In response to detecting one or more treatable arrhythmia conditions, the processor 118 is configured to prompt the patient to respond by emitting a patient notification output, where the patient notification output can be an auditory output, a tactile output, a visual output, or some combination of any or all of these types of notification outputs. In the absence of a response from the patient to the notification output, the processor is configured to cause the treatment delivery circuit 130 to deliver one or more treatment pulses to the patient.

[0283] Figure 15Depicts an example of process 1500 for determining whether to initiate a treatment sequence and apply a treatment pulse to a patient's body. In an implementation, processor 118 receives S1502 the patient ECG signal from ECG electrodes 112 and analyzes S1504 the ECG signal to obtain an arrhythmia condition. Processor 118 determines S1506 whether the arrhythmia is a life-threatening condition and whether treatment is required. If the arrhythmia is not life-threatening, processor 118 may store a portion of the ECG signal in memory for later analysis and continue to monitor the patient ECG signal. If the arrhythmia is life-threatening, processor provides S1508 a patient notification output and requests S1510 a patient response to the provided notification output. In an implementation, the patient responds to the warning by interacting with a user interface (e.g., Figure 16 user interface 208), where the user interface includes, for example, one or more buttons (e.g., Figure 5C button 111) or a touchscreen interface button with haptic feedback (e.g., Figure 12A to B and 14 of the wrist-worn remote device 810 and the arm-worn remote device 1010 or touchscreen buttons 811, 1011 of the user interface of a similar device such as a smart phone running a user-facing interactive application). The response may be, for example, pressing one or more buttons in a specific order or for a specific duration. Processor 118 determines S1512 whether a patient response is received. If the patient responds to the notification output, it is notified to processor 118 that the patient is conscious and returns to the monitoring mode. If the patient is unconscious and unable to respond to the provided warning, processor 118 initiates S1514 a treatment sequence and treats S1516 the patient by delivering energy to the patient's body.

[0284] In an implementation, an exemplary therapeutic medical device can include an in-hospital continuous monitoring defibrillator and / or a pacing device, such as an in-hospital wearable defibrillator. In such an example, electrodes can be adhesively attached to a patient's skin. For example, the electrodes can include disposable adhesive electrodes. For example, the electrodes can include sensing components and treatment components disposed on separate sensing electrode attachment patches and treatment electrode attachment patches. In some implementations, both the sensing components and the treatment components can be integrated and disposed on the same electrode attachment patch that is then attached to the patient. In an exemplary implementation, the electrodes can include a front adhesively attachable treatment electrode, a back adhesively attachable treatment electrode, and a plurality of adhesively attachable sensing electrodes. For example, the front adhesively attachable treatment electrode is attached to the front of the patient's torso to provide pacing or defibrillation therapy. Similarly, the back adhesively attachable treatment electrode is attached to the back of the patient's torso. In an exemplary scenario, at least three ECG adhesively attachable sensing electrodes can be attached at least above the patient's chest near the right arm, above the patient's chest near the left arm, and attached towards the bottom of the patient's chest in a manner prescribed by a trained professional.

[0285] A patient being monitored by an in-hospital defibrillator and / or pacing device may be restricted to a hospital bed or a hospital ward for a relatively long amount of time (e.g., 90% or more of the patient's hospital stay). As a result, the user interface can be configured to interact with a user other than the patient (e.g., a nurse) to perform device-related functions such as initial device baselining, setting and adjusting patient parameters, and replacing the device battery.

[0286] In an implementation, examples of therapeutic medical devices can include short-term continuous monitoring defibrillators and / or pacing devices, such as short-term outpatient wearable defibrillators. For example, a physician can prescribe such a short-term outpatient wearable defibrillator for a patient presenting with syncope. The wearable defibrillator can be configured to monitor a patient presenting with syncope by, for example, analyzing the patient's cardiac activity to detect abnormal patterns that may indicate abnormal physiological function. For example, such abnormal patterns can occur before, during, or after the onset of symptoms. In such an exemplary implementation of a short-term wearable defibrillator, the electrode assembly can be adhesively attached to the patient's skin and have a configuration similar to that of the in-hospital defibrillator described above.

[0287] Figures 1 to 5C, FIGS. 9A - B and 12A - 13C illustrate exemplary medical devices 10 (such as devices 10A - 10G), 100, 800, 900, where these exemplary medical devices are external, mobile, and wearable by a patient, and are configured to implement one or more of the configurations described herein. For example, medical devices 10, 100, 800 can be non - invasive medical devices configured to be substantially outside the patient's body. Such a medical device can be, for example, a mobile medical device capable and designed to move with the patient as the patient goes about his or her daily business. The exemplary medical devices described herein can be attached to the patient's body via an attachment pad and / or via a wearable support and / or support garment worn around the patient's torso. For example, the medical device can be a wearable cardioverter - defibrillator. Such a wearable defibrillator is typically worn for 2 to 3 months almost continuously or substantially continuously at a time. During the period of time the patient wears it, the wearable defibrillator can be configured to continuously or substantially continuously monitor the patient's vital signs and, when determined to be necessary, can be configured to deliver one or more therapeutic electrical pulses to the patient. For example, such a therapeutic shock can be a pacing, defibrillation, or transcutaneous electrical nerve stimulation (TENS) pulse. In some implementations, medical devices 10, 100, 800, 900 can be specified for a long - term wear duration and include a wearable support and / or support garment. In some implementations, medical devices 10, 100, 800, 900 can be specified for a short - term wear duration and rely only on an adhesive without one or more additional wearable supports and / or support garments to provide reliability and patient comfort throughout the wear duration.

[0288] In an example, the medical device can include a physiological sensor configured to detect one or more cardiac signals. Examples of such signals include ECG signals and / or other sensed cardiac physiological signals from the patient. In a particular implementation, the physiological sensor can include additional components such as an accelerometer, a vibration sensor, and other measuring devices for recording additional parameters, etc. For example, the physiological sensor can also be configured to detect other types of patient physiological parameters and vibration signals, such as tissue fluid level, cardiac vibrations, lung vibrations, respiration - related vibrations of anatomical features in the airway path, patient movement, etc. An exemplary physiological sensor can include an ECG sensor, where, as described, for example, in U.S. Patent 6,253,099 titled “Cardiac Monitoring Electrode Apparatus and Method”, the ECG sensor includes a metal electrode having an oxide coating, such as a tantalum pentoxide electrode, etc., the entire content of the above - mentioned document being incorporated herein by reference.

[0289] In an example, a physiological sensor may include a heart rate sensor for detecting a heartbeat and monitoring a patient's heart rate. For example, such a heart rate sensor may include an ECG sensor and the associated circuitry described above. In some examples, the heart rate sensor may include a radio-frequency-based pulse detection sensor or a pulse oximetry sensor worn adjacent to a patient's artery. In an implementation, the heart rate sensor may be worn around a patient's wrist, for example incorporated on and / or within a watch or bracelet. In some examples, the heart rate sensor may be integrated within a patch attached to an artery of a patient's skin.

[0290] In some examples, the treatment electrode 110 may also be configured to include a sensor configured to detect an ECG signal and other physiological signals of the patient. The ECG data acquisition and conditioning circuit 125 is configured to amplify, filter, and digitize these cardiac signals. One or more treatment electrodes 110 may be configured to deliver one or more therapeutic defibrillation shocks to a patient's body in the event that the medical devices 100, 800 determine, based on signals detected by the ECG sensor 115 and processed by the processor 118, that such a treatment is approved. Exemplary treatment electrodes 110 may include conductive metal electrodes such as stainless steel electrodes, where in a particular implementation, the conductive metal electrodes include one or more conductive gel deployment devices configured to deliver a conductive gel to the metal electrodes prior to delivering a treatment shock.

[0291] In some implementations, a medical device as described herein may be configured to switch between a treatment medical device and a monitoring medical device, where the monitoring medical device is configured to only monitor a patient (e.g., not provide or perform any treatment functions). The treatment element may be deactivated (e.g., via a physical or software switch) such that the treatment medical device essentially behaves as a monitoring medical device for a particular physiological purpose or a particular patient. As an example of a software switch, an authorized person may access a protected user interface of the medical device and, via the user interface, select a pre-configured option or perform some other user action to deactivate the treatment element of the medical device.

[0292] Figure 16 A horizontal view of exemplary components of a medical device is shown. As Figure 16 shown, the medical device housing 120 may include a treatment delivery circuit 130 including a polarity switch component such as an H-bridge 228, a data storage 204, a network interface 206, a user interface 208, at least one battery 140, a sensor interface 212 including, for example, an ECG data acquisition and conditioning circuit 125, an alarm manager 214, at least one processor 118, and one or more capacitors 135. A patient monitoring medical device may include with respect to Figure 16Components similar to those described, but excluding the therapy delivery circuit 130. Optionally, the patient monitoring medical device may include components similar to those described with respect to Figure 16 Components similar to those described, but including a switching mechanism for deactivating the therapy delivery circuit 130.

[0293] The therapy delivery circuit 130 is coupled to two or more therapy electrodes 110 configured to deliver therapy to a patient. As Figure 16 shown, in an example, at least one of the two or more therapy electrodes 110 is within the housing 120 and the other therapy electrodes of the two or more therapy electrodes 110 are remote from the housing 120. For example, the therapy delivery circuit 130 includes or is operatively connected to circuit components configured to generate and deliver therapy shocks. Circuit components may include, for example, resistors, one or more capacitors, relays and / or switches, a bridge such as an H-bridge 228 (e.g., an H-bridge including a plurality of insulated gate bipolar transistors (or IGBTs) for delivering and truncating therapy pulses), voltage and / or current measurement components, and other similar circuits arranged and connected such that the circuits work in cooperation with the therapy delivery circuit and under the control of one or more processors (e.g., processor 118) to, for example, provide one or more pacing or defibrillation therapy pulses.

[0294] Pacing pulses can be used to treat cardiac arrhythmias such as bradycardia (e.g., in some implementations, fewer than 30 beats per minute) and tachycardia (e.g., in some implementations, more than 150 beats per minute) using, for example, fixed rate pacing, demand pacing, anti-tachycardia pacing, etc. Defibrillation pulses can be used to treat ventricular tachycardia and / or ventricular fibrillation.

[0295] In an implementation, each of the treatment electrodes 110 has a conductive surface adapted to be placed near a patient's skin and has an impedance reducing component included therein or thereon for reducing the impedance between the treatment electrode and the patient's skin. As previously described with respect to the implementation, each treatment electrode may include a conductive impedance reducing adhesive layer, such as a breathable anisotropic conductive hydrogel disposed between the treatment electrode and the patient's torso. In an implementation, the attachment-coupled patient-wearable arrhythmia monitoring and treatment device 100, 800 may include a gel deployment circuit configured to cause the delivery of a conductive gel substantially proximate to the treatment site (e.g., the surface of the patient's skin in contact with the treatment electrode 110) prior to delivering a treatment shock to the treatment site. As described in U.S. Patent No. 9,008,801, titled "WEARABLE THERAPUETIC DEVICE," issued on April 14, 2015 (hereinafter referred to as the "'801 patent," which is incorporated herein by reference in its entirety), the gel deployment circuit may be configured to cause the delivery of the conductive gel immediately prior to, or within a short time interval prior to, delivering a treatment shock to the treatment site (e.g., within about 1 second, 5 seconds, 10 seconds, 30 seconds, or one minute). Such a gel deployment circuit may be coupled to or integrated within a first component 102, 802, a second component 107, 807, and / or a third component of the device.

[0296] In the case where a treatable cardiac condition is detected and no patient response is received after a device prompt, the gel deployment circuit may be signaled to deploy the conductive gel. In some examples, the gel deployment circuit may be configured as one or more separate and independent gel deployment modules. These modules may be configured to receive a removable and / or replaceable gel cartridge (e.g., a cartridge containing one or more conductive gel reservoirs). As such, the gel deployment circuit may be permanently disposed within the device as part of a treatment delivery system, while the cartridge may be removable and / or replaceable.

[0297] In some implementations, the gel deployment module may be implemented as a gel deployment pack and includes at least a portion of the gel deployment circuit and one or more gel reservoirs within the gel deployment pack. In such an implementation, the gel deployment pack including one or more gel reservoirs and the associated gel deployment circuit may be removable and / or replaceable. In some examples, the gel deployment pack including one or more gel reservoirs and the associated gel deployment circuit and the treatment electrodes may be integrated into a treatment electrode assembly, where the treatment electrode assembly may be removed and replaced as a single unit after use or in the event of damage or breakage.

[0298] Continuing Figure 16 the description of the exemplary medical device, in an implementation, as Figure 17As shown, one or more capacitors 135 are a plurality of capacitors (e.g., two, three, four, or more capacitors) including a capacitor bank 402. These capacitors 135 can be switched to series connection during defibrillation pulse discharge. For example, four capacitors of about 650 μF can be used. In one implementation, the capacitors can have a surge rating of 200 to 2500 volts and can be charged by the battery 140 in about 5 to 30 seconds depending on the amount of energy to be delivered to the patient. Additional implementations of capacitor properties and arrangements on the patient-worn medical device are provided in subsequent sections herein.

[0299] For example, each defibrillation pulse can deliver 60 to 400 joules (J) of energy. In some implementations, the defibrillation pulse can be a biphasic truncated exponential waveform, whereby the signal can switch between a positive portion and a negative portion (e.g., the charging direction). The amplitudes and widths of the two phases of the energy waveform can be automatically adjusted to deliver a predetermined amount of energy.

[0300] The data storage 204 can include one or more of non-transitory computer-readable media such as flash memory, solid-state memory, magnetic memory, optical memory, cache memory, combinations thereof, etc. The data storage 204 can be configured to store executable instructions and data for operating the medical device. In a particular implementation, the data storage 204 can include executable instructions, where these executable instructions, when executed, are configured to cause the processor 118 to perform one or more functions.

[0301] In some examples, the network interface 206 can facilitate information communication between the medical device and one or more other devices or entities via a communication network. For example, the network interface 206 can be configured to communicate with a remote computing device such as a remote server or other similar computing devices. The network interface 206 can include communication circuitry for sending data according to the Bluetooth wireless standard to exchange such data over a short distance to an intermediate device (e.g., a base station, a "hotspot" device, a smart phone, a tablet, a portable computing device, and / or other devices near the wearable medical device 100). The intermediate device can in turn communicate the data to the remote server via a broadband cellular network communication link. The communication link can implement broadband cellular technologies (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellular standards) and / or Long Term Evolution (LTE) technologies or GSM / EDGE and UMTS / HSPA technologies for high-speed wireless communication. In some implementations, the intermediate device can communicate with the remote server via a WI-FI communication link based on the IEEE 802.11 standard.

[0302] In a particular implementation, the user interface 208 may include one or more physical interface devices such as input devices, output devices, and combined input / output devices, as well as a software stack configured to drive the operation of the devices. These user interface elements may present visual, audio, and / or tactile content. Thus, the user interface 208 can receive input or provide output, enabling a user to interact with the medical device. In some implementations, the user interface 208 may be implanted as a handheld user interface device. (See, for example, Figure 1 the patient interface box 40 in

[0303] and the wrist-worn remote device 810 and the arm-worn remote device 1010 in FIGS. 12 and 14.) For example, the handheld user interface device may be a smart phone or other portable device configured to communicate with the processor 118 via the network interface 206. In an implementation, the handheld user interface device may also be an intermediate device for facilitating the transfer of information from the device to a remote server.

[0304] The sensor interface 212 may be coupled to one or more sensors configured to monitor one or more physiological parameters of a patient. As Figure 16 shown, the sensors may be coupled to the medical device controller (e.g., the processor 118) via a wired or wireless connection. The sensors may include one or more sensing electrodes (e.g., the ECG sensor 115), a vibration sensor 224, and a tissue fluid monitor 226 (e.g., based on an ultra-wideband radio frequency device). For example, the sensor interface 212 may include an ECG circuit (such as Figure 6 and 8 the ECG acquisition and conditioning circuit 125 of

[0305] and / or an accelerometer circuit, each configured to receive and condition the corresponding sensor signal. Figure 16

[0305] The sensing electrodes may, for example, monitor the patient's ECG information. For example, Figure 16The sensing electrode can be an ECG sensor 115 and can include a conductive electrode with a storage gel deployment (e.g., a metal electrode with a storage conductive gel configured to disperse at the electrode-skin interface when needed), a conductive electrode with a conductive adhesive layer, or a dry electrode (e.g., a metal substrate with an oxide layer in direct contact with the patient's skin). The sensing electrode can be configured to measure the patient's ECG signal. The sensing electrode can send information describing the ECG signal to the sensor interface 212 for subsequent analysis.

[0306] The vibration sensor 224 can detect cardiac or pulmonary (cardiopulmonary) vibration information of the patient. For example, the cardiopulmonary vibration sensor 224 can be configured to detect cardiac vibration biomarkers in the cardiac vibration signal, including any one or all of the S1, S2, S3, and S4 cardiac vibration biomarkers. Based on these cardiac vibration biomarkers, specific electromechanical metrics can be calculated, including any one or more of electromechanical activation time (EMAT), percentage of EMAT (%EMAT), systolic dysfunction index (SDI), left ventricular diastolic perfusion time (LDPT), and left ventricular systolic time (LVST). The cardiopulmonary vibration sensor 224 can also be configured to detect heart wall motion, for example, by placing the sensor 224 in the region of the apical impulse.

[0307] The vibration sensor 224 can include an acoustic sensor, where the acoustic sensor is configured to detect vibrations from the cardiac or pulmonary (cardiopulmonary) system of the subject and provide an output signal in response to the detected vibrations of the target organ. For example, in some implementations, the vibration sensor 224 is capable of detecting vibrations generated in the trachea or lungs due to the airflow during respiration. The vibration sensor 224 can also include a multi-channel accelerometer, such as a three-channel accelerometer configured to sense movement along each of the three orthogonal axes so that patient movement / body position can be detected. The vibration sensor 224 can send information describing the cardiopulmonary vibration information or the patient's position / movement to the sensor interface 212 for subsequent analysis.

[0308] The tissue fluid monitor 226 can use radio frequency (RF)-based technology to evaluate the change in the cumulative fluid level over time. For example, the tissue fluid monitor 226 can be configured to measure the fluid content in the lungs (e.g., time-varying changes and absolute levels) to diagnose and subsequently observe pulmonary edema or pulmonary congestion in patients with heart failure. The tissue fluid monitor 226 can include one or more antennas, where the one or more antennas are configured to direct RF waves through the patient's tissue and measure the output RF signal in response to the waves that have passed through the tissue. In a specific implementation, the output RF signal includes a parameter indicating the fluid level in the patient's tissue. The tissue fluid monitor 226 can send information describing the tissue fluid level to the sensor interface 212 for subsequent analysis.

[0309] The sensor interface 212 can be coupled to any one or combination of sensing electrodes / other sensors to receive other patient data indicative of patient parameters. Once the sensor interface 212 has received data from the sensor, the data can be directed by the processor 118 to appropriate components within the medical device. For example, if cardiac data is collected by the cardiorespiratory vibration sensor 224 and sent to the sensor interface 212, the sensor interface 212 can send the data to the processor 118, where the processor 118 in turn relays the data to the cardiac event detector. Cardiac event data can also be stored on the data storage 204.

[0310] The alert manager 214 can be configured to manage an alert profile and notify one or more intended recipients of events designated as of interest to the intended recipients within the alert profile. These intended recipients can include external entities such as users (e.g., patients, physicians, other caregivers, patient care representatives, and other authorized monitors) and computer systems (e.g., monitoring systems or emergency systems). The alert manager 214 can be implemented using hardware or a combination of hardware and software. For example, in some examples, the alert manager 214 can be implemented as a software component stored within the data storage 204 and executed by the processor 118. In this example, the instructions included in the alert manager 214 can cause the processor 118 to configure the alert profile and notify the intended recipients according to the configured alert profile. In some examples, the alert manager 214 can be an application specific integrated circuit (ASIC) that is coupled to the processor 118 and configured to manage the alert profile and notify the intended recipients using the alerts specified within the alert profile. Thus, examples of the alert manager 214 are not limited to a particular hardware or software implementation.

[0311] In some implementations, processor 118 includes one or more processors (or one or more processor cores), where each of the one or more processors is configured to perform a series of instructions for obtaining operational data and / or controlling the operation of other components of the medical device. In some implementations, when performing a particular process (e.g., cardiac monitoring), processor 118 may be configured to make a determination based on specific logic based on the received input data, and is also configured to provide one or more outputs that can be used to control or otherwise notify other processors or circuits to which processor 118 is communicatively coupled of subsequent processes to be performed. Thus, processor 118 responds to a particular input stimulus in a particular manner and generates a corresponding output based on that input stimulus. In some exemplary cases, processor 118 may continue to perform a series of logical transitions, where various internal register states and / or other bit cell states, either internal or external to processor 118, may be set to a logical high or a logical low. Processor 118 may be configured to execute functions stored in software. For example, such software may be stored in a data storage coupled to processor 118 and is configured to cause processor 118 to continue to make a series of various logical decisions that result in the execution of the function. The various components described herein as being executable by processor 118 may be implemented in various forms of dedicated hardware, software, or a combination thereof. For example, the processor may be a digital signal processor (DSP), such as a 24-bit DSP processor. Processor 118 may be a multi-core processor, e.g., a processor having two or more processing cores. The processor may be an advanced RISC machine (ARM) processor, such as a 32-bit ARM processor or a 64-bit ARM processor. The processor may execute an embedded operating system and include services provided by the operating system that can be used for file system operations, display and audio generation, basic networking, firewalls, data encryption, and communication.

[0312] In an implementation, the therapy delivery circuit 130 includes or is operatively connected to circuit components configured to generate and provide therapy shocks. As previously described, the circuit components include, for example, resistors, one or more capacitors 135, relays and / or switches, a bridge such as an H-bridge 228 (e.g., an H-bridge circuit including a plurality of switches (e.g., insulated gate bipolar transistors (or IGBTs), silicon carbide field effect transistors (SiC FETs), metal oxide semiconductor field effect transistors (MOSFETs), silicon controlled rectifiers (SCRs), or other high-current switching devices, etc.)), voltage and / or current measurement elements, and other similar circuit components, where these similar circuit components are arranged and connected such that the circuit assembly works in cooperation with the therapy delivery circuit 130 and under the control of one or more processors (e.g., processor 118) to provide, for example, one or more pacing or defibrillation therapy pulses.

[0313] In an implementation, apparatuses 100, 800 further include an electrical energy source for storing and providing energy to the therapy delivery circuit 130, such as one or more capacitors 135. The one or more therapy pulses are defibrillation pulses of electrical energy, and one or more arrhythmias treatable include ventricular fibrillation and ventricular tachycardia. In an implementation, the one or more therapy pulses are biphasic exponential pulses. Such therapy pulses can be generated by charging one or more capacitors 135 and discharging the energy stored in the one or more capacitors 135 into the patient's body. For example, the therapy delivery circuit 130 can include one or more power converters for controlling the charging and discharging of the one or more capacitors 135. In some implementations, the discharge of energy from the one or more capacitors 135 can be controlled by, for example, an H-bridge for controlling the discharge of energy into the patient's body, where the H-bridge is, for example, the H-bridge circuit described in U.S. Patent No. 6,280,461, titled "PATIENT-WORN ENERGY DELIVERY APPARATUS," issued on August 28, 2001, and U.S. Patent No. 8,909,335, titled "METHOD AND APPARATUS FOR APPLYING A RECTILINEAR BIPHASIC POWER WAVEFORM TO A LOAD," issued on December 9, 2014, each of which is incorporated herein by reference in its entirety.

[0314] As Figure 17 shown in the embodiment of, the H-bridge 228 is electrically coupled to a capacitor bank 402 including four capacitors 135a-d, where the four capacitors 135a-d are charged in parallel during a preparation phase 227a and discharged in series during a treatment phase 227b. In some implementations, the capacitor bank 402 can include more or fewer than four capacitors 135. During the treatment phase 227b, the H-bridge 228 applies a therapy pulse, where the therapy pulse causes current to flow through the patient's torso 5 in a desired direction for a desired duration. The H-bridge 228 includes H-bridge switches 229a-d, where the H-bridge switches 229a-d are selectively opened and closed by switching transistors such as insulated gate bipolar transistors (IGBTs), silicon carbide field effect transistors (SiC FETs), metal oxide semiconductor field effect transistors (MOSFETs), silicon controlled rectifiers (SCRs), or other high-current switching devices. Switching a pair of transistors to a closed position (e.g., switches 229a and 229c) enables current to flow in a first direction during a first pulse segment P1. Opening switches 229a and 229c and closing switches 229b and 229d enables current to flow through the patient's torso 5 in a second pulse segment P2 in a direction opposite to the flow of the first pulse segment P1.

[0315] Although the subject matter contained herein has been described in detail for purposes of illustration, it should be understood that these details are for that purpose only and that the invention is not limited to the disclosed embodiments. On the contrary, the invention is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

[0316] Other examples are within the scope and spirit of the specification and claims. Additionally, some of the above functions may be implemented using software, hardware, firmware, hardwiring, or any combination thereof. The features implementing the functions may also be physically located in various positions, including being distributed such that portions of the functions are implemented at different physical locations.

Claims

1. A patient-wearable arrhythmia monitoring and treatment device, comprising: At least one component of a lighter component, the at least one component comprising: At least one treatment electrode configured to deliver a treatment pulse, at least one of the at least one treatment electrode being configured to be disposed on an attachment pad; At least one ECG sensing electrode configured to sense the patient's ECG signal, the at least one ECG sensing electrode being attached and coupled to the torso; and At least one component of a heavier component disposed on a wearable support, the at least one component being configured to minimize a layering force, and the at least one component comprising: A device controller, which includes: At least one capacitor configured to provide energy for the treatment pulse, At least one rechargeable battery for supplying power to the at least one capacitor, At least one processor, which includes a circuit board, and A user interface, Wherein, when the device is mounted on the patient, the center of mass of the components of the heavier component is below the center of volume of the components of the heavier component with respect to the vertical axis of the components of the heavier component.

2. The device according to claim 1, wherein, The device has a weight of 250 grams to 2500 grams.

3. The device according to claim 1, wherein The device has a weight of 250 grams to 750 grams.

4. The device according to claim 1, wherein The device has a weight of 500 grams to 1000 grams.

5. The apparatus according to claim 1, wherein The wearable support includes at least one of a belt, a girdle, a vest, a shirt, a sash, a strip, a strap, and a shoulder strap.

6. The device according to claim 1, wherein, The user interface includes at least one of one or more buttons and a touch screen.

7. The apparatus according to claim 1, wherein, The user interface includes at least one of one or more user input and output interface elements configured to enable interaction with the device by receiving input and / or providing output.

8. The apparatus according to claim 7, wherein The user interface is configured to present visual, audio, and / or tactile content.

9. The apparatus according to claim 1, wherein The at least one processor is configured to analyze at least one ECG signal of the patient and detect one or more treatable arrhythmias based on the analysis.

10. The device according to claim 1, wherein The device controller includes a housing, and the at least one rechargeable battery is configured to be removable from the housing.

11. The device according to claim 10, wherein, The device controller further includes an ECG acquisition circuit disposed in the housing.

12. The device according to claim 10 or 11, wherein The device controller further includes a treatment delivery circuit disposed in the housing, and the at least one processor is configured to cause the treatment delivery circuit to deliver the treatment pulse to the patient when one or more treatable arrhythmias are detected.

13. The device according to claim 10 or 11, wherein The treatment pulse includes at least one of a pacing pulse and a defibrillation pulse.

14. The apparatus according to claim 12, wherein, The one or more detected treatable arrhythmias include at least one of ventricular fibrillation and ventricular tachycardia.

15. The device according to claim 1, further comprising an attachment pad.

16. The device according to claim 15, wherein, The at least one treatment electrode is mounted on the attachment pad.

17. The device according to claim 16, wherein, The at least one treatment electrode adheres to the attachment pad.

18. The device according to claim 15, wherein, The at least one treatment electrode is disposed on the patient contact surface of the attachment pad.

19. The device according to claim 15, wherein The at least one treatment electrode is configured to extend through the attachment pad such that a skin contact surface of the at least one treatment electrode is coplanar with or protrudes from a patient contact surface of the attachment pad.

20. The apparatus according to any one of claims 15 to 19, wherein The at least one treatment electrode is removable from the attachment pad.

21. The apparatus according to claim 15, wherein, The at least one treatment electrode is permanently integrated with the attachment pad.

22. The apparatus according to claim 21, wherein, The at least one treatment electrode is formed within the attachment pad.

23. The apparatus according to any one of claims 15 to 19, further comprising: Another treatment electrode of the at least one treatment electrode, the another treatment electrode being configured to be disposed at a lower position on the torso compared to the at least one treatment electrode configured to be disposed on the attachment pad.

24. The device according to any one of claims 15 to 19, wherein, At least one ECG sensing electrode attached to the torso is integrated with the attachment pad.

25. The device according to any one of claims 15 to 19, wherein The at least one ECG sensing electrode is mounted on the attachment pad.

26. The apparatus according to claim 25, wherein, The at least one ECG sensing electrode adheres to the attachment pad.

27. The device according to any one of claims 15 to 19, wherein, The at least one ECG sensing electrode is disposed on a patient contact surface of the attachment pad.

28. The device according to any one of claims 15 to 19, wherein The at least one ECG sensing electrode is configured to extend through the attachment pad such that a skin contact surface of the at least one ECG sensing electrode is coplanar with or protrudes from a patient contact surface of the attachment pad.

29. The apparatus according to claim 24, wherein The at least one ECG sensing electrode is removable from the attachment pad.

30. The device according to any one of claims 15 to 19, wherein, The at least one ECG sensing electrode is permanently integrated with the attachment pad.

31. The device according to claim 30, wherein The at least one ECG sensing electrode is formed within the attachment pad.

32. The apparatus according to claim 30, wherein, The at least one ECG sensing electrode is screen printed onto the attachment pad.

33. The device according to any one of claims 15 to 19, wherein, The attachment pad includes a contoured pad.

34. The apparatus according to claim 33, wherein, The contoured pad includes a flexible material configured to conform to a unique curvature of a region of the patient's torso.

35. The apparatus according to claim 34, wherein, The flexible material includes at least one of a polyurethane film, neoprene, thermoformed plastic, injection molded rubber, injection molded plastic, silicone, and biocompatible synthetic rubber.

36. The apparatus according to any one of claims 15 to 19, further comprising: A breathable anisotropic conductive gel, which is disposed between the attachment pad and the at least one treatment electrode.

37. The apparatus according to claim 36, wherein, The breathable anisotropic conductive gel is configured to be disposed over an area that occupies less area than an entire area of the attachment pad.

38. The apparatus according to claim 37, wherein, One or more patches of the breathable anisotropic conductive gel are configured to be disposed between the at least one treatment electrode and the torso.

39. The apparatus according to any one of claims 15 to 19, further comprising: A breathable adhesive, which is disposed between the attachment pad and the torso, wherein a ratio of an area occupied by the breathable adhesive to an area occupied by the attachment pad ranges from 0.05 to 0.

25.

40. The device according to any one of claims 15 to 19, wherein, The attachment pad and components thereon include a cumulative weight ranging from 0.05 kg to 1.0 kg.

41. The apparatus according to any one of claims 15 to 19, wherein, The attachment pad includes a width ranging from 1 cm to 4 cm and a length ranging from 2 cm to 10 cm.

42. The apparatus according to claim 41, wherein, The attachment pad includes an area occupancy of approximately 100 square centimeters.

43. The apparatus according to claim 42, wherein, The attachment pad and the components thereon have a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied.

44. The apparatus according to claim 15, wherein The attachment pad further includes another attachment pad configured to be attached to the patient's torso, and another treatment electrode of the at least one treatment electrode is configured to be disposed on the another attachment pad.

45. The apparatus according to claim 44, wherein, The other attachment pad includes another ECG sensing electrode of the at least one ECG sensing electrode, and the another ECG sensing electrode of the at least one ECG sensing electrode is configured to be disposed on the other attachment pad.

46. The apparatus according to claim 44 or 45, wherein, The attachment pad and the other attachment pad include a shape formed of at least one of the following: rectangle, triangle, polygon, square, circle, ellipse, octagon, trefoil, trapezoid, and a polygon or non-polygon shape customized according to the patient's body shape and / or preference.

47. The device according to claim 44 or 45, wherein, The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

48. The device according to claim 44 or 45, wherein, The other attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

49. The apparatus according to claim 48, wherein, The other attachment pad includes an area occupancy of approximately 100 square centimeters.

50. The apparatus according to claim 49, wherein, The other attachment pad and the components thereon include a cumulative weight in the range of 0.05 kg to 1.0 kg.

51. The apparatus according to claim 50, wherein, The other attachment pad and the components thereon have a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied.

52. The device according to claim 1 further comprises an attachment pad, wherein the water vapor permeability of the attachment pad is 600 g / m 2 / day to 1400 g / m 2 / day.

53. The device according to claim 52, wherein, The attachment pad has an area occupancy of 100 square centimeters to 300 square centimeters.

54. The apparatus according to claim 53, wherein, The ratio of the weight of the patient-wearable arrhythmia monitoring and treatment device to the area occupied by the attachment pad ranges from 5 kg / m 2 to 100 kg / m 2 .

55. The apparatus according to any one of claims 52 to 54, further comprising: A breathable anisotropic conductive gel is disposed at a position close to the at least one treatment electrode between the attachment pad and the torso.

56. The device according to claim 55, wherein, The ratio of the area occupancy of the breathable anisotropic conductive gel to the area occupancy of the attachment pad ranges from 0.30 to 0.

75.

57. The apparatus according to claim 56, wherein, One or more patches of the breathable anisotropic conductive gel are configured to be disposed between each treatment electrode of the at least one treatment electrode and the torso.

58. The apparatus according to claim 57, further comprising: A breathable adhesive is disposed between the attachment pad and the torso, and the ratio of the area occupancy of the breathable adhesive to the area occupancy of the attachment pad ranges from 0.05 to 0.

25.

59. The device according to any one of claims 52 to 54, wherein, The device controller includes a housing, and an ECG acquisition circuit is disposed within the housing.

60. The device according to any one of claims 52 to 54, wherein, The device controller includes a housing, and the housing includes a treatment delivery circuit, and the at least one processor is configured to cause the treatment delivery circuit to deliver the treatment pulse to the patient when one or more treatable arrhythmias are detected.

61. The apparatus according to claim 60, wherein, The housing includes a plurality of separate outer shells, and one or more of the treatment delivery circuit, the ECG acquisition and conditioning circuit, the at least one processor, the at least one capacitor, and the at least one rechargeable battery are respectively within one of the plurality of separate outer shells.

62. The apparatus according to any one of claims 52 to 54, wherein The treatment pulse includes at least one of a pacing pulse and a defibrillation pulse.

63. The device according to any one of claims 52 to 54, wherein, The one or more detected treatable arrhythmias include at least one of ventricular fibrillation and ventricular tachycardia.

64. The apparatus according to any one of claims 52 to 54, wherein The at least one treatment electrode is mounted on the attachment pad.

65. The apparatus according to claim 64, wherein, The at least one treatment electrode adheres to the attachment pad.

66. The apparatus according to any one of claims 52 to 54, wherein, The at least one treatment electrode is disposed on the patient contact surface of the attachment pad.

67. The apparatus according to any one of claims 52 to 54, wherein The at least one treatment electrode is configured to extend through the attachment pad such that the skin contact surface of the at least one treatment electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

68. The apparatus according to any one of claims 52 to 54, wherein, The at least one treatment electrode can be removed from the attachment pad.

69. The device according to any one of claims 52 to 54, wherein, The at least one treatment electrode is permanently integrated with the attachment pad.

70. The apparatus according to claim 69, wherein, The at least one treatment electrode is formed within the attachment pad.

71. The device according to any one of claims 52 to 54, further comprising another treatment electrode among the at least one treatment electrodes, the another treatment electrode being configured to be disposed at a lower position on the torso compared to the at least one treatment electrode configured to be disposed on the attachment pad.

72. The apparatus according to any one of claims 52 to 54, wherein, At least one ECG sensing electrode attached to the torso is integrated with the attachment pad.

73. The apparatus according to any one of claims 52 to 54, wherein The at least one ECG sensing electrode is mounted on the attachment pad.

74. The apparatus according to claim 73, wherein, The at least one ECG sensing electrode adheres to the attachment pad.

75. The apparatus according to any one of claims 52 to 54, wherein, The at least one ECG sensing electrode is disposed on the patient contact surface of the attachment pad.

76. The apparatus according to any one of claims 52 to 54, wherein The at least one ECG sensing electrode is configured to extend through the attachment pad such that the skin contact surface of the at least one ECG sensing electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

77. The apparatus according to claim 72, wherein, The at least one ECG sensing electrode is removable from the attachment pad.

78. The apparatus according to any one of claims 52 to 54, wherein, The at least one ECG sensing electrode is permanently integrated with the attachment pad.

79. The apparatus according to claim 78, wherein, The at least one ECG sensing electrode is formed within the attachment pad.

80. The apparatus according to claim 78, wherein, The at least one ECG sensing electrode is screen printed onto the attachment pad.

81. The device according to any one of claims 52 to 54, wherein The attachment pad includes a contoured pad.

82. The apparatus according to claim 81, wherein, The contoured pad includes a flexible material configured to conform to the unique curvature of a region of the patient's torso.

83. The apparatus according to claim 82, wherein, The flexible material includes at least one of polyurethane film, neoprene, thermoformed plastic, injection molded rubber, injection molded plastic, silicone, and biocompatible synthetic rubber.

84. The device according to claim 81 further comprises: A breathable anisotropic conductive gel, which is disposed between the attachment pad and the at least one treatment electrode.

85. The apparatus according to claim 84, wherein, The breathable anisotropic conductive gel is configured to be disposed over an area that occupies a smaller area than the entire area of the attachment pad.

86. The device according to claim 85, wherein, One or more patches of the breathable anisotropic conductive gel are configured to be disposed between the at least one treatment electrode and the torso. The apparatus according to any one of claims 52 to 54, wherein The attachment pad and components thereon include a cumulative weight ranging from 0.05 kg to 1.0 kg.

88. The apparatus according to any one of claims 52 to 54, wherein, The attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

89. The apparatus according to claim 88, wherein The attachment pad includes an area occupancy of approximately 100 square centimeters.

90. The apparatus according to claim 89, wherein, The attachment pad and the components thereon have a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied.

91. The apparatus according to claim 52, wherein, The attachment pad further includes another attachment pad configured to be attached to the patient's torso, and another treatment electrode among the at least one treatment electrodes is configured to be disposed on the another attachment pad.

92. The apparatus according to claim 91, wherein, The another attachment pad includes another ECG sensing electrode among the at least one ECG sensing electrodes, and the another ECG sensing electrode among the at least one ECG sensing electrodes is configured to be disposed on the another attachment pad.

93. The device according to claim 91 or 92, wherein, The attachment pad and the another attachment pad include a shape constituted by at least one of the following: rectangle, triangle, polygon, square, circle, ellipse, octagon, trefoil, trapezoid, and a polygon or non-polygon shape customized for the patient's form and / or preference.

94. The device according to claim 91 or 92, wherein, The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

95. The apparatus according to claim 91 or 92, wherein, The other attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

96. The apparatus according to claim 95, wherein, The other attachment pad includes an area occupancy of approximately 100 square centimeters.

97. The apparatus according to claim 96, wherein, The other attachment pad and the components thereon include a cumulative weight in the range of 0.05 kg to 1.0 kg.

98. The apparatus according to claim 97, wherein, The other attachment pad and the components thereon have a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied.

99. The apparatus according to claim 1, wherein The device controller includes a housing, and the height of the housing is configured to be 1 cm to 5 cm.

100. The device according to claim 99, wherein, The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

101. The apparatus according to claim 99 or 100, wherein, The at least one capacitor includes a film capacitor having an envelope volume ranging from 10 cm 2 to 15 cm 2 in volume.

102. The apparatus according to claim 99 or 100, wherein, The at least one rechargeable battery includes a flat-pack battery, the flat-pack battery including a combined volume ranging from 1 cm 2 to 7 cm 2 in combination.

103. The apparatus according to claim 99 or 100, wherein The device controller further includes an ECG acquisition circuit disposed within the housing.

104. The apparatus according to claim 99 or 100, wherein The housing of the device controller further includes a treatment delivery circuit, and the at least one processor is configured to cause the treatment delivery circuit to deliver a treatment pulse to the patient when one or more treatable arrhythmias are detected.

105. The apparatus according to claim 104, wherein, The housing includes a plurality of separate enclosures, and one or more of the treatment delivery circuit, the ECG acquisition and conditioning circuit, the at least one processor, the at least one capacitor, and the at least one rechargeable battery are each within one of the plurality of separate enclosures.

106. The apparatus according to claim 99 or 100, wherein The treatment pulse includes at least one of a pacing pulse and a defibrillation pulse.

107. The device according to claim 99 or 100, wherein, One or more of the detected treatable arrhythmias include at least one of ventricular fibrillation and ventricular tachycardia.

108. The device according to claim 99 or 100, further comprising an attachment pad.

109. The apparatus according to claim 108, wherein, The at least one treatment electrode is mounted on the attachment pad. The apparatus according to claim 109, wherein, The at least one treatment electrode adheres to the attachment pad.

111. The apparatus according to claim 108, wherein, The at least one treatment electrode is disposed on the patient contact surface of the attachment pad.

112. The apparatus according to claim 108, wherein, The at least one treatment electrode is configured to extend through the attachment pad such that the skin contact surface of the at least one treatment electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

113. The apparatus according to claim 108, wherein, The at least one treatment electrode is removable from the attachment pad.

114. The apparatus according to claim 108, wherein, The at least one treatment electrode is permanently integrated with the attachment pad.

115. The apparatus according to claim 114, wherein, The at least one treatment electrode is formed within the attachment pad.

116. The device according to claim 108, further comprising another treatment electrode of the at least one treatment electrode, the another treatment electrode being configured to be disposed at a lower position on the torso compared to the at least one treatment electrode configured to be disposed on the attachment pad.

117. The apparatus according to claim 108, wherein, At least one ECG sensing electrode attached to the torso is integrated with the attachment pad.

118. The apparatus according to claim 108, wherein, The at least one ECG sensing electrode is mounted on the attachment pad.

119. The apparatus according to claim 118, wherein, The at least one ECG sensing electrode adheres to the attachment pad. The apparatus according to claim 108, wherein, The at least one ECG sensing electrode is disposed on the patient contact surface of the attachment pad.

121. The apparatus according to claim 108, wherein, The at least one ECG sensing electrode is configured to extend through the attachment pad such that a skin contact surface of the at least one ECG sensing electrode is coplanar with or protrudes from a patient contact surface of the attachment pad.

122. The apparatus according to claim 117, wherein, The at least one ECG sensing electrode is removable from the attachment pad. The device according to claim 108, wherein The at least one ECG sensing electrode is permanently integrated with the attachment pad.

124. The apparatus according to claim 123, wherein, The at least one ECG sensing electrode is formed within the attachment pad.

125. The device according to claim 123, wherein, The at least one ECG sensing electrode is screen printed onto the attachment pad.

126. The apparatus according to claim 108, wherein, The attachment pad includes a contoured pad.

127. The device according to claim 126, wherein, The contoured pad includes a flexible material configured to conform to a unique curvature of a region of the patient's torso.

128. The apparatus according to claim 127, wherein, The flexible material includes at least one of polyurethane film, neoprene, thermoformed plastic, injection molded rubber, injection molded plastic, silicone, and biocompatible synthetic rubber. The apparatus according to claim 108, further comprising: A breathable anisotropic conductive gel is disposed at a location proximate the at least one treatment electrode between the attachment pad and the torso.

130. The apparatus according to claim 129, wherein, The breathable anisotropic conductive gel is configured to be disposed over an area that occupies less area than an entire area of the attachment pad.

131. The apparatus according to claim 130, wherein, One or more patches of the breathable anisotropic conductive gel are configured to be disposed between the at least one treatment electrode and the torso.

132. The apparatus according to claim 129, further comprising: A breathable adhesive is disposed between the attachment pad and the torso, wherein a ratio of an area occupied by the breathable adhesive to an area occupied by the attachment pad ranges from 0.05 to 0.

25.

133. The apparatus according to claim 108, wherein, The attachment pad and components thereon include a cumulative weight in the range of 0.05 kg to 1.0 kg.

134. The apparatus according to claim 108, wherein, The attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

135. The apparatus according to claim 134, wherein, The attachment pad includes an area occupancy of approximately 100 square centimeters.

136. The apparatus according to claim 135, wherein, The attachment pad and the components thereon have a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied. The apparatus according to claim 108, wherein The attachment pad further includes another attachment pad configured to attach to the patient's torso, and another treatment electrode of the at least one treatment electrode is configured to be disposed on the another attachment pad.

138. The apparatus according to claim 137, wherein, The another attachment pad includes another ECG sensing electrode of the at least one ECG sensing electrode, and the another ECG sensing electrode of the at least one ECG sensing electrode is configured to be disposed on the another attachment pad.

139. The device according to claim 137, wherein, The attachment pad and the another attachment pad include a shape consisting of at least one of: rectangular, triangular, polygonal, square, circular, oval, octagonal, trefoil, trapezoidal, and a polygonal or non-polygonal shape customized to the patient's form and / or preference.

140. The apparatus according to claim 137, wherein, The patient-wearable arrhythmia monitoring and treatment device weighs within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

141. The apparatus according to claim 137, wherein, The another attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

142. The apparatus according to claim 141, wherein, The attachment pad includes an area occupancy of approximately 100 square centimeters.

143. The apparatus according to claim 142, wherein, The another attachment pad and components thereon include a cumulative weight in the range of 0.05 kg to 1.0 kg.

144. The device according to claim 143, wherein, The other attachment pad and the components thereon include a weight-to-area ratio of 5 kg / m 2 to 100 kg / m 2 of the occupied area of the region.

145. The apparatus according to claim 1, wherein, The device controller includes a housing, and a height of the housing is configured to be 1 cm to 4 cm.

146. The apparatus according to claim 145, wherein, The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

147. The device according to claim 145 or 146, wherein, The at least one capacitor includes a thin film capacitor having an envelope volume ranging from 10 cm 2 to 15 cm 2 in volume.

148. The device according to claim 145 or 146, wherein, The at least one rechargeable battery includes a flat-pack battery, the flat-pack battery including a combined volume ranging from 1 cm 2 to 7 cm 2 in combination volume.

149. The device according to claim 145 or 146, wherein, The device controller further includes an ECG acquisition circuit disposed within the housing. The apparatus according to claim 145 or 146, wherein, The housing of the device controller further includes a treatment delivery circuit, and the at least one processor is configured to cause the treatment delivery circuit to deliver a treatment pulse to the patient when one or more treatable arrhythmias are detected.

151. The apparatus according to claim 150, wherein, The housing includes a plurality of separate enclosures, and one or more of the treatment delivery circuit, the ECG acquisition and conditioning circuit, the at least one processor, the at least one capacitor, and the at least one rechargeable battery are each within one of the plurality of separate enclosures.

152. The device according to claim 145 or 146, wherein, The treatment pulse includes at least one of a pacing pulse and a defibrillation pulse.

153. The device according to claim 145 or 146, wherein, The one or more detected treatable arrhythmias include at least one of ventricular fibrillation and ventricular tachycardia.

154. The device according to claim 145 or 146, further comprising an attachment pad.

155. The apparatus according to claim 154, wherein, The at least one treatment electrode is mounted on the attachment pad.

156. The device according to claim 155, wherein, The at least one treatment electrode adheres to the attachment pad.

157. The apparatus according to claim 154, wherein, The at least one treatment electrode is disposed on the patient contact surface of the attachment pad.

158. The apparatus according to claim 154, wherein, The at least one treatment electrode is configured to extend through the attachment pad such that the skin contact surface of the at least one treatment electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

159. The device according to claim 154, wherein, The at least one treatment electrode is removable from the attachment pad. The apparatus according to claim 154, wherein, The at least one treatment electrode is permanently integrated with the attachment pad.

161. The apparatus according to claim 160, wherein, The at least one treatment electrode is formed within the attachment pad.

162. The apparatus according to claim 154, further comprising: Another treatment electrode of the at least one treatment electrode, the another treatment electrode being configured to be disposed at a lower position on the torso compared to the at least one treatment electrode configured to be disposed on the attachment pad. The apparatus according to claim 154, wherein, At least one ECG sensing electrode attached to the torso is integrated with the attachment pad.

164. The apparatus according to claim 154, wherein, The at least one ECG sensing electrode is mounted on the attachment pad.

165. The apparatus according to claim 164, wherein, The at least one ECG sensing electrode adheres to the attachment pad.

166. The apparatus according to claim 154, wherein, The at least one ECG sensing electrode is disposed on the patient contact surface of the attachment pad.

167. The apparatus according to claim 154, wherein, The at least one ECG sensing electrode is configured to extend through the attachment pad such that the skin contact surface of the at least one ECG sensing electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

168. The apparatus according to claim 154, wherein, The at least one ECG sensing electrode is removable from the attachment pad. The apparatus according to claim 154, wherein, The at least one ECG sensing electrode is permanently integrated with the attachment pad.

170. The apparatus according to claim 169, wherein, The at least one ECG sensing electrode is formed within the attachment pad.

171. The apparatus according to claim 169, wherein, The at least one ECG sensing electrode is screen printed onto the attachment pad. The apparatus according to claim 154, wherein, The attachment pad includes a contour pad.

173. The apparatus according to claim 172, wherein, The contour pad includes a flexible material configured to conform to the unique curvature of a region of the patient's torso.

174. The apparatus according to claim 173, wherein, The flexible material includes at least one of a polyurethane film, neoprene, thermoformed plastic, injection molded rubber, injection molded plastic, silicone resin, and biocompatible synthetic rubber. The apparatus according to claim 154, further comprising: A breathable anisotropic conductive gel is disposed at a position close to the at least one treatment electrode between the attachment pad and the torso.

176. The device according to claim 175, wherein, The breathable anisotropic conductive gel is configured to be disposed on an area that occupies a smaller area than the entire area of the attachment pad.

177. The apparatus according to claim 176, wherein, One or more patches of the breathable anisotropic conductive gel are configured to be disposed between the at least one treatment electrode and the torso. The apparatus according to claim 175, further comprising: A breathable adhesive is disposed between the attachment pad and the torso, wherein the ratio of the area occupied by the breathable adhesive to the area occupied by the attachment pad ranges from 0.05 to 0.

25. The apparatus according to claim 154, wherein, The attachment pad and the components thereon include a cumulative weight in the range of 0.05 kg to 1.0 kg. The apparatus according to claim 154, wherein, The attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

181. The device according to claim 180, wherein, The attachment pad includes an area occupancy of approximately 100 square centimeters.

182. The apparatus according to claim 181, wherein, The attachment pad and the components thereon include a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied.

183. The apparatus according to claim 154, wherein, The attachment pad further includes another attachment pad configured to be attached to the torso of the patient, and another treatment electrode of the at least one treatment electrode is configured to be disposed on the another attachment pad.

184. The device according to claim 183, wherein, The another attachment pad includes another ECG sensing electrode of the at least one ECG sensing electrode, and the another ECG sensing electrode of the at least one ECG sensing electrode is configured to be disposed on the another attachment pad.

185. The apparatus according to claim 183, wherein, The attachment pad and the another attachment pad include a shape composed of at least one of the following: rectangle, triangle, polygon, square, circle, ellipse, octagon, trefoil, trapezoid, and a polygon or non-polygon shape customized according to the shape and / or preference of the patient.

186. The apparatus according to claim 183, wherein, The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

187. The device according to claim 183, wherein, The another attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

188. The device according to claim 187, wherein, The attachment pad includes an area occupancy of approximately 100 square centimeters.

189. The apparatus according to claim 188, wherein, The another attachment pad and the components thereon include a cumulative weight in the range of 0.05 kg to 1.0 kg. The apparatus according to claim 189, wherein, The other attachment pad and the components thereon have a weight-to-area occupation ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied.

191. The device according to claim 1, wherein The device controller includes a housing, and the housing is configured to extend 1 cm to 3 cm. The apparatus according to claim 191, wherein, The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams.

193. The apparatus according to any one of claims 191 to 192, wherein, The at least one capacitor includes a thin film capacitor having an envelope volume ranging from 10 cm 2 to 15 cm 2 in size.

194. The device according to any one of claims 191 to 192, wherein, The at least one rechargeable battery includes a flat-pack battery, the flat-pack battery including a combined volume ranging from 1 cm 2 to 7 cm 2 in volume. The apparatus according to any one of claims 191 to 192, wherein The device controller further includes an ECG acquisition circuit disposed in the housing.

196. The apparatus according to any one of claims 191 to 192, wherein, The housing of the device controller further includes a treatment delivery circuit, and the at least one processor is configured to cause the treatment delivery circuit to deliver a treatment pulse to the patient when one or more treatable arrhythmias are detected.

197. The apparatus according to claim 196, wherein, The housing includes a plurality of separate outer housings, and one or more of the therapy delivery circuitry, the ECG acquisition and conditioning circuitry, the at least one processor, the at least one capacitor, and the at least one rechargeable battery are each within one of the plurality of separate outer housings.

198. The device according to any one of claims 191 to 192, wherein The therapy pulses include at least one of a pacing pulse and a defibrillation pulse.

199. The device according to any one of claims 191 to 192, wherein, One or more detectable arrhythmias to be treated include at least one of ventricular fibrillation and ventricular tachycardia.

200. The apparatus according to any one of claims 191 to 192, further comprising an attachment pad. The device according to claim 200, wherein, The at least one therapy electrode is mounted on the attachment pad. The device according to claim 201, wherein, The at least one therapy electrode adheres to the attachment pad. The apparatus according to claim 200, wherein, The at least one therapy electrode is disposed on the patient contact surface of the attachment pad. The device according to claim 200, wherein The at least one therapy electrode is configured to extend through the attachment pad such that a skin contact surface of the at least one therapy electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

205. The apparatus according to claim 200, wherein, The at least one therapy electrode is removable from the attachment pad. The device according to claim 200, wherein, The at least one therapy electrode is permanently integrated with the attachment pad. The apparatus according to claim 206, wherein The at least one therapy electrode is formed within the attachment pad. The apparatus according to claim 200, further comprising: Another therapy electrode of the at least one therapy electrode, the another therapy electrode being configured to be disposed at a lower position on the torso compared to the at least one therapy electrode configured to be disposed on the attachment pad. The apparatus according to claim 200, wherein At least one ECG sensing electrode attached to the torso is integrated with the attachment pad.

210. The apparatus according to claim 200, wherein, The at least one ECG sensing electrode is mounted on the attachment pad. The apparatus according to claim 210, wherein, The at least one ECG sensing electrode adheres to the attachment pad.

212. The apparatus according to claim 200, wherein, The at least one ECG sensing electrode is disposed on the patient contact surface of the attachment pad. The apparatus according to claim 200, wherein, The at least one ECG sensing electrode is configured to extend through the attachment pad such that a skin contact surface of the at least one ECG sensing electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

214. The apparatus according to claim 200, wherein, The at least one ECG sensing electrode is removable from the attachment pad.

215. The apparatus according to claim 200, wherein, The at least one ECG sensing electrode is permanently integrated with the attachment pad.

216. The apparatus according to claim 215, wherein, The at least one ECG sensing electrode is formed within the attachment pad.

217. The apparatus according to claim 215, wherein, The at least one ECG sensing electrode is screen printed onto the attachment pad.

218. The apparatus according to claim 200, wherein, The attachment pad includes a contoured pad. The apparatus according to claim 218, wherein The contoured pad includes a flexible material configured to conform to a unique curvature of a region of the patient's torso. The apparatus according to claim 219, wherein, The flexible material includes at least one of a polyurethane film, neoprene, thermoformed plastic, injection molded rubber, injection molded plastic, silicone, and biocompatible synthetic rubber. The apparatus according to claim 200, further comprising: A breathable anisotropic conductive gel, which is disposed at a position proximate to the at least one therapy electrode between the attachment pad and the torso. The apparatus according to claim 221, wherein, The breathable anisotropic conductive gel is configured to be disposed over an area that occupies a smaller area than the entire area of the attachment pad.

223. The device according to claim 222, wherein, One or more patches of the breathable anisotropic conductive gel are configured to be disposed between the at least one therapy electrode and the torso.

224. The apparatus according to claim 221, further comprising: A breathable adhesive is disposed between the adhesive pad and the torso, wherein a ratio of an area occupied by the breathable adhesive to an area occupied by the adhesive pad ranges from 0.05 to 0.

25. The device according to claim 200, wherein, The adhesive pad and components thereon include a cumulative weight ranging from 0.05 kg to 1.0 kg.

226. The apparatus according to claim 200, wherein, The adhesive pad includes a width ranging from 1 cm to 4 cm and a length ranging from 2 cm to 10 cm.

227. The apparatus according to claim 226, wherein, The adhesive pad includes an area occupied of approximately 100 square centimeters.

228. The apparatus according to claim 227, wherein, The attachment pad and the components thereon have a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied. The apparatus according to claim 200, wherein, The adhesive pad further includes another adhesive pad configured to be adhesively coupled to the patient's torso, and another treatment electrode of the at least one treatment electrode is configured to be disposed on the another adhesive pad. The apparatus according to claim 229, wherein, The another adhesive pad includes another ECG sensing electrode of the at least one ECG sensing electrode, and the another ECG sensing electrode of the at least one ECG sensing electrode is configured to be disposed on the another adhesive pad.

231. The apparatus according to claim 229, wherein, The adhesive pad and the another adhesive pad include a shape formed of at least one of the following: rectangular, triangular, polygonal, square, circular, oval, octagonal, trefoil, trapezoidal, and a polygonal or non-polygonal shape customized to the patient's profile and / or preference. The device according to claim 229, wherein The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams. The apparatus according to claim 229, wherein, The another adhesive pad includes a width ranging from 1 cm to 4 cm and a length ranging from 2 cm to 10 cm.

234. The apparatus according to claim 233, wherein, The adhesive pad includes an area occupied of approximately 100 square centimeters. The apparatus according to claim 234, wherein, The another adhesive pad and components thereon include a cumulative weight ranging from 0.05 kg to 1.0 kg. The apparatus according to claim 235, wherein, The other attachment pad and the components thereon include a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the weight and the area occupied by the region.

237. The apparatus according to claim 1, wherein, The device controller includes a housing and an adhesive pad, and the housing extends from a surface of the adhesive pad. The apparatus according to claim 237, wherein, The at least one processor is disposed within the housing and is configured to: Analyze at least one ECG signal of the patient and detect one or more treatable arrhythmias based on the analysis. The device according to claim 237 or 238, wherein, The at least one rechargeable battery is disposed within the housing, and the at least one rechargeable battery is configured to be removable from the housing. The apparatus according to claim 237 or 238, wherein, The device controller further includes an ECG acquisition circuit disposed within the housing.

241. The device according to claim 237 or 238, wherein, The device controller further includes a treatment delivery circuit disposed within the housing, and the at least one processor is configured to cause the treatment delivery circuit to deliver treatment pulses to the patient when one or more treatable arrhythmias are detected.

242. The apparatus according to claim 241, wherein, The housing includes a plurality of separate enclosures, and one or more of the treatment delivery circuit, the ECG acquisition and conditioning circuit, the at least one processor, the at least one capacitor, and the at least one rechargeable battery are each within one of the plurality of separate enclosures.

243. The apparatus according to claim 241, wherein, The attachment pad, the housing, the therapy delivery circuitry, the ECG acquisition and conditioning circuitry, the at least one processor, the at least one capacitor, and the at least one rechargeable battery are assembled as a component of the heavier components such that when the device is mounted on the patient, the center of mass is below the center of volume.

244. The device according to claim 243, wherein, The at least one capacitor includes a thin film capacitor having an envelope volume in the range of 10 cm 2 to 15 cm 2 and the at least one rechargeable battery includes a flat-pack battery, the flat-pack battery including a combined volume in the range of 1 cm 2 to 7 cm 2 of combined volume. The device according to claim 243, wherein, The ratio of the lateral distance between the center of mass and the patient-facing surface of the attachment pad divided by the lateral distance between the center of volume and the patient-facing surface of the attachment pad is in the range of 10% to 70%.

246. The device according to claim 237 or 238, wherein, The therapy pulses include at least one of a pacing pulse and a defibrillation pulse.

247. The device according to claim 237 or 238, wherein One or more detectable arrhythmias to be treated include at least one of ventricular fibrillation and ventricular tachycardia. The apparatus according to claim 237 or 238, wherein The at least one therapy electrode is mounted on the attachment pad.

249. The apparatus according to claim 248, wherein, The at least one therapy electrode adheres to the attachment pad. The device according to claim 237 or 238, wherein, The at least one therapy electrode is disposed on the patient contact surface of the attachment pad. The apparatus according to claim 237 or 238, wherein The at least one therapy electrode is configured to extend through the attachment pad such that the skin contact surface of the at least one therapy electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

252. The apparatus according to claim 248, wherein, The at least one therapy electrode is removable from the attachment pad. The device according to claim 237 or 238, wherein The at least one therapy electrode is permanently integrated with the attachment pad. The apparatus according to claim 253, wherein, The at least one therapy electrode is formed within the attachment pad. The apparatus according to claim 248, further comprising: Another therapy electrode of the at least one therapy electrode is configured to be disposed at a lower position on the torso compared to the at least one therapy electrode configured to be disposed on the attachment pad. The apparatus according to claim 237 or 238, wherein At least one ECG sensing electrode attached to the torso is integrated with the attachment pad. The device according to claim 237 or 238, wherein, The at least one ECG sensing electrode is mounted on the attachment pad.

258. The apparatus according to claim 257, wherein, The at least one ECG sensing electrode adheres to the attachment pad. The device according to claim 237 or 238, wherein, The at least one ECG sensing electrode is disposed on the patient contact surface of the attachment pad. The device according to claim 237 or 238, wherein The at least one ECG sensing electrode is configured to extend through the attachment pad such that the skin contact surface of the at least one ECG sensing electrode is coplanar with or protrudes from the patient contact surface of the attachment pad.

261. The apparatus according to claim 256, wherein, The at least one ECG sensing electrode is removable from the attachment pad. The apparatus according to claim 256, wherein The at least one ECG sensing electrode is permanently integrated with the attachment pad.

263. The apparatus according to claim 262, wherein, The at least one ECG sensing electrode is formed within the attachment pad.

264. The apparatus according to claim 262, wherein, The at least one ECG sensing electrode is screen printed onto the attachment pad. The apparatus according to claim 237 or 238, wherein The attachment pad includes a contoured pad.

266. The apparatus according to claim 265, wherein, The contoured pad includes a flexible material configured to conform to the unique curvature of a region of the patient's torso.

267. The apparatus according to claim 266, wherein, The flexible material includes at least one of a polyurethane film, neoprene, thermoformed plastic, injection molded rubber, injection molded plastic, silicone, and biocompatible synthetic rubber.

268. The apparatus according to claim 265, further comprising: A breathable anisotropic conductive gel disposed at a location between the attachment pad and the torso proximate to the at least one therapy electrode.

269. The apparatus according to claim 268, wherein, The breathable anisotropic conductive gel is configured to be disposed over an area that occupies less area than the entire area of the attachment pad. The apparatus according to claim 269, wherein, One or more patches of the breathable anisotropic conductive gel are configured to be disposed between the at least one treatment electrode and the torso. The apparatus according to claim 268, further comprising: A breathable adhesive, which is disposed between the attachment pad and the torso, wherein a ratio of an area occupied by the breathable adhesive to an area occupied by the attachment pad ranges from 0.05 to 0.

25. The device according to claim 237 or 238, wherein The attachment pad includes a width of 2 cm to 18 cm and a length of 12 cm to 36 cm. The apparatus according to claim 272, wherein, The attachment pad includes an area occupied ranging from 200 to 300 square centimeters. The apparatus according to claim 273, wherein The attachment pad and components thereon include a cumulative weight ranging from 0.25 kg to 10 kg. The apparatus according to claim 274, wherein, The attachment pad and the components thereon include a weight-to-area occupancy ratio of 10 kg / m 2 to 100 kg / m 2 of the area occupied. The apparatus according to claim 237 or 238, wherein The attachment pad further includes another attachment pad configured to be attached to the torso of the patient, and another treatment electrode of the at least one treatment electrode is configured to be disposed on the another attachment pad. The device according to claim 276, wherein The another attachment pad includes another ECG sensing electrode of the at least one ECG sensing electrode, and the another ECG sensing electrode of the at least one ECG sensing electrode is configured to be disposed on the another attachment pad. The apparatus according to claim 276, wherein The attachment pad and the another attachment pad include a shape formed of at least one of the following: rectangular, triangular, polygonal, square, circular, oval, octagonal, three-leafed, trapezoidal, and a polygonal or non-polygonal shape customized to the shape and / or preference of the patient.

279. The apparatus according to claim 276, wherein, The weight of the patient-wearable arrhythmia monitoring and treatment device is within at least one of the following ranges: 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams. The apparatus according to claim 276, wherein The another attachment pad includes a width of 1 cm to 4 cm and a length of 2 cm to 10 cm.

281. The apparatus according to claim 280, wherein, The attachment pad includes an area occupied of approximately 100 square centimeters. The apparatus according to claim 281, wherein The another attachment pad and components thereon include a cumulative weight ranging from 0.05 kg to 1.0 kg. The apparatus according to claim 282, wherein, The other attachment pad and the components thereon have a weight-to-area occupancy ratio of 5 kg / m 2 to 100 kg / m 2 of the area occupied.

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