Patient-worn arrhythmia monitoring and treatment device

Abstract

The present invention relates to a patient-worn arrhythmia monitoring and treatment device. The patient-worn arrhythmia monitoring and treatment device weighing 250 grams to 2500 grams includes: at least one outer pad configured to be attached to the patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the at least one outer pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the at least one outer pad. At least one housing configured to form a watertight seal with the at least one outer pad extends no more than 5 cm from the outer pad. A processor disposed within the housing is connected 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 the one or more treatable arrhythmias are detected.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

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

[0003] In one example, a patient-worn arrhythmia monitoring and treatment device includes: at least one outer pad configured to be attached to the patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the outer pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the outer pad. At least one housing is configured to form a watertight seal with the outer pad, and the at least one housing extends no more than 5 cm from the surface of the outer pad. ECG acquisition and conditioning circuitry may be disposed in 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 in 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 an example, a processor is disposed in 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-worn monitoring and treatment device has a weight of 250 grams to 2500 grams.

[0004] Implementations of the apparatus may include one or more of the following features.

[0005] In an example, at least one shell is configured to extend 1 cm to 5 cm from a surface of at least one form pad.

[0006] In an example, at least one shell is configured to extend 1 cm to 4 cm from a surface of at least one form pad.

[0007] In an example, at least one shell is configured to extend 1 cm to 3 cm from a surface of at least one form pad.

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

[0009] 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.

[0010] In an example, the 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, the one or more treatable arrhythmias include tachycardia and bradycardia.

[0011] In an example, the contour pad is configured to be attached to the patient for a short duration. In an example, the short duration is a duration of at least one of about 24 hours, about 48 hours, about 4 days, about 1 week, and about 2 weeks. In an example, the patient-worn 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.

[0012] In an example, the contour pad includes a flexible material configured to conform the contour pad to a curvature of an area of ​​the torso. In an example, the contour pad includes a plurality of sections separated by a flexible material to conform the contour pad to a curvature of an area of ​​the torso. In an example, at least one housing includes a plurality of housings, wherein each of the plurality of housings is disposed on a corresponding 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 supply.

[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 supply. 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 supply may each be within a separate housing.

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

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

[0016] In an example, the rotational torque at the center of mass 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 a range of about 10 cm 2 Up to 15cm 2 At least one capacitor has a capacity of 140 microfarads and a rated voltage of at least 1600V.

[0018] In an example, at least one power source included in the electronic device includes one or more batteries, wherein the batteries have a combined envelope volume of no more than 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-packed lithium polymer batteries. In an example, the one or more batteries may have a range of about 1 cm 2 Up to 7cm 2 combined volume.

[0019] In an example, an apparatus 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.

[0020] In an example, the apparatus includes a passive thermal management system disposed within at least one housing. The passive thermal management system may include a removably inserted cooling pack. The passive thermal management system may include a metal heat sink layer disposed on one or more of the plurality of ECG sensing electrodes and / or the plurality of therapy electrodes. The passive thermal management system may include one or more through holes extending between an interface between the contour pad and the patient's torso and an outer surface of the at least one housing.

[0021] In an example, at least one contour pad includes a second pad configured to be attached to a torso of a patient. In an example, the second pad is configured to be contoured. A wireless transceiver may be integrated with the second pad to be configured to communicate with a therapy delivery circuit, and a second therapy electrode of the plurality of therapy electrodes may be integrated with the second pad and wirelessly communicate with the therapy delivery circuit.

[0022] In an example, at least one contour pad includes a second pad configured to be attached to the patient's torso. In an example, the second pad is configured to be contoured. A second therapy electrode of the plurality of therapy electrodes can be integrated with the second pad and in wired communication with the therapy delivery circuit.

[0023] In an example, at least one contour pad includes a third pad configured to be attached to a torso of a patient. In an example, the third pad is configured to be contoured. The third pad may include a transceiver integrated with the third pad, wherein the transceiver is configured to communicate with a therapy delivery circuit. A third therapy electrode of the plurality of therapy electrodes may be integrated with the third pad and in wired communication with the therapy delivery circuit. In an example, the third pad is configured to be attached to a torso adjacent to an atrium.

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

[0025] In an example, the ratio of the weight of the patient-worn monitoring and treatment device to the area footprint of the at least one contour pad is in the range of about 10 kg / m 2 Up to 100kg / m 2 .

[0026] In an example, the apparatus includes an air permeable anisotropic conductive gel disposed between at least one contour pad and the torso and configured to be placed along at least one of the plurality of therapy electrodes. In an example, a ratio of an area footprint of the air permeable anisotropic conductive gel to an area footprint of the at least one contour pad is in a range of about 0.30 to 0.75. A air permeable adhesive may be disposed between the at least one contour pad and the torso, wherein a ratio of an area footprint of the air permeable adhesive to an area footprint of the at least one contour pad is in a range of about 0.05 to 0.25.

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

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

[0029] Patients with heart failure experience symptoms caused by a weak or damaged heart that contracts inefficiently and cannot effectively pump oxygenated blood 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 arrhythmias and ventricular arrhythmias are common in patients with heart failure. One of the most lethal arrhythmias is ventricular fibrillation, which occurs when normal regular electrical impulses are replaced by irregular and rapid impulses, causing the heart muscle to stop contracting normally. Since there is no perceptible warning of the impending fibrillation for the victim, death often occurs before necessary medical assistance can arrive. Other arrhythmias can include a too slow heart rate known as bradycardia or a too 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 (cessation of all electrical activity in the heart), cause the heart to provide inadequate levels of blood flow to the brain and other vital organs required to sustain life. It is generally useful to monitor patients with heart failure to assess symptoms of heart failure at an early stage and to provide interventional treatment as quickly as possible.

[0032] Wearable cardiac monitoring and treatment devices are provided to monitor such arrhythmias and provide treatment when life-threatening arrhythmias are detected. Patients wear such devices continuously to provide constant protection. As such, the devices need to be designed to be comfortable and easy to use. Summary of the invention

[0033] In one example, a patient-worn arrhythmia monitoring and treatment device includes: at least one outer pad configured to be attached to the patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the outer pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the outer pad. At least one housing is configured to form a watertight seal with the outer pad, and the at least one housing extends no more than 5 cm from the surface of the outer pad. ECG acquisition and conditioning circuitry may be disposed in 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 in 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 an example, a processor is disposed in 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-worn monitoring and treatment device has a weight of 250 grams to 2500 grams.

[0034] A patient-wearable arrhythmia monitoring and treatment device comprises: an anterior attachment connection pad configured to be attached to the anterior upper region of the patient's torso, wherein the anterior attachment connection pad has a weight in the range of 0.05 to 1.0 kg; a posterior attachment connection pad configured to be attached to the posterior region of the torso, wherein the posterior attachment connection pad has a weight in the range of 0.05 to 1.0 kg; a therapy electrode pair configured to contact the patient's torso and deliver one or more therapy pulses, one therapy electrode in the therapy electrode pair being integrated in the anterior attachment connection pad, and another therapy electrode in the therapy electrode pair being integrated in the posterior attachment connection pad; a plurality of ECG sensing electrodes, It is integrated with the front attachment connection pad and the rear attachment connection pad and is configured to contact the patient's torso; a device controller, which is in wired communication with the front attachment connection pad and the rear attachment connection pad, and the device controller includes: a shell; an ECG acquisition and conditioning circuit, which is arranged in the shell and electrically connected to the multiple ECG sensing electrodes to provide at least one ECG signal of the patient; a treatment delivery circuit, which is arranged in the shell and configured to deliver one or more treatment pulses to the patient through electrical connection with the treatment electrode pair; a processor, which is arranged in the shell and can communicate with the ECG acquisition and conditioning circuit and the treatment delivery circuit.

[0035] Implementations of the apparatus may include one or more of the following features.

[0036] In an example, at least one shell is configured to extend 1 cm to 5 cm from a surface of at least one form pad.

[0037] In an example, at least one shell is configured to extend 1 cm to 4 cm from a surface of at least one form pad.

[0038] In an example, at least one shell is configured to extend 1 cm to 3 cm from a surface of at least one form pad.

[0039] In an example, the 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, the 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, the one or more treatable arrhythmias include tachycardia and bradycardia.

[0042] In an example, the contour pad is configured to be attached to the patient for a short duration. In an example, the short duration is a duration of at least one of about 24 hours, about 48 hours, about 4 days, about 1 week, and about 2 weeks. In an example, the patient-worn 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 contour pad includes a flexible material configured to conform the contour pad to a curvature of an area of ​​the torso. In an example, the contour pad includes a plurality of sections separated by a flexible material to conform the contour pad to a curvature of an area of ​​the torso. In an example, at least one housing includes a plurality of housings, wherein each of the plurality of housings is disposed on a corresponding 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 supply.

[0044] 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 supply. 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 supply may each be within a separate housing.

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

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

[0047] In an example, the rotational torque at the center of mass 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 a range of about 10 cm 2 Up to 15cm 2 At least one capacitor has a capacity of 140 microfarads and a rated voltage of at least 1600V.

[0049] In an example, at least one power source included in the electronic device includes one or more batteries, wherein the batteries have a combined envelope volume of no more than 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-packed lithium polymer batteries. In an example, the one or more batteries may have a range of about 1 cm 2 Up to 7cm 2 combined volume.

[0050] In an example, an apparatus 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.

[0051] In an example, the apparatus includes a passive thermal management system disposed within at least one housing. The passive thermal management system may include a removably inserted cooling pack. The passive thermal management system may include a metal heat sink layer disposed on one or more of the plurality of ECG sensing electrodes and / or the plurality of therapy electrodes. The passive thermal management system may include one or more through holes extending between an interface between the contour pad and the patient's torso and an outer surface of the at least one housing.

[0052] In an example, at least one contour pad includes a second pad configured to be attached to a torso of a patient. In an example, the second pad is configured to be contoured. A wireless transceiver may be integrated with the second pad to be configured to communicate with a therapy delivery circuit, and a second therapy electrode of the plurality of therapy electrodes may be integrated with the second pad and wirelessly communicate with the therapy delivery circuit.

[0053] In an example, at least one contour pad includes a second pad configured to be attached to the patient's torso. In an example, the second pad is configured to be contoured. A second therapy electrode of the plurality of therapy electrodes can be integrated with the second pad and in wired communication with the therapy delivery circuit.

[0054] In an example, at least one contour pad includes a third pad configured to be attached to a torso of a patient. In an example, the third pad is configured to be contoured. The third pad may include a transceiver integrated with the third pad, wherein the transceiver is configured to communicate with a therapy delivery circuit. A third therapy electrode of the plurality of therapy electrodes may be integrated with the third pad and in wired communication with the therapy delivery circuit. In an example, the third pad is configured to be attached to a torso adjacent to an atrium.

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

[0056] In an example, the ratio of the weight of the patient-worn monitoring and treatment device to the area footprint of the at least one contour pad is in the range of about 10 kg / m 2 Up to 100kg / m 2 .

[0057] In an example, the apparatus includes an air permeable anisotropic conductive gel disposed between at least one contour pad and the torso and configured to be placed along at least one of the plurality of therapy electrodes. In an example, a ratio of an area footprint of the air permeable anisotropic conductive gel to an area footprint of the at least one contour pad is in a range of about 0.30 to 0.75. A air permeable adhesive may be disposed between the at least one contour pad and the torso, wherein a ratio of an area footprint of the air permeable adhesive to an area footprint of the at least one contour pad is in a range of about 0.05 to 0.25.

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

[0059] In one example, a patient-worn arrhythmia monitoring and treatment device includes: at least one outer pad configured to be attached to the patient's torso; a plurality of treatment electrodes, at least one of which is integrated with the outer pad; and a plurality of ECG sensing electrodes, at least one of which is integrated with the outer pad. At least one housing is configured to form a watertight seal with the outer pad, and the at least one housing extends from the surface of the outer pad by about 1 cm to 5 cm. ECG acquisition and conditioning circuitry may be disposed in 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 in 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 an example, a processor is disposed in 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-worn monitoring and treatment device has a weight of 250 grams to 2500 grams.

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

[0061] In an example, the delivery of at least one defibrillation pulse includes 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, the 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, the one or more treatable arrhythmias include tachycardia and bradycardia.

[0064] In an example, the contour pad is configured to be attached to the patient for a short duration. In an example, the short duration is a duration of at least one of about 24 hours, about 48 hours, about 4 days, about 1 week, and about 2 weeks. In an example, the patient-worn monitoring and treatment device weighs 250 grams to 1250 grams. In an example, the patient-worn monitoring and treatment device weighs 500 grams to 1000 grams. In an example, the patient-worn monitoring and treatment device weighs 750 grams to 900 grams.

[0065] In an example, the contour pad includes a flexible material configured to conform the contour pad to a curvature of an area of ​​the torso. In an example, the contour pad includes a plurality of sections separated by a flexible material to conform the contour pad to a curvature of an area of ​​the torso. In an example, at least one housing includes a plurality of housings, wherein each of the plurality of housings is disposed on a corresponding 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 supply.

[0066] 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 supply. 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 supply may each be within a separate housing.

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

[0068] In an example, the ratio of the distance between the center of mass and the lower edge line of at least one shell 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 center of mass and the lower edge line of at least one shell 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 center of mass and the lower edge line of at least one shell 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 center of mass 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 center of mass 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 center of mass 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 center of mass 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 a range of about 10 cm 2 Up to 15cm 2 At least one capacitor has a capacity of 140 microfarads and a rated voltage of at least 1600V.

[0071] In an example, at least one power source included in the electronic device includes one or more batteries, wherein the batteries have a combined envelope volume of no more than 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-packed lithium polymer batteries. In an example, the one or more batteries may have a range of about 1 cm 2 Up to 7cm 2 combined volume.

[0072] In an example, an apparatus 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 apparatus includes a passive thermal management system disposed within at least one housing. The passive thermal management system may include a removably inserted cooling pack. The passive thermal management system may include a metal heat sink layer disposed on one or more of the plurality of ECG sensing electrodes and / or the plurality of therapy electrodes. The passive thermal management system may include one or more through holes extending between an interface between the contour pad and the patient's torso and an outer surface of the at least one housing.

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

[0075] In an example, the at least one contour pad includes a second contour pad configured to be attachably coupled to a torso of a patient.A second therapy electrode of the plurality of therapy electrodes may be integrated with the second contour pad and in wired communication with the therapy delivery circuit.

[0076] In an example, at least one of the contour pads includes a third contour pad configured to be attached to the patient's torso. The third contour pad may include a transceiver integrated with the third contour pad, wherein the transceiver is configured to communicate with the therapy delivery circuit. A third therapy electrode of the plurality of therapy electrodes may be integrated with the third contour pad and in wired communication with the therapy delivery circuit. In an example, the third contour pad is configured to be attached to the torso adjacent to the atrium.

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

[0078] In an example, the ratio of the weight of the patient-worn monitoring and treatment device to the area footprint of the at least one contour pad is in the range of about 10 kg / m 2 Up to 100kg / m 2 .

[0079] In an example, the apparatus includes an air permeable anisotropic conductive gel disposed between at least one contour pad and the torso and configured to be placed along at least one of the plurality of therapy electrodes. In an example, a ratio of an area footprint of the air permeable anisotropic conductive gel to an area footprint of the at least one contour pad is in a range of about 0.30 to 0.75. A air permeable adhesive may be disposed between the at least one contour pad and the torso, wherein a ratio of an area footprint of the air permeable adhesive to an area footprint of the at least one contour pad is in a range of about 0.05 to 0.25.

[0080] In an example, at least one outer shape pad includes one or more receptacles for receiving at least one shell in a watertight fit. The one or more receptacles may include a sealing lip. The sealing lip may include a resilient waterproof material and engage with an upper surface of the at least one shell. At least one shell may include a peripheral flange, and the sealing lip receives the peripheral flange.

[0081] In one example, a patient-worn arrhythmia monitoring and treatment device includes: an anterior attachment pad configured to be attached to an anterior upper region of a patient's torso, wherein the anterior attachment pad has a weight in the range of 0.05 to 1.0 kg; and a posterior attachment pad electrically connected to the anterior attachment pad. The posterior attachment pad may be configured to be attached to a posterior region of the torso, wherein the posterior attachment pad has a weight in the range of 0.05 to 1.0 kg. The device includes a wearable support, wherein the wearable support is integrated with the anterior attachment pad and the posterior attachment pad and at least partially tracks a path from the anterior upper region of the torso, over the patient's shoulder, and terminating at 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 pad and the posterior attachment pad. The device includes a therapy electrode pair, wherein the therapy electrode pair is configured to contact the patient's torso and deliver one or more therapy pulses. One of the treatment electrode pairs can be integrated in the front attachment pad, and the other of the treatment electrode pair can be integrated in the rear attachment pad. Multiple ECG sensing electrodes can be integrated with the front attachment pad and the rear attachment pad, and are configured to contact the patient's torso. The first housing can be configured to form a watertight seal with the front attachment pad, and the second housing can be configured to form a watertight seal with the rear attachment pad. ECG acquisition and conditioning circuits can be arranged in the first housing or the second housing and electrically connected to multiple ECG sensing electrodes to provide at least one ECG signal of the patient, and treatment delivery circuits can be arranged in the first housing or the second housing and configured to deliver one or more treatment pulses to the patient through electrical connection with the treatment electrode pair. The processor can be arranged in the first housing or the second housing and connected 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 can 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 is coupled to the therapy delivery circuit and the therapy electrode pair.

[0082] Implementations of the apparatus 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 a shoulder of the patient.

[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 may be made of a non-adhesive stretchable fabric. In an example, the non-adhesive stretchable fabric includes a conductive thread in communication with a front attachment pad and a rear attachment pad. In an example, the tensile strength of the shoulder harness is greater than at least 10% of a load applied by at least one of the front attachment pad and the rear attachment pad, and not more than 10 times the load applied by at least one of the front attachment pad and the rear attachment 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 adapts to the contour of the patient's body. The shoulder strap can be designed into a shape that matches the contour 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 attachment coupling pad and the rear attachment coupling pad. The shoulder harness may be designed to match the contour 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 than either of the front attachment coupling pad and the rear attachment coupling pad.

[0088] In an example, the shoulder harness further comprises at least one length adjuster configured to tension the shoulder harness. The at least one length adjuster may be at least one of a draw cord, a belly strap, a lockable elastic draw cord, a zipper and spring loaded toggle stop, a ratchet strap, an adjustable buckle, an extendable and removable hook and loop strap, a tie strap, a snap, and a button.

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

[0090] In an example, the shoulder straps do not expand or contract more than 1 inch with an applied force of 22 lbf.

[0091] In an example, the shoulder strap does not expand or contract more than 2 inches with an applied force of 30 lbf.

[0092] In an example, with an applied force of 30 lbf, the shoulder straps expand and contract 0.5 to 3 inches.

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

[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-term duration. The long-term duration can be a duration including and 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-term duration includes and 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 side attachment pad has a range of about 500 to 1200 g / m 2 / day MVTR, and the area of ​​the front side attachment coupling pad occupies 25 to 50% of the area with a range of about 250 to 500 g / m 2 MVTR / day.

[0096] In an example, 50 to 75% of the area occupied by the rear side attachment pad has a range of about 500 to 1200 g / m 2 / day MVTR, and 25 to 50% of the area occupied by the area of ​​the rear side attachment coupling pad has a 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 footprint of 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 is in a range of 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 is in a range of about 0.05 to 0.25.

[0100] In one example, a patient-wearable arrhythmia monitoring and treatment device includes: a contour pad configured to be attached to the 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 an example, the device includes at least one housing configured to form a watertight seal with the contour pad. In an example, the device includes an ECG acquisition and conditioning circuit disposed in 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 in at least one housing and configured to deliver one or more treatment pulses to the patient through the plurality of treatment electrodes. In an example, a processor is disposed in at least one 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, 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] Implementations of the apparatus may include one or more of the following features.

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

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

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

[0105] In an 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 an example, the contour pad is configured to be attached to the patient for a short duration. The short duration can 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-worn arrhythmia monitoring and treatment device includes: a first contour pad configured to be attached to the patient's torso to support a first component; a second contour pad coupled to the first contour pad, the second contour pad configured to be attached to the patient's torso to support a second component; and a wearable support integrated with at least one of the first attachment pad and the second attachment 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 an example, the first component includes: a plurality of therapy electrodes, at least one of which is integrated with the contour pad; a plurality of ECG sensing electrodes, at least one of which is integrated with the contour pad; at least one housing configured to form a watertight seal with the contour pad, the at least one housing extending from a surface of the contour pad by about 1 cm to 5 cm; ECG acquisition and conditioning circuitry disposed within at least one housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal of the patient; therapy delivery circuitry disposed within at least one housing and configured to deliver one or more therapy pulses to the patient through the plurality of therapy electrodes; and a processor disposed within at least one housing and coupled to the therapy delivery circuitry. In an 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 therapy delivery circuit to deliver at least one defibrillation pulse to the patient when the one or more treatable arrhythmias are detected.

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

[0109] In an example, the patient-worn monitoring and treatment device may weigh between 500 grams and 10 kilograms. The patient-worn monitoring and treatment device may weigh between 1000 grams and 8000 grams. The patient-worn monitoring and treatment device may weigh between 2500 grams and 6000 grams. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

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

[0114] Figure 3C Depicted Figure 3B A side cross-sectional view of a portion 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 and an adhesive coupling portion for wired communication is depicted.

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

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

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

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

[0120] Figure 5B A schematic diagram of an exemplary adhesively coupled wearable cardiac monitoring and treatment device including a first component mounted on the posterior side and a second component mounted on the anterior side is depicted.

[0121] Figure 5C Depicted Figure 5A and 5B Schematic diagram of an example of an adhesively coupled portion of a wearable cardiac monitoring and treatment device.

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

[0123] Figure 7 An exemplary schematic diagram of the electrical connection components of a wearable cardiac monitoring and treatment device is depicted.

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

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

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

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

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

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

[0130] Figure 10D An exemplary schematic diagram of a skin-interfacing surface of an exemplary wearable cardiac monitoring and treatment device including a continuous attachment ring and a conductive gel patch including a plurality of perforations is depicted.

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

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

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

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

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

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

[0137] Figure 13C An example of an attachment-coupled wearable cardiac monitoring and treatment device comprising three attachment pads and a wearable support is depicted.

[0138] Figure 14 An exemplary system including a user interface and an attachably coupled wearable cardiac monitoring and treatment device is depicted.

[0139] Figure 15 is a schematic diagram of an exemplary method of using an adhesive to connect a wearable cardiac monitoring and treatment device.

[0140] Figure 16 A schematic diagram of an embodiment of an adhesively coupled wearable cardiac monitoring and treatment device is depicted.

[0141] Figure 17 A schematic diagram of an embodiment of an adhesively coupled wearable cardiac monitoring and treatment device electrical component is depicted. DETAILED DESCRIPTION

[0142] The present invention relates to a patient-wearable, attached, and connected cardiac monitoring and treatment device for detecting one or more treatable arrhythmias based on physiological signals from the 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 asystole). The wearable medical device disclosed herein is attached to the patient and monitors the patient's physiological condition (e.g., cardiac signals, respiratory parameters, and patient activity), and delivers potentially life-saving treatment to the patient. Embodiments of the patient-wearable, attached, and connected 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 a garment or wearable support and an attached, connected component.

[0143] As described in U.S. Patent No. 8,983,597, issued on March 17, 2015, and entitled “MEDICAL MONITORING AND TREATMENT DEVICE WITH EXTERNAL PACING” (hereinafter “the '597 patent,” which is incorporated herein by reference in its entirety), an exemplary patient-worn cardiac monitoring and treatment device may be, for example, an ambulatory medical device capable of and designed to move with the patient as the patient goes about his or her daily routine. For example, 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 back side can be integrated and / or adhered to the patient's skin by an attachment patch 15 that surrounds some or all of the treatment electrode 14b. The patch can provide an attachment boundary for attaching the one or more treatment electrodes 14b covered and / or integrated to the patient's torso 5. The heavier components disposed on the wearable support (belt 50) may include a medical device controller 20, wherein 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. In this example, the treatment electrode 14a placed on the front side can also be integrated or attached to the belt 50. By providing support in the form of, for example, a belt 50, the device 10B can keep 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 manner, the device 10B thereby encourages the patient to comply with the prescribed wearing duration by avoiding discomfort associated with the weight.

[0147] Such compliance may 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. Figures 3A to 3C As shown, in the embodiment, the device 10C includes a first component 102 fixed to the lower left front position of the torso 5 by a belt 50, and a second component 107 connected by a wire to the first component 102. The second component 107 can be attached and fixed to the upper back torso position, generally between the patient's shoulder blades. Figure 3B and 3C As shown, the first component may include a first outer pad 105 and one or more treatment electrodes 110 and / or a plurality of ECG sensing electrodes 115 integrated with the outer pad 105. The first component may 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 outer pad 105. In a specific implementation, the housing 120 may extend from the surface of the outer pad 105 by about 1 cm to 5 cm. The housing 120 may include at least ECG acquisition and conditioning circuitry, treatment delivery circuitry, a processor 118, one or more capacitors 135, and one or more batteries 140. In an implementation, the second component 107 may include only relatively light components (e.g., a second component weighing about 10 to 500 grams) compared to the first component 102, such as one or more treatment electrodes 110 and / or one or more ECG sensing electrodes 115.

[0148] In embodiments such as Figure 4AIn the embodiment of the present invention (see the embodiment of the present invention to the embodiment of the present invention), the first component and the second component can both be placed on the front 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. Figure 4A , 4C As shown in FIG. 4D , in an embodiment, the device 10D includes a first component 102 and a second component 107 connected by wire. Optionally, as Figure 4B As shown, in an embodiment, for example, when the device is used to monitor a cardiac condition, the device 10D, 10F, 10G includes a first component 102 and a second component 107 for wireless communication. In some examples, the wire 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 wire 116 to the first component 102 and the second component 107.

[0149] exist Figure 4A In embodiments of FIG. 1 to B, the wearable support may be a belt 50 or a waist belt configured to support the first component 102 and relatively heavy components included therein (e.g., a first component weighing approximately 500 grams to 10 kg). In an implementation, the belt 50 may include a tensioner 52 for tightening and / or loosening the belt 50 about the patient's torso 5. In an implementation, the tensioner 52 may also fasten the belt 50 about the patient's torso 5, such as a hook and loop fastener system or a ratchet strap and buckle assembly. In an embodiment, the first component 102 may be disposed on or integrated with the wearable support. For example, in Figure 4A In B, the first component 102 can form a link portion of the belt 50 so that the sensor integrated with the outer pad 105 is in contact with the patient's skin. In some embodiments, the first component 102 and / or the second component 107 can be covered by a wearable support. For example, Figure 4C As shown by the dashed line in D, the support garment can be a band 51 located in the lower torso area, or a strap 53 extending diagonally across the torso 5 and covering the first component 102 and / or the second component 107. In an embodiment, the band 51 and the strap 53 may include a tensioner 52 configured to tighten the wearable support about the torso 5, add compression to the first component 102 and / or the second component 107, and help maintain the first component 102 and the second component 107 in contact with the torso 5.

[0150] As previously described, in some examples, 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, second component 107 may include one or more components that are heavier than first component 102 (e.g., a second component weighing approximately 500 grams to 10 kg), such as one or more capacitors, batteries, and / or therapy circuits. Additional wearable support (such as Figure 4D The strap 53 shown, for example, can help maintain a relatively heavy second assembly 107 comprising heavier components on the upper region of the torso 5. Providing such an additional wearable support helps prevent the second assembly 107 from pulling on the patient's skin while adherently attached.

[0151] Later on, it will target Figures 5A to 5C In an example described in further detail, the apparatus 100 may include an adhesively attached first component 102 and an adhesively attached second component 107 without requiring a wearable support and / or a clothing-based support.

[0152] The attachment coupling device described herein can be configured for short-term or long-term use. For example, a short-term device can be prescribed for a patient within the duration from discharge or outpatient clinical interview to subsequent medical appointments. In this regard, the short-term wearing duration can include a time period of less than one hour (e.g., 10 minutes to about 60 minutes in a medical office waiting room), or 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, the short-term wearing duration can, 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 to 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 period of time may be greater than the short-term duration described above. For example, the long-term wear duration may include a period of about 1 month to about 3 months, or about 3 months to about 6 months. Thus, advantages of the configurations herein include providing physicians and caregivers with additional diagnostic and therapeutic options for treating the patients under their care.

[0154] Since these devices need to be continuously operated and worn by the patient to whom they are prescribed, advantages realized herein include the use of comfortable, non-irritating, biocompatible adhesives and materials of construction and features designed to enhance patient compliance. Such compliance-inducing design features include, for example, device ergonomics, weight of components and / or distribution of weight, overall device shape, and unobtrusive appearance when worn under clothing, etc.

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

[0156] Sudden cardiac arrest or other arrhythmia conditions may occur at any time and with little warning. Each patient is encouraged to comply with the device use guidelines, including wearing the device at all times during the prescribed duration (including in the shower or when sleeping). In order to improve the patient's compliance with these guidelines, the device described herein is lightweight, comfortable and compact so that they can be hidden under the patient's clothes. In addition, the device is configured to allow uncomplicated application and adhesion to the skin of the patient's body. In some implementations described herein, the device includes 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 lasting adhesion, easy application and removal, and inconspicuous appearance.

[0157] The device here is configured to be attached to the patient's trunk in short-term and long-term durations. The device includes a biocompatible adhesive, such as a pressure-sensitive adhesive with viscosity, adhesion and bonding properties, which is suitable for use with a medical device applied to the skin in short-term and long-term durations. These pressure-sensitive adhesives can include polymers with high initial viscosity to adhere to the skin, such as acrylic resins, rubbers, silicones and polyurethanes. These pressure-sensitive adhesives also maintain adhesion during showers or when the patient sweats. The adhesive can also be removed without leaving uncomfortable residues. For example, this adhesive can be a rubber mixed with a tackifier.

[0158] In any of the examples previously presented or described above, the device herein includes a low skin irritation adhesive. In embodiments, the device can be continuously worn by a 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) without the patient experiencing significant skin irritation. For example, the measure of skin irritation can be based on one or more skin irritation ratings set forth in Table C.1 of Appendix C of American National Standard ANSI / AAMI / ISO 10993-10:2010, wherein Table C.1 is reproduced herein in its entirety:

[0159] Table C.1 – Human skin irritation test, grading scale

[0160]

[0161] Table 1

[0162] A skin irritation rating 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 / ISO10993-10:2010, wherein 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 without skin irritation. The treatment site is inspected for signs of skin irritation, and the response is scored immediately after the patch is removed and at time intervals of (1±0.1) hours to (2±1) hours, (24±2) hours, (48±2) hours, and (72±2) hours after the patch is removed. In another implementation, the patient can wear the attachment device for a duration of (24±2) hours as indicated, and if the patient's skin does not show a reaction at the end of the duration, the attachment device is rated as a skin irritation rating of "zero".

[0163] In addition to the biocompatible adhesive, such short-term wearable device and long-term wearable device include a plurality of sensing electrodes, wherein these sensing electrodes are disposed on the patient's body and are configured to monitor cardiac signals such as electrocardiogram (ECG) signals. Therefore, before delivering treatment to the patient, the device determines the appropriate treatment for the patient based on the detected cardiac signals and / or other physiological parameters. Then, the device 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 therapeutic electrodes, at least one of which is integrated with the outer shape pad described in detail herein. A plurality of therapeutic electrodes are disposed on the patient's body and are configured to deliver therapeutic shocks. In some implementations, the device may also be configured to allow the patient to report his / her symptoms, including one or more missed 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 a wearable medical device.

[0164] In an implementation, the device includes one or more outer pads configured to be attached to the 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 contained in at least one housing configured to form a watertight seal with the outer pad. In some implementations, multiple housings may be provided on multiple sections of the outer pad. Each of the multiple housings may include different parts of the device circuit, such as ECG acquisition and conditioning circuits, treatment delivery circuits, energy storage units, processors, and power supplies. The energy storage unit is configured to store energy of at least one treatment pulse (e.g., a defibrillation pulse). The treatment delivery circuit is configured to cause the delivery of at least one treatment pulse via multiple treatment electrodes. In an implementation, the energy storage unit is electrically connected to multiple treatment electrodes (e.g., via printed circuit board traces, flexible circuits, or direct contact connections).

[0165] As described above, the implementation of the wearable medical device described herein can be used continuously by the patient during a short-term or long-term wearing duration. This continuous use can be substantially continuous or almost continuous in nature. During substantially continuous or almost continuous use, the wearable medical device can be used continuously except for sporadic time periods when the use is temporarily stopped (for example, when the patient re-equips a new and / or different device, when the battery is charged and / or replaced, etc.). However, this substantially continuous or almost continuous use as described herein can still be considered as continuous use. For example, continuous use can include continuously wearing or attaching the wearable medical device to the patient. In implementation, one or more electrodes are continuously attached to the patient during the monitoring time period and 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 use can include continuously monitoring the patient while the patient is wearing the device to obtain heart-related information (for example, electrocardiogram (ECG) information, including arrhythmia information, heart vibration, etc.) and / or non-cardiac information (for example, blood oxygen, the patient's body temperature, glucose level, tissue fluid level and / or lung vibration). For example, the wearable medical device can perform its continuous monitoring and / or recording at periodic or non-periodic 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 specified by a caregiver). Alternatively or in addition, the monitoring and / or recording during the intervals or times can be triggered by user actions or other events.

[0166] As described above, the wearable medical device can be configured to monitor other physiological parameters of the patient in addition to heart-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 tissue fluid (e.g., using a radio frequency transmitter and sensor), etc.

[0167] As will be described in detail below, Figure 5A C to C depict an exemplary monitoring and treatment device 100 that is retained on a patient's torso solely by an adhesive connection, and Figure 4A 1000 to 1000, 12A to 12B, 13A to 13C and 14 relate to an adherently coupled monitoring and treatment device 10D to 1000, 800A to 1000 including one or more wearable supports.

[0168] Figure 5AAn exemplary attached monitoring and treatment device 100 is shown in FIG. 1A to B. As shown, the device 100 is external, mobile, and attached to a patient. The medical device 100 is an external or non-invasive medical device that is, for example, located outside of the patient's body and is configured to provide percutaneous treatment to the body. The device 100 is, for example, a mobile medical device that is capable of and designed to move with the patient as the patient goes about his or her daily routine. The device 100 includes a first component 102, wherein the first component 102 includes a contour pad 105 configured to be attached to the patient's torso 5. In an implementation, multiple treatment electrodes and / or multiple ECG sensing electrodes can be integrated with the contour pad. In addition, as shown in FIG. Figure 6 As shown, the device 100 may include a housing 120 configured to form a watertight seal with the outer shape pad 105. In a specific implementation, the housing 120 may extend from the surface of the outer shape 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 ECG signal of the patient 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, the device 100 includes components having specific physical dimensions, weights, and functional attributes, wherein the combination of these components enables the total weight of the device 100 to be in the range of 250 grams to 2500 grams, while enabling the device 100 to be used as a monitoring and treatment device.

[0169] In the example, Figure 5A As shown in FIG. 1B and as will be described in further detail later, the first component 102 can be coupled to a second component 107 including a second different profile pad 109. For example, Figure 5A As shown, the second component 107 can be configured to be located at the upper right front position of the patient's torso 5. In other examples, such as Figure 5B As shown, the second component 107 can be configured to be located at a rear upper position of the patient's torso 5, such as a rear upper right position. Figure 5A and 5B The implementation of depicts a first component 102 having a substantially rectangular shape and a second component having a triangular shape, but the shapes of the first component and the second component can be any shape, including, for example, polygonal, square, circular, elliptical, octagonal, trilobal, trapezoidal, or polygonal or non-polygonal shapes customized to the patient's appearance and / or preferences. In an implementation, the second component 107 may include one or more of the components and / or materials described for the implementation of the first component 102, such as for Figures 6 to 8 The components and materials described are used to implement the invention.

[0170] The contour pad 105 is configured to be attached to the patient's torso 5. The contour pad 105 is formed of a flexible material and is configured to conform to the unique curvature of a region of the patient's torso 5. Additionally or alternatively, as Figure 3C As schematically shown in , the contour pad 105 can include multiple segments separated by flexible material to conform the contour pad 105 to the curvature of the area of ​​the torso 5 to which it is applied. The contour pad 105 can 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 front portion of the torso, the upper back portion of the torso, or one or more sides of the torso, etc.). In an implementation that includes a contour pad 105 formed of conformable materials and / or segments, the contour pad can accommodate various body shapes and sizes and shape changes associated with the movement of the patient's body. For example, the contour pad 105 can accommodate the telescoping, expansion, and contraction of the lower region of the torso 5 when the patient is standing, walking, sitting, or lying prone.

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

[0172] In an example, the patient can apply the contour pad 105 in a unique preferred orientation and position. By consulting with the 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 wearing duration. For example, at the beginning of the prescribed wearing duration, the caregiver or physician can position the pad 105 in a first position on the patient's torso 5. At least one of the patient, the caregiver, and the physician can reposition the contour pad 105 to a second position that overlaps, is tangential to, is adjacent to, or is away from the first position, but is within a prescribed torso region. For example, the first component 102 can initially be placed in the front lower area of ​​the torso along the line of the bottom of the patient's rib cage to seek comfort and minimize the appearance of any bulge in clothing worn on the device 100. The patient, caregiver, or physician can, for example, remove the contour pad 105 and re-adhere an inch of the contour pad 105 in any lateral and / or rotational direction. This provides the patient's skin with a chance to breathe and regenerate (e.g., fall off) and reduces the effects of skin irritation that may be caused by the adhesive. By maintaining the contoured pad in the area of ​​initial application, the first component 102 of the device 100 continues to operate in conjunction with the second component 107, where the second component 107 is positioned relative to the first component and with particular attention paid to the shock wave vector traveling between the components 102, 107 and through the heart.

[0173] In an embodiment, the contour pad 105 is designed to be durable, flexible, and breathable to allow sweat to evaporate. In an embodiment, the contour pad 105 is non-irritating when in contact with the skin as described above with respect to the skin irritation classification 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 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 may include or be composed of polyurethane, such as TEGADERM polyurethane film (available from 3M), OPSITE polyurethane film (available from Smith & Nephew, London, United Kingdom), or HYDROFILM polyurethane film (available from Hartman USA, Rock Hill, SC), etc. In other examples, the contour pad 105 may include or be composed 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 contour pad 105 is a laminate pad including 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 electronic components disposed therein. In an example, the contour pad 105 is perforated to facilitate evaporation of water vapor from the skin.

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

[0175] Figure 6 A first component 102 is depicted as part of a device 100. The device 100 includes a profile pad 105 and a housing 120 configured to form a watertight seal with the profile pad 105. Figure 6 , the device 100 includes at least one of a plurality of therapy electrodes 110 integrated with the outer shape pad 105. Exemplary therapy 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. The device 100 may also include at least one of a plurality of ECG sensors 115 integrated with the outer shape pad 105. Figure 6 In the implementation of the present invention, two ECG sensors 115a and 115b are shown as being integrated with the outer shape pad 105. In the example, the ECG sensor 115 monitors the ECG information of the patient. As described in detail in subsequent examples, the ECG sensor 115 can be a non-polarizable ECG electrode (e.g., a clinical grade Ag / AgCl electrode) or a polarizable electrode (e.g., a electrode having a structure such as Ta) configured to measure changes in electrophysiological phenomena of the patient to measure the ECG information of the patient. 2 O 5An exemplary ECG sensor 115 includes a tantalum pentoxide electrode as described, for example, in U.S. Pat. No. 6,253,099, entitled “Cardiac Monitoring Electrode Apparatus and Method,” the entire contents of which are incorporated herein by reference. In implementation, the ECG sensor 115 may be made of a core plastic or metal substrate element coated with a thick film polymer compound filled with a conductive Ag / Ag / Cl metal filler.

[0176] In some examples, such as Figure 6 As shown, at least one therapy electrode 110 and one or more ECG sensors 115 are formed within the form pad 105 such that the skin contacting surface of each component is coplanar with or protrudes from the patient contacting surface of the form pad 105. In an example, the therapy electrode 110 and the ECG sensor 115 are disposed on the patient contacting surface of the form pad 105. In some implementations, the therapy electrode 114 and the ECG sensor 115 are metal plates (e.g., stainless steel) or substrates formed as a permanent part of the device 100. The metal plate or substrate can be adhered to the form pad 105, for example, by a polyurethane adhesive or a polymer dispersion adhesive (such as a polyvinyl acetate (PVAc)-based adhesive or other such adhesive). In an example, the plurality of ECG sensors 115 are a plurality of dry ECG sensing electrodes. In an example, the ECG sensor 115 is a flexible dry surface electrode, such as a conductive polymer-coated nanoparticle-loaded polysiloxane electrode or the like mounted to the form pad 105. In some examples, ECG sensor 115 is a flexible dry surface electrode, such as a silver-coated conductive polymer foam soft electrode mounted to outer pad 105. In an example, ECG sensor 115 is screen printed onto outer pad 105 with a metallic ink (such as a silver-based ink). In an implementation, therapy electrodes 110 each have a conductive surface suitable for placement adjacent to the patient's skin. In some implementations, therapy electrode 110 may include an impedance reducing material and / or mechanism as described subsequently.

[0177] In an implementation, at least one therapy electrode 110 and at least one ECG sensor 115 are manufactured as an integral component of topographic pad 105. For example, therapy electrode 110 and / or ECG sensor 115 may be formed from the warp and weft of a fabric that forms at least one layer of topographic pad 105. In an implementation, therapy electrode 110 and / or 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 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 the patient. In an example, the ECG acquisition and conditioning circuit 125 includes a signal processor configured to amplify, filter, and digitize the cardiac signal before sending the cardiac signal to the processor 118 of the device 100. Thus, the ECG sensor 115 may send information describing the ECG signal to the sensor interface via the ECG acquisition and conditioning circuit 125 for subsequent analysis.

[0179] In the example, Figure 6 As shown, the therapy delivery circuit 130 is disposed in at least one housing 120 and is configured to deliver one or more therapy pulses to the patient through the plurality of therapy electrodes 110 of the device 100. In an example, the processor 118 is disposed in at least one housing 120 and is coupled to the therapy delivery circuit 130. The processor 118 is configured to analyze the ECG signal 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 various circuits and hardware components of first assembly 102 (e.g., processor 118, therapy delivery circuit 130, therapy electrode 110, ECG acquisition and conditioning circuit 125, ECG sensing electrode 115, etc.). Figure 7 As shown in the schematic diagram of , printed circuit board 145 can route signals between therapy delivery circuit 130 and therapy electrode 110 and ECG acquisition and conditioning circuit 125 and ECG sensing electrode 115. In implementations of form factor pad 105 that include multiple sections separated by flexible material, one or more circuit boards 145 can be distributed between some or all of the multiple sections and can be electrically interconnected by one or more wiring and / or flexible traces or cables in examples.

[0181] Continuing with the description of an implementation of the device 100 of FIGS. 5-6 , in an implementation, the therapy delivery circuit 130 is operably connected to one or more capacitors 135. In an implementation, the one or more capacitors 135 are a plurality of capacitors (e.g., three, four, or more capacitors) that can be switched into series connection during the discharge of a defibrillation pulse. For example, four capacitors of approximately 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 approximately 5 to 30 seconds depending on the amount of energy to be delivered to the patient. Additional implementations of capacitor properties and arrangements within the device 100 are provided herein in subsequent sections.

[0182] 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., a charging direction). The amplitude and width of the two phases of the energy waveform can be automatically adjusted to deliver a predetermined amount of energy.

[0183] In implementations, the therapy delivery circuit 130 includes or is operably connected to circuit components configured to generate and deliver a therapeutic shock. As will be described in detail later with respect to implementations of the device 100, the circuit components include, for example, resistors, one or more capacitors 135, relays and / or switches, bridges such as H-bridges (e.g., H-bridge circuits 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, wherein 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., processor 118) to, for example, provide one or more pacing or defibrillation therapy pulses.

[0184] As previously described, at least one housing 120 forms a watertight seal with the outer gasket 105. Figure 6 In the example of the present invention, various circuits and hardware components (e.g., processor 118, therapy delivery circuit 130, therapy electrode 110, ECG acquisition and conditioning circuit 125, ECG sensing electrode 115, PCB 145, etc.) are located in a compartment defined by at least one housing 120 and form pad 105. 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 device 100 from shorting or corrosion of moisture-sensitive electronics, such as when a patient wears the device in the shower. These features can also protect from the ingress of other liquids and solid particles.

[0185] In an example, the outer shell 105 includes one or more receptacles for receiving at least one shell 120 in a watertight fit. Figure 9AIn the example of the embodiment of the present invention, one or more receptacles include a sealing lip 106, and the sealing lip 106 can be engaged with the upper surface of at least one housing 120. In the implementation, the sealing lip 106 includes an elastic waterproof material. For example, one or more receptacles may 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. For example, the sealing lip 106 and the outer shape pad 105 can be injection molded into an integral structure. In the example, at least one housing 120 may also include a peripheral flange 121, and the sealing lip 106 fixedly receives the peripheral flange 121 in a watertight fitting structure. In the example, one or more of the housings 120 or multiple housings are removable and / or replaceable. When the housing 120 is pulled away from the outer shape pad 105, the sealing lip 106 is retracted, 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 multiple housings in a sealed structure again. In other implementations, the housing 120 may be heat welded to the form pad 105. In other implementations, the housing 120 may be locked to the form pad 105 and held in compression by a spring loaded clamp. In some or all implementations, the housing and / or the form pad may include a deformable waterproof grommet therebetween, such as an elastomeric silicone seal around the perimeter of the interface between the housing and the form pad 105, or the like.

[0186] In addition to forming a watertight seal with the outer shell, 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 in the 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., capacitors 135, therapy delivery circuitry 130, processor 118) is housed in one or more water resistant housings 120 or casings.

[0187] Exemplary protection from liquid ingress by the water resistant housing 120 according to one or more scenarios as set forth in Table 2:

[0188]

[0189]

[0190] Table 2

[0191] In some implementations, at least one housing 120 is water resistant and has a predetermined ingress protection rating in compliance with one or more rating levels set forth in IEC standard 60529. The liquid ingress protection rating may be one or more of any level (e.g., levels 3 to 9) for which a rating compliance test is specified in the standard. For example, to have a liquid ingress protection rating level of 6, at least one housing 120 of the device 100 will protect against the ingress of water provided by a powerful water jet. The powerful water jet test requires that the housing 120 be sprayed from all possible directions with a stream of water from a test nozzle having a diameter of 12.5 mm. The water is sprayed at a volume of 100 liters per minute (+ / - 5%), 1 minute per square meter for a minimum of 3 minutes, such that the core of the water stream is a circle with a diameter of approximately 120 mm at a distance of 2.5 meters from the nozzle. For example, in order to have a rating level of 7, water cannot enter when the housing 120 is fully immersed in water at a depth of between 0.15m and 1m, so that the lowest point of the housing 120 less than 850mm in height is located 1000mm below the water surface, and the highest point of the housing less than 850mm in height is located 150mm below the water surface. The housing 120 is immersed for a duration of up to 30 minutes, and the water temperature does not differ from the temperature of the housing by more than 5K. Table 3 provides the rating levels and tests for liquid ingress protection according to IEC standard 60529:

[0192]

[0193]

[0194]

[0195] Table 3

[0196] For example, the housing 120 may be constructed to be water resistant and therefore tested for ingress protection according to the IEC 60529 standard. For example, one or more housings 120 of the device may be configured to have a rating level 7, thereby protecting against immersion in water up to 1 meter deep for up to 30 minutes. This enables the patient to wear the device 100 in a bathtub or shower for uninterrupted continuous use. In an implementation, one or more housings 120 of the device 100 may be multi-coded, including two or more levels. For example, the housing 120 of the device 100 may maintain a liquid ingress protection level 7 to protect against the effects of temporary immersion, and a liquid ingress protection level 5 to protect against the effects of water jets.

[0197] As previously described, at least one housing 120 shields one or more of the therapy delivery circuitry, the ECG acquisition and conditioning circuitry 125, the processor 118, the at least one capacitor 135, and the at least one power source (e.g., battery 140) from environmental influences. The housing 120 covers and / or surrounds the hardware components therein, thereby protecting them from wear and tear and protecting the patient from contact with high voltage components. For example, the housing 120 protects the components from liquid ingress during a patient shower.

[0198] As previously described, with respect to the contour pad 105, the housing 120 is non-conductive, water vapor permeable, and substantially liquid impermeable or waterproof. The housing 120 may include or be formed 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), etc. In other examples, the contour pad 105 may include 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, etc.). In an example, the housing 120 may include a non-woven laminate material, such as at least one of spandex, nylon-spandex, and nylon-LYCRA, etc. In an example, the housing 120 may include a thermoformed layer coated with a waterproof or hydrophobic layer, such as a non-woven polyurethane fabric material layer, etc. One or more steam release valves or through holes may be formed into the housing or provided therethrough to discharge sweat out of the housing 120. In other examples, housing 120 may include or be formed from a fabric having a biocompatible surface treatment, thereby making the fabric water resistant and / or waterproof. For example, the fabric may be enhanced by dipping in a fluorocarbon bath such as Teflon or fluorinated decyl polyhedral oligomeric silsesquioxane (F-POSS).

[0199] In addition to waterproof and / or water resistant properties, the volumetric dimensions of the attachment coupling device 100 are designed to be comfortable for the patient. In an example, the patient wearable monitoring and treatment device 100 has a weight of 250 grams to 2500 grams. For example, the device 100 can have a weight ranging from 250 grams to 1250 grams, 500 grams to 1000 grams, and 750 grams to 900 grams. Keeping the weight within this exemplary range improves patient comfort. Because the device 100 adheres to the skin of the patient's torso 5, the example of the device 100 includes weight distribution and attachment features for encouraging patient compliance by improving comfort and maintaining attachment throughout the prescribed duration.

[0200] In an implementation where the outer shape pad 105 includes multiple sections, the housing 120 may include multiple housings, and one or more of the therapy delivery circuit 130, the ECG acquisition and conditioning circuit 125, the processor 118, the at least one capacitor 135, and the at least one power source (e.g., a battery 140) may each be located in a separate housing disposed on a corresponding one of the multiple sections. By distributing components within separate housings, the device 100 may be modular in implementation. Such modularity allows one or more components to be removed for repair or replacement. For example, the housing of the battery may be releasably sealed around a rechargeable battery so that the patient or caregiver may recharge and replace the battery 140 periodically during a prescribed wearing duration. As previously described, in an example, the outer shape pad 105 may include a sealing lip formed of an elastomeric material, wherein when the housing 120 or one of the multiple housings 120 is pulled away from the outer shape pad 105, the sealing lip retracts, thereby allowing the housing or one or more of the multiple housings 120 to be pulled away from the sealing lip. Since the sealing lip is resilient, the deformation is not permanent and the sealing lip retracts to a resting state to again receive the housing 120 or one or more of the housings 120 in a sealed configuration.

[0201] Regardless of whether the at least one housing is a single shell or multiple shells, the components of the device 100 can be distributed to provide comfort to the patient. Figure 8 In the example of the present invention, the outer cushion 105, the housing 120 and the electronic devices (e.g., the EGC acquisition and conditioning circuit 125, the processor 118, the treatment delivery circuit 130, the capacitor 135, the battery 140 and the PCB 145) are assembled into an assembly so that when the first assembly 102 is mounted on the patient's torso 5, the center of mass 147 of the assembly is below the volume center 150 (e.g., the centroid of the volume) of the assembly. As previously described, in the example, the first assembly 102 and the second assembly 107 of the device 100 are attached to the patient's torso 5.

[0202] refer to Figure 5A , 5B and 6, when the patient is standing or sitting, and when the attached coupled assembly is attached to the patient in accordance with medical indications for application and use, the vertical axis 137 of the first assembly 102 and the second assembly 107 are anti-parallel to gravity.

[0203] Many forces applied to an attachment joint can cause it to fail prematurely. These forces include one or more of the following:

[0204] 1) Tension is a pulling force applied equally to the entire joint. Under the action of tension on the attachment joint, the pulling direction is orthogonal to the attachment joint;

[0205] 2) Shear force on the adhesive bond is a pulling force directed through the adhesive parallel to the adhesive bond, which acts to force the substrates to slide relative to each other;

[0206] 3) The cleavage force is a pulling force concentrated on one edge of the attached joint, used to apply a prying force on the joint. The other edge of the joint is theoretically under zero stress; and / or

[0207] 4) The peel force is concentrated along a thin line at the edge of the bond where one substrate is flexible. The line is the precise point where the adhesive separates if the flexible surface is peeled from its mating surface. Once peeling begins, the stress line remains in front of the advancing bond separation.

[0208] The leveraging effect of cleavage and peel forces concentrates stresses on a smaller bond area, resulting in failure at lower force levels than those observed in tension and shear. Delamination forces (e.g., cleavage and peel, etc.) can be minimized by taking advantage of non-uniformity in relative component density (such as by placing components within the housing, etc.) and distributing the electronic components so that the center of mass 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. This helps to secure the first component 102 to the patient while minimizing any undesirable partial or complete separation of the device 100 from the patient's skin for the prescribed wear duration. If the outer shape pad 105 is pulled away from the patient's skin, the therapy electrode 110 and ECG sensor 115 may lose contact with the skin, thereby preventing proper monitoring of the patient.

[0209] In the implementation, Figure 6 As shown, the center of mass or gravity 147 of the shell 120 is located below the volume center 150 of the shell 120 relative to the vertical axis 137, so that the ratio of the distance V1 between the center of mass or gravity 147 of the shell 120 and the lower edge line 136 divided by the distance V2 between the volume center 150 and the lower edge line 136 is less than 90%. Figure 6 As shown in the example of , the lower edge line 136 is a line (or plane) tangent to the bottom end 123 of the shell 120. In other implementations, the ratio V1 / V2 of the distances may be less than 80%. In other implementations, the ratio V1 / V2 of the distances may be less than 75%. In other implementations, the ratio V1 / V2 of the distances may be less than 70%. In other implementations, the ratio V1 / V2 of the distances may be less than 50%. In other implementations, the ratio V1 / V2 of the distances may be less than 30%. In other implementations, the ratio V1 / V2 of the distances may be less than 20%. In an implementation, the ratio V1 / V2 of the distances may be in the range of 1% to 90%. In an implementation, the ratio V1 / V2 of the distances may be in the range of 5% to 80%. In an implementation, the ratio V1 / V2 of the distances may be in the range of 10% to 70%.

[0210] In other implementations, such as Figure 8 As shown, a second axis may be selected to determine the distance ratio, such as a transverse axis H for measuring proximity to the patient's skin. In these implementations, the ratio of the transverse distance H1 between the center of mass or gravity 147 and the patient-facing surface of the contour pad 105 divided by the transverse distance H2 between the volume center 150 and the patient-facing surface of the contour pad 105 is less than 90%. In other implementations, the ratio of the transverse distances H1 / H2 may be less than 80%. In other implementations, the ratio of the transverse distances may be less than 70%. In other implementations, the ratio of the transverse distances H1 / H2 may be less than 50%. In other implementations, the ratio of the transverse distances H1 / H2 may be less than 30%. In other implementations, the ratio of the transverse distances H1 / H2 may be less than 20%. In implementations, the ratio of the transverse distances H1 / H2 may be in the range of 1% to 90%. In implementations, the ratio of the transverse distances H1 / H2 may be in the range of 5% to 80%. In implementations, the ratio of the transverse distances H1 / H2 may be in the range of 10% to 70%.

[0211] In some implementations, more than one vertical axis 137 may 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 on his back sleeping. To meet the above criteria for the distance ratio of the two orientations, the center of gravity or mass 147 is located in the lower rear quadrant of the housing 120.

[0212] In an example, the heaviest electrical components (e.g., at least one capacitor 135 and battery 140) are disposed below the volume center 150 of the first assembly 102. Alternatively or additionally, the heaviest electrical components are positioned proximate to the contour pad 105. For example, Figure 8 As shown, both the capacitor 135 and the battery 140 have flat geometries that enable them to be stacked at one end of the first assembly 102 below the volume center 150. Relatively lighter electrical components such as integrated circuits or systems on a chip (SoCs) such as the therapy delivery circuit 130 and the ECG acquisition and conditioning circuit 125 are disposed above the volume center 150 within the housing 120. Because the center of mass 147 of the first assembly 102 is below the volume center 150, the contour pad 105 is less likely to peel away from the patient's torso 5 under the influence of gravity and other forces acting on the device when the patient moves.

[0213] Additionally or alternatively, in examples (e.g. Figure 8 In the example of FIG. 1 , the first component 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 outer cushion 105. Figure 8In examples where the center of mass 147 is below the volume center 150 and heavier and / or larger components are below the volume center 150, the shell 120 can be ergonomically shaped to follow the general contour of the components housed therein. For example, the distance D that the shell 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 than the bottom end). In one example, the side profile has the appearance of a right triangle with rounded surfaces and edges, or approximates the shape of a teardrop. Figure 8 In the example of FIG. 1 , 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 provides a comfortable weight distribution that reduces the pull on the skin under the action of gravity that attempts to rotate the top end 122 away from the torso 5. Thus, the teardrop-shaped cross-section of the first component counteracts the peeling forces that tend to pull the contour pad 105 away from the torso. In addition, the streamlined contour shape closely follows the contour of the front lower area of ​​the torso 5, making the device 100 unnoticeable or protruding very little when worn under clothing. This comfortable, compact structure encourages patient compliance by maintaining the patient's privacy during the prescribed wearing duration.

[0214] As previously mentioned Figures 3A to 4D As described in the example of, an implementation of the attached connected wearable device 100 may include an additional wearable support and / or support garment to counteract one or more forces such as peeling forces, shearing forces, cleavage forces, and tensile forces and maintain the wearable device 100 in contact with the patient's torso 5. In this implementation, the wearable support and / or support garment helps prevent the device 100 from pulling on the patient's skin and thereby increases and / or ensures patient comfort throughout the wear duration. Ensuring patient comfort eliminates obstacles to patient compliance with wearing the device for the entire prescribed duration. Such a wearable support and / or support garment is particularly beneficial during a long prescribed wear duration.

[0215] As mentioned above and as Figure 10A As shown in the examples of 1 to 4, the device 100 may also include a breathable anisotropic conductive gel 660 disposed between the outer shape pad 105 and the torso 5 and configured to be placed along at least one of the plurality of treatment electrodes 110. In an example, the ratio of the area footprint (e.g., the surface area defined by the perimeter) of the breathable anisotropic conductive gel 660 to the area footprint of the outer shape pad 105 is in a range of about 0.30 to 0.75. In an example, the ratio of the area footprint of the breathable adhesive 665 to the area footprint of the outer shape pad 105 is in a range of about 0.05 to 0.25.

[0216] By limiting the area footprint of adhesive 665 to only that required to support the weight of 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 footprint of contour pad 105. This limits the potential for the adhesive to irritate the skin and facilitates evaporation of moisture from areas of the skin not contacted by the adhesive. Figure 10C In some implementations (such as the embodiment of the present invention), the adhesive 665 is only disposed on a portion of the periphery of the outer shape pad 105, thereby providing one or more outlets 670 that promote evaporation of moisture. Figure 10D In the example of FIG. 1 , etc.), the gel 660 includes a plurality of perforations 662 for promoting evaporation of sweat at the device-skin interface.

[0217] Now back to Figure 8 As previously described, in an implementation, the shell extends a distance D of approximately 1 cm to 5 cm from the surface of the contour pad. For example, the shell may 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 contour pad. In addition to keeping the center of mass 147 below the volume center 150, the device 100 also maintains a low profile and is worn under the patient's clothing in an unnoticeable manner. The device does not protrude too much from the patient's skin to create one or more noticeable protrusions under clothing, thereby integrating more seamlessly 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 shell 120 and therefore the distance of the shell from the surface of the contour pad depends on a combination of component size, shape, and relative placement.

[0218] In an example, at least one power source of the device 100 includes one or more batteries 140, wherein the batteries 140 have a combined envelope volume of no more than one quarter of the volume of at least one housing 120 and have a capacity of no less than 1200 mAh. In an example, at least one power source includes one or more batteries, wherein the batteries have a combined envelope volume of no more than 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 battery 140 is configured to provide power to one or more components such as one or more capacitors 135. In an example, the battery 140 may include a rechargeable battery or a multi-cell battery pack. In an example, the battery 140 may include a non-rechargeable replaceable battery. In an exemplary implementation, the battery 140 may include three or more 2200 mAh lithium-ion batteries for providing power to other components within the device 100. In an implementation, at least one power source includes at least one 1470 mAh 3V lithium-ion battery. In an example, the battery 140 may include a plurality of button-type batteries. In an example, one or more batteries are flat-packed lithium polymer batteries. In an example, the battery 140 can be a flat package (e.g., prismatic) battery, such as a lithium ion battery with a size ranging from, for example, 12 mm x 4 mm x 1 mm to 35 mm x 50 mm x 2 mm. In an example, at least one power source includes one or more batteries 140, wherein the batteries 140 have a size ranging from about 1 cm 2 Up to 7cm 2 The device 100 may have a combined volume of 100 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, the one or more batteries 140 are rechargeable and can provide a power output in the range of 20 mA to 3000 mA and can support 24 hours, 48 ​​hours, 72 hours, or more of run time between charges. In a specific implementation, the battery capacity, run time, and type (e.g., lithium ion, nickel cadmium, or nickel metal hydride) can be varied to best suit a specific application of the device 100 (e.g., defibrillation, pacing, etc.).

[0219] It should be understood that the capacitor 135 of the device 100 can be constructed with various form factors. For example, the capacitor 135 can include an encapsulated rigid shell. In implementation, the shape of the rigid shell can be designed to be consistent with the curvature of the patient's trunk 5, so as to produce a comfortable fit when worn. For example, the shell can be constructed of rigid plastic, wherein the rigid plastic includes, for example, acrylonitrile-butadiene-styrene (ABS) plastic with a contour surface consistent with the patient's body shape. For example, the contour surface can be configured to be consistent with the curvature of a part of the patient's trunk (such as the lower part of the trunk, the upper front part of the trunk, the upper rear part of the trunk, one or more side parts of the trunk, etc.). The specific shape of the contour surface can be pre-configured or uniquely designed for the patient. For example, various body size measurements can be obtained from the patient, and a unique customized shell can be 3D printed, for example, by any suitable thermoplastic (such as ABS plastic).

[0220] In some implementations, capacitor 135 may be a compact film capacitor, such as a small film capacitor having a maximum thickness of 1 mm to 40 mm, a capacitance of 700 μF, and a rated breakdown voltage of 500 to 2500 volts. In an example, capacitor 135 has a range of about 10 cm 2 Up to 15cm 2 The envelope volume of the device 100 is 140 microfarads. In an example, the capacitor 135 has a capacity of 140 microfarads and a rated voltage of at least 1600V. The film capacitor 135 can be made of tightly wound dielectric layers, wherein the 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 portion of the torso, the upper front portion of the torso, the upper rear portion of the torso, or one or more sides of the torso, etc.). Shaping one or more film capacitors 135 to accommodate one or more contour areas of the patient's torso 5 increases the comfort of the patient and minimizes the bulky volume associated with cylindrical or stacked capacitors. Therefore, the device 100 may protrude less from the surface of the patient's skin than in the case where the capacitor has a larger volume and / or a smaller adaptable contour. Table 4 provides an example of the weight of various components of an implementation of the device 100:

[0221]

[0222] Table 4

[0223] The weights of the various components may be selected for comfort, size, and performance characteristics. For example, as previously described, one or more batteries 140 may 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 the short-term and long-term wear embodiments of the attachment coupling device 10, 100, 800:

[0224] Lithium-ion prismatic cell example:

[0225]

[0226]

[0227] Table 5

[0228] Example of a lithium-ion cylindrical battery

[0229]

[0230]

[0231] Table 6

[0232] In another example, as previously described, in an embodiment, capacitor 135 can be an approximately 140 microfarad, 1600V film capacitor weighing approximately 118 grams. Alternatively, 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 into a compact, lightweight design without affecting performance. For example, the H-bridge can be a compact, surface-mounted silicon carbide FET (SiC FET) rather than a 4-part IGBT configuration. The ECG acquisition and conditioning circuitry, processor, and therapy delivery circuitry can be included on one or more ASICs, or one or more wire-bonded, epoxy-protected "chip-on-board" flip chips.

[0233] Other features of the outer cushion 105 contribute to the stability of the device 100 for the prescribed wear duration. For example, the outer cushion 105 is sized to accommodate components disposed within the housing 120 and / or integrated within the outer cushion 105 while providing sufficient attachment surface area to secure the first component 102 of the device 100 to the patient's skin for the prescribed 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 footprint") in the range of about 200 to 300 square centimeters. In an implementation, the contour pad 105 has an area footprint of about 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 of about 10 kg / m 2 Up to 100kg / m 2 Table 7 provides additional examples of weight (kg) to area occupied area (m2) ratios for the first assembly 102. The weights shown below are examples. Other weights are possible, including a range of about 2.25 kg to about 10 kg, depending on the selection and design of the components and whether a wearable support is used.

[0234]

[0235] Table 7

[0236] As previously mentioned Figure 5A As described in the example of FIG. 1 and B, the device 100 includes a first component 102 and a separate second component 107, wherein 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 conductive wires or wires configured to deliver an electrical pulse (such as a 360J defibrillation pulse).

[0237] Second component 107 may include breathable and non-irritating materials and adhesives as described above with respect to first component 102 and contour pad 105. In an example, second component 107 includes a second therapy electrode of a plurality of therapy electrodes 110 that is integrated with pad 109 of second component 107 and in wired communication with therapy delivery circuit 130. In an example, second component 107 includes ECG sensor 115. Because first component 102 includes therapy delivery circuitry and various other electrical components, second component 107 may be more compact than the first component. For example, second component may be a low-profile adhesive pad that includes therapy electrode 110 and ECG electrode 115 and has a pad thickness of approximately 0.1 cm to 2 cm. In one example, as Figure 11BAs shown, the contour 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 contour pad 109 defines a patient skin area (e.g., "area footprint") of about 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 of about 5 kg / m 2 Up to 100kg / m 2 Table 8 provides additional examples of weight (kg) to area occupied area (m2) ratios for the second component 107. The weights shown below are examples. Other weights are possible, including a range of about 1 kg to about 10 kg, depending on the selection and design of the components and whether a wearable support is used.

[0238]

[0239] Table 8

[0240] 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 conductive wires or wiring used to couple the second component 107 to the first component 102 can be encased in a waterproof layer. In an example, the one or more conductive wires or wiring can be connected to or mated 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 ports or connectors for receiving the one or more conductive wires or wiring.

[0241] In an embodiment, the outer shape pad 109 of the second component is designed to be durable, flexible, and breathable to allow sweat to evaporate. In an embodiment, the outer shape pad 109 is non-irritating when in contact with the skin as described above with respect to the skin irritation classification 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 outer shape pad 109 is generally non-conductive, flexible, water vapor permeable, and substantially liquid impermeable or waterproof. The non-conductive, flexible, water vapor permeable outer shape pad 105 may include or be composed 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), etc. In other embodiments, the outer shape pad 109 may include or be composed 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 outer shape pad 109 is a laminate pad including 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 outer shape pad 109 is perforated to facilitate evaporation of water vapor from the skin.

[0242] In an embodiment, the second component 107 may include a conductive adhesive layer. As described in the '976 patent, which is incorporated herein in its entirety by reference, a water vapor permeable conductive adhesive material may, for example, be selected from a group comprising: poly (3,4-ethylenedioxythiophene), doped poly (styrene sulfonate) (PEDOT:PSS) poly (aniline) (PANI), poly (propylene sulfide), poly (9,9-dioctylfluorene co-dithiophene) (F8T2) and combinations thereof. Such polymers may be printed as flexible, water vapor permeable conductive adhesive layers 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 a material including, but not limited to, one or more of carbon black, silver, nickel, graphene, graphite, carbon nanotubes, and / or other conductive biocompatible metals such as aluminum, copper, gold, and / or platinum.

[0243] In the example, Figure 3A and 5AAs shown in Figures 1 to 4, the second component 107 includes at least one of a plurality of treatment electrodes 110 integrated with the outer pad 109. 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, etc. In an example, the second component may also include at least one of a plurality of ECG sensors 115 integrated with the outer pad 109. As described with respect to the first component 102, the ECG sensor 115 of the second component 107 may be a non-polarizable ECG electrode (e.g., a clinical grade Ag / AgCl electrode) or a polarizable electrode (e.g., a electrode having a conductive conductive layer such as Ta) configured to measure changes in electrophysiological phenomena of the patient to measure ECG information of the patient. 2 O 5 An exemplary ECG sensor 115 includes a tantalum pentoxide electrode as described, for example, in U.S. Pat. No. 6,253,099, entitled “Cardiac Monitoring Electrode Apparatus and Method,” the entire contents of which are incorporated herein by reference. In implementation, the ECG sensor 115 may be made of a core plastic or metal substrate element coated with a thick film polymer compound filled with a conductive Ag / Ag / Cl metal filler.

[0244] In some examples, at least one therapy electrode 110 and one or more ECG sensors 115 are formed within the form pad 109 such that the skin contacting surface of each component is coplanar with or protrudes from the patient contacting surface of the form pad 105. In examples, the therapy electrode 110 and the ECG sensor 115 are disposed on the patient contacting surface of the form pad 105. In some implementations, the therapy electrode 114 and the ECG sensor 115 are metal plates (e.g., stainless steel) or substrates formed as a permanent part of the second component 107. The metal plate or substrate can be adhered to the form pad 109, for example, by a polyurethane adhesive or a polymer dispersion adhesive (such as an adhesive based on polyvinyl acetate (PVAc) or other such adhesive). In examples, the ECG sensor 115 is a flexible dry surface electrode, such as a conductive polymer coated nanoparticle loaded polysiloxane electrode mounted to the form pad 109. In some examples, the ECG sensor 115 is a flexible dry surface electrode, such as a silver coated conductive polymer foam soft electrode mounted to the form pad 109. In an example, ECG sensor 115 is screen printed onto contour pad 109 using a metallic ink, such as a silver-based ink, etc. In an implementation, therapy electrodes 110 each have a conductive surface suitable for placement adjacent to a patient's skin. In some implementations, therapy electrodes 110 may include impedance reducing materials and / or mechanisms as described subsequently.

[0245] In an implementation, at least one therapy electrode 110 and at least one ECG sensor 115 are manufactured as an integral component of topographic pad 109. For example, therapy electrode 110 and / or ECG sensor 115 may be formed from the warp and weft of a fabric that forms at least one layer of topographic pad 109. In an implementation, at least one of therapy electrode 110 and ECG sensor 115 is formed from conductive fibers interwoven with non-conductive fibers of the fabric.

[0246] In an example, the device 100 may include a third component configured to be adherently coupled to the patient's torso. The third pad may include one of a plurality of therapy electrodes 110 integrated with the pad of the third component and in wired communication with the therapy delivery circuit 130. The third component may have similar characteristics to those described above with respect to the second component 107. In an example, the third pad may be configured to be adherently attached to the posterior portion of the patient's torso 5 between the patient's shoulder blades, for example, while the first component 102 is positioned along the lower spine of the thorax and the second component 107 is positioned on the anterior upper portion of the torso 5 adjacent to the apex of the heart. In an example, the third component includes a torso configured to be adherently coupled to the patient's atrium.

[0247] Reference Figure 4A 1000 is external, mobile, and wearable by a patient, and is configured to implement one or more of the configurations described herein. In implementations, the wearable support medical device 800, 1000 is, for example, a mobile medical device capable of and designed to move with the patient as the patient goes about his or her daily routine.

[0248] For example, Figure 12A and 12B As shown, the device 800 may include: one or more front attachment coupling pads 807A, 807B, which are configured to be attached to the front region of the patient's torso 5; and one or more rear attachment coupling pads 802A, 802B, which are electrically connected to the one or more front attachment coupling pads 807A, 807B and are configured to be attached to the rear region of the torso 5. In an example (such as Figure 13A In the example of FIG. 1A to FIG. 1B , the rear attachment coupling pad 802 can be adhered to the patient's torso 5 so that part or all of the rear attachment coupling pad 802 covers one side of the torso 5. This structure provides accessibility to the pad 802 for removal or adjustment and other device interaction. This structure also allows the device to be hidden between the patient's arm and torso 5. Similarly, Figure 14The device 1000 is configured to be hidden by connecting the rear attachment coupling pads 1002a, 1002b to the front pads via a connection 1005 located under the patient's arm. The connection 1005 can be attached to the patient's torso 5 to help support the monitoring and treatment components of the device 1000.

[0249] In implementation (such as Figure 13A and 13B In an implementation of the invention, the garment 805 integrated with the front and rear attachment pads at least partially traces a path from the front attachment pad 807 attached to the front upper region of the torso 5, over the patient's shoulders, and terminating at the rear attachment pad 802 on the rear region of the torso 5. In an example, the garment 805 is a wearable support including a shoulder strap 806, wherein the shoulder strap 806 is configured to carry at least a portion of the weight of at least one of the front attachment pad 807 and the rear attachment pad 802. In an example, the front attachment pad 807 and the rear attachment pad 802 each weigh 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 pads 807, 802.

[0250] As mentioned above about Figure 6 , 8 As described in and 9A, for example, the wearable support device 800 includes a plurality of therapy electrodes and / or a plurality of ECG sensing electrodes integrated with the front attachment coupling pad 807 and the rear attachment coupling pad 802. The housing 820a-c forms a watertight seal with each of the front attachment coupling pads 807a-b and the rear attachment coupling pad 802. For example, as Figure 13A As shown in FIG. 5 to FIG. 8 , the first housing 820b is configured to form a watertight seal with the front side attachment coupling pad 806, and the second housing is configured to form a watertight seal with the rear side attachment coupling pad 802. As described with respect to the embodiment of the device 100 of FIGS. 5 to 8 , Figures 12A to 13C Embodiments of the invention are water resistant and / or water repellent. At least one housing may conceal at least an ECG acquisition and conditioning circuit, a therapy delivery circuit, and a processor. For example, the processor may analyze the patient's ECG signal, detect one or more treatable arrhythmias, and cause the therapy 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 therapy electrodes, the therapy delivery circuit, and the processor are as described above with respect to Figures 6 to 8 The embodiment operates as described in FIG.

[0251] In an implementation, the processor is configured to cause the therapy delivery circuit to deliver up to five therapy pulses to the patient when one or more treatable arrhythmias are detected. At least one power source is disposed within the first housing or the second housing and is coupled to the therapy delivery circuit and the therapy electrode pair to provide energy for up to five therapy pulses.

[0252] In an implementation, the capacitor 135 can be one or more capacitors disposed in one or both of the front attachment connection pad 807 and the rear attachment connection pad 802. In some examples, one of the front attachment connection pad 807 and the rear attachment connection pad 802 contains all circuits and power components. The other of the front attachment connection pad 807 and the rear attachment connection pad 802 includes at least one treatment electrode and at least one ECG sensor in electrical communication with the circuits and power components. In an implementation, the wearable support 805 includes a conductive thread that communicates with the front attachment connection pad 807 and the rear attachment connection pad 802. In an implementation, the conductive thread can be integrated into the fabric of the wearable support 805. In an example, the conductive thread can be integrated in a zigzag or other folding pattern to straighten as the garment stretches. Therefore, the zigzag or folding pattern accommodates garment expansion and contraction and patient movement while preventing the conductive thread from contacting the patient's skin. Integrating the conductive thread into the garment reduces and / or eliminates wiring or wires hanging on external objects. In other examples, the conductive thread may be routed on an 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 implementations, the conductive thread may be routed on an outer surface of the garment and appropriately retained using loops, closable fabric retaining tabs, or eyelets.

[0253] In an embodiment, the apparatus 800B to D further comprises a breathable adhesive disposed between at least a portion of the wearable support 805 and the patient's shoulder. The garment 805 may be at least one of a vest, a shirt, a ribbon, a belt, and a shoulder harness. For example, in an embodiment, the garment 805 is a wearable support comprising a shoulder harness 806 made of a non-adhesive stretchable fabric, and the adhesive is applied along the length of the harness at least at the peripheral edge. In an implementation, the fabric is a biocompatible, non-irritating, latex-free fabric, such as a spandex fabric, a nylon-spandex fabric, or a nylon-LYCRA fabric, or the like. The adhesive may be applied to, for example, 20 to 25%, 25 to 30%, 30 to 35%, 40 to 45%, 45% to 50%, 50 to 60%, 60 to 65%, 65 to 70%, 70 to 75%, 75% to 80%, 85% to 90%, 95% to 100% of the surface area of ​​the garment 805. In some examples, the adhesive is applied only to the front and rear adhesive coupling pads 807, 802, and the shoulder strap 806 is retracted and held in place on the patient's torso 5 via compression. In examples such as Figure 12AIn the examples of FIG. 8A to B, etc.), the garment 805 is a fully adhered wearable support that is properly held against the patient's torso 5 by adhesion.

[0254] As previously described, in examples, one of the front attachment pad 807 and the rear attachment pad 802 includes therapy delivery circuitry, ECG acquisition and conditioning circuitry, a processor, and a PCB. One of the front attachment pad 807 and the rear attachment pad 802 that includes a relatively heavy set of electronic components can be placed lower on the torso 5 than the other. The garment 805 is a wearable support that is configured to help comfortably support the weight of both the front attachment pad 807 and the rear attachment pad 802. In examples such as Figure 13A In the example of A to B, etc.), the garment 805 is a wearable support 805 including a shoulder strap 806, wherein the shoulder strap 806 tracks a path between the front attachment pad 807 and the rear attachment pad 802 and across the patient's shoulder. In an implementation, the tensile strength of the shoulder strap 806 is at least 10% greater than the load applied by the component 807 without the attachment connection, and does not exceed 10 times the load applied by the component 807 without the attachment connection. In some examples, the shoulder strap 806 has an elongation percentage of about 10% to 200%. Therefore, the shoulder strap 806 helps to maintain and support the weight of the device 800 on the patient's torso 5, which can be particularly beneficial during long-term wearing durations. In other implementations, the elastic parameters (e.g., 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 compound curvature of the shoulder and neck region, the elasticity may be lower along the long axis of the shoulder strap 806 compared to the short axis of the shoulder strap 806. Anisotropy allows more stretch along the shoulder and neck region for more comfort while carrying the load of the support shell 120.

[0255] 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 adapts to the contour of the patient's body. In the example, the garment 508 is a wearable support including a shoulder strap 806, wherein the shoulder strap 806 is designed to match the contour of the patient's body in at least one of a molded, 3D printed, and knitted shape. Thus, the device 800 can be customized to fit the individual body shape of the patient, thereby ensuring comfort and encouraging the patient to comply with the wearing instructions.

[0256] 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 outer shape of the receiving portion of the patient's torso 5 in a manner of 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 can be formed as a part of the wearable support 805. In an implementation where the garment 805 includes the shoulder strap 806, for example, the wearable support 805 can be a mold die-cut from a single sample of a fabric or a forming substrate, and can 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, wearable support 805 cooperates with separately formed front attachment coupling pad 807 and separately formed rear attachment coupling pad 802 .

[0257] In examples, the front attachment coupling pad 807 and the rear attachment coupling pad 802 can each include a loop or buckle configured to receive, for example, an end of a load-bearing belt or shoulder strap 806. In these examples, the shoulder strap 806 is adjustable in length to achieve a preferred patient comfort setting. In addition, 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, so 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 can be interconnected by a wiring that releasably attaches the shoulder strap so that the two pads continue to communicate when the shoulder strap is temporarily removed.

[0258] In other examples, the front side attachment coupling pad 807 and the rear side attachment coupling pad 802 can each include a connector for electrically connecting to the mating portion on either end of the replaceable strap in a watertight structure. The replaceable strap can include a conductive wiring or conductive wire extending through the replaceable strap or extending on the replaceable strap and terminating at a connector at either end of the shoulder strap. In these examples, the shoulder strap can be removed, cleaned, replaced and / or discarded. Allowing the patient to clean, discard and / or replace the shoulder strap without having to remove the front side attachment coupling pad 807 and the rear side attachment coupling pad 802 helps to maintain a clean and comfortable wearable support garment 805 throughout the prescribed wearing duration.

[0259] In an example, the garment 805 is a wearable support having a greater tensile strength and a lower stiffness coefficient than either of the front attachment pad 807 and the rear attachment pad 802. This helps the garment 805 to be soft enough to conform to the contour of the patient's torso 5, while also being strong enough to hold the weight of the front attachment pad 807 and the rear attachment pad 802 without tearing. In an example, the garment 805 includes a shoulder strap 806 that supports at least 1.0 lbf ft of rotational torque at least at one end. In an implementation, the garment 805 is a wearable support (e.g., shoulder strap 806) that expands and contracts no more than 1 inch when a force of 22 lbf is applied. In an implementation, the wearable support 805 expands and contracts no more than 2 inches when a force of 30 lbf is applied. In an implementation, the wearable support 805 expands and contracts 0.5 to 3.0 inches when a force of 30 lbf is applied.

[0260] In some implementations, the garment 805 is a wearable support that also includes at least one length adjuster configured to tension the shoulder strap 806 to a desired comfort level for the patient wearing the device 800. The length adjuster may include, for example, at least one of a draw cord, a belly band, a lockable elastic draw cord, a zipper and spring-loaded toggle stop, a ratchet strap, an adjustable buckle, an extendable and removable hook and loop fastener, a tie, 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 tension and, therefore, the compressive force acting on the patient's torso 5. For example, the patient may prefer more or less tension when sitting, lying, 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 beginning of a prescribed wearing duration, and the patient can adjust the garment 805 extending between the first component 102 and the second component 107 throughout the wearing duration to accommodate movement, positioning, fabric expansion and contraction, and / or weight gain or loss. By limiting the garment 805 to a single supportive shoulder strap 806, for example, the device 800 covers only a portion of the torso 5, while the remainder of the torso is not covered by the device 800. This can help maintain patient comfort during the wearing duration by minimizing the skin surface area covered on the torso 5 and thereby helping to allow natural biological processes such as evaporation and skin shedding.

[0261] In the example, with Figures 10A to 10D As with the embodiment of the device 100 shown, Figures 12A to 13CThe wearable support device 800A-D of can include a breathable anisotropic conductive gel disposed between at least one treatment electrode of the rear attachment coupling pad 802 and the torso 5. As with the outer shape 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 is in a range of about 0.30 to 0.75. Also as with the outer shape 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 is in a range of about 0.05 to 0.25. In an implementation, the front attachment coupling pad 807 and the rear attachment coupling pad 802 each include a treatment electrode for providing treatment pulses to the patient's torso 5. In an implementation, the front attachment coupling pad 807 and the rear attachment coupling pad 802 each include a breathable anisotropic conductive gel disposed between at least one treatment electrode of each pad 802, 807 and the torso 5.

[0262] As previously introduced, in implementations, the device 100, 800 may include an impedance reducing material and / or mechanism for reducing the impedance between the treatment electrode and the patient's skin 7. In an example, the device includes a conductive hydrogel layer disposed between the treatment electrode 110 and the patient's skin. In implementations, the impedance reducing layer includes an anisotropic conductive gel such as a conductive hydrogel.

[0263] In an example, the conductive gel can be a conductive adhesive layer. The conductive adhesive layer can be a conductive adhesive material that is permeable to water vapor. The flexible, water vapor permeable conductive adhesive material can include a material selected from the group comprising the following: electrospun polyurethane adhesive, polymerized microemulsion pressure-sensitive adhesive, organic conductive polymer, organic semiconductor conductive polymer, organic conductive compound and semiconductor conductive compound, and a combination thereof. In one example, the thickness of the flexible, water vapor permeable conductive adhesive material can be between 0.25 and 100 mil. In another example, the water vapor permeable conductive adhesive material can include conductive particles. In implementation, the conductive particles can be microscopic or nano-scale particles or fibers of a material, including but not limited to one or more of carbon black, silver, nickel, graphene, graphite, carbon nanotubes, and / or other conductive biocompatible metals such as aluminum, copper, gold and / or platinum.

[0264] In an implementation, the device 100, 800 may include a gel deployment circuit configured to cause delivery of a conductive gel substantially proximate to a treatment site (e.g., a surface of a patient's skin in contact with the treatment electrode 114) prior to delivery of a therapeutic shock to the treatment site. As described in U.S. Pat. No. 9,008,801, issued on April 14, 2015, entitled "WEARABLE THERAPUETIC DEVICE" (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 delivery of a conductive gel immediately prior to delivery of a therapeutic shock to the treatment site or within a short time interval prior to delivery of 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 can be constructed as one or more separate and independent gel deployment modules. These modules can be configured to receive a removable and / or replaceable gel box (e.g., a box containing one or more conductive gel reservoirs). As such, the gel deployment circuit can be permanently disposed in the device as part of the treatment delivery circuit 130, while the box can be removable and / or replaceable. Such a gel deployment circuit can be coupled to or integrated into the first component 102, 802, the second component 107, 807, and / or the third component of the device.

[0265] In the event that a treatable cardiac condition is detected and no patient response is received after the device prompts, the gel deployment circuit can be signaled to deploy the conductive gel. In some examples, the gel deployment circuit can be constructed as one or more separate and independent gel deployment modules. These modules can be configured to receive a removable and / or replaceable gel box (e.g., a box containing one or more conductive gel reservoirs). As such, the gel deployment circuit can be permanently disposed in the device as part of the treatment delivery system, while the box can be removable and / or replaceable.

[0266] 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 implementations, the gel deployment pack including the one or more gel reservoirs and associated gel deployment circuits may be removable and / or replaceable. In some examples, the gel deployment pack including the one or more gel reservoirs and associated gel deployment circuits and the therapy electrode may be integrated into a therapy electrode assembly, where the therapy electrode assembly may be removed and replaced as a single unit after use or in the event of damage or breakage.

[0267] In addition to including impedance reducing materials and / or mechanisms, short-term and long-term wear implementations of device 100, 800 also include materials and / or mechanisms of device 10, 100, 800 that adhere to the patient's skin for promoting moisture vapor transmission from the patient's skin.

[0268] Implementations of the apparatus 100, 800 according to the present invention may exhibit a relative humidity of, for example, about 600 g / m2 when worn by a subject in an environment of room temperature (e.g., about 25°C) and, for example, about 70% relative humidity. 2 / day to about 1400g / m 2 The vapor permeability of the device 100, 800 is greater than 100 g / m2 as measured by the vapor transmission standard of ASTM E-96-80 (E96 / E96M-13 Edition) using the "in contact with water vapor" ("dry") or "in contact with liquid" ("wet") method. 2 / 24 hours. This test method is described in the '976 patent, the disclosure of which is incorporated herein by reference in its entirety.

[0269] In an implementation, the wearable support device 800 has a 100 g / m 2 In an implementation, the device 800 includes a shoulder strap 806 having a higher MVTR than either or both of the front attachment coupling pad 807 and the back attachment coupling pad 802. In an implementation, the shoulder strap 806 has a MVTR in a range of at least about 1200 to 2500 g / m 2 / 24 hours MVTR, and the front side attachment coupling pad 807 and the back side attachment coupling pad 802 have a range of about 50 to 1000 g / m 2 In implementations of the device 100, 800, 50 to 75% of the area occupied by the front side attachment pad 807 has a MVTR in the range of about 500 to 1200 g / m 2 / day MVTR, and the area of ​​the front side attachment coupling pad 807 occupies 25 to 50% of the area with a range of about 250 to 500 g / m 2 In an implementation, 50 to 75% of the area occupied by the rear attachment pad 802 has a MVTR in the range of about 500 to 1200 g / m 2 / day MVTR, and the area of ​​the rear side attachment coupling pad occupies 25 to 50% of the area with a range of about 250 to 500 g / m 2 In implementations, the portion of the area footprint of the front side attachment coupling pad 807 or the back side attachment coupling pad 802 having a lower MVTR is the portion having one or more breathable adhesives and / or breathable conductive hydrogels applied thereto.

[0270] In addition to having one or more breathable adhesives and / or breathable conductive hydrogel layers disposed between the contour pad and the patient's skin, implementations of the device 100, 800 include one or more water vapor and thermal management systems. In implementations, as previously described, the device 100, 800 includes one or more vapor permeable shells. As previously described, the shell 120, 820 is non-conductive, water vapor permeable, and substantially liquid impermeable or waterproof. The shell 120, 820 may include or be made 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), etc. In an example, the shell 120, 820 may include a non-woven laminate material, such as at least one of spandex, nylon-spandex, and nylon-LYCRA, etc. In an example, the shell 120 may include a thermoformed layer coated with a waterproof or hydrophobic layer, such as a non-woven polyurethane fabric material layer. In other examples, housing 120 may include or be formed from a fabric having a biocompatible surface treatment, thereby making the fabric water resistant and / or waterproof. For example, the fabric may be enhanced by dipping in a fluorocarbon bath such as Teflon or fluorinated decyl polyhedral oligomeric silsesquioxane (F-POSS).

[0271] One or more steam release valves or through holes can be formed into or disposed through the contour pad 105, and / or the therapy electrode 110, and / or the housing to allow moisture generated by sweating and moisture evaporation from the patient's skin to escape from the housing 120, 820. As previously described, in an implementation, one or more steam release valves (e.g., Figure 6 and 9A The steam release valves 149a-c in some implementations may be formed into the housing 120 or disposed through the housing 120 to direct sweat out of the housing 120, 820. As moisture from the skin dissipates through the breathable adhesive and the vapor permeable outer pad 105, the vapor pressure within the housing 120 may increase. In some implementations, the steam release valves are pressure activated such that when moisture increases within the housing 120, 820 and the pressure within 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 evaporates sufficiently to reduce the pressure within the housing to below a threshold, the steam release valve closes. In an implementation, the steam release valve may communicate with a processor of the device (e.g., Figure 6 processor 118) and is electromechanically controlled.

[0272] In an example, the topographic 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 nonwoven laminate having a plurality of microscopic punctures that are stippled through. The punctures form through-holes that are small enough to allow water vapor from the interior of the housing to escape by evaporation, but are too small to facilitate water entry. For example, such through-holes may have a diameter ranging from 0.02 microns to 250 microns (e.g., about 0.001 mil to 10 mil). In an implementation, the device 100, 800 may include a water vapor absorbing, vapor permeable, and / or wicking material in the topographic pad 105, 109, 802, 809 to help move moisture from the patient's skin through the housing 120, 820 to be discharged by evaporation.

[0273] In implementations, the apparatus 10, 100, 800 may include one or more passive thermal management systems and / or one or more active thermal management systems. For example, in implementations, the apparatus may include one or more active thermal management systems disposed within at least one housing. In implementations, the active thermal management system may include a thermoelectric cooling device (e.g., Figure 8 and 9B In an implementation, the active thermal management system may include a low profile fan (e.g., Figure 9A Fan 144 and Figure 9B 944). Such a low profile fan can improve air circulation within the housing 120, 820, 920 of the device and assist in surface cooling at the device-skin interface. In an implementation, the fan 144 assists in drawing moisture vapor away from the skin, through the breathable adhesive and the vapor permeable outer pad 105, and through the vapor permeable housing 120. In an implementation, the fan 144 can be used in conjunction with one or more vapor transport features, such as one or more steam release valves 149a to c (collectively referred to as steam release valves 149) described below with respect to implementations for releasing vapor emanating from the skin into the housing 120, 820. In some implementations, the device includes one or more steam release valves without an accompanying fan 144.

[0274] In implementation (such as Figure 9B In the implementation of the present invention, the fan 944 can also draw air from the air inlet 945 of the housing 920 to generate 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 the breathable contour pad 905 and the patient's skin 7 via one or more air channels 946 to increase comfort. (For simplicity, in Figure 9B) In an implementation, the air inlet 945 is a channel or gap defined by the topographic pad 905 on one side and the inner shell wall 921 on the other side. The inner shell wall 921 is shorter than the topographic pad 105 so that the gap 948 is defined between the end of the inner shell wall 921 and the connecting portion 918 of the shell 120 that is anchored to the topographic pad 905. In an implementation, the inner shell wall 921 includes one or more supports 923 for anchoring the shell 920 to the topographic pad 905 at a distance that defines the width Wc of the channel. In an implementation, the one or more supports 923 can be conductive connectors configured to engage with one or more therapy electrodes 110 or ECG electrodes 115.

[0275] In the implementation, Figure 6 , 8 As shown in Figures 9A to 9B, the first assembly 102, 802, 902 may include a passive thermal management system disposed within at least one housing. In an implementation, the passive thermal management system may include a cooling device 943, such as a removably inserted cooling pack, etc. In an implementation, the passive thermal management system may 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 therapy electrodes. In some examples, the metal heat sink layer 146 may be, for example, Figure 9A One or more pieces of lightweight metal, such as aluminum or stainless steel, are located within the housing and in contact with the outer shape pad as depicted in FIG. In implementation, the metal heating layer can be formed as a printed circuit board (such as Figure 6 A portion of a printed circuit board 145, etc.

[0276] In an implementation, the device may 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 multiple ECG electrodes and / or multiple therapy electrodes. The gel layer conducts heat from the patient's skin 7 into the housing for active or passive removal, for example, by evaporation through one or more through-holes and / or fan-driven displacement of the housing 120.

[0277] As previously described, in an implementation, the passive thermal management system may include one or more through holes (e.g., Figure 6 In one implementation, one or more steam release valves (e.g., Figure 6 and 9AThe steam release valves 149a-c in some implementations may be formed into the housing 120 or disposed through the housing 120 to direct sweat out of the housing 120, 820. As moisture 903 from the patient's skin 7 dissipates through the breathable adhesive and the vapor-permeable outer pad 105, the vapor pressure within the housing 120 may increase. In some implementations, the steam release valves are pressure activated such that when moisture increases within the housing 120, 820 and the pressure within the housing increases to a threshold or trigger value, one or more steam release valves 149a-c open, allowing the water vapor to evaporate. When the water vapor evaporates sufficiently to reduce the pressure within the housing to below a threshold, the steam release valve closes. In an implementation, the steam release valves may communicate with a processor of the device (e.g., Figure 6 processor 118) and is electromechanically controlled.

[0278] In implementation, one or more steam release valves 149 can be manually activated by the patient or caregiver by manually pressing a button, or by finger tapping the device or a remote device communicating with the processor 118 to provide an instruction to the device 100, 800. For example, a remote watch or smart phone running an application can provide a user interface for tapping to request valve activation. In implementation, the device 100, 800 can include a humidity sensor in the housing 120, 820. The humidity sensor can communicate with the processor 118 so that the processor automatically activates the steam release mechanism when the steam level in the housing reaches a threshold. In implementation, a threshold for automatically activating the steam release valve is preset on the device 100, 800. In implementation, the threshold for automatically activating the steam release valve can be configured by the patient, physician or other care representative to customize the frequency of steam release for a specific patient's sweat 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, and when the patient is resting, he or she can set the frequency of opening the steam release valve to once per hour.

[0279] As described above, the teachings of the present invention may be generally applied to external medical monitoring and / or treatment devices (e.g., devices that are not fully implanted in a patient's body). External medical devices may, for example, include mobile medical devices that are capable of and designed to move with a patient as the patient goes about his or her daily routine. Exemplary mobile medical devices may 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, etc.

[0280] The wearable medical cardiac monitoring device can be used continuously by the patient. In addition, 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 the patient for a long period of time, such as a period of 24 hours or longer, days, weeks, months or even years. Therefore, the use of the long period of time can be uninterrupted until the physician or other caregiver provides the patient with a specific provision 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 to use. In an example, the wearable medical device can be prescribed for a period of at least 30 days for the patient to use. In an example, the wearable medical device can be prescribed for a period of at least one month for the patient to use. In an example, the wearable medical device can be prescribed for a period of at least two months for the patient to use. In an example, the wearable medical device can be prescribed for a period of at least three months for the patient to use. In an example, the wearable medical device can be prescribed for a period of at least six months for the patient to use. In an example, the wearable medical device can be prescribed for a long period of at least one year for the patient to use. In some implementations, extended use can be uninterrupted until a physician or other caregiver provides the patient with specific prescriptions to cease use of the wearable medical device.

[0281] Implementations of the attached connected wearable device may include an additional wearable support and / or support garment to counteract one or more forces such as peeling forces, shearing forces, cleavage forces, and tensioning forces and maintain the wearable device in contact with the patient's torso. In such implementations, the wearable support and / or support garment helps prevent the wearable device from pulling on the patient's skin and thereby increases and / or ensures patient comfort throughout the wear duration. Ensuring patient comfort eliminates barriers to patient compliance in wearing the device throughout the prescribed duration. Such a wearable support and / or support garment is particularly beneficial during a long prescribed wear duration.

[0282] Regardless of the time period of wearing, the use of the wearable medical device may include continuous or almost continuous wearing of the patient as described above. For example, continuous use may include continuous wearing or attachment of the wearable medical device to the patient. In implementation, during the monitoring time period and 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 through one or more electrodes. Continuous use may include continuous monitoring of the patient to obtain heart-related information (e.g., electrocardiogram (ECG) information, including arrhythmia information, heart vibration, etc.) and / or non-cardiac information (e.g., blood oxygen, the patient's body temperature, glucose level, tissue fluid level and / or lung vibration) while the patient is wearing the device. For example, the wearable medical device can perform its continuous monitoring and / or recording at periodic or non-periodic time intervals or times (e.g., every few minutes, hours, once a day, once a week, or other intervals set by a technician or specified by a caregiver). Alternatively or in addition, monitoring and / or recording during intervals or times can be triggered by user actions or other events.

[0283] As described above, the wearable medical device can be configured to monitor other physiological parameters of the patient in addition to heart-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), tissue fluid (e.g., using a radio frequency transmitter and sensor), etc.

[0284] In implementations, the patient-worn 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 issuing a patient notification output, wherein the patient notification output may 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 therapy delivery circuit 130 to deliver one or more therapy pulses to the patient.

[0285] Figure 15An example of a process 1500 for determining whether to initiate a therapy sequence and apply therapy pulses to a patient's body is depicted. In an implementation, the processor 118 receives S1502 a patient ECG signal from the ECG electrodes 112 and analyzes S1504 the ECG signal for an arrhythmia condition. The processor 118 determines S1506 whether the arrhythmia is a life-threatening condition and requires treatment. If the arrhythmia is not life-threatening, the processor 118 may cause a portion of the ECG signal to be stored in a memory for later analysis and continue to monitor the patient ECG signal. If the arrhythmia is life-threatening, the processor provides S1508 a patient notification output and requests S1510 a patient response to the provided notification output. In an implementation, the patient receives S1506 a patient notification output by interacting with a user interface (e.g., Figure 16 The user interface 208 of the embodiment of the present invention can be used to respond to the warning by interacting with the user interface 208, wherein the user interface includes, for example, one or more buttons (e.g., Figure 5C 111) or a touch screen interface button with tactile feedback (e.g., Figure 12A The processor 118 determines S1512 whether a patient response is received. If the patient responds to the notification output, the processor 118 is notified that the patient is conscious and returns to monitoring mode. If the patient is unconscious and unable to respond to the warning provided, the processor 118 initiates S1514 a treatment sequence and treats S1516 the patient by delivering energy to the patient's body.

[0286] In an implementation, an exemplary therapeutic medical device may include an in-hospital continuous monitoring defibrillator and / or pacing device, such as an in-hospital wearable defibrillator. In such an example, the electrode may be attached to the patient's skin. For example, the electrode may include a disposable attachment electrode. For example, the electrode may include a sensing component and a treatment component disposed on a separate sensing electrode attachment patch and a treatment electrode attachment patch. In some implementations, both the sensing component and the treatment component may be integrated and disposed on the same electrode attachment patch that is then attached to the patient. In an exemplary implementation, the electrode may include a frontally attachable treatment electrode, a back-attachable treatment electrode, and a plurality of attachably attachable sensing electrodes. For example, a frontally attachable treatment electrode is attached to the front of the patient's torso to provide pacing or defibrillation therapy. Similarly, a back-attachable treatment electrode is attached to the back of the patient's torso. In an exemplary scenario, at least three ECG attachably attachable sensing electrodes may be attached to at least the upper chest of the patient near the right arm, the upper chest of the patient near the left arm, and toward the bottom of the patient's chest in a manner prescribed by a trained professional.

[0287] Patients being monitored by in-hospital defibrillators and / or pacemakers may be confined to a bed or room for a significant amount of time (e.g., 90% or more of the patient's stay in the hospital). As a result, the user interface may be configured to interact with a user other than the patient (e.g., a nurse) to perform device-related functions such as initial device baseline, setting and adjusting patient parameters, and replacing device batteries.

[0288] In an implementation, examples of therapeutic medical devices may include a short-term continuous monitoring defibrillator and / or pacing device, such as a short-term outpatient wearable defibrillator. For example, a physician may prescribe such a short-term outpatient wearable defibrillator for a patient presenting with syncope. The wearable defibrillator may 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 an abnormal pattern may occur before, during, or after the onset of symptoms. In this exemplary implementation of a short-term wearable defibrillator, the electrode assembly may be adherently attached to the patient's skin and have a configuration similar to that of the in-hospital defibrillator described above.

[0289] Figures 1 to 5C, 9A to B and 12A-13C show exemplary medical devices 10 (e.g., devices 10A to 10G), 100, 800, 900, wherein these exemplary medical devices are external, mobile, and wearable by patients, and are configured to implement one or more configurations described herein. For example, medical devices 10, 100, 800 can be non-invasive medical devices configured to be substantially external to the patient's body. Such medical devices can be, for example, mobile medical devices that can and are designed to move with the patient as the patient goes about his or her daily affairs. The exemplary medical devices described herein can be attached to the patient's body via attachment pads and / or via wearable supports and / or support garments worn around the patient's torso. For example, the medical device can be a wearable cardioverter defibrillator. Such wearable defibrillators are typically worn almost continuously or substantially continuously for 2 to 3 months at a time. During the period of time that the patient is wearing the wearable defibrillator, the wearable defibrillator may be configured to continuously or substantially continuously monitor the patient's vital signs, and may be configured to deliver one or more therapeutic electrical pulses to the patient when it is determined that treatment is required. For example, such a therapeutic shock may be a pacing, defibrillation, or transcutaneous electrical nerve stimulation (TENS) pulse. In some implementations, the medical device 10, 100, 800, 900 may be specified for long-term wearing durations and include a wearable support and / or support garment. In some implementations, the medical device 10, 100, 800, 900 may be specified for short-term wearing durations and rely solely on an adhesive without one or more additional wearable supports and / or support garments to provide reliability and patient comfort throughout the wearing duration.

[0290] In an example, a medical device may 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 a patient. In a specific implementation, the physiological sensor may include additional components, such as accelerometers, vibration sensors, and other measurement devices for recording additional parameters. For example, the physiological sensor may also be configured to detect other types of patient physiological parameters and vibration signals, such as tissue fluid levels, heart vibrations, lung vibrations, breathing-related vibrations of anatomical features in the airway path, patient movement, etc. An exemplary physiological sensor may include an ECG sensor, wherein the ECG sensor includes a metal electrode with an oxide coating, such as a tantalum pentoxide electrode, etc., as described in, for example, U.S. Patent No. 6,253,099 entitled "Cardiac Monitoring Electrode Apparatus and Method", the entire contents of which are incorporated herein by reference.

[0291] In an example, the physiological sensor may include a heart rate sensor for detecting heartbeats and monitoring the patient's heart rate. For example, such a heart rate sensor may include an ECG sensor and the related circuits 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 an artery of the patient. In an implementation, the heart rate sensor may be worn around the patient's wrist, such as 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 connected to the patient's skin.

[0292] In some examples, the treatment electrode 110 may also be configured to include a sensor configured to detect ECG signals 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 the patient's body if the medical device 100, 800 determines that such treatment is approved based on the signal detected by the ECG sensor 115 and processed by the processor 118. Exemplary treatment electrodes 110 may include conductive metal electrodes such as stainless steel electrodes, wherein in a specific implementation, the conductive metal electrode includes one or more conductive gel deployment devices configured to deliver conductive gel to the metal electrode before delivering the therapeutic shock.

[0293] In some implementations, a medical device as described herein may be configured to switch between a therapeutic medical device and a monitoring medical device, wherein the monitoring medical device is configured to monitor only the patient (e.g., not provide or perform any therapeutic functions). The therapeutic element may be deactivated (e.g., by a physical or software switch), thereby essentially causing the therapeutic medical device to behave as a monitoring medical device for a specific physiological purpose or a specific patient. As an example of a software switch, an authorized person may access a protected user interface of the medical device and select a preconfigured option or perform some other user action via the user interface to deactivate the therapeutic element of the medical device.

[0294] Figure 16 Schematic diagram of an exemplary component horizontal view of a medical device. Figure 16 As shown, the medical device housing 120 may include a therapy 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, ECG data acquisition and conditioning circuitry 125, an alarm manager 214, at least one processor 118, and one or more capacitors 135. The patient monitoring medical device may include a device that is associated with a patient. Figure 16Components similar to those described above, but not including the therapy delivery circuit 130. Optionally, the patient monitoring medical device may include components similar to those described above, but not including the therapy delivery circuit 130. Figure 16 The assembly described has similar components, but includes a switching mechanism for disabling the therapy delivery circuit 130.

[0295] Therapy delivery circuit 130 is coupled to two or more therapy electrodes 110 configured to provide therapy to a patient. Figure 16 As shown, in an example, at least one of the two or more therapy electrodes 110 is within the housing 120, and the other of the two or more therapy electrodes 110 is remote from the housing 120. For example, the therapy delivery circuit 130 includes or is operably connected to circuit components configured to generate and provide a therapy shock. The circuit components include, for example, resistors, one or more capacitors, relays and / or switches, bridges such as H-bridge 228 (e.g., an H-bridge including multiple insulated gate bipolar transistors (or IGBTs) for delivering and intercepting therapy pulses), voltage and / or current measurement components, and other similar circuits arranged and connected so that the circuit works 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.

[0296] Pacing pulses may be used to treat cardiac arrhythmias such as bradycardia (e.g., less than 30 beats per minute in some implementations) and tachycardia (e.g., more than 150 beats per minute in some implementations) using, for example, fixed-rate pacing, demand pacing, anti-tachycardia pacing, etc. Defibrillation pulses may be used to treat ventricular tachycardia and / or ventricular fibrillation.

[0297] In an implementation, the treatment electrodes 110 each have a conductive surface suitable for placement near the patient's skin and have an impedance reducing component contained therein or thereon for reducing the impedance between the treatment electrode and the patient's skin. As previously described with respect to implementations, the treatment electrodes each 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 adherently coupled patient-wearable arrhythmia monitoring and treatment device 100, 800 may include a gel deployment circuit configured to cause delivery of a conductive gel substantially proximate to a treatment site (e.g., a surface of the patient's skin in contact with the treatment electrode 110) prior to delivering a therapeutic shock to the treatment site. As described in U.S. Pat. No. 9,008,801, entitled “WEARABLE THERAPUETIC DEVICE,” issued on April 14, 2015 (hereinafter “the '801 patent,” which is incorporated herein by reference in its entirety), a gel deployment circuit can be configured to cause delivery of a conductive gel immediately prior to delivery of a therapeutic shock to a treatment site or within a short time interval (e.g., within about 1 second, 5 seconds, 10 seconds, 30 seconds, or one minute) prior to delivery of a therapeutic shock to a treatment site. Such a gel deployment circuit can be coupled to or integrated within the first component 102, 802, the second component 107, 807, and / or the third component of the device.

[0298] In the event that a treatable cardiac condition is detected and no patient response is received after the device prompts, the gel deployment circuit can be signaled to deploy the conductive gel. In some examples, the gel deployment circuit can be constructed as one or more separate and independent gel deployment modules. These modules can be configured to receive a removable and / or replaceable gel box (e.g., a box containing one or more conductive gel reservoirs). As such, the gel deployment circuit can be permanently disposed in the device as part of the treatment delivery system, while the box can be removable and / or replaceable.

[0299] 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 implementations, the gel deployment pack including the one or more gel reservoirs and associated gel deployment circuits may be removable and / or replaceable. In some examples, the gel deployment pack including the one or more gel reservoirs and associated gel deployment circuits and the therapy electrode may be integrated into a therapy electrode assembly, where the therapy electrode assembly may be removed and replaced as a single unit after use or in the event of damage or breakage.

[0300] continue Figure 16 Description of an exemplary medical device, in an implementation such as Figure 17As shown, the one or more capacitors 135 are multiple capacitors (e.g., two, three, four or more capacitors) that comprise a capacitor bank 402. These capacitors 135 can be switched to be connected in series during the 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 a patient-worn medical device are provided herein in subsequent sections.

[0301] 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., a charging direction). The amplitude and width of the two phases of the energy waveform can be automatically adjusted to deliver a predetermined amount of energy.

[0302] The data storage 204 may 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 may be configured to store executable instructions and data for operating the medical device. In a specific implementation, the data storage 204 may include executable instructions that, when executed, are configured to cause the processor 118 to perform one or more functions.

[0303] In some examples, the network interface 206 can facilitate information communication between the medical device and one or more other devices or entities through 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 device. The network interface 206 may include a communication circuit for sending data according to the Bluetooth wireless standard to exchange such data to an intermediate device (e.g., a base station, a "hotspot" device, a smart phone, a tablet computer, a portable computing device, and / or other devices near the wearable medical device 100) over a short distance. 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 technology (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellular standards) and / or long-term evolution (LTE) technology or GSM / EDGE and UMTS / HSPA technology 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.

[0304] In a specific implementation, the user interface 208 may include one or more physical interface devices such as input devices, output devices, and combined input / output devices, and a software stack configured to drive the operation of the device. These user interface elements may present visual, audio, and / or tactile content. Thus, the user interface 208 may receive input or provide output, thereby 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 12 and 14.) For example, the handheld user interface device may be a smartphone or other portable device configured to communicate with the processor 118 via the network interface 206. In implementations, the handheld user interface device may also be an intermediary device for facilitating the transfer of information from the device to a remote server.

[0305] As described, the medical device may also include at least one battery 140 configured to provide power to one or more components such as one or more capacitors 135. The battery 140 may include a rechargeable multi-cell battery pack. In an exemplary implementation, the battery 140 may include three or more 2200mAh lithium-ion batteries for providing power to other device components. For example, the battery 140 may provide a power output ranging from 20mA to 1000mA (e.g., 40mA) output, and may support 24 hours, 48 ​​hours, 72 hours, or more of run time between each charge. As previously described in detail, in a specific implementation, the battery capacity, run time, and type (e.g., lithium ion, nickel cadmium, or nickel metal hydride) may be varied to best suit the specific application of the medical device.

[0306] The sensor interface 212 may be coupled to one or more sensors configured to monitor one or more physiological parameters of a patient. Figure 16 As shown, the sensor can be coupled to a medical device controller (e.g., processor 118) via a wired or wireless connection. The sensor can include one or more sensing electrodes (e.g., ECG sensor 115), a vibration sensor 224, and an interstitial fluid monitor 226 (e.g., based on an ultra-wideband radio frequency device). For example, the sensor interface 212 can include an ECG circuit (such as Figure 6 and 8 ECG acquisition and conditioning circuit 125) and / or accelerometer circuit, each of which is configured to receive and condition the corresponding sensor signal.

[0307] The sensing electrodes can, for example, monitor the patient's ECG information. 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 be dispersed in 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.

[0308] The vibration sensor 224 can detect the patient's heart or lung (cardiopulmonary) vibration information. 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 the electromechanical activation time (EMAT), the percentage of EMAT (%EMAT), the systolic dysfunction index (SDI), the left ventricular diastolic perfusion time (LDPT) and the left ventricular contraction 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 area of ​​the apex beat.

[0309] The vibration sensor 224 may include an acoustic sensor configured to detect vibrations from the heart or lung (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 airflow during breathing. The vibration sensor 224 may also include a multi-channel accelerometer, such as a three-channel accelerometer configured to sense movement in each of three orthogonal axes so that patient movement / body position can be detected. The vibration sensor 224 may send information describing cardiopulmonary vibration information or patient position / movement to the sensor interface 212 for subsequent analysis.

[0310] The tissue fluid monitor 226 can use radio frequency (RF)-based technology to assess the cumulative fluid level over time. For example, the tissue fluid monitor 226 can be configured to measure the fluid content (e.g., time-varying changes and absolute levels) in the lungs to diagnose and subsequently observe pulmonary edema or pulmonary congestion in patients with heart failure. The tissue fluid monitor 226 may include one or more antennas, wherein the one or more antennas are configured to guide RF waves through the patient's tissue and measure output RF signals in response to the waves that have passed through the tissue. In a specific implementation, the output RF signal includes parameters 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.

[0311] The sensor interface 212 may 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 sensors, the data may be directed by the processor 118 to appropriate components within the medical device. For example, if cardiac data is collected by the cardiopulmonary vibration sensor 224 and sent to the sensor interface 212, the sensor interface 212 may send the data to the processor 118, which in turn relays the data to the cardiac event detector. The cardiac event data may also be stored on the data store 204.

[0312] The alarm manager 214 may be configured to manage alarm profiles and notify one or more intended recipients of events specified in the alarm profile as being of interest to the intended recipients. These intended recipients may include external entities such as users (e.g., patients, physicians, other caregivers, patient care representatives, and other authorized monitoring personnel) and computer systems (e.g., monitoring systems or emergency systems). The alarm manager 214 may be implemented using hardware or a combination of hardware and software. For example, in some examples, the alarm manager 214 may be implemented as a software component stored in the data store 204 and executed by the processor 118. In this example, the instructions included in the alarm manager 214 may cause the processor 118 to configure the alarm profile and notify the intended recipient according to the configured alarm profile. In some examples, the alarm manager 214 may be an application specific integrated circuit (ASIC), which is connected to the processor 118 and is configured to manage the alarm profile and notify the intended recipient using the alarm specified in the alarm profile. Therefore, the example of the alarm manager 214 is not limited to a specific hardware or software implementation.

[0313] In some implementations, the processor 118 includes one or more processors (or one or more processor cores), wherein each of the one or more processors is configured to perform a series of instructions for obtaining operation data and / or controlling the operation of other components of the medical device. In some implementations, when performing a specific process (e.g., cardiac monitoring), the processor 118 may be configured to perform a judgment based on a 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 the processor 118 and / or other processors or circuits to which the processor 118 is communicatively connected to perform subsequent processing to be performed. Therefore, the processor 118 reacts to a specific input stimulus in a specific manner and generates a corresponding output based on the input stimulus. In some exemplary cases, the processor 118 may continue to perform a series of logical transitions, wherein various internal register states and / or other bit unit states inside or outside the processor 118 may be set to logic high or logic low. The processor 118 may be configured to execute functions stored in software. For example, such software may be stored in a data storage connected to the processor 118 and configured to cause the processor 118 to continue to perform a series of various logical decisions that cause the function to be executed. The various components described herein as executable by the 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. The processor 118 may be a multi-core processor, such as 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 includes services provided by the operating system that may be used for file system operations, display and audio generation, basic networking, firewalls, data encryption, and communications.

[0314] In implementations, the therapy delivery circuit 130 includes or is operably connected to circuit components configured to generate and deliver a therapeutic shock. As previously described, the circuit components include, for example, resistors, one or more capacitors 135, relays and / or switches, bridges such as 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, wherein these similar circuit components are configured and connected so that the circuit components work in cooperation with the therapy delivery circuit 130 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.

[0315] In an implementation, the device 100, 800 also includes an electrical energy source, such as one or more capacitors 135, for storing and providing energy to the therapy delivery circuit 130. The one or more therapy pulses are defibrillation pulses of electrical energy, and the one or more treatable arrhythmias 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 the one or more capacitors 135 and discharging the energy stored in the one or more capacitors 135 into the patient. For example, the therapy delivery circuit 130 may 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 one or more capacitors 135 can be controlled by, for example, an H-bridge for controlling the discharge of energy into a patient, such as the H-bridge circuit described in U.S. Patent 6,280,461, entitled “PATIENT-WORN ENERGY DELIVERY APPARATUS,” issued on August 28, 2001, and U.S. Patent 8,909,335, entitled “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.

[0316] like Figure 17 , the H-bridge 228 is electrically coupled to a capacitor bank 402 including four capacitors 135a-d, wherein the four capacitors 135a-d are charged in parallel during the preparation phase 227a and discharged in series during the treatment phase 227b. In some implementations, the capacitor bank 402 may include more or less than four capacitors 135. During the treatment phase 227b, the H-bridge 228 applies a treatment pulse, wherein the treatment 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, wherein 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 in 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.

[0317] Although the subject matter contained herein has been described in detail for illustrative purposes, it should be understood that such details are used for that purpose only and that the invention is not limited to the disclosed embodiments, but rather 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 present 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.

[0318] Other examples are within the scope and spirit of the specification and claims. In addition, some of the functions described above can be implemented using software, hardware, firmware, hard wiring, or any combination of these. Features that implement functions can also be physically located in various locations, including being distributed so that parts of the functions are implemented at different physical locations.

Claims

1. A patient-wearable arrhythmia monitoring and treatment device, include: an anterior attachment coupling pad configured for attachment to an anterior upper region of a patient's torso, wherein the anterior attachment coupling pad has a weight in the range of 0.05 to 1.0 kg; a rear attachment coupling pad configured for attachment to a rear region of the torso, wherein the rear attachment coupling pad has a weight in the range of 0.05 to 1.0 kg; a therapy electrode pair configured to contact the patient's torso and deliver one or more therapy pulses, one therapy electrode of the therapy electrode pair being integrated within the anterior attachment pad and the other therapy electrode of the therapy electrode pair being integrated within the posterior attachment pad; a plurality of ECG sensing electrodes integrated with the anterior attachment coupling pad and the posterior attachment coupling pad and configured to contact the patient's torso; a device controller in wired communication with the front attachment connection pad and the rear attachment connection pad, the device controller comprising: a housing configured with a side profile having an approximately teardrop-shaped, right-angled triangular appearance with rounded surfaces and edges, the approximately teardrop shape of the housing configured to counteract peel forces; ECG acquisition and conditioning circuitry disposed within the housing and electrically coupled to the plurality of ECG sensing electrodes to provide at least one ECG signal for the patient; a therapy delivery circuit disposed within the housing and configured to deliver one or more therapy pulses to the patient via electrical connection to the therapy electrode pair; A processor is disposed within the housing and is in operable communication with the ECG acquisition and conditioning circuitry and the therapy delivery circuitry.

2. The device according to claim 1, in, The processor is configured to: analyzing at least one ECG signal of the patient and detecting one or more treatable arrhythmias based on the analysis; as well as Upon detection of one or more treatable arrhythmias, the therapy delivery circuit is caused to deliver up to five therapy pulses to the patient.

3. The device according to claim 1 or 2, in, The one or more therapy pulses include at least one of a pacing pulse and a defibrillation pulse.

4. The device according to claim 1 or 2, in, The one or more treatable arrhythmias include at least one of ventricular fibrillation and ventricular tachycardia.

5. The device according to claim 1 or 2, in, The device controller also includes at least one capacitor disposed within the housing, the at least one capacitor configured to provide energy for the one or more therapy pulses.

6. The device according to claim 5, in, The device controller also includes at least one rechargeable battery disposed within the housing to provide power to at least the processor and the at least one capacitor.

7. The device according to claim 1, further comprising: include: A wearable support integrated with the anterior attachment coupling pad and the posterior attachment coupling pad and configured to at least partially trace a path from the anterior upper region of the torso, over the patient's shoulders, and terminating at the posterior region of the torso, wherein the wearable support is 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.

8. The device according to claim 7, further comprising: include: A breathable adhesive is disposed between at least a portion of the wearable support and a shoulder of the patient.

9. The device according to claim 7 or 8, in, The wearable support is a garment.

10. The device according to claim 9, in, The wearable support is at least one of a vest, a shirt, a ribbon, a strap, a belt, and a shoulder harness.

11. The device according to claim 10, in, The shoulder strap is made of non-adhesive stretchable fabric.

12. The device according to claim 11, in, The non-adhesive, stretchable fabric includes conductive threads in communication with the front and rear adhesion coupling pads.

13. The device according to claim 11, in, The tensile strength of the shoulder strap is at least 10% greater than the load applied by at least one of the front attachment coupling pad and the rear attachment coupling pad and is no more than 10 times the load applied by at least one of the front attachment coupling pad and the rear attachment coupling pad.

14. The device according to claim 11, in, The shoulder strap has an elongation percentage of 10% to 200%.

15. The device according to claim 11, in, The elasticity of the shoulder strap along the long axis of the shoulder strap is relatively lower than the elasticity along the short axis of the shoulder strap.

16. The device according to claim 10, in, The shoulder strap is integrally formed with at least one of the front attachment coupling pad and the rear attachment coupling pad.

17. The device according to claim 7, in, The wearable support includes a shoulder strap having a curvature that conforms to the contour of the patient's body.

18. The device according to claim 17, in, The shoulder strap is designed into a shape matching the body shape of the patient by at least one of molding, 3D printing and knitting.

19. The device according to claim 18, in, The shoulder strap is integrally formed with at least one of the front attachment coupling pad and the rear attachment coupling pad.

20. The device according to claim 17, in, The shoulder harness is designed into a shape matching the outer shape of the receiving part of the patient's body by at least one of molding, 3D printing and knitting.

21. The device according to claim 7 or 8, in, The wearable support includes a shoulder strap further comprising at least one length adjuster configured to tension the shoulder strap.

22. The device according to claim 21, in, The at least one length adjuster is at least one of a draw cord, a belly band, a lockable elastic draw cord, a zipper and spring loaded toggle stop, a ratchet strap, an adjustable buckle, an extendable and removable hook and loop strap, a tie strap, a snap and a button.

23. The device according to claim 7 or 8, in, The wearable support comprises a higher moisture vapor transmission rate (MVTR) than either or both of the front attachment coupling pad and the back attachment coupling pad.

24. The device according to claim 23, in, The wearable support includes an MVTR in the range of at least 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 50 to 1000 g / m 2 / 24 hours.

25. The device according to claim 7 or 8, in, The processor is configured to: analyzing at least one ECG signal of the patient and detecting one or more treatable arrhythmias based on the analysis; as well as Upon detection of one or more treatable arrhythmias, the therapy delivery circuit is caused to deliver up to five therapy pulses to the patient.

26. The device according to claim 25, in, The one or more therapy pulses include at least one of a pacing pulse and a defibrillation pulse.

27. The device according to claim 25, in, The one or more treatable arrhythmias detected include at least one of ventricular fibrillation and ventricular tachycardia.

28. The device according to claim 25, in, The device controller also includes at least one capacitor disposed within the housing, the at least one capacitor configured to provide energy for the one or more therapy pulses.

29. The device according to claim 28, in, The device controller also includes at least one power source disposed within the housing to provide power to the at least one capacitor.

30. The device according to claim 1, in, The water vapor permeability of the device is greater than 100 g / m 2 / 24 hours.

31. The device according to claim 30, in, The front and rear attachment pads are configured for adherence to a torso for an extended duration.

32. The device according to claim 31, in, The long-term duration is a duration including and up to at least one of about 2 weeks, about 1 month, about 6 weeks, about 8 weeks, and about 2 months.

33. The device according to claim 31, in, The long-term duration includes and is up to at least one of about 6 months, about 1 year, and about 2 years.

34. The device according to claim 30, in, 50 to 75% of the area occupied by the front side attachment pad has a range of 500 to 1200 g / m 2 / day MVTR, and 25 to 50% of the area occupied by the front side attachment pad has a range of 250 to 500 g / m 2 MVTR / day.

35. The device according to any one of claims 30 to 34, further comprising: include: A breathable anisotropic conductive gel is disposed between the rear attachment pad and the torso.

36. The device according to claim 35, in, One or more patches of air permeable anisotropic conductive gel are configured to be disposed between each therapy electrode in the therapy electrode pair and the torso.

37. The device according to claim 35, in, The ratio of the area occupied by the air permeable anisotropic gel to the area occupied by the rear attachment coupling pad ranges from 0.30 to 0.

75.

38. The device according to claim 37, in, The ratio of the area occupied by the adhesive to the area occupied by the rear side adhesive coupling pad is in the range of 0.05 to 0.

25.

39. The device according to any one of claims 30 to 34, in, The processor is configured to: analyzing at least one ECG signal of the patient and detecting one or more treatable arrhythmias based on the analysis; as well as Upon detection of one or more treatable arrhythmias, the therapy delivery circuit is caused to deliver up to five therapy pulses to the patient.

40. The device according to claim 39, in, The one or more therapy pulses include at least one of a pacing pulse and a defibrillation pulse.

41. The device according to claim 39, in, The one or more treatable arrhythmias detected include at least one of ventricular fibrillation and ventricular tachycardia.

42. The device according to claim 39, in, The device controller also includes at least one capacitor disposed within the housing to provide energy for the one or more therapy pulses.

43. The device according to claim 42, further comprising: include: At least one rechargeable battery is disposed within the housing and is configured to provide power to the at least one capacitor.

44. The device according to claim 1, in, The housing is disposed on the first pad or the second pad.

45. The device according to claim 44, in, The processor is configured to: analyzing at least one ECG signal of the patient and detecting one or more treatable arrhythmias based on the analysis; as well as Upon detection of one or more treatable arrhythmias, the therapy delivery circuit is caused to deliver up to five therapy pulses to the patient.

46. ​​The device according to claim 44 or 45, in, The device controller also includes at least one capacitor disposed within the housing to provide energy for the one or more therapy pulses.

47. The device according to claim 46, in, The device controller also includes at least one power source disposed within the housing and configured to provide power to the at least one capacitor.

48. The device according to claim 44 or 45, in, The one or more therapy pulses include at least one of a pacing pulse and a defibrillation pulse.

49. The device according to claim 44 or 45, in, The ratio of the weight of the device to the area occupied by the device ranges from 0.008 to 0.030 lb / in 2 .

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