Wearable heart device

Abstract

The present application relates to wearable cardiac devices. Systems and methods for providing arrhythmia treatment to a patient are also described. For example, the system includes an arrhythmia monitoring and treatment component configured to be worn on the torso of a patient. The component has a housing that extends inconspicuously from the skin surface of the patient. The component is configured to provide treatment when one or more arrhythmia conditions of the patient are detected. At least one first user response button is disposed on the component at a first position on the torso hidden under clothing, and at least one second user response button is configured to be worn at a second position on the patient's body, the second position being a position other than the torso that is accessible to the patient. The system suspends an upcoming treatment upon receiving a user input from one of the at least one first user response button or the at least one second user response button.

Description

Technical Field

[0001] The present invention relates to wearable cardiac monitoring and treatment devices. Background Art

[0002] 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.

[0003] 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 to 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.

[0004] Cardiac arrest can occur with 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), resulting in the heart providing inadequate levels of blood flow to the brain and other vital organs for sustaining 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.

[0005] 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

[0006] In one example, a system for providing arrhythmia treatment to a patient is partially worn under the patient's clothing and includes an arrhythmia monitoring and treatment component configured to be worn on the patient's torso. The arrhythmia monitoring and treatment component has a housing extending from at least about 1 cm to about 10 cm from the patient's skin surface, and the arrhythmia monitoring and treatment component is configured to provide treatment to the patient when one or more arrhythmia conditions of the patient are detected. The system includes: at least one first user response button, which is disposed at a first position on the patient's torso on the arrhythmia monitoring and treatment component so that the at least one first user response button is hidden under the patient's clothing; and at least one second user response button, which is configured to be worn at a second position at a position on the patient's body other than the torso, so that the at least one second user response button is accessible to the patient. The system includes a processor disposed on an arrhythmia monitoring and treatment component, the processor being configured to: analyze ECG signals of a patient received via the arrhythmia monitoring and treatment component to detect one or more arrhythmia conditions of the patient; cause the arrhythmia monitoring and treatment component to provide a warning of an upcoming therapy to be delivered to the patient in response to the detected one or more arrhythmia conditions of the patient; receive user input in response to the warning of the upcoming therapy from at least one of at least one first user response button and at least one second user response button; and cause the arrhythmia monitoring and treatment component to pause the upcoming therapy.

[0007] Implementations of the system may include one or more of the following features.

[0008] In an example, the housing of the arrhythmia monitoring and treatment assembly extends from a range of 2 cm to 9 cm from the patient's skin surface.

[0009] In an example, the housing of the arrhythmia monitoring and treatment assembly extends from 4 cm to 7 cm from the patient's skin surface.

[0010] In an example, the longest axis of the arrhythmia monitoring and treatment assembly is 2 to 20 times longer than the highest height of the housing from the skin surface.

[0011] In an example, the vertical side profile of the arrhythmia monitoring and treatment assembly is asymmetric about one or both of the horizontal axis and the vertical axis. In an example, the position of the highest height of the arrhythmia monitoring and treatment assembly from the skin surface is disposed lower on the torso than the position of the lowest height of the arrhythmia monitoring and treatment assembly from the skin surface. The ratio of the highest height to the lowest height may be in the range of 10:1 to 2:1.

[0012] In an example, the arrhythmia monitoring and treatment components cover approximately 10% to 70% of the total surface area of ​​the patient's torso.

[0013] In one example, a system for providing arrhythmia treatment to a patient is partially worn under the patient's clothing and includes an arrhythmia monitoring and treatment component configured to be worn on the patient's torso. The component includes an asymmetric shell extending from the patient's skin surface to a maximum height of no more than 10 cm. The arrhythmia monitoring and treatment component is configured to provide treatment to the patient when one or more arrhythmia conditions of the patient are detected. The system includes: at least one first user response button, which is disposed at a first position on the patient's torso on the arrhythmia monitoring and treatment component so that the at least one first user response button is hidden under the patient's clothing; and at least one second user response button, which is configured to be worn at a second position at a position of the patient's body other than the torso, so that the at least one second user response button is accessible to the patient. The system includes a processor disposed on an arrhythmia monitoring and treatment component, the processor being configured to: analyze ECG signals of a patient received via the arrhythmia monitoring and treatment component to detect one or more arrhythmia conditions of the patient; cause the arrhythmia monitoring and treatment component to provide a warning of an upcoming therapy to be delivered to the patient in response to the detected one or more arrhythmia conditions of the patient; receive user input in response to the warning of the upcoming therapy from at least one of at least one first user response button and at least one second user response button; and cause the arrhythmia monitoring and treatment component to pause the upcoming therapy.

[0014] Implementations of the system may include one or more of the following features.

[0015] In an example, the housing of the arrhythmia monitoring and treatment assembly extends from a range of 2 cm to 9 cm from the patient's skin surface.

[0016] In an example, the housing of the arrhythmia monitoring and treatment assembly extends from 4 cm to 7 cm from the patient's skin surface.

[0017] In an example, a vertical side profile of an arrhythmia monitoring and treatment assembly is asymmetric about one or both of a horizontal axis and a vertical axis. In an example, a position of a highest height of an arrhythmia monitoring and treatment assembly from a skin surface is disposed lower on the torso than a position of a lowest height of the arrhythmia monitoring and treatment assembly from a skin surface. In an example, a ratio of the highest height to the lowest height is in a range of 10:1 to 2:1. In an example, an asymmetric housing includes at least one of one or more batteries and one or more capacitors disposed within a portion of the housing having a highest height. In an example, one or more batteries have a combined envelope volume of one quarter or less of a volume defined by the housing of the arrhythmia monitoring and treatment assembly and the skin surface of the patient. One or more batteries may have a capacity in a range of 200 to 8000 mAh.

[0018] In one example, a system for providing arrhythmia treatment to a patient is partially worn under the patient's clothing and includes an arrhythmia monitoring and treatment component configured to be worn on the patient's torso. The arrhythmia monitoring and treatment component includes a housing having a maximum height extending from the patient's skin surface of no more than 10 cm. The arrhythmia monitoring and treatment component is configured to provide treatment to the patient when one or more arrhythmia conditions of the patient are detected. The arrhythmia monitoring and treatment component includes a flexible skin interface layer configured to engage with the patient's skin surface, and the longest axis of the arrhythmia monitoring and treatment component is 2 to 20 times longer than the maximum height of the housing from the skin surface. The system includes: at least one first user response button, which is set at a first position on the patient's torso on the arrhythmia monitoring and treatment component so that the at least one first user response button is hidden under the patient's clothing; and at least one second user response button, which is configured to be worn at a second position at a position of the patient's body other than the torso, so that the at least one second user response button is accessible to the patient. The system includes a processor disposed on an arrhythmia monitoring and treatment component, the processor being configured to: analyze ECG signals of a patient received via the arrhythmia monitoring and treatment component to detect one or more arrhythmia conditions of the patient; cause the arrhythmia monitoring and treatment component to provide a warning of an upcoming therapy to be delivered to the patient in response to the detected one or more arrhythmia conditions of the patient; receive user input in response to the warning of the upcoming therapy from at least one of at least one first user response button and at least one second user response button; and cause the arrhythmia monitoring and treatment component to pause the upcoming therapy.

[0019] Implementations of the system may include one or more of the following features.

[0020] In an example, the flexible skin interface layer includes rubber and elastomer in a ratio ranging from 9:6 to 4:1, and the flexible skin interface layer is configured to flex and bend with the patient's skin.

[0021] In an example, the vertical side profile of the arrhythmia monitoring and treatment assembly is asymmetric about one or both of the horizontal axis and the vertical axis. In an example, the position of the highest height of the housing from the skin surface is set lower on the torso compared to the position of the lowest height of the housing. The ratio of the highest height to the lowest height can be in the range of 10:1 to 2:1.

[0022] In an example, the arrhythmia monitoring and treatment assembly covers approximately 10% to 70% of the total surface area of ​​the patient's torso.In an example, the flexible skin interface layer follows a continuous full circumferential path around the patient's torso in a range of 90 degrees to 360 degrees.

[0023] In an example, 10% to 90% of the flexible skin interface layer is covered with one or more components of the monitoring and treatment assembly, and the remaining 90% to 10% of the flexible skin interface layer extends beyond the perimeter around the one or more components.

[0024] In one example, a system for providing arrhythmia treatment to a patient is partially worn under the patient's clothing. The system includes an arrhythmia monitoring and treatment component configured to be worn on the patient's torso and inconspicuously extending from the patient's skin surface. The arrhythmia monitoring and treatment component is configured to provide treatment to the patient when one or more arrhythmia conditions of the patient are detected. The system includes: at least one first user response button, which is disposed at a first position on the patient's torso on the arrhythmia monitoring and treatment component so that the at least one first user response button is hidden under the patient's clothing; and at least one second user response button, which is configured to be worn at a second position at a position of the patient's body other than the torso, so that the at least one second user response button is accessible to the patient. The system includes a processor disposed in the arrhythmia monitoring and treatment component. The processor is configured to: analyze ECG signals of a patient received via an arrhythmia monitoring and treatment component to detect one or more arrhythmia conditions of the patient; cause the arrhythmia monitoring and treatment component to provide a warning of an upcoming therapy to be delivered to the patient in response to the detected one or more arrhythmia conditions of the patient; receive user input in response to the warning of the upcoming therapy from at least one of at least one first user response button and at least one second user response button; and cause the arrhythmia monitoring and treatment component to pause the upcoming therapy.

[0025] In an example, the arrhythmia monitoring and treatment component also includes a plurality of ECG sensing electrodes and associated circuits configured to monitor the patient's ECG signals, and a plurality of treatment electrodes and associated treatment delivery circuits configured to deliver treatment to the patient. In an example, the processor is connected to a plurality of ECG sensing electrodes and associated circuits configured to monitor the patient's ECG signals, and a plurality of treatment electrodes and associated treatment delivery circuits. The processor is also configured to: analyze the patient's ECG signals received via the plurality of ECG sensing electrodes and detect one or more treatable arrhythmias based on the ECG signals, cause the treatment delivery circuit to deliver one or more defibrillation pulses to the patient via the plurality of treatment electrodes when one or more treatable arrhythmias are detected, and cause the plurality of treatment electrodes to stop delivering one or more defibrillation pulses to the patient when receiving a user input in response to a warning of an impending treatment.

[0026] Implementations of the system may include one or more of the following features.

[0027] In an example, the system also includes a garment configured to be worn about a patient's torso to couple the arrhythmia monitoring and treatment device to the patient's torso such that when therapy is delivered, one or more defibrillation or pacing pulses are discharged into the torso via the plurality of therapy electrodes.

[0028] In an example, a plurality of ECG sensing electrodes and a plurality of therapy electrodes are integrated into a first pad configured to be coupled to a patient's torso. The first pad may include a pressure-sensitive adhesive configured to couple the first pad to the patient's torso. In an example, the system further includes a second pad configured to be coupled to the patient's torso, and at least one therapy electrode integrated with the second pad. The at least one therapy electrode integrated with the second pad may be in wired communication with the therapy delivery circuit.

[0029] In an example, the at least one second user response button and the at least one first user response button disposed on the arrhythmia monitoring and treatment assembly are configured to be worn simultaneously by the patient.

[0030] In an example, the system further comprises a wearable article. At least one second user response button is provided by the wearable article, and the wearable article further comprises a communication circuit configured to send user input from the at least one second user response button to a processor disposed in the arrhythmia monitoring and treatment component. In an example, the wearable article comprises at least one of: a bracelet at an accessible location, a ring, a retractable pendant, a necklace, a band configured to be worn on clothing, a ribbon configured to be worn on clothing, a bolo tie, a watch, an armband, or a patch configured to be worn on clothing of a patient.

[0031] In an example, the wearable article is configured to be disposed at least partially under the patient's clothing.

[0032] In an example, the processor and the at least one second user response button are in wireless communication.

[0033] In an example, at least one second user response button is uniquely paired with the arrhythmia monitoring and treatment component.

[0034] In an example, the system further includes a wired link extending between the arrhythmia monitoring and treatment component and the wearable article to enable the communication circuit and the processor to communicate wired. The wired link can be configured to be detachable from one or both of the arrhythmia monitoring and treatment component and the wearable article. At least one of the arrhythmia monitoring and treatment component and the wearable article can also include a retractable spool and pawl configured to adjust the length of the wired link.

[0035] In an example, the wearable article further comprises one or more sensors configured to verify the identity of the patient based on at least one of audible information, tactile-based information, signal-based information, and visual information, and to delay treatment delivery based at least in part on the verified identity. At least one of the arrhythmia monitoring and treatment device and the wearable article may also include a video camera configured to detect visual information associated with the patient. In an example, the system may also include a 3D laser ranging sensor that communicates with the video camera and is configured for at least one of feature recognition and gesture detection. In an example, the tactile-based information includes at least one of one or more touches to the wearable article, patient fingerprint detection, and repeated tapping. In an example, the signal-based information includes at least one of ECG signal detection and biometric sensing. In an example, the audible information includes at least one of voice recognition and reception of a password or phrase.

[0036] In an example, the at least one first user response button includes one or more tactile response buttons disposed on the housing of the arrhythmia monitoring and treatment assembly such that the at least one first user response button can be positioned through one or more layers of clothing. The at least one first user response button can be disposed on the housing and raised or depressed relative to a surface of the housing so as to be tactilely detectable under one or more layers of clothing.

[0037] In an example, the wearable article further includes at least one of a mechanically actuatable button, a touch screen interface, and at least one touch screen button.

[0038] In one example, a method of treating a cardiac arrhythmia includes providing an arrhythmia monitoring and treatment device configured to be worn on the torso of a patient to be at least partially hidden under the patient's clothing. The device is configured to provide treatment to the patient when one or more arrhythmia conditions of the patient are detected, and includes a plurality of ECG sensing electrodes and associated circuits configured to monitor the patient's ECG signals. The device includes: at least one first user response button, which is disposed on the device at a first position on the patient's torso so that the at least one first user response button is hidden under the patient's clothing; and a processor, which communicates with the at least one first user response button and the plurality of ECG sensing electrodes and associated circuits. The method includes providing at least one second user response button, which is configured to be worn at a second position at a position other than the torso of the patient's body so that the at least one second user response button is accessible to the patient, wherein the at least one second user response button communicates with the processor. The method includes: analyzing, by a processor, an ECG signal of a patient received via a device to detect one or more arrhythmia conditions of the patient; causing, by the processor, the device to provide a warning of an upcoming therapy to be delivered to the patient in response to the detected one or more arrhythmia conditions of the patient; receiving, at the processor, user input from at least one of at least one first user response button and at least one second user response button in response to the warning of the upcoming therapy; and causing, by the processor, the device to pause the upcoming therapy. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1A Depicted is a schematic front view of an exemplary wearable cardiac monitoring and treatment system including a wearable device and a wearable article.

[0040] Figure 1B Depicted is a schematic rear view of an exemplary wearable cardiac monitoring and treatment system including a wearable device and a wearable article.

[0041] Figure 2 A schematic diagram of an exemplary wearable cardiac monitoring and treatment device including a wearable support is depicted.

[0042] Figure 3 A schematic diagram of an exemplary wearable cardiac monitoring and treatment device including a wearable support and an attachment coupling portion is depicted.

[0043] Figure 4A A schematic diagram of an exemplary wearable cardiac monitoring and treatment device including a wearable support and an attachment coupling portion is depicted.

[0044] Figure 4B Depicted Figure 4AA plan view schematic diagram of a portion of an exemplary wearable cardiac monitoring and treatment device.

[0045] Figure 4C Depicted Figure 4B A side cross-sectional view of a portion of an exemplary wearable cardiac monitoring and treatment device.

[0046] Figure 5A 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.

[0047] Figure 5B 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.

[0048] Figure 5C 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.

[0049] Figure 5D 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.

[0050] Fig. 6A 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.

[0051] Figure 6B A schematic diagram of an exemplary adherently coupled wearable cardiac monitoring and treatment device including a first component mounted on a posterior side and a second component mounted on an anterior side is depicted.

[0052] Figure 6C Depicted Fig. 6A and 6B Schematic diagram of an example of an adhesively coupled portion of a wearable cardiac monitoring and treatment device.

[0053] Fig. 7A A schematic diagram of an exemplary cardiac monitoring and treatment system including an adhesively coupled wearable cardiac monitoring and treatment assembly including a first assembly and a second assembly mounted on a front side and a wearable article in wired communication with the assembly is depicted.

[0054] Figure 7BA schematic diagram of an exemplary cardiac monitoring and treatment system including an adhesively coupled wearable cardiac monitoring and treatment assembly including a first assembly and a second assembly mounted on a front side and a wearable article in wireless communication with the assembly is depicted.

[0055] Figure 8 A side cross-sectional schematic diagram of an exemplary wearable cardiac monitoring and treatment device in communication with a wearable article is depicted.

[0056] Fig. 9A A side cross-sectional schematic diagram of an exemplary ergonomic wearable cardiac monitoring and treatment device in communication with a wearable article is depicted.

[0057] Fig. 9B Depicted Fig. 9A Dimensioned asymmetric vertical side profile schematic of an exemplary ergonomic wearable cardiac monitoring and treatment device.

[0058] Fig. 9C Depicted Fig. 9A and 9B A dimensioned front view of an exemplary ergonomic wearable cardiac monitoring and treatment device.

[0059] Fig.10 Depicted is a rear perspective view of an example of an adherently coupled wearable cardiac monitoring and treatment device including a wearable support and a wearable article in communication with the device.

[0060] Fig.11 Depicted is a schematic diagram of an exemplary cardiac monitoring and treatment system including a wearable cardiac monitoring and treatment device in communication with a wearable article.

[0061] Fig.12 is a schematic diagram of an exemplary method of using a cardiac monitoring and treatment system including a wearable cardiac monitoring and treatment device in communication with a wearable article.

[0062] Fig.13 A schematic diagram of an embodiment of an attachably coupled wearable cardiac monitoring and treatment device of a cardiac monitoring and treatment system is depicted.

[0063] Fig.14 A schematic diagram of an embodiment of electrical components of an attachably coupled wearable cardiac monitoring and treatment device of a cardiac monitoring and treatment system is depicted. DETAILED DESCRIPTION

[0064] The present invention relates to a cardiac monitoring and treatment system for detecting one or more arrhythmias based on physiological signals from a patient. The system is at least partially worn under clothing. 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, etc.). The system disclosed herein includes an arrhythmia monitoring and treatment component worn under clothing. The system disclosed herein includes an article worn by a patient that communicates with the arrhythmia monitoring and treatment component. For example, the article is set at an easily accessible position on the patient's body. In implementation, both the arrhythmia monitoring and treatment component and the easily accessible wearable article include patient input features for communicating with the system and providing control inputs to the system. Such communication can, for example, include patient input for delaying or preventing the delivery of treatments (such as defibrillation or pacing shocks, etc.). In some implementations, the arrhythmia monitoring and treatment component includes a wearable medical device attached to the patient. Wearable medical devices monitor the patient's physiological conditions, such as cardiac signals, respiratory parameters, and patient activity, and deliver potentially life-saving treatment to the patient. Embodiments of arrhythmia monitoring and treatment assemblies may include a garment or wearable support for supporting one or more components on the patient's torso, a component that is adherently coupled to the patient's torso, or some combination of an adherently coupled component and a garment or wearable support.

[0065] like Figures 1A to 1B As shown, in an implementation, system 300 includes a wearable arrhythmia monitoring and treatment assembly as a patient-worn cardiac monitoring and treatment device 100. Device 100 is configured to be worn on the patient's torso 5 and to extend inconspicuously from the patient's skin surface under clothing (e.g., shirt 500) worn on device 100. In some implementations (such as Figures 1A to 1B In some implementations (such as the implementation of the invention), the various components of the device 100 are arranged around the patient's torso 5 to reduce the volume of any one component or multiple co-located components. Various treatment and monitoring components can be attached to and / or maintained against the patient's torso through clothing (such as support structure 101, etc.). In some embodiments, the support structure 101 is an attachment pad for maintaining the monitoring and treatment components against the patient's skin. In other embodiments, the structure is a tight-fitting garment and / or other uniform that includes a closure mechanism for fixing the wearable medical device 100 around the patient's torso 5.

[0066] In an implementation, the support structure 101 is a flexible skin interface layer configured to engage with a patient's skin surface and support multiple treatment and monitoring components of the wearable medical device 100. In an implementation, the flexible skin interface layer is a soft substrate configured to flex and bend with the patient's skin. In an implementation, the flexible skin interface layer includes at least rubber and elastomer in a ratio ranging from 9:6 to 4:1. In an implementation, the wearable medical device 100 is an arrhythmia monitoring and treatment assembly covering approximately 10% to 70% of the total surface area of ​​the patient's torso 5. By preventing the bulk of many components at a single location on the support structure 101, the wearable medical device 100 presents a low profile as a whole, such as Figures 1A to 1B Implementations with a low profile, wraparound support structure 101, etc. Figure 1A and 1B As shown, in an implementation, the device 100 includes a support structure 101 (e.g., a flexible skin interface layer) that follows a continuous full-circumference path P around the patient's torso 5. In an implementation, the full-circumference path P covers a range of 90 degrees to 360 degrees of the full circumference of the patient's torso 5. In an implementation, 10% to 90% of the flexible skin interface layer is covered with one or more treatment and monitoring components (e.g., T1 to T3, E1 to E2, C1) of the wearable medical device 100, and the remaining 90% to 10% extends beyond the perimeter of the one or more monitoring components. Covering more of the torso 5 with the flexible skin interface layer enables the components to be distributed at different locations along the support structure 101 more independently or in a smaller, less bulky manner. This helps with weight distribution and increased patient comfort during the prescribed wearing duration, while also providing an unobtrusive appearance that more closely follows the natural shape of the patient's body.

[0067] like Figures 1A to 1B As shown in the implementation of the system, the system includes a wearable article 400 that communicates with the device 100. At least one first user response button 111 is provided on the wearable medical device 100, and at least one second user response button 411 is configured to be worn at a second position on the patient's body other than the torso 5, so that the at least one second user response button 411 is easily accessible to the patient. Figures 1A to 1BIn the example of , the wearable article 400 is a wrist-worn device worn at or near the cuff 505 of a shirt 500, which is worn over the low-profile device 100. Such a wrist-worn article 400 may be similar to and / or also function as a constantly worn device such as a watch, a bracelet, or a fitness device. In this regard, the wearable article 400 may be configured to be secured around the patient's forearm (e.g., secured between the patient's wrist region and below the elbow). As such, a patient wearing short-sleeved clothing will be able to easily access the wearable article 400. In an implementation, the wearable article 400 is configured to be secured around the wrist region of the patient's forearm.

[0068] The wearable article 400 can be worn on the dominant arm or the non-dominant arm. For example, a patient may choose to wear the article 400 on the dominant arm to, for example, ensure quicker and / or more reliable access to the article 400 in the event of a cardiac emergency than if it were worn on the non-dominant arm. In an implementation, the device 100 includes one or more routing eyelets 113 or routing loops for guiding a wire 117 connecting the device 100 to the wearable article 400 on either arm. In an implementation, the routing loop is attached to the support structure 101 so that the wire 117 can be optionally routed around the dominant shoulder in one direction or the other. In other implementations, the device 100 may include a bi-directional retaining element. For example, such a bi-directional element may include a single centrally located ring that engages the support structure 101 at a ball joint, thereby enabling the patient to quickly and easily manipulate the wire 117 around one shoulder or the other to route the wearable article 400 to the dominant side of the body (e.g., left or right arm).

[0069] In an implementation, a processor disposed in device 100 is configured to analyze a patient's ECG signals received via device 100 to detect one or more arrhythmia conditions of the patient. In response to detecting the one or more arrhythmia conditions, the processor is configured to cause device 100 to provide a warning of an impending treatment to be delivered to the patient. In response to the warning of the impending treatment, the patient may then pause the treatment by touching and / or pressing at least one of at least one first user response button 111 and at least one second user response button 411. Such an action may cause a command to be transmitted to the processor of device 100 to pause the treatment. Because device 100 is worn under clothing such as shirt 500, the at least one second user response button 411 provides the patient with an easily accessible interface for communicating with device 100 when an impending treatment alarm sounds. Figures 1A to 1BIn an embodiment of the present invention, wearable article 400 is in wired communication with device 100 (e.g., via wire 117 extending from device 100 to wearable article 400). In other implementations, as will be described later, wearable article 400 can be in wireless communication with a processor of device 100 to send a user instruction to delay treatment.

[0070] If the patient's detected arrhythmia condition has stabilized or improved and the patient is conscious, the patient can delay treatment that would otherwise change his heart rhythm. Providing at least one second user response button 411 on the housing or user interface touch screen of the wearable article 400 enables the patient to easily delay treatment. In implementation, the wearable article 400 is a commonly worn and familiar item. This further enhances the unobtrusive appearance of the system 300, thereby facilitating the patient's compliance to wear the system 300 as prescribed by the physician for a continuous short-term or long-term duration. In implementation, at least one second user response button includes two buttons, so that by design, the patient presses the two buttons simultaneously with two fingers. This two-finger structure helps prevent accidental collision and button pressing of a single button when an impending treatment warning sounds. In other structures, at least one second user response button may include only a single response button. In this structure, the patient is prompted to provide a confirmation user input to verify that the button press is intentional. The mechanism for detecting intentional input to one or more second user response buttons will be discussed later with respect to the implementation of the system 300, and is applicable to all implementations described herein.

[0071] As described in U.S. Pat. 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 2As 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).

[0072] 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.

[0073] In an embodiment according to the present invention (such as Figures 3 to 5D In the embodiments of the present invention, it is possible to eliminate Figure 2 One or more portions of the garment 11 in the device 10A, such as a holster portion and the remainder in combination with other attachment mechanisms, etc. 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 may be, for example, shoulder straps, a vest, a belt, a brace, a bandeau, and / or a ribbon. In an implementation, the wearable support may be fitted to the body as a lightweight, retractable support garment or other structure for supporting heavier components of the devices 10B to 10G. In one example, as Figures 3 to 5D As shown, the wearable support may be a band 50 or a strap 53. The band 50 or strap 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 (e.g., an ECG sensor) may be adherently attached to the patient's torso 5.

[0074] In one example, if Figure 3As 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 (band 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 band 50. By providing support in the form of a band 50, for example, 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.

[0075] This compliance can be further encouraged by minimizing the volume and weight of one or more components to minimize or eliminate any skin irritation associated with surface area contact and / or weight-based forces. Figures 4A to 4C 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 4B and 4CAs shown, the first component may include a first pad 105 and one or more treatment electrodes 110 and / or a plurality of ECG sensing electrodes 115 integrated with the 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 pad 105. As previously described with respect to implementation, the pad 105 may be a flexible skin interface layer configured to interface with the patient's skin and support a plurality of treatment and monitoring components of the wearable medical device 100. In an implementation, the pad 105 is a flexible skin interface layer configured to expand and contract with the patient's skin. In an implementation, the pad 105 includes at least a rubber and an elastomer having a ratio ranging from 9:6 to 4:1. In a specific implementation, the housing 120 may extend from the surface of the pad 105 by about 1 cm to 5 cm. The housing 120 may include at least an ECG acquisition and conditioning circuit, a therapy delivery circuit, a processor 118, one or more capacitors 135, and one or more batteries 140. In an implementation, second component 107 may include only relatively light components compared to first component 102 (e.g., a second component weighing approximately 10 to 500 grams), such as one or more therapy electrodes 110 and / or one or more ECG sensing electrodes 115, etc.

[0076] In embodiments such as Figures 5A to 5D In embodiments such as those of the present invention, the first component and the second component may both be placed on the front portion of the torso 5. The second component 107 of the device 10D may be placed above the right nipple of the patient's torso 5, and the first component 102 may be placed on the left side of the patient's torso 5 opposite to the placement of the second component 107. Figure 5A , 5C As shown in FIG. 5D , in an embodiment, the device 10D includes a first component 102 and a second component 107 connected by wire. Optionally, as Figure 5B As shown, in an embodiment, for example, when the device is used to monitor a cardiac condition, the device 10E 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. In an implementation, at least one of the first component 102 and the second component 107 is in the front portion of the torso, and the other component is in the back portion of the torso. This structure helps, for example, to establish an effective treatment vector through the heart to treat the patient with a defibrillation shock.

[0077] exist Figures 5A to 5BIn an embodiment, the wearable support can 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 can include a tensioner 52 for tightening and / or loosening the belt 50 about the patient's torso 5. In an implementation, the tensioner 52 can also fasten the belt 50 about the patient's torso 5 and can be, for example, a hook and loop fastener system or a ratchet strap and buckle assembly. In an embodiment, the first component 102 can be disposed on or integrated with the wearable support. For example, in Figures 5A to 5B In the embodiment of the present invention, the first component 102 can form a link portion of the band 50 so that the sensor integrated with the pad 105 contacts 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, as Figures 5C to 5D As shown by the dashed lines in , 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.

[0078] 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. Providing additional wearable support (such as Figure 5D The strap 53 shown, etc.) can, for example, help hold the relatively heavy second component 107, which includes heavier components, against the upper region of the torso 5. Providing such additional wearable support helps prevent the second component 107 from pulling on the patient's skin while adherently attached.

[0079] Later on, it will target Figures 6A to 7B In an example described in further detail, the device 100 may include an adhesively attached first component 102 and an adhesively attached second component 107 without a wearable support and / or a clothing-based support. In an example, the system 300 includes the device 100 and a wearable article 400 that communicates with the device in wired or wireless communication to send user input (including input responsive to a warning of an upcoming treatment).

[0080] 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 a discharge or outpatient clinical interview to a subsequent medical appointment. 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 waiting room of a medical office), 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.

[0081] 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.

[0082] 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.

[0083] 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 cardiac 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 period of at least one week for the patient to use. In an example, the wearable medical device can be specified as a period of at least 30 days for the patient to use. In an example, the wearable medical device can be specified as a period of at least one month for the patient to use. In an example, the wearable medical device can be specified as a period of at least two months for the patient to use. In an example, the wearable medical device can be specified as a period of 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.

[0084] 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.

[0085] The device here is configured to remain against the patient's trunk and / or be attached to the patient's trunk in short-term and long-term durations. The attachment connection of the device is implemented to include 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.

[0086] In addition to the biocompatible adhesive, the short-term wearable device and the long-term wearable device include a plurality of sensing electrodes, wherein the 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, and in an implementation, at least one of the plurality of therapeutic electrodes is integrated with the pad described in detail herein. The 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.

[0087] In an implementation, the device includes one or more pads configured to be held against and / or attached to the patient's torso. One or more energy storage units are operably connected to a treatment delivery circuit. The energy storage unit and the treatment delivery circuit are contained in at least one housing configured to form a seal with the pad. In an implementation, the seal formed is a watertight seal. In some implementations, multiple housings may be provided on multiple sections of the 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., by printed circuit board traces, flexible circuits, or direct contact connections).

[0088] As described above, the implementation of the wearable medical device 100 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 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, such substantially continuous or almost continuous use as described herein can still be considered as continuous use. For example, continuous use can include wearing or attaching the wearable medical device to the patient continuously. 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 may include continuously monitoring the patient while the patient is wearing the device to obtain cardiac related information (e.g., electrocardiogram (ECG) information, including arrhythmia information, cardiac vibrations, etc.) and / or non-cardiac information (e.g., blood oxygen, the patient's body temperature, glucose levels, tissue fluid levels, and / or lung vibrations). For example, the wearable medical device may 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, monitoring and / or recording during intervals or times may be triggered by user actions or other events.

[0089] As described above, the wearable medical device 100 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.

[0090] As will be described in detail below, Figures 6A to 9C Depicts an exemplary monitoring and treatment device 100 held on a patient's torso 5 solely by an adhesive connection, and Figures 1A to 1B , 3, 4A, 5A to 5D and 10 relate to an attached coupled monitoring and treatment device 10B to 10C, 10D to 10G, 100 including one or more wearable supports.

[0091] Exemplary arrhythmia monitoring and treatment components are Figures 6A to 7B1 is a monitoring and treatment device 100 shown as being attached. 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 pad 105 (e.g., a contour pad) 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 pad 105. In addition, as shown in FIG. Figure 8 and 9A 9C, the device 100 may include a housing 120 configured to form a watertight seal with the pad 105. In a specific implementation, the housing 120 may extend about 1 cm to 10 cm (e.g., 2 to 9 cm, 3 to 8 cm, 4 to 7 cm) from the surface of the patient's skin 7, thereby maintaining a low profile and minimizing any visible protrusions or projections under clothing. In an implementation, this height includes the thickness of the pad 105. In order to achieve this low profile structure, the housing 120 of the assembly 102 includes compact components organized into a compact assembly as described later with respect to the implementation. In some examples, the compact components are nested and arranged so that the housing 120 has an asymmetric vertical profile with an upper end narrower than a lower end, and the heavier components are gathered at the lower end of the housing where the volume is relatively larger to make the patient comfortable. For example, the housing 120 may include at least an ECG acquisition and conditioning circuit 125, a treatment delivery circuit 130, and a processor 118. For example, the processor 118 can analyze the patient's ECG signal received and conditioned via the ECG acquisition and conditioning circuit 125, and detect one or more treatable arrhythmias. The processor 118 can cause the therapy delivery circuit 130 to deliver at least one defibrillation pulse to the patient upon detection of the one or more treatable arrhythmias. As described in further detail below, the device 100 includes components having specific physical dimensions, weights, and functional attributes, wherein these components combine to provide an overall weight of the device 100 within a range of 250 grams to 2500 grams while enabling the device 100 to be used as a monitoring and treatment device.

[0092] In the example, Figures 6A to 7B As shown and as will be described in further detail later, the first component 102 can be coupled to a second component 107 including a different second pad 109. For example, Figures 6A to 7B 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 6BAs 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. In implementation, at least one of the first component 102 and the second component 107 is located at the front portion of the torso 5, while the other component is located at the rear portion of the torso 5. This structure helps, for example, to establish an effective treatment vector through the heart to treat the patient with a defibrillation shock. Although Figures 6A to 7B The implementation of the embodiment depicts a first component 102 having a substantially rectangular shape and a second component 107 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 can include one or more of the components and / or materials described for the implementation of the first component 102, such as for Figures 8 to 9A The components and materials described in the implementation of 9C.

[0093] The pad 105 is configured to be attached to the patient's torso 5. The 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 4C As schematically shown in , the pad 105 may include multiple segments separated by flexible material to conform the pad 105 to the curvature of the area of ​​the torso 5 to which it is applied. The pad 105 may be configured to conform to the curvature of a portion of the patient's torso 5 (such as the lower portion of the torso, the upper front portion of the torso, the upper back portion of the torso, or one or more sides of the torso, etc.). In an implementation including a pad 105 formed of conformable material and / or segments, the pad can accommodate various body shapes and sizes and shape changes associated with the movement of the patient's body. For example, the 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 down.

[0094] In implementations, the dimensions of the pad 105 can be designed to accommodate a variety of body sizes. In some implementations, the pad 105 can be manufactured in various sizes to accommodate a range of body sizes. The specific shape and size of the pad 105 can be preconfigured or uniquely customized for the patient. For example, various body size measurements and / or shape mapping can be obtained from the patient, and a unique customized shape pad 105 can be 3D printed, for example, from any suitable thermoplastic (e.g., ABS plastic) or any elastic and / or flexible 3D printable material. Thus, the pad 105 accommodates variable patient sizes and / or shapes, and / or some or all portions of the pad can be customized to fit a patient's specific body size and shape.

[0095] In an example, the patient can apply the 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. At least one of the patient, the caregiver, and the physician can reposition the pad 105 to a second position that overlaps, is tangent 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 region of the torso along the line of the bottom of the patient's thorax to seek comfort and minimize the appearance of any bulge in the clothing worn on the device 100. The patient, the caregiver, or the physician can, for example, remove the pad 105 in any lateral and / or rotational direction and re-adhere the pad 105 at a new position one inch from the previous position. This provides the patient's skin with an opportunity 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 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.

[0096] In an embodiment, the pad 105 is designed to be durable, flexible, and breathable to allow sweat to evaporate. In an embodiment, the 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 American National Standard ANSI / AAMI / ISO 10993-10:2010. In an example, the pad 105 is generally non-conductive, flexible, water vapor permeable, and substantially liquid impermeable or waterproof. The non-conductive, flexible, water vapor permeable pad 105 can 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, 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, 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, pad 105 is perforated to facilitate evaporation of water vapor from the skin.

[0097] In an embodiment, Figure 8 As shown, 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, a flexible, water vapor permeable conductive adhesive material, which includes 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 implementations, the conductive particles may be microscopic or nanoscale particles or fibers of materials 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.

[0098] Figure 8 A first component 102 is depicted as part of an apparatus 100. The apparatus 100 includes a pad 105 and a housing 120 configured to form a watertight seal with the pad 105. Figure 8 , assembly 102 includes at least one of a plurality of therapy electrodes 110 integrated with pad 105. Exemplary therapy electrodes 110 include, for example, conductive metal electrodes such as those made of stainless steel, tin or aluminum, conductive ink, or conductive polymers. Assembly 102 may also include at least one of a plurality of ECG sensors 115 integrated with pad 105. Figures 6A to 6CIn the implementation, two ECG sensors 115a and 115b are shown as being integrated with the 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., an electrode having a metal substrate containing an oxide layer such as a Ta2O5 coating) configured to measure changes in the electrophysiological phenomena of the patient to measure the ECG information of the patient. For example, as described in U.S. Patent 6,253,099 entitled "Cardiac Monitoring Electrode Apparatus and Method", the exemplary ECG sensor 115 includes a tantalum pentoxide electrode, the contents of which are incorporated herein by reference. In the implementation, the ECG sensor 115 can be made of a core plastic or metal substrate element, wherein the core plastic or metal substrate element is coated with a thick film polymer compound filled with a conductive Ag / Ag / Cl metal filler.

[0099] In some examples, such as Figure 8 As shown, at least one therapy electrode 110 and one or more ECG sensors 115 are formed within the pad 105 such that the skin contacting surface of each component is coplanar with or protrudes from the patient contacting surface of the pad 105. In an example, the therapy electrode 110 and the ECG sensor 115 are disposed on the patient contacting surface of the 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 pad 105, for example, by a polyurethane adhesive or a polymer dispersion adhesive (such as an adhesive based on polyvinyl acetate (PVAc) or other such adhesives). 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 mounted to the pad 105, etc. 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 pad 105, etc. In an example, ECG sensor 115 is screen printed onto pad 105 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.

[0100] In an implementation, at least one therapy electrode 110 and at least one ECG sensor 115 are manufactured as an integral component of pad 105. For example, therapy electrode 110 and / or ECG sensor 115 may be formed from the warp and weft of at least one layer of fabric that forms pad 105. In an implementation, therapy electrode 110 and ECG sensor 115 are formed from conductive fibers interwoven with non-conductive fibers of the fabric.

[0101] The assembly 102 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.

[0102] In the example, Figure 8 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.

[0103] like Figure 8 and 9A As shown, in an example, one or more printed circuit boards 145 connect 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, etc.) of first assembly 102. 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 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 in an example can be electrically interconnected by one or more wires and / or flexible traces or cables.

[0104] continue Figures 7A to 9C100 is described below, in which an implementation of the device 100 is described, in which the therapy delivery circuit 130 is operably connected to one or more capacitors 135. In an implementation, the one or more capacitors provide a total capacitance of 162 μF. In an implementation, the one or more capacitors 135 are multiple 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.

[0105] For example, each defibrillation pulse may deliver 60 to 400 joules (J) of energy. In some implementations, the defibrillation pulse may be a biphasic truncated exponential waveform, whereby the signal may 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 may be automatically adjusted to deliver a predetermined amount of energy.

[0106] 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.

[0107] Reference now Figure 8 , the system 300 disclosed herein includes an attachment coupling assembly 102 as previously described, and the attachment coupling assembly communicates with a wearable article 400. The wearable article is configured to be disposed at an easily accessible location on the patient's body and worn simultaneously with the device 100. As previously described with respect to FIGS. 1A to 1B , the wearable medical device 100 is configured to be worn on the patient's torso 5 and to extend inconspicuously from the patient's skin surface to beneath clothing worn on the device 100.

[0108] like Figure 8As shown, the housing 120 of the assembly 102 can extend from the patient's skin surface by about 1cm to 10cm, thereby maintaining a low profile and minimizing any visible protrusion or bulge under the clothes. In an implementation, the housing 120 can extend from the patient's skin surface by about 0 to 5cm. In an implementation, the housing 120 can extend from the patient's skin surface by about 5 to 10cm. In an implementation, the housing 120 can extend from the patient's skin surface by about 2 to 9cm. In an implementation, the housing 120 can extend from the patient's skin surface by about 3 to 8cm. In an implementation, the housing 120 can extend from the patient's skin surface by about 4 to 7cm. In an implementation, the height of the housing 120 from the skin surface includes the thickness of the pad 105, which can range from about 0.1cm to 2cm. The housing 120 can include at least an ECG acquisition and conditioning circuit, a treatment delivery circuit, and a processor. For example, the processor can analyze the patient's ECG signal received and regulated via the ECG acquisition and conditioning circuit, and detect one or more disposable arrhythmias. The processor may cause the therapy delivery circuit to deliver at least one defibrillation pulse to the patient upon detection of one or more treatable arrhythmias.

[0109] In implementations, the housing 120 may include a surface coating to reduce the friction value and / or electrostatic adsorption value between the housing 120 and clothing worn on the housing 120. For example, the housing 120 may be treated with a silicone spray and / or Teflon coating to allow clothing to slide over the housing 120 rather than adhere to or hang on the housing 120. Preventing or reducing adhesion between the housing 120 and clothing helps minimize the visibility of the device 100 to bystanders and encourages patient compliance in wearing the assembly 102 for the entire prescribed duration. In an embodiment, the outer surface of the housing 120 may be made of an electrostatic dissipative material such as a conductor-filled plastic or a conductive plastic to prevent electrostatic adsorption of the patient's clothing. Optionally, in an embodiment, the housing 120 is made of a non-conductive plastic coated with an electrostatic dissipative coating such as LICRON CRYSTAL ESD Safe Coating (TECHSPRAY, Kennesaw, GA), a transparent electrostatic dissipative polyurethane coating, or the like.

[0110] Additionally or alternatively, in examples (e.g. Figures 9A to 9B In the example of FIG. 1 , the first component 102 of the device 100 has an ergonomic profile as will now be described. For example, the housing 120 extends a distance D of about 1 cm to 5 cm from the surface of the pad 105. Fig. 9AIn 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 shaped to follow the general outline of the components housed therein. For example, the distance D that the shell 120 extends from the surface of the pad 105 can vary from the top end 122 to the bottom end 123 (e.g., while the first component 102 is worn such that 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. Figures 9A to 9B 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 . Figures 9A to 9B 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 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.

[0111] like Figures 9B to 9C As shown in the simplified diagram of FIG. 1 , in an implementation, the vertical side profile of the arrhythmia monitoring and treatment component 102 is asymmetric about one or both of the horizontal axes H1, H2 and the vertical axis V1. For example, the highest height of the arrhythmia monitoring and treatment component from the skin surface (e.g., distance D3) is set at a position on the torso that is lower than the shortest height of the arrhythmia monitoring and treatment component (e.g., distance D1). In an implementation, the ratio of the highest height to the shortest height is in the range of 10:1 to 2:1. In an implementation (such as Fig. 9A In the implementation shown in FIG. 1 , etc., the asymmetric housing 120 has a larger volume at the lower end 123. At least one of the one or more batteries 140 and the one or more capacitors 135 is disposed within a portion of the housing 120 having the highest height (e.g., D3) (positioned toward the lower end 123). As described later with respect to implementations of compact batteries, the one or more batteries 140 can have a combined envelope volume of one quarter or less of the volume defined by the housing 120, the pad 105, and / or the patient's skin surface 7 of the arrhythmia monitoring and treatment assembly. As described later with respect to implementations of compact batteries, the capacity of the one or more batteries can have a capacity ranging from 200 to 8000 mAh.

[0112] As previously described, in an implementation, the housing 120 extends a distance D of about 1 cm to 10 cm from the surface of the pad 105 on which the assembly 102 is disposed and / or the patient's skin. For example, the housing may extend 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm, 8 cm, 8.5 cm, 9 cm, 9.5 cm, and 10 cm from the pad 105 on which the assembly 102 is disposed and / or the patient's skin 7. In addition to keeping the center of mass 147 below the volume center 150, the assembly 102 also maintains a low profile and is worn inconspicuously under the patient's clothing. The housing 120 does not protrude too much from the patient's skin 7 to create one or more noticeable bulges under clothing, and thus more seamlessly integrates with the patient's lifestyle. Patients who are less likely to feel disturbed by wearing the system 300 are more likely to comply with wearing the system 300 for a prescribed duration. In an example, the volume under the housing 120 and therefore the distance of the housing from the surface of the pad depends on a combination of component size, shape, and relative placement. In an implementation, patient comfort and compliance are further encouraged by establishing a comfortable size for the device. For example, Figures 9B to 9C As shown together, the longest axis L1 of the arrhythmia monitoring and treatment assembly is 2 to 20 times longer than the highest height of the housing 120 from the skin surface (e.g., D3). In an implementation, the height of the housing 120 from the skin surface includes the thickness of the pad 105, which can range from about 0.1 cm to 2 cm. A flatter, wider device 100 with a flexible interface layer to attach to the patient's skin enables a more comfortable weight distribution around the patient's torso 5 while minimizing any protrusion that may be perceived by bystanders. By increasing the unobtrusive nature of the housing 120 and overall system 300 and minimizing any potential insight by bystanders, the patient will feel more confident that privacy is maintained throughout the prescribed wearing duration.

[0113] As previously described, the device 100 is configured to provide treatment to the patient upon detection of one or more arrhythmic conditions in the patient. In implementations, both the device 100 (including the assembly 102) and the easily accessible wearable article 400 include patient input features for communicating with and providing control inputs to the system 300. Such communications may, for example, include patient inputs for delaying or preventing the device 100 from delivering treatment, such as a defibrillation or pacing shock. As previously described with respect to Figure 8 As described in the implementation of Fig. 9AThe system 300 includes a wearable article 400 in communication with the component 102. At least one first user response button 111 is disposed on the housing 120 of the component 102 hidden under clothing. In an implementation, the at least one first user response button 111 includes two or more buttons disposed on the housing 120, and the processor 118 requires input to the two or more buttons simultaneously to delay the delivery of the treatment. In an implementation, as Figure 8 and Fig. 9A As shown, at least one first user response button 111 is at least one tactile response button disposed on housing 120, and at least one tactile response button 111 is raised or depressed relative to the housing surface so as to be tactilely perceptible under one or more layers of clothing.

[0114] Since assembly 102 is configured to be hidden under the patient's clothing, one or more first user response buttons 111 are not easily accessible when hidden. The patient actuates at least one first user response button 111 by blindly pressing on one or more layers of clothing to locate and actuate one or more first user response buttons 111, or by lifting or removing one or more layers of clothing to expose at least one first user response button 111 and part or all of the patient's torso 5. Both options require time and flexibility, and the latter lacks patient privacy. Therefore, the patient can benefit from a more easily accessible input for communicating with assembly 102.

[0115] At least one second user response button 411 is configured to be worn at a second location on the patient's body other than the torso 5, such that the at least one second user response button 411 is easily accessible to the patient. Figures 1A to 1B In the example of the embodiment of the present invention, the wearable article 400 is a wrist-worn device disposed on the patient's body at or near the cuff 505 of a shirt 500 (which is worn over the low-profile device 100). Such a wrist-worn article 400 can be similar to and / or also used as a commonly worn device such as a watch, a bracelet, or a fitness device, thereby increasing the unobtrusiveness of the system 300. The privacy, ease of use, and simplicity provided by the wrist-worn article encourages the patient to comply with wearing the wearable article 400 simultaneously with the assembly 102. Fig. 9A As shown, at least one second user response button 411 includes at least one of a mechanically actuated button, a touch screen interface, and at least one touch screen button on user interface 405 of wearable article 400 .

[0116] As previously described, in an implementation, the processor 118 disposed in the assembly 102 is configured to analyze the patient's ECG signals received via the assembly 102 to detect one or more arrhythmia conditions of the patient. In response to detecting the one or more arrhythmia conditions, the processor 118 is configured to cause the system 300 to provide a warning of an impending treatment to be delivered to the patient. In response to the warning of the impending treatment, the patient may then input a command to the processor 118 by touching and / or pressing at least one of the at least one first user response button 111 and the at least one second user response button 411 to pause the impending treatment. Since the assembly 102 is configured to be worn under clothing such as the shirt 500, the at least one second user response button 411 provides the patient with an easily accessible interface for communicating with the processor 118 when the impending treatment alarm sounds.

[0117] In an implementation, the accessible wearable article 400 is disposed at a location on the patient's body other than the torso 5 for easy access and / or retrieval. Such a location may include, for example, a location around the patient's waist, a location on the patient's wrist, arm, or hand, a location at, near, or around the patient's neck. In an implementation of the system 300, the wearable article 400 includes at least one of the following: a bracelet, a ring, a retractable pendant, a necklace, a band configured to be worn on clothing, a ribbon configured to be worn on clothing, a bolo tie, a watch, an armband, a bracelet, and a patch configured to be worn on the patient's clothing at an accessible location not covered by clothing. In an implementation, the accessible wearable article 400 is easily accessible so that it is not hidden under clothing. In an implementation, the easily accessible wearable article is located on an uncovered area of ​​the patient's body, or is at least partially disposed under the patient's clothing at a location near a clothing opening. For example, a wearable article may be placed on a patch or strap adjacent to or slightly below the collar of a shirt for quick and easy access.

[0118] In implementation (such as Fig.10 In an implementation of the invention, the wearable article 400 includes an adjustable armband configured to be worn along the length of the patient's arm. For example, the armband can be an elastic band that is configured to be worn on the upper arm when the patient wears a short-sleeved shirt, and then slides to the wrist when the patient wears a long-sleeved shirt. Such an armband may include a hook and loop fastening system or other adjustable closure mechanism for tightening the wearable article 400 about the patient's variable arm circumference.

[0119] In an implementation, at least one second user response button 411 is provided on a handheld device operated by the patient. For example, the handheld device may include a smartphone device, a tablet computer, or a dedicated handheld unit that is paired with the arrhythmia monitoring and treatment component of the system 300 (e.g., the wearable medical device 100) and wirelessly communicates with the processor 118 of the component 102.

[0120] In implementations, the apparatus 100 communicates with the wearable article 400 via a wired and / or wireless communication link. Figure 8 and 9A 9C , device 100 includes a receiver and / or transceiver 132 in communication with processor 118 and configured to communicate with wearable article 400. Wearable article 400 includes a transceiver 432 for receiving communications from device 100 and communicating user input from at least one second user response button 411 to processor 118 of component 102.

[0121] In an implementation, the processor 118 and the wearable article 400 communicate wirelessly directly or indirectly via a network. Such a communication link may include BLUETOOTH, 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 device 100 and the wearable article 400 may communicate with a remote server via a WI-FI communication link based on the IEEE 802.11 standard. In some implementations, the device 100 and the wearable article may communicate via a human body area network based on the IEEE802.15 standard.

[0122] In an implementation, at least one second user response button 411 is uniquely paired with the arrhythmia monitoring and treatment component 102. In an implementation, the wearable article 400 also includes one or more sensors configured to verify the patient's identity based on at least one of audible information, tactile-based information, signal-based information, and visual information, and to delay treatment delivery based at least in part on the verified identity. In an implementation, at least one of the arrhythmia monitoring and treatment component 102 and the wearable article 400 also includes a video camera configured to detect visual information associated with the patient. In an implementation, the system also includes a 3D laser ranging sensor that communicates with the video camera and is configured for at least one of feature recognition and gesture detection. The patient can rely on interaction with these sensors to confirm identity and pair the wearable article 400 with the processor 118 of the arrhythmia monitoring and treatment component 102. In an implementation, the tactile-based information includes at least one of one or more touches to a remote control, patient fingerprint detection, and repeated tapping. In an implementation, the signal-based information includes at least one of ECG signal detection and biometric sensing for identifying a patient associated with the arrhythmia monitoring and treatment assembly 102 and the wearable article 400, as described, for example, in U.S. Pat. No. 8,271,082, entitled “Medical Device Configured to Test For User Responsiveness,” the contents of which are incorporated herein by reference. In an implementation, the audible information includes at least one of voice recognition and receipt of a password or phrase.

[0123] Additionally or alternatively, in implementing (such as Figure 1A , 7A In the implementation of 10, etc.), the wearable article 400 and the device 100 including the arrhythmia monitoring and treatment component 102 are in wired communication by being connected via the line 117. In the implementation, the line 117 (e.g., a wired link) extends between the arrhythmia monitoring and treatment component 102 and the wearable article 400, so that the communication circuit (e.g., the transceiver 432) and the processor 118 are in wired communication.

[0124] In implementation (such as Fig.11, etc.), the system may include at least one optionally connected wired communication link (e.g., wire 117). In an implementation, wire 117 is configured to be detachable from one or both of arrhythmia monitoring and treatment component 102 and wearable article 400. System 300 may include a first optional connector 103 for attaching and detaching removable wire 117 relative to component 102, and a second optional connector 403 for attaching and detaching removable wire 117 relative to wearable article 400. In an implementation, a patient wears device 100 for a short or long duration and routes wire 117 from component 102 under clothing to wearable article 400 disposed at an accessible location on the patient's body. For example, as Fig. 7A As shown, the cord 117 encircles the patient's torso 5 in the following manner: rising along the back of the torso 5, over the shoulder, and down the patient's arm to the wrist-worn wearable article 400. The patient can apply medical tape 119 to secure the cord at the shoulder and keep the cord 117 appropriately and unobtrusively hidden under clothing. At the end of the day, the patient may wish to remove the cord 117 and / or the tape 119. Enabling the patient to selectively and optionally remove the cord 117 and untie the cord-connected wearable article 400 assists the user in complying with the wearable system 300 for a prescribed duration by improving the accessibility of the at least one second user input button throughout the wake time.

[0125] Additionally or alternatively, in an implementation, at least one of the arrhythmia monitoring and treatment component 102 and the wearable article 400 further includes a retractable shaft, for example, a ratchet shaft claw assembly configured to enable a patient to easily and quickly adjust the length of the wire 117 and the amount of tension on the wire, and to maintain the adjusted length position throughout the duration of wear.

[0126] As mentioned above about implementation (e.g. Figure 8 and 9A As described in the implementation of FIG9C , the medical device 100 includes an arrhythmia monitoring and treatment component 102 configured to be worn unobtrusively under one or more pieces of clothing. If the arrhythmia monitoring and treatment component 102 does not protrude under clothing, the patient may feel more comfortable wearing it continuously for a specified duration, thereby displaying their private health status to bystanders. The implementation of the low-profile component 102 is configured to extend no more than 10 cm from the patient's skin surface. This low-profile structure is achieved by sizing and placing the various components of the component 102 into a compact and comfortable to wear arrangement.

[0127] In an example, at least one power source of the arrhythmia monitoring and treatment component 102 includes one or more rechargeable batteries, wherein the rechargeable batteries are configured to be charged by an external battery or power source that can be connected to a gas-sealed charging port disposed on the housing 120. In an implementation, the battery has a capacity of 200 to 300 mAh and is configured to be recharged daily by the external power source. In an implementation, the charging port includes a magnetic assist for aligning a connector of the external power source with the charging port. In an implementation, the external power source is configured to be inconspicuously worn by the patient while charging the battery of the arrhythmia monitoring and treatment component 102, so that no part of the component 102 needs to be removed during charging throughout the prescribed wearing duration. In an implementation, a wearable support or garment of the device 100 is configured to inconspicuously accommodate an external power source, wherein the external power source is configured to be selectively inserted into a garment or a pocket of a garment while charging one or more batteries. In an implementation, wearable article 400 includes an external power source such that when the wearable article is connected to device 100, one or more batteries of device 100 are recharged.

[0128] In an example, at least one power source of the arrhythmia monitoring and treatment component 102 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 1200mAh. 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 1200mAh to 8000mAh. 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 2200mAh 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 1470mAh 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×4 mm×1 mm to 35 mm×50 mm×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 2The device 100 may have a combined volume of 100 and a weight of 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 ranging from 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.).

[0129] 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) or any elastic and / or flexible 3D printable material.

[0130] 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 2The film capacitor 135 may be made of tightly wound dielectric layers that are compressed and molded to match the patient's body shape. For example, multiple capacitors may be configured to conform to the curvature of a portion of the patient's torso 5 (such as the lower portion of the torso, the upper 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 patient's comfort and minimizes the bulk associated with cylindrical or stacked capacitors. Therefore, the device 100 may protrude less from the surface of the patient's skin than would be the case if the capacitor had a larger volume and / or a smaller compliant profile.

[0131] As previously described, the 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:

[0132] Lithium-ion prismatic cell example:

[0133]

[0134] Table 5

[0135] Example of a lithium-ion cylindrical battery

[0136]

[0137]

[0138] Table 6

[0139] 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 in the form of 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.

[0140] As previously mentioned Figures 6A to 7B As described in the example of the present invention, the arrhythmia monitoring and treatment 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).

[0141] Second component 107 may include breathable and non-irritating materials and adhesives as described above with respect to first component 102 and 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 contains 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 about 0.1 cm to 2 cm.

[0142] In an example, the second component 107 includes at least one of a plurality of therapy electrodes 110 integrated with the pad 109. The exemplary therapy electrode 110 includes, for example, a conductive metal electrode, such as a conductive metal electrode made of stainless steel, tin or aluminum, conductive ink or a conductive polymer, etc. In an example, the second component may also include at least one of a plurality of ECG sensors 115 integrated with the 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., an electrode having a metal substrate including an oxide layer such as a Ta2O5 coating) configured to measure changes in an electrophysiological phenomenon of a patient to measure ECG information of the patient. For example, as described in U.S. Patent 6,253,099, entitled "Cardiac Monitoring Electrode Apparatus and Method," the entire contents of which are incorporated herein by reference. In an 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.

[0143] In some examples, at least one therapy electrode 110 and one or more ECG sensors 115 are formed within pad 109 such that the skin contacting surface of each component is coplanar with or protrudes from the patient contacting surface of pad 105. In examples, therapy electrode 110 and ECG sensor 115 are disposed on the patient contacting surface of pad 105. In some implementations, therapy electrode 114 and ECG sensor 115 are metal plates (e.g., stainless steel) or substrates formed as a permanent part of second component 107. The metal plate or substrate may be adhered to 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, ECG sensor 115 is a flexible dry surface electrode, such as a conductive polymer coated nanoparticle loaded polysiloxane electrode mounted to pad 109. In some examples, ECG sensor 115 is a flexible dry surface electrode, such as a silver coated conductive polymer foam soft electrode mounted to pad 109. In an example, ECG sensor 115 is screen printed onto 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.

[0144] In an implementation, at least one therapy electrode 110 and at least one ECG sensor 115 are manufactured as an integral component of pad 109. For example, therapy electrode 110 and / or ECG sensor 115 may be formed from the warp and weft of at least one layer of fabric that forms pad 109. In an implementation, therapy electrode 110 and ECG sensor 115 are formed from conductive fibers interwoven with non-conductive fibers of the fabric.

[0145] In an example, the device 100 may include a third component (not shown) 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.

[0146] In an implementation, the device 100 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 may be constructed as one or more separate and independent gel deployment modules. The modules may be configured to receive a removable and / or replaceable gel cartridge (e.g., a cartridge containing one or more conductive gel reservoirs). As such, a gel deployment circuit may be permanently disposed in the device as part of the therapy delivery circuit 130, while the cartridge may be removable and / or replaceable. Such a gel deployment circuit may be coupled to or integrated into the first component 102, the second component 107, and / or the third component of the device.

[0147] 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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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 cardiac related information (e.g., electrocardiogram (ECG) information, including arrhythmia information, cardiac 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.

[0153] 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.

[0154] In implementations, the patient-worn arrhythmia monitoring and treatment device 100 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.

[0155] Fig.12 An example of a process 1200 for determining whether to initiate a therapy sequence and apply therapy pulses to a patient's body is depicted. In an implementation, processor 118 receives S1202 a patient ECG signal from therapy electrodes 114 and analyzes S1204 the ECG signal for an arrhythmia condition. Processor 118 determines S1206 whether the arrhythmia is a life-threatening condition and requires treatment. If the arrhythmia is not life-threatening, 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, processor 118 provides S1208 a patient notification output and requests S1210 a patient response to the provided notification output. In an implementation, the patient receives S1206 a patient notification output by interacting with a user interface (e.g., Fig.13 The user interface 208 of the device may be used to interact with the user to respond to the warning, wherein the user interface may include, for example, one or more buttons (e.g., at least one first button 111 of the device, such as Figure 1A , 6C , 8 and 9A) or a touch screen interface button with tactile feedback (e.g., a touch screen button on the user interface 208 of the housing 120 and / or at least one second button 411 of the wearable article 400 or a similar device such as a smart phone running a user-oriented interactive application). The response can be, for example, pressing one or more buttons in a specific order or for a specific duration. The processor 118 determines S1212 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 the monitoring mode. If the patient is unconscious and cannot respond to the warning provided, the processor 118 initiates S1214 a treatment sequence and treats S1216 the patient by delivering energy to the patient's body.

[0156] In an implementation, a method for treating an arrhythmia includes providing an arrhythmia monitoring and treatment device configured to be worn on a patient's torso to be at least partially concealed under the patient's clothing, wherein the device is configured to provide treatment to the patient upon detection of one or more arrhythmia conditions of the patient. The device includes: a plurality of ECG sensing electrodes and associated circuitry configured to monitor the patient's ECG signals; and at least one first user response button disposed at a first position on the patient's torso on the arrhythmia monitoring and treatment assembly so that the at least one first user response button is concealed under the patient's clothing. The device includes a processor in communication with the at least one first user response button and the plurality of ECG sensing electrodes and associated circuitry. The method includes providing at least one second user response button, the at least one second user response button configured to be worn at a second position on the patient's body other than the torso so that: the at least one second user response button is accessible to the patient, and the at least one second user response button communicates with the processor.

[0157] As previously described with respect to implementation, the processor analyzes ECG signals of a patient received via the arrhythmia monitoring and treatment device to detect one or more arrhythmia conditions of the patient, and in response to the detected one or more arrhythmia conditions of the patient, causes the arrhythmia monitoring and treatment component to provide a warning of an impending therapy to be delivered to the patient. Fig.12 The processor 118 may be configured to receive a user input from at least one of the at least one first user response button and the at least one second user response button in response to a warning of an upcoming treatment, and the processor 118 may pause the upcoming treatment delivery to the patient's body. In an implementation, if the at least one second user response button is pressed for longer than a threshold duration (e.g., longer than 5 seconds), the processor instructs the device to prompt the patient to release the button. If the at least one second user response button is not released, the device will return to a state of upcoming treatment delivery and will warn the patient of the upcoming shock. In an implementation where the at least one second user response button is pressed for longer than a threshold duration (e.g., the user falls and presses the at least one second user response button with a hand), if the patient is conscious and cannot move the hand away from touching the easily accessible wearable item, the processor 118 may require the patient to press the at least one first user response button to delay the treatment.

[0158] In implementations, if at least one first user response button 311 and / or at least one second user response button is pressed for longer than a threshold duration without being released, the device 10, 100 may prompt the user to indicate consciousness. For example, the device 100 may vibrate, prompting the user to tap the housing 120 of the device in a conscious and voluntary action by one or more taps to stop the vibration. The device may include a second, repeated vibration prompt to ensure that the user is conscious by requiring receipt of a second one or more taps against the housing 120 to stop the vibration. An accelerometer or other sensor included in the housing may detect one or more user taps against the housing.

[0159] 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.

[0160] Patients being monitored by in-hospital defibrillators and / or pacing devices 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.

[0161] 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.

[0162] Figures 1 to 11 show exemplary medical devices 10 (e.g., devices 10A to 10G), 100, which are external, mobile, and wearable by patients, and are configured to implement one or more configurations described herein. For example, medical devices 10, 100 can be non-invasive medical devices configured to be substantially located outside the patient's body. Such medical devices can be, for example, mobile medical devices that can and are designed to move with the patient when the patient is doing 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 clothing worn around the patient's torso. For example, the medical device can be a wearable cardioverter defibrillator. Such wearable defibrillators are usually worn almost continuously or substantially continuously for 2 to 3 months at a time. During the time period that the patient wears, the wearable defibrillator can be configured to continuously or substantially continuously monitor the patient's vital signs, and can be configured to deliver one or more therapeutic electrical pulses to the patient when it is determined that treatment is required. For example, such therapeutic shocks may be pacing, defibrillation, or transcutaneous electrical nerve stimulation (TENS) pulses. In some implementations, the medical device 10, 100 may be specified for long-term wear durations and include a wearable support and / or support garment. In some implementations, the medical device 10, 100 may be specified for short-term wear 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 wear duration.

[0163] 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 measuring 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., such 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.

[0164] 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.

[0165] 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 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.

[0166] 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 a patient only (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.

[0167] Fig.13 Schematic diagram of an exemplary component horizontal view of a medical device. Fig.13 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. Fig.13 Components 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. Fig.13 The assembly described has similar components, but includes a switching mechanism for disabling the therapy delivery circuit 130.

[0168] Therapy delivery circuit 130 is coupled to two or more therapy electrodes 110 configured to provide therapy to a patient. Fig.13 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.

[0169] 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.

[0170] 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 attachment-coupled patient-wearable arrhythmia monitoring and treatment device 100 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, the second component 107, and / or the third component of the device.

[0171] 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.

[0172] 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.

[0173] continue Fig.13 Description of an exemplary medical device, in an implementation such as Fig.14 As 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.

[0174] For example, each defibrillation pulse may deliver 60 to 400 joules (J) of energy. In some implementations, the defibrillation pulse may be a biphasic truncated exponential waveform, whereby the signal may 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 may be automatically adjusted to deliver a predetermined amount of energy.

[0175] 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.

[0176] 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 IEEE802.11 standard.

[0177] 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 implemented as a wearable item or a handheld user interface device. (See, for example, the user interface 208 includes Figure 2 The patient interface box 40 and Figures 1A to 1B ) For example, the handheld user interface device may be a smart phone or other portable device configured to communicate with the processor 118 via the network interface 206. In implementations, the handheld user interface device may also be an intermediate device for facilitating the transmission of information from the device to a remote server.

[0178] 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 operating time between each charge. As previously described in detail, in a specific implementation, the battery capacity, operating time, and type (e.g., lithium ion, nickel cadmium, or nickel metal hydride) may be changed to best suit the specific application of the medical device.

[0179] The sensor interface 212 may be coupled to one or more sensors configured to monitor one or more physiological parameters of a patient. Fig.13 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 8 and 9A ECG acquisition and conditioning circuit 125) and / or accelerometer circuit, each of which is configured to receive and condition the corresponding sensor signal.

[0180] The sensing electrodes can, for example, monitor the patient's ECG information. Fig.13 The 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.

[0181] 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.

[0182] 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 can send information describing cardiopulmonary vibration information or patient position / movement to the sensor interface 212 for subsequent analysis.

[0183] 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.

[0184] 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.

[0185] 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.

[0186] 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 cell states inside or outside the processor 118 may be set to a 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.

[0187] 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.

[0188] In an implementation, the device 100 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.

[0189] like Fig.14In the embodiment shown in FIG. 2 , the H-bridge 228 is electrically coupled to a capacitor bank 402 including four capacitors 135a to 135d, wherein the four capacitors 135a to 135d 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 135a to 135d. 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 for a desired duration and in a desired direction. The H-bridge 228 includes H-bridge switches 229a to 229d, wherein the H-bridge switches 229a to 229d 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.

[0190] Although the subject matter contained herein has been described in detail for illustrative purposes, it should be understood that these details are for that purpose only and that the invention is not limited to the disclosed embodiments, but rather, the invention is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

[0191] 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.

[0192] CROSS-REFERENCE TO RELATED APPLICATIONS

[0193] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 785,805, filed on December 28, 2018, entitled “Wearable Medical Device Response Mechanisms And Methods Of Use,” which is incorporated herein by reference in its entirety.

Claims

1. A wearable cardiac device that is worn at least partially under clothing to treat a patient's cardiac arrhythmia, the wearable cardiac device comprising: an attachment electrode configured to be attachment-coupled to a portion of the patient's torso to detect ECG signals of the patient and to deliver electrical therapy to the patient; A housing comprising a cardiac monitoring and treatment circuit, the cardiac monitoring and treatment circuit comprising: A processor configured to: controlling detection of the ECG signal, analyzing the detected ECG signal of the patient to detect one or more arrhythmia conditions of the patient, and causing the wearable cardiac device to deliver the electrical therapy to the patient in response to one or more detected arrhythmia conditions of the patient, and a transceiver in communication with the processor, the transceiver configured to wirelessly transmit information related to one or more prompts from the processor for notifying the patient of impending delivery of electrical therapy; two mechanically actuatable user response buttons mounted on the housing and configured to receive input from the patient in response to the one or more prompts; and a handheld device physically separate from the housing, the handheld device being configured to be operated by the patient while wearing the wearable cardiac device and to receive wirelessly transmitted information related to the one or more prompts, and comprising: a communications transceiver for wirelessly communicating with the processor, and a remote user response button in communication with the communications transceiver, the remote user response button configured to receive input from the patient in response to the one or more prompts, wherein the processor is further configured to cause the wearable cardiac device to cease delivery of the electrical therapy in response to the patient actuating the remote user response button of the handheld device in response to receiving the one or more prompts.

2. The wearable cardiac device of claim 1, wherein: The processor is in communication with the two mechanically actuatable user response buttons, the transceiver, and the attachment electrodes.

3. The wearable cardiac device of claim 2, wherein: The processor is configured to cause the wearable cardiac device to cease delivery of the electrical therapy in response to the patient actuating the two mechanically-actuatable user response buttons in response to receiving the one or more prompts.

4. The wearable cardiac device of claim 2, wherein: The electrical therapy includes at least one of one or more defibrillation pulses and one or more pacing pulses delivered to the patient upon detection of the one or more arrhythmia conditions.

5. The wearable cardiac device of claim 2, wherein: A plurality of components are disposed in the housing, including one or more of: one or more batteries, one or more capacitors, one or more circuit boards, and one or more user interfaces in operable communication with the processor.

6. The wearable cardiac device of claim 5, wherein: The plurality of components are arranged within the shell such that a center of mass of the plurality of components is below a center of volume of the shell when worn on a torso.

7. The wearable cardiac device of claim 2, wherein: One of the attachment electrodes is configured to be disposed in an upper torso region, and another of the attachment electrodes is configured to be disposed in a lower torso region.

8. The wearable cardiac device of claim 1, wherein: The processor is in communication with the mechanically actuatable user response button.

9. The wearable cardiac device of claim 8, wherein: The processor is configured to cause the wearable cardiac device to cease delivery of the electrical therapy in response to the patient actuating at least one of the two mechanically actuatable user response buttons in response to receiving the one or more prompts and actuating the remote user response button in response to receiving the one or more prompts.

10. The wearable cardiac device of claim 9, wherein: The electrical therapy includes at least one of one or more defibrillation pulses and one or more pacing pulses delivered to the patient upon detection of the one or more arrhythmia conditions.

11. The wearable cardiac device of claim 8, wherein: A plurality of components are disposed in the housing, including one or more of: one or more batteries, one or more capacitors, one or more circuit boards, and one or more user interfaces in operable communication with the processor.

12. The wearable cardiac device of claim 11, wherein: The plurality of components are arranged within the shell such that a center of mass of the plurality of components is below a center of volume of the shell when worn on a torso.

13. The wearable cardiac device of claim 8, wherein: One of the attachment electrodes is configured to be disposed in an upper torso region, and another of the attachment electrodes is configured to be disposed in a lower torso region.

14. The wearable cardiac device of claim 1, wherein: The remote user response button includes at least one of a mechanically actuatable button, a touch screen interface, and at least one touch screen button.

15. The wearable cardiac device of claim 1, wherein: The handheld device includes at least one of a smart phone device, a tablet computer, and a dedicated handheld unit that is paired with and in wireless communication with the processor.

16. The wearable cardiac device of claim 15, wherein: The handheld device includes a processor that runs an interactive application for a user.

17. The wearable cardiac device of claim 15, wherein: The handheld device is configured to communicate with a remote server over a network via a wireless communication link.

18. The wearable cardiac device of claim 1, further comprising a removable wire extending between a connector disposed on the housing and a connector disposed on the handheld device, enabling the handheld device to perform wired communication with a processor disposed within the housing.

19. The wearable cardiac device of claim 1, wherein: The processor is in communication with the remote user response button of the handheld device, the communication transceiver, and the attachment electrode.

20. The wearable cardiac device of claim 19, wherein: The remote user response button includes at least one of a mechanically actuatable button, a touch screen interface, and at least one touch screen button.

21. The wearable cardiac device of claim 20, wherein: The handheld device includes at least one of a smart phone device, a tablet computer, and a dedicated handheld unit that is paired with and in wireless communication with the processor.

22. The wearable cardiac device of claim 21, wherein: The handheld device includes a processor that runs an interactive application for a user.

23. The wearable cardiac device of claim 22, further comprising a removable wire extending between a connector disposed on the housing and a connector disposed on the handheld device, enabling the handheld device to perform wired communication with a processor disposed within the housing.

24. The wearable cardiac device of claim 23, wherein: The removable cord is configured to be detachable from one or both of the housing and the handheld device.

25. The wearable cardiac device of claim 24, wherein: At least one of the housing and the handheld device also includes a retractable jaw configured to adjust the length of the removable wire.

26. The wearable cardiac device of claim 21, wherein: The handheld device includes one or more sensors configured to verify the identity of the patient based on at least one of audible information, tactile-based information, signal-based information, and visual information, and to delay therapy delivery based at least in part on the verified identity.

27. The wearable cardiac device of claim 26, wherein: At least one of the housing and the handheld device also includes a video camera configured to detect visual information associated with the patient.

28. The wearable cardiac device of claim 27, wherein: The video camera is configured for at least one of feature recognition and gesture detection.

29. The wearable cardiac device of claim 26, wherein: The tactile-based information includes at least one of one or more touches to the handheld device, patient fingerprint detection, and repeated taps.

30. The wearable cardiac device of claim 26, wherein: The signal-based information includes at least one of ECG signal detection and biometric sensing.

31. The wearable cardiac device of claim 26, wherein: The handheld device includes a microphone and the audible information includes at least one of voice recognition of the patient and receipt of a password or phrase.

32. The wearable cardiac device of claim 26, wherein: The processor is configured to cause the wearable cardiac device to cease delivery of the electrical therapy in response to the patient actuating at least one of the two mechanically actuatable user response buttons and the remote user response button.

33. The wearable cardiac device of claim 32, wherein: The electrical therapy includes at least one of one or more defibrillation pulses and one or more pacing pulses delivered to the patient upon detection of the one or more arrhythmia conditions.

34. The wearable cardiac device of claim 33, wherein: A plurality of components are disposed in the housing, including one or more of: one or more batteries, one or more capacitors, one or more circuit boards, and one or more user interfaces in operable communication with the processor.

35. The wearable cardiac device of claim 34, wherein: The plurality of components are arranged within the shell such that a center of mass of the plurality of components is below a center of volume of the shell when worn on a torso.

36. The wearable cardiac device of claim 33, wherein: One of the attachment electrodes is configured to be disposed in an upper torso region, and another of the attachment electrodes is configured to be disposed in a lower torso region.

37. The wearable cardiac device of claim 1, further comprising a flexible skin interface layer configured to engage a skin surface of the patient.

38. The wearable cardiac device of claim 37, wherein: The housing is disposed on the flexible skin interface layer.

39. The wearable cardiac device of claim 38, wherein: The highest height of the housing extends no more than 10 cm from the patient's skin surface.

40. The wearable cardiac device of claim 38, wherein: The vertical side profile of the housing is asymmetrical about one or both of the horizontal axis and the vertical axis.

41. The wearable cardiac device of claim 40, wherein: The position at which the housing is at its highest height from the skin surface is arranged lower on the torso than the position at which the housing is at its lowest height.

42. The wearable cardiac device of claim 38, wherein: The flexible skin interface layer includes a pressure sensitive adhesive configured to couple the flexible skin interface layer to the torso of the patient.

43. The wearable cardiac device of claim 42, wherein: The processor is in communication with the two mechanically actuatable user response buttons, the transceiver, and the attachment electrodes.

44. The wearable cardiac device of claim 43, wherein: The processor is configured to cause the wearable cardiac device to cease delivery of the electrical therapy in response to the patient actuating the two mechanically actuatable user response buttons.

45. The wearable cardiac device of claim 44, wherein: The electrical therapy includes at least one of one or more defibrillation pulses and one or more pacing pulses delivered to the patient upon detection of the one or more arrhythmia conditions.

46. ​​The wearable cardiac device of claim 45, wherein: A plurality of components are disposed in the housing, including one or more of: one or more batteries, one or more capacitors, one or more circuit boards, and one or more user interfaces in operable communication with the processor.

47. The wearable cardiac device of claim 46, wherein: The plurality of components are arranged within the shell such that a center of mass of the plurality of components is below a center of volume of the shell when worn on a torso.

48. The wearable cardiac device of claim 42, wherein: One of the attachment electrodes is configured to be disposed in an upper torso region, and another of the attachment electrodes is configured to be disposed in a lower torso region.

49. The wearable cardiac device of claim 48, wherein: At least one of the attachment electrodes is integrated with the flexible skin interface layer.

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