Modular wearable medical device

Abstract

A modular wearable medical device is provided. The device includes a garment, an ECG sensing electrode connected at a first predetermined location on the garment, at least one pocket configured to allow insertion of one type of module and to prevent insertion of other types of modules, wherein a module having device electronics within a housing includes a sensor interface module that receives and pre-processes and / or digitizes an ECG signal to detect cardiac arrhythmias, a wire or cable permanently integrated into the garment and connecting the ECG sensing electrode to the sensor interface module, a therapy electrode connected to a second predetermined location on the garment, a gel deployment circuit, one or more capacitors that store energy, and a therapy control module.

Description

[0001] This application is a divisional application of the application filed on November 21, 2016, with application number 201680060591.9 and invention title "Clothing for Wearable Medical Devices".

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Provisional Application Serial No. 62 / 258,666, filed November 23, 2015, entitled “GARMENTS FOR WEARABLE MEDICALDEVICES”, the entire contents of which are incorporated herein by reference and used for all purposes. Technical Field

[0004] This disclosure relates to clothing used with wearable medical devices, including, for example, wearable monitoring devices and / or wearable therapeutic devices. Background Technology

[0005] A wide variety of electronic and mechanical devices exist for monitoring and treating a patient's medical condition. In some examples, depending on the underlying medical condition being monitored or treated, medical devices such as pacemakers or defibrillators may be surgically implanted into the patient or connected externally to the patient. In some cases, physicians may use medical devices alone or in combination with drug therapy to treat a patient's medical condition.

[0006] One of the most deadly arrhythmias is ventricular fibrillation, which occurs when normal, regular electrical impulses are replaced by irregular, rapid impulses. This causes the heart muscle to stop contracting normally and begin to fibrillate. Normal blood flow stops, and if normal cardiac contractions are not restored, organ damage or death can occur within minutes. Because victims often receive no noticeable warning of impending fibrillation, death frequently occurs before necessary medical assistance can arrive. Other arrhythmias can include excessively slow heart rates, known as bradycardia.

[0007] Implantable or external pacemakers and defibrillators (such as automated external defibrillators or AEDs) have significantly improved the ability to treat these otherwise life-threatening conditions. These devices work by applying corrective electrical impulses directly to the patient's heart. For example, bradycardia can be corrected by using an implantable or external pacemaker. Ventricular fibrillation can be treated using an implantable or external defibrillator.

[0008] External pacemakers, defibrillators, and other medical monitors designed for outpatient and / or long-term use have further enhanced the ability to detect and treat life-threatening conditions in a timely manner. For example, certain medical devices operate by continuously or substantially continuously monitoring a patient's heart for treatable arrhythmias via one or more sensing electrodes, and, upon detection of such a treatable arrhythmia, by applying corrective electrical pulses directly to the heart via one or more therapeutic electrodes. Summary of the Invention

[0009] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment worn on the torso of a patient, the garment having at least a front and a rear portion; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to provide treatment to the patient; and a controller. The controller is configured to detect the patient's cardiac condition based on the monitored cardiac activity and to provide treatment to the patient based on the detected cardiac condition, the controller including a plurality of modules configured to be integrated into the garment and distributed throughout the garment. It should be understood that at least one of the at least one sensing electrode and the at least one therapeutic electrode may be configured to be integrated into the garment.

[0010] In some examples, the garment includes at least one of the following: a vest, a wrap-around garment, and shoulder straps worn on the patient's upper body. In some examples, the garment includes a one-shoulder garment configured to be worn on one shoulder of the patient and wrap around the upper torso.

[0011] In some examples, the garment is configured to be machine washable. In some examples, the garment is configured to be water-resistant. In some examples, the garment comprises a material with low skin irritation.

[0012] In some examples, the plurality of modules are distributed throughout the garment by weight to achieve uniform weight distribution. In some examples, one or more of the plurality of modules are permanently attached to the garment. In some examples, one or more of the plurality of modules are configured to be removably attached to the garment. In some examples, one or more of the plurality of modules are configured to be attached to one or more corresponding pockets provided in the garment. In some examples, one or more of the plurality of modules are configured to be movably attached to the garment. In some examples, one or more of the plurality of modules are configured to be slidably attached to the garment.

[0013] In some examples, the wearable cardiac device further includes one or more sensors configured to monitor one or more of patient activity, patient movement, heart sounds, lung sounds, tissue fluid, pulmonary fluid, blood oxygen levels, and blood pressure. In some examples, the wearable cardiac device also includes one or more components for delivering drug treatment to the patient.

[0014] In some examples, at least two of the plurality of modules are electrically connected via conductive filaments integrated into the garment. In some examples, at least two of the plurality of modules are operatively connected via optical fibers integrated into the garment.

[0015] In some examples, the multiple modules include at least one low-voltage module and at least one high-voltage module. In some examples, the at least one low-voltage module includes circuitry for controlling at least one of the following: user interaction, cardiac signal acquisition and monitoring, arrhythmia detection, synchronization of defibrillation pulses with cardiac signals, treatment sequence, patient alarms, data communication, and data storage. In some examples, the at least one high-voltage module includes at least one of a treatment control module and an energy storage module.

[0016] In some examples, the multiple modules include an operation module for monitoring cardiac data received from at least one electrode and guiding the administration of treatment to the patient. In some examples, the multiple modules include a communication module configured to communicate with at least one external system.

[0017] In some examples, the plurality of modules includes an energy storage module for storing energy used in at least one treatment pulse. In some examples, the energy storage module includes a plurality of capacitors and at least one non-rechargeable battery for supplying power to the plurality of capacitors. In some examples, the energy storage module is connected to a treatment control module for at least controlling the release of energy from the energy storage device.

[0018] In some examples, the plurality of modules includes a first energy storage module for storing energy used in a first portion of the treatment pulse, and a second energy storage module, different from the first energy storage module, for storing energy used in a second portion of the treatment pulse. In some examples, the plurality of modules includes a first energy storage module integrated into the front portion of the garment and a second energy storage module integrated into the back portion of the garment. In some examples, the plurality of modules includes a plurality of capacitors distributed throughout the garment and integrated into the garment.

[0019] In some examples, at least one of the plurality of modules is removably connected to a rechargeable battery. In some examples, the garment is removably connected to a rechargeable battery.

[0020] In some examples, the wearable cardiac device includes at least one therapeutic electrode integrated into the garment. In some examples, the wearable cardiac device includes at least one user interface module integrated into the garment. In some examples, the wearable cardiac device includes at least one user interface module communicatively connected to at least one of the plurality of modules.

[0021] According to at least one aspect, a wearable cardiac monitoring device is provided. The wearable cardiac monitoring device includes: a garment worn on the torso of a patient, the garment being configured to be removably connected to at least one treatment module; at least one sensing electrode configured to be integrated into the garment and monitor the patient's cardiac activity; and a plurality of cardiac monitoring modules distributed throughout the garment and integrated into the garment to conform to the patient's ergonomics.

[0022] In some examples, at least two of the plurality of monitoring modules are electrically connected via conductive filaments integrated into the garment. In some examples, at least two of the plurality of monitoring modules are operatively connected via optical fibers integrated into the garment.

[0023] In some examples, the garment includes at least one of hook and loop fasteners, magnets, and snap fasteners to allow the at least one treatment module to be removably connected to the garment. In some examples, the garment is configured to be electrically connected to the at least one treatment module using at least one of conductive wires, conductive snap fasteners, and conductive contacts. In some examples, the garment is configured to be operatively connected to the at least one treatment module using at least one of capacitive coupling, IR coupling, and inductive coupling.

[0024] In some examples, the plurality of monitoring modules include at least one low-voltage module, and the at least one treatment module includes at least one high-voltage module.

[0025] In some examples, at least one treatment module includes an energy storage module for storing energy used for at least one treatment pulse. In some examples, the energy storage module includes a plurality of capacitors and at least one non-rechargeable battery for supplying power to the plurality of capacitors. In some examples, at least one treatment module includes a treatment control module connected to the energy storage module to at least control the release of energy from the energy storage module.

[0026] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment worn on the torso of a patient; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to provide treatment to the patient; and a controller. The controller is configured to detect the patient's cardiac condition based on the monitored cardiac activity and to provide at least one therapeutic pulse to the patient based on the detected cardiac condition. The controller may include a plurality of separate and distinct modules distributed throughout the garment. The plurality of separate and distinct modules may include at least one high-voltage module and at least one low-voltage module, the high-voltage module including one or more high-voltage components operating at one or more high-voltage levels, and the low-voltage module including one or more low-voltage components operating at a voltage level lower than the one or more high-voltage levels. It should be understood that conductive filaments may be integrated into the garment to electrically connect at least two of the plurality of modules.

[0027] In some examples, at least one low-voltage module includes circuitry for controlling at least one of the following: user interaction, cardiac signal acquisition and monitoring, arrhythmia detection, synchronization of defibrillation pulses with cardiac signals, treatment sequence, patient alarms, data communication, and data storage. In some examples, the one or more high-voltage levels include at least one of 100 volts, 1000 volts, and 1500 volts.

[0028] In some examples, at least one low-voltage module includes an operation module for monitoring cardiac data received from at least one electrode and guiding the administration of treatment to the patient. In some examples, at least one low-voltage module includes a communication module configured to communicate with at least one external system. In some examples, at least one high-voltage module includes at least one energy storage device for storing energy used in the at least one treatment pulse. In some examples, at least one high-voltage module includes at least one power control device for controlling one or more characteristics of the at least one treatment pulse.

[0029] In some examples, one or more of the plurality of modules are permanently attached to the garment. In some examples, one or more of the plurality of modules are configured to be removably attached to the garment. In some examples, one or more of the plurality of modules are configured to be attached to one or more corresponding pockets provided in the garment. In some examples, at least one of the at least one sensing electrode and the at least one therapeutic electrode is integrated into the garment.

[0030] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment worn on the torso of a patient; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to provide treatment to the patient; and a controller. The controller includes a plurality of separate and distinct modules distributed throughout the garment, the plurality of separate and distinct modules including: at least one monitoring module integrated into the garment to detect the patient's cardiac condition based on monitored cardiac activity; and at least one therapeutic module removably attached to the garment to provide treatment to the patient based on the detected cardiac condition.

[0031] In some examples, at least two of the plurality of modules are electrically connected via conductive wires integrated into the garment. In some examples, the garment includes at least one of hook-and-loop fasteners, magnets, and snap fasteners to allow the at least one treatment module to be removably connected to the garment. In some examples, the garment is configured to be electrically connected to the at least one treatment module using at least one of conductive wires, conductive snap fasteners, and conductive contacts. In some examples, the garment is configured to be operatively connected to the at least one treatment module using at least one of capacitive coupling, IR coupling, and inductive coupling. In some examples, at least one of the at least one sensing electrode and the at least one treatment electrode is integrated into the garment.

[0032] In some examples, the at least one treatment module includes an energy storage module for storing energy used in at least one treatment pulse. In some examples, the energy storage module includes a plurality of capacitors and at least one non-rechargeable battery for supplying power to the plurality of capacitors. In some examples, the at least one treatment module further includes a treatment control module connected to the energy storage module to control one or more characteristics of the at least one treatment pulse.

[0033] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment worn on the torso of a patient; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to provide treatment to the patient; and a controller comprising a plurality of separate and distinct modules distributed throughout the garment. The plurality of modules includes: an operation module connected to the at least one sensing electrode and configured to detect at least one cardiac condition of the patient; an energy storage module connected to the at least one therapeutic electrode and configured to store energy for at least one therapeutic shock to be applied to the patient; and a communication module connected to the operation module for communicating with at least one external device.

[0034] In some examples, the plurality of modules further includes a sensor interface module connected between the operating module and the at least one sensing electrode, the sensor interface module being configured to receive cardiac data from the at least one sensing electrode, digitize the cardiac data, and communicate the digitized cardiac data to the operating module. In some examples, the plurality of modules further includes a treatment control module connected between the energy storage module and the operating module, the treatment control module being configured to control at least one characteristic of at least one therapeutic shock to be applied to the patient.

[0035] In some examples, the plurality of modules are operatively connected via at least one of conductive filaments, conductive cables, and fiber optic cables integrated into the garment. In some examples, one or more of the plurality of modules are permanently attached to the garment. In some examples, one or more of the plurality of modules are configured to be removably attached to the garment. In some examples, one or more of the plurality of modules are configured to be attached to one or more corresponding pockets provided in the garment.

[0036] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment worn on the torso of a patient; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to provide treatment to the patient; and a controller. The controller is configured to detect the patient's cardiac condition based on the monitored cardiac activity and to provide at least one therapeutic pulse to the patient based on the detected cardiac condition. The controller includes a plurality of separate and distinct capacitor modules integrated into the garment and connected to the at least one therapeutic electrode and at least one charger circuit for charging the plurality of capacitors.

[0037] In some examples, each capacitor module includes one or more capacitors encapsulated within a housing integrated into the garment. In other examples, each capacitor module includes multiple capacitors integrated into the garment.

[0038] In some examples, the plurality of capacitor modules are organized into a plurality of parallel capacitor groups. In some examples, the plurality of parallel capacitor groups are charged in parallel by at least one charger and discharged in series to the at least one therapeutic electrode. In some examples, at least two of the plurality of parallel capacitor groups are connected by at least one switch integrated into the garment.

[0039] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment worn on the torso of a patient, the garment having at least a front and a rear portion; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to deliver a therapeutic shock to the patient based on the monitored cardiac activity; a gel deployment package removably connected to the garment and the at least one therapeutic electrode, the gel deployment package being configured to release conductive gel onto the patient's skin substantially near the therapeutic electrode; and a plurality of modules permanently disposed within and distributed throughout the garment. The plurality of modules may be configured to detect the patient's cardiac condition based on the monitored cardiac activity, and, based on the detected cardiac condition, cause the release of the conductive gel and delivery of the therapeutic shock to the patient.

[0040] According to at least one aspect, a wearable cardiac monitoring device is provided. The wearable cardiac monitoring device includes: a garment configured to be worn on the torso of a patient; and a patient monitoring circuit disposed within the garment and configured to monitor one or more physiological signals from the patient. The patient monitoring circuit includes a plurality of separate and distinct modules communicatively connected to each other via one or more communication links. The patient monitoring circuit is configured to at least monitor the patient's cardiac activity, detect the presence of arrhythmias in the patient, and provide one or more notifications related to the arrhythmias. The plurality of separate and distinct modules are integrated into the garment and distributed throughout the garment to conform to the patient's ergonomics. The wearable cardiac monitoring device also includes a high-voltage circuit comprising treatment control circuitry and an energy storage device. The high-voltage circuit is disposed within a treatment module configured to be separable from the wearable cardiac monitoring device.

[0041] In some examples, the patient monitoring circuitry includes: an ECG sensor circuit configured to sense and process the patient's electrocardiogram (ECG) signal; an acoustic sensor circuit configured to detect and process the patient's heart sounds and / or lung sounds; a respiration sensor circuit configured to sense and process the patient's respiration; and a radio frequency (RF) circuit configured to detect and process the patient's fluid level. The ECG sensor circuit, the acoustic sensor circuit, the respiration sensor circuit, and the RF circuitry may be configured within separate and different modules.

[0042] In some examples, the treatment control circuitry is configured to initiate treatment to the patient based on one or more notifications related to the arrhythmia.

[0043] In some examples, the treatment control circuit is configured to initiate treatment on the patient, wherein the treatment includes at least one of pacing therapy, defibrillation therapy, and transcutaneous electrical nerve stimulation (TENS) therapy.

[0044] In some examples, the garment includes at least one of the following: a vest worn on the upper body of the patient, a wrap garment, and a one-shoulder garment configured to be worn on one shoulder and wrap around the upper torso of the patient.

[0045] In some examples, the garment is configured to be machine washable, water-resistant, and permeable (to allow moisture and water vapor to be transferred from the inner layer of the garment to the outer layer), and the garment comprises a material with low skin irritation.

[0046] In some examples, the garment is configured to have an average moisture transfer rate of 100 g / m³. 2 / day ~250g / m 2 / between days.

[0047] In some examples, the garment is configured to have an average moisture transfer rate of 250 g / m³. 2 / day ~20000g / m 2 / between days.

[0048] In some examples, the garment is configured to have an average moisture transfer rate of 20,000 g / m³. 2 / day ~50000g / m 2 / between days.

[0049] In some examples, the garment is configured to be breathable to facilitate ventilation through the garment.

[0050] In some examples, the individual and distinct modules are distributed throughout the garment by weight to achieve a uniform weight distribution.

[0051] In some examples, one or more of the individual and distinct modules are permanently attached to the garment.

[0052] In some examples, one or more of the individual and distinct modules are configured to be removably attached to the garment.

[0053] In some examples, one or more of the individual and distinct modules are configured to be movably attached to the garment.

[0054] In some examples, one or more of the individual and distinct modules are configured to be slidably attached to the garment.

[0055] In some examples, the wearable cardiac monitoring device also includes one or more sensors configured to monitor one or more of patient activity, patient movement, heart sounds, lung sounds, tissue fluid, pulmonary fluid, blood oxygen level, and blood pressure.

[0056] In some examples, the wearable cardiac monitoring device also includes one or more components for delivering drug treatment to the patient.

[0057] In some examples, at least two of the plurality of modules are electrically connected via conductive filaments integrated into the garment.

[0058] According to at least one aspect, a wearable cardiac monitoring device is provided. The wearable cardiac monitoring device includes: a garment configured to be worn on the torso of a patient; a plurality of cardiac sensing electrodes supported by the garment and configured to monitor the patient's cardiac activity; at least one therapeutic electrode supported by the garment and configured to provide treatment to the patient; and a cardiac monitoring circuit disposed within the garment and configured to monitor the patient's cardiac activity. The cardiac monitoring circuit includes a plurality of separate and distinct modules integrated into and supported by the garment. The wearable cardiac monitoring device further includes a controller configured to detect the patient's cardiac condition based on the monitored cardiac activity. The plurality of separate and distinct modules include at least a therapeutic control circuit and an energy storage device disposed within at least one therapeutic module. The at least one therapeutic module is configured to be removably attached to the garment and to provide treatment to the patient based on the detected cardiac condition.

[0059] In some examples, the plurality of modules further includes low-voltage circuitry configured within at least one low-voltage module and high-voltage circuitry configured within at least one high-voltage module that is separate from and different from the at least one low-voltage module.

[0060] In some examples, the low-voltage circuit operates at a voltage below approximately 100 volts.

[0061] In some examples, the high-voltage circuit includes at least one component that operates at a voltage higher than about 100 volts.

[0062] In some examples, the low-voltage circuit is configured to control at least one of the following: user interaction, cardiac signal acquisition and monitoring, arrhythmia detection, synchronization of defibrillation pulses with cardiac signals, treatment sequence, patient alarms, data communication, and data storage.

[0063] In some examples, the high-voltage circuit includes at least one of the treatment control circuit and the energy storage device.

[0064] In some examples, the plurality of modules includes at least one processor configured in an operating module separate from the other modules to monitor cardiac data received from at least one electrode and to communicate with the treatment control circuitry to guide the administration of treatment to the patient.

[0065] In some examples, the plurality of modules further includes communication circuitry configured in a separate communication module and configured to communicate with at least one external system.

[0066] In some examples, the energy storage device is configured to store energy used for at least one treatment pulse.

[0067] In some examples, the energy storage device includes a plurality of capacitors and at least one non-rechargeable battery for supplying power to the plurality of capacitors.

[0068] In some examples, the energy storage device is connected to the treatment control circuit, and the treatment control circuit is configured to at least control the release of energy from the energy storage module.

[0069] In some examples, the plurality of modules includes a first energy storage device for storing energy used in a first portion of the treatment pulse, and a second energy storage device, different from the first energy storage device, for storing energy used in a second portion of the treatment pulse.

[0070] In some examples, the plurality of modules includes a first energy storage device integrated into the front portion of the garment and a second energy storage device integrated into the back portion of the garment.

[0071] In some examples, the multiple modules include multiple capacitors distributed throughout the garment and integrated into the garment.

[0072] In some examples, at least one of the multiple modules is removably connected to a rechargeable battery.

[0073] In some examples, the garment is removably connected to a rechargeable battery for powering one or more of the plurality of modules.

[0074] In some examples, the at least one therapeutic electrode is permanently integrated into the garment.

[0075] In some examples, the wearable cardiac monitoring device also includes at least one user interface integrated into the garment.

[0076] In some examples, the wearable cardiac monitoring device further includes at least one user interface that is communicatively connected to at least one of the plurality of modules.

[0077] In some examples, the plurality of modules include: an ECG sensor circuit configured to sense and process the patient's electrocardiogram (ECG) signal; an acoustic sensor circuit configured to detect and process the patient's heart sounds and / or lung sounds; a respiratory sensor circuit configured to sense and process the patient's respiration; and a radio frequency circuit configured to detect and process the patient's fluid level.

[0078] In some examples, the ECG sensor circuit, the acoustic sensor circuit, the respiration sensor circuit, and the radio frequency circuit are configured within the plurality of modules.

[0079] In some examples, the treatment control circuitry is configured to initiate treatment to the patient based on one or more notifications related to the arrhythmia.

[0080] In some examples, the treatment includes at least one of pacing therapy, defibrillation therapy, and transcutaneous electrical nerve stimulation (TENS) therapy.

[0081] In some examples, the garment includes at least one of the following: a vest worn on the upper body of the patient, a wrap garment, and a one-shoulder garment configured to be worn on one shoulder and wrap around the upper torso of the patient.

[0082] In some examples, the garment is configured to be machine washable, water-resistant, and permeable (to allow moisture and water vapor to be transferred from the inner layer of the garment to the outer layer), and the garment comprises a material with low skin irritation.

[0083] In some examples, the garment is configured to have an average moisture transfer rate of 100 g / m³. 2 / day ~250g / m 2 / between days.

[0084] In some examples, the garment is configured to have an average moisture transfer rate of 250 g / m³. 2 / day ~20000g / m 2 / between days.

[0085] In some examples, the garment is configured to have an average moisture transfer rate of 20,000 g / m³. 2 / day ~50000g / m 2 / between days.

[0086] In some examples, the garment is configured to be breathable to facilitate ventilation through the garment.

[0087] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment configured to be worn on the torso of a patient; at least one sensing electrode disposed in the garment and configured to monitor the patient's cardiac activity; at least one therapeutic electrode disposed in the garment and configured to provide electrical therapy to the patient based on the monitored cardiac activity; a cardiac monitoring circuit disposed in the garment and configured to monitor the patient's cardiac activity, detect the patient's cardiac condition based on the monitored cardiac activity, and provide at least one therapeutic pulse to the patient based on the detected cardiac condition, the cardiac monitoring circuit including a plurality of separate and distinct modules distributed throughout the garment, the plurality of separate and distinct modules including at least one high-voltage module and at least one low-voltage module, the high-voltage module including a high-voltage circuit operating at one or more high-voltage levels, and the low-voltage module including a low-voltage circuit operating at a voltage level lower than the one or more high-voltage levels; and conductive wires integrated into the garment to electrically connect at least two of the plurality of modules.

[0088] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment configured to be worn on the torso of a patient; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to provide treatment to the patient; and a cardiac monitoring circuit comprising a plurality of separate and distinct modules distributed throughout the garment. The plurality of modules includes: an operation module connected to the at least one sensing electrode and configured to detect at least one cardiac condition of the patient; an energy storage module connected to the at least one therapeutic electrode and configured to store energy for at least one therapeutic shock to be applied to the patient; and a communication circuit disposed within a communication module separate from and independent of the operation module and the energy storage module and connected to at least one of the operation module and the energy storage module, the communication circuit being configured to communicate with at least one external device.

[0089] According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes: a garment configured to be worn on the torso of a patient; at least one sensing electrode configured to monitor the patient's cardiac activity; at least one therapeutic electrode configured to provide treatment to the patient; and a cardiac monitoring circuit configured to detect the patient's cardiac condition based on the monitored cardiac activity, and to provide at least one therapeutic pulse to the patient based on the detected cardiac condition. The controller includes a plurality of separate and distinct capacitor modules, each capacitor module including a capacitor having a form factor suitable for housing within a respective housing adapted to conform to a predetermined part of the patient's body. Each capacitor module is connected to the at least one therapeutic electrode and at least one charger circuit for charging the plurality of said capacitors.

[0090] Other features and advantages of the invention will become apparent from the accompanying drawings, detailed description, and claims. Furthermore, it should be understood that the foregoing information and the following detailed description are merely illustrative examples of various aspects and are intended to provide an overview or framework for understanding the nature and characteristics of the claimed subject matter. Any example disclosed herein may be combined with any other example. References to “example,” “some examples,” “alternative examples,” “various examples,” “an example,” “at least one example,” or “this example and other examples,” etc., are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described in conjunction with the example may be included in at least one example. The appearance of these terms herein does not necessarily refer to the same example.

[0091] Furthermore, in the event of any inconsistency in the use of terminology between this document and the references included herein by reference, the terminology used in the referenced references shall supplement the terminology used herein; in the case of irreconcilable inconsistencies, the terminology used herein shall prevail. Additionally, the accompanying drawings are included herein to provide illustration and further understanding of the aspects and examples, and are incorporated in and constitute a part of this specification. The drawings, along with the remainder of this specification, serve to explain the principles and operation of the described and claimed aspects and examples. Attached Figure Description

[0092] The following figures are not intended to be drawn to scale. Similar reference numerals are used in the figures to denote the same or nearly identical components. For clarity, not every component is labeled in all figures. In the figures:

[0093] Figure 1 An example wearable defibrillator is shown;

[0094] Figure 2A and Figure 2B Example medical device controller shown;

[0095] Figure 3 A schematic block diagram of an example wearable medical device is shown;

[0096] Figures 4A to 4C This shows an example module group for wearable medical devices;

[0097] Figure 5A and Figure 5B An example garment showing a wearable medical device with modular components;

[0098] Figures 6A to 6F Various communication and / or power transmission methods are shown for enabling the module to be operatively connected to clothing used in wearable medical devices;

[0099] Figures 7A to 7D Various techniques are shown for garments used to removably attach modules to wearable medical devices;

[0100] Figure 8A and Figure 8B Various techniques are shown for adjusting the position of modules on clothing used in wearable medical devices;

[0101] Figure 9A and Figure 9B This shows an example module used in wearable medical devices;

[0102] Figure 10A and Figure 10B An example integrated therapeutic electrode is shown with a housing for accommodating a replaceable gel pack;

[0103] Figure 11 An example sensor interface module is shown integrated into clothing used in wearable medical devices;

[0104] Figure 12A and Figure 12B An example energy storage module is shown integrated into clothing used in wearable medical devices;

[0105] Figure 13A and Figure 13B Example clothing for wearable medical devices is shown;

[0106] Figure 14 Another example garment used in wearable medical devices is shown;

[0107] Figure 15 Another example garment for wearable medical devices is shown; and

[0108] Figure 16A and Figure 16B The conformal housing used by the module is shown. Detailed Implementation

[0109] Systems and techniques disclosed herein are provided to improve the ergonomics of various wearable medical devices. For example, wearable medical devices disclosed herein may be cardiac devices that monitor a patient's physiological condition (e.g., cardiac signals, respiratory parameters, patient activity, etc.). For instance, in cases where such a medical device includes a cardiac monitor, it may be configured to determine whether a patient is likely experiencing a cardiac condition, or to allow the patient to report his / her symptoms and correlate the patient's physiological data with these reports. The medical device may include at least one or more sensing electrodes disposed at one or more locations on the patient's body and configured to detect or monitor the patient's cardiac signals. In some implementations, as described in more detail below, the medical device may be configured to monitor other physiological parameters. For example, in specific cardiac monitoring applications such as mobile cardiac telemetry (MCT) applications and / or continuous event monitoring (CEM) applications, these devices may function as cardiac monitors. In addition to or instead of cardiac monitoring, these devices may also monitor respiratory parameters (e.g., monitoring congestion, pulmonary fluid status, apnea, etc.), patient activity (e.g., posture, gait, sleep status, etc.), and other physiological conditions.

[0110] In some implementations, the medical device disclosed herein can be configured to determine appropriate treatment for a patient based on detected cardiac signals (and / or other physiological parameters) and to deliver treatment to the patient. For example, as described in more detail below, the device can deliver one or more therapeutic shocks (e.g., defibrillation and / or pacing shocks) to the patient's body. Therefore, the medical device may include one or more therapeutic electrodes disposed at one or more locations on the patient's body and configured to deliver treatment to the patient, such as delivering therapeutic shocks.

[0111] The medical device described herein can be configured to monitor a patient's arrhythmia status, such as bradycardia, ventricular tachycardia (VT), or ventricular fibrillation (VF). Furthermore, although the detection methods and systems described below are disclosed for detecting VT and VF, this should not be construed as limiting the invention, as other arrhythmias can also be detected, such as, but not limited to, atrial arrhythmias (e.g., premature atrial contractions (PAC), multifocal atrial tachycardia, atrial flutter, and atrial fibrillation), supraventricular tachycardia (SVT), junctional arrhythmias, tachycardia, junctional rhythms, junctional tachycardia, junctional premature contractions, and ventricular arrhythmias (e.g., premature ventricular contractions (PVC) and accelerated ventricular voluntary rhythms). In the case of therapeutic devices such as pacing and / or defibrillation devices, if an arrhythmia is detected, the device can automatically provide pacing, defibrillation, and / or transcutaneous electrical nerve stimulation (TENS) pulses or shocks as needed to treat the condition. Defibrillation devices as described herein may include the ability to provide pacing pulses, TENS pulses, and other types of therapy in addition to defibrillation pulses.

[0112] Example wearable medical devices

[0113] External medical devices can be defibrillators that provide continuous or substantially continuous monitoring within a facility (e.g., for patients confined to limited spaces within a facility, such as in a patient room in a hospital setting) or wearable defibrillators for outpatients. In some implementations, the medical device can be used in specific, dedicated conditions and / or environments such as in war zones or ambulances. The medical device can be a mobile device (e.g., a device that is capable of and designed to move with the patient as he or she performs his or her daily activities).

[0114] For example, such a mobile medical device could be a wearable defibrillator (e.g., the one located in Chelmsford, Massachusetts). Medical company provided Wearable defibrillator). Figure 1 An example wearable medical device 100 is shown. The wearable medical device 100 includes a plurality of sensing electrodes 112 that can be configured at various locations on a patient's body. The sensing electrodes 112 are electrically connected to a medical device controller 120 via a connection housing 130. Figure 1As shown, the controller 120 can be mounted on the strap portion of the garment worn by the patient. As also shown, the sensing electrode 112 and the connection box 130 can be assembled into the garment 110. The sensing electrode 112 is configured to monitor the patient's cardiac function (e.g., by monitoring one or more cardiac signals) and is therefore referred to herein as a cardiac sensing electrode. For example, the connection box 130 may include ECG signal acquisition circuitry for acquiring the sensed ECG signal from the sensing electrode 112. This ECG signal acquisition circuitry also filters, amplifies, and digitizes the sensed ECG signal before sending it to the controller 120.

[0115] The wearable medical device 100 also includes a plurality of therapeutic electrodes 114 electrically connected to the medical device controller 120 via a connection box 130. The therapeutic electrodes 114 are configured to deliver such treatment to the patient’s body when it is determined that one or more therapeutic defibrillation shocks are permitted.

[0116] The controller 120 includes one or more user interface elements, such as response buttons and a touchscreen, which the patient can interact with to communicate with the medical device 100. The controller 120 also includes a speaker for communicating information to the patient and / or bystanders. In some examples, if the controller 120 determines that the patient is experiencing an arrhythmia, the speaker may emit an audible alarm to alert the patient and bystanders to the patient's medical condition. In some examples, the controller 120 may instruct the patient to press and hold all response buttons on the medical device controller 120 to indicate that the patient is conscious, thereby instructing the medical device controller 120 to halt the delivery of one or more therapeutic defibrillation shocks. If the patient does not respond to the instructions from the controller 120, the medical device 100 may determine that the patient is unconscious and proceed with a treatment sequence, ultimately delivering treatment (e.g., one or more defibrillation shocks) to the patient's body.

[0117] Figure 2A and Figure 2BAn example of a medical device controller 120 is shown. The controller 120 may be powered by a rechargeable battery 212. The rechargeable battery 212 can be removed from the housing 206 of the medical device controller 120 to allow the patient and / or caregiver to replace a depleted (or nearly depleted) battery 212 with a rechargeable battery. The controller 120 includes a user interface such as a touchscreen 220 that can provide information to the patient, caregiver, and / or bystander. The patient and / or caregiver can interact with the touchscreen 220 to control the medical device 100. The controller 120 also includes a speaker 204 for communicating information to the patient, caregiver, and / or bystander. The controller 120 includes a response button 210. In some examples, if the controller 120 determines that the patient is experiencing an arrhythmia, the speaker 204 may emit an audible alarm to alert the patient and bystanders to the patient's medical condition. The medical device controller 120 also includes a port 202 for removably connecting a sensing device (e.g., ECG sensing electrode 112) and / or a treatment device (e.g., treatment electrode 114) to the medical device controller 120.

[0118] Example of integrated clothing

[0119] Advantages for mobile (e.g., wearable) medical devices include clothing configured such that some or all of the device electronics are distributed as separate modules and integrated into the clothing worn by the patient. These separate modules can be divided into distinct sub-modules or modular components. Groups of modular components can communicate with each other and collectively form or perform the functions of the individual modules as described herein. Individual modules can communicate with each other and collectively form or perform the functions of the wearable medical device as described herein. For example, the aforementioned device controller and connection box (e.g., Figure 1 The controller 120 and connection box 130 can be divided into multiple modules and distributed and integrated into the garment in various ways. For example, the controller 120 may include multiple separate and different capacitor modules or modular components. Integration into the garment can provide several benefits, such as enhanced patient comfort and facilitated modular use of the device. Such modules can be integrated, for example, by permanently attaching them to the garment, making them an inremovable part of the garment. These modules can then be connected to each other via conductive wires or other communication and / or power transmission mechanisms as described below. Other technologies for integrating modules into the garment can be employed. For example, one or more modules can use one or more connection mechanisms or fasteners (such as...) Hook and loop fasteners, buckles (including conductive buckles), and zipper pulls can be removably attached to garments.

[0120] In some implementations, wearable cardiac monitoring / treatment devices include garments configured to be worn on a patient's torso, and patient monitoring circuitry disposed within the garment and configured to monitor one or more physiological signals from the patient. The patient monitoring circuitry includes multiple separate and distinct modules or modular components communicatively connected to each other via one or more communication links. The patient monitoring circuitry is configured to at least monitor the patient's cardiac activity, detect the presence of arrhythmias in the patient, and provide one or more notifications related to the arrhythmias. The separate and distinct modules or modular components are integrated into the garment and distributed throughout the garment to conform to the patient's ergonomics. The patient monitoring circuitry may include ECG sensor circuitry configured to sense and process the patient's electrocardiogram (ECG) signals, acoustic sensor circuitry configured to detect and process the patient's heart sounds and / or lung sounds, respiratory sensor circuitry configured to sense and process the patient's respiration, and radio frequency circuitry configured to detect and process the patient's fluid levels. The ECG sensor circuitry, acoustic sensor circuitry, respiratory sensor circuitry, and radio frequency circuitry are disposed within separate and distinct modules or modular components. The wearable cardiac monitoring / treatment device may also include a high-voltage circuit that includes treatment control circuitry and an energy storage device, wherein the high-voltage circuit is configured within a treatment module or modular component that is configured to be separable from the wearable cardiac monitoring device.

[0121] In implementation, patients can select a portion of the multi-component medical device as described herein for a specific purpose, and the entire medical device for other purposes. As an example, in the case of a patient deemed to have a low risk of developing a cardiac condition during a specific time period, the patient can use clothing that includes only physiological monitoring components (e.g., with the treatment module removed) for use during that time period. For example, this time period could be during activities such as showering. In another example, the patient can remove one or more communication and / or user interface modules (as described in more detail below) from the clothing for a period of time while still actively monitoring one or more physiological conditions.

[0122] This disclosure acknowledges an understanding of the various challenges patients face when living with wearable medical devices over extended periods. For example, a patient may have recently experienced a cardiac event and is at high risk of cardiac arrest (SCA) in the near future or substantially in the near future (e.g., this risk may manifest as a prominent likelihood of an event occurring within the next few hours, days, or weeks, as determined by a physician). Patients may be prescribed by their physician to wear a wearable defibrillator for several days or weeks until the risk of SCA subsides or until an implantable defibrillator becomes available. Patients may have to wear the wearable medical device for daily activities, including, for example, sleeping, going to work, shopping, exercising, and / or operating a motor vehicle. Additionally, patients may not want their wearable medical device to be easily visible to others, thereby revealing their condition to the general public.

[0123] The garments disclosed herein for use in such wearable medical devices provide ergonomic conformity to the patient, such as providing optimal fit and comfort over extended periods and / or avoiding pressure or injury to the patient. For example, such garments may include at least a front portion (e.g., a flexible, substantially flexible, or substantially semi-rigid fabric or other material-based element disposed on the front of the patient) and a back portion (e.g., a flexible, substantially flexible, or substantially semi-rigid fabric or other material-based element disposed on the back of the patient). In some implementations, the front portion may be coupled or connected to the back portion via one or more sides. In some implementations, the front portion may be coupled or connected to the back portion via one or more shoulders or shoulder straps. For example, the shoulders or shoulder straps may include back straps configured to support the remainder of the garment and / or garment components via one or more of the patient's shoulders. One or more of the front, back, sides, and shoulders may be formed from a single, continuous wearable garment. In some implementations, one or more of the front, back, sides, and / or shoulders may be independent and separable from each other. Furthermore, without significantly departing from the principles described herein, one or more of the above sections may be omitted and / or replaced by alternative connection structures. These sections may be configured to be removably coupled or connected to each other. For example, such ergonomic clothing can distribute the weight of the components of the wearable medical device evenly across one or more sections of the clothing as described herein, thereby simplifying the wearable medical device. Additionally, in some implementations, loose cables that might easily dangle from an object may be permanently configured with the clothing and / or removably and securely attached to it. In the examples, in addition to distributing the weight of the wearable medical device, various clothing structures are disclosed herein to, for example, reduce the visibility of the wearable medical device and / or make it easier to wear. These garments may also be washable (e.g., machine washable) to allow users to easily wash the garment, and / or they may be water-resistant / waterproof to allow patients to shower while wearing the wearable medical device.

[0124] In various embodiments, the garment may be configured to be worn on the patient's torso, and may be a vest worn on the patient's upper body, a wrap-around garment, or a one-shoulder garment configured to be worn on one shoulder and wrap around the patient's upper torso.

[0125] Furthermore, the garment may include an outer surface (e.g., a surface of the garment including the portion facing away from the patient's skin) and an inner surface (e.g., a surface of the garment including the portion facing the patient's skin), each possessing different material properties and / or design purposes. For example, the garment may be constructed such that the outer surface of the garment is water-resistant and substantially prevents water ingress, while the inner surface of the garment may be configured to substantially allow moisture vapor (such as that generated from the patient's skin) to be transferred away from the patient's skin. The garment may be permeable to allow moisture and water vapor to pass from the inner layer of the garment to the outer layer. Such garment may be composed of a single fabric and / or material comprising both an inner surface and / or an outer surface. In some implementations, the garment may be composed of a single fabric and / or material laminated and / or coated with other materials on one or both sides. For example, such material may be cotton, nylon, polyester, and / or mixtures of these materials, and may be laminated and / or coated with polytetrafluoroethylene, expanded polytetrafluoroethylene (e.g., PTFE), on one or both sides. Materials) and / or polyurethane materials. Clothing may be made of materials with low skin irritation. Clothing may be breathable to promote ventilation through the garment.

[0126] In some implementations, the garment may comprise one or more layers of fabric or other materials, wherein at least an outer layer forms the outer surface of the garment and an inner layer forms the inner surface. Additional layers may be configured between the inner and outer layers. Furthermore, the outer, inner, and / or additional layers may have different material properties and / or purposes. For example, the inner layer of the garment may be breathable, for instance, permeable to moisture and / or water vapor, such that moisture and / or water vapor can be transferred from the inner layer to the outer layer based on a pre-designed moisture transfer rate. For example, this moisture transfer can be expressed as an average moisture transfer rate and may be designed to be greater than about 100 g / m³. 2 / day. In some implementations, the average rate can be greater than approximately 250 g / m³. 2 / day. Depending on the type of material chosen for one or more layers, the selected average moisture transfer rate can vary, allowing the average moisture transfer rate of the garment to be approximately 100 g / m² in various implementations. 2 / day and approximately 250g / m 2 Between / days, at approximately 250g / m 2 / day and approximately 20,000g / m 2 Between / day, or around 20000g / m 2 / day and 50000g / m 2 / between days.

[0127] The outer layer can be based on hydrophobic and / or superhydrophobic materials, such as materials that repel water or moisture from the outer layer. For example, some materials used in clothing can have an average moisture transport rate greater than 20,000 g / m³. 2 / day (e.g., 20000g / m 2 / day ~50000g / m 2 / day). Materials used for this purpose may include nylon, polyester, and may be based on polytetrafluoroethylene, expanded polytetrafluoroethylene (e.g., PTFE, expanded polytetrafluoroethylene). Laminate or coat with materials and / or polyurethane materials.

[0128] For example, the rate of moisture transfer or resistance to wet vapors through one or more layers of clothing can be optimized by subjecting the fabric to tests such as the vertical cup method (ASTM E96-80-Procedure B) and the sweating hot plate method (ISO 11092). In short, the vertical cup method determines water loss from a plate covered with a fabric sample over a predetermined period of time. The results can be expressed in g / m². 2 / day is used to represent the heat loss through evaporation along the water vapor pressure gradient. The results can be expressed in m... 2 Pa / W is used to express this. One or more layers of clothing can be designed to optimize patient comfort and clothing durability based on the results of these tests. Additionally, one or more layers of clothing can be tested to measure wicking or water transport properties through the fabric, including longitudinal wicking "strips" tests, transverse or cross-plane wicking plate tests, air wicking point tests, and siphon tests. Details of such tests can be found in "ASurvey and Comparison of Laboratory Test Methods for Measuring Wicking," published by Harnett, PR and Mehta, PN in the Textile Research Journal in July 1984.

[0129] Furthermore, in some implementations, the garment can be configured to be breathable and to facilitate ventilation through the garment at a pre-designed rate to enhance long-term patient comfort and garment durability. For example, materials such as polyethylene, polypropylene, and / or polyurethane membranes can be used to construct one or more layers of the garment.

[0130] In some examples, weight is distributed throughout the garment by dividing various patient monitoring and / or treatment components into multiple modules and distributing these modules across different parts of the garment. For example, these modules may include device electronics within a housing constructed to be impermeable to water ingress. For example, the modules and / or subsystems described herein may be protected against, for example, condensation or dripping (e.g., vertical dripping), water dripping at one or more angles (e.g., angles between about 15 degrees and about 60 degrees relative to the vertical), water splashing from any angle, low-pressure water flow from any angle, high-pressure water flow from any angle, water immersion (e.g., immersion at a depth of about 1 meter for a period of about 30 minutes, as required by the appropriate level of entry protection as defined by International Standard EN 60529, British Standard BS EN 60529:1992, and European Standard IEC 60509:1989), and / or continuous water immersion under underwater conditions. Garments can be constructed such that one or more modules are included between one or more layers of the garment (e.g., between an inner and outer layer of the garment as described above). The modules can be connected by one or more wires, cables, and / or conductive threads to form a removable assembly from the garment. In another example, the modules can be connected by one or more cables to form an assembly permanently configured within and as part of the garment. For example, one or more of these modules can be permanently held in place within the garment by seams, riveting, and / or garment fasteners configured around the periphery of the module and / or on its housing, thereby substantially securing the module to the garment.

[0131] For example, a first subset of multiple modules can be interconnected with each other via a first one or more wires or cables, and a second subset of multiple modules can be interconnected with each other via a second one or more wires or cables. Each subset and its corresponding wire or cable can be removable from the garment. For example, each module in the assembly can be attached to the garment using one or more hooks or loops at various locations on the garment. Hooks or loops used to removably attach the assembly to the garment can include, for example, hook and loop fasteners, snaps, and zipper pulls.

[0132] For example, garments can be operatively connected to modules via conductive hook-and-loop fasteners, conductive snaps, infrared (IR) coupling, capacitive coupling, inductive coupling, and / or conductive magnets. Modules can be removably secured to garments via the same mechanisms used to operatively connect garments (e.g., via conductive hook-and-loop fasteners) and / or via separate mechanisms. For example, garments may include pockets and / or sleeves for receiving and securing modules in appropriate locations on the garment.

[0133] In other examples, in addition to associated wires or cables interconnecting multiple modules or subsets of modules, multiple modules or subsets of modules are permanently connected, making these modules non-removable parts of the garment. For example, components of one or more modules can be connected to each other via conductive filaments, wires, or cables. It should be understood that other technologies can be used to operatively connect multiple modules. For example, multiple modules can communicate wirelessly via various wireless (e.g., radio frequency) communication methods, fiber optics, and / or via Body Area Network (BAN) standard protocols (IEEE 802.15.6 standard).

[0134] In some examples, wearable medical devices may include various monitoring components for monitoring a patient's condition and therapeutic components for providing treatment to the patient. In these examples, the therapeutic components may be separate from the monitoring components, allowing a user (e.g., a patient) to appropriately reconfigure the medical device as either a therapeutic or monitoring device. Enabling a user to reconfigure the wearable medical device can advantageously allow a lighter wearable medical device when the patient's condition does not require the therapeutic components. In these examples, the wearable medical device may monitor the patient's condition and notify the patient of changes in condition that may require the therapeutic components. In some implementations, the therapeutic components may have a separate therapeutic processor for controlling the therapeutic protocol, and in some cases, for handling the issuance of alarms related to the therapeutic protocol. For example, a therapeutic protocol may include: detecting a patient response to an alarm related to an impending treatment; initiating a treatment sequence if no response is detected from the patient; deploying a conductive gel (where such a gel is used) substantially close to the treatment site; charging an energy storage device to prepare it for charge delivery; and issuing one or more electric shocks to the patient based on the detected condition. Therefore, in the case of a wearable medical device without therapeutic components, one or more processors (e.g., a main processor in the wearable medical device) can be configured to monitor only the cardiac condition or other physiological condition detected in the patient and issue any associated warnings. In one example, where the therapeutic components are included in the clothing, the therapeutic processor may be disabled, and the main processor can automatically reconfigure itself to manage the therapeutic protocol. In another example, where the therapeutic components are included in the clothing, the therapeutic processor can continue to manage the therapeutic protocol, and the main processor can be configured to monitor the patient's treatable physiological conditions, and if such conditions are detected, the main processor can cause the therapeutic processor to initiate a therapeutic protocol.

[0135] One or more modules may be configured within a conformal housing or enclosure, which is configured to be included within or integrated into clothing worn by the patient. For example, see reference... Figure 16A and Figure 16B In some examples, at least one of the housings or shells used in the device may be specially molded to conform to the unique body shape of each patient, such as conforming to the shape between the patient's shoulder blades or to a small portion of the patient's back. A housing or shell shaped like a conventional box may be noticeably more uncomfortable for the user than a housing or shell of the same volume that conforms to the patient's anatomical surface. The overall size of a combined package of an inner housing containing electronics and other components and an outer conformal shell may be larger than that achievable with only an inner housing, but the housing is configured to be comfortable for the patient, including when the patient is asleep, due to the conformal characteristics of the outer surface. Due to the adaptability described herein, wearable devices can also be adapted for active use such as jogging, dancing, or sports. The conformal shell can be configured to reduce shell displacement while the patient is engaged in these activities, for example, by a structure that allows for a better, more snug fit to the patient.

[0136] For example, such as Figure 16A As shown, when the conformal housing 1600 is applied to the inner housing 1602, in addition to having a patient-fitting surface 1604 facing the patient to conform to the patient's body shape, it may also have a tapered edge 1606, wherein the tapered edge 1606 gradually blends the edge of the device with the patient's surface. Thus, when the patient is lying on top of the conformal housing 1600, for example, while sleeping at night, the feeling of lying on the device is more like lying on a pillow than on bricks. In some examples, the inner housing 1602 contains all the electronics, power supply, etc., and may have a thickness of approximately 1 / 2 to 1”. In some implementations, the overall size is designed to fit within the patient's shoulder blades 1614, which are approximately 6 inches wide. In these implementations, the conformal housing may be constructed with recesses to conform to the patient's spine 1616. Some other examples of possible locations for the conformal housing include a small portion of the back, in the armpit area, or around the waist.

[0137] In some versions, the inner housing 1602 may contain a therapeutic delivery element, such as those from Chelmsford, Massachusetts. medical companies Defibrillator electrodes used in wearable defibrillators, etc. In this example, the conformal housing 1600 may be configured to have at least one hole on the patient-facing surface to allow a therapeutic agent to be ejected by the therapeutic delivery element. The therapeutic agent may be a conductive gel to, for example, reduce the impedance between the therapeutic delivery element and the patient's skin 1612.

[0138] In one example, a flexible and compressible foam shell can be molded for each patient based on a three-dimensional representation generated using 3D surface imaging technology with human anatomy integrity (e.g., 3dMDthorax System (3dMD LLC in Atlanta, Georgia)). The conformal shell 1600 can be fabricated using materials such as VisiJet C4 spectrum plastics, such as a ProJet 4500 full-color plastic printer (3DSystems Rock Hill SC). It should be understood that other methods and / or other materials can be used to construct the conformal shell 1600.

[0139] In some examples, such as Figure 16B As shown, a disposable moisture-wicking material 1608 can be inserted between the conformal housing 1600 and the patient's skin 1612. This wicking material may include materials such as Coolmax (DuPont) polyester fabric with enhanced capillary and wicking effects. An additional moisture-wicking layer 1610 may also be added between the moisture-wicking material and the conformal housing 1600 to further enhance system comfort and wick away more moisture from the patient's skin 1612. The moisture-wicking layer 1610 may contain materials such as powdered sodium polyacrylate, used in commercially available diapers or sanitary napkins that can absorb up to, for example, about 800 times their weight in water.

[0140] Wearable devices as described herein can enable continuous, substantially continuous, long-term and / or extended-duration use or wearing by a patient, or installation or connection to a patient. For example, devices as described herein can be used or worn by a patient, or installed or connected to a patient, for example, for hours or more (e.g., weeks, months or even years) without substantial interruption. In some implementations, without departing from the scope of the examples described herein, these devices can be removed for a period of time to change or wash clothing, and / or shower before resuming (e.g., replacing batteries) use, wearing, installation or connection to the patient.

[0141] In addition to cardiac monitoring, medical devices can monitor other physiological conditions of a patient. For example, the device can be configured to use various sensors, including radio frequency (RF) sensors, ultrasound sensors, electrodes, etc., to monitor blood oxygen saturation, body temperature, blood glucose levels, sleep apnea, snoring and / or other sleep conditions, heart sounds, lung sounds, tissue fluid, etc. In some instances, the device can perform monitoring at periodic or non-periodic time intervals or periods. For example, monitoring during an interval or period can be triggered by a user action or another event. For example, one or more durations between periodic or non-periodic intervals or periods can be user-configurable.

[0142] In some implementations, sensing electrodes and / or therapeutic electrodes are configured on a disposable adhesive electrode patch and connected to the medical device. In some implementations, sensing electrodes and therapeutic electrodes are configured on a single integrated disposable adhesive electrode patch and connected to the medical device. In some implementations, the medical device, as described herein, may be configured to monitor patients experiencing syncope (e.g., by analyzing a patient's cardiac activity to obtain abnormal patterns that may indicate abnormal physiological function).

[0143] Example of integrated clothing subsystem

[0144] Such as using Figure 3 As shown in the schematic block diagram of an example wearable medical device 300, the components of the wearable medical device (e.g., including a device controller and / or a connection box) can be organized into one or more modules or subsystems. The wearable medical device 300 includes a sensor system 306, a treatment delivery system 308 containing treatment control circuitry, a processor configuration 310, a user interface 312, a communication system 314, and a data storage 316. The sensor system 306 is operatively connected to one or more patient sensing elements (e.g., ECG sensors and heart sound sensors). The treatment delivery system 308 is operatively connected to one or more treatment electrodes or other treatment delivery elements. The treatment control circuitry in the treatment delivery system 308 can be configured to initiate treatment to the patient based on one or more notifications related to a detected arrhythmia in the patient. The treatment control circuitry in the treatment delivery system 308 can be configured to provide the patient with at least pacing therapy, defibrillation therapy, and transcutaneous electrical nerve stimulation (TENS) therapy. It should be understood that the wearable medical device 300 may include... Figure 3 Other components, such as power sources (e.g., batteries), are not shown. As described above, each subsystem and / or module may be configured within a respective housing, which is shaped and configured to be included within or integrated into clothing worn by the patient.

[0145] In some implementations, it can be Figure 3The subsystems shown are divided into a low-voltage (LV) system 302 and a high-voltage (HV) system 304. Dividing the wearable medical device into LV system 302 and HV system 304 can be advantageous for reducing electrical interference between HV system 304 and other components. Thus, HV system 304 can be packaged together and located in a module separate from (and in some cases remote from) LV system 302 and / or shielded relative to LV system 302. The high-voltage circuitry included in the wearable cardiac monitoring device (e.g., in the HV system) may include treatment control circuitry and energy storage devices. The high-voltage circuitry may be configured within a treatment module or modular assembly that is configured to be separable from the wearable cardiac monitoring device. It should be understood that the following description is based on the division of the device (e.g., into LV and HV systems) according to the operating voltage of the components of the wearable medical device; however, other methods may exist to separate the components of the device. For example, it may be desirable to divide the device based on one or more functions of the components. Thus, the communication module may include communication circuitry as described below, the energy storage module may include one or more capacitors for storing charge, the self-test module may be configured to monitor periodic and non-periodic self-tests of various aspects of the device, and the power supply module is used to ensure that the battery remains within its operating range and is ready to charge one or more capacitors if needed. In some examples, the HV system 304 may be one or more systems, or may include one or more components operating at voltage levels of about several hundred to several thousand volts. In an implementation, the HV system 304 may be one or more systems operating at voltage levels between 25% and 100% of the peak voltage value of one or more treatment pulses. For example, the treatment delivery system 308 may provide treatment pulses (e.g., defibrillation pulses) at a peak voltage of about 1600 volts. In this example, the HV system may have one or more components operating at voltages greater than about 400 volts (e.g., 25% of the peak voltage), including, for example, high-voltage converters. It should be understood that, depending on the particular implementation, other voltage classifications may be employed to distinguish the HV system from the LV system. For example, the HV system 304 may be a system with one or more components operating at voltage levels exceeding 100 volts. Therefore, in some implementations, high-voltage components may include one or more components that operate at voltage levels between about 100V and about 2000V, or between 400V and about 2000V, or between about 500V and about 2000V.

[0146] The LV system can be a system that operates at a voltage level lower than (and / or substantially lower than) that of the HV system 304 (e.g., less than 100 volts). For example, the sensor system 306, processor configuration 310, user interface 312, communication system 314, and / or data memory 316 can all operate at voltages substantially lower than 100 volts. For example, the LV system may include components operating at voltage levels between about 1 mV and about 5 V. In some examples, the LV system may include components operating at voltage levels between about 5 V and about 100 V. It should be understood that the 100-volt level demarcation between the HV system 304 and the LV system 302 can be adjusted based on a particular implementation. For example, the treatment delivery system 308 may operate at a voltage level of 500 V, and the demarcation between the LV system and the HV system may be a voltage level between 500 volts and the operating voltages of the remaining components of the wearable medical device. Furthermore, it should be understood that in some implementations, the HV system 304 may include one or more LV components. For example, such an LV component can be associated with a portion or all of the implementation and / or control of the HV component.

[0147] The treatment delivery system 308 may include a method for delivering treatment via one or more treatment electrodes (e.g., Figure 10A and Figure 10B A treatment delivery system 308 may include a treatment electrode and / or a treatment delivery element to provide treatment to a patient. For example, the treatment delivery system 308 may include various means for providing treatment pulses (e.g., including TENS pulses, pacing pulses, and / or defibrillation pulses) to the patient. The treatment pulses may be generated by charging a capacitor bank and discharging the energy stored in the capacitor bank to the patient. For example, the treatment delivery system 308 may include one or more power converters for controlling the charging and discharging of the capacitor bank. In some implementations, energy release from the capacitor bank can be controlled by, for example, an H-bridge circuit described in the following documents: U.S. Patent 6,280,461 entitled “PATIENT-WORN ENERGY DELIVERY APPARATUS”, issued August 28, 2001 (hereinafter referred to as the “'461 Patent”) and U.S. Patent 8,909,335 entitled “METHOD AND APPARATUS FOR APPLYING A RECTILINEAR BIPHASIC POWER WAVEFORM TO A LOAD”, issued December 9, 2014 (hereinafter referred to as the “'335 Patent”), the entire contents of which are incorporated herein by reference.

[0148] In some examples, the therapeutic delivery system 308 may include one or more therapeutic delivery mechanisms comprising various drug delivery devices or one or more components for delivering drug therapy to a patient. For example, the therapeutic delivery system 308 may include a device for intravenous delivery and / or patch absorption of a drug. The patch absorption device may include a microneedle array comprising a plurality of microneedles (e.g., each microneedle is much thinner than a human hair) coated and / or filled with a drug to be applied to the patient. Using a microneedle array for drug delivery may be advantageous in some examples because the needles are so small that they do not reach nerves in the skin, thereby delivering the drug with minimal pain experienced by the patient. In some implementations, the therapeutic delivery mechanism may include a microneedle array-based electrode patch for delivering therapeutic electrical energy through the patient's skin. It should be understood that in some implementations, the therapeutic delivery system 308 may include one or more therapeutic delivery mechanisms that do not require high voltage, such as those comprising drug delivery devices.

[0149] The therapeutic delivery system 308 may include a gel deployment circuit configured to deliver a conductive gel substantially close to a treatment site (e.g., a surface of a patient's skin in contact with a therapeutic electrode) prior to the delivery of a therapeutic shock. The gel deployment circuit may be configured to deliver the conductive gel immediately before or within a short time interval (e.g., about 1 second, 5 seconds, 10 seconds, 30 seconds, or 1 minute) prior to the delivery of the therapeutic shock to the treatment site. This gel deployment circuit may be connected as a single unit to or integrated within the therapeutic electrode or other therapeutic delivery device. In the event of a detected treatable cardiac condition and no patient response received after device prompting, the gel deployment circuit may be signaled to deploy the conductive gel. In some examples, the conductive deployment circuit may be constructed as one or more separate and independent gel deployment modules. Such modules may be configured to receive a removable and / or replaceable gel cartridge (e.g., a cartridge housing one or more conductive gel storage sections). Thus, the gel deployment circuit may be permanently configured in clothing as part of the therapeutic delivery system, while the cartridge may be removable and / or replaceable.

[0150] In some implementations, the gel deployment module may be implemented as a gel deployment package, and at least a portion of the gel deployment circuitry and one or more gel storage units may be included within the gel deployment package. In such an implementation, the gel deployment package, including one or more gel storage units and associated gel deployment circuitry, may, for example, employ the following... Figure 10A and Figure 10BThe manner illustrated is removable and / or replaceable. In other examples, a gel deployment package, including one or more gel storage sections and associated gel deployment circuitry, and a treatment electrode can be integrated into a treatment electrode assembly that can be removed and replaced as a single unit after use or in the event of damage or breakage.

[0151] Sensor system 306 includes systems for sensing various physiological parameters of a patient. For example, sensor system 306 may include ECG electrodes for monitoring the patient's ECG, acoustic sensors for monitoring the patient's heart sounds and / or lung sounds, a respiratory monitor for monitoring the patient's breathing, such as during sleep studies or when monitoring sleep apnea, and / or radio frequency-based fluid monitoring sensors. Other example physiological parameters that can be monitored using sensor system 306 include patient movement, patient body position (e.g., standing, supine, etc.), patient posture, lung sounds, tissue fluid, pulmonary fluid, oxygen content, and / or blood pressure levels. Sensor system 306 may also include various sensor acquisition circuitry for filtering and / or preprocessing these sensor signals, for example, before providing them to processor configuration 310.

[0152] Sensor system 306 may include sensors located at one or more locations on clothing for monitoring a patient's heart sounds and / or lung sounds, sleep, activity, and other types of body sounds or patient activity. For example, the sensor may include a triaxial multichannel MEMS accelerometer, such as a three-channel accelerometer. A first channel may be configured to monitor sounds produced by the patient's heart, a second channel may be configured to monitor the patient's breathing, and a third channel may be configured to monitor the patient's movement. Such a sensor is described, for example, in U.S. Patent Publication 2015 / 0005588 (hereinafter referred to as "'588 Publication"), entitled "THERAPEUTIC DEVICE INCLUDING ACOUSTIC SENSOR," published January 1, 2015, and entirely incorporated herein by reference. The sensor may be configured to communicate with a recording system (e.g., a local storage module or a remote server) for storage and analysis. In some implementations, sensor system 306 may be configured to connect to at least one of communication module 408 and user interface module 410 to provide alerts to the patient, the patient's caregiver, relatives, and / or other alarm agencies. For example, sensor system 306 may be configured to analyze signals representing sounds produced by a patient's heart, and further configured to alert the patient and / or another entity upon detection of an abnormal cardiac condition or other condition. In some implementations, sensor system 306 may be configured to include a processor for performing the above analysis based on one or more software modules stored on the processor. For example, such a processor may be physically connected to one or more sensors substantially close to sensor system 306. In another example, the processor may be within processor configuration 310 described below.

[0153] In some examples, processor configuration 310 can execute a series of instructions controlling the operation of other components of wearable medical device 300. Processor configuration 310 can execute one or more software components, such as those stored in data memory 316. These software components may include cardiac monitoring components configured to recognize arrhythmias. In some implementations, these software components may include acoustic sensors for monitoring heart sounds and movement and / or lung sounds during sleep studies or sleep apnea monitoring. In some implementations, the software components can operate and monitor the acoustic sensors used to monitor heart sounds and movement and / or lung sounds, and can combine information from these sensors with ECG information for processing and analysis.

[0154] Sensor system 306 may include a pulse oximetry sensor configured to monitor a patient's oxygen saturation. For example, the sensor may be located in a pocket or other concealed area within clothing and may be removable and connected to one or more modules within an integrated module within the clothing. For example, the sensor may be removed from a pocket within clothing and placed on a finger, and communicatively connected (e.g., via an electrical connection through a cord, a wireless connection, an optical connection, etc.) to a processor configured within the clothing. For example, the processor may be part of a processor configuration 310 as described in more detail below. For example, the sensor may be connected to a handheld device (e.g., a smartphone or tablet) or a wrist-mounted device such as a watch. The handheld device may include software components configured to receive signals from the sensor and store and / or process these signals for analysis.

[0155] Processor configuration 310 may include multiple processors and / or multi-core processors connected to shared memory (e.g., a memory module accessible for reading and / or writing by any of the multiple processors or processor cores). In some implementations, each processor and / or processor core may be configured to operate using a corresponding independent memory module. In some examples, each of the multiple processors within the processor configuration may be configured to perform a subset of the tasks performed by processor configuration 310. For example, as described in U.S. Patent 8,904,214 (hereinafter referred to as the "'214 Patent") entitled "SYSTEM AND METHOD FOR CONSERVING POWER IN A MEDICAL DEVICE," issued December 2, 2014, which is incorporated herein by reference in its entirety, processor configuration 310 may include a digital signal processor (DSP) for receiving and analyzing sensor data to identify medical conditions requiring treatment, and a general-purpose processor for controlling user interface components.

[0156] In some examples, processor configuration 310 includes an LV processor for managing LV system 302 and an HV processor for managing HV system 304. The LV processor and HV processor may be located, for example, within a processor module and communicate with the HV system and LV system, or they may be located within a module (one of these modules) controlled by the respective processor.

[0157] In some implementations, the LV processor may be configured, for example, to acquire data from the sensor system 306, initiate communication with external systems via the communication system 314, provide notifications to external entities via the user interface 312, and / or store sensor data in the data memory 316. The HV processor may be configured, for example, to control the charging of the capacitor bank and / or the application of therapeutic pulses to the patient. It should be understood that the HV processor can operate at low voltage and does not necessarily have to operate at the same voltage as the HV system controlled by the HV processor.

[0158] In some examples, the LV processor can be a multi-core processor having: a first core configured to process sensor data acquisition from various sensors; and a second core configured to perform ECG monitoring to detect arrhythmias, control the user interface, control treatment sequence, provide data storage, and / or manage data storage. In these examples, the first core of the LV processor can be a digital signal processor core, and the second core can be a general-purpose processor core, including, for example, an ARM core.

[0159] As described above, the LV processor and HV processor can have shared memory to share information. For example, the LV processor can store at least a portion of the data from the sensor system 306 in the shared memory for access by the HV processor. It should be understood that other processor configurations 310 can be employed. For example, multiple different single-core processors and / or a single multi-core processor including any number of cores can be employed.

[0160] Communication system 314 may include various systems for communicating with external devices, such as a central server and / or a remote base station. U.S. Patent Publication 2012 / 0112903 (hereinafter referred to as the "'903 Publication"), entitled "REMOTEMEDICAL DEVICE ALARM" and published May 10, 2012, in its entirety, described an example base station capable of communicating with wearable medical devices, in addition to various remote device communications. Communication system 314 may include, for example, a transmitter, receiver, transceiver, and / or antenna for wireless communication. Regarding wireless communication, it can be achieved by including, for example… Wireless wireless links can be implemented using any one or a combination of wireless communication standards and protocols such as Wireless USB, ZigBee, and Wireless Ethernet.

[0161] Example module structure

[0162] As described above, the components of a wearable medical device can be organized into multiple LV systems 302 and / or HV systems 304. Each component in the LV system 302 and / or HV system 304 can be packaged into multiple LV modules and / or HV modules. The multiple LV modules and / or HV modules can be individual and distinct modules. At least two of the multiple modules can be electrically connected via conductive filaments, wires, or cables integrated into the garment. At least one user interface can be communicatively connected to at least one of the modules or modular components. These modules can be distributed throughout the garment to provide uniform weight distribution. These modules can be created, for example, by mounting one or more components to a printed circuit board (PCB) or other substrate and housing the PCB within a housing.

[0163] In some implementations, multiple modules or modular components include low-voltage circuitry configured within at least one low-voltage module or modular component, and high-voltage circuitry configured within at least one high-voltage module or modular component that is separate from and different from the at least one low-voltage module or modular component. The low-voltage circuitry may be configured to control at least one of the following: user interaction, cardiac signal acquisition and monitoring, arrhythmia detection, synchronization of defibrillation pulses with cardiac signals, treatment sequencing, patient alarms, data communication, and data storage. The high-voltage circuitry may include at least one of the following: treatment control circuitry and energy storage devices.

[0164] Figure 4AAn example module group 400A including an LV module and an HV module is shown. As shown, the module group 400A includes an energy storage module 402, a sensor interface module 426, a treatment control module 404, an operation module 406, a communication module 408, and a user interface module 410. The module group 400A can be operatively connected via a link 424. The link 424 may include communication, for example, via a BAN, a wireless communication link, optical fiber, cable, and / or conductive filaments woven into clothing. The link 424 may be a thread or conductive filament woven into clothing and may be flexible or stretchable, or patterned, such as a coiled arrangement or zigzag pattern that allows the link to stretch along with a portion of the clothing to which it is integrated or mounted. The link 424 may be able to support communication, power transmission, or both. In the example where the link 424 is a conductive filament, thread, or cable, different links in the link 424 may have different sizes, for example, having a different thickness, diameter, or cross-sectional area than other links in the link 424. The cross-sectional area of ​​these different links 424 can be selected based on the voltage, current, or power that each link 424 is configured to transmit. A link 424 configured to deliver a higher amount of power (e.g., the link 424 with the therapeutic electrode 114) can have a larger cross-sectional area than the link 424 with the sensing electrode 112. For example, as shown in the table below, the cross-sectional area or specification of the link 424 can be selected based on the maximum current rating:

[0165] Table 1: Link Specifications vs. Maximum Current Rating

[0166] Link Specification Link diameter (mm) Maximum current rating (amperes) 40 0.079 0.014 35 0.142 0.044 30 0.254 0.142 25 0.455 0.457 20 0.813 1.5 15 1.45 4.7 10 2.59 15 5 4.62 47

[0167] Table 1 assumes conductive wires / filaments formed from a single strand of copper. If other materials are used or conductive wires / filaments with different numbers of strands are used, different maximum current ratings may be applicable to different specifications.

[0168] Conductive wires integrated into clothing and configured to deliver one or more therapeutic pulses to a patient (e.g., via one or more therapeutic electrodes) can be selected based on the maximum current to be carried in the wire during the instantaneous duration of the current. For example, assuming a therapeutic pulse in the range of about 1200V to about 1800V, the typical maximum current through the conductive wire during an instantaneous duration of about 5 to 50 ms can be between 60 and 80 A. The instantaneous duration used to determine the appropriate specification of the conductive wire can be, for example, less than 10 ms, less than 20 ms, less than 30 ms, less than 50 ms, and 100 ms. For example, specifications between 15 and 35 can meet these requirements. As an example, a specification 28 wire can be used to support an instantaneous continuous current in the range of 60-80 A. In some implementations, various modules can be configured in the clothing, for example, these modules can be constructed as permanent parts or components of the clothing. For example, these modules can be permanently configured within or attached to the clothing. The various modules can be separate and distinct modules, wherein one or more of these separate and distinct modules are permanently fixed to the clothing. In other examples, these modules may be configured to be removably attached to clothing. The various modules may be separate and distinct modules, wherein one or more of these separate and distinct modules are configured to be removably attached to the clothing or movably (e.g., slidably) attached to the clothing. For example, the operation module 406 may be permanently attached to the clothing, and the treatment control module 404 may be removably attached to the clothing using conductive hook-and-loop fasteners. It should be understood that one or more of these modules may be separate from the clothing portion of the wearable medical device. For example, as described in '903, the user interface module 410 may be implemented as a wrist-mounted device (e.g., similar to a watch).

[0169] Energy storage module 402 can store energy used for therapeutic pulses, including, for example, defibrillation pulses, pacing pulses, and / or TENS pulses. This energy can be stored in an energy storage device (e.g., capacitor 412) for rapid discharge to the patient. The energy storage device can include multiple capacitors and at least one battery (e.g., a non-rechargeable battery) for supplying power to the multiple capacitors. The energy storage device can be configured to store energy used for at least one therapeutic pulse. The energy storage device can be connected to treatment control circuitry in a treatment control module 404, for example, configured to at least control the release of energy from the storage module. In some examples, energy storage module 402 can be an HV module due to the charging voltage of the capacitors. The energy storage device can be configured in a module or modular component. The energy storage device can include a first energy storage device for storing energy used for a first portion of the therapeutic pulse, and a second energy storage device, different from the first energy storage device, for storing energy used for a second portion of the therapeutic pulse. Multiple modules or modular components of a wearable cardiac monitoring device may include a first energy storage device integrated into the front portion of the garment and a second energy storage device integrated into the back portion of the garment, and / or multiple capacitors distributed throughout the garment and integrated into it. The energy storage module may be divided into multiple separate and distinct capacitor modules or modular components. Each capacitor module or modular component may include a capacitor having a form factor adapted to be housed within a corresponding housing adapted to conform to a predetermined location on a patient's body. Each capacitor module or modular component may be connected to at least one therapeutic electrode and at least one charger circuit for charging the multiple capacitors. In some implementations, a single capacitor may be included in one or more separate and distinct capacitor modules or modular components and may be electrically connected to other capacitor modules or modular components.

[0170] In some implementations, the wearable cardiac monitoring device may include individual and distinct modules or modular components, at least one of which may comprise treatment control circuitry and an energy storage device. This at least one treatment module or modular component may be configured to be removably attached to clothing and to provide treatment to the patient based on the detected cardiac condition.

[0171] In some examples, the energy storage module 402 may include a battery 420 for charging the capacitor. Positioning the battery 420 close to the capacitor 412 and / or the charging circuitry used by the capacitor 12 can be advantageous because this shortens the distance the charging current needs to travel from the battery to the capacitor. Similarly, a treatment pad (e.g., treatment pad 114) may be connected to the energy storage module 402 to minimize the distance the energy must travel from the capacitor to the treatment pad. For example, the link connecting the capacitor to the treatment pad may be able to withstand electrostatic discharge (ESD) of 1600 volts to 15000 volts. This avoids or at least minimizes the length of electrical pathways that would require supporting large charging currents and / or discharge energies. The energy storage module 402 may be separate and distinct from other modules of the wearable cardiac device, may be connected to at least one treatment electrode, and may be configured to store energy for at least one therapeutic shock to be applied to the patient.

[0172] In some examples, battery 420 is a non-rechargeable battery. Making battery 420 a non-rechargeable battery can be advantageous in some examples for several reasons. For example, non-rechargeable batteries typically have a higher energy density compared to rechargeable batteries, allowing for lighter batteries and thus reducing the weight of wearable medical devices. Using a non-rechargeable battery can also have other advantages, including that battery capacity does not decrease over time as the battery undergoes more charge and discharge cycles, and / or that internal impedance does not increase with more charge and discharge cycles. The increased internal impedance and / or reduced capacity of older rechargeable batteries may prevent them from providing sufficient energy to charge the capacitor and deliver treatment to the patient.

[0173] It should be understood that in some examples, battery 420 is a rechargeable battery. The disadvantages of rechargeable batteries discussed above can be mitigated, for example, by introducing a battery testing sequence to test the condition of the battery. Battery testing may include an impedance test to determine whether the battery's internal impedance exceeds a threshold. If the battery's internal impedance exceeds the threshold, the wearable medical device can alert the user via a user interface to notify the user that the rechargeable battery should be replaced.

[0174] At least one of the modules or modular components of the wearable cardiac monitoring device may be removably connected to rechargeable battery 420 or different rechargeable batteries. The garment may be removably connected to rechargeable battery 420 or different rechargeable batteries for powering one or more of the modules or modular components.

[0175] In some examples, the wearable medical device monitors the state of charge (SoC) of battery 420. If the SoC exceeds a minimum threshold, the wearable medical device may, for example, issue a notification to replace battery 420 and / or request services from the wearable medical device. The SoC of battery 420 can be monitored, for example, by monitoring the number and / or amount of energy of electric shocks applied to the patient in a treatment pulse, and / or by monitoring the battery voltage.

[0176] Sensor interface module 426 (e.g., similar to sensor system 306) may include circuitry for sensing physiological parameters of a patient via one or more sensors 428. Sensors 428 of sensor interface module 426 may include, for example, ECG electrodes for monitoring a patient's ECG, acoustic sensors for monitoring a patient's heart sounds and / or lung sounds, a respiratory monitor for monitoring a patient's breathing, such as during sleep studies or when monitoring sleep apnea, and / or radio frequency-based fluid monitoring sensors. Sensors 428 may also include one or more sensors configured to monitor one or more of the following: patient activity, tissue fluid, pulmonary fluid, blood oxygen level, or blood pressure. The ECG sensor circuitry, acoustic sensor circuitry, respiratory sensor circuitry, and radio frequency circuitry may each be configured within separate and distinct modules or modular components, which are physically separated from each other and, for example, distributed throughout the garment to achieve uniform weight distribution. Each module may include one or more memory buffers for locally storing the sensed raw data, or communication circuitry (e.g., a low-power radio frequency transmitter) for wirelessly communicating the sensed raw data to another module (e.g., an operations module) or a remote location for further processing. For example, an operations module or operations modular component may be separate and distinct from other modules of the wearable cardiac device, may be connected to at least one sensing electrode configured to monitor a patient's cardiac activity, and may be configured to detect at least one cardiac condition of the patient. Communication circuitry may be configured within a separate and distinct communication module or modular component relative to the operations module or modular component and the energy storage device, may be connected to at least one of the operations module or modular component and the energy storage device, and may be configured to communicate with at least one external device. Each module may include one or more processors for deriving one or more measurements from the sensed raw data before storing or transmitting it. For example, a local ECG processor within an ECG sensor module may process raw ECG data to derive heart rate information and transmit that heart rate information to another location.

[0177] The ECG sensor circuitry can be configured within a module that includes ECG processing and communication circuitry, such as amplifiers, filters, analog-to-digital converters for amplifying signals received from one or more ECG sensors, and one or more processors configured to receive ECG signals and detect one or more ECG measures based on the received ECG signals. For example, such detected ECG measures may include QRS waveforms, P waveforms, and T waveforms, as well as other ECG measures such as heart rate, heart rate variability, atrial fibrillation, and other arrhythmias.

[0178] Acoustic sensor circuitry can be configured in a module that includes acoustic sensors and correlation processing and communication circuitry, such as amplifiers, filters, analog-to-digital converters for amplifying heart sound signals from one or more acoustic sensors (e.g., microphones), and one or more processors configured to receive heart sound signals and detect one or more heart sound metrics based on the received heart sound signals. For example, such detected heart sound metrics may include S1, S2, S3, and S4 sounds, as well as other heart sound metrics. Such derived heart sound metrics may be based solely on heart sounds, or on a combination of heart sounds and ECG information such as: electromechanical activation time (EMAT), such as the systolic time interval from the start of the QRS complex to the peak of the first heart sound (S1); and left ventricular systolic time (LVST), such as the systolic time from the peak of the first heart sound (S1) to the peak of the second heart sound (S1) (end of systole).

[0179] A respiratory sensor circuit can be configured within a module that includes a respiratory sensor and associated processing and communication circuitry. For example, the respiratory sensor may include an accelerometer disposed within clothing and located at a predetermined position on the patient's torso. For example, one or more accelerometers may be located on the patient's chest cavity or thorax, and digital signal processing circuitry can be used to estimate respiratory rate and associated data. For example, the accelerometer may include an ADXL204 biaxial accelerometer (+ / - 1 / 7g type) with a sensitivity of approximately 620 mV / g. For example, the accelerometer may be located in the sagittal plane and on the upper left side of the anterior torso of the patient. The patient's breathing can cause periodic movements of the patient's chest cavity, thereby altering the tilt and / or displacement of the accelerometer placed on the patient's chest in the horizontal and vertical directions. For example, respiratory signals can be detected along a direction perpendicular to the direction of gravity, which is the most sensitive direction for measuring chest cavity movement. Therefore, the processing circuitry associated with the respiratory sensor can be configured to process the signal in the sagittal plane.

[0180] In some examples, the respiratory sensor may include ECG sensing electrodes and associated circuitry, where the associated circuitry can extract, for example, the patient's respiratory rate based on changes in the signal amplitude of the body surface potential difference between two electrodes configured on the patient's torso. For example, these electrodes may be configured to acquire changes in transthoracic impedance as the patient's lungs fill and empty during the respiratory cycle. In another method of measurement, changes in heart rate over the duration of the RR interval can be recorded as respiration-related.

[0181] In various examples, the respiratory sensor can implement other respiratory monitoring techniques. For instance, the sensor can be based on: devices for measuring changes in motion, volume, or tissue (e.g., transthoracic impedance technology, rib inductance plethysmography); devices for measuring airflow (e.g., a thermistor for measuring airflow through the mouth and nose) that can be removably attached to a garment (e.g., via hook and loop, snap, or pocket) and used by a patient to measure respiratory data; and devices for measuring blood gas changes such as changes in pulse oxygen saturation or expiratory O2. Respiratory data can include estimates of respiratory rate, quantitative information related to tidal volume, and gas exchange parameters.

[0182] Radio frequency (RF) circuitry for detecting changes in tissue fluid may include an RF sensor and associated circuitry, wherein the RF sensor and associated circuitry are used to transmit ultrawideband RF signals to underlying tissue (e.g., a portion of a patient's lung), receive reflected RF signals, and process one or more of the amplitude and phase changes of these RF signals.

[0183] As described in U.S. Patent 8,600,486 (hereinafter referred to as the “'486 Patent”), entitled “METHOD OF DETECTING SIGNAL CLIPPING IN A WEARABLE AMBULATORY MEDICAL DEVICE”, issued December 3, 2013, which is incorporated herein by reference in its entirety, the sensor interface module 426 may include various sensor acquisition circuitry, wherein such sensor acquisition circuitry is used, for example, to filter and / or preprocess sensor signals before providing them for analysis to identify one or more patient conditions. In some examples, the sensor signals may be provided to one or more processors in the operation module 406 (described below). For example, the sensor interface module 426 may include a cardiac monitoring module that receives ECG and / or heart sound data and analyzes the data to determine the presence of one or more cardiac conditions. For example, based on ECG signals and / or heart sound data, the cardiac monitoring module may detect one or more arrhythmias and issue an alert to the patient via the user interface module 410. In at least one example, the sensor interface module 426 is an LV module and includes only LV components.

[0184] It should be understood that one or more functions of the sensor interface module 426 may be included as functions of the operation module 406. For example, circuitry for preprocessing sensor signals may be included in the circuitry of the operation module 406, and the sensor 428 may be directly connected to the operation module 406.

[0185] The treatment control module 404 controls the delivery of treatment pulses to the patient using energy stored in one or more capacitors 412, such as in the energy storage module 402. For example, the treatment control module 404 can control various characteristics of the treatment pulses, including the amplitude, shape, and / or duration of the treatment pulses delivered to the patient. The characteristics of the pulses can be controlled by various power control devices, including, for example, an insulated-gate bipolar transistor (IGBT) 414. It should be understood that other types of power control devices (e.g., silicon controlled rectifiers, thyristors, etc.) can be used, and any number of power control devices can be used. In some examples, the treatment control module 404 can be an HV module due to the high voltage controlled, for example, by the IGBT. In at least one example, the battery 420 and / or the treatment pad 114 can be connected to the treatment control module 404. As discussed above, it may be advantageous to position the battery 420 close to the capacitor charging circuitry (e.g., the circuitry in the treatment control module 404) to shorten the distance the charging current needs to travel from the battery 420 to the capacitor 412 and / or the distance the discharging current needs to travel from the capacitor 412 to the treatment pad 114. In some implementations, the components of the treatment control module 404 may be powered by a separate battery power source from the battery 420 within the treatment control module itself.

[0186] Operation module 406 includes means for controlling the operation of the medical device. For example, operation module 406 may include one or more processors 416 connected to data storage element 418 to monitor sensed cardiac data, identify arrhythmias based on the cardiac data, initiate the delivery of conductive gel to the patient's skin via gel deployment circuitry, and / or guide the application of treatment to the patient. These sensing systems may be connected to operation module 406 to provide processor 416 with direct access to sensor data. In at least one example, operation module 406 may be an LV module and include only LV components. Operation module 406 may include at least one processor configured separately from other modules or modular components to monitor cardiac data received from at least one electrode and communicate with treatment control circuitry to guide the application of treatment to the patient.

[0187] In some examples, processor 416 may include components from the above references. Figure 3 The processor configuration 310 includes one or more processors. For example, a general-purpose processor from the processor configuration 310 may be housed in the operation module 406. A high-voltage processor in the processor configuration 310 may be housed, for example, in the operation module 406 or the treatment control module 404.

[0188] The communication module 408 may include communication circuitry 422 to enable the wearable medical device to communicate with external systems. For example, the communication module 408 may employ one of various methods to communicate with a base station and / or external systems, wherein these methods include, for example... Wireless USB, ZigBee, and wireless Ethernet. In at least one example, communication module 408 is an LV module and includes only LV components. Communication module 408 may include communication circuitry configured in a communication module or modular component separate from other modules or modular components and configured to communicate with at least one external system.

[0189] User interface module 410 enables the wearable medical device to communicate with external entities, including, for example, patients, physicians, emergency responders, bystanders, and / or caregivers of patients. For example, as described in U.S. Patent 9,135,398 (hereinafter referred to as the "'398 Patent"), entitled "SYSTEM AND METHOD FOR ADAPTING ALARMS IN AWEARABLE MEDICAL DEVICE," issued September 15, 2015, and which is incorporated herein by reference in its entirety, user interface module 410 can issue alerts to notify the patient of various medical conditions. User interface module 410 may include one or more of the user interface elements described above for wearable medical device 100, wherein these user interface elements include, for example, a display 220, a speaker 204, and / or response buttons (or multiple buttons such as two response buttons to be pressed together) 210. In some implementations, as described in U.S. Patent Publication 2015 / 0039053 (hereinafter referred to as "'053 Publication"), entitled "SYSTEMS AND METHODS OF DELIVERYING THERAPY USING AN AMBULATORY MEDICALDEVICE" published on February 5, 2015 (which is incorporated herein by reference in its entirety), the application of treatment to a patient may be delayed in response to the detection of simultaneous pressing of multiple response buttons 210 and / or the detection of pressing one response button 210 in a particular sequence. In at least one example, the user interface module 410 is an LV module and includes only LV components.

[0190] User interface module 410 can be implemented in any of a variety of form factors. For example, in some examples, user interface module 410 may be implemented as a computer-implemented watch with display 220 and / or speaker 204 to provide visual and / or auditory notifications to the user. Display 220 may be a touchscreen display to more easily allow external entities to navigate within the user interface. It should be understood that other devices may be included in the computer-implemented watch or any other implementation of user interface module 410 to communicate with external entities, including, for example, haptic vibrators. The computer-implemented watch may also include, for example, a response button 210 mounted on the side or elsewhere of the computer-implemented watch to delay the application of treatment. The computer-implemented watch may wirelessly communicate with one or more modules in module group 400A and receive power from a rechargeable battery built into the computer-implemented watch. In some examples, the watch may include an adjustable strap for securing the computer-implemented watch to the patient's wrist. In other examples, the watch may include a larger strap for securing the device to the patient's biceps. The larger band could be an elastic band that bends as the patient moves around during daily activities to allow for biceps contraction.

[0191] User interface module 410 can also be implemented as an application on a computer-implemented portable electronic device, including, for example, a smartphone, smartwatch, personal digital assistant, and tablet computer. For example, the portable electronic device can be implemented using, for example... Various wireless communication methods can be used to communicate with one or more modules in module group 400A. Applications on the portable electronic device can utilize existing hardware on the portable electronic device as various user interface elements. For example, the application can display a virtual response button 210 on the touchscreen of the portable electronic device, which can be activated by the user by touching the touchscreen at the appropriate location. In some examples, the touchscreen can identify whether the person touching the screen is a patient associated with the device or another person through fingerprint analysis, voice analysis, or other analyses.

[0192] In some implementations, one or more functions of the operation module 406 may be included in the functions of the user interface module 410. For example, the user interface module 410 may be implemented as an application on a computer-implemented wearable device and / or a computer-implemented portable electronic device as described above. In this example, the user interface module 410 may utilize the processing power of the computer-implemented device to receive sensor data from the sensor interface module 426 and monitor the patient's medical condition. This can reduce and / or eliminate the size, weight, and / or bulkiness of the operation module 406 in the clothing.

[0193] The operation module 406, communication module 408, and / or user interface module 410 can receive power from battery 420 and / or from an auxiliary battery (not shown). For example, the operation module 406, communication module 408, and / or user interface module 410 can be removably connected to one or more rechargeable batteries. In some examples, these rechargeable batteries can be periodically replaced by the patient and / or charged by various energy sources (e.g., renewable energy sources). For example, the operation module 406 may include a solar panel attached to the outer surface of the module to generate power for charging the rechargeable batteries. The garment can also be used to collect solar energy for charging the rechargeable batteries by integrating solar fabric into the garment. In other examples, piezoelectric elements can be incorporated into the garment to convert energy from the patient's movement into electrical energy.

[0194] Figure 4B Another module group 400B is shown, which, in addition to including two energy storage modules 402 and two treatment control modules 404, also includes an operation module 406, a communication module 408, and a user interface module 410. In some examples, each pair of energy storage modules 402 and treatment control modules 404 provides a portion of a treatment pulse. For example, a wearable medical device may be configured to deliver biphasic defibrillation pulses to a patient. In this example, a first pair of energy storage modules and treatment control modules may provide the energy used for the first phase of the pulse, and a second pair of energy storage modules and treatment control modules may provide the energy used for the second phase of the pulse. In another implementation, a first pair of energy storage modules and treatment control modules may provide the energy used for the first pulse, and a second pair of energy storage modules and treatment control modules may provide the energy used for the second pulse. Following this logic, the delivery of subsequent pulses can be shared between these pairs in a predetermined configuration. For example, such a configuration may be as follows: the two pairs alternate in delivering energy until pulses are no longer needed. In another implementation, a first pair of energy storage modules and a treatment control module can provide the energy used for the positive portion of the pulse waveform, and a second pair of energy storage modules and a treatment control module can provide the energy used for the negative portion of the pulse waveform. In some examples, a controller connected to these two pairs can intelligently control the pulse characteristics and the energy delivery from these pairs. Dividing the energy storage modules and treatment control modules as illustrated can balance the weight and distribution of the wearable medical device. For example, Figure 4B The energy storage modules 402 shown are Figure 4A The single energy storage module 402 shown can be smaller and lighter compared to other types. Furthermore, these smaller and lighter modules can be separated on clothing to improve weight distribution.

[0195] It should be understood that any module described herein (e.g., energy storage module 402) can be divided into multiple modules and / or sub-modules. For example, a module group may include energy storage modules 402 for each treatment pad. Similarly, the treatment control module 404 can be divided into any number of modules. For example, it can be... Figure 4B The two treatment control modules 404 shown are combined to form a single treatment control module 404 connected to the total energy storage module 402.

[0196] In some examples, the treatment delivery system can be separated from the monitoring system. For example, in cases where the treatment delivery system is not installed in the wearable medical device, the wearable medical device can function as a medical monitoring device. Separating the treatment delivery system from the monitoring system can, in some examples, advantageously reduce the weight of the wearable medical device used by patients who do not require treatment components (e.g., modules 402 and 404) or who do not currently require these treatment components. Figure 4C Another example module group 400C with separable therapeutic components is shown. (e.g.) Figure 4C As shown, the energy storage module 402 and the treatment control module 404 are separable from the remaining modules via a connecting element 430 (e.g., an electrical connector). Thus, the patient can disconnect the energy storage module 402 and / or the treatment control module 404 and remove these modules from the assembly 400C. The wearable medical device can also automatically detect the installation of the treatment delivery system and operate as a wearable treatment device, and similarly detect separation from the treatment delivery system and operate as a wearable monitoring device. In response to detecting the installation of the treatment delivery system, the wearable medical device can initiate and perform a self-test to, for example, check that the treatment delivery system is properly installed and electrically or otherwise connected to other parts of the wearable medical device, and / or check that the components of the treatment delivery system are functioning correctly, such as checking that the conductive gel in the conductive gel deployment module has not reached its expiration date, or checking that one or more batteries included in the components of the wearable medical device have sufficient power, etc.

[0197] It should be understood that the treatment components may be separable using other mechanisms separate from and independent of the connecting element 430. For example, the link 424 connecting the operation module 406 to the treatment control module 404 may be a wireless communication link. In this example, the wearable medical device can configure itself as a wearable treatment device when modules 404 and 402 are within range of the wireless communication of the operation module 406. Thus, a patient can configure the wearable medical device as a treatment device by attaching the treatment components to clothing, and conversely, configure it as a monitoring device by removing the treatment components from clothing. In some implementations, the user interface may prompt the patient to confirm whether the wearable medical device should be configured as a treatment device or a monitoring device in response to the detection of the proximity of modules 404 / 402 and 406 or the absence of proximity of modules 404 / 402 and 406. It should be understood that the treatment components (e.g., components 402 and 404) may be wired together as a single component, which can be removed from or added to clothing as a single unit.

[0198] In some implementations, the operation module 406 may receive signals representing patient activity from one or more patient monitor detectors, accelerometers, and / or sensors. In addition to receiving or associating input from the patient (e.g., via a response button), one or more processors in the operation module 406 may analyze these signals for patient activity and determine, based on these signals, whether treatment is appropriate. For example, if the patient is unconscious, signals from one or more patient monitor detectors, accelerometers, and / or sensors may indicate the absence of patient activity. The operation module 406 may allow the treatment sequence to continue, ultimately delivering treatment to the patient's body. One or more motion detectors, accelerometers, and / or sensors may be included in a separate module or subsystem or configured within one or more of the other modules or subsystems described herein. For example, the motion detectors, accelerometers, and / or sensors used in this application may include those described in U.S. Patent 7,974,689, entitled “WEARABLE MEDICAL TREATMENTDEVICE WITH MOTION / POSITION DETECTION”, issued June 5, 2011, which is incorporated herein by reference in its entirety.

[0199] In some implementations, the operation module 406 may also receive signals representing audio input from the patient when determining whether to pause treatment. For example, such audio input may include one or more sounds (such as one or more spoken words or phrases) emitted by the patient, which the operation module 406 is configured to recognize. An example implementation of such an audio input element is described in U.S. Patent 8,369,944 (hereinafter referred to as the "'944 Patent") entitled "Wearable Defibrillator with Audio Input / Output," issued February 5, 2013, and which is incorporated herein by reference in its entirety. A microphone for receiving the patient's audio input may be configured on one or more of the housing of a garment, the housing of the communication module 408, or the housing of any other module. In some implementations, the microphone may be configured within the garment, for example, substantially close to the patient's upper body. In some implementations, the microphone may be integrated into the shoulder or front of the garment and electrically connected (e.g., using conductive threads, wires, or cables embedded in the garment) or (e.g., using...) (Technology) Wireless connection to operation module 406.

[0200] Example integrated clothing with one or more modules that can be installed in a removable manner.

[0201] like Figures 4A to 4C The diagram illustrates how the various components of a wearable medical device are divided into modular components, enabling the distribution of weight, such as that of the medical device controller, throughout the garment. These modules can be distributed throughout the garment to ensure a uniform weight distribution. For example, the weight on the left side of the garment can be equal to (or substantially equal to) the weight on the right side to provide a uniform weight distribution across the patient's shoulder.

[0202] Figure 5A and Figure 5B Example clothing 500 is shown, which comes from Figure 4B The module group 400B is distributed throughout the garment 500. The garment 500 includes a front portion 504 and a back portion 506 covering the upper and lower torso of the patient. As shown, the garment 500 includes a shoulder portion 508 and a side portion 510 connecting the front portion 504 of the garment 110 to the back portion 506. The side portion 510 may extend from below the arm to near the waistline (e.g., to the bottom of the torso) in a manner similar to a vest or T-shirt. The shoulder portion 508 may be a narrow band constructed in a manner similar to the shoulder of a vest. For example, the garment may include stretchable, antibacterial, breathable, and / or moisture-wicking fabrics.

[0203] In one example, the shoulder or other portion of the garment may include an extension mechanism configured to shorten or lengthen straps and / or other portions of the garment. In one example implementation, the shoulder or other portion of the garment may include one or more adjustable buckles. An adjustable buckle may include a first end and a second end, two substantially inelastic portions, and a substantially short elastic portion. The substantially short elastic portion may be located between the two substantially inelastic portions and provides longitudinal extension of the strap up to a predetermined limit. A buckle may be attached to the first end of the strap to secure a portion of the strap adjacent to the second end of the strap.

[0204] Garment 500 may include a plurality of sensors 428 permanently configured in the garment and / or removably attached to the garment. In some examples, such as those discussed in U.S. Patent 9,008,801 entitled “WEARABLE THERAPUETIC DEVICE” (hereinafter referred to as the “'801 Patent”), which is incorporated herein by reference in its entirety, sensor 428 is an ECG sensor constructed of conductive filaments and / or metal surfaces sewn into the garment. Similarly, treatment pad 114 may be permanently and / or removably attached to the garment. For example, sensor 428 may be a capacitance-based dry sensing electrode. In one example, as described in U.S. Patent 6,253,099 (hereinafter referred to as the "'099 Patent") entitled "CARDIAC MONITORING ELECTRODE APPARATUS AND METHOD" issued June 26, 2001, which is incorporated herein by reference in its entirety, sensor 428 may include an ECG sensing electrode that can be permanently or removably attached to a predetermined location on and supported by the garment, and may include an oxide layer (e.g., a titanium pentoxide insulating layer or a dielectric layer) formed on a substrate. In some embodiments, sensor 428 may be removably attached to a predetermined location on the garment by one or more conductive engagement structures. For example, the conductive engagement structure may include a receiving portion (e.g., part of sensor interface module 426) interconnected via conductive filaments, threads, or cables woven into the garment and connected to an electrical connection to the ECG acquisition module.

[0205] In some implementations, such as in, for example, U.S. Patent 8,706,215 (hereinafter referred to as the “'215 Patent”), entitled “WEARABLE AMBULATORY MEDICAL DEVICE WITH MULTIPLE SENSING ELECTRODES”, which is incorporated herein by reference in its entirety, issued April 22, 2014. Figure 1 A~ Figure 1As shown and described in F, sensor 428 includes ECG sensing electrodes that can be configured at various predetermined locations, including different axial positions around the patient's body. In some examples, sensor interface module 426 and / or operation module 406 may include a multiplexer for controlling which ECG sensing electrode pairs are being monitored. For example, sensor interface module 426 and / or operation module 406 may identify one or more optimal pairs (e.g., pairs with optimal signal quality) and control the state of the multiplexer to receive ECG signals from the identified pairs. It should be understood that these electrodes can be multiplexed manually. For example, clothing may include multiple predetermined locations for receiving ECG electrodes, and pairs can be selected by connecting ECG sensing electrodes only at a subset of these predetermined locations.

[0206] Modules 402, 404, 406, and 408 are distributed throughout the garment to evenly distribute the weight of the medical device across the patient's left and right shoulders. As shown, the user interface module 410, as previously described, is implemented as a computer-generated watch. It should be understood that other implementations of the user interface module 410 may be employed. For example, the user interface may be permanently configured with the garment or removably mounted to the garment and accessible to the patient.

[0207] In some examples, one or more of modules 402, 404, 406, and 408 are removable from the garment. For example, link 424 may be a cable (e.g., conductive cable and / or fiber optic cable) attached to the modules in these modules to form a single removable component. These cables may be covered with a sheath to protect them from environmental influences. In these examples, the component may be attached to the garment using one or more of hook and loop fasteners, snaps, buttons, or various other technologies.

[0208] Color coding can be used to indicate the location where components are installed in clothing to help patients (or physicians) install the components. For example, communication module 408 may include a red hook-and-loop fastener, and a red hook-and-loop fastener may also be used to attach communication module 408 to the appropriate location in the clothing. To aid assembly, some components may include a mounting mechanism (e.g., a snap fastener), and other components may include different types (e.g., hook-and-loop fasteners, magnets, or buttons). This encourages users of wearable medical devices to install the modules in the correct positions. It should be understood that components can also be as described above. Figure 4C The two-piece assembly discussed utilizes, for example, a connecting element 430, which can be separated and includes a monitoring component and a treatment component.

[0209] It should be understood that the link 424 between modules 402, 404, 406, and 408 may not be uniform. For example, the link between communication module 408 and user interface module 410 may be a wireless link, while the link between communication module 408 and operation module 406 may be a wired link (e.g., via cable). Furthermore, the wired links between modules 402, 404, 406, and 408 (where present) may not be uniform. For example, the link 424 connecting energy storage module 402 to treatment pad 114 may support ESD from 1600 volts to 15000 volts, while the link 424 between operation module 406 and communication module 408 may have lower voltage and ESD ratings. In some examples, one or more of the links 424 may be integrated into the garment. In some examples, one or more of the links 424 may be configured between two layers of fabric in the garment. For example, the link 424 may be constructed from conductive filaments, wires, cables, and / or fiber optic cables integrated into the garment. In these examples, the garment can be configured to house the modules and, when these modules are mounted to the garment, to operatively connect to link 424 integrated into the garment. In these examples, a user (e.g., a patient, physician, or caregiver) can configure the wearable medical device for monitoring or treatment based on the modules removably connected to the garment. For example, the wearable medical device can be configured as a wearable monitoring device without the treatment module installed. In this example, the therapeutic function of the wearable therapeutic device can be restored by mounting an appropriate treatment module to the garment.

[0210] Figures 6A to 6F Several different techniques can be used to enable the module to be operatively connected to one or more links 424 integrated into the garment 500. Figure 6A For example, a conductive hook-and-loop fastener 604 is shown that enables module 602 to be operatively connected to conductive threads in clothing. These conductive hook-and-loop fasteners can be constructed, for example, by using conductive threads in various parts of the hook-and-loop fastener. It should be understood that any number of individual conductive hook-and-loop fasteners 604 can be used. For example, the number of individual hook-and-loop fasteners for a given module can be equal to the number of channels required between the clothing and the module. For example, a module can be connected to clothing using four conductive hook-and-loop fasteners, wherein: the first fastener is used for power supply, the second fastener for grounding, and the remaining two fasteners for data transmission.

[0211] Figure 6BThe optical coupling between the module and the garment is illustrated. For example, the garment may include an IR transmitter 606 that transmits information to an infrared (IR) receiver 608 in the module, and vice versa. The IR transmitter 606 may include, for example, a light-emitting diode capable of emitting light in an intermittently pulsed modulated IR spectrum. The IR receiver 608 may include, for example, a photosensitive device that detects IR light pulses from the IR transmitter. It should be understood that the module 602 may include an IR transmitter 606 in addition to the IR receiver 608 for bidirectional communication with the garment.

[0212] Figure 6C and Figure 6D The capacitive coupling 610 and inductive coupling 612 between module 602 and the garment are shown. Other technologies can be used to transmit information and / or power based on altered electric and / or magnetic fields. Figure 6E A conductive magnet 614 is shown, which is attracted to a conductive contact 616. The conductive contact 616 may include at least a portion of an ferrocontaining material, such as steel. The conductive magnet 614 may be sufficient to hold the module in place on the garment. Figure 6F An example conductive snap fastener 618 is shown. The conductive snap fastener 618 not only establishes a connection between the garment 500 and the module 602, but also secures the module 602 in place.

[0213] It should be understood that these modules can be used in any combination of the techniques described above to enable them to be operatively connected to conductive filaments, wiring, or cables integrated into the garment, and / or to hold the modules in proper position on the garment. For example, in addition to including one or more IR receivers, the modules may also include steel magnets.

[0214] In some examples, these modules can use one or more techniques to keep them in the proper position on the garment. Figures 7A to 7D For example, various techniques are shown to allow modules to be removably attached to clothing. Figure 7A As shown, the module can be secured to the garment 500 using hook and loop fasteners 702. Figure 7B The illustration shows a pocket 704 for accommodating the module and a flap 706 secured by a hook and loop fastener 702 to cover the opening of the pocket 704. Figure 7C Another example pocket 704 for accommodating the module is shown, having a flap 706 secured by a snap 708. Figure 7D Another example pocket 704 for accommodating a module is shown, in which a zipper pull 710 secures the module in place. It should be understood that... Figures 7B to 7D The pocket 704 shown may include the above reference. Figures 6A-6F The aforementioned includes one or more of communication and / or power transmission devices, such as IR transmitters.

[0215] In some examples, pocket 704 may be shaped to accommodate a specific module but not others. For example, a given pocket 704 may be shaped to allow insertion of a specific module while preventing the insertion of other types of modules. This encourages users of wearable medical devices to install these modules in the appropriate positions. Pocket 704 may also be shaped, for example, tapered, to facilitate or ensure that the desired module is inserted into pocket 704 in the correct orientation. It should be understood that pocket 704 may also be shaped similarly, and the positions of the modules may be interchangeable. For example, an energy operation module can be inserted into any pocket 704 and function correctly. Thus, users of wearable medical devices can insert any module into any pocket 704.

[0216] In at least one example, these modules can be moved by the patient at various points on the garment. This allows the patient to rearrange the position of one or more modules to suit their specific preferences. Figure 8A and Figure 8B The example shown is a garment module 602 that can slide along its side via a tape 802. Figure 8A In this configuration, the module is removably attached to a guide 804 that slides along the band 802. Figure 8B In the middle, module 602 is directly connected to belt 804 and slides along the belt.

[0217] In some examples, the band 802 includes elements that can be generated by... Figure 8A The guide 804 and / or Figure 8B The conductive wires or wiring are engaged with module 802 in the garment. Module 602 can communicate with other modules that are removably fixed in the garment via conductive wires or wiring (e.g., tape 802) sewn into the garment.

[0218] It should be understood that module 602 can be constructed in various structures and is not limited to any single structure. Figure 9A and Figure 9B Two example structures of example module 602 are shown. Similar to the modules described previously, Figure 9A The module 602 connected to link 424 includes a housing having a flat surface 902 encapsulating one or more electronic devices. This housing may be constructed of a rigid plastic, such as acrylonitrile butadiene styrene (ABS) plastic. Figure 9B Another example of module 602 is shown, featuring a contoured surface 904 that can better conform to the patient's body. The specific shape of the contoured surface 904 can be pre-configured or uniquely designed for the patient. For example, various body size measurements can be obtained from the patient, and a uniquely customized shell can be 3D printed using, for example, any suitable thermoplastic (e.g., ABS plastic).

[0219] Example integrated clothing with one or more permanently installed modules.

[0220] As discussed above, the functional components of wearable monitoring and / or treatment devices can be divided into various modules and distributed throughout the garment. In at least one example, one or more modules from the module group are integrated into the garment 500 and connected using links 424 integrated into the garment (e.g., using conductive wires). As described in more detail below, modules can be integrated into the garment, for example, by permanently attaching the modules to the garment. For example, the rigid housing of one or more modules can be permanently attached to the garment using rivets and / or studs. Integrating one or more modules into the garment 500 in this way can reduce the bulkiness of these modules and make it easier for the user to conceal the wearable medical device. For example, the integrated garment can appear as ordinary clothing (e.g., a shirt) and / or can be easily concealed under normal clothing (e.g., a button-down shirt).

[0221] In some examples, at least one therapeutic electrode is permanently integrated into the garment. In some examples, at least one therapeutic electrode is supported by the garment. In some examples, as described in '801 patent, one or more therapeutic electrodes may be integrated into the garment 500 and configured to accommodate a gel deployment package. For example, the gel deployment package may be operatively coupled or connected to a gel deployment circuit as described above, and may receive operating signals from such circuitry. Figure 10A and Figure 10B This integrated therapeutic electrode is shown. Figure 10A An open receiving portion 1006 for a gel deployment pack is shown on garment 500. The gel deployment pack is mounted in the receiving portion 1006 by means of connection points 1004. Both connection points 1004 hold the gel deployment pack in place and allow the gel deployment pack to be operatively connected to a conductive filament 1002 or wiring integrated into the garment. Connection points 1004 may be adopted as described above. Figures 6A-6E Similar technologies to those described above. After installing the gel deployment package, such as... Figure 10BAs shown, a pouch containing the integrated therapeutic electrode 114 can be folded onto a gel deployment pouch. In some implementations, the gel pouch may include a control unit configured to release a conductive gel through the pouch containing the therapeutic electrode onto a surface of the patient's skin. This control unit may be operatively connected to a gel deployment circuit to determine the appropriate timing for initiating gel delivery. For example, the gel deployment circuit may initiate gel delivery before or in conjunction with the delivery of an electric shock, thereby reducing the impedance between the subject's skin and the therapeutic electrode 114. After the conductive fluid is deployed, an external defibrillator applies an electric shock to the subject via the therapeutic electrode 114 and the conductive fluid. The used gel pouch can be removed from the wearable therapeutic device and replaced with another gel pouch containing at least one dose of conductive fluid. In some implementations, the garment and / or integrated therapeutic electrode may include perforations and / or holes for allowing the conductive gel to pass from the gel pouch through the garment and / or integrated therapeutic electrode to the patient's skin.

[0222] In some examples, one or more therapeutic electrodes can deliver one or more therapeutic shocks to a patient without the need for a conductive gel. In some examples, instead of deploying a conductive gel, therapeutic electrode 114 can be adhesively attached to the patient's skin and include a hydrogel layer to promote conductivity. For example, a long-term (e.g., more than 7 days) hydrogel-based electrode can be configured on the patient's skin facing the patient and utilize the non-patient-facing side. The hook and loop fastener is attached to the garment. An example of a long-term adhesive electrode for this purpose is described in U.S. Patent Publication 2013 / 0325096 (hereinafter referred to as "'096 Publication") entitled "LONG TERM WEARMULTIFUNCTION BIOMEDICAL ELECTRODE", published January 1, 2015, which is incorporated herein by reference in its entirety.

[0223] Figure 11An example sensor interface module 426 integrated into garment 500 is shown. Sensor interface module 426 may include cardiac monitoring circuitry configured within the garment to monitor a patient's cardiac activity. In some implementations, the cardiac monitoring circuitry is configured within the garment to monitor a patient's cardiac activity, detect the patient's cardiac condition based on the monitored cardiac activity, and provide at least one therapeutic pulse to the patient based on the detected cardiac condition. The cardiac monitoring circuitry may include multiple separate and distinct modules or modular components distributed throughout the garment. As shown, sensor interface module 426 receives signals from ECG electrode 1102 and ground electrode 1104 via conductive filaments 1002 or wiring woven into garment 500. The conductive filaments 1002 or wiring may be woven into garment 500 with one or more extensions 1108 between sensor interface module 426 and ECG electrode 1102 and / or ground electrode 1104. The extensions 1108 allow garment 500 to expand and contract. For example, the conductive filament 1002 or wiring may include inelastic conductive filaments or threads, while the garment 500 may include elastic threads. In this example, the extension 1108 enables the garment 500 to stretch without breaking the connection between the inelastic conductive filament or wiring or various devices (e.g., ECG electrode 1102) and the conductive filament or wiring. It should be understood that the extension 1108 in the conductive filament 1002 or wiring does not necessarily have to employ the methods described above. Figure 11 The serrated design is shown. For example, the extension 1108 can be woven into the garment 500 as smooth crests and troughs.

[0224] In some implementations, the conductive wire 1002 or wiring can be laid out along a non-critical dimension; for example, instead of stretching the conductive wire 1002 or wiring around the patient's torso, it can be configured to be laid out via the patient's shoulders. In this respect, the conductive wire 1002 or wiring arranged along a non-critical dimension can avoid being subjected to changes in the expansion and contraction of clothing.

[0225] Sensor interface module 426 may, for example, preprocess and / or digitize the signals received from ECG electrode 1102 and ground electrode 1104 before providing information to other components (e.g., operation module 406). For example, operation module 426 may use the signal from the ground electrode to reduce and / or eliminate common-mode noise in the signal received from ECG electrode 1102 to improve the quality of the ECG signal. The ECG signal may be digitized, for example, by a digital-to-analog converter and communicated to other components via bus 1106. For example, bus 1106 may be a Controller Area Network (CAN) bus. In this example, sensor interface module 426 may communicate the digitized ECG signal to other components via the CAN bus. For example, the controller of a wearable cardiac monitoring device may be configured to detect a patient's cardiac condition based on monitored cardiac activity. The CAN bus may be integrated into clothing 500 using two or more strands of conductive wire or wiring. It should be understood that bus 1106 may also support power delivery and, for example, provide power to operation module 426.

[0226] In some implementations, the patient monitoring circuitry of the sensor interface module may include multiple separate and distinct modules or modular components integrated into and supported by the garment. For example, the patient monitoring circuitry of the sensor interface module may include one or more filters, amplifiers, signal analysis units, signal multiplexers, or demultiplexers that can be included in separate and distinct modules or modular components.

[0227] In some examples, such as Figure 12A and Figure 12B As shown, the energy storage module 402 can be integrated into the garment 500. For example, the charging capacity of the energy storage module 402 can be distributed across a network of small capacitors 1204, each integrated into different locations within the garment 500 and connected via conductive wires 1002 or wiring. The capacitors 1204 can be integrated at various locations to distribute the weight of the energy storage module 402 evenly. Distributing the capacitance of the capacitor bank among multiple smaller capacitors 1204 advantageously allows for a reduction in the size of each capacitor 1204. For example, each capacitor 1204 can be a small ceramic capacitor with a volume less than 1 cubic centimeter, a capacitance less than 100 μF, and a breakdown voltage rating between 200 volts and 500 volts. Thus, the capacitors 1204 can be easily integrated into the garment 500 without interfering with the patient's mobility. It should be understood that one or more battery sources can similarly be distributed into multiple battery cells and integrated into the garment.

[0228] refer to Figure 12ACapacitors 1204 can be organized into multiple capacitor groups (e.g., four capacitor groups), each connected to charger 1202. These capacitor groups can be connected to each other via one or more switches 1206 for controlling the connection between capacitor groups based on control signals from, for example, treatment control module 404. Thus, each capacitor group (e.g., by opening switch 1206) is charged in parallel by charger 1202 and discharged in series with each other (e.g., by closing switch 1206). It should be understood that the number of capacitor groups used and / or the specific number of capacitors 1204 in each group can be varied based on a particular implementation. Furthermore, a single charger 1202 can be used to charge multiple capacitor groups. For example, Figure 12A The four chargers 1202 shown can be replaced by a single charger connected to all four capacitor banks.

[0229] In some implementations, each capacitor bank can have a total capacitance rating (e.g., 650 μF) split among multiple capacitors 1204 connected in parallel. The total capacitance of the capacitor bank is equal to the sum of the capacitances of the individual capacitors in the bank. Thus, a target total capacitance rating can be achieved by matching the sum of the capacitances of the capacitors 1204 in the bank to a target. For example, a capacitor bank can be designed to have a capacitance of 650 μF, and the capacitor bank can be constructed from 100 capacitors, each with a capacitance of 6.5 μF (6.5 μF * 100 = 650 μF). It should be understood that other capacitor structures can be employed, including, for example, 130 capacitors, each with a capacitance of 5 μF (5 μF * 130 = 650 μF). Although... Figure 12A and Figure 12B Four capacitor banks, each comprising multiple capacitors (where each capacitor bank may have a total capacitance of approximately 650 μF), are shown. However, it should be understood that other examples may include capacitor banks with different capacitances or capacitor banks each having only a single capacitance. For example, in one implementation, a wearable monitoring and / or therapeutic device may include four capacitors each having a capacitance of approximately 650 μF.

[0230] refer to Figure 12B Capacitors can be organized into multiple groups connected in series without the need for switch 1206. In these implementations, the capacitor groups can be charged in series by charger 1202. Charging and discharging capacitor groups with a series structure can omit one or more components (e.g., switch 1206), but may require higher charging voltages to store the capacitors. Figure 12A The parallel charging structure shown has the same energy.

[0231] It should be understood that capacitor 1204 can be constructed in various form factors. For example, each capacitor 1204 can be constructed as a capacitor module comprising a capacitor (e.g., a ceramic capacitor) encapsulated in a rigid housing integrated into the garment. These capacitor modules can also be custom capacitors created by filling a dielectric between two conductive plates and attaching conductive filaments or wiring to the conductive plates. In some implementations, capacitor 1204 can be a small capacitor directly integrated into the garment and connected using conductive filaments or wiring.

[0232] In some examples, capacitor 1204 can be integrated into other components of a wearable medical device. For example, a wearable medical device may include one or more flat or contoured surfaces, such as a back side having a gel deployment pack and / or a back side having therapeutic electrodes. In these examples, the capacitor can be integrated into these flat or contoured surfaces by placing a dielectric between two conductors.

[0233] The circuitry in the treatment control module 404, operation module 406, communication module 408, and / or at least one user interface 410 can also be integrated into the garment. For example, various circuit components of these modules can be mounted to a flexible substrate that can bend towards the contours of the patient's body. The flexible substrate with the various circuit components can be permanently attached to the garment and held between two fabrics. It should be understood that the electrical components mounted to the flexible substrate can be made waterproof and / or water-resistant, for example, by covering these components with a waterproof coating (e.g., an epoxy coating). These electrical components can also be encapsulated in a waterproof and / or water-resistant housing permanently disposed within the garment. Thus, the garment can be washed without damaging the electrical components permanently disposed within it.

[0234] Additional sample clothing

[0235] Although various techniques for distributing and / or integrating components into garments have been described, it should be understood that these techniques can also be applied to a variety of garments. Figure 13A , Figure 13B , Figure 14 and Figure 15 Various examples of these garments are shown.

[0236] Figure 13A and Figure 13BA garment 1300 for use with a wearable medical device is shown. The garment 1300 includes a front portion 1308 and a back portion 1310 connected by a side portion 1304 and an adjustable strap 1302. The garment 1300 also includes buckles 1306 for removably securing the side portion 1304. The garment wraps around the patient's upper torso and, in addition to a treatment electrode 114 on the back portion 1310, includes another treatment electrode 114 on the front portion 1308 and a sensor 428.

[0237] Figure 14 Another example garment 1400 for use with a wearable medical device is shown. Garment 1400 can be configured to wrap around the upper torso of a patient. For example, a first part 1404 can wrap around both the patient and a second part 1406 (similar to a bathrobe) to secure it in place via hook and loop fasteners on a cover 1408. Garment 1400 extends to the shoulders using two shoulder straps 1402.

[0238] Figure 15 Another example garment 1500 for use with a wearable medical device is shown. Garment 1500 includes a front portion 1504 for wrapping around the upper torso of a subject, the front portion 1504 being secured in place by hook and loop fasteners 702. Garment 1500 also includes a back portion 1502 connected to the front portion by a single shoulder strap 1506. The front portion 1504 includes therapeutic electrodes, and the back portion 1502 includes additional therapeutic electrodes and a plurality of sensors 428.

[0239] It should be understood that any garment described herein may include multiple parts. For example, a garment may include a vest worn on the upper torso of a patient and separate straps detachable from the vest. In this example, sensor 428 and / or treatment pad 114 may be integrated into the vest, and various modules (e.g., modules 402, 404, 406, 408 described above) may be integrated into the straps. The straps may be detachable from the vest using, for example, snaps, hooks and loops, and / or fasteners. Additionally, one or more garments may be designed to be inexpensive and / or disposable. For example, the vest portion of the garment may be disposable, while the straps (including the various modules) can be washed and redeployed to a new patient with new garments.

[0240] While various aspects of at least one example of this disclosure have been illustrated, it should be understood that various changes, modifications, and improvements will readily occur to those skilled in the art. Such changes, modifications, or improvements are intended to be part of and within the scope of this disclosure. Therefore, the foregoing description and figures are by way of example only.

Claims

1. An improved modular wearable medical device for monitoring a patient's ECG signals and providing therapeutic electric shocks in the event of arrhythmia, comprising: Clothing, configured to be worn around the patient's torso, Multiple ECG sensing electrodes, permanently attached to a first predetermined location on the garment, are configured to sense the patient's ECG signal. At least one pocket is disposed on the garment and configured to removably attach a module having device electronics within a housing to the garment. The pocket is configured to allow insertion of one specific type of module and prevent insertion of other types of modules. The module containing the device electronics within the housing includes a sensor interface module configured to receive ECG signals from the patient and preprocess and / or digitize the ECG signals to detect arrhythmias. Multiple lines are permanently integrated into the garment, enabling operative connection of multiple permanently connected ECG sensing electrodes on the garment to a sensor interface module on the garment. Multiple treatment electrodes are removably connected to a second predetermined location on the garment. A gel deployment circuit is configured to deliver a conductive gel substantially close to the skin in contact with the plurality of therapeutic electrodes prior to delivering the therapeutic shock to the patient. Multiple capacitor modules, wherein each capacitor module includes: One or more capacitors configured to store energy for therapeutic electric shocks to be delivered to the patient, and A housing encapsulates the one or more capacitors, wherein the housing is integrated into the garment. The plurality of capacitor modules are distributed on different parts of the garment, and the capacitor modules are included in a conformal housing that conforms to the surface of the patient's human body. A battery source for supplying power to the one or more capacitors, the battery source being divided into multiple battery cells and integrated into the garment, and A treatment control module is configured to control the delivery of therapeutic shocks to the patient via the plurality of treatment electrodes in the event of arrhythmia, utilizing energy stored in the one or more capacitors. The plurality of threads are arranged between two fabric layers of the garment.

2. The apparatus according to claim 1, wherein, The garment includes a flexible material configured to provide an ergonomic fit to the patient.

3. The apparatus according to claim 2, wherein, The garment comprises a stretchable fabric and is configured to cover both the upper and lower parts of the patient's torso.

4. The apparatus according to claim 1, wherein, At least one of the plurality of lines is flexible and at least one of stretchable.

5. The apparatus according to claim 4, wherein, At least one of the plurality of lines is configured to include a pattern comprising at least one of coiled arrangement and zigzag pattern, such that at least one of the plurality of lines stretches and contracts along with a portion of the garment.

6. The apparatus according to claim 4, wherein, At least one of the plurality of lines is one of the following: integrated with and attached to the garment.

7. The apparatus according to claim 1, wherein, The garment comprises an inner fabric layer and an outer fabric layer, the inner fabric layer and the outer fabric layer having different material properties.

8. The apparatus according to claim 7, wherein, The inner fabric layer includes a material permeable to moisture and / or water vapor, allowing moisture and / or water vapor to be transferred from the inner fabric layer to the outer fabric layer.

9. The apparatus according to claim 8, wherein, The inner fabric layer has a density of 100 g / m 2 / day up to 50,000 g / m 2 Average moisture transport rate per day.

10. The apparatus according to claim 7, wherein, The outer fabric layer includes a hydrophobic material.

11. The apparatus according to claim 7, wherein, The outer fabric layer comprises a superhydrophobic material.

12. The apparatus according to claim 1, wherein, The line includes cables.

13. The apparatus according to claim 7, wherein, The outer fabric layer comprises at least one of the following: nylon; polyester; and at least one of polytetrafluoroethylene material, expanded polytetrafluoroethylene material, and polyurethane material laminated or coated.

14. The apparatus according to claim 1, wherein, The garment is configured to be machine washable.

15. The apparatus according to claim 1, wherein, The garment includes a strap portion and a back portion, the strap portion being configured to be detachable from the back portion by at least one of a buckle, a hook and loop fastener, and a snap fastener.

16. The apparatus according to claim 15, wherein, The strap portion includes an adjustable buckle configured to secure the first end to the second end.

17. The apparatus according to claim 15, wherein, The garment includes one or more adjustable shoulder straps that connect to the back portion and the belt portion.

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