CN115227257A

CN115227257A - Maintainable wearable cardiac treatment device

Info

Publication number: CN115227257A
Application number: CN202210337497.0A
Authority: CN
Inventors: P·H·阿姆斯勒; N·J·B·安
Original assignee: Zoll Medical Corp
Current assignee: Zoll Medical Corp
Priority date: 2021-04-23
Filing date: 2022-03-31
Publication date: 2022-10-25

Abstract

The present application relates to a maintainable wearable cardiac treatment device. A maintainable wearable cardiac treatment device for continuous extended use by an ambulatory patient includes a garment and a device controller. The garment is configured with a plurality of ECG sensing electrodes and a plurality of therapy electrodes disposed therein. The device controller is configured to be in separable electrical communication with the plurality of ECG sensing electrodes and the plurality of therapy electrodes. The device controller includes an anti-ballistic energy core including a frame and a capacitor permanently bonded to the frame. The device controller includes a critical function circuit board containing a critical function processor and circuitry, and a non-critical function circuit board containing a non-critical function processor and circuitry. The critical function circuit board is in electrical communication with the capacitor and is configured to control critical operations of the device controller regardless of operability of the non-critical function circuit board. The non-critical function circuit board is configured to control non-critical operations of the device controller.

Description

Maintainable wearable cardiac treatment device

Technical Field

The present disclosure relates to wearable cardiac monitoring and treatment devices (wearable cardiac monitoring and treatment devices).

Background

Patients with heart failure experience symptoms caused by a weak or damaged heart that contracts inefficiently and fails to pump efficiently to circulate oxygenated blood through the body. The heart may be weakened by, for example, abnormal heart rhythms (e.g., arrhythmias), hypertension, coronary artery disease, myocardial infarction, and myocarditis.

If left untreated, heart failure may result in certain life-threatening arrhythmias. Atrial and ventricular arrhythmias are common in patients with heart failure. One of the most fatal cardiac arrhythmias is ventricular fibrillation that occurs when a normal, regular electrical pulse is replaced with an irregular and rapid pulse, causing the heart muscle to stop contracting normally. Because the victim has no perceptible warning of impending tremors, death often occurs before the necessary medical assistance can arrive. Other arrhythmias can include either a too slow heart rate (referred to as bradycardia) or a too fast heart rate (referred to as tachycardia).

Cardiac arrest may occur when various arrhythmias of the heart, such as ventricular fibrillation, ventricular tachycardia, pulseless Electrical Activity (PEA) and asystole (the heart stops all electrical activity), result in insufficient blood levels provided by the heart to the brain and other vital organs for life support. It is often useful to monitor patients with heart failure to assess heart failure symptoms early and provide interventional therapy (interventional therapy) as soon as possible.

Disclosure of Invention

A wearable cardiac monitoring and treatment device is provided for monitoring the arrhythmia and providing treatment (treatment) upon detection of a life-threatening arrhythmia. The device is worn continuously by the patient to provide continuous protection. These devices are often refurbish and reused by subsequent patients (reuse). As such, the device needs to be designed to be resilient and easy to maintain.

In one example, a maintainable wearable cardiac treatment device for continuous extended use by an ambulatory patient is provided, the maintainable wearable cardiac treatment device comprising a garment and a device controller. The garment is structured to have disposed therein a plurality of ECG sensing electrodes and a plurality of therapy electrodes in continuous prolonged contact with the patient for monitoring and treating the patient's arrhythmia. The device controller is configured to be in separable electrical communication with the plurality of ECG sensing electrodes and the plurality of therapy electrodes in the garment. The device controller includes an impact resistant energy core, first and second circuit boards attached to opposite sides of the energy core, and an intrusion prevention housing. The impact resistant energy core includes a frame and at least one capacitor. The at least one capacitor is permanently bonded to the frame such that the frame together with the bonded at least one capacitor is an integral mass. The at least one capacitor is configured to hold a charge sufficient to treat the arrhythmia. The first circuit board and the second circuit board include arrhythmia monitoring and therapy circuitry in electrical communication with at least one capacitor. The first circuit board and the second circuit board are attached to opposite sides of the impact-resistant energy core in a manner that allows separation from the impact-resistant energy core during maintenance. The intrusion-resistant housing is configured to enable removal of the impact-resistant energy core and the first and second circuit boards during maintenance.

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

In an example, the frame includes a pocket configured to receive at least one capacitor therein. The device can include a compound disposed within the pocket for at least partially encapsulating the at least one capacitor, thereby immovably coupling the at least one capacitor to the frame to form an integral mass. In an example, the compound includes an insulating material that encapsulates the at least one capacitor within the pocket. The compound can include an epoxy resin having a hardness rating ranging from about 80-85 shore D when cured after initial application. In an embodiment, the compound is a bonding compound.

In an example, the at least one capacitor comprises a film capacitor. In an example, the at least one capacitor includes at least two capacitors.

In an example, the apparatus includes at least one electrical wire extending from the impact resistant energy core. In an example, the at least one capacitor includes two capacitors connected in parallel, and the at least one wire is connected to the first circuit board. In an example, the two capacitors are two film capacitors configured side-by-side each comprising two major planes, such that the two major planes of each of the two film capacitors are arranged adjacent to the first and second sides of the frame.

In an example, the at least one capacitor is configured to occupy at least 50% to 95% of a volume defined within the pocket of the frame.

In an example, the apparatus includes a gap between the at least one capacitor and the inner surface of the frame, the gap being between 0.5mm and 10 mm.

In an example, the apparatus includes one or more releasable fasteners for attaching the first circuit board and the second circuit board to opposite sides of the impact-resistant energy core. The one or more releasable fasteners can include one or more screws, clamps, snaps, tabs, and bands.

In an example, the first circuit board includes at least one processor and a high voltage circuit in communication with the at least one processor. The at least one processor can include an arrhythmia detection processor. The at least one processor includes an arrhythmia detection processor and a therapy control processor. The high voltage circuit can include a therapy delivery circuit.

In an example, an apparatus includes a flexible connector extending from a first circuit board to a second circuit board. The second circuit board can include low voltage circuitry including communication circuitry. In an example, a first circuit board includes a display stand for holding a display screen in wired communication with a second circuit board.

In an example, the impact-resistant energy core and the attached first and second circuit boards occupy approximately 25% -90% of a volume defined by the intrusion-resistant housing.

In an example, the intrusion prevention housing includes a rear case configured to be disposed adjacent to the second circuit board and a front case configured to be disposed adjacent to the first circuit board, the front case cooperating with the rear case to be in a sealed configuration. In an embodiment, the anti-intrusion housing has an IP67 or IP66 rating as set forth in the IEC60529 standard for intrusion protection. In an embodiment, the anti-intrusion housing has at least one of IP6X, IPX6 and IPX7 ratings, where "X" is a variable representing a rating from 1 to 9 as set forth in IEC60529 for intrusion prevention. The mating edges of the front and rear shells are configured to engage in a fitted interlock when the front and rear shells are mated to form an intrusion resistant housing. In an embodiment, at least one of the front shell and the rear shell comprises a mortise in the mating edge, and the other of the front shell and the rear shell comprises a protrusion configured to engage with the mortise. The insert interlock can include a compressible silicone seal configured to be disposed in the mortise.

In an example, the front and rear housings are configured to be held in a sealed configuration by one or more releasable fasteners. The device can include one or more plates configured to be secured over the one or more releasable fasteners to prevent the ingress of liquids and particulate matter.

In an example, the front and rear housings are configured to be separable for at least impact resistant energy core and removal and replacement of the attached first and second circuit boards. In an embodiment, the front case can include a touch screen disposed therein, and the touch screen can be affixed to the front case via an anti-intrusion sealant. In an embodiment, the front shell includes a speaker disposed therein, the speaker being sealed with an intrusion resistant sealant.

In an example of the device, the separable electrical communication includes a connector in communication with the plurality of ECG sensing electrodes and the plurality of therapy electrodes, the connector configured to fit into the anti-intrusion housing in electrical communication with one or both of the first circuit board and the second circuit board. In an example, the intrusion-resistant housing includes a receiving port for the connector, the receiving port in electrical communication with one or both of the first circuit board and the second circuit board. In an embodiment, the receiving port includes a grommet for receiving the mating edges of the front and rear shells in the sealed configuration of the intrusion resistant housing. The grommet includes an upper flange, a lower flange, and a well (well) between the upper flange and the lower flange to receive the mating edges of the front case and the rear case therein.

In an example, the rear housing further comprises a battery connector extending through the rear housing for receiving a complementary connector of a removable battery. In an embodiment, the battery connector is sealed with an anti-intrusion sealant and is configured to be in wired communication with at least one processor disposed on the first circuit board. The intrusion-proof sealant is at least one of an epoxy resin and a pressure-sensitive adhesive. The apparatus can also include a flexible connector extending within the intrusion-resistant housing between the battery connector and the first circuit board.

In an example, the rear housing defines a compartment for receiving the removable battery module such that, in the mated configuration, an outer surface of the removable battery module is flush with an outer surface of the anti-intrusion housing.

In an example, the rear housing further comprises at least one vibration dampening spacer for protecting the impact resistant energy core and the attached first and second circuit boards from mechanical impact. In an embodiment, the front shell further comprises at least one vibration absorbing spacer for protecting the impact resistant energy core and the attached first and second circuit boards from mechanical impact.

In an example, the device further comprises at least one vibration-damping spacer disposed within the anti-intrusion housing. At least one vibration-damping spacer is configured to support the impact-resistant energy core and the attached first and second circuit boards within the intrusion-resistant housing.

In an example, the plurality of ECG sensing electrodes are configured to sense ECG signals of the patient for further analysis by at least one processor disposed on the first circuit board.

In an embodiment, a method of constructing a maintainable wearable cardiac treatment device controller for continuous extended use by an ambulatory patient, the method comprising: providing a frame; and inserting at least one capacitor into the frame. The at least one capacitor may be configured to hold a charge sufficient to treat the arrhythmia of the patient. The method comprises the following steps: at least one capacitor is bonded to the frame such that the frame, along with the bonded capacitor, includes an impact resistant energy core. The method comprises the following steps: attaching first and second circuit boards to opposite sides of the impact-resistant energy core in a manner that allows separation from the impact-resistant energy core during maintenance, the first and second circuit boards including arrhythmia monitoring and treatment circuitry in electrical communication with the at least one capacitor; and packaging the energy core and the attached first and second circuit boards within an anti-intrusion housing configured to enable removal of the impact-resistant energy core and the first and second circuit boards during maintenance.

Implementations of the method may include one or more of the following features.

In an embodiment, the frame comprises a pocket for receiving at least one capacitor therein. Bonding the at least one capacitor to the frame includes disposing a self-curing polymer within the pocket to at least partially encapsulate the at least one capacitor, thereby immovably bonding the at least one capacitor to the frame to form an integral mass.

The intrusion prevention housing can include a rear case configured to be disposed adjacent to the second circuit board and a front case configured to be disposed adjacent to the first circuit board. In an embodiment of a method of constructing a maintainable wearable cardiac treatment device controller, comprising: the energy core and the attached first and second circuit boards are packaged within the intrusion-resistant housing by mating the front housing with the rear housing in a sealed configuration. The method can include: the front and rear shells are secured in their sealed configurations using one or more releasable fasteners.

Mating the front shell with the rear shell can include engaging mating edges of the front shell with mating edges of the rear shell in a snap-in interlock to form an intrusion-resistant housing. In an embodiment, mating the front shell with the rear shell includes engaging a mortise disposed on a mating edge of one of the front shell and the rear shell with a protrusion disposed on a mating edge of the other of the front shell and the rear shell. The method can further include disposing a compressible silicone seal in the mortise.

In one or more examples, a maintainable wearable cardiac treatment device is provided for continuous extended use by an ambulatory patient. The device comprises: a garment configured to have disposed therein a plurality of ECG sensing electrodes and a plurality of therapy electrodes in continuous prolonged contact with a patient; and a device controller configured to detachably electrically communicate with the plurality of ECG sensing electrodes and the plurality of therapy electrodes in the garment. The device controller includes: an impact-resistant energy core, comprising: a frame; and at least one capacitor permanently bonded to the frame. The at least one capacitor is configured to hold a charge sufficient to treat the arrhythmia. The device controller includes a critical function circuit board including at least one critical function processor and critical function circuitry in communication with the at least one critical function processor. The critical function circuit board is in electrical communication with the at least one capacitor and is configured to control critical operations of the device controller. The device controller also includes a non-critical function circuit board including at least one non-critical function processor and non-critical function circuitry in communication with the at least one non-critical function processor. The non-critical function circuit board is configured to control non-critical operations of the device controller. The critical function circuit board is configured to control critical operations of the device controller regardless of operability of the non-critical function circuit board.

Embodiments of the maintainable wearable cardiac treatment device for continuous extended use by ambulatory patients can include one or more of the following features. In an example, the frame includes a pocket configured to receive at least one capacitor therein. In an example, the device further includes a compound disposed within the pocket for at least partially encapsulating the at least one capacitor, thereby immovably coupling the at least one capacitor to the frame to form the integral mass. In an example, the device further includes one or more releasable fasteners for attaching the critical function circuit board and the non-critical function circuit board to opposite sides of the impact-resistant energy core. In an example, the device controller further includes an anti-intrusion housing configured to enable removal of the impact-resistant energy core and the critical and non-critical function circuit boards during maintenance. In an example, the apparatus further includes at least one vibration-dampening spacer disposed within the intrusion housing, the at least one vibration-dampening spacer configured to support the impact-resistant energy core and the critical and non-critical functional circuit boards within the intrusion housing.

In an example, the critical function circuit board is configured to remain operable to control critical operations of the device controller in the event of a suspension of operability of the non-critical function circuit board. In an example, the critical function circuit board is configured to remain operable to control critical operations of the device controller in the event of a failure of the non-critical function circuit board.

In an example, key operations of the device controller include: acquiring an ECG signal via an ECG sensing electrode; analyzing the ECG signal to determine if the patient is experiencing a disposable arrhythmia; and in response to determining that the patient is experiencing a disposable arrhythmia, initiating a treatment procedure. In an example, the treatment procedure includes: alerting the patient to an impending electric shock; monitoring the response button to determine whether the response button is pressed; and in response to determining that the response button is not pressed, controlling delivery of a treatment shock to the patient. In an example, each of the therapy electrodes includes a gel for reducing impedance, and controlling delivery of the treatment shock includes: deployment of the gel is initiated. In an example, the device further comprises a battery, and the critical operations of the device controller include: communicating with the battery to monitor charging of the battery.

In an example, the apparatus further comprises a user interface, and the at least one non-critical function processor is configured to provide output and receive input via the user interface. In an example, non-critical operations of the device controller include: the patient is trained via the user interface. In an example, non-critical operations of the device controller include: data relating to operation of a maintainable wearable cardiac treatment device is compressed for long term storage. In an example, non-critical operations of the device controller include: establishing a communication link with a remote server; and transmit data related to operation of the maintainable wearable cardiac treatment device to a remote server via a communication link. In an example, non-critical operations of the device controller include: the patient is instructed to complete the patient health survey. In an example, non-critical operations of the device controller include: and guiding the patient to complete the ambulatory exercise test. In an example, non-critical operations of the device controller include: the patient is guided through a cardiac rehabilitation program. In an example, the device controller further includes a service port in communication with the non-critical function circuit board.

Drawings

Fig. 1 depicts a schematic front view of an exemplary wearable cardiac monitoring and treatment device including a device controller.

Fig. 2 depicts a schematic diagram of an embodiment of a device controller for a wearable cardiac monitoring and treatment device.

Fig. 3 depicts a front perspective view of a core assembly of an exemplary device controller for a wearable cardiac monitoring and treatment device.

FIG. 4 depicts an exploded view of the core assembly of FIG. 3.

Fig. 5 depicts an exploded view of an example device controller for a wearable cardiac monitoring and treatment device.

Fig. 6A depicts an exploded perspective view of an example frame component of a capacitor of an example device controller for a wearable cardiac monitoring and treatment device.

Fig. 6B depicts a plan view of the example frame assembly of fig. 6A.

Fig. 6C depicts a perspective view of another example frame component of a capacitor of an example device controller for a wearable cardiac monitoring and treatment device.

Fig. 6D depicts a plan view of the example frame assembly of fig. 6C.

Fig. 7 depicts a side cross-sectional view of an assembled example device controller for a wearable cardiac monitoring and treatment device.

Fig. 8 depicts a front perspective view of internal components of an exemplary device controller for a wearable cardiac monitoring and treatment device.

Fig. 9 depicts a rear perspective view of the inner assembly of fig. 8.

Fig. 10A depicts an exploded view of an exemplary housing of a device controller for a wearable cardiac monitoring and treatment device.

Fig. 10B depicts an enlarged view of the gasket portion of the housing of fig. 10A.

Fig. 11A depicts a side perspective view of an assembled example device controller for a wearable cardiac monitoring and treatment device.

Fig. 11B depicts a top view of an assembled example device controller for a wearable cardiac monitoring and treatment device.

Fig. 12 depicts a schematic cross-sectional view of the mating portion of an assembled example device controller for a wearable cardiac monitoring and treatment device.

Fig. 13 depicts a portion of a side view of an assembled example device controller for a wearable cardiac monitoring and treatment device.

Fig. 14A depicts a rear perspective view of an assembled example device controller for a wearable cardiac monitoring and treatment device with the battery removed.

Fig. 14B depicts a rear perspective view of the assembled example device controller of fig. 14A with a battery inserted.

Fig. 15 depicts an exemplary battery connector for a device controller of a wearable cardiac monitoring and treatment device.

Fig. 16 depicts a plan view of an interior surface of an exemplary housing of a device controller for a wearable cardiac monitoring and treatment device.

Fig. 17 is a schematic diagram of an exemplary method of using a wearable cardiac monitoring and treatment device.

Fig. 18 depicts a schematic diagram of an embodiment of the electrical components of a controller for a cardiac monitoring and treatment device.

Fig. 19A depicts a diagram of an example capacitor component of a device controller for a wearable cardiac monitoring and treatment device.

Fig. 19B depicts a rotated view of the exemplary capacitor assembly of fig. 19A.

Fig. 20 depicts an exemplary method of constructing a maintainable wearable cardiac treatment device controller for continuous extended use by an ambulatory patient.

Fig. 21A depicts a schematic diagram of exemplary components of a wearable monitoring and treatment device.

Fig. 21B depicts a schematic diagram of exemplary components of a wearable monitoring and treatment device.

Fig. 22 depicts another example diagram of exemplary components of a wearable monitoring and treatment device.

Detailed Description

Heart failure patients can be prescribed cardiac monitoring devices or cardiac monitoring and treatment devices. In some cases, a physician may use a medical device to treat a heart failure condition, either alone or in combination with a drug therapy. Depending on the underlying condition being monitored or treated, a medical device such as a cardiac monitor or defibrillator may be surgically implanted in or externally connected to the patient. In some examples, the cardiac monitoring device may be an external wearable cardiac device for ambulatory use. Wearable medical devices, such as cardiac event monitoring devices, are used in clinics or clinics to monitor and record various physiological signals of a patient. In some examples, the wearable cardiac monitoring and treatment device may be a wearable defibrillator configured to monitor arrhythmias and provide treatment when life-threatening arrhythmias are detected. The device can be continuously worn by a patient to provide continued protection, and can subsequently be refurbished for reuse by another patient. The systems and techniques disclosed herein improve the recoverability (resiliency) and maintainability of device controllers for wearable cardiac monitoring and treatment devices.

The present disclosure relates to patient-worn cardiac monitoring and treatment devices that detect one or more treatable arrhythmias based on physiological signals from a patient. Treatable arrhythmias include arrhythmias that can be treated with defibrillation pulses, such as Ventricular Fibrillation (VF) and shockable Ventricular Tachycardia (VT), or arrhythmias that can be treated with pacing pulses, such as bradycardia, tachycardia, and asystole. Wearable medical devices as disclosed herein monitor physiological conditions of a patient, such as cardiac signals, respiratory parameters, and patient activity, and deliver potentially life-saving treatments to the patient. The medical device can include a plurality of sensing electrodes disposed at various locations on a patient's body and configured to monitor a patient's cardiac signal, such as an Electrocardiogram (ECG) signal. In some embodiments, the device can also be configured to allow the patient to report his/her symptoms, including one or more beats (spiped beats), shortness of breath, dizziness, accelerated heartbeat, fatigue, fainting, and chest discomfort. The device determines an appropriate treatment for the patient based on the detected cardiac signals and/or other physiological parameters prior to administering therapy (therapy) to the patient. The device then generates one or more therapeutic shocks, such as defibrillation and/or pacing shocks, to be delivered to the patient's body. The wearable medical device includes a plurality of therapy electrodes disposed on a patient's body and configured to deliver a therapeutic shock.

In embodiments, the garment portion of the wearable cardiac monitoring and treatment device is configured to be worn or otherwise secured around the torso of a patient. A plurality of energy storage units are operably connected to the therapy delivery circuit. The energy storage unit is configured to store energy for at least one therapeutic pulse. The therapy delivery circuit is configured to deliver at least one therapeutic pulse via the plurality of therapy electrodes. In an embodiment, the energy storage unit is electrically coupled to the plurality of therapy electrodes by one or more cables. For example, when the garment is assembled with a plurality of energy storage cells, therapy delivery circuitry, and therapy electrodes, the one or more cables are electrically insulated and physically isolated from the patient's skin and other components of the device.

In some embodiments, the wearable cardiac monitoring and treatment device includes a sensor configured to detect one or more physiological signals of a patient. The physiological sensor may include at least one physiological sensor configured to monitor a signal indicative of heart activity, such as an ECG signal and/or heart rate of the patient. For example, the ECG sensor can include one or more ECG electrodes configured to be in contact with a patient. The ECG electrodes can be placed in contact with the patient's skin, for example on the patient's torso. In some examples, the one or more ECG electrodes are a plurality of ECG sensors in contact with the torso of the patient and configured to monitor an ECG signal of the patient.

The devices described herein are intended to be worn continuously and for long durations, typically over the course of weeks or months. For example, the prescribed duration can be a duration in which the caregiver instructs the patient to wear the device following the device usage instructions. Devices designed to have extended wear durations may be specified as some or all of the designed durations as described later. Sudden cardiac arrest or other arrhythmia conditions may occur at any time and with little or no warning. Patients are encouraged to follow the guidelines for use of the device, including wearing the device at any time, including while showering or sleeping. In some embodiments, continuous use can be substantially or almost continuous in nature. That is, the wearable medical device can be continuously used except for, for example, the following sporadic periods of temporary stop of use: when the patient takes a bath, when the patient re-wears a new garment and/or a different garment, when the battery is charged/replaced, when the garment is washed, etc. Nevertheless, such substantially or nearly continuous use as described herein may be considered continuous use. In some embodiments, the patient can remove the wearable medical device within a short time of day (e.g., within a half hour of bathing). Thus, the device is configured to withstand impacts from environmental factors and forces associated with daily continuous use by ambulatory patients. In addition, the device is configured to allow uncomplicated assembly and disassembly during maintenance for repair and/or refurbishment for reuse by a subsequent patient.

Further, the wearable medical device can be configured as a long-term or extended use medical device. The device can be configured for extended periods of over 24 hours, days, weeks, months, or even years of use by the patient. Thus, extended use can be uninterrupted until a physician or other caregiver provides specific instructions to the patient to discontinue use of the wearable medical device. For example, the wearable medical device can be prescribed for use by a patient for an extended period of at least one week. In an example, the wearable medical device can be prescribed for use by a patient for an extended period of at least 30 days. In an example, the wearable medical device can be prescribed for extended periods of at least one month of use by the patient. In an example, the wearable medical device can be prescribed for extended periods of at least two months for use by a patient. In an example, the wearable medical device can be prescribed for use by a patient for an extended period of at least three months. In an example, the wearable medical device can be prescribed for use by a patient for an extended period of at least six months. In an example, the wearable medical device can be prescribed for use by a patient for an extended period of at least one year.

In embodiments, examples of therapeutic medical devices can include short-term continuous-monitoring defibrillators and/or pacing devices, such as short-term outpatient wearable defibrillators. For example, a physician can prescribe the short-term outpatient wearable defibrillator for patients who present with syncope. Wearable defibrillators can be configured to monitor patients for syncope by, for example, analyzing abnormal patterns in the patient's heart activity that can indicate abnormal physiological function. For example, the abnormal pattern may occur before, at the time of, or after the onset of symptoms. In an exemplary embodiment of the short term wearable defibrillator, the electrode assembly is capable of adhering to the skin of a patient and has a similar construction to the previously described in-hospital defibrillators.

Regardless of the extended wear period, use of the wearable medical device can include continuous or nearly continuous wear by the patient as described above. For example, continuous use can include the wearable medical device being continuously worn or continuously attached to a patient. In embodiments, the continuous attachment is through one or more electrode components as described herein or otherwise attached to the patient during monitoring and during periods when the device is not monitoring the patient but is still worn by the patient. Continuous use can include continuously monitoring the patient while the patient is wearing the device to acquire information associated with the heart (e.g., electrocardiogram (ECG) information including arrhythmia information, heart vibrations, etc.) and/or non-cardiac information (e.g., blood oxygen, patient temperature, glucose level, tissue fluid level, and/or lung vibrations). For example, the wearable medical device can perform its continuous monitoring and/or recording at periodic or aperiodic intervals or times (e.g., once every few minutes, once every few hours, once per day, once per week, or other intervals set by a technician or prescribed by a caregiver). Alternatively or additionally, monitoring and/or recording during intervals or times can be triggered by user behavior or other events.

Fig. 1 illustrates an exemplary medical device 100, the medical device 100 being external, ambulatory, and wearable by a patient and configured to implement one or more configurations described herein. For example, the medical device 100 can be a non-invasive medical device configured to be substantially external to a patient. The medical device 100 can be, for example, a non-stationary medical device that is movable and designed to move with the patient as the patient performs its daily activities. For example, a medical device 100 as described herein can be attached to a patient's body, such as may be derived from

Life available from Medical Corporation

A wearable cardioverter defibrillator. In one exemplary scenario, the wearable defibrillator canCan be worn almost continuously or substantially continuously for two to three months at a time. The wearable defibrillator can be configured to continuously or substantially continuously monitor vital signs of a patient during wear of the wearable defibrillator by the patient, and upon determining that treatment is needed, the wearable defibrillator can deliver one or more therapeutic electrical pulses to the patient. For example, the therapeutic shock can be a pacing, defibrillation or Transcutaneous Electrical Nerve Stimulation (TENS) pulse.

The medical device 100 can include one or more of: a garment 111, one or more sensing electrodes 112 (e.g., ECG electrodes), one or

more therapy electrodes

114a and 114b (collectively therapy electrodes 114), a medical device controller 120, a connection box 130, a patient interface box (interface pod) 140, a strap 150, or any combination of these. In some examples, at least some components of the medical device 100 can be configured to be affixed to a garment 111 (or, in some examples, permanently integrated in the garment 111) that can be worn around the torso 5 of a patient.

The medical device controller 120 (e.g., controller 120) can be operably coupled to the sensing electrode 112, and the sensing electrode 112 can be affixed to the garment 111, e.g., assembled into the garment 111 or removably attached to the garment, e.g., using hook and loop fasteners. In some embodiments, sensing electrode 112 can be permanently integrated into garment 111. The controller 120 can be operably coupled to the therapy electrode 114. For example, the therapy electrode 114 can also be assembled into the garment 111, or in some embodiments, the therapy electrode 114 can be permanently integrated into the garment 111. The controller 120 contains hardware and electronics for monitoring and treating a patient. In an embodiment, the controller 120 can be maintained and/or refurbished for subsequent use by another patient. Accordingly, embodiments of the controller 120 described herein include one or more features intended to facilitate uncomplicated and successful disassembly and reassembly without compromising the intrusion-protective assembly of the controller 120.

Other component configurations are possible in addition to the component configuration shown in fig. 1. For example, sensing electrodes 112 can be configured to be attached at various locations around the patient's body. Sensing electrode 112 can be operably coupled to controller 120 by a connection box 130. In some embodiments, sensing electrodes 112 can be adhered to the patient's body, such as to torso 5. In some embodiments, the sensing electrode 112 and the at least one therapy electrode 114 can be included on a single integrated patch and can be affixed to the body of the patient.

The sensing electrodes 112 can be configured to detect one or more cardiac signals. Examples of such signals include ECG signals and/or other sensed cardiac physiological signals from the patient. In certain embodiments, sensing electrode 112 can include additional components, such as accelerometers, acoustic signal detection devices, and other measurement devices for recording additional parameters. For example, sensing electrodes 112 can also be configured to detect other types of patient physiological parameters and acoustic signals, such as interstitial fluid levels, cardiac vibrations, lung vibrations, respiratory vibrations, patient movement, and so forth. Exemplary sensing electrodes 112 include metal electrodes with oxide coatings, such as tantalum pentoxide electrodes.

In some examples, the therapy electrode 114 can also be configured to include sensors configured to detect ECG signals and other physiological signals of the patient. In some examples, the junction box 130 can include a signal processor configured to amplify, filter, and digitize the cardiac signals prior to transmission to the controller 120. The one or more therapy electrodes 114 can be configured to deliver one or more therapeutic defibrillation shocks to the torso 5 of the patient when the medical device 100 determines that the treatment is approved based on the signals detected by the sensing electrodes 112 and processed by the medical device controller 120. The exemplary therapy electrode 114 can comprise a conductive metal electrode, such as a stainless steel electrode. In certain embodiments, each therapy electrode 114 includes one or more conductive gel deployment devices configured to deliver a conductive gel to the metal electrode prior to delivery of the therapeutic shock.

In an embodiment, each of the at least one pair of

treatment electrodes

114, 114a, 114b has a conductive surface adapted for placement adjacent the skin of the patient and each contains an impedance-reducing member, such as an impedance-reducing conductive gel, for reducing the impedance between the treatment electrode and the skin of the patient. In an embodiment, patient-worn arrhythmia monitoring and treatment device 100 may include a gel deployment circuit (e.g., gel deployment circuit 205 of fig. 2) configured to deliver a conductive gel substantially proximate to a treatment site (e.g., a surface of a patient's skin in contact with therapy electrode 14) prior to delivering a therapeutic shock to the treatment site. As described in U.S. patent No. 9,008,801 entitled "therapeutic DEVICE" issued on 14.4.2015 (hereinafter, the "801 patent," the entire contents of which are incorporated herein by reference), the gel deployment circuit can be configured to deliver the electrically conductive gel immediately prior to delivery of the therapeutic shock to the treatment site, or within a short time interval, such as within about 1 second, 5 seconds, 10 seconds, 30 seconds, or 1 minute, prior to delivery of the therapeutic shock to the treatment site. The gel deployment circuitry (e.g., gel deployment circuitry 205 of fig. 2) may be coupled to or integrated within a therapy electrode or other therapy delivery device as a single unit. When a disposable cardiac condition is detected and no patient response is received after device prompting, a signal can be sent to the gel deployment circuit to deploy the conductive gel. In some examples, the gel deployment circuitry may be constructed as one or more separate and independent gel deployment modules. The module may be configured to receive a removable and/or replaceable gel cartridge (e.g., a cartridge (cartridge) containing one or more conductive gel reservoirs). As such, the gel deployment circuitry may be permanently disposed in the garment as part of the therapy delivery system, while the cartridge may be removable and/or replaceable.

In some embodiments, the gel deployment module may be implemented as a gel deployment package and include at least a portion of the gel deployment circuitry and one or more gel reservoirs located within the gel deployment package. In this embodiment, the gel deployment package including one or more gel reservoirs and associated gel deployment circuitry may be removable and/or replaceable. In other examples, a gel deployment package including one or more gel reservoirs and associated gel deployment circuitry and a treatment electrode can be integrated into a treatment electrode assembly that can be removed or replaced as a single unit after use or in the event of damage or breakage.

Fig. 2 shows a sample component level schematic of an exemplary medical device controller 200, which can be, for example, an embodiment of the device controller 120 of fig. 1. As shown in fig. 2, the medical device controller 200 can include therapy delivery circuitry 202 (including a polarity switch component such as an H-bridge 228), data storage 204, a network interface 206, a user interface 208, at least one battery 210, at least one capacitor 240, a sensor interface 211, an alarm manager 213, and at least one processor 218. The patient monitoring medical device can include a medical device controller 200 having similar components as described above but without at least the therapy delivery circuit 202 and the at least one capacitor 240.

Therapy delivery circuitry 202 can be coupled to one or more therapy electrodes 214 (e.g., therapy electrodes 114 as described above in connection with fig. 1) configured to provide therapy to a patient. For example, the therapy delivery circuit 202 can include or be operatively connected to circuit components configured to generate and provide a therapeutic shock. The circuit components can include, for example, resistors, one or more capacitors, relays, and/or switches, bridges such as an H-bridge 228 (e.g., including a plurality of insulated gate bipolar transistors or IGBTs that deliver and intercept therapeutic pulses as described in further detail below), voltage and/or current measurement components, and other like circuits configured and connected such that the circuits operate in cooperation with therapy delivery circuit 202 and under the control of one or more processors (e.g., processor 218) to provide, for example, one or more pacing or defibrillation therapeutic pulses.

Pacing pulses can be used to treat arrhythmias such as bradycardia (e.g., in some embodiments, less than 30 beats per minute) and tachycardia (e.g., in some embodiments, more than 150 beats per minute) using, for example, fixed rate pacing, on-demand pacing, anti-tachycardia pacing, and the like. Defibrillation pulses can be used to treat ventricular tachycardia and/or ventricular fibrillation.

In an embodiment, the one or more capacitors comprise a parallel capacitor bank (capacitor bank) of one capacitor or a plurality of capacitors (e.g., two, three, four or more capacitors). These capacitors can be switched to a series connection during discharge to perform a defibrillation pulse. For example, four capacitors of approximately 500uF can be used. In one embodiment, the capacitor can have a surge rating (surging) of between 500 and 2500 volts and can be charged from a battery pack (battery pack) in approximately 5 to 30 seconds depending on the amount of energy to be delivered to the patient. In subsequent sections, additional embodiments are provided herein regarding capacitor performance and configuration of patient-worn medical devices.

In an embodiment, the gel deployment circuit 205 is coupled to the processor 218 and is configured to deliver the electrically conductive gel immediately prior to delivering the therapeutic shock to the treatment site, or within a short time interval, such as within about 1 second, 5 seconds, 10 seconds, 30 seconds, or 1 minute, prior to delivering the therapeutic shock to the treatment site. The gel deployment circuit 205 may be coupled to or integrated within the therapy electrode 214 or other therapy delivery device as a single unit. When a disposable heart condition is detected and no patient response is received after device prompting, a signal can be sent to the gel deployment circuit 205 to deploy the conductive gel.

The data storage 204 can include one or more of non-transitory computer readable media, such as flash memory, solid state memory, magnetic memory, optical memory, cache memory, combinations thereof, and others. The data storage 204 can be configured to store executable instructions and data for the operation of the medical device controller 200. In some embodiments, the data storage 204 can include executable instructions that, when executed, cause the processor 218 to perform one or more functions.

In some examples, the network interface 206 can facilitate communication of information between the medical device controller 200 and one or more other devices or entities via a communication network. For example, where medical device controller 200 is included in an ambulatory medical device (e.g., medical device 100), the meshNetwork interface 206 can be configured to communicate with a remote computing device, such as a remote server or other similar computing device. The network interface 206 can include a network interface for receiving a request from a user

Wireless standard communication circuitry to communicate data over short distances to one or more intermediate devices, such as base stations, "hot spot" devices, smartphones, tablets, portable computing devices, and/or other devices located in proximity to the wearable medical device. The one or more intermediary devices may in turn communicate the data to the remote server via the broadband cellular network communication link. The communication link may implement broadband cellular technology (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellular standards) and/or Long Term Evolution (LTE) technology or GSM/EDGE and UMTS/HSPA technology for high-speed wireless communications. In some embodiments, one or more intermediary devices may communicate via Wi-Fi based on the IEEE 802.11 standard ^TM The communication link is in communication with a remote server.

In certain embodiments, the user interface 208 can include one or more physical interface devices, such as input devices, output devices, and combination input/output devices, as well as a software stack configured to drive the operation of the devices. The user interface elements may present visual, audio, and/or tactile content. Thus, the user interface 208 may receive input or provide output, thereby enabling a user to interact with the medical device controller 200. For example, the user interface 208 can include one or a combination of a screen display, a touch screen display, an LED/or LCD display screen, LED lights, physical buttons, soft buttons (e.g., a touch field on the screen), one or more speakers, and/or one or more microphones.

The medical device controller 200 can also include at least one battery 210 configured to provide power to one or more components integrated in the medical device controller 200. The battery 210 can include a rechargeable multi-cell battery pack. In an exemplary embodiment, the battery 210 can include three or more batteries, for example, 2000mAh lithium ion batteries, which provide power to other device components within the medical device controller 200. For example, the battery 210 can provide a power output ranging from 20mA to 1000mA (e.g., 40 mA), and can support run times of 24 hours, 48 hours, 72 hours, or more between charges. In certain embodiments, the battery capacity, run time, and type (e.g., lithium ion, nickel cadmium, or nickel metal hydride) can be varied to best suit a particular application of the medical device controller 200.

The sensor interface 211 can be coupled to one or more sensors configured to monitor one or more physiological parameters of the patient. As shown, the sensors may be coupled to the medical device controller 200 via a wired or wireless connection. The sensors can include one or more Electrocardiogram (ECG) sensing electrodes 212 (e.g., similar to sensing electrodes 112 described above in connection with fig. 1), a cardiac vibration sensor 224, and a interstitial fluid monitor 226 (e.g., an ultra-wideband based radio frequency device).

The ECG sensing electrodes 212 are capable of monitoring the patient's ECG information. For example, ECG sensing electrodes 212 can include conventional adhesive electrodes, conductive electrodes with stored gel deployment (e.g., metal electrodes with stored conductive gel configured to disperse in the electrode-skin interface when desired), or dry electrodes (e.g., metal substrates with an oxide layer in direct contact with the patient's skin). The ECG sensing electrodes 212 can be configured to measure the ECG signal of the patient. The ECG sensing electrodes 212 can transmit information describing the ECG signal to the sensor interface 211 for subsequent analysis.

The vibration sensor 224 can include a cardiac vibration sensor to detect cardiac vibration information of the patient. For example, the vibration sensor 224 can be configured to detect cardiac vibration values including any or all of S1, S2, S3, and S4. From these values of cardiac vibrations, certain electromechanical indices may be calculated, including any one or more of electromechanical activation time (EMAT), EMAT percentage (% EMAT), systolic Dysfunction Index (SDI), and left ventricular contraction time (LVST). The vibration sensor 224 can include an acoustic sensor configured to detect vibrations from the subject's cardiac system and provide an output signal in response to the detected cardiac vibrations. The vibration sensor 224 can also include a multi-channel accelerometer, for example, a three-channel accelerometer configured to sense movement in each of three orthogonal axes, thereby enabling detection of patient movement/body position. The vibration sensor 224 can transmit information describing cardiac vibration information or patient position/movement to the sensor interface 211 for subsequent analysis.

The interstitial fluid monitor 226 can use Radio Frequency (RF) based techniques to assess fluid levels and accumulation in the patient's body tissues. For example, the interstitial fluid monitor 226 can be configured to measure fluid content in the lungs, typically for diagnosis and follow-up observation of pulmonary edema or pulmonary congestion in heart failure patients. The interstitial fluid monitor 226 can include one or more antennas configured to direct RF waves through tissue of a patient and to output RF signals in response to wave measurements that have passed through the tissue. In certain embodiments, the output RF signal includes a parameter indicative of the fluid level in the patient tissue. The interstitial fluid monitor 226 can transmit information describing the interstitial fluid level to the sensor interface 211 for subsequent analysis.

Sensor interface 211 can be coupled to any one or combination of sensing electrodes/other sensors to receive other patient data indicative of patient parameters. Once the sensor interface 211 has received the data from the sensors, the data can be directed by the processor 218 to the appropriate components within the medical device controller 200. For example, if cardiac data is acquired by cardiac vibration sensor 224 and transmitted to sensor interface 211, sensor interface 211 can transmit the data to processor 218, which processor 218 in turn relays the data to a cardiac event detector. Cardiac event data can also be stored on the data storage 204.

In some embodiments, the alert manager 213 can be configured to manage alert profiles and notify intended recipients of events specified within the alert profiles that are of interest to one or more intended recipients. These intended recipients can include external entities such as users (patients, physicians, and monitoring personnel) and computer systems (monitoring systems or emergency response systems). The alert manager 213 can be implemented using hardware or a combination of hardware and software. For example, in some examples, the alert manager 213 can be implemented as a software component stored within the data storage 204 and executed by the processor 218. In this example, instructions included in the alert manager 213 can cause the processor 218 to configure an alert profile and notify the intended recipient using the alert profile. In other examples, the alert manager 213 can be an Application Specific Integrated Circuit (ASIC) coupled to the processor 218 and configured to manage the alert profile and notify the intended recipient using alerts specified within the alert profile. Thus, examples of the alert manager 213 are not limited to a particular hardware or software implementation.

In some embodiments, processor 218 includes one or more processors (or one or more processor cores), each configured to execute a sequence of instructions: generate manipulated data and/or control the operation of other components of the medical device controller 200. In some embodiments, when performing a particular procedure (e.g., cardiac monitoring), the processor 218 can be configured to make a particular logic-based decision based on received input data, and can be further configured to provide one or more outputs that can be used to control or otherwise inform subsequent processing to be performed by the processor 218 and/or other processors or circuits communicatively coupled to the processor 218. Thus, the processor 218 reacts to a particular input stimulus in a particular manner and generates a corresponding output based on the input stimulus. In some examples, the processor 218 is capable of a series of logical transitions as follows: various internal register states and/or other bit cell states internal or external to the processor 218 may be set to logic high or logic low. The processor 218 can be configured to perform functions stored in software. For example, the software may be stored in a data store that is coupled to the processor 218 and may be configured to cause the processor 218 to make a series of various logical decisions that result in the functions being performed. The various components described herein as being executable by the processor 218 can be implemented in various forms of dedicated hardware, software, or combinations thereof. For example, the processor can be a Digital Signal Processor (DSP), such as a 24-bit DSP processor. The processor can be, for example, a multi-core processor having two or more processing cores. The processor can be an Advanced RISC Machine (ARM) processor, such as a 32-bit ARM processor. The processor can execute an embedded operating system and can include services provided by: the operating system can be used for file system manipulation, display and audio generation, basic networking, firewalling, data encryption and communications.

In an embodiment, the controller 200 is configured to provide one or more high energy shocks to the torso 5 of a patient, for example defibrillation shocks of energy 150J to 500J in up to five consecutive times to a patient experiencing an arrhythmia such as ventricular fibrillation or ventricular tachycardia. Thus, the controller 200 includes precautions for avoiding exposure of the patient to high pressure components, as well as precautions for protecting internal components from damage due to normal use and intrusion of fluids or other contaminants during a prescribed continuous wear.

In an embodiment, a maintainable, rugged, wearable cardiac treatment device for continuous prolonged use by an ambulatory patient includes a garment (e.g., garment 111 of fig. 1) configured with a plurality of ECG sensing electrodes 212 and therapy electrodes 214 disposed therein in continuous prolonged contact with the torso 5 of the patient to monitor and treat arrhythmia of the patient. The device can include an impact-resistant, anti-intrusion device controller (e.g., controller 120 or controller 200) configured to be in detachable electrical communication with the plurality of ECG sensing electrodes 212 and therapy electrodes 214 in the garment.

In embodiments such as fig. 3-5, the device controller 200 includes an impact energy core 300, a first circuit board 320, a second circuit board 330, and an

anti-intrusion housing

220, 220a, 220b, the

anti-intrusion housing

220, 220a, 220b configured to enclose the core 300, the first circuit board 320, and the second circuit board 330 while still being able to remove the impact energy core 300, the first circuit board 320, and the second circuit board 330 during maintenance. In an embodiment, impact resistant energy core 300 includes frame 310 and at least one capacitor (e.g., capacitor 240). In an embodiment, at least one capacitor (e.g., capacitor 240) is permanently bonded (bond) to the frame 310 such that the frame 310 together with the bonded at least one capacitor comprises a unity mass.

The frame 310 can be a lightweight structure made of a non-conductive material such as plastic and/or thermoplastic that acts as an electrical insulator. The material properties of the frame include maximizing dielectric strength, minimizing moisture absorption, and maximizing mechanical strength. For example, the frame 310 can include at least one of polypropylene, polyethylene (PE), polyvinyl chloride (PVC), acrylic, polycarbonate, ULTEM1000, NORYL N1150, and VALOX E45329. In an embodiment, frame 310 exhibits high flexural strength according to ASTM D638 and ISO527 standards, resistance to absorption of moisture according to ASTM D570 and ISO 62 standards, resistance to a wide range of bases and acids, high resistance to fatigue according to ASTM D790 and ISO178 standards, and high impact strength according to ASTM D256 and ISO 180/1A standards. In an embodiment, the frame 310 can have a dielectric strength in air in the range of about 500-900V/mil. In an embodiment, the frame can have a dielectric constant ranging from about 2.75-3.25 at 1kHZ,50% rh. In an embodiment, the frame can have a dissipation factor in the range of about 0.001-0.002 and a volume resistivity of about 1.0 x 10 (^ 17) Ohm-cm at 1/16. In embodiments, the frame can have a moisture absorption rate ranging from about 0.05% to 0.25%. In an embodiment, the frame can have a tensile strength in a range of about 7,500-16,000psi at 23 degrees celsius (e.g., 73 degrees fahrenheit). In an embodiment, the frame 310 can have a flexural yield strength in the range of about 10,000-25,000psi. In an embodiment, the frame 310 can have an impact strength (izod, notched) according to ASTM D256 standards in the range of about 1.0-2.0 ft-lb/in. In an embodiment, the frame 310 can have a rockwell hardness at the "M" scale according to ASTM standard D785 of 109. In an embodiment, the frame 310 can have an ultimate shear strength in the range of about 10,000-20,000psi. In an example, the above materials provide some or all of these properties. In one example, the frame 310 can be made of a material having the properties shown in table 1 below:

TABLE 1

Performance of	Unit	Example values
			Water absorption, @ equilibrium, 73 deg.F (23 deg.C)	％	0.25
Tensile Strength, break, 73 ℃ F	psi	15,000
			Elongation, break, 73 ℃ F., ASTM D638	％	60
Elongation, yield, 73 ℃ F., ASTM D638	％	7-8
			Flexural Strength, 73 ℃ F	psi	22,000
Flexural modulus, 73 ℃ F	psi	475,000
			Izod impact strength, notched, 73 ℃ F	ft-lb/in	1.0
Rockwell hardness	"M" scale	110
			Compressive Strength, ASTM D695	psi	21,500
Compression modulus, ASTM D695	psi	475,000
			Shear strength, ultimate limit	psi	15,000
Dielectric strength in air	V/mil	700
			Dielectric constant, 1kHz,50% RH	-	3.10
Dissipation factor, 1kHz,50% RH,73 ℃ F. (23 ℃ C.)	-	0.0012
			Volume resistivity, 1/16"	ohm-cm	10x10 ¹⁷

Returning to the structure of the energy core 300, in an embodiment, the frame 310 receives at least one capacitor 240 therein. As shown in fig. 6A and 6C, for example, the frame 310, 310 'can include pockets or wells 312, 312', the pockets or wells 312, 312 'being sized, shaped, and/or configured to receive at least one capacitor 240, 240' therein. In one example, as shown in fig. 6C-7, the pocket 312 encapsulates at least one

capacitor

240, 240a, 240b disposed in the pocket 312 by having a solid wall forming the pocket 312 and including a port 313, 313' at an open end of the pocket 312 through which the at least one capacitor 240 passes for receiving the at least one capacitor 240. In an embodiment, pocket 312 is at least as deep as the height H of at least one capacitor 240 such that when inserted, the at least one capacitor is located at a mouth 313 of pocket 312 or below a mouth 313 of pocket 312. Because the frame 310 comprises a non-conductive insulating material, such as plastic, the pocket 312 isolates the high voltage of the at least one capacitor 240 from other components of the controller 200.

In an embodiment, as shown in fig. 6C-7, the high energy core 300 includes a compound 315, the compound 315 being disposed within a pocket 312, immovably coupling the at least one capacitor 240 to the frame 310 to form an integral mass. In an embodiment, compound 315 is a bonding compound. The compound 315 can at least partially encapsulate the at least one capacitor 240. In an embodiment, the compound 315 can include an electrically insulating material (which can be dispersed in a bonding medium). The compound 315 is capable of encapsulating at least one capacitor 240 within the pocket 312. In an embodiment, compound 315 can be an epoxy configured to be applied to the pocket in a liquid state and to have a hardness rating ranging from about 80-85 shore D when solidified after initial application. In embodiments, compound 315 is a low viscosity epoxy resin (e.g., having a viscosity of 400-700 Centipoise (CPS)), which outgases and releases bubbles during the curing stage to release air and maintain the high pressure properties of the assembly. In embodiments, compound 315 is a viscose polymer (viscose polymer) that hardens at room temperature (e.g., about 25-55 ° F). In an embodiment, compound 315 is at least one of a marine grade epoxy and a UL-listed epoxy. For example, compound 315 can be at least one of the WEST SYSTEM epoxy resins produced by WEST MARINE, walnebivol, california, such as 105 epoxy resin. For example, compound 315 can be at least one of the TAP marine grade epoxies, such as TAP314 epoxy, produced by inc. For example, the compound can be at least one of the epoxy resins listed in UL, such as the epoxy resins listed in UL 94V-0, manufactured by EPOXIES, etc., of klandton, rhode island. In an embodiment, as described above, the material comprises a dielectric material that absorbs moisture while providing voltage isolation of the at least one capacitor 240.

In one example, compound 315 can have a tensile strength ranging from about 8,000-12,000PSI, a compressive strength ranging from about 20,000-24,000PSI, and a flexural strength ranging from about 14,000-20,000PSI. In one example, compound 315 is characterized as having a crack resistance when exposed to shock, vibration, and thermal shock, and compound 315 has a tensile strength ranging from 10,000psi, a compressive strength of 22,000psi, and a flexural strength of 17,000psi. In an embodiment, compound 315 has a dielectric strength of less than or equal to 6.0 at both 1kHz and 1MHz according to ASTM D150. In an embodiment, compound 315 has a dissipation factor or dielectric loss of less than or equal to 0.03 at 1kHz and less than or equal to 0.05 at 1MHz according to ASTM D150. In an embodiment, compound 315 has a dielectric strength in the range of about 200-650Volts/mil at about 25 ℃, and a dielectric constant between about 3-6 and a dissipation factor between about 0.005-0.01 at about 25 ℃ and 100 hz. In one example, compound 315 has a dielectric strength of 500Volts/mil, a dielectric constant of 4.4, and a dissipation factor of 0.007 at about 25 ℃ and 100 hz. In an embodiment, the volume resistivity of compound 315 is greater than or equal to 0.1 tera-ohm-meters at about 25 ℃ and greater than or equal to 1.0 mega-ohm-meters at 125 ℃, according to ASTM D257.

In an embodiment, the compound 315 can be applied at the mouth 313 of the pocket 312 throughout the exposed end of the at least one capacitor 240. In other embodiments, the compound 315 can be applied to the bottom of the pocket 312 prior to inserting the at least one capacitor 240. The compound 315 can be applied to the bottom of the pocket 312 prior to inserting the at least one capacitor 240, and the compound 315 can be applied across the mouth 313 of the pocket 312 and the exposed end of the at least one capacitor, thereby adhering the compound 315 to the at least one capacitor 240 and the frame 310. Once solidified, the compound 315 immovably couples the at least one capacitor 240 to the frame 310. As such, the at least one capacitor 240 does not move relative to the frame 310 and cannot be removed from the frame 310. In this manner, once the compound 315 hardens, the at least one capacitor 240 and the frame 310 are assembled into a unitary mass with no moving parts. Thus, the impact resistant energy core 300 is a solid mass comprising at least one capacitor 240 immovably coupled to the frame 310 and inseparable from the frame 310. In view of at least these aspects of its structure, the core 300 is able to withstand impacts without damaging the high-voltage components confined therein. The core 300 is resistant to impact damage and is therefore designed to prevent electrical failure. By reinforcing the core 300, the device 100 can be used by ambulatory patients in a daily continuous schedule during normal donning and doffing activities without compromising the ability of the device 100 to monitor the patient and deliver treatment if necessary.

While the above-described embodiments of the energy core 300 include a frame 310 having a pocket 312 with continuous, unperforated, unbroken walls, other embodiments can include a pocket with one or more semi-perforated or scaffold-like walls and/or no bottom walls to reduce the overall weight of the frame 310. For example, in the embodiment of fig. 6A, the energy core 300 'includes a pocket 312' having two perforated side walls 311a ', 311 b'. In this embodiment, an assembled core 300', such as that of fig. 6B, includes additional structural elements configured to retain at least one capacitor 240' on the frame 310 'until a curable hardening compound is added to one or both ends of the pocket 312' to bond the at least one capacitor 240 'to the frame 310'.

Returning to fig. 7, a cross-sectional view of an embodiment of the core 300 is depicted. In an example, the at least one capacitor 240 includes a film capacitor. In an example such as fig. 7, the at least one capacitor includes at least two

capacitors

240a, 240b. At least two

capacitors

240a, 240b can be inserted side by side into pocket 312 in the following manner: both main planes of each capacitor are arranged adjacent to the first side wall 311a and the second side wall 311b of the frame 310. In an embodiment, at least two capacitors are shorted together at both ends (top and bottom) such that they are electrically in parallel and effectively act as one capacitor in the circuit of the controller 200. In the example, both

capacitors

240a, 240b are flat film capacitors with a maximum thickness between 1mm and 40mm, a capacitance of at least 50 microfarads, and a breakdown voltage rating between 1300 volts and 2500 volts. In an example, the at least two

capacitors

240a, 240b are each 81.25 μ f film capacitors (e.g., a combined capacitance of about 162.5 μ f), and each have a combined surge rating of about 1600V.

In an example, the at least two

capacitors

240a, 240b are shorted together at respective aligned ends with a conductive plate, and the energy core 300 includes at least one wire extending from the at least two

capacitors

240a, 240b beyond the pocket 312 of the frame 310. At least two

capacitors

240a, 240b can be connected in parallel and at least one wire can be connected to the first circuit board 320 to communicate with the at least one processor 218 and the therapy delivery circuit 202. In an embodiment, as shown in fig. 6C-6D and 19A-19B, the at least one wire includes two

wires

340, 342.

Fig. 19A-19B depict top and bottom views of an embodiment of two capacitors 240a, 240B, the two capacitors 240a, 240B connected in parallel by first and second connectors 341a, 341B, such as conductive metal plates, electrically coupled at respective ends of the two capacitors 240a, 240B. The ends of the first and

second connectors

341a, 341b can be attached to the two

capacitors

240a, 240b with conductive solders 347a-b, 348a-b applied to the top and bottom ends of the two

capacitors

240a, 240b, such that the first and second connectors are adhered to and bridge the top and bottom surfaces of the two

capacitors

240a, 240b. The first wire 340 can be electrically connected to a top end of at least one capacitor (e.g., at least two

capacitors

240a, 240 b), and the second wire 342 can be electrically connected to a bottom end of the at least one capacitor. Although the adjectives "top" and "bottom" are applied herein in one configuration, the terms can be applied instead. The example of fig. 19A and 19B also includes an arrow 1900 indicating a direction of inserting the two electrically coupled capacitors 240a, 240B into the pocket 312 of the frame 310. In this example, when the energy core 300 is fully assembled, the top ends of the electrically coupled

capacitors

240a, 240b are closest to the mouth 313 of the pocket 312.

Because the second wire 342 is connected to the bottom ends of the electrically coupled

capacitors

240a, 240b, the second wire 342 is at least as long as the height H of the coupled

capacitors

240a, 240b. For example, as shown in FIG. 7, the second wire 342 is connected to the shorted ends of the at least two

capacitors

240a, 240b at the bottom of the pocket and passes out (threaded up) of the pocket 312 along and between the at least two capacitors toward the mouth 313 of the pocket 312. As shown in fig. 6D, a first wire 340 connected to a shorted end of at least two capacitors at the mouth 313 of the pocket 312 extends from the pocket 312 adjacent to a second wire 342. The

wires

340, 342 can be prevented from disconnecting from the at least two capacitors by the compound flowing around the first and

second wires

340, 342 when added to the energy core 300 and then hardening to immovably bond the first and

second wires

340, 342 to the overall mass of the energy core 300. The first wire 340 and the second wire 342 are configured to be electrically connected to the first circuit board 320 attached to the energy core 300.

In an embodiment, the at least one capacitor 240 occupies at least 50% to 95% of the volume defined by pocket 312 of frame 310. In some examples, at least one capacitor 240 contacts one or more walls 311 of pocket 312 and is electrically insulated by high dielectric frame 310. In other examples, a gap between one or more portions of the inner surface of pocket 312 and at least one capacitor 240 disposed therein of between 0.5mm and 10mm is configured to receive compound 315 such that the compound extends between the at least one capacitor and the inner surface of pocket 312 along a height H of the at least one capacitor. In embodiments such as fig. 7, the compound flows around second wires 342 extending from the bottom of the at least one capacitor through pocket 312 to port 313 and hardens over time to secure second wires 342 in this configuration within pocket 312.

Thus, impact resistant energy core 300 is the integral mass of at least one capacitor bonded to frame 310 by a compound such as a self-curing polymer that immobilizes at least one capacitor 240 and at least one wire electrically connected to at least one capacitor 240. Additional components of the controller 200 are formed around the high energy core 300, and the high energy core 300 provides a central, stable, strong, inflexible, and impact resistant foundation upon which to attach additional hardware.

As previously described with reference to fig. 3-5, the controller 200 includes a first circuit board 320 and a second circuit board 330. Although the first circuit board 320 and the second circuit board 330 are described herein as "first" and "second," these terms are merely illustrative and are used to describe embodiments of features and characteristics associated with each of the two circuit boards. The terms "first" and "second" can alternatively be applied to the other plate. In an embodiment, the first circuit board 320 and the second circuit board 330 include arrhythmia monitoring and therapy circuitry in electrical communication with the at least one capacitor 240. First circuit board 320 and second circuit board 330 can be attached to opposite sides of impact energy core 300 in a manner that allows for separation from impact energy core 300 during maintenance. In an embodiment, one or more releasable fasteners attach first circuit board 320 and second circuit board 330 to opposing sides of impact-resistant energy core 300. For example, the one or more releasable fasteners can include one or more of a screw (screw), a clip (clamp), a snap (snap), a tab (clip), and a tape (tape).

In examples such as fig. 3 and 4, the first circuit board 320 and the second circuit board 330 are affixed to the frame 310 with one or more removable screws. For example, first circuit board 320 is configured to be attached to frame 310 using a plurality of screws 323a-323g, screws 323a-323g configured to be inserted through receiving holes disposed around a periphery of first circuit board 320 and securely screwed into receiving threads of screw bosses 322a-322g disposed around a periphery of the frame. Similarly, second circuit board 330 is configured to be attached to the frame using a plurality of screws 326a-326f, screws 326a-326f being configured to be inserted through receiving holes disposed around a periphery of the first circuit board and to be securely screwed into receiving threads of screw bosses (e.g., screw bosses 325a-325d of FIG. 6C) disposed around a periphery of the frame. Although the embodiments described herein include screws that can be repeatedly inserted, tightened, loosened, and removed, embodiments of the controller 200 can include other releasable fasteners for holding the first circuit board 320 and the second circuit board 330 on opposite sides of the energy core 300. For example, four spring-loaded press-fit retention clips can engage four sides of two major faces of the core, and both the first circuit board 320 and the second circuit board 330 can be pressed into the retention clips such that one of the two largest planes of the first circuit board 320 and the second circuit board 330 is face-to-face with one of the two largest planes of the energy core 300. In other embodiments, double-sided tape can be used to secure the first and

second circuit boards

320 and 330 to opposite sides of the core 300. In some embodiments, one or both of the first circuit board 320 and the second circuit board 330 may be fixed using a variety of fastening means (e.g., screws and tape, or screws and epoxy material).

In an embodiment, the first circuit board 320 and the second circuit board 330 are configured to be disposed on opposite sides of the energy core 300. The opposite side is the largest plane of the energy core 300. In an embodiment, the first circuit board 320 and the second circuit board 330 each have two largest planes, wherein one largest plane is configured to be arranged face-to-face on one of the opposite sides of the energy core 300, such that the assembly of the energy core 300 with the first circuit board 320 and the second circuit board 330 is compact. In an embodiment, 50% -100% of the periphery of the first circuit board 320 and the periphery of the second circuit board 330 contact the energy core 300. In an embodiment, first circuit board 320 and second circuit board 330 are configured to electrically communicate via a flexible connector 344 (fig. 4) extending from first circuit board 320 to second circuit board 330. The flexible connector 344 is releasably connectable to the first and

second circuit boards

320, 330 via releasable connectors 345a, 345b at each end and includes a flexible flat ribbon cable 346 wrapped around the outer edge of the frame 310 therebetween.

In an embodiment, the first and

second circuit boards

320, 330 overlap the pockets 312 of the energy core 300 and the at least one capacitor 240 located therein. In embodiments such as fig. 8 and 9, the frame 310 can include a protrusion (overhang) 327, the protrusion 327 extending beyond the mouth 313 of the pocket 312 such that the entire length of the first circuit board 320 is disposed over the entire length of the frame 310. In an embodiment, second circuit board 330 is shorter than first circuit board 320 and does not extend over protrusion 327. The tab can include

sidewall constrictions

328a, 328b such that the sidewall of the tab is shorter than the sidewall of the pocket. Thus, the protrusion 327 is configured to receive therein a battery well or compartment formed in the rear shell 220b of the intrusion prevention housing 220. The well and rear housing will be described later with reference to an embodiment of the intrusion housing 220.

Returning to fig. 8-9, in an embodiment, the first circuit board 320 includes hardware and circuitry that supports critical monitoring and treatment functions and the second circuit board 330 includes hardware and circuitry that supports non-critical functions, which can be suspended (suspended) or updated, for example, without interfering with the critical monitoring and treatment functions of the first circuit board 320. In an example, the first circuit board 320 includes at least one processor (e.g., processor 218) and high voltage circuitry (e.g., therapy delivery circuitry 202) in communication with the at least one processor. In an embodiment, the at least one processor includes an arrhythmia detection processor. In an embodiment, the at least one processor includes an arrhythmia detection processor and therapy delivery circuitry 202. The first circuit board 320 can include a speaker thereon for communicating alerts and critical notifications and instructions to the patient or caregiver, a health indicator LED, and at least one

user response button

343, 343a, 343b for the patient to communicate directly with one or more processors on the first circuit board 320. For example, the patient can press and release at least one

user response button

343, 343a, 343b to indicate consciousness and delay treatment in response to notification of an impending shock. The at least one user response button can be two

response buttons

343a, 343b located at the top of the housing 220, at opposite sides of the housing. In an embodiment, two opposing

response buttons

343a, 343b can be located at a center point along the top of the controller 200. This configuration can allow the patient to quickly reach down and place a finger on the response button without having to remember which end of the housing 220 includes at least one response button.

For example, as best shown in fig. 10A and 14A-14B, the location of at least one response button (e.g., two response buttons 343a, 343B) is centrally located at the top edge 219 of the front and rear shells 220A, 220B. In addition to their central location, the two

response buttons

343a, 343b can be recessed within the front and

rear housings

220a, 220b so that the patient can quickly locate the response buttons and center their fingers on the buttons for proper alignment and application of force. The top edges 219 of the front and rear shells can be notched and chamfered to further facilitate effective and accurate positioning of the response buttons. Additionally, as best shown in fig. 10A, the two

response buttons

343a, 343b can be covered with an overmold (overmolds) 349a, 349b, such as at least one of rubber, silicone, and polyurethane thermoplastic, etc. The overmold can include textured elements, such as one or more raised bumps and ridges that are easily felt by the finger belly. When the controller 200 provides an alert of an impending shock, an alert patient attempting to delay treatment may be scared and/or worried about providing a response to delay treatment quickly. By placing the buttons along the easily located edges of the housing 220, by recessing them and by covering them with a patterned overmold, the patient can easily quickly discern the

buttons

343a, 343a through the material of the front and back shells 220a, 22b using tactile feel, and align their fingers with the buttons to effectively apply force.

In some embodiments, alternatively or additionally, the patient can provide a response to an alarm of arrhythmia detection by touching an area on display 329. In an example, upon detection of an arrhythmia, the processor 218 of the device can output an alert and/or notification to the display 329. The alert and/or notification can include one or more capacitive fields structured to receive a touch input or touch pattern from a responsive patient requesting treatment delay. In an embodiment, the processor 218 may require a series of touches to verify that the patient intentionally requests delayed treatment, rather than accidentally touching a button on the display 329.

While the first circuit board 320 includes at least one processor 218 for controlling alarms, treatment, and user interaction with the display 329 and/or the

response buttons

343a, 343b, in an embodiment, the second circuit board 330 includes low voltage circuitry (including at least one of communication circuitry (e.g., cellular, wiFi, NFC), display, and touch screen drivers) and one or more ultracapacitors to drive the shutdown of applications running on the one or more processors of the second circuit board 330. In an embodiment such as that of fig. 8, the first circuit board 320 includes a display stand 324 for receiving and holding a display screen 329. In an embodiment, the display screen 329 is in wired communication with the second circuit board 330 and the display and touch screen drivers. In an embodiment, the second circuit board 330 includes the network interface 206. The network interface can include communication circuitry for transmitting data according to the BLUETOOTH wireless standard to exchange the data over short distances to one or more intermediary devices (e.g., base stations, "hot spot" devices, smartphones, tablets, portable computing devices, and/or other devices located near the wearable medical device 100). In an embodiment, the network interface is capable of communicating data to a remote server via a broadband cellular network communication link. The communication link may implement broadband cellular technology (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellular standards) and/or Long Term Evolution (LTE) technology or GSM/EDGE and UMTS/HSPA technology for high-speed wireless communications. In some embodiments, the network interface is capable of communicating with a remote server via a WI-FI communication link based on the IEEE 802.11 standard.

As described above with reference to the embodiments, the first circuit board 320 and the second circuit board 330 and the respective associated hardware and circuit components are assembled around the energy core 300. Thus, the energy core 300 and the at least one capacitor 240 located therein form the core of the components of the controller 200, and the at least one capacitor 240 is in electrical communication with the first circuit board 320 and the second circuit board 330 via at least one electrical wire. As shown in fig. 9, in an embodiment, at least one electrical wire (e.g., first electrical wire 340 and second electrical wire 342) is in electrical communication with first circuit board 320 such that at least one capacitor 240 is in communication with at least one processor 218 and the high voltage circuitry (e.g., therapy delivery circuitry 202). In an embodiment, at least one wire (e.g., first wire 340 and second wire 342) is soldered to a corresponding at least one contact via or through a hole on first circuit board 320. As depicted in fig. 9, the first circuit board 320 and the second circuit board 330 are affixed to opposite sides of the overall mass of the energy core, and at least one wire (e.g., first wire 340 and second wire 342) extends from the energy core and is configured to be attached to the first circuit board 320 within the boundaries of the frame 310. If the energy core 300 and the assembly of the first and

second circuit boards

320, 330 are jostled (jostle) during daily activities of a patient wearing the device 100, the at least one wire is not subjected to any tension or torque and is not pulled away or separated from the first circuit board 320. Thus, at least one wire is protected by being fixed with respect to the frame 310 and the first circuit board 320.

In other device embodiments, a separate electrolytic capacitor can be mounted on the circuit board at one end. For example, the capacitor bank may include free standing electrolytic capacitors (free standing electrolytic capacitors) that are individually soldered to the circuit board in a manner that secures four individual leads. If one of the individual electrolytic capacitors is removed and disconnected from the circuit board in response to an impact, the entire capacitor bank will not provide enough energy to deliver a therapeutic shock.

Rather, the energy core 300 is the overall mass at the core of the components of the controller 200. The controller 200 is formed around at least one capacitor 240 (e.g., two capacitors electrically connected in parallel). This reduces the number of wires that need to be connected to the circuit board and reduces the number of points of failure. Additionally, in embodiments of the at least one capacitor 240 comprising two capacitors connected in parallel and bonded to the dielectric frame 310 by a compound, the two capacitors are stationary with respect to each other. Unlike free-standing capacitors, at least one capacitor (e.g., two

capacitors

240a, 240b of fig. 7) is part of the overall mass of the energy core 300 and withstands impacts associated with, for example, daily activities of the patient and impacts from accidental drops. The energy core 300 and the at least one capacitor 240 held therein withstand the force of the impact without moving relative to each other and without moving relative to the first circuit board 320 and the second circuit board 330 attached to the energy core 300.

In addition to including a strong, impact-resistant energy core 300, the apparatus 100 also includes an intrusion-resistant housing 220 (hereinafter, interchangeably referred to as "housing 220"). Housing 220 is configured to enable impact resistant energy core 300 and first and

second circuit boards

320 and 330 to be removed during maintenance. The housing 220 is configured to provide additional utility to withstand the daily activities encountered by the patient during continued use of the wearable device 100. For example, ambulatory patients may wear the device 100 and the controller 200 continuously for hours, days, and weeks during activities such as walking, driving, sleeping, bathing, and the like. By securely assembling the controller 200 around the impact resistant integral mass as the energy core 300, the high and low voltage components are securely attached to withstand the impact. By enclosing the controller with the intrusion-resistant housing 220, the energy core 300, the first circuit board 320, the second circuit board 330, and other components and circuits, such as the therapy delivery circuit 202 and the user interface 208 (e.g., a display and/or touch screen), are also protected from environmental influences such as liquids and dust.

In an embodiment, impact resistant energy core 300 and attached first and

second circuit boards

320 and 330 occupy approximately 25% -90% of the volume defined by anti-intrusion housing 220. This, in addition to providing a compact controller 200 that is more comfortable for the patient to wear and manipulate, reduces the amount of volume that can be accumulated by dust or liquid. For example, as depicted in the exploded views of fig. 5 and 10A, the intrusion prevention housing includes a rear case 220b configured to be disposed adjacent to the second circuit board 330 and a front case 220A disposed adjacent to the first circuit board 320, the front case 220A cooperating with the rear case 220b to be in a sealed configuration. Although the front and

rear housings

220a and 220b are described herein as "front" and "rear," these terms are merely illustrative and are used to describe embodiments of features and characteristics associated with each of the two housings. The terms "front" and "rear" may be applied alternatively.

In some embodiments, the intrusion-resistant housing on the controller 200 is waterproof and has a predetermined level of intrusion protection that complies with one or more levels set forth in IEC standard 60529. The liquid intrusion protection rating can be one or more of any rating (e.g., rating 3 to rating 9), where the rating is within the standards for compliance with the test specification. For example, for a liquid intrusion protection rating level of 6, the intrusion prevention housing 220 of the controller 200 will prevent intrusion of water provided by the power water jet. The power water jet test requires that water flow from a test nozzle of 12.5mm diameter be sprayed into the housing of the controller 200 from all practical directions. The water was sprayed at 1 minute per square meter for a minimum of three minutes, a volume of 100 liters per minute (+/-5%), so that the core of the water stream (core) was a circle of approximately 120mm in diameter at a distance of 2.5 meters from the nozzle. For example, for a grade level of 7, when the housing of the controller 200 is fully immersed in water at a depth between 0.15m and 1m, such that the lowest point of the housing of the controller 200 having a height below 850mm is located 1000mm below the water surface, and the highest point of the housing of the controller 200 having a height below 850mm is located 150mm below the water surface, water intrusion will not be possible. The controller 200 is immersed in water for a duration of 30 minutes and the water temperature differs from the housing of the controller 200 by no more than 5K.

In an embodiment, the assembled intrusion-resistant housing 220 of the controller 200 can be constructed to be waterproof and can be tested according to the IEC60529 standard for intrusion Protection (Ingress Protection). For example, the controller 200 of the apparatus 100 may be configured to have a rating of 7, thereby shielding immersion in water for thirty minutes up to one meter. This enables the patient to wear the device 100 while in the bathtub or shower for uninterrupted continuous use. In an embodiment, the controller 200 of the apparatus 100 may be multi-coded, including two or more stages. For example, the controller 200 of the device 100 can maintain a liquid ingress protection rating of 7, thereby protecting against temporary immersion, and can maintain a liquid ingress protection rating of 5, thereby protecting against water jets. In an embodiment, the anti-intrusion housing comprises an IP67 rating as set forth in the IEC60529 standard for intrusion prevention, and the controller 200 of the device 100 is capable of maintaining a liquid intrusion prevention rating of 6, thereby preventing a powerful water jet, and is capable of maintaining a liquid intrusion prevention rating of 7, thereby preventing temporary immersion. In an example, the intrusion-resistant housing 220 of the controller 200 can include or be constructed of at least one of neoprene, thermoformed plastic, or injection molded rubber or plastic (such as silicone or other biocompatible synthetic rubber).

Accordingly, the intrusion-resistant housing 220 of the controller 200 protects the components located thereunder (e.g., the processor 218, the therapy delivery circuitry 202 including polarity switching components such as the H-bridge 228, the data storage 204, the network interface 206, the user interface 208, the at least one battery 210, the sensor interface 211, the alarm manager 213, and the at least one capacitor 240) from the external environment, e.g., from effects associated with solid particle intrusion, dust intrusion, and/or moisture, water vapor, or liquid intrusion. The intrusion protection protects the electronic components of the device 100 from shorting or corrosion of moisture sensitive electronic devices, for example, when a patient is taking a shower.

In an embodiment, for example, two interlocking shell portions (e.g., front shell 220a and back shell 220 b) are configured to mate in a sealed press-fit manner. For example, as shown in fig. 10A-11B, a compressible grommet, O-ring, or silicone seal 222 can be inserted between and/or around the mating surfaces such that the intruding interlocked shells are shielded. As shown in fig. 12, for example, the mating edge 221a of the front shell 220a and the mating edge 221b of the rear shell 220b are configured to engage in a snap-in interlock when the front shell 220a and the rear shell 220b mate to form the intrusion prevention housing 220. In an embodiment, at least one of the front and

rear shells

220a, 220b includes a mortise in the mating edge, and the other of the front and rear shells includes a protrusion configured to engage the mortise. In an embodiment, such as the embodiment depicted in fig. 12, the front shell 220a includes a mortise 223a at its mating edge 221a and the rear shell 220b includes a protrusion 223b at its mating edge 221b configured to engage the mortise of the mating edge 221a of the front shell 220a. The embedded interlock can include a compressible silicone seal 222 disposed in a mortise 223 a. For example, in an embodiment such as that shown in fig. 12, compressible silicone seal 222 has a profile with a cross-section of "H" and provides resistance to taking a compression set such that the mated seal is tightly held and impervious to the ingress of liquids and particulates. In an embodiment, the compressible silicone seal 222 has a hardness in the range of about 10 to 90 shore a.

In an embodiment, the front and

rear housings

220a, 220b can be held in a sealed configuration by press fitting. Additionally or alternatively, in an embodiment, the front and

rear shells

220a, 220b can be held in a sealed configuration by one or more releasable fasteners. For example, as shown in the exploded assembly of fig. 5, the front and

rear housings

220a, 220b can be held in a sealed configuration by a plurality of screws 232. In an embodiment, the plurality of screws 232 are each configured to be inserted through a corresponding one 234 of the plurality of holes 234 in the front shell 220a and engage with a corresponding one 236a-236e of a plurality of screw bosses 236 disposed on an inner surface of the rear shell 220 b. In an embodiment, the housing 220 can include one or more tabs 238 disposed on one of the front and

rear shells

220a, 220b for engagement with the other of the front and rear shells. In embodiments such as fig. 5 and 10A, the rear housing 220b includes tabs 238 formed as flexible tabs (tabs) to the rear housing that are configured to retain the front housing 220A in mating engagement. In an embodiment, a single flexible sheet along one edge of the front or

rear shells

220a, 220b can mate and hold the two shell portions of the housing 220 together with the plurality of holes 234 aligned with the corresponding plurality of screw bosses 236 to receive the plurality of screws therein. In an embodiment, one or more tabs 238 comprise flexible sheets that are approximately 0.5 "to 1.0" long. As shown in fig. 7, in an embodiment, the tab 238 can include a barbed free end configured to engage the retention slot 235 on the other shell.

Returning to fig. 5, a plurality of holes 234 in the front shell 220a can be sealed to maintain the IP67 intrusion protection rating for the housing 220. In an embodiment, the plurality of apertures can each include a rubber O-ring or grommet disposed therein for sealing the aperture 234 from the intrusion of liquids and particulate matter. Additionally or alternatively, as shown in fig. 5, the housing 220 can include one or more water-impermeable plates configured to be secured over one or more releasable fasteners to prevent the ingress of liquids and particulate matter. For example, two plates 239a, 239b are configured to attach to the front shell 220a, thereby covering the holes 234a-234e and the screws 232a-232e disposed therein. One or more water-impermeable panels (e.g., panels 239a, 239 b) can be releasably attached to the outer surface of front shell 220a by at least one of a snap-fit engagement, an adhesive tape, snaps, or tabs.

One or more plates are releasably attached such that releasable fasteners (e.g., a plurality of screws 232a-232 e) are accessible for removal from the housing 220 during maintenance of the controller 200. In an embodiment, front and

rear housings

220a and 220b are configured as separate bodies for the purpose of at least impact resistant energy core 300 and removal and replacement of attached first and

second circuit boards

320 and 330. As shown in fig. 5 and 10A, the front housing 220A can include a touch screen 225 for interacting with a display 329 and a speaker 227 for providing audible alerts, notifications and instructions to the patient and/or bystanders. The first plate 239a and the second plate 239b are sized and shaped to follow the contour of the front shell 220a such that the touch screen 225 is accessible and not covered by the first plate 239a and the second plate 239b that are attached to the front shell 220a. Additionally, at least one panel (e.g., panel 239 a) can include a plurality of apertures 241 configured to be positioned adjacent to the plurality of speaker openings 242 in the front casing 220a to transmit audible messages, alerts, and notifications without obstruction.

In an embodiment, the touch screen 225 is disposed on an inner surface of the front case 220a. The touch screen 225 can be attached to the front housing with an anti-intrusion sealant so that the assembled anti-intrusion housing 220 maintains an IP67 rating. Similarly, in an embodiment, the speaker 227 is disposed on an inner surface of the front case 220a. The speaker 227 can be sealed with an intrusion resistant sealant so that the assembled intrusion resistant housing 220 maintains an IP67 rating. Additionally or alternatively, in an embodiment, the front housing 220a can include a particulate trap screen disposed across the speaker opening for preventing ingress of particulate matter and liquids as specified by the IP67 rating. In an embodiment, the speaker 227 can be adhered to the front case 220a by a cured adhesive such as DP100 epoxy. Additionally or alternatively, the speaker can be adhered to the front shell 220a of the housing 220 by double-sided pressure sensitive adhesive tape. During maintenance such as cleaning or refurbishment, the housing 220 can be disassembled, the front housing 220a, as well as the used and possibly dusty and dirty touch screen 225 and speaker 227 can be removed and replaced with new components of the same elements that are similarly assembled and sealed to maintain the IP67 intrusion protection rating.

Any additional openings in the housing 220 can be similarly sealed against intrusion, such as any openings including

user input buttons

343a, 343b or electronic ports for mating with wired components. In some examples, the port for receiving the connector can be sealed to the housing 220 to prevent intrusion. In an embodiment, the anti-intrusion housing 220 of the controller 200 includes at least one anti-intrusion receiving port 250 configured to receive at least one connector 256 for electrically coupling the plurality of ECG sensing electrodes 212 and therapy electrodes 214 to the controller 200. As previously described, the plurality of ECG sensing electrodes 212 and therapy electrodes 214 can be in continuous prolonged contact with the torso 5 of the patient to monitor and treat the patient's arrhythmia. In an embodiment, the plurality of ECG sensing electrodes 212 are configured to sense ECG signals of the patient for further analysis by the at least one processor 218 disposed on the first circuit board 320.

The controller 200 can be in detachable electrical communication with the plurality of ECG sensing electrodes 212 and the therapy electrode 214. Separable electrical communication includes a connector 256 in communication with the plurality of ECG sensing electrodes 212 and the plurality of therapy electrodes 214. The connector 256 is capable of mating to the anti-intrusion housing 220 via the receiving port 250 such that the connector 256 and the plurality of ECG sensing electrodes 212 and the plurality of therapy electrodes 214 are in electrical communication with one or both of the first circuit board 320 and the second circuit board 330. As shown in fig. 10A and 10B, receiving port 250 can be in electrical communication with one or both of first circuit board 320 and second circuit board 330 via, for example, one or more flexible cable connectors 255.

In an embodiment, the at least one anti-ingress receiving port 250 can have an IP67 rating such that the apparatus 100 can be connected to the controller 200 and operable, for example, when a patient is showering or bathing. As shown in fig. 10A-10B, the intrusion receiving port 250 can include a grommet 251 configured to receive mating edges of the front and rear cases 220A and 220B in an assembled configuration of the intrusion housing 220. As shown in fig. 10B, the grommet 251 includes upper and

lower flanges

252, 253 and a well 254 therebetween to receive mating edges of the front and rear housings therein. Additionally or alternatively, the grommet 251 can be sealed to the assembled housing 220 with an anti-intrusion sealant. Grommet 251 can be made of at least one of a compressible rubber, polyurethane, silicone, and any thermoplastic elastomer such that the intersection of front and

rear shells

220a and 220b with grommet 251 maintains the IP67 intrusion protection rating.

Turning now to fig. 14A-15, additional openings in the housing 220 can include openings for battery connectors 260. In an embodiment, the rear housing 220b further includes a battery connector 260 extending through the rear housing 220b for receiving a complementary connector of the removable battery 210. As depicted in fig. 15, the battery connector 260 can be sealed to the housing 220 with an anti-intrusion sealant and can be in wired communication with the at least one processor 218 disposed on the first circuit board 320. The wired communication can include, for example, a flexible cable connector 262 disposed between the energy core 300 and the inner surface of the rear housing 220 b. Accordingly, the flexible cable connector 262 extends between the battery connector 260 and the first circuit board 320 located within the intrusion prevention housing 220, thereby electrically connecting the battery connector 262 to the first circuit board 320. In an embodiment, the intrusion-proof sealant is at least one of an epoxy resin and a pressure-sensitive adhesive. For example, the battery connector 260 can be attached and sealed to the housing 220 by a compound such as an epoxy (e.g., DP100 epoxy). Additionally or alternatively, the battery connector 260 can be attached to the housing by a pressure sensitive adhesive.

Returning to fig. 14A-14B, in an embodiment, the rear housing 220B defines a compartment (component) 270 configured to receive a removable battery module 215 housing a battery 210 therein. In the mated configuration, the exterior surface of the removable battery module 215 is flush with the exterior surface of the intrusion prevention housing 220. As previously described with reference to fig. 8 and 9, the frame 310 can include the following projections 327: the mouth 313 extends beyond the pocket 312 such that the entire length of the first circuit board 320 is disposed over the entire length of the frame 310, while the relatively short second circuit board 330 does not extend over the protrusion 327. Thus, the protrusion 327 is configured to receive therein a compartment 270 formed in the rear case 220b of the intrusion prevention housing 220 for receiving the battery module 215. In an embodiment, the largest wall of the compartment nests within the protrusion 327 of the frame 310 such that the wall of the compartment is substantially parallel and adjacent to the portion of the first circuit board 320 disposed on the protrusion 327 of the frame 310.

While the projections 327 provide support for the first circuit board 320 and prevent it from buckling, the device 100 can also include additional impact resistant features for further reinforcing the controller 200 to withstand the wear, stress, and impact associated with everyday use. For example, as shown in fig. 16, the inner surface of the front case 220a includes one or more impact resistant features for protecting the energy core 300 and the first and

second circuit boards

320 and 330. In an embodiment, front shell 220a includes at least one vibration dampening spacer 280a-280f configured to protect impact resistant energy core 300 and attached first and

second circuit boards

320 and 330 from mechanical impact. Additionally or alternatively, rear housing 220b includes at least one vibration dampening spacer configured to protect impact resistant energy core 300 and attached first and

second circuit boards

320 and 330 from mechanical impact. If the controller 200 is impacted, the energy core 300 and the first and

second circuit boards

320 and 330 may deform into the at least one vibration damping spacer, and the first and

second circuit boards

320 and 330 may not deflect. This protects the high-voltage and low-voltage circuit components mounted to first and

second circuit boards

320, 330 from damage due to forces or torques associated with board buckling. Thus, the intrusion prevention housing 220 is designed to be robustly usable and protect components therein from damage. At the same time, the anti-intrusion housing 220 enables maintenance for repair and refurbishment of the controller 200 for use by another patient.

In an embodiment such as that of fig. 20, a method 2000 of constructing a serviceable wearable cardiac treatment device controller 200 for continuous extended use by an ambulatory patient includes S2002 and S2004, providing a frame 310 at S2002, and inserting at least one capacitor 240 into the frame at S2004. The at least one capacitor can be configured to hold a charge sufficient to treat the arrhythmia of the patient. The method includes S2006, at S2006, bonding at least one capacitor to the frame such that the frame, with the bonded at least one capacitor, includes the impact resistant energy core 300. The method includes S2008, where the first circuit board 320 and the second circuit board 330 are attached to opposite sides of the impact energy core in a manner that allows separation from the impact energy core during maintenance S2008. The first circuit board and the second circuit board include arrhythmia monitoring and therapy circuitry in electrical communication with at least one capacitor. The method includes S2010, at S2010, wrapping the energy core and the attached first and second circuit boards (encloses) within an anti-intrusion housing 220 configured to enable removal of the impact resistant energy core and the first and second circuit boards during maintenance.

In an embodiment, the frame 310 includes a pocket 312 for receiving at least one capacitor therein. At S2007, bonding the at least one capacitor to the frame includes disposing a self-curing polymer within the pocket to at least partially encapsulate (encapsulate) the at least one capacitor, thereby immovably bonding the at least one capacitor to the frame to form an integral mass.

As previously described with reference to the embodiment of the device controller 200, the intrusion prevention housing may include a rear case 220b configured to be disposed adjacent to the second circuit board and a front case 220a configured to be disposed adjacent to the first circuit board. In an embodiment of a method of constructing a serviceable wearable cardiac treatment device controller, including S2012, the energy core and the attached first and second circuit boards are packaged within an anti-intrusion housing by mating the front and back housings to be in a sealed configuration S2012. The method can include S2013, at S2013, securing the front and rear shells in their sealed configurations with one or more releasable fasteners 232a-232e.

Mating the front shell with the rear shell can include engaging a mating edge of the front shell with a mating edge of the rear shell in a snap-in interlock to form an intrusion-resistant housing. In an embodiment, mating the front shell with the rear shell includes engaging a mortise 223a disposed on a mating edge of one of the front shell and the rear shell with a protrusion 223b disposed on a mating edge of the other of the front shell and the rear shell. The method can further include S2011, at S2011, disposing the compressible silicone seal 222 in the mortise to achieve an ingress protection rating of at least one of IP6X, IPX6, and IPX7, wherein "X" is a variable representing a rating from 1 to 9 as set forth in the IEC60529 standard for ingress protection.

As noted above, the teachings of the present disclosure are generally applicable to external medical monitoring and/or treatment devices (e.g., devices that are not fully implanted within a patient). For example, the external medical device can include a non-stationary medical device that is movable and designed to move with the patient as the patient performs its daily activities. Exemplary non-stationary medical devices can be wearable medical devices, such as Wearable Cardioverter Defibrillators (WCDs), wearable cardiac monitoring devices, in-hospital devices (such as in-hospital wearable defibrillators), short-term wearable cardiac monitoring and/or therapeutic devices, and other similar wearable medical devices.

The wearable medical cardiac monitoring device is capable of continuous use by a patient. Further, the wearable medical device can be configured as a long-term or extended use medical device. The device can be designed for prolonged use by the patient, for example, 24 hours or more, days, weeks, months, or even years. Thus, long term use can be uninterrupted until a physician or other caregiver provides specific instructions to the patient to discontinue use of the wearable medical device. For example, the wearable medical device can be prescribed for use by a patient for a period of at least one week. In an example, the wearable medical device can be prescribed for use by a patient for a period of at least 30 days. In an example, the wearable medical device can be prescribed for use by a patient for a period of at least one month. In an example, the wearable medical device can be prescribed for use by a patient for a period of at least two months. In an example, the wearable medical device can be prescribed for use by a patient for a period of at least three months. In an example, the wearable medical device can be prescribed for use by a patient for a period of at least six months. In an example, the wearable medical device can be prescribed for use by a patient for a period of at least one year. In some embodiments, extended use can be uninterrupted until a physician or other caregiver provides specific instructions to the patient to discontinue use of the wearable medical device.

Regardless of the length of wear, use of the wearable medical device can include continuous or nearly continuous wear by the patient as previously described. For example, continuous use can include the wearable medical device being continuously worn by a patient. Continuous use can include continuously monitoring the patient while the patient is wearing the device to obtain information associated with the heart (e.g., electrocardiogram (ECG) information including arrhythmia information, cardiac vibrations, etc.) and/or non-cardiac information (e.g., blood oxygen, patient temperature, glucose level, tissue fluid level, and/or lung vibrations). For example, the wearable medical device can perform its continuous monitoring and/or recording at periodic or aperiodic intervals or times (e.g., once every few minutes, once every few hours, once per day, once per week, or other intervals set by a technician or prescribed by a caregiver). Alternatively or additionally, monitoring and/or recording during an interval or number of times can be triggered by user behavior or another event.

As described above, the wearable medical device can be configured to monitor other physiological parameters of the patient in addition to the parameters associated with the heart. For example, the wearable medical device can be configured to monitor, for example, lung vibrations (e.g., using a microphone and/or accelerometer), respiratory vibrations, parameters associated with sleep (e.g., snoring, sleep apnea), interstitial fluid (e.g., using a radio frequency emitter and sensor), and so forth.

In an embodiment, the patient-worn arrhythmia monitoring and treatment device 100 also includes a patient notification output (patient notification output) that is output via an output device, such as display 329. In response to detecting one or more disposable arrhythmia conditions, the processor 218 is configured to prompt the patient to respond by issuing a patient notification output, which can be an audible output, a tactile output, a visual output, or some combination of any or all of these types of notification outputs. In the absence of a response from the patient to the notification output, the processor is configured to cause the therapy delivery circuit 202 to deliver one or more therapeutic pulses to the patient.

Fig. 17 depicts an example of a process 1700 for determining whether to initiate a therapy procedure (therapy sequence) and apply therapeutic pulses to a chest region of a patient. In an embodiment, at S1702, processor 218 receives a patient ECG signal from ECG sensing electrode 212, and at S1704, processor 218 analyzes the ECG signal for an arrhythmia condition. At S1706, the processor 218 determines whether the arrhythmia is life threatening and requires treatment. If the arrhythmia is not life threatening, the processor 218 can cause a portion of the ECG signal to be stored in memory for later analysis and continue to monitor the patient ECG signal. If the arrhythmia is life-threatening, the processor 218 provides a patient notification output at S1708, and the processor 218 requests the patient to respond to the provided notification output at S1710. In an embodiment, the patient responds to the alert by interacting with a user interface (e.g., user interface 208 of fig. 2) that includes, for example, one or more buttons (e.g., at least one

button

343a, 343b of apparatus 100 as shown in fig. 8-10A) or at least one second response button of a touchscreen interface button with haptic feedback (e.g., a touchscreen button on touchscreen 225 of controller 200 and/or a wearable item (e.g., an arm band or wrist worn item that includes at least one of a mechanically actuatable button, a touchscreen interface, and at least one touchscreen button located on a user interface of the wearable item) or similar device, such as a smartphone running a user-facing interactive application). The response may be, for example, pressing one or more buttons in a particular order or for a particular duration. At S1712, the processor 218 determines whether a patient response is received. If the patient responds to the notification output, the processor 218 is notified that the patient is conscious and the processor 218 returns to the monitor mode, thereby delaying delivery of the therapeutic defibrillation or pacing shock. If the patient is unconscious and unable to respond to the provided alert, the processor 218 initiates a treatment procedure at S1714 and the processor 218 treats the patient by delivering energy to the chest region of the patient at S1716. In an embodiment, if the user response button is pressed longer than a threshold duration (e.g., longer than 5 seconds), the processor 218 instructs the device to prompt the patient to release the button. If the user response button is not released, the device will return to the state in which therapy is about to be delivered and will alert the patient that a shock is about to occur.

In an example, a medical device can include a physiological sensor configured to detect one or more cardiac signals. Examples of such signals include ECG signals from the patient and/or other sensed cardiac physiological signals. In some embodiments, the physiological sensor can include additional components such as accelerometers, vibration sensors, and other measurement devices for recording additional parameters. For example, the physiological sensor can also be configured to detect other types of patient physiological parameters and vibration signals, such as interstitial fluid levels, cardiac vibrations, lung vibrations, vibrations associated with breathing of anatomical features in the respiratory tract, patient movement, and the like. Exemplary physiological sensors can include ECG sensors that include metal electrodes, such as tantalum pentoxide electrodes, with oxide coatings, for example, as described in U.S. patent No. 6,253,099, entitled "cardioc Monitoring Electrode Apparatus and Method," the contents of which are incorporated herein by reference.

In an example, the physiological sensor can include a heart rate sensor for detecting heartbeats and monitoring the patient's heart rate. For example, the heart rate sensor can include the ECG sensor and associated circuitry described above. In some examples, the heart rate sensor can include a radio frequency based pulse detection sensor or a pulse oximetry sensor worn near an artery of the patient. In an embodiment, the heart rate sensor can be worn on the wrist of the patient, for example incorporated on and/or within a watch or bracelet. In some examples, the heart rate sensor can be integrated within a patch adhesively coupled to the skin over an artery of the patient.

In some examples, the therapy electrodes 114, 214 can also be configured to include sensors for detecting ECG signals as well as other physiological signals of the patient. The ECG data acquisition and conditioning circuitry is configured to amplify, filter, and digitize the cardiac signals. One or more of the therapy electrodes 114, 214 can be configured to deliver one or more therapeutic defibrillation shocks to the patient's body when the medical device determines that the treatment is approved based on the signals detected by the

ECG sensing electrodes

112, 212 and processed by the processor 218. The exemplary therapy electrodes 114, 214 can include conductive metal electrodes, such as stainless steel electrodes, and in some embodiments, one or more conductive gel deployment devices configured to deliver a conductive gel to the metal electrodes prior to delivery of a therapeutic shock.

In some embodiments, a medical device as described herein can be configured to switch between a therapeutic medical device and a monitoring medical device configured to monitor only a patient (e.g., not providing or performing any therapeutic function). The therapeutic element can be disabled (e.g., by means of a physical or software switch) for a particular physiological purpose or for a particular patient, thereby making the therapeutic medical device essentially a monitoring medical device. As an example of a software switch, an authorized person can access the protected user interface of the medical device and select a preconfigured option, or perform some other user action via the user interface, to deactivate the therapeutic element of the medical device.

Fig. 2 illustrates an exemplary component level view of the controller 200. As shown in fig. 7, the controller 200 can include therapy delivery circuitry 202 having a polarity switching component such as an H-bridge 228, data storage 204, a network interface 206, a user interface 208, at least one battery 210, a sensor interface 211 having, for example, ECG data acquisition and conditioning circuitry, an alarm manager 213, at least one processor 218, and one or more capacitors 240. The patient monitoring medical device can include components similar to those described with reference to fig. 7, but does not include the therapy delivery circuitry 202.

The therapy delivery circuit 202 is coupled to two or more therapy electrodes configured to provide therapy to the patient. For example, the therapy delivery circuit 202 includes or is operatively connected to circuit components configured to generate and provide a therapeutic shock. The circuit components include, for example, resistors, one or more capacitors, relays, and/or switches, a bridge such as an H-bridge 228 (e.g., an H-bridge comprising a plurality of insulated gate bipolar transistors or IGBTs that deliver and intercept therapeutic pulses), voltage and/or current measurement components, and other similar circuits configured and connected such that the circuits operate in cooperation with therapy delivery circuit 202 and under the control of one or more processors (e.g., processor 218) to provide, for example, one or more pacing or defibrillation therapeutic pulses.

Pacing pulses can be used to treat cardiac arrhythmias such as bradycardia (e.g., in some embodiments, less than 30 beats per minute) and tachycardia (e.g., in some embodiments, more than 150 beats per minute) using, for example, fixed rate pacing, on-demand pacing, anti-tachycardia pacing, and the like. Defibrillation pulses can be used to treat ventricular tachycardia and/or ventricular fibrillation.

In an embodiment, each of the therapy electrodes 114, 214 has a conductive surface adapted to be placed near the skin of the patient and has contained therein or thereon an impedance reducing member for reducing the impedance between the therapy electrode and the skin of the patient. In an embodiment, each of the therapy electrodes can include a conductive impedance-reducing adhesive layer, such as a gas-permeable anisotropic conductive hydrogel disposed between the therapy electrode and the torso of the patient. In an embodiment, the patient-worn cardiac monitoring and treatment device may include a gel deployment circuit configured to deliver an electrically conductive gel substantially proximate to a treatment site (e.g., a surface of the patient's skin in contact with the therapy electrode 14) prior to delivering a therapeutic shock to the treatment site. As described in U.S. patent No. 9,008,801 entitled "therapeutic DEVICE" that was announced on day 14/4/2015 (hereinafter, the "801 patent," the entire contents of which are incorporated herein by reference), the gel deployment circuit can be configured to deliver the conductive gel immediately prior to delivery of the therapeutic shock to the treatment site, or within a short time interval, such as about 1 second, 5 seconds, 10 seconds, 30 seconds, or 1 minute, prior to delivery of the therapeutic shock to the treatment site. The gel deployment circuitry can be coupled to the therapy electrodes 114, 214 or integrated with the therapy electrodes 114, 214.

When a disposable cardiac condition is detected and no patient response is received after device prompting, a signal can be sent to the gel deployment circuit to deploy the conductive gel. In some examples, the gel deployment circuit can be constructed as one or more separate and independent gel deployment modules. The module can be configured to receive a removable and/or replaceable gel cartridge (e.g., a cartridge (cartridge) containing one or more conductive gel reservoirs). As such, the gel deployment circuit can be permanently disposed in the device as part of the therapy delivery system, while the cartridge can be removable and/or replaceable.

In some embodiments, the gel deployment module can be implemented as a gel deployment package and include at least a portion of the gel deployment circuitry and one or more gel reservoirs located within the gel deployment package. In this embodiment, the gel deployment package including one or more gel reservoirs and associated gel deployment circuitry can be removable and/or replaceable. In some examples, a gel deployment package including one or more gel reservoirs and associated gel deployment circuitry can be integrated with a treatment electrode assembly that can be removed or replaced as a single unit after use or in the event of damage or breakage.

Continuing with the description of the exemplary medical device of fig. 2, in an embodiment, the at least one capacitor 240 is a plurality of capacitors (e.g., two, three, four, or more capacitors) comprising a capacitor bank. The plurality of capacitors can be switched to a series connection during discharge to perform a defibrillation pulse. For example, four capacitors of approximately 650 μ F can be used. In one embodiment, the capacitor can have a surge rating between 200 and 2500 volts and can be charged from the battery 210 in approximately 5 to 30 seconds depending on the amount of energy to be delivered to the patient. In another example, the at least one capacitor is two capacitors shorted together in parallel electrical communication. The two capacitors can have a combined capacitance of 162.5 muf and a surge rating ranging between 1000V to 2000V.

For example, each defibrillation pulse can deliver between 60 joules (J) and 400 joules (J). In some embodiments, the defibrillation pulse can be a biphasic truncated exponential wave, whereby the signal can switch between positive and negative portions (e.g., charge direction). The amplitude and width of the two phases of the energy waveform can be automatically adjusted to deliver a predetermined energy.

The data storage 204 can include one or more of non-transitory computer readable media, such as flash memory, solid state memory, magnetic memory, optical memory, cache memory, combinations thereof, and others. The data storage 204 can be configured to store executable instructions and data for the operation of the medical device. In some embodiments, the data storage 204 can include executable instructions that, when executed, cause the processor 218 to perform one or more functions.

In some examples, the network interface 206 can facilitate communication of information between the medical device and one or more other devices or entities via a communication network. For example, the network interface 206 can be configured to communicate with a remote computing device, such as a remote server or other similar computing device. The network interface 206 can include communication circuitry for communicating data in accordance with the BLUETOOTH wireless standard for exchanging the data over short distances to one or more intermediate devices (e.g., base stations, "hot spot" devices, smartphones, tablets, portable computing devices, and/or other devices in the vicinity of the wearable medical device 100). The one or more intermediary devices may in turn communicate the data to the remote server via the broadband cellular network communication link. The communication link may implement broadband cellular technology (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellular standards) and/or Long Term Evolution (LTE) technology or GSM/EDGE and UMTS/HSPA technologies for high-speed wireless communications. In some embodiments, one or more intermediary devices may communicate with the remote server via a WI-FI communication link based on the IEEE 802.11 standard.

In some embodiments, the user interface 208 can include one or more physical interface devices, such as input devices, output devices, and combination input/output devices, as well as a software stack configured to drive the operation of the devices. These user interface elements may present visual, auditory, and/or tactile content. Thus, the user interface 208 may receive input or provide output, thereby enabling a user to interact with the medical device. In some implementations, the user interface 208 can be implemented as a wearable item or a handheld user interface device (e.g., a wearable item, including the patient interface pod 140 of fig. 1 and wrist-worn and arm-worn remote devices). For example, the handheld user interface device can be a smartphone or other portable device configured to communicate with the processor 218 via the network interface 206. In embodiments, the handheld user interface device may also be an intermediary device that facilitates the transfer of information from the device to a remote server.

As described, the medical device can also include at least one battery 210 configured to provide power to one or more components, such as at least one capacitor 240. The battery 210 can include a rechargeable multi-cell battery pack. In an exemplary embodiment, the battery 210 can include three or more 2200mAh lithium ion batteries that provide power to other device components. For example, the battery 210 can provide a power output ranging from 20mA to 1000mA (e.g., 40 mA), and can support run times of 24 hours, 48 hours, 72 hours, or more between charges. As previously detailed, in certain embodiments, the battery capacity, run time, and type (e.g., lithium ion, nickel cadmium, or nickel metal hydride) can be varied to best suit a particular application of the medical device.

The sensor interface 211 can be coupled to one or more sensors configured to monitor one or more physiological parameters of the patient. As shown in fig. 2, the sensor can be coupled to a medical device controller (e.g., processor 218) via a wired or wireless connection. The sensors can include one or more sensing electrodes (e.g., ECG sensing electrodes 212), a vibration sensor 224, and a interstitial fluid monitor 226 (e.g., based on an ultra-wideband radio frequency device). For example, the sensor interface 211 can include ECG circuitry (such as ECG acquisition and conditioning circuitry) and/or accelerometer circuitry, each configured to receive and condition a respective sensor signal.

The sensing electrodes can monitor, for example, ECG information of the patient. For example, the sensing electrode of fig. 2 can be an ECG sensing electrode 212 and can include a conductive electrode with stored gel deployment (e.g., a metal electrode with stored conductive gel configured to disperse in the electrode-skin interface when desired), a conductive electrode with a conductive adhesive layer, or a dry electrode (e.g., a metal substrate with an oxide layer in direct contact with the patient's skin). The sensing electrode can be configured to measure an ECG signal of the patient. The sensing electrodes can transmit information describing the ECG signal to the sensor interface 211 for subsequent analysis.

The vibration sensor 224 is capable of detecting cardiac or pulmonary (cardiopulmonary) vibration information of the patient. For example, the cardiorespiratory vibration sensor 224 can be configured to detect cardiac vibration biomarkers in the cardiac vibration signal, including any or all of S1, S2, S3, and S4 cardiac vibration biomarkers. From these cardiac vibratory biomarkers, certain electromechanical indicators can be calculated, including any one or more of electromechanical activation time (EMAT), EMAT percentage (% EMAT), systolic Dysfunction Index (SDI), left ventricular diastolic perfusion time (LDPT), and Left Ventricular Systolic Time (LVST). The cardiorespiratory vibration sensor 224 may also be configured to detect heart wall motion, for example, by placing the cardiorespiratory vibration sensor 224 in the apical beat region.

The vibration sensor 224 can include an acoustic sensor configured to detect vibrations from the heart or pulmonary (cardiopulmonary) system of the subject and provide an output signal in response to the detected vibrations of the target organ. For example, in some embodiments, the vibration sensor 224 is capable of detecting vibrations in the trachea or lungs due to air flow during breathing. The vibration sensor 224 can also include a multi-channel accelerometer, for example, can also include a three-channel accelerometer configured to sense movement in each of the three orthogonal axes, thereby enabling detection of patient movement/body position. The vibration sensor 224 can transmit information describing cardiorespiratory vibration information or patient position/movement to the sensor interface 211 for subsequent analysis.

The interstitial fluid monitor 226 can use Radio Frequency (RF) based techniques to assess changes in the accumulated fluid levels over time. For example, the interstitial fluid monitor 226 can be configured to measure fluid content (e.g., time-varying changes and absolute levels) in the lungs for diagnosis and follow-up observation of pulmonary edema or pulmonary congestion in heart failure patients. The interstitial fluid monitor 226 can include one or more antennas configured to direct RF waves through tissue of a patient and to output RF signals in response to wave measurements that have passed through the tissue. In certain embodiments, the output RF signal includes a parameter indicative of the fluid level in the patient tissue. The interstitial fluid monitor 226 can transmit information describing the interstitial fluid level to the sensor interface 211 for subsequent analysis.

Sensor interface 211 can be coupled to any one or combination of sensing electrodes/other sensors to receive other patient data indicative of patient parameters. Once the sensor interface 211 has received the data from the sensors, the data can be directed by the processor 218 to the appropriate components within the medical device. For example, if cardiac data is acquired by the cardiorespiratory vibration sensor 224 and transmitted to the sensor interface 211, the sensor interface 211 can transmit the data to the processor 218, which in turn relays the data to the cardiac event detector. Cardiac event data can also be stored on the data storage 204.

The alert manager 213 can be configured to manage alert profiles and notify intended recipients of events specified within an alert profile that are of interest to one or more intended recipients. These intended recipients can include external entities such as users (e.g., patients, physicians, other caregivers, patient care representatives, and other authorized monitoring personnel) and computer systems (e.g., monitoring systems or emergency response systems). The alert manager 213 can be implemented using hardware or a combination of hardware and software. For example, in some examples, the alert manager 213 can be implemented as a software component stored within the data storage 204 and executed by the processor 218. In this example, the instructions included in the alert manager 213 can cause the processor 218 to configure an alert profile and notify the intended recipient according to the configured alert profile. In some examples, the alert manager 213 can be an Application Specific Integrated Circuit (ASIC) coupled to the processor 218 and configured to manage alert profiles and notify intended recipients using alerts specified within the alert profiles. Thus, examples of the alert manager 213 are not limited to a particular hardware or software implementation.

In some embodiments, processor 218 includes one or more processors (or one or more processor cores), each configured to execute a series of instructions: generate manipulated data and/or control the operation of other components of the medical device. In some embodiments, when performing a particular procedure (e.g., cardiac monitoring), the processor 218 can be configured to make a particular logic-based decision based on received input data, and can be further configured to provide one or more outputs that can be used to control or otherwise inform subsequent processing to be performed by the processor 218 and/or other processors or circuits communicatively coupled to the processor 218. Thus, the processor 218 reacts in a particular manner to a particular input stimulus and generates a corresponding output based on the input stimulus. In some illustrative examples, the processor 218 is capable of performing a series of logical transformations as follows: various internal register states and/or other bit cell states internal or external to the processor 218 can be set to logic high or logic low. The processor 218 can be configured to perform functions stored in software. For example, the software can be stored in a data store coupled to the processor 218 and can be configured to cause the processor 218 to make a series of various logical decisions that produce the function being performed. The various components described herein as being executable by the processor 218 can be implemented in various forms of dedicated hardware, software, or combinations thereof. For example, the processor can be a Digital Signal Processor (DSP), such as a 24-bit DSP processor. The processor 218 can be a multi-core processor, such as a processor having two or more processing cores. The processor can be an Advanced RISC Machine (ARM) processor, such as a 32-bit ARM processor or a 64-bit ARM processor. The processor can execute an embedded operating system and can include services provided by: the operating system can be used for file system manipulation, display and audio generation, basic networking, firewalling, data encryption and communications.

In an embodiment, therapy delivery circuit 202 includes or is operably connected to circuit components configured to generate and provide a therapeutic shock. As previously described, the circuit components include, for example, resistors, one or more capacitors 240, relays and/or switches, bridges such as the H-bridge 228 (e.g., an H-bridge circuit including a plurality of switches (e.g., insulated gate bipolar transistors or IGBTs, silicon carbide field effect transistors (SiC FETs), metal Oxide Semiconductor Field Effect Transistors (MOSFETs), silicon Controlled Rectifiers (SCRs), or other high current switching devices), and other like circuits configured and connected such that the circuit components operate in cooperation with the therapy delivery circuit 202 and under the control of one or more processors (e.g., processor 218) to provide, for example, one or more pacing or defibrillation therapeutic pulses.

In an embodiment, the apparatus further comprises a source of electrical energy, such as one or more capacitors 240, that stores energy and provides the energy to the therapy delivery circuit 202. The one or more therapeutic pulses are defibrillation pulses of electrical energy, and the one or more treatable arrhythmias include ventricular fibrillation and ventricular tachycardia. In an embodiment, the one or more therapeutic pulses are biphasic index pulses. The therapeutic pulse can be generated by charging one or more capacitors 240 and discharging the energy stored in the one or more capacitors 240 into the patient. For example, therapy delivery circuitry 202 can include one or more power converters for controlling the charging and discharging of one or more capacitors 240. In some embodiments, the discharge of energy from one or more capacitors 240 can be controlled by, for example, controlling an H-bridge such as described in the following U.S. patents that discharge energy into the patient: U.S. Pat. No. 6,280,461 issued on 8/28 th of 2001 AND entitled "PATIENT-WORN ENERGY DELIVERY APPATUS" AND U.S. Pat. No. 8,909,335 issued on 12/9 th of 2014 AND entitled "METHOD AND APPATUS FOR APPLYING A RECTILINEAR BIPHASIC POWER WAVEFORM TO A LOAD", the entire contents of which are incorporated herein by reference.

As shown in the embodiment of FIG. 18, the H-bridge 1228 is electrically coupled to a capacitor bank 1402 that includes four capacitors 1135a-1135d, which are charged in parallel during a preparation phase 1227a and discharged in series during a disposal phase 1227 b. In some implementations, the capacitor bank 1402 can include more or less than four capacitors 1135. During treatment phase 1227b, the H-bridge 1228 applies therapeutic pulses of a desired duration that cause current to flow in a desired direction through the torso 5 of the patient 101. The H-bridge 1228 includes H-bridge switches 1229a-1229d that are selectively opened and closed by switching transistors, such as Insulated Gate Bipolar Transistors (IGBTs), silicon carbide field effect transistors (SiC FETs), metal Oxide Semiconductor Field Effect Transistors (MOSFETs), silicon Controlled Rectifiers (SCRs), or other high current switching devices. Switching a pair of transistors (e.g., switches 1229a and 1229 c) to a closed position can cause current to flow in a first direction for a first pulse segment P1. Opening switches 1229a and 1229c and

closing switches

1229b and 1229d enables current to flow through the torso 5 of the patient in the second pulse segment P2 in a direction opposite to the flow of the first pulse segment P1.

As discussed above, in an embodiment, the first circuit board 320 includes hardware and circuitry to support critical operations of the controller 200, and the second circuit board 330 includes hardware and circuitry to support non-critical operations of the controller 200. Fig. 21A and 21B show an exemplary schematic block diagram 2100a and an exemplary block diagram 2100B illustrating components implementing key or core functions of the medical apparatus 100 and components implementing non-key or supplemental functions of the medical apparatus 100. As shown, exemplary block diagrams 2100a, 2100b include garment 111 and electrode belt 150. Garment 111 and electrode belt 150 may also include one or more sensing electrodes, such as sensing electrodes 112 and/or 212, and one or more therapy electrodes, such as therapy electrodes 114 and/or 214, that are temporarily or permanently affixed to garment 111 and/or electrode belt 150. The example block diagrams 2100a, 2100b also include a battery pack 210 and a battery charger 2102 for the battery pack 210, and a device monitor or controller 2101 (e.g., controller 120 and/or 200). As shown, the guardian 2101 includes a detection and disposal subsystem 2104 and an application subsystem 2106. The detection and treatment subsystem 2104 also includes a system control processor 2108 and a high voltage processor 2110. In an embodiment, the detection and handling subsystem 2104 is implemented by the first circuit board 320 and the application subsystem 2106 is implemented by the second circuit board 330.

As shown in fig. 21A and 21B, the core functions of the medical device 100 may be separated from the complementary features of the medical device 100. Fig. 21A shows the components of the medical device 100 that implement the core functionality in solid lines, with the complementary components shown in dashed lines. Thus, as shown, the core functionality may be implemented by the garment 111, the electrode belt 150, the battery pack 210, the battery charger 2102, and the detection and disposal subsystem 2104 of the monitor 2101. Fig. 21B shows in solid lines the components of the medical device 100 that perform the supplemental functions, with the core components shown in dashed lines. As shown, the complementary features of the medical device 100 may be implemented by an application subsystem 2106 of the monitor 2101.

Thus, in such embodiments, the first circuit board is a critical function circuit board that includes at least one critical function processor (e.g., system control processor 2108 and high voltage processor 2110) and critical function circuitry in communication with the at least one critical function processor. The critical function circuit board may also be in electrical communication with at least one capacitor (e.g., one or more capacitors 240) configured to hold a charge sufficient to treat the arrhythmia and configured to control critical operations of the device controller 2101. Similarly, the second circuit board may be a non-critical function circuit board that includes at least one non-critical function processor and non-critical function circuitry in communication with the at least one non-critical function processor. Thus, the non-critical function circuit board may be configured to control non-critical operations of the device controller 2101.

In an embodiment, the critical operations of the device controller 2101 may include operations performed by the system control processor 2108 and operations performed by the high voltage processor 2110. The operations performed by the system control processor 2108 may include: communicate with battery 210 (e.g., through an SMBus interface) to monitor the discharge process, retrieve charge state information, and/or track flags from internal circuitry of battery 210 that monitors battery 210 during charging and discharging.

In an embodiment, the operations of the system control processor 2108 may include: instructional information is received (e.g., from the application subsystem 2106) during the patient setup process and sent back for verification (e.g., sent back to the application subsystem 2106 for display for verification). Once the instructional information is verified, the critical function circuit board may store the verified instructional information locally, so detection and treatment of the arrhythmia may occur independent of the application subsystem 2106.

In an embodiment, the operations of the system control processor 2108 may include: acquiring an ECG signal via an ECG sensing electrode (e.g., sensing electrodes 112 and/or 212), analyzing the ECG signal to determine whether the patient is experiencing a treatable arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation), and initiating a treatment procedure in response to determining that the patient is experiencing a treatable arrhythmia. The treatment procedure may include, for example: a notification procedure is initiated to alert the patient to an impending treatment pulse or shock. Further, the notification program may include alerts and messages intended to alert the patient and prompt interaction to determine whether the patient is able to respond by pressing a response button (e.g., buttons 343a and/or 343b of apparatus 100). As such, system control processor 2108 may include or be in electronic communication with an audio component (e.g., speaker 227) that provides audible alerts and notifications, an LED (e.g., on buttons 343a and/or 343 b) that blinks to provide visual alerts, and/or a haptic component, etc. The system control processor 2108 is further configured to monitor the response button during the treatment procedure to determine whether the patient is responding to the notification procedure. If the patient does not respond, the notification program may be upgraded to audibly alert bystanders to not disturb, after which the system control processor 2108 instructs the high voltage processor 2110 to deliver a treatment shock to the patient. As such, the system control processor 2108 may perform at least a portion of the process 1700 shown in fig. 17 (e.g., S1702, S1704, S1708, S1710, S1712, and S1714 of the process 1700). In an embodiment, as discussed above, the therapy electrodes (e.g., therapy electrodes 114 and/or 214) include one or more conductive gel deployment devices, and system control processor 2108 may further initiate deployment of the gel as part of the treatment procedure (e.g., including gel deployment circuitry 205). Additionally, the system control processor 2108 may continue to monitor the patient after delivering the treatment pulses to determine if a treatable arrhythmia is still present. In an embodiment, operation of the system control processor 2108 may also include monitoring the response button for non-treatment reasons, e.g., to confirm normal operation and/or "wake up" the user interface 208 during a startup procedure, etc.

In an embodiment, the operations performed by the high pressure processor 2110 may include: during a treatment procedure initiated by the system control processor 2108, an energy storage capacitor (e.g., one or more capacitors 240) is charged to a predetermined voltage based on a prescribed energy setting. Upon receiving a command from the system control processor 2108 to treat the patient, the high voltage processor 2110 may further disable the capacitor charging circuit and drive the switching circuit to control pulse delivery. Accordingly, the high pressure processor 2110 may perform at least a portion of the process 1700 shown in fig. 17 (e.g., S1716 of fig. 17). In an embodiment, the high voltage processor 2110 is configured to monitor the energy storage capacitor voltage as well as the defibrillation pulse current. The high voltage processor 2110 may use these two measurements to calculate and control the delivered energy. In an embodiment, the high voltage processor 2110 further comprises or controls a discharge path for discharging the energy storage capacitor. In some embodiments, the high voltage processor 2110 may additionally have the capability of providing pacing current pulses to the patient through the therapy electrodes, as described above.

In an embodiment, the operations performed by the high pressure processor 2110 include: after the gel is deployed from the one or more therapy electrodes, transthoracic impedance measurements are performed to calculate patient impedance. The high voltage processor 2110 notifies the system control processor 2108 when the measured transthoracic impedance is judged to be too high or too low. The application subsystem 2106, under the command of the system control processor 2108, may also draw a screen displayed on the user interface 208 to provide a supplemental visual message to the patient. In an embodiment, the operations performed by the high pressure processor 2110 include: therapy electrode detachment measurements are performed to determine whether the therapy electrode has sufficient contact with the patient (e.g., contact sufficient to provide an ECG signal of a certain quality and/or amplitude, contact sufficient to deliver a treatment shock). If the high voltage processor 2110 detects an insufficient contact, the high voltage processor 2110 notifies the system control processor 2108 to alert the patient. The system control processor 2108 then enters a functional workflow in which the system control processor 2108 generates an alert. The application subsystem 2106, under the direction of the system control processor 2108, may also draw screens that are displayed on the user interface 208.

In an embodiment, non-critical operations performed by application subsystem 2106 include: when the system control processor 2108 indicates that the data is ready for transfer, the data is read from the short-term memory. Once data related to the operation of the medical device 100 (e.g., ECG data and/or data records, etc.) is retrieved from the short-term memory, the application subsystem 2106 may compress the data for long-term storage, such as in flash memory, etc. In an embodiment, the operations performed by the application subsystem 2106 include: a communication link is established with the remote server and data relating to the operation of the medical device 100 is transmitted to the remote server via the communication link.

In an embodiment, the operations performed by the application subsystem 2106 include: providing output and receiving input via the user interface 208. In an embodiment, the application subsystem 2106 is configured to interact with a user (e.g., a patient, a caregiver, and/or a technician, etc.) via the user interface 208 to facilitate input and verification of patient parameters, to facilitate user training (e.g., training a patient how to wear and use the medical device 100, what to do during times when the medical device 100 detects a disposable arrhythmia, etc.), and to provide diagnostic information, such as service codes or troubleshooting messages.

In an embodiment, the operations performed by the application subsystem 2106 include: non-instruction directed activities and/or activities separate from the patient's instructions to treat the shock are performed. As an example, a non-instructional guidance activity facilitated by the application subsystem 2106 may guide the patient through a patient health survey. As another example, the application subsystem 2106 may direct a patient to complete an ambulatory exercise test, such as a six minute walk test recommended by the American Thoracic Society (ATS), or the like. As another example, the application subsystem 2106 may guide a patient through a device-guided cardiac rehabilitation plan. For example, such a cardiac rehabilitation program may be prescribed to a patient, for example, when recovering from a myocardial infarction, when working on a heart failure care program, or when recovering from another cardiac condition requiring surgery or medical intervention. Such cardiac rehabilitation includes supervised programs involving physical activity, education about healthy life (including, for example, how to eat healthily, take prescribed medicines, and quit smoking, etc.), counseling through reduced pressure, and mental health improvement techniques. For example, the cardiac rehabilitation plan may be based on a rehabilitation plan developed by a caregiver of the patient, with the application subsystem 2106 providing the patient with reminders to perform activities from the rehabilitation plan, tracking the patient's ability to complete the activities, and in embodiments, modifying the rehabilitation plan if the patient is unwilling and/or unable to complete one or more of the reminded activities. As another example, the application subsystem 2106 may track trend information related to the patient's body position and/or heart rate, etc. Application subsystem 2106 may facilitate the performance of non-instruction guided activities, e.g., via user interface 208 and/or via speaker 227, etc.

In an embodiment, the operations performed by the application subsystem 2106 include: screen images, text translations, audio prompts, and operating system components (e.g., for use by user interface 208) and patient settings (e.g., received via user interface 208) are stored. The application subsystem 2106 may also be configured to perform configuration updates. In an embodiment, application subsystem 2106 is configured to provide a service interface for medical device 100 diagnostic purposes, as well as the ability to quickly retrieve data from long term memory. Thus, the device controller 2101 may also include a service port (e.g., a USB 2.0On-The-Go port) that communicates with The application subsystem 2106.

FIG. 22 shows another exemplary block diagram 2200 illustrating electronic communication between components internal and external to the device controller 2101. As shown in fig. 22, in an implementation, the system control processor 2108 and the high voltage processor 2110 of the detection and treatment subsystem 2104 are configured to be in electronic communication with each other. The system control processor 2108 is configured to electronically communicate with the application subsystem 2106, the strap connector 150, and the battery pack 210. The high voltage processor 2110 is also configured to transmit commands to the belt connector 150.

As shown in fig. 22, and as discussed above, detection and handling subsystem 2104 and application subsystem 2106 may interact with each other to perform some functions. For example, the application subsystem 2106 may receive information from a user via the user interface 208, the application subsystem 2106 transmitting the information to the detection and handling subsystem 2104 for storage. However, as additionally discussed above, critical operations of detection and handling subsystem 2104 may be isolated from non-critical operations of application subsystem 2106. As examples, critical operations including monitoring battery conditions, storing verified instructional information, acquiring ECG signals, analyzing ECG signals to detect a disposable arrhythmia, initiating a treatment procedure, and the like are performed by detection and treatment subsystem 2104 without input from application subsystem 2106. Moreover, as discussed further above, detection and handling subsystem 2104 may be implemented by a critical function circuit board (e.g., first circuit board 320) and application subsystem 2106 may be implemented by a non-critical function circuit board (e.g., second circuit board 330). Thus, the critical function circuit boards may be configured to control critical operations of the medical device 100 regardless of the operability of the non-critical function circuit boards. For example, the critical function circuit board may be configured to remain operable to control critical operations of the controller 200 including acquiring ECG signals, identifying a treatable arrhythmia, and initiating a treatment procedure if operability of the non-critical function circuit board is suspended temporarily (e.g., during maintenance) or permanently. As another example, critical function circuit boards may be configured to remain operable to control critical operations of the controller 200 if a failure of a non-critical function circuit board occurs.

Although the subject matter contained herein has been described in detail for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that the disclosure is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Other examples are within the scope and spirit of the description and claims. Additionally, some of the functionality described above can be implemented using software, hardware, firmware, hard-wired, or a combination thereof. Features implementing functions can also be physically located at various locations, including being distributed such that portions of functions are implemented at different physical locations.

Priority

This application claims the benefit of U.S. application Ser. No. 16/949,467 entitled "WEARABLE MEDICAL DEVICE CONTROL WITH CAPACITOR FRAMING" filed on 30/10/2020, and claims the benefit of U.S. provisional application Ser. No. 62/929,721 entitled "WEARABLE MEDICAL DEVICE CONTROL WITH CAPACITOR FRAMING" filed on 11/1/2019. All matters hithertofore set forth in the above-referenced application are hereby incorporated in their entirety by reference into the present application, as if fully set forth herein.

Claims

1. A maintainable wearable cardiac treatment device for continuous prolonged use by an ambulatory patient, the device comprising:

a garment configured to have disposed therein a plurality of ECG sensing electrodes and a plurality of therapy electrodes in continuous prolonged contact with the patient; and

a device controller configured to be in separable electrical communication with the plurality of ECG sensing electrodes and the plurality of therapy electrodes in the garment, the device controller comprising:

an impact-resistant energy core, comprising:

a frame; and

at least one capacitor permanently bonded to the frame, the at least one capacitor configured to hold a charge sufficient to treat an arrhythmia;

a critical function circuit board comprising at least one critical function processor and critical function circuitry in communication with the at least one critical function processor, wherein the critical function circuit board is in electrical communication with the at least one capacitor and is configured to control critical operations of the device controller; and

a non-critical function circuit board comprising at least one non-critical function processor and non-critical function circuitry in communication with the at least one non-critical function processor, wherein the non-critical function circuit board is configured to control non-critical operations of the device controller,

wherein the critical function circuit board is configured to control critical operations of the device controller regardless of operability of the non-critical function circuit board.

2. The apparatus of claim 1, wherein the frame comprises a pocket configured to receive the at least one capacitor therein.

3. The device of claim 2, further comprising a compound disposed within the pocket for at least partially encapsulating the at least one capacitor, thereby immovably coupling the at least one capacitor to the frame to form a unitary mass.

4. The apparatus of claim 1, further comprising one or more releasable fasteners configured to affix the critical-function circuit board and the non-critical-function circuit board to opposite sides of the impact-resistant energy core.

5. The device of claim 1, wherein the device controller further comprises an anti-intrusion housing configured to enable removal of the impact-resistant energy core and the critical-function and non-critical-function circuit boards during maintenance.

6. The apparatus of claim 5, further comprising at least one vibration-dampening spacer disposed within the intrusion housing, the at least one vibration-dampening spacer configured to support the impact-resistant energy core and the critical-function and non-critical-function circuit boards within the intrusion housing.

7. The apparatus of claim 1, wherein the critical function circuit board is configured to remain operable to control the critical operation of the apparatus controller in the event of a suspension of operability of the non-critical function circuit board.

8. The device of claim 7, wherein the critical function circuit board is configured to remain operable to control the critical operation of the device controller in the event of a failure of the non-critical function circuit board.

9. The device of claim 1, wherein the critical operations of the device controller comprise:

acquiring an ECG signal via the ECG sensing electrode;

analyzing the ECG signal to determine if the patient is experiencing a disposable arrhythmia; and

in response to determining that the patient is experiencing a treatable arrhythmia, a treatment procedure is initiated.

10. The apparatus of claim 9, wherein the treatment procedure comprises:

alerting the patient to an impending shock;

monitoring a response button to determine whether the response button is pressed; and

controlling delivery of a treatment shock to the patient in response to determining that the response button is not pressed.

11. The apparatus of claim 10, wherein each of the therapy electrodes includes a gel configured to reduce impedance, and controlling delivery of the treatment shock includes: (iii) initiating deployment of the gel.

12. The device of claim 1, wherein the device further comprises a battery, and the critical operations of the device controller comprise: communicating with the battery to monitor charging of the battery.

13. The apparatus of claim 1, wherein the apparatus further comprises a user interface, and the at least one non-critical function processor is configured to provide output and receive input via the user interface.

14. The device of claim 13, wherein the non-critical operations of the device controller comprise: training the patient via the user interface.

15. The device of claim 1, wherein the non-critical operation of the device controller comprises: data relating to operation of the maintainable wearable cardiac treatment device is compressed for long term storage.

16. The device of claim 1, wherein the non-critical operations of the device controller comprise:

establishing a communication link with a remote server; and

transmitting data related to operation of the maintainable wearable cardiac treatment device to the remote server via the communication link.

17. The device of claim 1, wherein the non-critical operation of the device controller comprises: instructing the patient to complete a patient health survey.

18. The device of claim 1, wherein the non-critical operations of the device controller comprise: instructing the patient to complete an ambulatory exercise test.

19. The device of claim 1, wherein the non-critical operation of the device controller comprises: guiding the patient through a cardiac rehabilitation plan.

20. The device of claim 1, wherein the device controller further comprises a service port in communication with the non-critical function circuit board.