Patent Description:
There are <NUM>,<NUM> Out of Hospital Cardiac Arrests (OHCA) that occur each year in the United States. Studies have shown that the use of an Automated External Defibrillator (AED) can increase the rate of survivability of OHCA by <NUM>%. However, only <NUM>% of OHCA will occur at a location at which an AED is available. While there is a big push to increase dissemination of Public Access Defibrillators (PAD), research has also shown that <NUM>% of OHCA happen in the home, where the majority of people do not have access to an AED.

Additionally, studies have shown that Sudden Cardiac Arrest (SCA) patients have improved outcomes when the length of time between incident and shock is reduced. When an AED is not readily available at the location at which the OHCA occurs, the time from incident to shock is dependent upon the timely arrival of Emergency Medical Services (EMS). The national average for time of EMS arrival is <NUM> minutes and, during these <NUM> minutes, the chance of patient survival decreases by <NUM>-<NUM>% every minute. Consequently, SCA patients are more likely to survive with favorable outcomes if the EMS response time is within <NUM> minutes.

There are three time-sensitive stages of cardiac arrest: <NUM>) electric phase (up to <NUM> minutes following cardiac arrest, during which the heart is most receptive to electrical shock); <NUM>) circulatory phase (approximately <NUM> minutes to <NUM> minutes following cardiac arrest); and <NUM>) metabolic phase (extending beyond approximately <NUM> minutes following cardiac arrest). Studies using wearable cardioverter defibrillators have shown that addressing cardiac arrest during the initial electric phase results in a <NUM>% first time cardioversion success rate. As a result, rapid administration of an AED treatment to the SCA patient during the electrical phase has shown success with survival rates as high as <NUM>%.

Currently, SCA is a leading cause of death among adults over the age of <NUM> in the United States and several other countries. alone, approximately <NUM>,<NUM> people of all ages experience out-of-hospital non-traumatic SCA each year, and nine out of ten of these victims die as a result. There are a number of AED solutions for the defibrillation of the lethal arrhythmias suffered by SCA patients. While some of these solutions attempt to make the AED more portable, they fail to meet the needs of the user because they are still cumbersome and heavy, thus are not truly portable devices. For example, the lightest AED currently available on the market is <NUM> pounds, making carrying an AED on-person unlikely. Other products attempt to assist the bystander by prompting them in giving quality CPR, although these products still have shortcomings. Studies show that decreasing the time-to-shock can greatly increase the chance of patient survival, such that four out of ten SCA patients survive when bystanders intervene by giving CPR and using an AED before the arrival of EMS personnel. Unfortunately, only one-third (<NUM>%) of SCA patients receive bystander CPR, and bystanders treat only <NUM>% of those with AEDs. If bystanders had a readily available AED that could also shorten the time to EMS notification, analysis of cardiac rhythm, and delivery of shock, potentially <NUM>,<NUM> people per year could be saved in the U.

<CIT> discloses an automated external defibrillator according to the preamble of claim <NUM>. <CIT> deals with a charge control circuit for a stroboscopic device of a camera, which solves the problem to supply the power of a battery to the stroboscopic charging circuit such that the battery power can be completely used up during the battery life.

In accordance with the disclosure provided herein, there is provided a non-claimed method for performing cardiac defibrillation with a portable automated external defibrillator (AED). The method includes initiating a cardiac defibrillation program on a control module communicative with an electrode pad, and detecting a patient's cardiac rhythm from the electrode pad. The method further includes connecting the control module to a mobile device, executing a call with emergency services, gathering geolocation information, and channeling the call to the emergency services on an audible speaker. The method also includes prompting a user to initiate cardiopulmonary resuscitation (CPR) if the cardiac rhythm is not detected, displaying instructions for CPR on the control module. The method continues with analyzing the patient's cardiac rhythm and notifying the user and emergency services when a shockable cardiac rhythm is detected, and notifying the user to halt CPR. The method also includes shocking the patient, analyzing the patient's cardiac rhythm for a normal pulse, and resuming instructions for CPR if the normal pulse is not detected.

According to the present invention, a compact, automated external defibrillator (AED) system according to claim <NUM> is provided. The system includes an electronics module, which in turn includes a power source and electronic circuitry for generating, storing, and dispensing electrical charge from the power source, the electrical charge being suitable for at least one electrical shock to be applied to a sudden cardiac arrest (SCA) patient. The electronics module also includes a display for providing guidance to a user of the system, including instructions on using the system, and firmware for controlling the electronic circuitry and the display. The system also includes at least two cardiac pads, electrically connected with the electronics module and configured for external attachment to the SCA patient so as to transfer the at least one electrical shock from the electronics module to the SCA patient, wherein the power source is a household battery. In an embodiment, the dimensions of the system is less than approximately <NUM>-inches by <NUM>-inches by <NUM>-inches. In another embodiment, the power source is a commonly-available household battery, such as a 9V battery or a plurality of CR123 batteries. In still another embodiment, each of the cardiac pads includes at least one sensor for measuring a patient cardiac rhythm and a body impedance of the SCA patient onto whom the cardiac pads have been attached, and wherein a firmware is configured for automatically adjusting the waveform characteristics of the electrical shock in accordance with the measured body impedance. In yet another embodiment, the system includes a bracket for housing the electronics module and the cardiac pads when the system is not in use. The bracket is configured for sensing at least one of: <NUM>) when the electronics module is removed from the bracket; <NUM>) when the power source is below a preset minimum power threshold; and <NUM>) when the system requires servicing.

Further, a non-claimed method for using a compact AED system is disclosed. The system includes an electronics module and at least two cardiac pads housed in a bracket. The method incudes initializing the system by removing the system from the bracket, contacting emergency medical services (EMS), attaching the cardiac pads on a sudden cardiac arrest (SCA) patient, and measuring at least a patient cardiac rhythm and a body impedance of the SCA patient using sensors included in the cardiac pads. The method further includes performing an AED administration protocol on the SCA patient, if so indicated by guidance from the electronics module, and continuing to monitor the patient cardiac rhythm of the SCA patient and following additional guidance from the electronics module until the arrival of EMS personnel.

While certain embodiments are described in terms of specific embodiments, it is to be understood that the invention is not limited to these disclosed embodiments. Many modifications and other embodiments of the invention will come to mind for those skilled in the art to which this invention pertains, and which are intended to be and are covered by both this disclosure and the appended claims. It is indeed intended that the scope of the invention should be determined by proper interpretation and construction of the appended claims, as understood by those of skill in the art, relying upon the disclosure in this specification and the accompanying drawings.

Embodiments of the present invention now will be described more fully hereinafter with reference to the accompanying drawings, which are intended to be read in conjunction with both this summary, the detailed description and any preferred and/or particular embodiments specifically discussed or otherwise disclosed. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of illustration only and so that this disclosure will be thorough, complete and will fully convey the full scope of the invention to those skilled in the art.

The present invention seeks to solve the problems described in the Background by providing an AED device with improved features over the existing products. For instance, as correct positioning of the cardiac pads has been correlated with improved survival rates, it would be desirable for an AED to provide an indication of whether the cardiac pads have been placed correctly on the SCA patient. Also, currently available AED devices do not provide an option to connect to a mobile device that can contact EMS to initiate a faster response by emergency medical personnel and, subsequently, earlier hospital arrival. Moreover, currently available AED devices do not provide a smartphone/mobile device application for the notification and treatment of suspected cardiac arrest instances to EMS.

It would be desirable to have a device that can significantly improve the outcome of an SCA patient by providing, even to a non-medically trained person, the ability to detect a shockable cardiac rhythm and apply a therapeutic electrical shock to the SCA patient. Therefore, there currently exists a need in the industry for a truly portable AED and associated methodology that closes the gap between time of incident, application of CPR, and delivery of shock.

To address the aforementioned shortcomings of the existing art, certain embodiments of the system described herein provides a compact Automated External Defibrillator and smartphone device application that assists in the notification of suspected cardiac arrest to Emergency Medical Services and assists in guiding bystander CPR and arrhythmia conversion.

Certain embodiments of the invention further include a smartphone device with associated application software. Alternatively, the smartphone device or a control module allows for cardiac monitoring, vital signs monitoring, defibrillation, and telecommunications that to enable GPS-specific contact with emergency services.

An exemplary embodiment of the AED includes: (<NUM>) a defibrillator including a battery to charge a capacitor to store and deliver an electric shock; (<NUM>) a communication module to connect the defibrillator to a smartphone/mobile device via wired or wireless connection; (<NUM>) cardiac pads with electrodes to detect and monitor chest wall compression depth, compression rate, and chest wall impedance, and heart rhythm; and (<NUM>) a smartphone or mobile device application to analyze information received from the cardiac pads and recommend appropriate therapy, the application also having the ability to contact EMS via the smartphone/mobile device with GPS, Wi-Fi and/or cellular capabilities. In certain embodiments, these components are connected as follows: a smartphone with application is connected to the defibrillator via either a wired or wireless connection, such as Bluetooth or Wi-Fi, then at least two electrodes with wires ending in cardiac pads connect from the battery/capacitor pack to the patient's chest.

Certain embodiments include one or more of the following: (<NUM>) the smartphone application installer resides in the battery pack and is automatically uploaded to any device connected thereto; (<NUM>) device connects to a smartphone or mobile device via a wired or wireless connection (e.g., Bluetooth, Wi-Fi), or through a microphone; (<NUM>) the charge for the defibrillating shock is generated from a replaceable device-centric source (e.g., battery) or from the internal battery of the smartphone; (<NUM>) device includes a control module, at least one capacitor and application to detect and deliver any range of electrical shock; (<NUM>) the system components and application detect the impedance of the victim's chest wall and cardiac pad placement; (<NUM>) given impedance information, the system and application automatically recommends or configures an electrical charge for the given SCA patient (e.g., child or adult); (<NUM>) the cardiac pads can be placed anywhere on the body of the SCA patient; (<NUM>) the cardiac pads detect the force of the CPR compressions on the SCA patient using, for example, a pressure sensor, impedance detector and/or accelerometer; (<NUM>) the smartphone interfaces with multiple other medical devices via wired or wireless connections (e.g., Bluetooth or Wi-Fi) or microphone; (<NUM>) the application monitors a variety of sources of data to: A) refine CPR-related guidance and/or B) bundle the data to be accessible by first responders; (<NUM>) the smartphone interfaces with other medical devices and detects and monitors vital signs on the SCA patient including, but not limited to, blood pressure, heart rate, oxygen saturation, temperature, respiratory rate, capnography, and electrical cardiac activity; (<NUM>) the device has two or more electrodes (e.g., cardiac pads) that connect to the patient; (<NUM>) the smartphone/device/electrode combination provide a <NUM>-lead electrocardiography (ECG) output; (<NUM>) the AED is brand agnostic with respect to the smartphone or operating system; (<NUM>) the smartphone can be paired via wireless communications or connect via wire to multiple medical devices simultaneously; (<NUM>) the AED can be connected/paired to multiple smartphones simultaneously and, if paired, each of these devices can have control over the AED; (<NUM>) the device allows the user to perform cardiac pacing/synchronized shock from the smartphone device, if the user has the appropriate knowledge; (<NUM>) the smartphone provides a live video, voice, data or any combination of these feeds to another medical facility; (<NUM>) the smartphone communicates with EMS via an automated voice annunciation via cellular network, video, SMS or any other modality by which EMS is able to receive information; (<NUM>) information given to EMS includes, but is not limited to, current vital signs, CPR results, detectable cardiac rhythm, number of shocks given, and GPS coordinates/geolocation of events in progress; (<NUM>) such information is generated on a periodic basis and transmitted to incoming EMS, or generated upon request by EMS via the application; (<NUM>) EMS is able to access the application on a paired mobile device, facilitating device location and data requests therefrom; (<NUM>) the application allows the control module to be paired with the information system used by EMS, thus allowing the remote administration of cardiac shock (e.g., if a child is using the device for an adult); (<NUM>) the device and software application communicates with cameras of related devices including, for example, smartphone cameras, Google Glass, or similar products to allow for direct visualization and display of events and instructions in progress; (<NUM>) the device and software application guides a user for proper cardiac pad placement; (<NUM>) the device and software application suggest confirmation of no pulse if the onboard photo-plethysmography (PPG) sensor does not detect a pulse; (<NUM>) the device provides guidance using industry standard for timing of delivery of shock and CPR; and (<NUM>) device automatically contacts EMS if no call to emergency services is manually initiated after delivery of first shock.

Certain embodiments differ from other currently available devices and solutions because the various embodiments described herein: (<NUM>) provide defibrillation of a cardiac arrest victim with an empowered smartphone; (<NUM>) use batteries that can be purchased off-the-shelf; (<NUM>) include specialized capacitors and circuitry that generate a therapeutic charge from the off-the-shelf battery; (<NUM>) continuously analyze the cardiac rhythm during CPR; (<NUM>) include sensors in the cardiac pads to detect impedance of the chest wall and ensure proper pad connection; (<NUM>) include additional sensors in the cardiac pad to monitor compression force, rate and depth of CPR; (<NUM>) by using the sensors to monitor vital signs, ensure that a cardiac shock is not given at an undesired time; and (<NUM>) via the sensors inside the cardiac pad, communicate information to the software system regarding size of chest wall which then allows for recommendation of a therapeutic shock that is correlated with the size of victim and their individual anatomy, e.g., child or adult.

Similarly, the associated method described herein differs from existing methods in that: (<NUM>) the smartphone software application gives the ability to call emergency services (such as <NUM> in the United States) and assist the bystander in providing effective CPR; (<NUM>) the smartphone device software application is able to upload and record data of the resuscitation efforts such as, but not limited to, vital signs, cardiac rhythm, quality of CPR, and outcome of electric shock. Certain embodiments also transmit data to another mobile device in real-time, or after the fact.

Certain embodiments of the present invention differ structurally from other known devices or solutions in that: (<NUM>) the device runs off of readily commercially available consumer batteries; (<NUM>) the device connects to a mobile device and is small enough for everyday portability; and (<NUM>) includes cardiac pads that can detect force, rate, and depth of compression along with impedance of chest wall.

Furthermore, the processes associated with certain embodiments of the invention differ from known processes and solutions in that: (<NUM>) the device includes a smartphone device software application initiate communications with EMS; (<NUM>) the software application guides a bystander through quality CPR using the data obtained from the cardiac pads, such as compression depth, compression rate, and placement of hands; (<NUM>) the device uses the data to prompt the user if the cardiac pads need to be checked or re-applied or if the CPR technique needs to be modified; (<NUM>) software application detects the cardiac rhythm during active chest compression; (<NUM>) the software application analyzes cardiac rhythm and provides electric shock for appropriate cardiac arrhythmias; and (<NUM>) the user will be prompted to stop CPR upon return of spontaneous circulation (ROSC).

Among other things, it is an object of certain embodiments of the present invention to provide an automated external defibrillator and smartphone device application that assist in the notification of suspected cardiac arrest to EMS and in guiding bystander CPR and arrhythmia conversion to overcome the problems or deficiencies associated with prior solutions.

It is still further an objective of certain embodiments of the present invention to create a automated external defibrillator device that is cost effective, thus increasing the public's access to AEDs and thereby saving lives.

Further still, it is an objective of certain embodiments of the present invention to provide a device that is smaller and more lightweight than other solutions, thereby enabling the device to be easily portable. Certain embodiments have a weight of less than one pound. By making it more portable it increases accessibility, thus the product will be utilized more frequently, ultimately saving more lives.

Further still, it is an objective of certain embodiments of the present invention to create a device that is able to help bystanders in a high stress situation to provide proper help in an efficient manner.

Certain embodiments of the invention are related to automated external defibrillator and smartphone device software application that assist in the notification of suspected cardiac arrest to EMS and assist in guiding bystander CPR and cardiac arrhythmia conversion.

Certain embodiments include: a smartphone/mobile device, external battery pack/specialized capacitors, at least two cardiac pads and sensors with associated wires. In an embodiment, these components are connected as follows: mobile device is connected via hardwire, Bluetooth or Wi-Fi to a case that holds the battery, specialized capacitors, and circuitry. The case also holds at least two cardiac pads with sensors connected via wire, that are in turn connected to the patient. In an exemplary embodiment, the case protects the user from the risk of electrical shock, and protects the internal electronics from electrostatic discharge (ESD), which can cause the electronics to fail or malfunction in an unsafe way. Suitable materials for the case includes, for example, a variety of plastics and other insulating materials.

Connecting the various components to the mobile device is done via wire to a connection port on the mobile device or via a wireless mechanism such as Bluetooth or Wi-Fi. The mobile device includes software for receiving input via wire or wireless connection from the case and other vital sign attachments. The software can recommend initiating a call to emergency services (e.g., <NUM>). The automated connection via cellular network, video or SMS to EMS will be able to disclose the location of the AED being operated. The device and software can automatically send the patient's information including, but not limited to, vital signs and cardiac rhythm to the EMS dispatch and/or regional medical center. The automated system can guide the user regarding correct depth and rate of compression and be able to advise cardiac shock. The case holds a portable battery, capacitors, and circuitry to generate and store at least one electrical charge to produce a therapeutic charge to cardiovert a patient in cardiac arrhythmia with the goal of return of spontaneous circulation (ROSC). The cardiac pads are connected to the to the case via hardwires. The cardiac pads are able to detect cardiac rhythm when active CPR is taking place. As an example, the cardiac pads have sensors embedded that will be able to detect rate and depth of compressions of the bystander providing CPR. The sensors in the cardiac pads send information back to the mobile device application for analysis of shockable versus non-shockable cardiac rhythm. The cardiac pads are used to deliver the therapeutic shock to the heart. The cardiac pads detect impedance of the chest to allow the application to calculate the correct therapeutic electric shock dosage and also ensure the cardiac pads have the proper connection on the patient to increase the best chance of cardioverting.

In certain examples, the non-claimed method includes: identifying a person, who is the victim of a suspected cardiac arrest; deploying a portable automated external defibrillator device; connecting the portable defibrillator device to a mobile using a wired or wireless connection; automatically initiating the software to prompt the user to call to EMS by screen button prompt; selecting an option on the screen of the mobile device to initiate a call to EMS; and advising EMS of the AED's current location using the mobile device's internal GPS system and request that help be sent once connected. In certain embodiments, a user opens cardiac pads and places them on the victim's chest in either the anterior/posterior placement or the anterior lateral placement described on a packing diagram provided on the case of the AED. As soon as the cardiac pads are placed on the victim's chest, the system attempts to detect and analyze the cardiac rhythm of the victim. Concurrently, the software gives voice prompts and a visual display of how to perform CPR to the user. The software also recommends hand placement, compression depth, and compression rate for effective quality CPR, in accordance with American Heart Association guidelines. As soon as a shockable rhythm is identified, the system will prompt via voice and video display to halt the CPR to initiate a shock to the victim. Once shock is delivered, the system will prompt the user to resume the proper steps of CPR. The device can also display the patient's vital signs on a screen during the time the device is deployed. The vital signs and cardiac rhythm can also be seen by other mobile devices and/or the emergency service dispatch or regional medical center. If at any time the sensors on the cardiac pads detect that CPR is not given at the appropriate rate or compression depth recommended by American Heart Association (AHA) guidelines (see, for example, "<NPL>)), the software prompts the user by voice and video image to adjust accordingly. The sensors also prompt the user if impedance is too high and recommend checking and/or reattaching the cardiac pads as necessary. Data regarding the entire event can be monitored and saved to another device or to the active device for real-time or subsequent comparative analysis.

Certain embodiments relate to a device, proprietary software and methodology associated with the device. With respect to certain embodiments, the present invention includes a portable defibrillator that works with a smartphone and software. When connected to a patient in cardiac arrest, via two or more electrodes and battery pack/specialized capacitor calls Emergency Medical Services providing a location. It will record patient information such as cardiac rhythm and vital signs that can then be transmitted to an approved facility for evaluation by medical providers. The device is also able to analyze cardiac rhythms, suggests administering one or more shocks to the patient in appropriate cardiac arrhythmia, and instructs bystanders on proper CPR. The portable defibrillator device and software can alert any other personnel with the app downloaded in a nearby location for assistance. This device can be used for any person that is believed to be in cardiac arrest by bystanders. The components of the invention include an application for smartphone, a device that is connected to the smartphone and activates software, the device includes two or more electrodes with cardiac pads for connection to a person's chest and to a battery pack and capacitor to provide electric shocks. In certain embodiments, the configuration includes: a smartphone which is connected by wire to battery pack and capacitor which are connected to electrodes that are connected to cardiac pads that are placed on the chest of the patient.

With respect to certain embodiments of the device AED module, it should be further noted that once the device has been applied to patient and plugged into the smartphone it will activate the software that will transmit location, vital signs, and cardiac rhythm to emergency services, it will also analyze placement of the cardiac pads to ensure proper rhythm analysis and proper CPR via depth, rate and impedance. Device will recommend administering electric shock to appropriate and susceptible cardiac arrhythmias. If the device is used properly and there is a shockable rhythm the goal is the return of spontaneous circulation (ROSC), activation of emergency medical services and recording and transmission of data that occurred during event. With respect to the associated method, in certain embodiments, the method includes: identifying a patient that may have cardiac arrest; placing a device and plugging into smartphone; accessing a smartphone application; following instructions from device and deliver shock if recommended or provide CPR if recommended and wait for emergency services to arrive. Ultimately, at the conclusion of these steps the device should notify emergency services if cell or Wi-Fi signal allows, provide instructions for CPR or recommend and deliver cardiac shock, record vital signs and cardiac rhythm, with the all-encompassing goal of helping bystanders provide emergent and adequate care in a life-threatening situation. A portable AED will lead to improved patient outcomes and more lives being saved.

Referring to the figures, <FIG> shows an automated external defibrillator (AED) module <NUM>, in accordance with an embodiment. As seen in <FIG>, AED module <NUM> includes a connector <NUM>, an electronics module <NUM>, at least two electroconductive cardiac pads <NUM>, and electrical conductors such as wiring <NUM> connecting cardiac pads <NUM> with electronics module <NUM>. Cardiac pads <NUM> includes sensors (not shown) for monitoring, for example, cardiac rhythm and body impedance of the SCA patient to whom cardiac pads <NUM> are connected. The sensors in cardiac pads <NUM> also indicates whether cardiac pads <NUM> are properly placed on the SCA patient, and can indicate to electronics module <NUM> if one or both of cardiac pads <NUM> are disconnected from the SCA patient. Furthermore, sensors in cardiac pads <NUM> can also include additional capabilities, such as detection of force, rate, and depth of compression, to help monitor any cardiopulmonary resuscitation (CPR) performed on the SCA patient. Connector <NUM> is attached to electronics module <NUM> via a wire <NUM> in the embodiment shown in <FIG>. Alternatively, the connection between the mobile device and electronics module <NUM> is established wirelessly through, for instance, Bluetooth or Wi-Fi. Connector <NUM> is attached via a receptacle <NUM> to a mobile device <NUM>.

While mobile device <NUM> in <FIG> is shown as a smartphone, it may be another suitable portable device, such as a cellphone, a tablet, a smart watch, electronic reader, laptop, or the like. A suitable mobile device has the capability to receive input via, for example, wired or wireless connections such as Bluetooth, audio, keyboard, mouse, trackpad, or touch-screen. Additionally, the mobile device produces an output, such as vibration, camera light, video display Bluetooth, Wi-Fi, or audio. Internal components of a suitable device include, for example, a microprocessor, a battery, GPS, Wi-Fi and/or Bluetooth, an operating system, software readable media, and storage. When mobile device <NUM> is connected with AED module <NUM>, a specialized application software, including features such cardiac rhythm recognition, patient monitoring, impedance measurement, and external communication options, is downloaded and installed on mobile device <NUM> such that it is able to communicate with AED module <NUM>.

AED module <NUM> connects to receptacle <NUM> of mobile device <NUM> via connector <NUM>, in the embodiment shown in <FIG>. Certain embodiments include standard connection mechanisms known to those skilled in the art, such as but not limited to micro USB, Lightning connector, and USB-C, <NUM>-pin, Thunderbolt, audio, or even simultaneous connections with multiple inputs of mobile device <NUM>. Alternatively, AED module <NUM> connects to mobile device <NUM> wirelessly (as indicated by symbol <NUM>) via a mechanism such as Bluetooth, Wi-Fi, or audio. Connector <NUM> receives and sends signals from and to electronics module <NUM>, such as communications related to, for instance, activation of the specialized software application, the cardiac rhythm analysis, and delivery of a therapeutic shock.

In certain embodiments, AED module <NUM> automatically activates the specialized software application installed on mobile device when connector <NUM> is connected to mobile device <NUM> via receptacle <NUM>. For instance, the installed software on mobile device <NUM> analyzes the cardiac rhythm from cardiac pads <NUM> that is processed/filtered in electronics module <NUM>. Alternatively, electronics module <NUM> performs the analysis of data received from cardiac pads <NUM> and displays the analysis results on mobile device <NUM>. Electronics module <NUM> generates and stores an electrical charge for at least one electrical shock. If electronics module <NUM> or the installed software in mobile device <NUM> deems the patient is currently undergoing cardiac arrest and can be treated with defibrillation, a control circuitry (not shown) in electronics module <NUM> sends the generated electrical charge to the SCA patient via cardiac pads <NUM>. Alternatively, shock will be delivered when the user approves the shock delivery through the specialized software installed on mobile device <NUM>.

In an embodiment, each of cardiac pads <NUM> is configured to accommodate electrical charge in the form of a biphasic waveform, as currently recommended by Advanced Cardiovascular Life Support (ACLS) and American Heart Association (AHA) standards. Cardiac pads <NUM> can be placed in the standard anterior/lateral position, or can be placed into the anterior/posterior position, among others.

In an embodiment, electronics module <NUM> itself or the specialized software on the mobile device will analyze the electrocardiography (ECG) signals received via the sensors in cardiac pads <NUM>. The analysis determines, for example, whether the cardiac rhythm measured from the SCA patient is indeed a shockable rhythm, in accordance with industry standards. Industry standard shockable rhythms include, for example, ventricular fibrillation (VF) having an average waveform amplitude greater than <NUM> mV, fine ventricular fibrillation (FVF) having an amplitude between <NUM> mV and <NUM> mV, and ventricular tachycardia (VT) of single morphology (monomorphic VT) or several morphologies (polymorphic VT) (see, for example, "<NPL>).

When analysis by electronics module <NUM> or the software installed on mobile device <NUM> determines that the cardiac rhythm detected is a shockable rhythm, data regarding body impedance is used to calculate and adjust the appropriate shock waveform to be delivered via cardiac pads <NUM> to the SCA patient. For instance, the energy output from electronics module <NUM> is adjusted, according to the body impedance, to produce a waveform according to the accepted standard biphasic pattern used in modern defibrillators. In certain embodiments, this voltage waveform is generally between <NUM>-<NUM> Joules in total energy.

In certain embodiments, the analysis performed by electronics module <NUM> or software provides an optional mode in which rhythms requiring an electrical shock at a smaller/different electrical output can be identified. An example for such a rhythm is supraventricular tachycardia (SVT), which requires therapeutic cardioversion or bradycardia with external electrical cardiac pacing. In an embodiment, electronics module <NUM> or software on mobile device <NUM> is able to distinguish the need for a synchronized shock to be delivered on the QRS waves of an ECG reading. Examples of these rhythms would be supraventricular tachycardia (SVT), stable ventricular tachycardia, symptomatic atrial fibrillation and others.

In certain embodiments, for further data input for the shockability analysis, additional electrodes can be placed in the industry standard positions to obtain, for instance, a <NUM>-lead ECG reading. With this option, the <NUM>-lead ECG data allows better analytics of the SCA patient's condition, such as the identification of a ST elevation myocardial infarction (STEMI). For instance, diagnostic ST elevation in the absence of left ventricular (LV) hypertrophy or left bundle-branch block (LBBB) is defined by the European Society of Cardiology/ ACCF/AHA/World Heart Federation Task Force for the Universal Definition of Myocardial Infarction as new ST elevation at the J point of an ECG reading in at least <NUM> contiguous leads of > <NUM> (<NUM> mV) in men or > <NUM> (<NUM> mV) in women in leads V2-V3 and/or of > <NUM> (<NUM> mV) in other contiguous chest leads or the limb leads. If such a condition is identified by electronics module <NUM> or the software installed on mobile device <NUM>, AED module <NUM> notifies EMS, in an embodiment, thus potentially shortening the time to cardiac catheterization that is needed for treatment of the condition.

In certain embodiments, the specialized software for mobile device <NUM> is made available on a software application marketplace (e.g., the Apple App Store), a specific website on the Internet, or be uploaded manually. Alternatively, a software installer is stored on electronics module <NUM> such that, when a mobile device <NUM> is connected, the specialized software is automatically downloaded and installed on mobile device <NUM>. In certain embodiments, the original equipment manufacturer will preload the specialized software is preloaded on electronics module <NUM>. In certain embodiments, the battery in mobile device <NUM> can be used to provide power AED module <NUM>.

Referring to <FIG>, certain embodiments of the internal configuration of an AED module or an electronics module <NUM> is shown. In certain embodiments, a battery <NUM> is a <NUM>-volt battery and, in certain embodiments, can include another off-the-shelf, household battery including, but not limited to, NiMH, NiCd, lithium ion, alkaline, silver-oxide, or silver zinc batteries, singularly or in a combination thereof.

In certain embodiments, electronics module <NUM> also includes a series of capacitors <NUM> to generate and store a charge for at least one electrical defibrillation. In certain embodiments, electronics module <NUM> also includes a boosting element <NUM> for amplifying and filtering the signal received from the cardiac pads. The signal from the cardiac pads are be received via wires <NUM>, amplified and filtered at boosting element <NUM>, and sent from a microprocessor <NUM> to the software on the mobile device to be analyzed. Filtering at boosting element <NUM> reduces electromyography (EMG) noise and/or electromagnetic interference (EMI) in the received signal. In an embodiment, boosting element <NUM> allows analysis of the cardiac rhythm while active chest compression (i.e., CPR) is being administered on the SCA patient. In certain embodiments, microprocessor <NUM> stores downloaded software from the manufacturer to be uploaded to mobile device <NUM>, in the event the software is not already installed on the device.

Electronics module <NUM> also receives from and transmits to mobile device <NUM> any information via wireless arrangements, such as Bluetooth and Wi-Fi using a transmitter <NUM>. In certain embodiments, a port <NUM> is provided on electronics module <NUM> to accept additional electrodes, such as vital sign devices <NUM> including, but not limited to, capnography, blood pressure, pulse oximetry, and glucose monitors, smart watches, and Google Glass. Software applications equivalent to vital sign devices <NUM> could also be installed on electronics module <NUM> or mobile device <NUM> using wireless connections, such as Bluetooth, Wi-Fi, or audio, or a wired connection.

In certain embodiments, a portable AED module <NUM> as shown in <FIG> is connected to mobile device <NUM> via wire <NUM>. Components of AED module <NUM> are placed in or on a housing <NUM>. Certain embodiments include a plurality of indicators <NUM> that visually show a user the steps for resuscitating a person affected with a cardiac episode. Still referring to <FIG>, in one example, the indicators include, for example, a Heart Analysis indicator 32a, a Place AED/CPR Pad indicator 32b, a Perform CPR indicator 32c, a Clear indicator 32d, a Warning Shock indicator 32e, and a Remove Pads indicator 32f. Indicators <NUM> are mounted on an upper cover <NUM>, in an embodiment. It will be appreciated by those skilled in the art that the indicators found on an AED module is not limited to these indicator types, and may include greater than or fewer than these indicator types.

In certain embodiments, indicators <NUM> are illuminated to allow a user to visually verify the steps for performing defibrillation/CPR on a SCA patient. For example, indicators <NUM> are translucent, and illuminated by lights 38a found on an indicator board <NUM>, as shown in <FIG>. In certain embodiments, a display <NUM> provides further information. For example, a display <NUM> may be an LCD, VFD, OLED, analog, or other display to provide information. In certain embodiments, display <NUM> provides user feedback, status information, or other information relevant to the process of defibrillation or CPR. In certain embodiments, display <NUM> provides heart rate information. In certain embodiments, display <NUM> forms a part of indicator board <NUM>.

Again referring to <FIG>, in certain embodiments, an interface <NUM> includes speakers that transmit audio cues for using the AED and/or administering CPR. In certain embodiments, a user listens to the audio cues from interface <NUM> and follows the instructions of the audio cues. The speakers can transmit other information including, but not limited to, GPS location, real-time conversation with EMS personnel, instructions for use, among others. In certain embodiments, interface <NUM> further includes a battery life indicator.

Still referring to <FIG>, certain embodiments of portable AED module <NUM> includes a housing bezel <NUM>. Housing bezel <NUM> is translucent as to allow light from lights 38b to pass through. Lights 38b are mounted on an AED power board <NUM> and illuminate an area <NUM> through housing bezel <NUM> to provide further visual information to assist a user while in the process of performing defibrillation and/or CPR. Illumination can occur outside of area <NUM> as well. It will be appreciated that lights 38a and 38b can be one or more colors as to provide color-specific information provided by any number of light sources, such as light emitting diodes (LEDs), incandescent lighting, or fluorescent lighting.

Referring to <FIG>, in certain embodiments, a AED power board <NUM> includes a bulk charge storage array <NUM> as to hold an electrical charge. In certain embodiments, battery <NUM> connected with AED power board <NUM> provides AED module <NUM> the charge necessary for defibrillation. Alternatively, other power sources, such as the battery within mobile device <NUM> can be used. In certain embodiments, an insulation <NUM> provides isolation of circuitry between indicator board <NUM> and AED power board <NUM>. Additionally, a back cover <NUM> encloses a portion of housing <NUM>. In certain embodiments, back cover <NUM> may be removable as to allow a user to replace battery <NUM>.

Referring to <FIG> and <FIG>, certain embodiments of AED module <NUM> is further connected to other components. For example, AED module <NUM> is connectable via wires <NUM>, <NUM>, <NUM> to a mobile device <NUM>, photoplethysmography (PPG) monitor <NUM>, and a plurality of pads <NUM>. For example, PPG monitor <NUM> attaches to an earlobe or finger to detect, vital signs such as blood flow, heart rate, a viable heart rhythm, and blood oxygen saturation (<NUM>%). In certain embodiments, PPG monitor <NUM> detecting no pulse triggers AED module <NUM> to direct the user to start administration of CPR.

Pads <NUM> include, for example, a CPR coaching pad <NUM> in addition to cardiac pads <NUM>. In certain embodiments, CPR coaching pad <NUM> includes or is connected with sensors such as accelerometer, pressure sensor, impedance sensor, and optionally to outputs such as speakers, light indicators, and others, as shown in <FIG>. An accelerometer measures the movement of the pad, and a pressure sensor measures the active force and release of CPR compressions. Thus, CPR coaching pad <NUM> directs the user on proper administration of CPR on the patients, including directives to go faster, harder, or to stop compressions. An example of CPR coaching pad <NUM> is shown in <FIG>. Sensors in CPR coaching pad <NUM> receives CPR data as a user is performing CPR, and generates real-time feedback to adjust the CPR accordingly so that industry standard timing of CPR and delivery of shock are performed.

Certain embodiments of cardiac pads <NUM> include sensors therein to detect data from the SCA patient such as, but not limited to, body impedance and ECG signals. In certain embodiments, each of cardiac pads <NUM> include an area <NUM> that visually/graphically indicates correct placement of such pad on the patient's body.

Continuing to refer to <FIG>, fat black arrows indicate AED output to cardiac pads <NUM>, fat open arrows indicate analog data transfer, and solid arrows indicate digital data transfer. Data from PPG monitor <NUM>, CPR coaching pad <NUM>, and cardiac pads <NUM> are gathered and processed by a safety processor <NUM>. Once a determination is made that defibrillation is appropriate in a given situation, safety processor <NUM> communicates with an AED power and waveform module <NUM> and a switch and isolation module <NUM> to initiate and deliver an electric shock to cardiac pads <NUM>. In certain embodiments, safety processor <NUM> communicates with mobile device <NUM> through an interface module <NUM>, such as a lightning or USB connector. Information regarding the patient status, defibrillation instructions, CPR instructions, emergency services communication, and others described herein are communicated from the safety processor <NUM> to the interface modules <NUM> using visual and audio cues, such as via a user interface (UI) speaker <NUM> and a UI display <NUM>. Safety processor also communicates with a battery and power supervision module <NUM>.

In certain embodiments, portable AED module <NUM> can be used as a stand-alone device, without connection to a mobile device. When used alone, AED module <NUM> provides, for example, three electric shocks with a biphasic waveform, each shock with a charge level suitable for therapeutic use and a delivery time of <NUM> minute or better at an ambient temperature of <NUM> from one standard household battery or battery pack, such as a 9V battery. For instance, AED module <NUM> starts to charge as soon as AED module <NUM> is powered on. In certain embodiments, delivery of the shock occurs within <NUM> minute of starting the charging sequence, after detection of an appropriate shockable cardiac rhythm. LED icons or indicators <NUM> located on AED module <NUM> prompts the user visually and with audible prompts to guide the user through the appropriate steps of setting up AED module <NUM> for defibrillation, according to industry -recommended standards. In some cases, AED module <NUM> directs the user to initiate CPR, if no pulse is detected from a PPG monitor, which can be provided as part of AED module <NUM>, and if no pulse confirmed by the user. In such a case, certain embodiments of AED module <NUM> provide real time CPR guidance with feedback, as previously discussed. In certain embodiments, pressure sensors in AED coaching pad <NUM> monitor patient chest recoil during CPR administration. In certain embodiments, AED module <NUM> coaches the user through the proper rate and depth of CPR using an impedance sensor and accelerometer. For instance, an XYZ accelerometer, used to measure acceleration and movement of AED coaching pad <NUM>, and a pressure sensor membrane, used to measure active force and release of each CPR compression, send CPR-related data to AED module <NUM> via a connector (such as wire <NUM>) to provide user feedback regarding the effectiveness of the CPR efforts, in accordance with an embodiment. AED coaching pad <NUM> includes, for example, an upper layer stiffener, accelerometer, flex circuit, pressure sensor membrane, and bottom layer stiffener with adhesive, in the embodiment shown in <FIG>. In certain embodiments, the guidance provided in the use of AED module <NUM> adheres to guidelines set forth by industry standard organizations, such as the American Heart Association (AHA) for steps in addressing cardiac arrest.

When an AED module is used with mobile device <NUM>, the above features, as well as additional features can be provided. In certain embodiments, AED module <NUM> receives geolocation data from mobile device <NUM>. When AED module <NUM> is connected with mobile device <NUM>, a software application is automatically opened. The communication capabilities of mobile device <NUM> can be used to contact EMS (such as "<NUM>" in the U. ) and provide location data to a dispatcher that receives the communication. In an embodiment, a Short Message Service (SMS) message is sent to EMS on current status of the SCA patient, and continue to update EMS of any changes to the SCA patient's condition. Information delivered to EMS includes, but not limited to, details of any shock provided, return of spontaneous circulation (ROSC), current heart rate, pulse oximeter readings, and cardiac rhythm status. Providing this information will give EMS or the hospital the ability to better prepare for needed intervention in care of the specific SCA patient.

<FIG> show the steps involved in using a portable AED module, in accordance with an embodiment. Certain embodiments include initiating an application; the application asking if there is an emergency situation; requesting to call emergency services; providing location to EMS via an automated voice over the device and via text message; automatically placing the open call to the emergency services on speakerphone; placing a PPG monitor; suggesting that CPR should begin if no pulse is detected; checking for pulse confirmation; providing a prompt via audio and visual displays on a screen to ensure effective compression is being performed; determining a person providing CPR is fatigued; recommending to change provider if low quality CPR is being performed; notifying when analyzing rhythm while CPR is in progress; notifying a person performing CPR and EMS via the speakerphone that a shockable/non-shockable rhythm is detected; notifying that victim is able to be shocked and advising to stop CPR and not to touch the patient; resuming CPR; recommending checking for pulse and responsiveness if PPG monitor detects a pulse and if a viable rhythm is detected; placing the patient in a recovery position displayed on the screen; and continuing to monitor the patient. In certain embodiments, an AED module includes other components, including but not limited to a GPS tracker, mobile phone services, modem, and Wi-Fi to communicate with emergency services.

Referring to <FIG>, an exemplary circuitry for generating a charge for defibrillation. In certain embodiments, a simplified AED Biphasic Truncated Exponential (BTE) power stage is an energy-based, two stage design having a constant current boost charger (e.g., a SEPIC multiplied boost charger) supplying a bulk energy storage capacitor, followed by a high voltage full-bridge for steering the positive- and negative-half phases. <FIG> shows an alternative embodiments of an alternative AED module, which includes a tapped inductor boost charger along with full-bridge steering. In an example, high-voltage and current-sensing feedback are provided to the microprocessor to prevent incorrect dosing and detect error conditions. Low-voltage ECG sensing stages are isolated by relays to prevent overvoltage damage during shock delivery. The current charger uses a low current constant charge rate (in the milliamp range) controlled by pulse-width modulation (PWM) signals from the microprocessor to charge the energy storage capacitor to the prescribed amount of energy within <NUM> seconds or less. In an example embodiment, a charge time of approximately <NUM> seconds or less has been achieved using four CR123 batteries as the power source. This length of time and level of charging current is such that a standard 9V alkaline battery can be used to meet the goal operating time of several hours with at least <NUM> fully rated shocks at full battery conditions and three shocks and <NUM> minutes of operating time at minimum indicated battery level prior to AED use. The output current is steered through the positive and negative phases using, for instance, a high-voltage full-bridge performing hard switching of the <NUM>-<NUM> total duration pulses. The phase transitions times are determined based on the body impedance (from <NUM> ohms to <NUM> ohms), as seen for example in <FIG>. That is, by adjusting the timing and amplitude of the positive and negative phases, the total energy of the shock applied to the SCA patient can be modified for the specific patient. In an exemplary embodiment, the body impedance is measured using the existing wiring of the cardiac pads by sending a low voltage square wave across the cardiac pads and calculating the load between the cardiac pads detected when the polarity of the square wave is reversed.

In the example shown in <FIG>, the waveforms correspond to different transition times and amplitudes calculated for different body impedance values, in accordance with an embodiment. The total energy applied to the SCA patient per shock can be calculated using the following Eq. <NUM>: <MAT> where <MAT>, R = body impedance, and t = time. In <FIG>, a waveform <NUM> corresponds to R = <NUM> ohms, a waveform <NUM> corresponds to R = <NUM> ohms, and a waveform <NUM> corresponds to R = <NUM> ohms. For instance, as shown, an energy peak of 200J for body impedance of <NUM> ohms corresponds to a current of i = ~<NUM> Amps. For the example of a charge provided by a <NUM> microfarad capacitor holding a charge of 1640V, the switching and end times (t<NUM> and t<NUM> in <FIG>) are summarized in TABLE <NUM>.

It is important to note that the embodiments described herein require innovative solutions to problems not faced by previously available AEDs. For instance, the embodiments described herein provide:.

These are requirements that go beyond those that have been faced by previous AED manufacturers.

It is particularly emphasized that, in order to achieve the necessary performance from a compact, portable AED from a household battery, the coordination of the electronic design and firmware is important. It is particularly emphasized that the generation of shock, and the regulation thereof, powered by a commercially-available household battery and presented in a user-friendly, compact package at an affordable price point is a significant engineering achievement. There are considerable challenges in reducing the package size of the AED, especially with the various voltage converters and high voltage drivers involved in generating the therapeutic shock according to best practices from a household battery. In particular, considerable engineering ingenuity is required to achieve the necessary performance under the above listed limitations, particularly as the operation of the high voltage device by an untrained user involves extensive consideration of safety measures provided in the physical features as well as the logic involved in the firmware and ease of use in the user interface. No device equivalent to the embodiments described herein is currently known.

The generation of the biphasic waveform from common household batteries, such as one or more 9V or CR123 batteries, is a significant challenge due to the limited voltage and current provided by such batteries. The circuitry required to generate an adjustable biphasic waveform, such as those illustrated in <FIG>, from household batteries while fitting within a highly portable package is a unique challenge solved in the embodiments described herein.

For instance, focusing on the H Bridge shown as "Full-bridge Steering" in <FIG>, the method used to generate the biphasic waveform in certain embodiments described herein is different from existing designs, such as those that separately generate the positive and negative phases then combines them using a time delay circuit when administering to the patient. In an exemplary embodiment, the biphasic waveform is generated by discharging a single high voltage capacitor using an H Bridge configuration under microprocessor control.

More specifically, in an exemplary embodiment shown in <FIG>, switches M4 and M3 are closed, then opened. Subsequently, switches M5 and M2 are closed, then opened. Software is used to determine the appropriate timing of each phase to deliver a total charge of, for instance, 150J in accordance with Eq. <NUM> above, with equal charge in each direction of the decaying resistor-capacitor (RC) potential for each phase (i.e., M4-M3 combination, then M5-M2 combination). This exemplary H Bridge configuration allows certain embodiments to generate the required biphasic waveform using only one charge reservoir, thus delivering all of the required charge from the one charge reservoir for both polarities. Furthermore, firmware logic is used to prevent erroneous control of the H Bridge (e.g., combinations such as M4-M2 and M5-M3 for the components shown in <FIG>). An H Bridge board, such as IXYS H-bridge driver board, is an example of a board that can be configured as disclosed herein. Additional potential candidates for use in the H Bridge configuration are, for example, Powerex modules and Isolated Gate Bi-polar Transistors (IGBTs), Texas Instruments modules and IGBTs, Infineon PCB modules, CT-Concept/Technologie Power Integrations, IXYS drivers and IGBTs, and others suitable equivalents.

Another point of innovation for certain embodiments described herein is the DC-DC converter implementation shown, for example, in <FIG> and <FIG>, capable of enabling capacitor charging within one minute, or as little as less than <NUM> seconds. In an example, the high voltage DC-DC converter uses a flyback transformer with a forward diode topology. Multiples of such DC-DC converters can be placed in parallel using diode ORing to reduce the charge time, with a trade-off of increasing the current draw from the battery. In an example, the power that can be generated from a 9V at <NUM> A is 9W. If an energy output of <NUM> Joules, which is equivalent to <NUM> W*seconds, then this level of energy output can be obtained in <NUM> W* seconds / 9W = <NUM> seconds at <NUM>% battery efficiency. Efficiency may be less, which could increase the charge time.

Alternatively, three or four CR123 batteries, which are also readily available with nominal voltage of <NUM>. 0V each, may be used in place of the 9V battery to supply sufficient charge within the required time frame. In an exemplary embodiment, the circuit design is based upon the use of a 9V operating at a current of <NUM> A, which can be achieved with parallel or series combinations of batteries. For instance, parallel combinations of N <NUM> V batteries will require diode ORing and will supply <NUM>/N current capability for each. Series combinations will require each battery to be <NUM>/N of 9V and to deliver the full <NUM> A. CR123 batteries (for example, Energizer Lithium/Manganese Dioxide EL123 AP batteries (http://data. com/pdfs/<NUM>. pdf )) can deliver <NUM> V at a continuous current of <NUM> A, and therefore three such CR123 batteries in series would meet the criteria.

In certain embodiments, a further variation for the high voltage DC-DC converter is used in order to more efficiently produce the required biphasic waveform within the FDA-required charge time. This variation is based on the knowledge that lower voltage DC-DC converters can produce higher current output than higher voltage DC-DC converters because converters are usually designed to put out a fixed amount of power. While a single off-the-shelf DC-DC converter does not provide a sufficiently short charge time, a multi-tier approach can be used by diode ORing the output of multiple DC-DC converters with different voltage capacities.

For example, different variants of off-the-shelf DC-DC converters can be tiered to yield outputs stepped from 2000V to 4000V from a 12V input. If a 9V input is connected to the same configuration, outputs would step from 1500V to 3000V.

This diode ORing concept for faster charging utilizes the lower voltage converter to deliver higher charging current up to 1500V, and then one or more of the higher voltage converters to bring the voltage up to the final desired value. In other words, rather than using a single, or even two, high voltage DC-DC converter, faster charging can be achieved by using a combination of lower voltage and higher voltage DC-DC converters in a tiered configuration. A combination of high voltage DC-DC converters, such as EMCO HV DC-DC converters American Power Designs, and Linear Tech DC-DC converters with custom transformer and circuit topologies, can be used to implement the embodiments as disclosed herein.

In certain embodiments, the firmware merges control logic for the circuitry, as well as impedance measurement across the cardiac pads (i.e., the impedance related to the patient's size) in order to adjust the parameters of the applied biphasic waveform to the specific patient. As an example, the microcontroller unit (MCU) within the AED serves to provide overall control of the performance of the AED in a variety of ways.

In an embodiment, the MCU has several responsibilities in the fully functional AED. For instance, the MCU:.

The activities in the above list need not happen simultaneously. For example, the device can progress through a charging sequence (item <NUM> above), while providing ECG signal input to the SIA (item <NUM> above) and also monitoring the patient for other physiological signs useful to the administration of CPR (item <NUM> above), as well as monitoring the user's CPR performance (item <NUM> above).

If the SIA indicates that a shock is needed, the MCU continues with the timed charging sequence (item <NUM> above), if not yet completed, while simultaneously guiding the user through the shock protocol (item <NUM> above) and possibly continuing to monitor physiological signs (item <NUM> above). In an exemplary embodiment, the MCU contains logic such that the administration of a shock is only commenced when certain criteria are fulfilled. For example, the MCU can be set such that shock is administered only when: <NUM>) a shock sequence was initiated by the user; <NUM>) the charging sequence has been completed; and <NUM>) the shock protocol has been completed with no alerts, such as due to displaced cardiac pads.

As another example, during the actual administering of a shock, the MCU turns off all other AED activities not essential to that primary function to avoid conflicts and to protect sensitive components. Additionally, after a shock has been administered, the MCU resets some of those other activities to a new-start state, as data gathered prior to the shock may be no longer relevant or accurate.

In an exemplary embodiment, the MCU has several tasks related to the shocking function, including:.

More specifically, in an embodiment, the MCU provides guidance to the user, such as to "stand back" or "stay clear" in anticipation of the shock administration, including a protocol to allow the user sufficient time to comply before administering the shock. The MCU can also provide logic to combine information about, for example, the placement of the cardiac pads on the SCA patient, the readiness state of the hardware (e.g., capacitor charged), and the analysis by the SIA and, if all of the requirements are satisfied, instruct the user to stand clear and, after a reasonable time, commence the shock.

In an embodiment, the MCU manages specific timing aspects of the generation of the biphasic waveform produced by the AED. For example, the MCU manages a sequence of several carefully timed processes that, once initiated, progress through all the steps in a prescribed order, all the way to completion without interruption. In an exemplary embodiment, the state machine within the MCU firmware administers the setting of the timers of various durations, and uses these timers to drive the output pins to control the AED hardware. For instance, the state machine includes eight unique states with timing on the order of milliseconds with a timing precision of <NUM> microseconds.

In an example, several events are required before a shock is administered. These include:.

These required events happen asynchronously with respect to each other. For example, the shock request can immediately trigger the user alert operation, or the charging sequence can be set to begin as soon as the AED unit is turned on, such that this step has no direct connection with the shock request from the SIA. Additionally, the MCU can include features such as, but not limited to:.

As an example, the main loop of the firmware contains the logic to check that a shock is required, and that the protocol prior to administering the shock (e.g., the user has been alerted to "stand back," the capacitors are fully charged) has been completed, and then automatically administer the shock. The firmware main loop managers, for instance: <NUM>) charging requests; <NUM>) shock requests; <NUM>) discharge request to safe state (e.g., if the shock protocol has been aborted); and <NUM>) battery test requests. Such requests can be presented to the firmware as buttons or as terminal commands. For instance, as buttons, the requests arrive in ISRs where minimal logic is allowed (e.g., no terminal output). In an example, buttons and terminal requests behave the same way; i.e., instead of direct action, the request is registered in a state variable that the main loop will check on its next iteration. Such a configuration safely allows for feedback to developers via the terminal, while still allowing the ISRs to exit quickly if necessary.

An example process flow of a firmware controlling the AED, in accordance with an embodiment, is described in <FIG>.

Referring first to <FIG>, a relational diagram shows the communications between an AED operations control module and other firmware within the AED module, in accordance with an embodiment. As shown in <FIG>, an AED operations control module (Ops Ctrl) <NUM> includes circuitry and logic to orchestrate the overall operation of the AED module, such as AED module <NUM> of <FIG>. Ops Ctrl <NUM> is in communications a standby power usage management and monitoring module (Stdby) <NUM>, which manages the operations of the AED module when in standby mode. Stdby <NUM> includes circuitry and logic to maintain, for example, a microprocessor and related circuitry in a low-power mode to facilitate a longer shelf life for the battery systems within the AED module. When the user activates the AED module for treatment use, Stdby <NUM> sends Ops Ctrl <NUM> a signal <NUM> to commence the treatment operation of the AED module.

In an embodiment, Stdby <NUM> communicates with a charging voltage battery test module (Charge BTM) <NUM>, which includes circuitry and logic to test the battery capacity status of the battery, which powers the shock generation for the AED module. Periodically, Stdby <NUM> instructs charge BTM <NUM> to check the battery capacity of the main battery in the AED module, then send an indication via main battery status channel <NUM> back to Stdby <NUM>.

In an exemplary embodiment, Stdby <NUM> is also connected with a control voltage battery test module (Control BTM) <NUM>, which tests a control battery for powering a microprocessor and related control circuits. Periodically, Stdby <NUM> instructs Control BTM <NUM> via a control battery status channel <NUM> to test the capacity of the control battery, then send an indication back to Stdby <NUM>.

Additionally, in an embodiment, Stdby <NUM> communicates with a user notification module (UI) <NUM>, which includes circuitry and logic to manage the conveyance of information to a user regarding device maintenance, as well as during AED operation. For instance, if either a signal from main battery status channel <NUM> or control battery status channel <NUM> indicates that the charge of the respective battery is low and requires replacement or maintenance, Stdby <NUM> sends a status alert signal <NUM> to UI <NUM> to display an alert indication to notify a user of the problem. UI <NUM> also is in direct communications with Ops Ctrl <NUM> via a UI communication channel <NUM> to display user guidance or alerts during the operations of the AED module, as will be explained in detailed as the appropriate juncture below.

Continuing to refer to <FIG>, in an exemplary embodiment, Ops Ctrl <NUM> is connected with a pads placement monitoring module (Pads Mon) <NUM>, which includes circuitry and logic to monitor whether a user has properly attached a pair of cardiac pads onto the SCA patient. Upon initiation of the AED operations, and after Ops Ctrl <NUM> prompts the user to place the cardiac pads on the SCA patient via UI communication channel <NUM> to UI <NUM>, Ops Ctrl <NUM> checks with Pads Mon <NUM> via a to ensure the cardiac pads have indeed been properly attached via a pad status channel <NUM>. Additionally, Pads Mon <NUM> can communicate with Ops Ctrl <NUM> on an asynchronous basis (indicated by a dashed arrow <NUM>) to alert Ops Ctrl <NUM> in case, for example, if a cardiac pad becomes detached from the SCA patient.

Still referring to <FIG>, Ops Ctrl <NUM> is also in communication with a multiple shock protocol management module (Multi-Shock) <NUM> via a multi-shock channel <NUM>, in an embodiment. Multi-Shock <NUM> includes logic to manage situational behavior of the AED in cases where the initial shock does not result in a return to normal sinus rhythm for the SCA patient. Ops Ctrl <NUM> also communicates with an event recording module <NUM> via an event recording channel <NUM>. In an embodiment, event recording module <NUM> includes circuitry and logic to manage the capture of data related to, for instance, the condition of the SCA patient, therapeutic efforts by the AED, and external communications records.

In an exemplary embodiment, Ops Ctrl <NUM> manages a charge/discharge management and monitoring module (Charge Mod) <NUM>. Charge Mod <NUM> includes circuitry and logic to manage the charging of the capacitor for storing the charge to a correct level in order to administer a therapeutic shock. Charge Mod <NUM> also includes circuitry and logic to manage the discharge of the capacitor in the event that a therapeutic shock is not required, such that the AED can be handled safely and returned to storage in a safe state. Charge Mod <NUM> communicates with Ops Ctrl <NUM> via a charge management channel <NUM> to receive and acknowledge, for example, a charge or a discharge command. Also, Charge Mod <NUM> can asynchronously communicate its status to Ops Ctrl <NUM> (as indicated by a dashed arrow <NUM>), such as to indicate the capacitor charge has been reduced to a safe handling level sometime after a discharge command has been received from Ops Ctrl <NUM>.

In an embodiment, Ops Ctrl <NUM> also controls a subject monitoring / shockability decision module (Subject Mon) <NUM>, including the SIA. Subject Mon <NUM> includes circuitry and logic to manage the gathering of physiological measurements, such as cardiac rhythm, body impedance, and/or ECG signal. Subject Mon <NUM> also includes circuitry and logic to analyze the collected data to determine whether the SCA patient's condition is one that requires or can benefit from a defibrillating shock. Ops Ctrl <NUM> issues requests to Subject Mon <NUM> to determine shockability of the SCA patient via a subject monitoring channel <NUM>. Whenever a determination of the shockability of the SCA patient has been made, sometime after receipt of the request for shockability determination from Ops Ctrl <NUM>, Subject Mon <NUM> send an indicator back to Ops Ctrl <NUM> via an asynchronous communication (indicated by a dashed arrow <NUM>). Finally, Ops Ctrl <NUM> also controls a shock control module (Shock Ctrl) <NUM> via a shock control channel <NUM>. In an embodiment, Shock Ctrl <NUM> includes circuitry and logic to manage the determination of the shock waveform parameters, such as the durations of the positive and negative components to a biphasic shock, based on analysis of physiological measurements such as body impedance. Shock Ctrl <NUM> further includes, in an embodiment, circuitry and logic to produce a biphasic shock waveform, according to the calculated parameters, then deliver the shock to the cardiac pads placed on the SCA patient. Shock Ctrl <NUM> asynchronously sends a communication to Ops Ctrl <NUM> (indicated by a dashed arrow <NUM>) to indicate, for example, that a shock has been delivered to the cardiac pads, as well as additional information such as the waveform parameters and patient vital signs.

<FIG> shows a standby process flow <NUM> showing the firmware process for AED standby mode, in accordance with an embodiment. Standby process flow <NUM> begins when the AED module is brought into service in a step <NUM>. This step may involve, for example, the insertion of a 9V battery into the appropriate receptacle, or the removal of an insulating strip from the battery compartment to bring the power source in contact with the rest of the internal circuitry. Then a decision <NUM> is made to determine whether the AED is to be activated in the normal mode of operation. If the decision is YES, then Stdby <NUM> sends standby signal <NUM> to Ops Ctrl <NUM> to commence normal, non-standby functions of AED module in service, as was also shown in <FIG>. If decision <NUM> is NO, then Stdby <NUM> activates the AED module in an On-the-shelf (low power) mode in a step <NUM>.

While in low power mode, in the embodiment shown in <FIG>, Stdby <NUM> is activated on a preset schedule to check the status of the batteries in a periodic wake-up step <NUM>. In one aspect, a message <NUM> is then sent to a step <NUM> in Charge BTM <NUM> to check the status of the household battery that is used to charge the capacitor (or multiple capacitors). A decision <NUM> is made at Charge BTM <NUM> to determine whether the charging battery status is okay (i.e., there is enough charge left in the charging battery to power the necessary therapeutic shock). Whether the charging battery status is YES okay or NO not okay, the battery status is recorded in a step <NUM>. Sequentially, or in parallel, a message <NUM> is sent to a step <NUM> in Control BTM <NUM> to check the status of a separate battery that is used to power the control circuitry in the AED module, in accordance with an embodiment. A determination is made in a decision <NUM> whether or not the controller battery status is okay and, whether the status is YES okay or NO not okay, the battery status is again recorded in step <NUM>. The status of both the charging battery and the controller battery are sent to UI <NUM> in a step <NUM>, then displayed to the user in a step <NUM>.

Considering now <FIG> and <FIG>, an exemplary embodiment of a process that is started when a signal <NUM> to commence the shock protocol of the AED is illustrated. When signal <NUM> is received at Ops Ctrl <NUM>, a step <NUM> initializes the AED module for normal operation. In a step <NUM>, a command to place the cardiac pads on the SCA patient is sent to UI <NUM>, at which an indicator or display message instructs the user to place the cardiac pads, in a step <NUM>. Then, in a step <NUM>, a multi-shock protocol is initialized at Multi-Shock <NUM>, where "multi-shock" refers to the treatment protocol in which, if certain preset conditions are met, then a series of shocks can be generated at the AED module then applied to the SCA patient as needed. The initialization of the multi-shock protocol at Multi-Shock <NUM> indicates to Multi-Shock <NUM> the start of an emergency session involving an SCA patient, and that future requests for authorization to shock are related to this specific SCA patient. Then, in a step <NUM>, logic to control the number of allowed shocks is initialized at Multi-Shock <NUM>. The logic may include, for example, an analysis of the number of shocks already applied, and the current status of the physiological indicators measured from the SCA patient. In a step <NUM>, a request is made to Multi-Shock <NUM> to request authorization to apply a shock. The logic within Multi-Shock <NUM> analyzes the request and, in a decision <NUM>, determines whether to approve the generation and application of a shock to the SCA patient. If the answer to decision <NUM> is NO, then the process is ended in a step <NUM>. If the answer to decision <NUM> is YES, then the process moves back to Ops Ctrl <NUM>, as shown in <FIG>.

Referring now to <FIG>, a YES result of decision <NUM> from Multi-Shock <NUM> is communicated to Ops Ctrl <NUM>, at which a step <NUM> issues a command to Charge Mod <NUM> to charge the capacitor. At the same time, or sequentially, Ops Ctrl <NUM> begins monitoring the patient in a step <NUM>. The monitoring involves, for example, sensing the cardiac pad placement on the SCA patient in a step <NUM> at Pads Mon <NUM>. The feedback from the cardiac pads, such as the correct placement of the cardiac pads on the SCA patient, are monitored in a step <NUM> at Pads Mon <NUM>, and the results are fed back to a step <NUM> to process the various monitoring signals. Patient monitoring of step <NUM> may also include monitoring the vital signs of the SCA patient in a step <NUM> at Subject Mon <NUM>. The vital signs, such as cardiac rhythm, are fed back to step <NUM> to be monitored. Additionally, Subject Mon <NUM> also determines, in a decision <NUM>, whether or not the detected cardiac rhythm corresponds to a shockable rhythm, as previously described above. If the answer to decision <NUM> is YES, then the result is communicated to step <NUM> as part of the signal monitoring. If the answer to decision <NUM> is NO, then Subject Mon <NUM> returns to step <NUM> to continue monitoring the vital signs.

In an embodiment, at Charge Mod <NUM>, a step <NUM> enables the capacitor charging circuitry, and the capacitor charging status is monitored in a step <NUM>. A decision <NUM> determines whether the capacitor has been sufficiently charged to enable the application of a shock to the SCA patient. If the answer to decision <NUM> is YES, then the result is communicated to step <NUM>. If the answer to decision <NUM> is NO, then Charge Mod <NUM> returns to step <NUM> to continue monitoring the capacitor charge status.

The monitored signals from step <NUM> are then fed into a decision <NUM> to determine whether both the charging system and the SCA patient are ready for the application of a shock. If the answer to decision <NUM> is NO, then Ops Ctrl <NUM> continues to monitor the incoming signals in step <NUM>. If the answer to decision <NUM> is YES, then Ops Ctrl <NUM> commands the user to stand clear of the SCA patient in a step <NUM>, which is communicated through UI <NUM>, which instructs the user to stand clear via a display message or other means in a step <NUM>. After a set time period, such as <NUM> to <NUM> seconds during which the user should have stood back from the SCA patient, Ops Ctrl <NUM> warns the user in a step <NUM> of the incoming shock, which is communicated to the user in a step <NUM> at UI <NUM>. Ops Ctrl <NUM> then requests a shock in a step <NUM>, which prompts Shock Ctrl <NUM> to initiate a shock management protocol in a step <NUM>. Upon completion of the shock application, Ops Ctrl <NUM> goes into a follow-up protocol step <NUM>.

Turning now to <FIG>, further details of the processing performed by Subject Mon <NUM>, in accordance with an embodiment, are described. Subject Mon <NUM>, as shown in <FIG> and <FIG>, receives a signal from Ops Ctrl <NUM> to begin patient monitoring. When this signal is received at Subject Mon <NUM>, a step <NUM> initializes the patient monitoring circuitry provided with the AED module. For example, sensors for electrocardiograph monitoring, cardiac rhythm monitoring, and respiratory rhythm can be included with the AED module. The various monitored signals are recorded in a step <NUM> at Event Recording Module <NUM>, and also returned to Ops Ctrl <NUM> to step <NUM> of processing the various monitoring signals. The patient vital signs so measured are also fed into a step <NUM> to apply a shockability analysis algorithm, as previously described, then to decision <NUM> to determine whether the SCA patient is exhibiting a shockable cardiac rhythm.

<FIG> and <FIG> illustrate further details of step <NUM> initiate shock management protocol as shown in <FIG>, in accordance with an embodiment. The shock management protocol involves the firmware process for managing a shock protocol and generating an electric shock, in accordance with an embodiment. When Ops Ctrl <NUM> requests a shock to be generated in step <NUM>, Shock Ctrl <NUM> receives the request and initializes a body impedance measurement circuit in a step <NUM>. Then, using sensors in the cardiac pads, for example, or by other measurement mechanism provided with the particular embodiment of the AED module, the body impedance of the SCA patient is measured in a step <NUM>. The measured body impedance is recorded at Event Recording Module <NUM> in a step <NUM>.

Continuing to refer to <FIG>, a decision <NUM> is made to determine whether the body impedance measured in step <NUM> is within the range in which the AED module power circuitry can adjust the shock waveform for safe application to the particular patient. For instance, if a biphasic waveform, such as shown in <FIG> is to be used for the shock, there is a range of body impedance values for which the AED module is able to accommodate and adjust the waveform parameters for application of shock within American Heart Association guidelines. If the measured body impedance is lower (i.e., the SCA patient is too small) or higher (i.e., the SCA patient is too large) than the range of allowable body impedance values, then Ops Ctrl <NUM> is so notified in a step <NUM> and no shock is administered. Shock Ctrl <NUM> then instructs UI <NUM> to display an error message in a step <NUM>, and UI <NUM> accordingly displays an error message for the user in a step <NUM>.

If decision <NUM> determines that the measured body impedance is within the range for which a suitable waveform can be generated, then the necessary waveform parameters are calculated in a step <NUM>. Step <NUM> involves, for example, uses an algorithm that, given vital sign measurements from the patient such as, but not limited to, body impedance, cardiac rhythm, and ECG data, calculates the appropriate timing and amplitudes of the positive and negative phases of the generated waveform, as shown in previously discussed <FIG>. The calculated waveform parameters are recorded at Event Recording module <NUM> in a step <NUM>, then instructions are sent to the high voltage drivers in the AED module to power up in a step <NUM>.

Referring now to <FIG>, once the high voltage drivers are powered up in step <NUM>, Shock Ctrl <NUM> instructs the high voltage drivers to generate a timed positive phase component of a biphasic waveform shock in a step <NUM>. Shock Ctrl <NUM> monitors the generation of the timed positive phase component and, in a decision <NUM>, determines whether the generation of the timed positive phase component is complete. If decision <NUM> determines that the high voltage drives have not completed the generation of the timed positive phase component, then Shock Ctrl <NUM> continues to monitor the high voltage drivers. When the result of decision <NUM> is YES, then Shock Ctrl <NUM> instructs the high voltage drivers to generate the timed interphase, or quiescent, component between the positive and negative phases of the biphasic waveform in a step <NUM>. Again, Shock Ctrl <NUM> monitors the generation of the timed interphase component and, in a decision <NUM>, determines whether the generation of the timed interphase component is complete. If decision <NUM> determines that the timed interphase component generation is not yet complete, then Shock Ctrl <NUM> continues to monitor the high voltage drivers. When the result of decision <NUM> is YES, then Shock Ctrl <NUM> instructs the high voltage drivers to generate the timed negative phase component in a step <NUM>. Yet again, Shock Ctrl <NUM> monitors the generation of the timed negative phase component and, in a decision <NUM>, determines whether the generation of the timed negative phase component is complete. If decision <NUM> determines that the timed negative phase component generation is not yet complete, then Shock Ctrl <NUM> continues to monitor the high voltage drivers. When the result of decision <NUM> is YES, then Shock Ctrl <NUM> instructs the high voltage drivers to power down in a step <NUM> and proceeds to the follow-up protocol at Ops Ctrl <NUM>. The details of the shock event are also recorded at Event Recording Module <NUM> in a step <NUM>.

In another embodiment, the portable AED is configured to be housed in a bracket, which is mountable on a wall or other location. The bracket can include, for example, a connection to a power outlet such that the bracket can serve as a charging station for the AED, if a rechargeable battery is used within the AED module, or to provide additional functions. For instance, the bracket provides a monitoring function for the AED so as to alert the user, e.g., via a visual warning on the bracket or communication through the associated mobile device application or user webpage, in the case of situations such as: <NUM>) the AED has been removed from the bracket; <NUM>) a battery in the AED is low and needs to be replaced; and <NUM>) the AED has a problem and needs to be serviced. The bracket can also include a button, either a physical button or on a touch screen, to immediately alert EMS or other contacts programmed into the mobile device application in the case of an emergency.

An exemplary embodiment of a bracket is shown in <FIG>. A bracket system <NUM> includes a bracket body <NUM>, which in turn includes one or more lips <NUM> (three are shown in the embodiment illustrated in <FIG>) for housing an AED module (not shown) when the AED module is not in use. In the example shown in <FIG>, bracket system <NUM> includes an emergency call button <NUM>, which can be pressed by a user to immediately contact emergency medical services (e.g., via a <NUM> call in the US). Alternatively, call button <NUM> can be replaced by a touchscreen including an emergency call function as well as being capable of displaying additional information, such as the AED battery status and AED user guidance. Call button <NUM> (or a touchscreen equivalent) can also be configured to alert specified contacts programmed into a software application installed on a mobile device. For instance, the firmware in bracket system <NUM> can be configured to automatically contact EMS as well as specified contacts (e.g., relatives and friends) programmed into the software application on a mobile device paired with bracket system <NUM>.

Bracket system <NUM> also includes a sensor <NUM> for detecting whether the AED module is housed in bracket body <NUM>. For instance, when the AED module is housed in bracket body <NUM>, sensor <NUM> detects the presence of the AED module such that bracket system <NUM> remains in a low power mode. When the AED module is removed from bracket system <NUM>, then bracket system <NUM> goes into an active mode, in which certain functions of the bracket system <NUM> are activated. Optionally, bracket system <NUM> can be configured such that, when sensor <NUM> detects that the AED module has been removed from bracket system <NUM>, bracket system <NUM> automatically prompts the user to contact EMS or even immediately contact EMS without additional user input.

As shown in <FIG>, bracket system <NUM> also includes an indicator <NUM>, which can be used to show the user the status of a Wi-Fi connection or cellular signal strength, if bracket system <NUM> is configured to be connectable to an external communication system. Bracket system <NUM> also includes a microphone <NUM> and a speaker <NUM> to facilitate hands-free communications with EMS via bracket system <NUM>. For instance, when the AED module is removed from bracket system <NUM>, bracket system <NUM> automatically alerts EMS that there is an emergency situation, and also prompts the user by audio (as shown in <FIG>) or by visual prompt (e.g., if a touchscreen is used instead of emergency call button <NUM>). As an example, the removal of the AED module from bracket system <NUM> leads to bracket system <NUM> automatically contacting EMS and generating a voice prompt <NUM> to the user. As an option, a lag time of, for instance, one minute may be given between the time the AED module is removed from bracket system <NUM> to when EMS is contacted such that, if the AED module is accidentally removed, the user is given time to replace the AED module and avoid unnecessarily contacting EMS.

<FIG> illustrate an exemplary embodiment of a portable AED module having features as described above. A portable AED module <NUM> has dimensions of approximately <NUM>-inches by <NUM>-inches by <NUM>-inches, and is shown in ISO, side, and bottom views in <FIG>, respectively. As shown in the exemplary embodiment, portable AED module <NUM> is powered by a battery arrangement <NUM> including a plurality of batteries <NUM>. In the embodiment shown in <FIG>, batteries <NUM> are four CR123 batteries, which are commonly-available household batteries. AED module <NUM> also include various connection ports <NUM> and <NUM> that provide connections for the cardiac pads, as well as test inputs and outputs. Outer enclosure <NUM> of portable AED module <NUM> is configured to minimize the risk of shock to the user, as well as to protect the internal electronic circuitry of the AED module from hazards, such as electrostatic discharge (ESD) and moisture. Portable AED module <NUM> further includes a plurality of button switches <NUM> for accessing various functionalities of portable AED module <NUM>, as well as serving as status indicators by color coded illumination of the button switches. Using a single household 9V alkaline battery, a high voltage of 1700V was achieved in <NUM> seconds, without current limiting, on the first charge cycle, and in <NUM> seconds, with current limiting for safety and battery power conservation. Embodiments replacing the 9V battery with four CR123 batteries in series have been demonstrated to achieve even faster charge times around <NUM> seconds using custom circuitry.

Turning now to <FIG>, an example of an electronics architecture <NUM> suitable for use with a portable AED module, in accordance with an embodiment, is shown. Electronics architecture <NUM> includes a microcontroller <NUM> (equivalent to microprocessor <NUM> of <FIG>) overseeing the operations of a logic control circuit <NUM>. Power to microcontroller <NUM> and logic control circuit <NUM> are supplied via a logic supply circuit <NUM> from a dedicated controller battery <NUM>, which is separate from a battery used to generate the therapeutic charge in the portable AED module, such that the controller operations do not drain the charge battery. The power source for the actual charge generation is a charge battery <NUM>, which is shown as a 9V battery in <FIG>, although other types of household batteries can be used as well. A current limiter <NUM> adjusts the current drawn from charge battery <NUM> for the charge generation. Current from charge battery <NUM> is directed through a high voltage DC-DC converter <NUM>, from which the output is used to charge a high voltage capacitor <NUM>. Logic control circuit <NUM> provides the necessary logic for safely operating high voltage DC-DC converter <NUM>, as well as discharging high voltage capacitor <NUM>, if the generated charge is not needed or the operation of the portable AED module is interrupted. The charge stored in high voltage capacitor <NUM> is output to the cardiac pads (shown in <FIG> as "paddles") via an H Bridge <NUM> controlled by an H Bridge driver <NUM>, which in turn is controlled by logic control circuit <NUM>. H Bridge driver <NUM> controls the generation of the appropriate shock waveform, such as a biphasic waveform, with the appropriate waveform parameters suitable for the specific SCA patient, as indicated by vital signs measurements. Electronics architecture <NUM> is suitable for use, for example, with the firmware configuration described in relation to <FIG>.

The illustrations of arrangements described herein are intended to provide a general understanding of the structure of various embodiments, and they are not intended to serve as a complete description of all the elements and features of apparatus and systems that might make use of the structures described herein. Many other arrangements will be apparent to those of skill in the art upon reviewing the above description. Other arrangements may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Figures are also merely representational and may not be drawn to scale. Certain proportions thereof may be exaggerated, while others may be minimized. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.

The descriptive labels associated with the numerical references in the figures are intended to merely illustrate embodiments of the invention, and are in no way intended to limit the invention to the scope of the descriptive labels. The present systems, methods, means, and enablement are not limited to the particular systems, and methodologies described, as there can be multiple possible embodiments, which are not expressly illustrated in the present disclosures. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the present application.

Claim 1:
A compact, automated external defibrillator (AED) system, the system comprising: an electronics module (<NUM>), including:
a power source,
electronic circuitry for generating, storing, and dispensing electrical charge from the power source, the electrical charge being suitable for at least one electrical shock to be applied to a sudden cardiac arrest (SCA) patient,
a display (<NUM>) for providing guidance to a user of the system, the guidance including instructions on using the system,
firmware for controlling the electronic circuitry and the display; and
at least two cardiac pads (<NUM>), electrically connected with the electronics module (<NUM>) and configured for external attachment to the SCA patient so as to transfer the at least one electrical shock from the electronics module to the SCA patient,
wherein the power source is a household battery (<NUM>),
wherein the electronics module (<NUM>) includes a current charger and a capacitor (<NUM>), the capacitor being configured to store a prescribed amount of energy to deliver the at least one electrical shock, characterized in that the current charger is configured to use a low current constant charge rate to charge the capacitor (<NUM>), and
wherein the electronics module (<NUM>) further includes a microprocessor (<NUM>), and wherein the low current constant charge rate is controlled by a pulse-width modulation (PWM) signal from the microprocessor (<NUM>), the current charger using a low current constant charge rate in the milliamp range controlled by pulse-width modulation (PWM) signals from the microprocessor (<NUM>) to charge the energy storage capacitor (<NUM>) to the prescribed amount of energy within <NUM> seconds or less.