Patent Description:
Embodiments disclosed herein relate to systems and methods for a wearable lifesaving defibrillator.

Automated External Defibrillators (AED) are portable devices used to defibrillate patients having a sudden cardiac arrest (SCD) event, generally due to ventricular tachycardia (VT) or ventricular fibrillation (VF). When a person loses consciousness, and there is a chance of VT or VF, an AED is brought to the patient for use. An AED generally functions as follows: two patches are affixed to the subject's chest and abdomen; the AED detects the heart rate and analyses the subject's heart condition using ECG electrodes integrated into the patches; and, if VF or VT are detected, the AED automatically delivers a high voltage and high energy electrical shock to the subject through the patches. This process differs from a standard defibrillator in which the high energy, high voltage shock is initiated by personnel operating the defibrillator. With an AED, the process of analyzing the heart condition and delivering of the shock is automated. The AED patches are adhered to the patient using a short-term adhesive since the patches are generally attached for not more than one hour. Further, since the patient has lost consciousness and is lying horizontally, the patches and adhesive are not designed for vertical adhesion or movement of the patient or for carrying the patch's weight.

Wearable Cardiac Defibrillators (WCD) differ from regular AEDs as WCDs are worn continuously by patients who are at high risk of sudden cardiac arrest (SCA) caused by VT or VF to provide continuous protection to the patient. Unless the VF is detected and defibrillation administered within a few seconds, VF and related SCA may cause sudden cardiac death (SCD). Patients who are at high risk for VF are candidates for an implantable cardioverter defibrillator (ICD). During the waiting period until the ICD implantation (in case such an implantation is not immediate), or in cases where the indication for ICD implantation is not sufficiently clear, a WCD is often used. The functionality provided by a WCD is thus similar to that of an ICD, but provided for a limited time period and without the need for an invasive implanting procedure.

WCDs usually include two types of patches/electrodes: sensing electrodes or patches and shocking electrode or patches. The sensing electrodes or patches are similar to standard ECG patches in function and are used to sense the ECG of the patient in order to detect VF. The defibrillation electrodes or patches are used to transmit a high voltage and high energy defibrillation shock to the patient's heart in a case of SCA. These shocks usually have a voltage in the range of 1000V-3000V and energy in the range of <NUM>-<NUM> Joules. In practice the voltage and energy to be delivered depends on the patient impedance, which is usually measured prior to shock delivery.

Some current WCDs consist of sensing patches and shocking electrode patches that are stuck onto the patient's skin using some form of adhesive. Since a wearable defibrillator must be used on a <NUM>/<NUM> basis and often for extended periods of time (several days and typically over one week), patches that are in contact with the patient's body via the adhesive may cause discomfort for the patient and skin irritations in some cases, and make it difficult to perform normal daily activities. The discomfort from the adhesive patches is therefore a function of both the time used and also the amount of activity.

To resolve the skin discomfort from adhesives, other current WCDs consist of a wearable vest/top where the sensing patches and shocking electrode patches are pressed against the patient's skin, usually by one or more tightening straps such as over-shoulder and torso straps. In order to sufficiently deliver the high energy defibrillation pulse, a good connection is required between the shocking electrode patches and the patient's skin. Since the patches in the vest are not stuck to the patient's body, they are held in tight direct contact with the patient's skin by the vest and also feature a gel release mechanism to enhance skin contact required during shock delivery. Tight vests force electrodes into contact with the patient's body, thus also causing major discomfort and making it difficult to perform normal daily activities. Additionally, the vest itself is in direct contact with the patient's skin and can also cause significant discomfort. Further the vest needs to be washed on a daily basis while active elements are removed and repositioned in a secondary vest, forcing the patient to ensure the repositioned active elements are placed correctly on a daily basis. In some known cases patients were not protected since the active elements were incorrectly positioned by the patient. Finally, such daily maintenance activity may not be appropriate for elderly patients or patients who need care or assistance.

Further, the defibrillation electrical elements (batteries, capacitors and electronic circuits) are usually provided in a box that must be worn, such as with a strap or clamp onto clothing, resulting in a cumbersome source of discomfort to the patient. These causes of discomfort (patches, vest, box) may result in the patient removing the vest or patches, thus causing compliance issues and potentially endangering the life of the patient.

Finally, although wearable defibrillators feature ECG patches attached to a patient, they generally do not make use of these for integration with a cardiac telemetry system. Cardiac telemetry is usually provided by devices such as Holter monitors or implantable recorder systems that feature ongoing heart monitoring.

<CIT> discloses a wearable external defibrillator with a plurality of ECG sensing electrodes and a first defibrillator pad electrode and a second defibrillator pad electrode. The ECG sensing electrodes and the defibrillator pad electrodes are configured for long term wear.

Exemplary embodiments disclosed herein relate to a wearable automated Belt Cardiac Defibrillator (BCD).

The BCD as disclosed herein is adapted so as provide AED functionality and automated ease of use in a wearable form that is comfortable for long term use by a subject. Improvements in comfort are provided by several innovations as described further herein:.

In some other embodiments, a proposed BCD includes defibrillation electrodes and ECG sensors mounted in a flexible removable patch strip for adhesion to the patient or insertion into a stretchable, washable top.

Further, in some embodiments, the BCD as disclosed performs cardiac telemetry by continuously monitoring and analyzing the subject's heart using the ECG sensor and controller, and reporting detected arrhythmias to a patient's phone and/or to a remote monitoring center.

In some embodiments, a flexible automated wearable belt cardiac defibrillator (BCD) for wearing by a subject, comprises: at least two patches adapted for adhering to the subject each comprises a defibrillation electrode and at least one ECG sensor; and a BCD controller connected to each of the patches, wherein the patches comprise an adhesive adapted for long-term adhering of the patches to the subject, wherein the patches and adhesive are adapted for movement of the subject while the patches are adhered to the subject, wherein the patches are replaceable, wherein the controller is housed in a flexible belt comprises a plurality of compartments for wearing by the subject, wherein the controller is adapted for being flexible, and wherein the adaptation for being flexible comprises distributing the controller components between the plurality of compartments.

In some embodiments, the controller components comprise a battery, at least one high voltage and high energy capacitor, and controller electronics, and each of the controller components is housed in a separate one of the plurality of compartments. In some embodiments, the belt comprises a flexible material. In some embodiments, "long-term" is between one day and <NUM> days. In some embodiments, "long-term" may be even longer than <NUM> days. In some embodiments, the compartments have the form of pockets. In some embodiments, the patches comprise a gel for enhancing electrical contact. In some embodiments, the adhesive is a biocompatible adhesive.

In some embodiments, at least one of the patches comprises a vibration element. In some embodiments, the vibration element is adapted for vibrating to alert the subject prior to an impending shock delivery by the defibrillation electrode. In some embodiments, the weight of the controller components is distributed around the belt. In some embodiments, the patches are small patches having dimensions of less than 8x8cm. In some embodiments, at least three patches for providing at least two defibrillation vectors. In some embodiments, the controller comprises a controller vibration pad.

In some embodiments, the controller vibration pad is adapted to generate vibration to alert the subject of an impending shock to be delivered by the defibrillation electrode. In some embodiments, the controller comprises an audio output device adapted to generate an alarm sound in case of an impending a shock about to be delivered by the defibrillation electrode. In some embodiments, the audio output device is adapted to sound an alarm following administering of a defibrillating shock. In some embodiments, the controller comprises a microphone adapted for recording the audio output of the subject.

In some embodiments, the controller is adapted for storage and/or analysis of ECG sensor data sensed by the ECG sensor. In some embodiments, the controller comprises an ECG event button and pressing the event button creates a time stamp in the collected ECG sensor data. In some embodiments, pressing of the ECG event button initiates recording via the microphone. In some embodiments, the controller is adapted to measure impedance between the patches and the body of the subject to determine the strength of the electrical connection therebetween. In some embodiments, the controller comprises an abort button adapted for aborting an impending shock from the defibrillation electrode. In some embodiments, the BCD further comprises a safety switch and the safety switch is adapted to electrically disconnect the controller from the defibrillation electrode.

In some embodiments, the controller comprises a controller motion sensor and/or the BCD comprises an ECG sensor motion sensor. In some embodiments, one or both of controller motion sensor and the ECG motion sensor are adapted for determining data related to movement of the subject. In some embodiments, the patches comprise multiple perforations throughout the patches. In some embodiments, the patches comprise connectors for connecting or disconnecting interconnection cables between the patches and/or between the patches and the controller.

In some embodiments, the controller is adapted for data communication with a remote monitoring center (RMC). In some embodiments, ECG data sensed by the ECG sensor is transmitted to the RMC for analysis and storage. In some embodiments, detected arrhythmia events are transmitted to the RMC. In some embodiments, the controller comprises a GPS receiver adapted for determining the geolocation of the BCD, wherein the determined location is transmitted to the RMC. In some embodiments, the controller comprises a microphone and an audio device and is adapted for initiating a voice call with the RMC.

In some embodiments, the controller is adapted for wireless communication with an external device. In some embodiments, the external device presents the status of the BCD using a display of the external device. In some embodiments, audible, visual and/or vibrating indication of an impending shock to be delivered by the defibrillator electrode is provided by the external device using display, audio, and/or vibrating functions of the external device. In some embodiments, the external device comprises an abort button for aborting an impending shock to be delivered by the defibrillator electrode. In some embodiments, the BCD is adapted to deliver high voltage temporary external percutaneous heart pacing via the patches following detection by the BCD of asystole after delivering a shock. In some embodiments, the pacing is ventricular demand pacing. In some embodiments, the pacing is provided at a rate of <NUM> BPM.

In some embodiments, the BCD functions without the need for any other part of the BCD to be in contact with the subject's skin other than the patches. In some embodiments, the controller is not attached to the subject via a patch touching the subject skin. In some embodiments, the patches include at least two ECG sensor electrodes for ECG sensing from at least one sensing vector. In some embodiments, the patches include electrodes delivering a high voltage and high energy defibrillation shock from at least one shocking vector.

In some embodiments, a method for usage of an BCD comprises: providing the BCD as described above; adhering of the patches to the subject; operating the BCD; and following completion of an operational period, positioning of the patches to alternative locations on the subject wherein each of the alternate locations represents an alternate shock vector.

In some embodiments, the alternate shock vector is selected from the list consisting of: a first shock vector comprises a first patch on a right side of the chest and a second patch on a left side of the abdomen, a second shock vector comprises the first patch on a left side of the chest and the second patch on a right side of the abdomen and a third shock vector comprises the first patch on an upper right side of the chest and the second patch on an upper left side of the back.

In some embodiments, the controller is adapted to indicate completion of the operational period for movement of the patches. In some embodiments, the external device is adapted to provide guided instructions for positioning of the patches.

In some embodiments, a BCD for wearing by a subject, comprises: a removable patch strip (RPS) comprising at least one defibrillation patch and at least one ECG sensor; and a top comprising a pocket for insertion of the RPS, such that the at least one defibrillation patch and the at least one ECG sensor are pressed against the torso of the subject. In some embodiments, the top comprises a stretchable material. In some embodiments, the top comprises a washable material.

As used herein, the terms "patch" or "pad" describe a patch incorporating one or both of a sensing electrode and a defibrillation electrode. The terms "patient" and "subject" are used herein interchangeably.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting.

Implementation of the method and system of the present disclosure may involve performing or completing certain selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present disclosure, several selected steps may be implemented by hardware (HW) or by software (SW) on any operating system of any firmware, or by a combination thereof. For example, as hardware, selected steps of the disclosure could be implemented as a chip or a circuit. As software or algorithm, selected steps of the disclosure could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the disclosure could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.

Although the present disclosure is described with regard to a "computing device", a "computer", or "mobile device", it should be noted that optionally any device featuring a data processor and the ability to execute one or more instructions may be described as a computer, including but not limited to any type of personal computer (PC), a server, a distributed server, a virtual server, a cloud computing platform, a cellular telephone, an IP telephone, a smartphone, a smart watch or a PDA (personal digital assistant). Any two or more of such devices in communication with each other may optionally comprise a "network" or a "computer network".

Aspects, embodiments and features disclosed herein will become apparent from the following detailed description when considered in conjunction with the accompanying drawings. Like elements may be marked with like numerals in different figures, where:.

Exemplary embodiments disclosed herein relate to a wearable AED (BCD) and method of use. <FIG> shows an exemplary schematic drawing of a BCD according to some embodiments. <FIG> shows a BCD <NUM> comprising a removable patch strip (RPS) <NUM> and a defibrillator controller <NUM>. RPS <NUM> comprises one or more defibrillation (shocking) patches <NUM> and ECG sensors <NUM>. RPS <NUM> comprises a soft structural base <NUM> comprising a soft material. In some embodiments, RPS <NUM> is biocompatible. In some embodiments, RPS <NUM> is held in place on the subject using a biocompatible adhesive (not shown). Defibrillator controller <NUM> monitors the subject's heart using sensors <NUM> and triggers defibrillation patches <NUM> if required. Sensors <NUM> and defibrillation patches <NUM> are connected to defibrillator controller <NUM> using wires <NUM>. In some embodiments, defibrillation patches <NUM> comprise either a constant gel layer or a gel release mechanism (not shown) for releasing gel prior to defibrillation to improve conductivity of the defibrillation shock.

<FIG> show exemplary schematic drawings of a BCD according to some embodiments. As shown in <FIG>, a BCD <NUM> comprises a stretchable top <NUM>, an RPS <NUM> and a controller <NUM>. RPS <NUM> comprises one or more defibrillation (shocking) patches <NUM> and ECG sensors <NUM>. RPS <NUM> is sized to removably slide into a pocket <NUM> of top <NUM>. In some embodiments, top <NUM> comprises a stretch material. In some embodiments, top <NUM> comprises a washable material.

As shown in the plan view of <FIG>, pocket <NUM> has borders <NUM> made to hold RPS <NUM> firmly in position while leaving an opening <NUM> for RPS <NUM> to touch the torso of the subject. ECG sensors <NUM> and defibrillation patches <NUM> are therefore continuously in contact with the skin.

<FIG> shows RPS <NUM> inserted into pocket <NUM>. It should be appreciated that stretchable top <NUM> holds RPS <NUM> and thus sensors <NUM> and defibrillation patches <NUM> pressed against the torso of a subject without the need for adhesives or adjusting straps. Further, a top <NUM> can be switched with another top <NUM> where RPS <NUM> can be removed from a first top <NUM> and placed in a second top <NUM>. This exchange can allow for laundering of the first top <NUM>, and vice versa.

In some embodiments, BCD <NUM> is adapted for use by a female subject. As shown in <FIG>, RPS <NUM> and pocket <NUM> are adapted to position defibrillation patches <NUM> above the right breast <NUM> of the subject.

<FIG> shows an exemplary schematic drawing of a BCD according to some embodiments. As shown in <FIG>, a BCD <NUM> comprises a top <NUM>, an RPS <NUM> and a defibrillator controller <NUM>. BCD <NUM> is the same as BCD <NUM> apart from defibrillator controller <NUM> which is replaced with defibrillator controller <NUM>. Controller <NUM> is integrated into RPS <NUM> and the components of controller <NUM> are distributed across RPS <NUM>. This distribution spreads the controller components over a larger area (compared to controller <NUM>) and thus provides enhanced weight distribution and greater comfort for the patient. In some embodiments, a housing <NUM> of controller <NUM> is cylindrical. In some embodiments, multiple housings <NUM> are provided for the components of controller <NUM>.

<FIG> shows an exemplary schematic drawing of a BCD according to some embodiments. As shown in <FIG>, a BCD <NUM> comprises a stretchable top <NUM>, an RPS <NUM>, a defibrillator controller <NUM> and an external device <NUM>. RPS <NUM> comprises one or more defibrillation patches <NUM> and ECG sensors <NUM>. RPS <NUM> is sized to removably slide into a pocket <NUM> of a top <NUM> of BCD <NUM>. Top <NUM> is the same as top <NUM> described above.

Non-limiting examples of external device <NUM> are a smart watch or smartphone. External device <NUM> is in wireless communication with defibrillation patches <NUM>, ECG sensors <NUM> and defibrillation controller <NUM>. A non-limiting example of a wireless communication protocol is Bluetooth. External device <NUM> is a computing device and runs software to monitor the subject's heart using data received wirelessly from sensors <NUM>, and triggers defibrillation patches <NUM> if required by communicating with controller <NUM> and/or defibrillation patches <NUM>. In some embodiments, controller <NUM> is integrated into RPS <NUM> similarly to the way controller <NUM> is integrated into RPS <NUM>.

<FIG> show exemplary schematic drawings of a BCD according to some embodiments. As shown in <FIG> BCD <NUM> comprises replaceable patches 510A and 510B (referred to also simply as "patches <NUM>") and a defibrillation controller belt (or simply "belt") <NUM>. Each of patches 510A, 510B comprises both a defibrillation electrode <NUM> and an ECG sensor <NUM>.

In some embodiments, each of patches <NUM> includes include three or more ECG sensors <NUM> for sensing simultaneous sensing vectors. Multiple sensing electrodes per EC sensor <NUM> provides better sensing and detection of VF and discrimination of non-VF arrhythmias.

In some embodiments, each of patches <NUM> includes three or more defibrillation electrodes <NUM> for providing multiple simultaneous shock vectors. for better coverage of the heart and reduction of defibrillation threshold energy.

Patches 510A, 510B are affixed to the body of the subject using a biocompatible adhesive that is non-irritating for skin, is adapted both for extended use and for ensuring adhesion while that the subject continues to be active and mobile. A non-limiting example of a suitable adhesive may be KM40C by Katecho LLC of Des Moines, Iowa. In some embodiments, extended use covers a period of over <NUM> days. In some embodiments, extended use covers a period of over <NUM> days.

In some embodiments, patches 510A, 510B comprise gel for enhancing electrical contact. In some embodiments, defibrillation electrode <NUM> performs ECG signal measurement and ECG sensor <NUM> is not required.

In some embodiments, replaceable patches 510A, 510B include a vibration element <NUM> used to alert the patient prior to shock delivery. In some embodiments, replaceable patches 510A, 510B are replaced periodically. In some embodiments, replaceable patches 510A, 510B are disposable. In some embodiments, BCD <NUM> comprises more than two patches <NUM>. Cables <NUM> provide electrical connectivity between patches <NUM> and cables <NUM> provide electrical connectivity between patches <NUM> and controller belt <NUM>. As shown in <FIG>, each of patches <NUM> includes connectors <NUM> for connecting of cables <NUM> and <NUM> to patches <NUM>. When one or more of patches <NUM> are replaced, they are disconnected at connectors <NUM> from cables <NUM> and/or <NUM>, and new patches <NUM> also including connectors <NUM> are connected to cables <NUM> and/or <NUM>. In some embodiments, controller belt <NUM> includes a switching component in order to carry both of sensing signals and shock current on the same electrode.

Controller belt <NUM> has the form of a flexible belt. Belt <NUM> comprises a flexible material. Controller belt <NUM> is flexible and wearable and comprises an adjustment means <NUM> such a belt adjustment means known in the art in order to fit controller belt <NUM> comfortably around the waist or torso of the subject. Alternatively, belt <NUM> may be worn on another part of the body or may be carried.

Controller belt <NUM> contains all the components of a defibrillator controller (such as controller <NUM>, high voltage capacitors, batteries, electronics, high voltage shock circuits, alarm system, communication system, operating software as well as detection algorithm software) embedded in a flexible manner. In the form of a flexible belt, controller <NUM> is portable and well suited for comfortable wearing by a patient on a daily basis and may be shifted around the waist of the subject (or worn elsewhere) for comfort. As shown in <FIG>, controller belt <NUM> comprises a belt <NUM> comprising a flexible material and compartments <NUM> for housing of the components of defibrillation controller <NUM>. It should be appreciated that distributing the components of defibrillation controller <NUM> between compartments <NUM> provides the required flexibility and overcomes the discomfort of wearing or carrying a box. It should further be appreciated that controller belt <NUM> does not need to touch the patient's body or skin and therefore is not a source of skin irritation. Only patches <NUM> need to be in contact with the patient's skin. It should further be appreciated that the controller is not attached to the subject via a patch touching the subject's skin.

Wiring (not shown) between compartments <NUM> provides for the electrical connections between the components of controller <NUM>. In some embodiments, compartments <NUM> are cylindrical in shape. In some embodiments, compartments <NUM> have the form of a pocket. In some embodiments, compartments <NUM> are rectangular in shape. In some embodiments, belt <NUM> is a lightweight belt. In some embodiments, belt <NUM> including the patches <NUM> and cables <NUM> weighs less than <NUM>.

Cables <NUM> enables removal of controller belt <NUM> from the subject for placing proximal to the patient while patches <NUM> remain attached to the subject to enable, for example, sleeping. In some embodiments, cables <NUM> are extendable for placing controller belt <NUM> further away from the subject. In some embodiments, compartments <NUM> are attached to controller belt <NUM> using flexible spacers (not shown).

In some embodiments, replaceable patches 510A, 510B can be placed in alternate locations to eliminate skin damage which may occur due to long-term usage of the patch in one position. A method for overcoming skin irritations which may be caused by patches and adhesives is shown in <FIG>. Defibrillators typically have one shocking electrode on the right side of the chest and a second shocking electrode on the left abdomen to provide a known shock vector. The inventors have determined that alternative shock vectors are possible, thus allowing periodic movement of the patches <NUM> to alternative positions to reduce long-term skin irritation.

In <FIG>, patches 510A and 510B are shown as located on the right side of the chest and left abdomen respectively. When a patch position location change is desired (normally within a week to avoid skin irritation), a second shock vector is provided by positioning patch 510A to the left side of the chest while patch 510B is positioned to the right side of the abdomen as shown in <FIG>. A third shock vector is provided by positioning patch 510B on the upper right side of the chest while patch 510A is positioned to the left upper side of the back as shown in <FIG>.

Alternating the sides for patches <NUM> enables use of relatively large patches compared to standard AED patches (desirable for conductivity) while reducing potential discomfort of subjects.

In the embodiment of <FIG>, controller <NUM> comprises batteries <NUM>, a capacitor <NUM> and electronics <NUM>. In the embodiment of <FIG>, wiring <NUM> provides for the electrical connections of the components of controller <NUM>. It should be appreciated that the separation of the components of controller <NUM> into separate compartments <NUM> provides for greater comfort as belt <NUM> remains flexible and the weight is distributed around belt <NUM>.

<FIG> show exemplary schematic drawings of a BCD according to some embodiments. As shown in <FIG> BCD <NUM> comprises replaceable patches <NUM> and defibrillation controller belt <NUM>. Each of patches <NUM> comprises both of a defibrillation electrode <NUM> and an ECG sensor <NUM>. Patches <NUM> are affixed to the body of the subject using biocompatible adhesive. Patches <NUM> are of smaller dimensions than patches typically used in the art. In some embodiments, patches <NUM> are smaller than 8x8cm. The smaller size enables changing of the patch location periodically to enhance patient tolerance to such patches.

To enable sufficient energy to be conveyed by defibrillation electrodes <NUM> to the heart of a subject during a shock, more than two patches <NUM> are affixed to the subject. Multiple defibrillation electrodes <NUM> provide multiple shock vectors between the affixed defibrillation electrodes <NUM>. As shown in <FIG>, a defibrillation vector "A" passes between electrode 616C through the heart <NUM> to electrode 616A, while defibrillation vector "B" passes between electrode 616B through heart <NUM> to electrode 616A. Although <FIG> show three patches <NUM>, it should be appreciated that more than three patches may be used depending on the size of the patches and the amount of energy to be conveyed in a shock.

In some embodiments, patches <NUM> comprise gel for enhancing electrical contact. In some embodiments, replaceable patches <NUM> are replaced periodically. Cables <NUM> provide electrical connectivity between patches <NUM> via connectors <NUM> and cables <NUM> provide electrical connectivity between patches <NUM> (via connector <NUM>) and controller belt <NUM> as described above with reference to <FIG>. Controller belt <NUM> is the same as controller belt <NUM> as described above.

<FIG> show exemplary schematic drawings of the components of a BCD according to some embodiments. As shown in <FIG>, BCD <NUM> comprises a defibrillation electrode <NUM>, an ECG sensor <NUM> and a controller <NUM>. In some embodiments, BCD <NUM> also comprises a vibration pad <NUM>. One or more of these components are in communication with an external device <NUM> and/or a remote monitoring center (RMC) <NUM>. Embodiments of controllers <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> are the same as controller <NUM>. Embodiments of patches/electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> have the same characteristics as defibrillation electrodes <NUM> and sensors <NUM>. In some embodiments, such as shown in <FIG>, electrodes <NUM> and sensors <NUM> are combined into a single patch <NUM> as with patches <NUM> or <NUM>. In some embodiments, vibration patch <NUM> is integrated into one or both of patches <NUM> and <NUM>.

It should be appreciated that the components of controller <NUM> as described below may be provided in a single housing (such as but not limited to the housings of controllers <NUM> or <NUM>) or alternatively may be distributed into multiple housings such as but not limited to the embodiment of <FIG> where controller <NUM> components are stored in compartments <NUM>, or the embodiment of <FIG> where controller <NUM> is housed in housing <NUM>.

In some embodiments, the ECG sensors <NUM> and controller are adapted for sensing simultaneous sensing vectors. The adaptation includes sensing from three or more sensing electrodes placed on two or more patches for better sensing and detection of VF and discrimination of non-VF arrhythmias.

In some embodiments, defibrillation electrodes <NUM> are adapted for providing multiple simultaneous shock vectors. The adaptation includes providing three or more shock electrodes each placed on a patch <NUM> for better coverage of the heart and reduction of defibrillation threshold energy.

In some embodiments, controller <NUM> comprises an activation switch <NUM> to turn BCD <NUM> ON once the patches are in place. In some embodiments, controller <NUM> comprises an audio output device <NUM> to generate an alarm sound such as beeping or buzzing to alert the patient in case VT or VF was detected and a shock is about to be delivered. Additionally, audio device <NUM> may play audio messages from RMC <NUM>, or messages related to the BCD <NUM> status. In some embodiments, controller <NUM> also comprises a microphone <NUM> for hearing comments from the subject. In some embodiments, audio output device <NUM> sounds an audible alarm following administering a defibrillating shock to warn/notify passers-by.

In some embodiments, ECG data as sensed by sensor patch <NUM> is collected for storage by controller <NUM>, analysis by controller <NUM> and/or transmission to RMC <NUM> for analysis and storage. In some embodiments, controller <NUM> includes an ECG event button <NUM> for creating a time stamp in the collected ECG data such as but not limited to when a patient feels an arrythmia or other sensation the patient wishes to record. In some embodiments, ECG event button <NUM> initiates recording via microphone <NUM> such that the patient can state the reason for pressing ECG event button <NUM>. In some embodiments, ECG data is continually buffered but only stored/recorded by controller <NUM> when ECG event button <NUM> is pressed including recording a time period before ECG event button <NUM> was pressed.

In some embodiments, controller <NUM> comprises visual indication means such as a display <NUM> and/or status lights <NUM> for displaying the status of BCD <NUM> and/or displaying messages related to BCD <NUM> and use thereof. In some embodiments, controller <NUM> measures impedance of patches <NUM>, <NUM> to the body of the subject to determine the strength of the electrical connection therebetween. In some embodiments, controller <NUM> displays the measured strength of the electrical connection of a patch <NUM> and/or <NUM> to the skin of the subject. In some embodiments, controller <NUM> indicates the level of connection of patches <NUM> and/or <NUM> with the skin of the subject. In some embodiments, controller <NUM> indicates a suggested period for replacement or movement of patches <NUM>, <NUM>.

In some embodiments, controller <NUM> comprises a vibration device <NUM> to generate vibration to alert the patient in case VF was detected and a shock is about to be delivered. Additionally or alternatively, in some embodiments, a vibration alert is delivered to the subject via vibration patch <NUM>.

In some embodiments, controller <NUM> comprises an abort button <NUM> used to abort a shock in a case the patient feels fine but the BCD <NUM> is alerting that a shock is about to be delivered. In some embodiments, controller <NUM> comprises an emergency call button <NUM>. In some embodiments, safety switch <NUM> electrically disconnects controller <NUM> from defibrillation patch <NUM>. In some embodiments, safety switch <NUM> is activated by abort button <NUM>.

In some embodiments, controller <NUM> is in wireless communications with an RMC <NUM>. In some embodiments, controller <NUM> notifies RMC <NUM> of an administered defibrillation shock. In some embodiments, controller <NUM> continuously analyzes the signal from ECG patch <NUM> to determine whether an arrhythmia has occurred. In some embodiments, detected arrhythmia events are stored by controller <NUM>. In some embodiments, detected arrhythmia events are transmitted to RMC <NUM>. In some embodiments, controller <NUM> comprises a GPS receiver <NUM>, and the location of controller <NUM> is transmitted along with any information transmitted to RMC <NUM>. In some embodiments, a patient can initiate a voice call with medical staff at the RMC <NUM> using microphone <NUM> and audio output <NUM>.

In some embodiments, controller <NUM> includes a motion sensor <NUM>. Motion sensor <NUM> may include one or more of a gravity sensor, linear acceleration sensor, rotation vector sensor, step counter, step detector, accelerometer and/or gyroscope. In some embodiments, sensor patch <NUM> includes a motion sensor <NUM>. Motion sensor <NUM> may include one or more of a gravity sensor, linear acceleration sensor, rotation vector sensor, step counter, step detector, accelerometer and/or gyroscope. In some embodiments, one or both of motion sensors <NUM>, and <NUM> may determine data related to movement of the patient. In some embodiments, movement data is collected by controller and combined with the ECG data provided sensor patch <NUM>. In some embodiments, motion sensor data, indicative of the movement of the patient, is used as part of monitoring of syncope by controller <NUM> and/or by RMC <NUM>.

In some embodiments, controller <NUM> comprises batteries <NUM> that can be replaceable and/or rechargeable. In some embodiments, rechargeable batteries <NUM> use either wireless charging or are charged using a cable (not shown) connected to the controllers from a power source.

In some embodiments, controller <NUM> is in wireless communication with external device <NUM>. Non-limiting examples of external device <NUM> include a smartphone or smart watch. External device <NUM> comprises a software application (app) <NUM> for running on the external device. In some embodiments, app <NUM> presents the status of BCD <NUM> using the display of the external device such as, for example, to indicate a need for charging of BCD <NUM> or to indicate an error in the functioning of BCD <NUM>. In some embodiments, the audible, visual and/or vibrating indication of an impending shock is provided by app <NUM> using the display, audio, and/or vibrating functions of external device <NUM>. In some embodiments, an abort button is provided by app <NUM> and the touchscreen capability for activating the abort button is provided by external device <NUM>. In some embodiments, an indication of the impending shock or activation of a shock is transmitted from controller <NUM> to external device <NUM> for further transmission by external device <NUM> using the built-in data communication functionality of external device <NUM> to a RMC <NUM>, such as for emergency response. In some embodiments, app <NUM> provides BCD <NUM> status information. In some embodiments, app <NUM> provides guided instructions for patch placement and rotation. In some embodiments, data from ECG patch <NUM> is provided to app <NUM> for analyzing of the signal from ECG patch <NUM> to determine whether an arrhythmia has occurred. In some embodiments, detected arrhythmia events are stored by app <NUM> on device <NUM>. In some embodiments, detected arrhythmia events are transmitted by app <NUM> to RMC <NUM> using the communication features of device <NUM>. In some embodiments, event button <NUM> is activated via app <NUM>.

In some embodiments, when BCD <NUM> detects asystole after delivering a shock, BCD <NUM> delivers high voltage temporary external percutaneous heart pacing via patches <NUM>. In some embodiments, the pacing is ventricular demand pacing (VVI). In some embodiments, the pacing is provided at a rate of <NUM> BPM.

In some embodiments, each patch <NUM>, <NUM> comprises multiple perforations throughout the patch allowing for breathing of the skin while the patch is applied.

In the claims or specification of the present application, unless otherwise stated, adjectives such as "substantially" and "about" modifying a condition or relationship characteristic of a feature or features of an embodiment, are understood to mean that the condition or characteristic is defined to within tolerances that are acceptable for operation of the embodiment for an application for which it is intended.

It should be understood that where the claims or specification refer to "a" or "an" element, such reference is not to be construed as there being only one of that element.

In the description and claims of the present application, each of the verbs, "comprise" "include" and "have", and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.

Claim 1:
A flexible automated wearable belt cardiac defibrillator, BCD, (<NUM>, <NUM>, <NUM>) for wearing by a subject, the subject having a body, the BCD characterized by comprising:
at least two disposable patches (<NUM>, <NUM>, <NUM>) adapted for adhering to the body of the subject, each patch comprising a defibrillation electrode (<NUM>, <NUM>, <NUM>), wherein at least one patch includes an ECG sensor (<NUM>, <NUM>, <NUM>); and
a controller (<NUM>, <NUM>, <NUM>) that is separate from the patches and connected via a connection cable (<NUM>, <NUM>) to each patch,
wherein the patches comprise an adhesive adapted for long-term adhering of the patches to the body of the subject,
wherein the patches and the adhesive are adapted for movement of the subject while the patches are adhered to the body of the subject,
wherein the controller is housed in a flexible belt (<NUM>) comprising a plurality of compartments (<NUM>, <NUM>) for wearing by the subject, is adapted for being flexible, and is not required to be in contact with the body of the subject,
and wherein the adaptation for being flexible comprises distributing components of the controller between the plurality of compartments.