WO2009147678A2

WO2009147678A2 - Pocket defibrillating system

Info

Publication number: WO2009147678A2
Application number: PCT/IL2009/000561
Authority: WO
Inventors: David Weintraub
Original assignee: Poems Ltd.; Eshel, Yoram
Priority date: 2008-06-05
Filing date: 2009-06-04
Publication date: 2009-12-10
Also published as: GB0810324D0; WO2009147678A3; GB2460690A

Abstract

A defibrillating system comprising a defibrillator device adapted to be attached to at least one defibrillation pad and thereby to a body of a patient, an attachment element adapted to attach said defibrillator device to said defibrillation pad and at least one electrode.

Description

POCKET DEFIBRILLATING SYSTEM

FIELD

The invention relates to defibrillator devices in general, and to pocket size defibrillator devices in particular.

BACKGROUND

Sudden cardiac arrest (SCA) is a leading cause of death in the United States (US) and Canada. In the US, the Center for Disease Control and Prevention estimates the annual number of deaths of out-of-hospital and emergency room SCA patients (patients) at approximately 325,000. Furthermore, the Center for Disease Control and Prevention estimates that approximately 70% of SCA incidents are witnessed by bystanders, yet approximately 95% of the SCA patients die before reaching the hospital.

SCA typically results from a disruption in the heart's electrical activity. During SCA the heart generally stops beating and blood circulation is interrupted. If help is not received in time this condition may leave the brain and other vital organs without sufficient oxygen, which may result in their permanent damage, and in most cases, death.

Major causes of SCA are ventricular tachycardia (VT) and ventricular fibrillation (VF). VT and VF are attributed to faults in the electrical activity of the heart, which interferes with the normal rhythmic contraction of the heart. Such interferences are generally known as arrhythmia. VT is an arrhythmic condition in which the heart suddenly beats at relatively high rates, usually in the range of 100 - 200 beats per minute. VF is an arrhythmic condition in which the ventricles of the heart flutter, contracting in a rapid, unsynchronized manner. When this occurs the heart stops pumping blood. A pulse-less VT and VF recognition are used as criteria to determine whether a patient's heart state is reversible by applying an electrical shock (hereinafter: "shockable") or not (hereinafter: "non-shockable")

Restoring normal functioning of an arrhythmic heart is usually done by stimulating the heart, either by electrical means, using a defibrillator, and/or by mechanical means, using CPR (cardio-pulmonary resuscitation). A defibrillator is adapted to provide an electric shock or stimulus to the heart, generally in an attempt to restore normal electrical activity to the heart. CPR comprises chest compression - a ventilation technique that is generally adapted to assist the heart in delivering blood to the coronary arteries and to the brain.

Defibrillators typically comprise two types of devices, internal defibrillators and external defibrillators. Internal defibrillators are implanted directly in a person's body much like a pacemaker, and are often in direct contact with the heart. They are designed to actively monitor heart activity and to apply an electrical stimulus to the heart following detection of a condition associated with VF. External defibrillators are electronic devices typically comprising a unit from which extend two electrical leads with an electrode at the end of each cable. The electrodes usually comprise a metal paddle with an insulated handle, or optionally, removable attachable, self adhered defibrillation pads, which are placed on the patient's thorax prior to administering defibrillation.

An automatic external defibrillator (AED) is typically used to administer defibrillation to out-of-hospital patients suffering from SCA. AEDs are generally, but not necessarily, designed for use by untrained personnel, referred to hereinafter as a "rescuer", possessing no prior experience using defibrillators. Usually, the rescuer is only required to connect the defibrillation pads (also referred to as the: "defibrillation pad", "defibrillator electrodes", "electrode" or "electrodes") to the patient and to activate the AED, whereas the other functions are generally pre-programmed into the device. AEDs today are adapted to monitor the electrical activity of the heart and to automatically administer the electrical stimulus when abnormal electrical activity is detected. Optionally, they are adapted to prevent administering the electrical stimulus if normal electrical activity is detected. In order to substantially eliminate electrical hazards to the rescuer during the application of the electrical stimulus, AEDs generally comprise a self adhered defibrillation pad, which may be attached to the patient's body. This enables the rescuer to place the pads on the patient's body and stay clear from touching the patient prior to delivery of the electrical stimulus.

AEDs are generally found in public places which accommodate large concentrations of people, particularly but not necessarily, of middle age and older. Examples of such public places are bus terminals, train stations, airports, hotels, sports stadiums and convention centers. The AEDs are usually designed for portability, relatively compact in size and reduced in weight compared to manual defibrillators. AEDs typically are not equipped with the variety of features and monitoring capabilities characterizing the manual defibrillators. AEDs may also be found in households of SCA prone people.

Probability of recovery from VP is generally greatest when defibrillation is performed within 2 minutes of the occurrence of SCA. According to the American Heart Association (AHA), studies show that for every minute that passes between patient loss of consciousness and defibrillation, survival rates decrease by 7% - 10%. As it is usually quite difficult for a rescuer to administer defibrillation within 2 minutes from patient loss of consciousness due to lack of a readily accessible defibrillator, the AHA recommends administering CPR prior to administering defibrillation. The studies further show that administering CPR prior to defibrillation may improve the patient's survival rate; for every minute that passes the decrease in survival rate being more gradual and averaging between 3% - 4%. If CPR is immediately provided, especially within 5 minutes of the occurrence, the studies also show that many adults survive with minimal, if any, neurological damage.

AHA CPR guidelines for rescuers call for 100 chest compressions per minute, each compression 1.5 inches - 2 inches in depth. The compressions should be given in the center of the chest at the nipple line, using the heel of both hands. Following each compression the chest should be allowed to recoil. A typical cycle of 30:2 compressions:ventilation ratio (30 compressions followed by two oral ventilations) is recommended for a single rescuer treating a patient and a 15:1 compressions: ventilation ratio is recommended if there are two rescuers. Five cycles of CPR compressions.ventilation should be administered prior to defibrillation and/or between defibrillations.

According to the AHA, CPR is generally recommended after defibrillation as many patients show asystole or pulseless electrical activity (PEA) for several minutes after shock. CPR may correct this condition. Generally, the rescuer should deliver one shock and then administer CPR, beginning with chest compressions. The rescuer is recommended to not delay chest compressions; to administer 5 CPR cycles and then connect the AED to monitor for electrical activity. Only then should another shock generally be administered, if required. More information on AED, CPR and guidelines for the administration of defibrillation and CPR may be found in Circulation: Journal of the American Heart Association, found online at http://circ.ahajournals.org/, and incorporated herein by reference.

SUMMARY An aspect of some embodiments of the invention relates to providing a small-sized, portable AED, essentially a pocket-sized defibrillating system, adapted to be attached to a patient's body via defibrillation pad. The term "patient", as used herein, may refer to any subject, such as but not limited to, a subject in a need of a treatment, for example defibrillation. The term "pocket size" or "pocket-sized", as used herein, refers to a size which may be suitably carried in a pocket. For convenience hereinafter, the pocket-sized defibrillating system, which comprises a pocket defibrillator device and a pair of flexible self adhered electrodes, or defibrillation pads, may be referred to also as "pooket defibrillating system" nr "Hefibriiiating system". The pocket defibrillating system may comprise portability features such that the pocket defibrillator device, which may hereinafter also be referred to as "defibrillator device" or "device", and the electrodes, may be adapted to be held by a rescuer or a potential patient in a hand, carried inside a pocket of a jacket, a vest, a gown, a shirt or a set of pants. Optionally, the defibrillator device may be attached to the waistband of the pants and/or attached to a belt. Optionally, the defibrillating system may be carried inside a briefcase or a handbag. Additionally or alternatively, the defibrillating system may be hand carried.

The pocket defibrillating system may be adapted for portability and use by both trained and untrained personnel. For example, the pocket defibrillating system may be adapted to be carried by a potential patient (an SCA prone person), or a potential trained rescuer, and may be further adapted to be operated by untrained (inexperienced) rescuers. The defibrillating system is further adapted to either automatically or semi-automatically defibrillate a patient. Automatic operation of the defibrillating system is based on thorax impedance and ECG measurements of the patient that allow determining a condition of a shockable VF/VT and a shock energy level to be applied. In a semi-automatically defibrillating mode the device alerts the rescuer that the patient is in a shockable state and the rescuer is advised to trigger the defibrillation by pressing a stimulus release button on the device. The decision if a patient is shock worthy is commonly described as either being shockable or being non-shockable. A shockable patient is defined as a patient in whom the defibrillating system has identified a state of a VF and pulseless VT. A non-shockable patient is defined as a patient in whom the defibrillating system has identified a state of Asystole (no heart beats) and PEA (pulseless electrical activity). The pocket defibrillating system of the present invention comprises an ECG (electro-cardiogram) monitor adapted to record a cardiogram of the patient, and preferably, but not necessarily a visual display of said cardiogram. Optionally, the defibrillating system may be adapted to guide a rescuer, either visually or audibly or both, how to defibrillate a patient. Additionally, the pocket defibrillating system may comprise an audio and\or visual cardiac massage feedback function adapted to assist the rescuer to perform cardiac massage on the patient following defibrillation. The term "cardiac massage" may be but is not necessarily, a part of a cardio-pulmonary resuscitation (CPR). Optionally, the pocket defibrillating system may be adapted to be used as a public access defibrillator (located in public places) and may optionally be further adapted to be operated by inexperienced rescuers. Additionally or alternatively, the pocket defibrillating system may be adapted to be carried and operated by professional personnel trained in the use of defibrillating systems. Optionally, the pocket defibrillating system may be adapted to be carried by SCA prone hospitalized patients and may optionally be further adapted to be operated by medically trained personnel. The defibrillating system of the present invention may further comprise a device override feature to be used by trained personnel to allow defibrillation despite a non-shockable decision by the defibrillating system. Optionally, the defibrillating system may comprise 2-way communication capabilities allowing a rescuer to communicate with professional personnel such as, for example, emergency medical services, trained medical personnel, rescue services (police, firemen and the like), and others. Optionally, the defibrillating system may comprise one-way data communication capabilities allowing the rescuer, or the device by itself, to send data related to the patient to a destination where the data may be analyzed. Optionally, the defibrillating system may be remotely operated by trained personnel. In such a scenario, data is transferred from a remote location to the defibrillating system and said data triggers defibrillation. Optionally, the defibrillator device may comprise rechargeable batteries, and/or may comprise means adapted to corroborate proper functioning of the defibrillating system.

According to an aspect of some embodiments of the invention, at least one of the electrodes is adapted to be mechanically, reversibly attached to the device. The term "reversibly attached" may be understood to mean that the electrode is detachable. The mechanical attachment of an electrode to the defibrillator device allows the rescuer to view the device in the same axis he views the patient and thus, to keep his or her eyes on the patient during the resuscitation procedure and later for monitoring purposes. The functional mechanical attachment of the defibrillator device to the electrode is allowed by virtue of the proportions and pocket size characterizing the defibrillator device of the present invention. The new and novel positioning of the defibrillator device further allows an effective monitoring of the patient and safe evacuation of the patient in a later stage by an ambulance, a helicopter or any other transportation, with no fear of cable detachment or damage to the device due to the transit of the patient. Thus, the mechanical attachment of the defibrillator device to the patient facilitates a novel practice that is highly beneficial to the resuscitation and evacuation processes. As mentioned above, the benefits of such attachment rely on the ability to transfer the patient and the device together at all stages of the event. It should be emphasized that said novel and improved practice, compared to the predicate practice, is enabled merely due to the pocket size and lightweight of the defibrillator device of the invention, wherein predicate devices are too large and heavy to facilitate such practice. Mechanical attachment of an electrode to a defibrillator device may be established in various ways. In a specific embodiment, at least one electrode may comprise a mechanical plug connector adapted to be inserted into a mechanical socket in the device or alternatively to a complementary structure attached to the device. Inserting the plug connector into the socket or to the complementary structure establishes a mechanical connection between the electrode and the device. In another embodiment, the plug connector may be comprised in the device and the socket comprised in the electrode. In yet a further embodiment, the mechanical connector is , integrated into the electrode and is adapted to be clipped on the device housing in any clipping method known in the art that is suitable for the purposes of the present invention. Optionally, the electrode may be attached directly to the housing of the device by means of a hook and loop (Velcro or Velcro type) fastening system. Additionally or alternatively, the electrode may be attached to the housing of the device by a magnetic fastening system wherein the housing of the device comprises a magnet and the electrode a metallic plate or vice versa, the device comprises the metal plate and the electrode the magnet. Optionally, the electrode may be attached to the housing of the device by a latching system wherein the housing of the device comprises a channel adapted to receive a latch on the electrode by sliding. Optionally, the housing of the device comprises the latch and the electrode the channel.

In an embodiment of the invention, each electrode is electrically connected to the defibrillator device by means of an electrically conducting cable which connects to a connector adapted to be inserted in a socket in the device. Optionally, a cable connects the second electrode with the first electrode, and the second electrode is electrically connected through the cable of the first electrode to the device. Optionally, the second electrode may be adapted to be mechanically attached to the defibrillator device, and may comprise a plug connector adapted to be inserted into the socket in the device. Optionally, the first electrode and the second electrode may be interchangeable. Optionally, the electrodes may be attached to the defibrillator device in an electromechanical connection. In such embodiment, the connector may be comprised in the device and the socket in the electrode or vice versa. Optionally, an electrically conducting cable connects the first electrode with the second electrode, and the first electrode is electrically connected through the cable of the second electrode to the device. According to an aspect of some embodiments of the invention, the pocket defibrillating system is further adapted to provide CPR feedback and/or CPR progress monitoring to assist the rescuer to perform CPR on the patient according to a preferred method, for example, the AHA method. In a specific embodiment of the invention, the defibrillating system is adapted to search for repetitive and frequent impedance changes that reflect chest compressions (and not artifacts). Impedance changes indicative of chest compressions are monitored for rate of change in order to verify that CPR is being administered. Once CPR is verified, the rate of impedance change and number of compressions are monitored and compared to preset threshold values, and feedback is provided to the rescuer. The feedback provided may be performed for example, by an audio indication of the actual compression and release rate, so as to encourage the rescuer to strive to match the rate of the compressions and release according to the feedback he/she obtains. In addition, but not necessarily, the indication may be visually provided on the device display.

There is provided in accordance with an embodiment of the invention, a defibrillating system comprising a defibrillator device adapted to be attached to a body of a patient, an attachment element adapted to attach the defibrillator device to the patient and at least two electrodes. The defibrillator device may be adapted to be externally attached to a body of a patient. Optionally, the attachment element is an integral part of the defibrillator device, an integral part of at least one electrode or an independent element. Optionally, the attachment element comprises glue, a vacuum cap, a mechanical fastening element or any combination thereof.

In some embodiments of the invention, the defibrillator device is adapted to fit in a pocket. Optionally, the defibrillator device is in an elongated structure proportions.

In some embodiments of the invention, the electrodes are reversibly attached to the defibrillator device. Optionally, the attachment element comprises a loop fastener located on at least one of the two electrodes and adapted to be attached to a hook fastener located on the underside of the defibrillator device. Optionally, the hook fastener is located on at least one of the two electrodes and adapted to be attached to a loop fastener located on the underside of the defibrillator device.

In some embodiments of the invention, the attachment element comprises a metal plate located on at least one of the two electrodes adapted to be attached to a magnet located on the underside of the defibrillator device. Optionally, the attachment element comprises a magnet located on at least one of the two electrodes adapted to be attached to a metal plate located on the underside of the defibrillator device.

In some embodiments of the invention, the attachment element comprises a latch located on at least one of the two electrodes adapted to be slidingly inserted into a channel located on the housing of the defibrillator device. Optionally, the attachment element comprises a channel located on at least one of the two electrodes adapted to slidingly receive a latch located on the housing of the defibrillator device. Optionally, at least one electrode is either mechanically or electromechanically attached to the defibrillator device. In some embodiments of the invention, the defibrillating system further comprises a housing, the housing comprising dimensions not greater than 19 cm x 10 cm x 4 cm, and preferably weighs less than or equal to 600 grams, so it can be carried in common work clothing pockets of firemen, EMTs, doctors etc.

In some embodiments of the invention, at least one of the electrodes is adapted to detect heartbeat. Optionally, the defibrillator device is adapted to stop energy discharge if a heartbeat is detected. Optionally, the defibrillator device is adapted either to stop energy discharge or to allow energy discharge upon receiving an override command.

In some embodiments of the invention, the defibrillating system is adapted to perform ECG monitoring. Optionally, the defibrillating system is adapted to measure thorax impedance. Optionally, at least one of the discharge electrodes is adapted to measure thorax impedance. Additionally or alternatively, the measured thorax impedance is used to calculate the appropriate discharge energy. Optionally, the defibrillating system is adapted to measure a rate or a magnitude of thorax impedance change, a number of thorax impedance changes or both.

In some embodiments of the invention, the defibrillating system is adapted to provide cardiac massage feedback, to monitor cardiac massage or both. Optionally, the defibrillator device is adapted for remote location data communication. Additionally or alternatively, data communication is either a one-way communication or a two-way communication. Optionally, the defibrillator device is adapted for two-way vocal communication.

In some embodiments of the invention, the defibrillating system is adapted to perform defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof. Optionally, the defibrillating system comprises a display adapted to show data relating to the defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof. Optionally, the defibrillating system is adapted to allow a caregiver to treat the patient while looking at the display, without substantially shifting his/her head from the patient.

In some embodiments of the invention, the defibrillating system is adapted to be abutted to the body of the patient to facilitate carrying the patient and thus to increase safety in transferring of the patient. In some embodiments of the invention, a defibrillation electrode comprises an attachment element reversibly attachable to a defibrillator device. Optionally, the attachment element is integrally formed with the electrode. Optionally the electrode comprises a loop fastener adapted to be attached to a hook fastener located on the housing of the defibrillator device. Optionally, the electrode comprises a hook fastener adapted to be attached to a loop fastener located on the housing of the defibrillator device. Optionally, the electrode comprises a metal plate adapted to be attached to a magnet comprised on the housing of the defibrillator device. Optionally, the electrode comprises a magnet adapted to be attached to a metal plate located on the housing of the defibrillator device. Additionally or alternatively, the electrode comprises a latch adapted to be slidingly inserted into a channel located on the housing of the defibrillator device. Optionally, the electrode comprises a channel adapted to slidingly receive a latch located on the housing of the defibrillator device. Optionally, the defibrillation electrode is adapted to be either mechanically or electromechanically attached to the defibrillator device.

There is provided in accordance with a further embodiment of the invention, a defibrillating system comprising a defibrillator device adapted to be attached to a defibrillation pad, and at least one defibrillation pad adapted to be attached to the defibrillator device to thereby attach said defibrillator device to a patient.

In some embodiments of the invention, the defibrillator device is adapted to fit a pocket, and characterized by elongated structure proportions.

In some other embodiments of the invention the defibrillation pad is reversibly attached to said defibrillator device. Optionally, the defibrillation pad comprises a loop fastener and adapted to be attached to a hook fastener located on the housing of the defibrillator device; or wherein the hook fastener is located on the defibrillation pad and adapted to be attached to a loop fastener located on the housing of the defibrillator device. Alternatively, said defibrillation pad comprises a metal plate adapted to be attached to a magnet located on the housing of the defibrillator device; or wherein the magnet is located on the defibrillation pad and adapted to be attached to a metal plate located on the housing of the defibrillator device. Alternatively, the defibrillation pad comprises a latch adapted to be slidingly inserted into a channel located on the housing of the defibrillator device; or wherein the channel is located on the defibrillation pad and adapted to slidingly receive a latch located on the housing of the defibrillator device. In some embodiments of the invention, at least one defibrillation pad is either mechanically or electromechanically attached to the defibrillator device. In some embodiments of the invention, the defibrillating system further comprises a housing with dimensions not greater than 19 cm x 10 cm x 4 cm. Optionally, said housing weighs less than or equal to 600 gr.

In some embodiments of the invention, at least one of said defibrillation pad is adapted to detect heartbeat, and said defibrillator device is adapted to stop energy discharge if a heartbeat is detected.

Optionally, the defibrillating system provided herein is further adapted to perform ECG monitoring. Additionally or alternatively, the defibrillating system is further adapted to measure thorax impedance, and at least one of the defibrillation pads is adapted to measure thorax impedance. In such embodiment, the measured thorax impedance is used to calculate the appropriate discharge energy.

Optionally, the defibrillating system of the present invention is adapted to provide cardiac massage feedback, to monitor cardiac massage or both. Additionally or alternatively, the defibrillating system is adapted to measure a rate or a magnitude of thorax impedance change, a number of thorax impedance changes or both.

In some embodiments of the invention, the defibrillator device is adapted either to stop energy discharge or to allow energy discharge upon receiving an override command. Alternatively or additionally, the defibrillator device is adapted for remote location data communication. The data communication may be either a one-way communication, or a two- way communication. In some embodiments of the invention, said defibrillator device is adapted for two-way vocal communication.

In some other embodiments of the invention, the defibrillating system may be adapted to perform defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof. Optionally, the defibrillating system is further comprising a display adapted to show data relating to the defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof.

In some other embodiments of the invention, the defibrillating system is adapted to allow a caregiver to treat the patient while looking at the display, without substantially shifting his/her head from the patient. Alternatively or additionally, the defibrillating system of the invention is further adapted to be abutted to a body of the patient to facilitate carrying the patient and thus to increase safety in transferring of the patient.

There is provided in accordance with an embodiment of the invention, a method of defibrillating using a defibrillator device adapted to fit in a pocket, the method comprising attaching two electrodes to a patient; and attaching the defibrillator device to a body of a patient using an attachment element. Optionally, the attachment element is an integral part of the defibrillator device, an integral part of at least one electrode or an independent element. Additionally or alternatively, the attachment element comprises glue, a vacuum cap, mechanical fastening element or any combination thereof.

In some embodiments of the invention, the method further comprises detecting heartbeat. Optionally, the method further comprises performing ECG monitoring. Additionally or alternatively, the method further comprises measuring thorax impedance. Optionally, the method further comprises calculating the appropriate discharge energy according to the measured thorax impedance. Additionally or alternatively, the method further comprises providing CPR feedback, monitoring CPR or both. Optionally, the method further comprises measuring a rate or a magnitude of thorax impedance change, a number of thorax impedance changes or both.

In some embodiments of the invention, the method further comprises data communication with a remote location. Optionally, the data communication is either a one-way communication or a two-way communication. Additionally or alternatively, the data communication is two-way vocal communication.

In some embodiments of the invention, the method further comprises performing defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof. Optionally, the method further comprises displaying data relating to the defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof.

In some embodiments of the invention, the method further comprises allowing a caregiver to treat the patient while looking at a display, without substantially shifting his/her head from the patient. Optionally, the method further comprises abutting the defibrillator device to the body of the patient to facilitate carrying the patient and thus to increase safety in transferring of the patient. There is provided in accordance with an embodiment of the invention, a defibrillating system comprising a monitor unit adapted to monitor the performance of a cardiac massage on a patient by measuring a rate and a number of impedance changes of the thorax of the patient. Optionally, the defibrillating system further comprises a feedback unit adapted to provide a feedback on the performance of a said cardiac massage to a caregiver. Optionally, the feedback is provided as an audio feedback, a visual feedback or both.

BRIEF DESCRIPTION OF FIGURES

Examples illustrative of embodiments of the invention are described below with reference to figures attached hereto. In the figures, identical structures, elements or parts that appear in more than one figure are generally labeled with a same numeral in all the figures in which they appear. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below. Figure IA schematically illustrates a perspective view of an exemplary pocket defibrillating system comprising a pair of flexible electrodes, the electrodes adapted to be mechanically attached to a pocket defibrillator, in accordance with an embodiment of the invention;

Figure IB schematically illustrates a perspective view of an underside of the pocket defibrillating system shown in Figure IA, in accordance with an embodiment of the invention;

Figure 1C schematically illustrates the pocket defibrillating system shown in Figure IA placed on a thorax of a patient, in accordance with an embodiment of the invention;

Figure ID schematically illustrates a functional block diagram of the pocket defibrillating system shown in Figure IA, in accordance with an embodiment of the invention. Figure 2A schematically illustrates a perspective view of an electrode comprised in a pocket defibrillating system, in accordance with one embodiment of the invention;

Figure 2B schematically illustrates a perspective view of an electrode comprised in a pocket defibrillating system, in accordance with another embodiment of the invention;

Figure 2C schematically illustrates a perspective view of an electrode comprised in a pocket defibrillating system, in accordance with another embodiment of the invention;

Figure 2D schematically illustrates a perspective view of an electrode comprised in a pocket defibrillating system, in accordance with another embodiment of the invention;

Figure 3 A schematically shows a perspective view of the pocket defibrillating system 0561

shown in Figure IA - ID placed on a patient in a position for defibrillating and/or CPR feedback and/or progress monitoring and/or heart activity monitoring, in accordance with an embodiment of the invention;

Figure 3B schematically shows a perspective view of the pocket defibrillating system and the patient shown in Figure 3 A during defibrillation, in accordance with an embodiment of the invention;

Figure 3 C schematically shows a perspective view of the pocket defibrillating system and the patient shown in Figure 3 A during administration of CPR and CPR feedback monitoring, in accordance with an embodiment of the invention; Figures 4 A and 4B schematically show a flow chart of an exemplary defibrillation process, and CPR feedback monitoring process, respectively, comprising the use of the pocket defibrillating system shown in Figures IA - ID, in accordance with an embodiment of the invention;

Figure 5A schematically illustrates an exemplary pocket defibrillating system comprising a pocket defibrillator device attached to a belt or a waistband of a patient's pants, or optionally a rescuer's pants, in accordance with an embodiment of the invention;

Figure 5B schematically shows the pocket defibrillator device of Figure 5 A partially inserted in a pocket of a pair of pants, in accordance with an embodiment of the invention;

Figure 5C schematically shows the pocket defibrillator device of Figure 5 A partially inserted in a pocket of a physician's coat, in accordance with an embodiment of the invention;

Figure 6A schematically shows a perspective view of a pocket defibrillating system, including a pocket defibrillator attached by means of an attachment element to a patient, in accordance with another embodiment of the invention;

Figure 6B schematically shows a perspective view of a pocket defibrillating system, including a pocket defibrillator attached by means of an attachment element to a patient, in accordance with another embodiment of the invention; and

Figure 6C schematically shows a perspective view of a pocket defibrillating system, including a pocket defibrillator attached by means of an attachment element to a patient, in accordance with another embodiment of the invention.

DETAILED DESCRIPTION

Reference is made to Figure IA, which schematically illustrates a perspective view of an exemplary pocket defibrillating system 10 comprising a pair of flexible electrodes 13, the IL2009/000561 electrodes adapted to be mechanically attached to a pocket defibrillator 11; to Figure IB which schematically illustrates a perspective view of an underside of pocket defibrillating system 10; to Figure 1C which schematically illustrates pocket defibrillating system 10 placed on a thorax of a patient 90; and to Figure ID which schematically shows a functional block diagram of pocket defibrillating system 10; all in accordance with an embodiment of the invention. Pocket defibrillating system 10 is adapted to defibrillate a patient 90, and is further adapted to be used for CPR feedback and/or CPR progress monitoring by monitoring, for example, thorax impedance changes during CPR. CPR feedback and/or CPR progress monitoring is intended to assist a rescuer to provide CPR in accordance with a preprogrammed method, for example, that of the AHA. Pocket defibrillating system 10 is further adapted to be utilized as a heart activity monitor.

In accordance with an embodiment of the invention, pocket defibrillating system 10 is adapted to be held in a hand, carried inside a pocket of a jacket, a coat, a shirt, a pair of pants, or other garment. Optionally, pocket defibrillating system 10 is adapted to be attached to the waistband of the pants and/or attached to a belt. Optionally, pocket defibrillating system 10 is adapted to be carried inside a briefcase or a handbag. Additionally or alternatively, pocket defibrillating system 10 is adapted to be hand carried. Pocket defibrillator device 11 comprises a housing 110 which is preferably contoured as an elongated structure as shown, and may be fabricated from a drop-resistant plastic and/or plastic-related material. Optionally, housing 110 may be fabricated from any material suitable for use in electronic and/or medical devices. Dimensions of housing 110 and/or the proportion of housing 110, for example the ratio between length and/or width and/or thickness are adapted to enable the housing to substantially comprise a major portion of components required to perform the functions of pocket defibrillating system 10, while maintaining pocket-size characteristics. The term "pocket size" as used herein refers to a size which may be suitable for carrying in a pocket. For example, housing 110 dimensions may be 17 cm x 7 cm x 3cm. Nevertheless, it may be appreciated by a person skilled in the art that the shape, dimensions, proportions and/or materials described for housing 110 are for illustrative purposes, and in no way are intended to be limiting in any form.

Pocket defibrillator 11 comprises an activation element such as a "POWER" button 16, a "SHOCK STATUS INDICATOR" light 171, a display 14, a "SHOCK RELEASE" button 17, a speaker 15, an optional microphone 151, a controller 1100 including associated control circuitry and signal processing, a power relay circuit 1101 comprising at least one capacitor, a DC source 1102, optional voice and/or data communications circuitry 1103. "POWER" button 16 is adapted to power on pocket defibrillating system 10 and sends a signal to controller 1100, which in response to the signal, initiates operation of one or more of the pocket defibrillator functions, including performing a "self test" to determine proper operation of pocket defibrillating system 10. "POWER" button 16 is preferably a pushbutton. "SHOCK STATUS INDICATOR" light 171 comprises a light emitting element which is activated responsive to "POWER" button 16 being activated. Optionally, when the at least one capacitor in power relay circuitry 1101 have been charged to a predetermined charging value, "SHOCK STATUS INDICATOR" light 171 may change to another color to advise the rescuer that pocket defibrillating system 10 is charged and ready to deliver an electrical stimulus to a patient. For example, a green light when "POWER" button 16 is activated, and an orange light when the at least one capacitor in power relay circuit 1101 has completed charging and defibrillating system 10 is ready to deliver a shock (system is "armed").

Display 14 may be adapted to display conditions related to the patient, such as for example, an ECG cardiogram 141 and heartbeat rate indicator 143. Display 14 may be further adapted to visually display information which may be related to the operation of pocket defibrillating system 10, battery state indicator 142 and/or to procedures for defibrillation. For example, display 14 may display to a rescuer step-by-step instructions as to how to perform defibrillation, which may include how to operate pocket defibrillating system 10, where to place electrodes 13, and when to press "SHOCK RELEASE" button 17. Warning information may be provided advising that defibrillating system 10 is charged and ready to release a shock, when it is safe to touch the patient, and when to stay clear from the patient. Additionally or alternatively, display 14 may indicate if pocket defibrillating system 10 is in an override mode (not shown), in which case defibrillation may be initiated by the rescuer in an event that the defibrillating system 10 has indicated "SHOCK IS NOT ADVISED". Display 14 may also display information related to CPR feedback and/or CPR progress monitoring, such as, for example rate of chest compressions, number of chest compressions, and/or a visual alert if compressions are stopped before a threshold value is reached, or a visual indication of a desired compressions:release ratio with respect to a predetermined desired ratio. Procedures related to administering CPR may also be displayed. Display 14 may optionally display alerts in case of equipment malfunction and/or the result of a self-test. Display 14 is preferably, but not necessarily, a digital display such as, for example, an LCD (liquid crystal display), or an LED (light emitting diode) display. "SHOCKRELEASE" button 17 is adapted to send a signal to controller 1100 to release the energy stored in the at least one capacitor through electrodes 13 during defibrillation. "SHOCK RELEASE" button 17 is preferably a relatively large pushbutton which may be easily identified and initiated by the rescuer, Speaker 15 is adapted to vocally provide information which may be related to the operation of pocket defibrillating system 10, and/or to procedures for defibrillation. For example, speaker 15 may vocally provide to rescuer step-by-step instructions as to how to perform defibrillation, which may include how to operate pocket defibrillating system 10, where to place electrodes 13, and when to press "SHOCK RELEASE" button 17. Speaker 15 may also vocally provide information related to CPR feedback and/or CPR progress monitoring such as, for example, rate of chest compressions, and/or number of chest compressions. Alerts displayed on display 14 may also be vocally provided through speaker 15. Warning information may be provided advising that the at least one capacitor is charged, when it is OK to touch the patient, and when to stay clear from the patient. Optionally, a vocal alert is provided if compressions are stopped before a threshold value is reached. Optionally, procedures and other information related to administering CPR may also be vocally provided. The audio indications may also alert an intended user (a potential patient or rescuer) of a malfunction state in the defibrillation system, or the state of the battery, for example, providing an audio alert when the battery level reaches a predefined charge level. Optionally, defibrillator device 11 may comprise a microphone 151, which may optionally be located in speaker 17, to allow 2-way verbal communications capability, for example, with remotely located trained personnel, or to notify emergency medical services.

Power relay circuit 1101 comprises the at least one capacitor adapted to store a relatively large amount of energy from DC source 1102, and to relatively quickly discharge the high energy upon a rescuer pressing "SHOCK RELEASE" button 17 provided that the patient 90 is shockable, and/or defibrillation system 10 is operated in an override mode. DC source 1102 may comprise a battery or a plurality of batteries. The batteries may be rechargeable from an AC source, although in some embodiments of the invention the batteries may be non- rechargeable and are replaced after defibrillation and/or optionally, periodically. Electrodes 13 are adapted to substantially maximize the transfer of the energy stored in the at least one capacitor, to the thorax of patient 90, when the capacitor discharges. Electrodes 13 are further adapted to detect impedance changes in the thorax due to chest compressions. Also, electrodes 13 are adapted to convey a patient's heartbeat signals to be processed by controller 1100. In accordance with an embodiment of the invention, at least one of flexible electrodes 13 is adapted to be mechanically attached to defibrillator device 11 either directly or indirectly. Each electrode 13 may comprise a mechanical plug connector 132 attached to an electrode pad 131. Plug connector 132 includes a plug 132A adapted to be inserted into a socket (not shown) on an underside 111 of device 11. Inserting plug 132A into the socket establishes a mechanical connection between electrode 13 and device 11. Optionally, connector 132 may be comprised on underside 111 of device 11, and the socket in electrode 13 attached to electrode pad 131. Optionally, plug connector 132 may be an electromechanical connector adapted to be connected to an electrically conducting socket on underside 111 of defibrillator 11. The mechanical attachment of electrode 13 to defibrillator device 11 allows the rescuer to view the device in the same axis he views the patient and thus, to keep his/her eyes on the patient during the resuscitation procedure and later for monitoring purposes. The functional mechanical attachment of defibrillator device 11 to electrode 13 is allowed by virtue of the proportions and pocket size characterizing the defibrillator device 11 of the present invention. The new and novel positioning of the defibrillator device 11 further allows an effective monitoring of the patient and safe evacuation of the patient in a later stage by an ambulance, a helicopter or any other transportation with no fear of cable detachment or damage to the defibrillation system 10 due to the transit of the patient. Thus, the mechanical attachment of defibrillator device 11 to the patient facilitates a novel practice that is highly beneficial to the resuscitation and evacuation processes. As mentioned above, the benefits of such attachment rely on the ability to transfer the patient and the defibrillating system together at all stages of the event. It should be emphasized that said novel and improved practice, compared to the predicate practice, is enabled merely due to the pocket size and lightweight of the defibrillator device of the invention, wherein predicate devices are too large and heavy to facilitate such practice. Optionally, defibrillator device 11 may be attached to the patient by other means such as, for example, adhesive medical tape, bandaging, strapping, or the like.

In an embodiment shown in figures IA - 1C, an electrical connection is established between defibrillator device 11 and electrodes 13 by means of electrical leads 12 to an electrical connector 121 adapted to be attached to an electrically conducting socket (not shown) in the defibrillator device. Optionally, an electrical lead 12 may comprise an electrical connector 122 adapted to be reversibly connected to an electrically conducting socket 133 in electrode 13. The use of removable connector 122 substantially facilitates replacing electrodes 13 without a need for replacing electrical leads 12. The electrical lead 12, according to the 0561

present invention, may be in a form of a cable, a flat cable, a flexible printed circuit board and any electrical lead known in the art that is suitable for the purposes of the invention.

Flexible electrodes 13 may comprise an electrically conducting foil 135, which may be a metal foil, adapted to conduct electricity between defibrillator device 11 via the electrical leads 12 to patient 90. Conducting foil 135 may be backed by a medical foam 131 and surrounded by an adhesive rim 136, the adhesive rim adapted to secure electrode 13 to the thorax of patient 90. The whole electrode, or at a minimum, adhesive rim 136, are generally covered by a removable protective liner which is adapted to be removed prior to attaching electrode 13 to patient 90, Conducting foil 135 may be coated with an electrically conducting gel, for example, hydro gel or any other water based gel known in the art, adapted to provide a mediating layer at the interface between the conducting foil and the skin of patient 90, to thereby provide better electrical conductivity between conducting foil 135 and the skin of patient 90. Electrodes 13 are generally replaced after every defibrillation, and/or periodically.

Pocket defibrillating system 10 comprises a controller 1100 adapted to process inputs received from the rescuer through the "POWER" button 16 and "SHOCK RELEASE" button 17. Controller 1100 initiates charging of the at least one capacitor with energy from DC source 1102, and sends a signal to discharge the energy. Optionally, controller 1100 is adapted to record, process and display ECG readings 141 from electrical signals received via electrodes 13 associated with heartbeats, and may be further adapted to filter CPR artifacts from the electrical signals.

Controller 1100 optionally is adapted to enable pocket defibrillating system 10 to store in a memory the number of defibrillations performed by pocket defibrillating system 10. Additionally, controller 1100 is adapted to run self-tests to determine pocket defibrillating system 10 integrity and battery state. Optionally, the controller is programmable, such that the energy level is re-definable, for example, according to the patient's age, gender, weight, height or any other parameter or any combination of parameters. In some embodiments of the invention, the controller may have a reset feature. Optionally, the controller is adapted to engage in one-way data communication with external memory storage device/devices and external data processing device/devices through an interface connector such as a USB connector, and/or wireless means. Optionally, the data communication is two-way. Data communication interfacing is through optional data communication circuitry 1103, the communication circuitry optionally adapted to provide 2- way voice communication.

Reference is made to Figure 2A, which schematically illustrates a perspective view of an electrode 23 comprised in a pocket defibrillating system 20, in accordance with another embodiment of the invention. Electrode 23 is adapted to be mechanically fastened to a socket comprised on an underside of a pocket defibrillator device (not shown) by the attachment of a connector 232 and plug 232A, comprised in electrode 23. Electrode 23, which is used in pairs in defibrillating system 20, is electrically connected to a pocket defibrillator device (not shown) through an electrical lead 220. Defibrillating system 20, including electrode 23 comprising mechanical connector 232 with plug 232A, and medical foam backing 231 may be the same or substantially similar to that shown in Figures IA and IB at 10, 13, 131, 132, and 132A, with a variation that electrical lead 220 is directly attached to electrode 23 instead of using a connector/plug and socket as shown at 122/122A and 133, respectively. Electrode 23 additionally comprises an electrode liner 237 extending along a substantial portion of a perimeter of electrode 23, and to which may be attached an adhesive rim (not shown) to an underside of the electrode liner. Optionally, connector 232 may be replaced by a socket similar to that on the underside of the defibrillator device, and the socket on the device may be replaced by a connector and plug similar to the connector 232 and plug 232A. Reference is made to Figure 2B, which schematically illustrates a perspective view of an electrode 33 comprised in a pocket defibrillating system 30, in accordance with another embodiment of the invention. Electrode 33 is adapted to be mechanically fastened to an underside of a pocket defibrillator device (not shown) by a hoop and loop fastening system, for example, the same or substantially similar to a Velcro fastening system. The underside of the device comprises a hook fastener to which a loop fastener 332, comprised in electrode 33, is attached. Electrode 33, which is used in pairs in defibrillating system 30, is electrically connected to the device through an electrical lead 320. Defibrillating system 30, including electrode 33 comprising medical foam backing 331 and electrode liner 337; and electrical lead 320; may be the same or substantially similar to that shown in Figure 2A at 20, 23, 231, 237, and 220, with a variation that the hook and loop fastening system is used to mechanically attach electrode 33 to the device. Optionally, loop fastener 332 may be replaced by a hook fastener similar to that on the underside of the pocket defibrillator device, and the hook fastener in the device may be replaced by a loop fastener similar to loop fastener 332 on electrode 33.

Reference is made to Figure 2C which schematically illustrates a perspective view of an electrode 43 comprised in a pocket defibrillating system 40, in accordance with another embodiment of the invention. Electrode 43 is adapted to be mechanically fastened to an underside of a pocket defibrillator device (not shown) by a magnetic fastening system. The underside of the device comprises a magnet to which may be attached a metal plate 432, comprised in electrode 43. Electrode 43, which is used in pairs in defibrillating system 40, is electrically connected to the device through an electrical lead 420. Defibrillating system 40, including electrode 43, medical foam backing 431 and electrode liner 437; and electrical lead 420; may be the same or substantially similar to that shown in Figure 2A at 20, 23, 231, 237, and 220, with a variation that the magnetic fastening system is used to mechanically attach electrode 43 to the device. Optionally, metal plate 432 may be replaced by a magnet similar to that on the underside of the pocket defibrillator device, and the magnet on the device may be replaced by a metal plate similar to metal plate 432.

Reference is made to Figure 2D, which schematically illustrates a perspective view of an electrode 43' comprised in a pocket defibrillating system 40', in accordance with another embodiment of the invention. Electrode 43' is adapted to be mechanically fastened to an underside of a pocket defibrillator device (not shown) by a latching system. The underside of the device comprises a channel adapted to slidingly receive a latch 432', comprised in electrode 43'. A direction of insertion of latch 432' into the channel may be indicated by an arrow 432A' optionally comprised in the latch. Latch 432' comprises a spring level mechanism 432B' adapted to exert a pressure essentially locking the latch inside the channel. Electrode 43', which is used in pairs in defibrillating system 40', is electrically connected to the device through an electrical lead 420. Defibrillating system 40', including electrode 43' comprising medical foam backing 431' and electrode liner 437'; and electrical lead 420'; may be the same or substantially similar to that shown in Figure 2A at 20, 23, 231, 237, and 220, with a variation that the latching system is used to mechanically attach electrode 43' to the device. Optionally, latch 432' may be replaced by a channel similar to that on the underside of the pocket defibrillator device, and the channel in the device replaced by a latch similar to latch 432'.

Reference is made to Figure 3A₃ which schematically shows a perspective view of pocket defibrillating system 10 placed on a patient 90 in a position for defibrillating and/or CPR feedback and/or CPR progress monitoring and/or heart activity monitoring, in accordance with an embodiment of the invention. Reference is made also to Figures IA - 1C. Electrodes 13 are connected to pocket defibrillator device 11 through electrical leads 12 attached to connector 121. One electrode 13 is mechanically attached to underside 111 of device 11 and is positioned on the thorax of patient 90, while the other electrode is placed to the right of defibrillator device 11 on a lower right portion of the thorax. Electrodes 13 are held in place by an adhesive coating of medical foam rim 136, and a uniform interface contact is maintained between conducting foil 135 and the skin of patient 90 by a hydro gel. Reference is made to Figure 3B, which schematically shows a perspective view of pocket defibrillating system 10 and patient 90 in Figure 3 A during defibrillation, in accordance with an embodiment of the invention. Pocket defibrillating system 10 is positioned as shown in Figure 3 A. A rescuer 92 presses on "SHOCK RELEASE" button 17 to defibrillate patient 90, optionally following procedures vocally or visually (displayed) provided by defibrillator device 11. Described further on in the Detailed Description is an exemplary defibrillation process which comprises a use of pocket defibrillating system 10.

Reference is made to Figure 3 C, which schematically shows a perspective view of pocket defibrillating system 10 and patient 90 in Figure 3 A during administration of CPR and CPR feedback and/or CPR progress monitoring, in accordance with an embodiment of the invention. Pocket defibrillating system 10 is positioned as shown in Figure 3A. A rescuer 92 provides CPR optionally following procedures vocally or visually (displayed), provided by defibrillator device 11. Optionally, the procedures are based on one or more preprogrammed methods, such, as for example, the AHA. Described further on in the Detailed Description is an exemplary CPR feedback monitoring process which comprises a use of pocket defibrillating system 10.

Reference is made to Figure 4A and to 4B, which schematically shows a flow chart of an exemplary defibrillation process, and CPR feedback monitoring process, respectively, comprising the use of pocket defibrillating system 10 shown in Figures IA- ID, in accordance with an embodiment of the invention. Reference is also made to Figures 3 A - 3C. Optionally, the process may comprise the use of any of the embodiments of the invention. [Step 500] Rescuer 92, upon identifying patient 90, presses "POWER" button 16 on pocket defibrillator device 11 for turning the device on. [Step 500A] Capacitor(s) in power relay circuit 1101 begin charging to a preset energy level. [Step 501] Electrodes 13 are attached to patient 90, as shown in exemplary Figure 3 A, following removal of a liner protecting adhesive rim 136.

[Step 502] Electrodes 13 are connected to pocket defibrillator device 11 by inserting connector 121 into the electrical socket in the device. [Step 503] Defibrillator device 11 is attached to electrode 13 positioned near center of thorax by mounting socket on underside 111 of the defibrillator device unto plug 132 A on connector 132 on electrode 13.

[Step 504] Defibrillator device 11 checks a quality of the electrodes 13 attachment to patient 90 by performing an Attachment Quality Test. In one embodiment of the invention, the test may comprise a measurement of the impedance of the patient's thorax, comparing said measurement outcome to a predetermined threshold value and alerting rescuer 92 in an event that the measurement deviates from said threshold. In another embodiment, the attachment quality of electrodes 13 may be concluded from a correlation found between the attachment quality and a signal: noise ratio of ECG measurement. If Test is passed, proceed to Step 505. Otherwise, go to Step 505A.

[Step 505] Rescuer 92 may instructs defibrillating system 10 whether to override the

VF/VT arrhythmia detection Step 508. If yes to override, go to Step 510. If not to override, continue to Step 506.

[Step 505A] Improve placement of electrodes 13. [Step 506] System 10 acquires ECG and thorax impedance measurement of patient 90.

[Step 507] Device 11 runs VF/VT detection algorithm.

[Step 508] Device 11 outputs to rescuer 92 visually through display 14, and/or vocally through speaker 15 the results of the VF/VT detection algorithm. If VF/VT is not detected, go to Step 513. If VF/VT is detected, device 11 is advising rescuer 92 that patient 90 is shockable and thus, to continue to next step.

[Step 509] Device 11 instructs rescuer to press "SHOCK RELEASE" button 17.

[Step 510] Rescuer 92 presses "SHOCK RELEASE" button 17.

[Step 511] Device 11 evaluates whether the capacitor(s) has charged to a level which corresponds with the thorax impedance of patient 90. If yes, go to Step 512. If no, continue to next step.

[Step 511A] Complete charging of capacitor(s) based on measured thorax impedance.

[Step 512] Defibrillation system 10 delivers shock. Go to Step 507.

[Step 513] Device 11 evaluates ECG pattern. If the ECG pattern is Normal PQRST go to

Step 515. If the ECG pattern is a straight line, continue to next step. [Step 514] Device 11 emits an alarm to alert rescuer (caregiver) 92 to proceed to CPR.

Alarm is emitted visually through display 14 and/or vocally through speaker 15.

[Step 515] Device 11 emits an alarm to alert rescuer (caregiver) 92 to check patient 90 airways and breathing.

[Step 516] System 10 checks to see if CPR is being performed. If not being performed, go to Step 507. If yes being performed, continue to next step.

[Step 517] System 10 goes into CPR feedback and/or progress monitoring mode.

[Step 518] System 10 searches for repetitive and frequent thorax impedance changes that reflect chest compressions (and not artifacts). T/IL2009/000561

[Step 519] System 10, based on the thorax impedance changes, determines whether or not CPR is in progress. If impedance changes do not indicate chest compressions, go to Step 516. If impedance changes indicate chest compression, continue to next step. [Step 520] System 10 monitors a rate of thorax impedance changes. [Step 521] System 10 compares the rate of thorax impedance changes with a preset threshold value representing compressions. If threshold value is not reached, system 10 determines that CPR is not in progress; go to Step 516. If system 10 determines that CPR is in progress, continue to the next step. [Step 522] System 10 initiates a rate meter to measure a rate of thorax impedance change, and a counter to count the number of impedance changes.

[Step 523] System 10 compares the rate of thorax impedance change with a preset threshold value. If the rate is less than the preset value, go to Step 523 A. If the rate reaches the threshold value, go to Step 524. [Step 523A] Device 11 provides feedback to rescuer 92, for example, in the form of a visual alert through display 14 and/or an audio alert through speaker 15. Visual alert, for example, may include textual and/or graphic contents on display 14, or by color change and/or gradual lighting of one or more LEDs, or any combination thereof. Audio alert, for example, may include contents such as "INCREASE/DECREASE COMPRESSION RATE", "PRESS HARDER", or announcing the actual number of compressions, such as "50, 51, 52 ...,", or any combination thereof. Go to Step 522.

[Step 524] System 10 compares the number of thorax impedance changes (number of compressions) with a preset threshold value. If the number of compressions is less than the preset value, go to Step 524A. If the number of compressions reaches or exceeds the threshold value, go to Step 525. [Step 524A] Device 11 provides feedback to rescuer 92, for example, in the form of a visual alert through display 14 and/or an audio alert through speaker 15. Visual alert, for example, may include textual and/or graphic content on display 14, or by color change and/or gradual lighting of one or more LEDs, or any combination thereof. Audio alert, for example, may include contents such as "INCREASE/DECREASE COMPRESSION RATE", "PRESS HARDER", or announcing the actual number of compressions, such as "50, 51, 52 ...,", or any combination thereof. Go to Step 522.

[Step 525] Device 11 emits an alarm to alert rescuer 92 to check patient 90 airways and breathing. System 10 monitors ECG. Go to Step 516. Reference is made to Figure 6A, which schematically shows a perspective view of a pocket defibrillating system 1OA, including a pocket defibrillator HA, attached by means of an attachment element 96 to a patient 90, in accordance with another embodiment of the invention. Pocket defibrillating system 1OA is placed on patient 90 for defibrillating and/or cardiac massage feedback and/or cardiac massage progress monitoring and/or heart activity monitoring, while additionally allowing a care-giver to treat the patient while looking at a display 14A and without requiring any substantial shifting of the caregiver's head from the patient. Furthermore, defibrillation system 1OA is attached to patient 90 so as to facilitate carrying (moving) of the patient and to increase safety while transferring the patient. Electrodes 13A are connected to pocket defibrillator device HA through electrical leads 12A attached to connector 121A. Electrodes 13A are held in place by an adhesive coating on a medical foam rim (not shown), and a uniform interface contact is maintained between the electrode and the skin of patient 90 by a hydro gel (not shown).

Defibrillator device HA is placed on the abdomen of patient 90 and held in place by attachment element 96. Optionally, device HA may be placed in any location on patient 90 suitable for allowing the care-giver to treat the patient while looking at a display 14A and without requiring any substantial shifting of the caregiver's head from the patient. Attachment element 96 comprises an adhesive tape, although in some embodiments of the invention, the attachment element may comprise any means of attaching defibrillator device HA to the abdomen, including glue, a vacuum cap, a mechanical fastening element, an elastic band, or any combination thereof.

Defibrillator device HA including display 14A, electrodes 13A, and electrical leads 12A including connector 121A, may be the same or substantially similar to that shown in Figures IA - 1C at 11, 14, 13, 12 and 121, respectively, with a difference that the electrodes are not adapted to be reversibly attached to the defibrillator device (electrodes 13A do not include the mechanical plug connector shown in Figure IA at 132). Optionally, electrodes 13A may be reversibly attached to pocket defibrillator device HA. Optionally, defibrillator device HA does not comprise means for allowing electrodes 13A to be reversibly attached to the device. Reference is made to Figure 6B, which schematically shows a perspective view of a pocket defibrillating system 1OB, including a pocket defibrillator HB attached by means of an attachment element 97 to a patient 90, in accordance with another embodiment of the invention, Pocket defibrillating system 1OB is placed on patient 90 for defibrillating and/or

CPR feedback and/or CPR progress monitoring and/or heart activity monitoring, while additionally allowing a care-giver to treat the patient while looking at a display 14B and without requiring any substantial shifting of the caregiver's head from the patient. Furthermore, defibrillation system 1OB is attached to patient 90 so as to facilitate carrying (moving) of the patient and to increase safety while transferring the patient. Electrodes 13B are connected to pocket defibrillator device HB through electrical leads

12B attached to connector 121B. Electrodes 13B are held in place by an adhesive coating on a medical foam rim (not shown), and a uniform interface contact is maintained between the electrode and the skin of patient 90 by a hydro gel (not shown).

Defibrillator device HB is placed on an upper arm of patient 90 and held in place by attachment element 97. Optionally, device HB may be placed in any location on patient 90 suitable for allowing the care-giver to treat the patient while looking at a display 14B and without requiring any substantial shifting of the caregiver's head from the patient. Attachment element 97 comprises an adhesive tape, although in some embodiments of the invention. The attachment element may comprise any means of attaching defibrillator device HB to the upper arm, including glue, a vacuum cap, a mechanical fastening element, an elastic band, or any combination thereof.

Defibrillator device HB including display 14B, electrodes 13B, and electrical leads 12B including connector 121B, may be the same or substantially similar to that shown in Figures IA- 1C at 11, 14, 13, 12 and 121, respectively with a difference that the electrodes are not adapted to be reversibly attached to the defibrillator device (electrodes 13B do not include the mechanical plug connector shown in Figure IA at 132). Optionally, electrodes 13B may be reversibly attached to pocket defibrillator device HB. Optionally, defibrillator device HB does not comprise means for allowing electrodes 13B to be reversibly attached to the device.

Reference is made to Figure 6C, which schematically shows a perspective view of a pocket defibrillating system 1OC, including a pocket defibrillator HC attached by means of an attachment element 98 to a patient 90, in accordance with another embodiment of the invention, Pocket defibrillating system 1OC is placed on patient 90 for defibrillating and/or cardiac massage feedback and/or cardiac massage progress monitoring and/or heart activity monitoring, while additionally allowing a care-giver to treat the patient while looking at a display 14C and without requiring any substantial shifting of the caregiver's head from the patient. Furthermore, defibrillation system 1OC is attached to patient 90 so as to facilitate carrying (moving) of the patient and to increase safety while transferring the patient.

Electrodes 13C are connected to pocket defibrillator device HC through electrical leads 12C attached to connector 121C. Electrodes 13C are held in place by an adhesive 0561

coating on a medical foam rim (not shown), and a uniform interface contact is maintained between the electrode and the skin of patient 90 by a hydro gel (not shown).

Defibrillator device HC is placed on the abdomen of patient 90 and held in place by attachment element 97. Optionally, device HC may be placed in any location on patient 90 suitable for allowing the care-giver to treat the patient while looking at a display 14C and without requiring any substantial shifting of the caregiver's head from the patient. Attachment element 98 comprises a wide adhesive tape adapted to form a pocket into which device HC may be inserted, although in some embodiments of the invention, the attachment element may comprise any means of attaching defibrillator device HB to the abdomen, including glue, a vacuum cap, a mechanical fastening element, an elastic band, or any combination thereof.

Defibrillator device HC including display 14C, electrodes 13C, and electrical leads 12C including connector 121C, may be the same or substantially similar to that shown in Figures IA - 1C at 11, 14, 13, 12 and 121, respectively with a difference that the electrodes are not adapted to be reversibly attached to the defibrillator device (electrodes 13C do not include the mechanical plug connector shown in Figure IA at 132). Optionally, electrodes 13C may be reversibly attached to pocket defibrillator device HC. Optionally, defibrillator device HC does not comprise means for allowing electrodes 13C to be reversibly attached to the device.

It may be appreciated by a person skilled in the art that the method described above may be performed with variations in the order and manner of execution of the steps and therefore, is in no way intended to be limiting in any form.

Reference is made to Figure 5 A, which schematically illustrates an exemplary pocket defibrillating system 70 comprising a pocket defibrillator device 71 attached to a belt or a waistband of a patient's pants 701, or optionally a rescuer's pants; to Figure 5B which schematically shows pocket defibrillator device 71 of Figure 5 A partially inserted in a pocket 711 of pants 701; and to Figure 5C which schematically shows pocket defibrillator device 71 of Figure 5A partially inserted in a pocket 702 of a physician's coat; in accordance with an embodiment of the invention. Pocket defibrillating system 70 may be the same or substantially similar to pocket defibrillating system 10 shown in Figures IA - ID. Optionally, pocket defibrillating system 70 may be the same or substantially similar to pocket defibrillating system 20 shown in Figure 2A, or to pocket defibrillating system 30 shown in Figure 2B, or to pocket defibrillating system 40 shown in Figure 2C, or to pocket defibrillating system 40' shown in Figure 2D. In accordance with an embodiment of the invention, electrodes (not shown), which may be the same or substantially similar to that shown as 13 in Figures IA - 1C, are adapted to be carried inside pocket 711 of pants 701, and/or inside pocket 702 of physician's coat. Optionally, the electrodes are adapted to be carried inside a pocket of a jacket, a vest, a gown, a shirt or a set of pants. Optionally, the electrodes may be folded to fit into the pocket. Optionally, the electrodes may be the same or substantially similar to electrodes 23 shown in Figure 2A, or optionally, electrodes 33 shown in Figure 2B, or optionally electrodes 43 shown in Figure 2C, or optionally electrodes 43' shown in Figure 2D.

In the description and claims of embodiments of the present invention, each of the words, "comprise" "include" and "have", and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

The invention has been described using various detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments may comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the invention that are described and embodiments of the invention comprising different combinations of features noted in the described embodiments, will occur to persons with skill in the art.

Claims

CLAIMSWhat we claim is;

1. A defibrillating system comprising:

a defibrillator device adapted to be attached to a body of a patient;

an attachment element adapted to attach said defibrillator device to the patient; and

at least two electrodes.

2. The defibrillating system of claim I₃ wherein said attachment element is an integral part of the defibrillator device, an integral part of at least one electrode or an independent element.

3. The defibrillating system of claim 1, wherein the attachment element comprises glue, a vacuum cap, a mechanical fastening element or any combination thereof.

4. The defibrillating system of claim 1, wherein said defibrillator device is adapted to fit in a pocket.

5. The defibrillating system of claim 1, wherein said defibrillator device is in an elongated structure proportions.

6. The defibrillating system according to claim 1, wherein the electrodes are reversibly attached to said defibrillator device.

7. The defibrillating system according to claim 1, wherein the attachment element comprises a loop fastener located on at least one of the two electrodes and adapted to be attached to a hook fastener located on the housing of the defibrillator device; or wherein the hook fastener is located on at least one of the two electrodes and adapted to be attached to a loop fastener located on the housing of the defibrillator device.

8. The defibrillating system according to claim 1, wherein the attachment element comprises a metal plate located on at least one of the two electrodes adapted to be attached to a magnet located on the housing of the defibrillator device or wherein the attachment element comprises a magnet located on at least one of the two electrodes adapted to be attached to a metal plate located on the housing of the defibrillator device.

9. The defibrillating system according to claim 1, wherein the attachment element comprises a latch located on at least one of the two electrodes adapted to be slidingly inserted into a channel located on the housing of the defibrillator device or wherein the attachment element comprises a channel located on at least one of the two electrodes adapted to slidingly receive a latch located on the housing of the defibrillator device.

10. The defibrillating system according to claim 1, wherein at least one electrode is either mechanically or electromechanically attached to the defibrillator device.

11. The defibrillating system according to claim 1, further comprising a housing, said housing comprising dimensions not greater than 19 cm x l0 cm x 4 cm.

12. The defibrillating system according to claim 11, wherein said housing weighs less than or equal to 600 gr.

13. The defibrillating system according to claim 1, wherein at least one of said electrodes is adapted to detect heartbeat.

14. The defibrillating system according to claim 1, wherein said defibrillator device is adapted to stop energy discharge if a heartbeat is detected.

15. The defibrillating system according to claim 1, wherein the defibrillating system is adapted to perform ECG monitoring.

16. The defibrillating system according to claim 1, wherein the defibrillating system is adapted to measure thorax impedance.

17. The defibrillating system according to claim 1, wherein at least one of said electrodes is adapted to measure thorax impedance,

18. The defibrillating system according to claim 17, wherein the measured thorax impedance is used to calculate the appropriate discharge energy.

19. The defϊbrillating system according to claim 1, wherein the defϊbrillating system is adapted to provide cardiac massage feedback, to monitor cardiac massage or both.

20. The defibrillating system according to claim 19, wherein the defϊbrillating system is adapted to measure a rate or a magnitude of thorax impedance change, a number of thorax impedance changes or both.

21. The defibrillating system according to claim 1, wherein said defibrillator device is adapted either to stop energy discharge or to allow energy discharge upon receiving an override command.

22. The defibrillating system according to claim 1, wherein said defibrillator device is adapted for remote location data communication.

23. The defibrillating system according to claim 22, wherein said data communication is either a one-way communication, or a two-way communication.

24. The defibrillating system according to claim 1, wherein said defibrillator device is adapted for two-way vocal communication.

25. The defibrillating system according to claim 1 adapted to perform defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof.

26. The defibrillating system according to claim 25, further comprising a display adapted to show data relating to the defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof.

27. The defibrillating system according to claim 26 adapted to allow a caregiver to treat the patient while looking at the display, without substantially shifting his/her head from the patient.

28. The defibrillating system according to claim 1 adapted to be abutted to the body of the patient to facilitate carrying the patient and thus to increase safety in transferring of the patient.

29. A defibrillation electrode comprising an attachment element reversibly attachable to a defibrillator device.

30. The defibrillation electrode according to claim 29, wherein the attachment element is integrally formed with the electrode.

31. The defibrillation electrode according to claim 29, wherein the electrode comprises a loop fastener adapted to be attached to a hook fastener located on the housing of the defibrillator device or wherein the electrode comprises a hook fastener adapted to be attached to a loop fastener located on the housing of the defibrillator device.

32. The defibrillation electrode according to claim 29, wherein the electrode comprises a metal plate adapted to be attached to a magnet comprised on the housing of the defibrillator device or wherein the electrode comprises a magnet adapted to be attached to a metal plate located on the housing of the defibrillator device.

33. The defibrillation electrode according to claim 29, wherein the electrode comprises a latch adapted to be slidingly inserted into a channel located on the housing of the defibrillator device or wherein the electrode comprises a channel adapted to slidingly receive a latch located on the housing of the defibrillator device.

34. The defibrillation electrode according to claim 29 adapted to be either mechanically or electromechanically attached to the defibrillator device.

35. A defibrillating system comprising a monitor unit adapted to monitor the performance of a cardiac massage on a patient by measuring a rate and a number of impedance changes of the thorax of the patient.

36. The defibrillating system according to claim 35, further comprising a feedback unit adapted to provide a feedback on the performance of a said cardiac massage to a caregiver.

37. The defibrillating system according to claim 36, wherein said feedback is provided as an audio feedback, a visual feedback or both.

38. A defibrillating system comprising:

a defibrillator device adapted to be attached to at least one defibrillation pad, and;

at least one defibrillation pad adapted to be attached to said defibrillator device to thereby attach said defibrillator device to a patient.

39. The defibrillating system of claim 38, wherein said defibrillator device is adapted to fit a pocket.

40. The defibrillating system of claim 38, wherein said defibrillator device is characterized by elongated structure proportions.

41. The defibrillating system of claim 38, wherein said defibrillation pad is reversibly attached to said defibrillator device.

42. The defibrillating system of claim 38, wherein said defibrillation pad comprises a loop fastener and adapted to be attached to a hook fastener located on the housing of the defibrillator device; or wherein the hook fastener is located on the defibrillation pad and adapted to be attached to a loop fastener located on the housing of the defibrillator device.

43. The defibrillating system of claim 38, wherein said defibrillation pad comprises a metal plate adapted to be attached to a magnet located on the housing of the defibrillator device; or wherein the magnet is located on the defibrillation pad and adapted to be attached to a metal plate located on the housing of the defibrillator device.

44. The defibrillating system of claim 38, wherein said defibrillation pad comprises a latch adapted to be slidingly inserted into a channel located on the housing of the defibrillator device; or wherein the channel is located on the defibrillation pad and adapted to slidingly receive a latch located on the housing of the defibrillator device.

45. The defibrillating system according to claim 38, wherein at least one defibrillation pad is either mechanically or electromechanically attached to the defibrillator device.

46. The defibrillating system according to claim 38, further comprising a housing, said housing comprising dimensions not greater than 19 cm x l0 cm x 4 cm.

47. The defibrillating system according to claim 46, wherein said housing weighs less than or equal to 600 gr.

48. The defibrillating system according to claim 38, wherein at least one of said defibrillation pad is adapted to detect heartbeat.

49. The defibrillating system according to claim 38, wherein said defibrillator device is adapted to stop energy discharge if a heartbeat is detected.

50. The defibrillating system according to claim 38, wherein the defibrillating system is further adapted to perform ECG monitoring.

51. The defibrillating system according to claim 38, wherein the defibrillating system is further adapted to measure thorax impedance.

52. The defibrillating system according to claim 38, wherein at least one of said defibrillation pad is adapted to measure thorax impedance.

53. The defibrillating system according to claims 51 and 52, wherein the measured thorax impedance is used to calculate the appropriate discharge energy.

54. The defibrillating system according to claim 38, wherein the defibrillating system is adapted to provide cardiac massage feedback, to monitor cardiac massage or both,

55. The defibrillating system according to claim 54, wherein the defibrillating system is adapted to measure a rate or a magnitude of thorax impedance change, a number of thorax impedance changes or both.

56. The defibrillating system according to claim 38, wherein said defibrillator device is adapted either to stop energy discharge or to allow energy discharge upon receiving an override command.

57. The defibrillating system according to claim 38, wherein said defibrillator device is adapted for remote location data communication.

58. The defibrillating system according to claim 57, wherein said data communication is either a one-way communication, or a two-way communication.

59. The defibrillating system according to claim 38, wherein said defibrillator device is adapted for two-way vocal communication.

60. The defibrillating system according to claim 38, adapted to perform defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof.

61. The defibrillating system according to claim 60, further comprising a display adapted to show data relating to the defibrillation, cardiac massage feedback, cardiac massage monitoring, ECG monitoring or any combination thereof.

62. The defibrillating system according to claim 60 adapted to allow a caregiver to treat the patient while looking at the display, without substantially shifting his/her head from the patient.

63. The defibrillating system according to claim 38 adapted to be abutted to a body of the patient to facilitate carrying the patient and thus to increase safety in transferring of the patient.