US20140039593A1 - External defibrillator - Google Patents

Abstract

A variety of arrangements and methods relating to a defibrillator are described. In one aspect of the invention, a defibrillator includes two paddles that each include a defibrillator electrode covered in a protective housing. The two paddles are sealed together using a releasable seal to form a paddle module such that the housings of the paddles form the exterior of the paddle module. An electrical system including at least a battery and a capacitor is electrically coupled with the paddles. The battery is arranged to charge the capacitor. The capacitor is arranged to apply a voltage at the defibrillator electrodes, which generates an electrical shock for arresting a cardiac arrhythmia.

Description

PRIORITY CLAIM/RELATED APPLICATIONS
• This application is a continuation of and claims priority under 35 USC 120 to U.S. patent application Ser. No. 12/724,269 filed on Mar. 15, 2010 and entitled “External Defibrillator” which in turns claims the benefit under 35 USC 119(e) to U.S. Provisional Patent Application Ser. No. 61/161,014 filed on Mar. 17, 2009 and entitled “External Defibrillator”, the entirely of both of which are incorporated herein by reference.
FIELD
• The present invention relates generally to methods and arrangements relating to cardiac medical devices. More specifically, the present invention relates to an external defibrillator.
BACKGROUND
• A primary task of the heart is to pump oxygenated, nutrient-rich blood throughout the body. Electrical impulses generated by a portion of the heart regulate the pumping cycle. When the electrical impulses follow a regular and consistent pattern, the heart functions normally and the pumping of blood is optimized. When the electrical impulses of the heart are disrupted (i.e., cardiac arrhythmia), sudden cardiac arrest may result, which inhibits the circulation of blood. As a result, the brain and other critical organs are deprived of nutrients and oxygen. A person experiencing sudden cardiac arrest may suddenly lose consciousness and die shortly thereafter if left untreated.
• A well known and effective treatment for sudden cardiac arrest or arrhythmia is defibrillation. Defibrillation involves passing a current through the person to shock the heart back into a normal rhythm. There are a wide variety of defibrillators. For example, implantable cardioverter-defibrillators (ICD) involve surgically implanting wire coils and a generator device within a person. ICDs are typically for people at high risk for a cardiac arrhythmia. When a cardiac arrhythmia is detected, a current is automatically passed through the heart of the user with little or no intervention by a third party.
• Another, more common type of defibrillator is the automated external defibrillator (AED). Rather than being implanted, the AED is an external device used by a third party to resuscitate a person who has suffered from sudden cardiac arrest.FIG. 1 illustrates aconventional AED100, which includes abase unit102 and twopads104. Sometimes paddles with handles are used instead of thepads104. Thepads104 are connected to thebase unit102 usingelectrical cables106.
• A typical protocol for using the AED100 is as follows. Initially, the person who has suffered from sudden cardiac arrest is placed on the floor. Clothing is removed to reveal the person'schest108. Thepads104 are applied to appropriate locations on thechest108, as illustrated inFIG. 1. The electrical system within thebase unit100 generates a high voltage between the twopads104, which delivers an electrical shock to the person. Ideally, the shock restores a normal cardiac rhythm. In some cases, multiple shocks are required.
• Although existing technologies work well, there are continuing efforts to improve the effectiveness, safety and usability of automatic external defibrillators.
SUMMARY
• The present invention relates to a variety of methods and arrangements for improving the portability, accessibility and performance of a defibrillator. In one aspect of the present invention, a defibrillator including two sealed paddles is described. Each paddle includes a defibrillator electrode covered in a protective housing. The two paddles are sealed together using a releasable seal to form a paddle module such that the housings of the paddles form the exterior of the paddle module. An electrical system including at least a battery and a capacitor is electrically coupled with the paddles. The capacitor is arranged to apply a voltage at the defibrillator electrodes, which helps generate an electrical shock suitable for arresting a cardiac arrhythmia.
• Various actions may be triggered by the opening of the seal. For example, in some embodiments the opening of the seal automatically causes the capacitor to be charged by the battery. After the seal has been opened, a wireless message may be sent to a suitable device (e.g., a telephone, a cell phone, a remote server, etc.) at an emergency care facility. The message may contain important information relating to the identity of the user, the location of the defibrillator and the condition of the person who is being defibrillated.
• Any capacitors and batteries in the electrical system of the defibrillator may be stored in a single paddle, both paddles or distributed across various discrete devices. In some designs, all capacitors and batteries are stored only in one or both of the paddles. Other designs involve placing at least a portion of the electrical system in a separate power module. The power module may be linked to one or more of the paddles with a cable. In some implementations, the power module and paddle module may be attached to a belt.
• One aspect of the invention involves a connecting structure that physically and electrically connects two defibrillator paddles and also plays an instructional role. The flexible connecting structure includes one or more sheet-like sections. There are instructions for properly using the defibrillator on a surface of the connecting structure. The instructions may be conveyed in a wide variety of ways, including audio prompts, electronic text, lighting patterns, etc. Generally, the flexible connecting structure is arranged to be easy for a user to reference while the user is simultaneously operating the defibrillator.
• In another aspect of the invention, a defibrillator with pads that each have electrically conductive protrusions will be described. Each pad has a defibrillator electrode that includes the electrically conductive protrusions. An electrical system including at least a battery and a capacitor is coupled with the two pads. Generally, the electrical system also may include an electrical control system that helps convert the energy from the battery to a voltage that charges that capacitor. The control system may also help regulate the flow of current from the capacitor to the load and/or help perform cardiac rhythm detection by analyzing signals received through the pads. In some embodiments, the electrically conductive protrusions on each pad are sharp, densely arranged, bristle-like and/or suitable for penetrating into the skin of a cardiac arrest victim. By pressing into the skin of the person, the protrusions may help reduce the electrical resistance of the skin. Therefore, defibrillation may be possible at lower voltage levels. This design may be combined with other aforementioned embodiments. For example, the electrically conductive protrusions may be sealed within a paddle module that is formed by sealing together the two paddles. An added advantage of such an approach is that it helps to ensure the sterility and safety of the protrusions.
• Additional embodiments relate to methods for using the above defibrillator designs.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention and the advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings in which:
• FIG. 1 diagrammatically illustrates an example of a conventional defibrillator.
• FIG. 2A illustrates a diagrammatic perspective view of a paddle module in accordance with a particular embodiment of the present invention.
• FIG. 2B illustrates a diagrammatic side view of defibrillator paddles and a connecting structure in accordance with a particular embodiment of the present invention.
• FIGS. 3A and 3B illustrates diagrammatic top and side views of a paddle module in accordance with a particular embodiment of the present invention.
• FIG. 3C-3F illustrates different approaches to sealing the paddle module in accordance with various embodiments of the present invention.
• FIG. 4A illustrates a diagrammatic end view of a paddle module in accordance with a particular embodiment of the present invention.
• FIG. 4B illustrates a diagrammatic side view of components of a defibrillator paddle in accordance with a particular embodiment of the present invention.
• FIG. 5 illustrates a diagrammatic top view of a paddle module while the paddle module is being unsealed in accordance with a particular embodiment of the present invention.
• FIGS. 6A and 6B illustrate diagrammatic side views of a sealed and unsealed paddle module in accordance with a particular embodiment of the present invention.
• FIG. 7 illustrates a diagrammatic top view of a connecting structure that extends between two defibrillator paddles in accordance with a particular embodiment of the present invention.
• FIGS. 8A-8C diagrammatically illustrate defibrillators with paddles that each include electrically conductive protrusions in accordance with various embodiments of the present invention.
• FIG. 9A-9B illustrate diagrammatic side and top views of a defibrillator with paddle guards in accordance with a particular embodiment of the present invention.
• FIGS. 10A-10B are block diagrams indicating different arrangements of the defibrillator electrical system in accordance with various embodiments of the present invention.
• FIGS. 11A-11B diagrammatically illustrate a belt with an attached power module and paddle module in accordance with a particular embodiment of the present invention.
• FIG. 12A is a block diagram illustrating various components of a defibrillator and associated devices in accordance with a particular embodiment of the present invention.
• FIG. 12B is a circuit diagram for a defibrillator according to a particular embodiment of the present invention.
• FIG. 12C is a circuit diagram for a charging circuit of a defibrillator according to a particular embodiment of the present invention.
• FIG. 13 is a flow chart illustrating a method of using a defibrillator in accordance with a particular embodiment of the present invention.
• FIG. 14A illustrates a diagrammatic perspective view of a paddle module that is being unsealed in accordance with a particular embodiment of the present invention.
• FIG. 14B illustrates a diagrammatic top view of a defibrillator being placed on a chest of a cardiac arrest victim in accordance with a particular embodiment of the present invention.
• FIG. 15 illustrates a diagrammatic top view of a connecting structure that extends between two defibrillator paddles in accordance with a particular embodiment of the present invention.
• FIG. 16A is a flow diagram illustrating a method for automatically performing one or more actions based on the breaking of the defibrillator seal in accordance with a particular embodiment of the present invention.
• FIG. 16B is a flow diagram illustrating a method for performing one or more actions based on signals received from defibrillator electrodes in accordance with a particular embodiment of the present invention.
• In the drawings, like reference numerals are sometimes used to designate like structural elements. It should also be appreciated that the depictions in the figures are diagrammatic and not to scale.
DETAILED DESCRIPTION OF ONE OR MORE EMBODIMENTS
• The present invention relates generally to methods and arrangement for arresting a cardiac arrhythmia using an external defibrillator. Some aspects of the invention relate to defibrillators with various types of arrangements, connecting structures, and electrodes.
• The steady circulation of blood is crucial to the proper functioning of the human body. The circulation of blood is governed by the heart, whose expansion and contraction is in turn controlled by a regular pattern of electrical impulses. When this pattern of electrical impulses becomes chaotic or overly rapid, a sudden cardiac arrest may take place. Tragically, the victim typically collapses and dies unless he or she receives proper medical attention.
• The most successful therapy for sudden cardiac arrest is prompt and appropriate defibrillation. A defibrillator uses electrical shocks to restore the proper functioning of the heart. A crucial component of the success or failure of defibrillation, however, is time. Ideally, a victim should be defibrillated immediately upon suffering a sudden cardiac arrest, as the victim's chances of survival dwindle rapidly for every minute without treatment.
• Accordingly, efforts have been made to improve the availability of automated external defibrillators (AED), so that they are more likely to be in the vicinity of sudden cardiac arrest victims. Advances in medical technology have reduced the cost and size of automated external defibrillators (AED). Some modern AEDs approximate the size of a laptop computer or backpack. Even small devices may typically weigh 10 pounds or more. Accordingly, they are increasingly found mounted in public facilities (e.g., airports, schools, gyms, etc.) and, more rarely, residences. Unfortunately, success rates for cardiac resuscitation remain abysmally low (less than 1%.)
• Such solutions, while effective, are still less than ideal for most situations. Assume, for example, that a person suffers from a cardiac arrest in an airport in which multiple AEDs have been distributed. The victim's companion would nevertheless have to locate and run towards the nearest AED, pull the device off the wall, and return to the collapsed victim to render assistance. During that time, precious minutes may have passed. According to some estimates, the chance of surviving a sudden cardiac arrest is 90% if the victim is defibrillated within one minute, but declines by 10% for every minute thereafter. A defibrillator design that reduces the time to defibrillation by even two to three minutes will save more lives.
• An additional challenge is that a sudden cardiac arrest may take place anywhere. People often spend time away from public facilities and their homes. For example, a sudden cardiac arrest could strike someone while biking in the hills, skiing on the mountains, strolling along the beach, or jogging on a dirt trail. Ideally, an improved AED design would be compact, light, and resistant to the elements and easily attached or detached from one's body. The typical AED design illustrated inFIG. 1, which includes a sizable console or power unit whose form factor is similar to that of a laptop or backpack, seems less than ideal for the outdoors and other rigorous environments.
• There are also improvements to be made in the area of usability. As noted above, every minute of delay or distraction can substantially decrease the victim's probability of survival. As a result, it is generally beneficial to streamline the operation of the defibrillator so that a user of the defibrillator, who is presumably under substantial mental duress, can focus his or her attention on a few, key variables. That is, aside from delivering a proper shock and monitoring the victim, a user of the defibrillator would ideally not have to worry whether the defibrillator is sterile, has been tampered with or is charged and ready to use. Additionally, during a time of crisis, the user ideally would not have to be concerned about contacting medical personnel, transmitting important information relating to location, the condition of the victim, etc.
• Accordingly, the present invention relates to various defibrillators with features to deal with one or more of the above concerns. Various implementations involve a sealed paddle module that is split apart to form defibrillator paddles that can be placed on the chest of a victim to arrest a cardiac arrhythmia. A frangible seal may be permanently deformed by the opening of the paddle, which helps indicate whether the paddle module is has already been used. One or more critical functions e.g., the charging of the defibrillator capacitors, the sending of GPS/health information, etc., may be triggered by the opening of the seal. Various embodiments are one-use (i.e., suitable for arresting a cardiac arrhythmia in one rather than many people), which allows the defibrillator to have a smaller power system and therefore be more compact. Some approaches involve conductive protrusions on the defibrillator electrodes, which facilitates the flow of current through the chest of the victim, thereby helping to reduce the power requirements of the defibrillator and further decrease its size. In some implementations, the defibrillator includes a connecting structure that extends between the paddles and helps instruct the user in the proper operation of the defibrillator. These and other embodiments will be discussed in more detail in the specification below.
• Initially, with reference toFIGS. 2A and 2B, anexemplary defibrillator200 according to one embodiment of the invention will be described. Thedefibrillator200 includes twodefibrillator paddles202aand202bthat are mounted over one another and directly sealed together to form apaddle module204. When a need arises to defibrillate a victim of sudden cardiac arrest, thepaddles202aand202bmay be pulled apart, which reveals a connectingstructure206, as seen asFIG. 2B, which physically and electrically connects the paddles. The connectingstructure206 may include a sheet-like portion207 with instructions that help a user operate thedefibrillator200.
• Preferably, thepaddles202aand202bare directly sealed together with a frangible seal. That is, when thepaddles202aand202bare first pulled apart from one another, the seal is irreversibly and permanently deformed. This feature can have several useful applications. A deformed seal helps indicate whether thepaddles202aand202bhave been used before, which in turn helps indicate whether they are sterile or have sufficient power. Additionally, various events may be triggered by the breaking of the seal. For example, when the seal is broken, one or more capacitors in thedefibrillator200 may start charging without requiring additional input from the user (i.e., a button or other mechanical switch need not be separately triggered to power up the defibrillator.) Upon the opening of thepaddle module204, personal data of the owner of thedefibrillator200 and/or GPS data indicating the location of thedefibrillator200 may be automatically and wirelessly sent to a remote device or server. As a result, medical personnel, family members or other important individuals can be informed automatically and immediately about the use of the defibrillator.
• The connectingstructure206 may serve the dual purpose of displaying useful information as well as electrically connecting thepaddles202aand202b. In some existing AEDs, paddles or patches are individually connected to a base unit with cables. Instructions are typically displayed on the base unit. The base unit and its display, however, take up considerable space in such systems. In the illustrated embodiment, at least some of the instructions are provided on a flexible connectingstructure206 that is compressed between thepaddles202aand202bwhen thepaddle module204 is sealed. When thepaddle module204 and thepaddles202 and202bare pulled apart, the connectingstructure206 unfolds or otherwise decompresses and extends between thepaddles202aand202b.
• The connectingstructure206 is attached to the defibrillator paddles202aand202bsuch that it is easily viewable and can be used as an instructional tool while the user is operating the defibrillator. In the illustrated embodiment, for example, eachdefibrillator paddle202ahas a defibrillator electrode with an electricallyconductive contact surface203. At the appropriate time, high voltage may be applied at the contact surfaces203 to deliver an electrical shock. Each sheet-like section207 of the connectingstructure206 includes atop surface209aand an opposingbottom surface209b. Thetop surface209amay include images, light emitting devices, light reflecting devices, display screens, electronic display devices, etc. that help instruct the user in the proper operation of the defibrillator. As seen inFIG. 2B, when the defibrillator paddles202aand202bare spread out and the conductive contact surfaces203 of the paddles face downward, instructions on thetop surface209aof the connectingstructure206 tend to face upward. Thus, a user of the defibrillator may easily reference the connectingstructure206 for further instructions and step-by-step guidance while holding the defibrillators over the chest of the victim.
• In some embodiments, the portability of thedefibrillator200 may be enhanced by incorporating some or all of the electrical system of the defibrillator into thepaddle module204. While some implementations involve connecting thepaddle module204 via a cable to an external power module, various other approaches involve placing all of the capacitors and batteries of thedefibrillator200 within the housings of thepaddles202aand202b. Such designs may free the twopaddles202aand202bfrom having to connect with a separate third device, which may help make thedefibrillator200 more convenient to carry, access and operate.
• Generally, the overall volume of thedefibrillator200 is influenced by the capacity of its electrical system. A defibrillator that is capable of delivering more shocks and charging the capacitors more times generally has more and/or larger batteries. More specifically, a larger battery can typically support a greater number of electrical shocks than a smaller one before requiring replacement or recharging. As far as the inventors are aware, existing AEDs have the capacity to deliver many shocks e.g., at least 50 shocks or many more than are typically needed to treat a single cardiac arrest victim.
• While having such a high capacity electrical system is generally perceived as beneficial, this conventional approach may also contribute to a larger and less portable defibrillator. Accordingly, some conventional AEDs have the bulk weight and form factor of a small briefcase, backpack or laptop. Such designs, however, while easily mountable on a wall or carried in a large backpack, are not as easily hung on a belt or carried in a pocket or purse. A higher degree of portability may allow people to comfortably carry the defibrillator while jogging, hiking or biking in remote areas. A defibrillator that is conveniently carried in a pocket, purse or belt is more likely to be carried on one's person and thus be immediately accessible in the event that the carrier is a first responder, such as a paramedic, police officer, medic or even a nurse in a hospital, emphasizing that the first few minutes are critical should a nearby person experience a sudden cardiac arrest.
• To reduce the size of the associated electrical system and improve portability, the present invention contemplates a defibrillator that is arranged to treat a single cardiac arrest victim. Accordingly, some embodiments involve adefibrillator200 that is arranged to deliver no more than five (5) electrical shocks to arrest a cardiac arrhythmia. Five (5) shocks are believed to be generally sufficient to address cardiac arrhythmia in a single individual, although the exact limitation may vary (e.g., no more than 4 to 10 shocks.) In some implementations, the limitation is enforced by software (e.g., computer code that counts the number of delivered shocks and prevents any additional charging of a capacitor, the delivery of more shocks to the defibrillator electrodes, etc.), hardware (e.g., limitations based on the physical size or specifications of a capacitor or battery, etc.) or both. Some designs involve a defibrillator in which the volume of the entire defibrillator is less than approximately 550 cubic centimeters and/or the volume of all the capacitors in the defibrillator is less than approximately 450 cubic centimeters. By way of comparison, some conventional, portable AEDs have a volume in excess of 9000 cubic centimeters. It should be appreciated that the defibrillator, even if only initially partially successful (i.e., the patient relapses into an unstable rhythm) may provide a critical “bridge” of therapy until the arrival of paramedics or professionally trained personnel. Some designs require that any defibrillator used to defibrillate a single individual be submitted to a technician to be refurbished (e.g., to replace a capacitor in the defibrillator) or reprogrammed before it can be used again to defibrillate someone else. This helps ensure the regular maintenance, charging and/or sterilization of the defibrillator.
• Referring now toFIG. 3A, a top view of anexemplary paddle module204 will be described. More specifically,FIG. 3A illustrates theouter housing306 of one of the defibrillator paddles202a, which together with thesecond defibrillator paddle202bhelps form the outer housing of thepaddle module204. Theexterior housing306 of thepaddle202amay be used to convey a wide variety of useful information to a user using any suitable medium or technology. By way of example, as shown inFIG. 3A, thehousing306 may include a firstinstructive image302 that helps a user properly position thedefibrillator paddle202aon the chest of a sudden cardiac arrest victim. A secondinstructive image304 may help indicate whether the battery of the defibrillator is fully charged. The housing of thedefibrillator paddle202amay incorporate a wide variety of technologies to convey messages to the user, including buttons, switches, LEDs, display screens, speakers, etc. To use a simple example, the secondinstructive image304, which depicts a battery symbol, may be superimposed over an LED and a mechanical lever. Accordingly, the secondinstructive image304 may emit light and flash when pushed to indicate whether the battery of the defibrillator is sufficiently charged. Different colored lights, flashing frequencies and/or speeds may help convey additional details e.g., whether the battery power is low, requires maintenance, is fully charged, etc. In another example, a display screen and/or speaker (not shown) may be exposed and mounted on thehousing306 to help communicate with the user of the defibrillator using electronic images and audio cues, respectively.
• Theouter housing306 may be designed in a wide variety of ways, depending on the needs of a particular application. Thehousing306 may be formed from any resilient material, such as a hard plastic, composite, etc. Some housing designs enhance the comfort and convenience in carrying thepaddle module204. When a person is engaged in a vigorous activity such as jogging and is carrying a sharp-edged object in his or her pocket, the sharp edges of the object can uncomfortably dig into the sides of the person. Additionally, a person may store thepaddle module204 amidst many other objects in a larger container, such as a purse. Under such circumstances, protrusions and recesses on the housing can trap particles and catch on other items. Thus, some designs for thepaddle module204 involve a generally smooth, rounded exterior without any deep recesses (e.g., a recess whose depth is greater than 4 mm) or sharp edges. Accordingly, the present invention contemplates a great many other configurations and is not limited to the above examples.
• Referring now toFIG. 3B, aside view301 of thepaddle module204 will be described. In the illustrated embodiment, thefirst defibrillator paddle202ais positioned over thesecond defibrillator paddle202b. The defibrillator paddles202aand202bare sealed together using afrangible seal312. The side of eachdefibrillator paddle202aand202bincludes agripping region310aand310b, respectively, which is arranged to help a user firmly hold the defibrillator paddle.
• Generally, thepaddle module204 is sealed in a manner that protects electrically conductive elements in the defibrillator while reducing the number of components that must be handled to operate the defibrillator. In the illustrated embodiment, for example, theseal312 is arranged such that the electrically conductive contact surfaces313aand313bof the defibrillator paddles202aand202bare facing one another, attached with one another and are hidden within the sealedpaddle module204. Various designs involve a seal that is entirely hidden within the housing of thepaddle module204. In some embodiments, theseal312 extends along astrip309 around the perimeter of thepaddle module204. In still other embodiments, the outer housing of theindividual paddles202aand202bmay form the majority, if not substantially all, of the exposed surface area of thepaddle module204.
• Thefrangible seal312 helps indicate whether thepaddle module204 has ever been opened or tampered with. Preferably, breaking or opening the seal requires permanently and irreversibly deforming theseal312 e.g., physical tearing of an adhesive, tape or other bonding material. Any suitable material or mechanism may used to form or support theseal312, including a magnetic lock, a tape, an adhesive, a latch, a pin, etc. It is also preferable that theseal312 is water resistant and helps prevent undesirable liquids and/or dust from penetrating into the interior of thepaddle module204 at the region where the defibrillator paddles202aand202binterface with one another.
• The defibrillator paddles202aand202bmay be sealed together using any suitable means or structure.FIGS. 3C-3F illustrates several exemplary approaches, although many more are possible.FIG. 3C illustrates anadhesive tape322 that is wrapped around the perimeter of thepaddle module204. Thetape322 is positioned along the interface between the defibrillator paddles202aand202band helps secure the paddles to one another. Preferably, the opening of thepaddle module204 requires a physical tearing of thetape322. InFIG. 3D, apaddle interface324 is inserted directly between thepaddles202aand202b. Rather than being directly secured to one another, the defibrillator paddles202aand202bare each positioned on opposite sides of thepaddle interface324 and are secured thereto. Thepaddle interface324 may include a slot, recess and/or opening that allows a connecting structure (not shown) to extend between the paddles. In some implementations, thepaddle interface324 contains no internal electrical circuitry and/or is meant to be discarded once the paddles are released from thepaddle interface324. In the illustrated embodiment, thepaddle interface324 is small relative to either paddle (e.g., has smaller dimensions and/or volume) and forms a continuous outer surface with the housings of the attached paddles.FIG. 3E illustrates an embodiment in which the seal between the defibrillator paddles202aand202bis supported at least in part bypins326. Thepins326 extend through bottom surfaces of the defibrillator paddles202aand202band are firmly secured to each of the paddles usingcorresponding anchors327. When thepaddle module204 is opened, thepins326 may be broken or severed. In some embodiments, sensors are coupled with thepins326 and arranged to detect the breaking of thepins326. This information is then passed on to a processor in the defibrillator and used to initiate follow-on actions, as described later in the present application. InFIG. 3F, the defibrillator paddles202aand202bare sealed together using anexternal housing328. Although theexternal housing328 ofFIG. 3F is depicted as entirely encapsulating the defibrillator paddles202aand202b, in other embodiments theexternal housing328 only covers portions of the sealed paddles. Generally, separating the defibrillator paddles202aand202brequires first opening or releasing theexternal housing328. Theexternal housing328 may be made of any suitably lightweight, resilient material, such as plastic, ceramic, etc. and may be watertight. To minimize the weight and size of theexternal housing328, it may be arranged to form-fit the defibrillator paddles202aand202b. Accordingly, when the paddles are sealed within theexternal housing328, the distance between an exterior surface of one of the paddles and an exterior surface of the external housing may be quite small (e.g., less than 2 cm.) Generally, electrical components of the defibrillator that are necessary for defibrillation are not situated within theexternal housing328, which in some implementations is meant to be discarded after it has been opened.
• In some implementations, any opening of the seal that secures the defibrillator paddles to one another (e.g., the opening of thefrangible seal312 ofFIG. 3B, the tearing of thetape322 inFIG. 3C, the breaking away of the paddles from thepaddle interface324 ofFIG. 3D, the breaking of apin326 ofFIG. 3E and the opening of theexternal housing328 ofFIG. 3F, etc.) is detected and communicated by one or more sensors in the defibrillator. A wide variety of sensors may be used to detect the opening of theseal312, including pressure sensors, electrical sensors, etc. In a preferred embodiment, a sensor generates signals to inform a processor in the defibrillator of the opening of the seal. Based on the sensor output, a variety of additional operations may be triggered within the defibrillator. For example, once the seal has been broken, one or more capacitors of the defibrillator may be automatically charged. In another embodiment, the opening of the seal triggers the sending of a wireless message to a remote server. The wireless message can include any appropriate information e.g., the GPS-determined location of the defibrillator approximately at the time of the breaking of the seal, contact information (e.g., name and cell phone number), etc. Thus, the user, who is preoccupied with caring for the victim of a sudden cardiac arrest, does not have spend time and energy notifying suitable personnel of the emergency.
• Returning toFIGS. 3A and 3B, optional features for improving the grip of a person on the defibrillator paddles202aand202bwill be described. In the illustrated embodiment, the grippingregions310aand310bare arranged in a manner that helps the user firmly hold the defibrillator paddles202aand202b. Eachgripping region310aand310bmay include one or more grooves for receiving a thumb or fingers. Preferably, thegripping region310ais situated on either side of each defibrillator paddle, as illustrated inFIG. 3A, so that the gripping regions can comfortably receive a hand that is curled around the paddle. To help reduce the chance of slippage, each gripping region may include ribbing, recesses, a flexible material (e.g., a flexible plastic, rubber, etc.) and/or any other suitably textured surface. Still other embodiments involve handles that extend out of eachdefibrillator paddle202aand202b. When the defibrillator paddles202aand202bare sealed together as apaddle module204, the handles, which may form various shapes (e.g., a full loop, partial loop, a wedge, etc.), may extend out of thepaddle module204 in opposite directions and/or be symmetrically arranged relative to one another.
• Referring now toFIG. 4A, another cross-sectional view of thepaddle module204 is illustrated. Rather than a lengthwise view,FIG. 4A illustrates a cross-sectional view from oneend314 of thepaddle module204, as indicated inFIG. 3A. This view better illustrates the contour of the groovedgripping region310aand310b. In the illustrated embodiment, thegrooves402aand402bof defibrillator paddles202aand202bare arranged symmetrically to receive thumbs of a user and facilitate the holding and breaking apart of the paddles. A raised edge of eachgroove402aand402bmay cooperate to form acentral ridge403 that extends along a central axis of thepaddle module204.
• Referring next toFIG. 4B, various internal components of one of the defibrillator paddles202awill be described. In the illustrated embodiment,defibrillator paddle202aincludes anouter housing411, adefibrillator electrode408, aconductive gel406 and an adhesive410. If the defibrillator includes an external power module, anexternal power cable412 may couple thedefibrillator electrode408 with the external power module. In another embodiment, there is noexternal power cable412 and no external power module to connect to. In that case, thedefibrillator paddle202amay incorporate some or all of the functionality of the power module into itself, and thus may include additional electrical components (e.g., one or more capacitors, batteries, etc.)
• Thedefibrillator electrode408 is used to generate a high voltage suitable for helping to arrest a cardiac arrhythmia in a person. To generate the high voltage, thedefibrillator electrode408 is coupled with one or more capacitors, which release their charge to deliver an electrical shock through thedefibrillator electrode408. The duration, voltage and waveform characteristics of the electrical shock may vary widely. By way of example, the electrical shock may involve a biphasic discharge between approximately 150 and 250 joules. During the electrical shock, a voltage differential of approximately 1400 to 2000 volts may be generated between the twodefibrillator electrodes408 of the two defibrillator paddles. Although the above voltage differentials work well, various implementations contemplate a voltage differential as high as 5000 volts.
• An electricallyconductive gel406 may be positioned on acontact surface414 of thedefibrillator electrode408. Theconductive gel406 is flexible and better conforms to the contours of the human body. By increasing the contact surface area, theconductive gel406 facilitates the flow of current from thedefibrillator electrode408 through the chest of a victim of sudden cardiac arrest. An electrically conductive adhesive410 may be positioned on theconductive gel406, which helps further strengthen the conductive connection between the chest of the victim and thedefibrillator paddle202a.
• Referring now toFIG. 5, various embodiments relating to the opening of thepaddle module204 will be described. Partially openedpaddle module204 includes defibrillator paddles202aand202b. In the illustrated embodiment, the seal (not shown) that previously bonded the defibrillator paddles202aand202btogether is being broken using a twisting motion. That is, the seal is arranged to be released by rotating thedefibrillator paddle202ain a direction that is substantially parallel to acontact surface502 on thedefibrillator paddle202b. Preferably, the seal is arranged to not open under the stresses of everyday carrying, but opens relatively easily when force is applied in a deliberate manner. By way of example, some embodiments feature a seal that does not break when force external to thepaddle module204 is applied to pull the sealed defibrillator paddles202aand202bdirectly apart (e.g., in a direction perpendicular to thecontact surface502 of the defibrillator paddle102b), but that does break when the same amount of external force is applied in a twisting or rotating motion (e.g., in a direction that is parallel to thecontact surface502.)
• AlthoughFIG. 5 illustrates the use of a twisting motion to break the seal of thepaddle module204, some designs contemplate different opening motions. For example, the opening of the seal may be triggered by the pressing of a mechanical lever or switch on an exterior surface of one or both of the defibrillator paddles202aand202b. Some implementations require that such pressing is combined with a force that pulls apart the paddles and/or twists the paddles. In other embodiments, the seal is broken by pulling a tab or pulling a strip around the sides and/or periphery of thepaddle module204. In still another implementation, the seal is broken by squeezing seal release levers on one or more sides of thepaddle module204.
• Referring next toFIG. 6A, an embodiment of apaddle module204 with an embedded connectingstructure206 will be described.FIG. 6A illustrates a sealedpaddle module204, which includes defibrillator paddles202aand202b. Eachdefibrillator paddle202aand202bmay include anoptional recess602aand602b. The defibrillator paddles202aand202bare mounted over one another such that theirrespective recesses602aand602bcooperate to form acavity604, which may be entirely hidden within and sealed inside thepaddle module204. Thecavity604 contains the connectingstructure206, which physically and electrically connects the twodefibrillator paddles202aand202b. Therefore, while thepaddle module204 remains sealed, the connectingstructure206 is unexposed and disposed directly between the twodefibrillator paddles202aand202b.
• Within thecavity604, the connectingstructure206 is in a compressed form. This compressed form may involve folding, coiling and any other suitable form of compression, depending on the physical characteristics of the connectingstructure206. By way of example, in the illustrated embodiment, the connectingstructure206 is compressed between the sealed defibrillator paddles202aand202b. It is formed from one or more sheet-like sections610. The sheet-like sections610 are connected in series. A flexible material extends between adjacent sheet-like sections610 to form a crease line608 that allows for folding along the crease line608. The crease line608 may involve any easily bendable structure. For example, the crease line608 may be formed from a bendable, flexible material, such as a soft plastic, a mechanical joint, a hinge, etc. When the seal is broken and the defibrillator paddles202aand202bare pulled apart from one another, the connectingstructure206 unfolds, as shown inFIG. 6B.
• The connectingstructure206 may take any appropriate form that is easily compressible and expandable. Some implementations involve coupling the connectingstructure106 with mechanisms that help compress it, expand it or address safety concerns. For example, one embodiment of the connectingstructure206 takes the form of a coilable ribbon. The ribbon is coiled within one or both of the defibrillator paddles202aand202bwhen thepaddle module104 is still sealed. When the defibrillator paddles202aand202bare pulled apart, the ribbon uncoils and extends substantially flat between the paddles. An additional benefit of the coiled ribbon may be reduced strain. That is, the reduction or elimination of folds and sharp bending in the ribbon may help reduce stress on the ribbon and any flex circuit or electrical connections inside the ribbon. In one embodiment, a recoiling mechanism within at least one of the paddles exerts a recoiling force on the ribbon, so that it tends to remain generally taut and flat between the paddles, even when the paddles are not pulled apart to their maximum extent. In still another embodiment, one or more of the defibrillator paddles202aand202bincludes a spring or lever arranged to eject the connectingstructure206 out of the defibrillator paddle once the seal is broken and thepaddle module204 is opened. Some approaches involve a mechanism in one or more of the defibrillator paddles202 and202bthat helps prevent recompression or refolding of the connectingstructure206 once it has already be unfolded or decompressed. Such features help confirm whether the device has already been opened or tampered with.
• Referring now toFIG. 7, the physical characteristics of one embodiment of a connectingstructure206 will be described in greater detail. The connectingstructure206 includes multiple sheet-like sections702 that are arranged in series. In the illustrated embodiment, the connectingstructure206 forms a direct physical and electrical connection between the paddles, although other embodiments may include an intervening device and/or a power module. Adjacent sheet-like sections are foldable along crease lines704. Embedded within the connectingstructure206 are one or moreconductive wires706, which serve to electrically couple the defibrillator paddles202aand202b.
• The connectingstructure206 is formed from a electrically insulating material that covers the embeddedconductive wires706. When the paddles and the connectingstructure206 are positioned on the bare chest of a cardiac arrest victim and an electrical shock is delivered, a high voltage (e.g., between 1400 and 2000 volts) is generated between the defibrillator paddles. To minimize the undesirable leakage of current from the embeddedwires706 and help prevent a short circuit, the insulating material in the connectingstructure206 helps direct electrical current through the embeddedconductive wires706 rather than through the body of the victim. Therefore, all or substantially all electrical current that is applied to the body using the defibrillator is applied through the defibrillator electrodes.
• The connectingstructure206 can also help instruct a user on the proper operation of the defibrillator. This information may be conveyed in a wide variety of ways. In the illustrated embodiment, for example, each sheet-like section702 includes asurface708 with instructions in the form of drawings. The drawings illustrate various steps in properly using the defibrillator. The instructions are not limited to drawings, however. In various embodiments, one or more of the sheet-like sections702 may include a display screen, an audio speaker, a light-emitting diode, a light source etc. Such components are coupled with at least one of the paddles and a battery of the defibrillator via conductive wires in the connectingstructure206. Accordingly, instructions on using the defibrillator may be conveyed using computer graphics, audio, the selective flashing or coloration of lights, etc.
• The connectingstructure206 ofFIG. 7 is arranged to be easily viewable by a person using the defibrillator. In the illustrated embodiment, when the defibrillator paddles are pulled apart and the contact surfaces are facing in one direction (e.g., in the context ofFIG. 7, into the page), theinstructional surface708 of the connectingstructure206 is arranged to generally face in the opposite direction (e.g., directly out of the page.) Therefore, the connectingstructure206, rather than merely helping to physically connect the defibrillator paddles202aand202b, can play a role in guiding the actions of a user while he or she is operating the defibrillator. As a result, there is less need for a separate instructional display elsewhere in the defibrillator, which in turn helps reduce the size and weight of the defibrillator as a whole.
• Referring now toFIG. 8A, adefibrillator800 that usesconductive protrusions804 will be described. In the illustrated embodiment, theconductive protrusions804 extend out of eachdefibrillator paddle202aand202b. Theconductive protrusions804 are coupled with the electrical system of thedefibrillator800. The electrical system, which includes one or more batteries and capacitors, may be stored within one or more of the defibrillator paddles202aand202b, as shown inFIG. 8A, or in anexternal power module806, as shown inFIG. 8B. In the latter case, the electrical system in thepower module806 is coupled with theconductive protrusions804 in the paddles via one ormore cables803. Theconductive protrusions804 are part of the defibrillator electrode in each paddle and are arranged to optimize current flow through a sudden cardiac arrest victim.
• Generally, theconductive protrusions804 are arranged to press or penetrate into the skin of the victim. Such pressing or penetration reduces the electrical resistance of the skin. As a result, less voltage needs to be generated at theconductive protrusions804 to ensure a current sufficient to arrest a cardiac arrhythmia in the victim. The corresponding reduction in power requirements for thedefibrillator800 may translate into a reduction in size of the electrical system of the defibrillator (e.g., a reduction in the size of its capacitors and/or batteries), which in turn helps enhance the portability of thedefibrillator800. In some embodiments, the volume of all capacitors in thedefibrillator800 may be limited to a total volume of approximately 400 cubic centimeters or less. In still other embodiments, thedefibrillator800 is arranged to apply a voltage at the defibrillator electrodes that is never in excess of 1400 volts during the normal operation of the defibrillator. (In comparison, some existing AEDs require the application of much more than 1400 volts to defibrillate a person.)
• FIG. 8C illustrates an enlarged view of one of the defibrillator paddles202aand itsconductive protrusions804 according to one embodiment of the present invention. The defibrillator electrode is coupled with the electrical system of the defibrillator (not shown) and includes an electricallyconductive base plate808. Extending substantially perpendicular out of asurface810 of thebase plate808 are theconductive protrusions804. During defibrillation, thecontact surface810 is arranged to face and be pushed into the skin of the victim, such that thecontact protrusions804 are embedded into the skin of the victim. It should be appreciated that theconductive protrusions804 depicted inFIG. 8C are diagrammatic, are not drawn to scale and may have any suitable dimensions. By way of example, the protrusions may be tiny relative to thebase plate808 and/or almost invisible to the human eye.
• The conductive protrusions may be arranged in any manner suitable for helping to minimize the electrical resistance in the outer layers of the skin. By way of example, theconductive protrusions804 inFIG. 7C may be densely distributed across the contact surface810 (e.g., at least 1 million protrusions or more on the surface810) in a bristle-like arrangement. Some embodiments involveconductive protrusions804 that are wire-like, pointed, tapered and/or sharp. In one implementation, at least a portion of eachconductive protrusion804 has a diameter of less than 33 gauge on the Stubs scale. In still other embodiments, theconductive protrusions804 are not bristle- or needle-like, but instead may each have substantially broader bases and/or distinctly different forms from what is shown inFIGS. 8A-8C.
• Where theconductive protrusions804 are arranged to penetrate the skin of a person, proper sterilization may become a concern. Accordingly, in a preferred embodiment, pre-sterilizedconductive protrusions804 ondefibrillator paddles202aand202bare initially sealed within apaddle module204, as described previously in connection withFIGS. 1-6. To preserve the sterility of theprotrusions804, thepaddle module204 may be watertight and/or hermetically sealed. Some designs involveprotrusions804 that have a sterilization assurance level (SAL) of approximately 10.sup.-3 or less. Thus, when a user breaks the frangible seal of thepaddle module204, he or she can have greater confidence that theconductive protrusions804 have not penetrated the skin of another person and are not contaminated. However, it should be appreciated that the describedconductive protrusions704 may be used in almost any known type of defibrillator system and are not limited to being used in the sealedpaddle module104 or any other previously described embodiment.
• Referring next toFIG. 9A, an embodiment of adefibrillator900 withpaddle guards902 will be described. The paddle guards902 extend out from the bottom of eachdefibrillator paddle202aand202band help protect the user's hands from contacting the body of the victim. Although generally not considered to be dangerous, contact with a victim during defibrillation may cause a small amount of electrical current to flow through the user of the defibrillator. Theguards902 can provide protection against electrical shock and also provide a degree of psychological comfort to the user who is operating the defibrillator. The paddle guards902 may be integrated into the defibrillator paddles or patches of any suitable type of known defibrillator, including but not limited to any of the previously described embodiments.
• FIG. 9B illustrates a top view of defibrillator paddles202aand202band their associatedpaddle guards902 after the paddles have been positioned over the chest of a sudden cardiac arrest victim. In the illustrated embodiment, thepaddle guard902 extends substantially beyond the profile of its associateddefibrillator paddle202a. In some embodiments, the paddle guard extends approximately 1 cm or more from the housing of thedefibrillator paddle202ain a direction outward and parallel to a contact surface of the paddle. As a result, when a user puts his hands over the defibrillator paddles202a, thepaddle guard202 is arranged to catch a finger or thumb that slips off of the paddle and would otherwise land onto the chest of the victim.
• The paddle guards902 may be deployed from the defibrillator paddles202aand202bin a wide variety of ways. In a preferred embodiment, thepaddle guard902 is specifically designed not to interfere with the contact area between the skin and the exposed electrically conductive area of its respective defibrillator paddle. In one embodiment, thedefibrillator paddle202aand202b, each of which includes acompressed paddle guard902, are sealed within apaddle module204, as previously described inFIGS. 1-6. When sealed, thecompressed paddle guards902 do not extend beyond the profiles of their respective defibrillator paddles. For example, they may be folded directly between the sealedpaddles202aand202b. When thepaddle module204 is opened, the paddle guards902 expand out of the housing of the defibrillator paddles202aand202bto extend therefrom in the manner ofFIGS. 9A and 9B. For such applications, thepaddle guard902 is preferably made from a flexible, electrically insulating material (e.g., plastic, etc) Some applications, however, contemplate apaddle guard902 that is made of a stiffer material and/or that extends outside the housing of the associateddefibrillator paddle202a/202b, even while the defibrillator paddles202aand202bremain sealed as thepaddle module204.
• Referring now toFIGS. 10A and 10B, embodiments ofdefibrillators1000 with different types of electrical systems will be described. In each figure, an electrical system including at least onecapacitor1006 and at least onebattery1008 is coupled to defibrillator electrodes in each paddle, although parts of the electrical system may be distributed within thedefibrillator1000 in different ways. Some designs involve positioning acapacitor1006 and/or abattery1008 within the housing of one or more of the defibrillator paddles202. An example of this approach is presented inFIG. 10A, which illustrates aninternal capacitor1006 in thepaddle202a, aninternal battery1008 in thepaddle202b, and a connectingstructure206. The batteries and capacitors may be arranged among the defibrillator paddles in any suitable manner e.g., they may be divided among the paddles, all of the batteries and capacitors may be in just one paddle, etc. In some embodiments, any battery or capacitor that is electrically coupled with any of the defibrillator paddles202 is situated only inside of the housing of the paddles. Another configuration is shown inFIG. 10B, where some or all of the capacitors and batteries of thedefibrillator1000 are situated within the housing of anexternal power module1004. Theexternal power module1004 is coupled to one or more of the defibrillator paddles202 with acable1108. In some implementations, as seen inFIG. 10B, thepower module1004 is directly connected to one of the paddles, while the paddles are directly connected to one another via connectingstructure206. In still other embodiments, thepower module1004 is connected directly and individually to the twopaddles202 with twoseparate cables1108.
• Referring next toFIG. 11A, an embodiment of a belt-mountedportable defibrillator1100 will be described. Thedefibrillator1100 includes apaddle module204 and anexternal power module1104, which are both attached to abelt1102. Thepower module1104 contains an electrical system for delivering electrical shocks through the paddles sealed in thepaddle module204. In this arrangement, thedefibrillator1100 has a power system external to the paddles, but nevertheless can be conveniently carried and rapidly deployed as necessary to defibrillate a victim of sudden cardiac arrest.
• In various embodiments, a user wearing thedefibrillator1100 need not remove, activate or otherwise be distracted by theexternal power module1104 to defibrillate someone. As shown inFIG. 11B, a user with a belt-holstereddefibrillator1100 may simply withdraw thepaddle module204 from thebelt1102, break the seal, and apply the defibrillator paddles as previously discussed. Theexternal power module1104 is coupled with and provides necessary power to the defibrillator paddles through theextendable cable1106. Some implementations involve acable1106 that is coiled within theexternal power module1104 or at thebelt1102 and that is increasingly uncoiled and exposed as the paddles of thepaddle module204 are positioned further away from theexternal power module1104. In still other embodiments, theexternal power module1104 is arranged to exert a pulling and/or recoiling force on thecable1106 to help reduce unnecessary slack in thecable1106. Thepower module1104, thepaddle module204 and/or any associated container(s) may be secured to thebelt1102 using any suitable means, such as a latch, a hook, a clip, a locking mechanism, etc. It should be appreciated that various embodiments of the belt-mountedpower module1104 may be reused and/or recharged after the paddles have been used to defibrillate a person. That is, the belt-mounteddefibrillator1100 may be but is not necessarily limited to “one use,” as the term is described herein with respect to various other defibrillator applications.
• Referring next toFIG. 12A, a block diagram1200 describing various components of anexemplary defibrillator1201 is illustrated. In the illustrated embodiment, thedefibrillator1201 includes abattery1200,capacitor1202,defibrillator electrodes1204,sensor1205,processor1206,input module1216, output module1209,memory1208 andwireless antenna1210. Thewireless antenna1210 is arranged to communicate with a wide variety of devices (e.g., aremote server1212, an emergency services network and/or aGPS satellite1214.) It should be appreciated that although the aforementioned components are referenced in the singular, the defibrillator1002 may include one or more of each component as appropriate (e.g., multiple batteries, capacitors, etc.)
• Thebattery1200 may be coupled with and provide electrical power to all of the electrical components of thedefibrillator1201, including theprocessor1206, thememory1208, theantenna1210, thedefibrillator electrodes1204 and thecapacitor1202. In preparation for defibrillation,battery1200 is arranged to charge thecapacitor1202. Once charged and at the appropriate time, thecapacitor1202 is arranged to deliver an electrical shock via thedefibrillator electrodes1204.
• When placed on the chest of a victim, thedefibrillator electrodes1204 receive electrical signals from the heart of the victim. These electrical signals are transmitted to theprocessor1206. Computer code for processing the electrical signals may be stored in thememory1208. Thememory1208 is suitable for storing a wide variety of computer readable data, including computer code for transmitting data, receiving data from, and controllingbattery1200,capacitor1202,defibrillator electrodes1204,sensor1205,input module1216, output module1209,antenna1210,remote server1212 andGPS satellite1214. Theprocessor1206 is arranged to execute any computer code stored in thememory1208.
• Output module1209 relates to any electrical component suitable for conveying information to the user. Examples include a speaker, an LCD screen, an electronic ink display, a plasma screen, one or more light-emitting devices, etc. Any suitable exterior portion of thedefibrillator1201 may serve as a location for the output module1209, e.g., the housing of one or both defibrillator paddles, the connecting structure, etc. Output module1209 is coupled with theprocessor1206 and may be arranged to respond to various signals received by theprocessor1206. For example, when theprocessor1206 determines that signals received throughdefibrillator electrodes1204 correspond with a cardiac arrhythmia, this finding may be expressed to the user using the output module1209 e.g., through the flashing of light, a line of electronic text, an audio prompt, etc.
• Processor1206 may also receive signals from thesensor1205.Sensor1205 includes any sensor suitable for assessing the physical environment around or within thedefibrillator1201. In some preferred embodiments, thesensor1205 detects the breaking or opening of a frangible seal that helps secure the twodefibrillator paddles202aand202bofFIGS. 1-6 to one another. When theprocessor1206 receives this information, a variety of actions may be triggered. By way of example, the charging of thecapacitor1202 by thebattery1200 may be initiated. In some embodiments, a wireless message may be sent via theantenna1210 to theremote server1212. In still other embodiments, theprocessor1208 will receive GPS data fromGPS satellite1214 viaantenna1210. Based on the GPS data, a wireless message indicating the global position of thedefibrillator1201 is then sent to theremote server1212 and/or an emergency services network.
• Some designs incorporate other types ofsensors1205, such as pressure or moisture sensors. In one embodiment, for example, apressure sensor1205 is coupled with adefibrillator electrode1204 in one or both of the paddles. Thepressure sensor1205 may measure the amount of pressure being applied against the chest of a cardiac arrest victim. Theprocessor1206 receives this information and instructs output module1209 to provide appropriate information to the user (e.g., a flashing light, text line and/or audio prompt indicating insufficient or sufficient pressure.) In still another embodiment, amoisture sensor1205 coupled with thedefibrillator electrode1204 may measure the degree of moisture in the vicinity of the defibrillator electrodes. Particularly with respect to victims of swimming accidents, excessive moisture can sometimes obstruct the flow of defibrillation current through the heart of a person, thus rendering defibrillation ineffective. In such applications, theprocessor1206 may assess signals from themoisture sensor1205 and likewise convey appropriate instructions to the user via the output module1209 (e.g., a flashing light, text line and/or audio prompt indicating the presence of too much water or sufficient dryness.) Various designs prevent the charging of thecapacitor1202 and/or the delivery of a shock at thedefibrillator electrodes1204 until the moisture sensor and/or the pressure sensor indicate that there is sufficient dryness and pressure, respectively.
• Input module1216 relates to any port arranged to receive input from an external source. By way of example,input module1216 may be an infrared receiver, a USB port, a wireless receiver, etc. A keyboard, a laptop, external electronic module or other device may then be used to transmit data to theprocessor1206 and thememory1208 using theinput module1216. In some embodiments, a laptop, cell phone, a digital recorder or other electronic device may be used to transmit relevant customizable data e.g., name, cell phone number, address, emergency phone numbers, doctor's phone number, audio recordings, etc. to theprocessor1206 via theinput module1216. Afterward,processor1206 stores the data in thememory1208. When theprocessor1206 is alerted by thesensor1205 that the seal has been opened and thedefibrillator1201 is about to be used, theprocessor1206 may perform various actions based on the stored data. In one embodiment, theprocessor1206 may then identify a destination device using the stored customizable data and establish a communications link e.g., the emergency line of a medical facility may be identified and called using a stored phone number, so that a stored, pre-recorded message may be transmitted to the staff there. In still another embodiment, personal customizable data is transmitted to aremote server1212 at a medical facility to inform them that the defibrillator is about to be used. In another example, initiating the device and/or unsealing the defibrillator within a hospital setting may trigger a signal directing emergency personnel to the location of the device and/or the appropriate site or room. It should be appreciated that thedefibrillator1201 need not necessarily directly perform any of the above actions. Instead, when the seal is opened, theprocessor1206 may send any stored data viaantenna1210 to aremote server1212, and then help direct theremote server1212 to make the desired calls and transmissions.
• Antenna1210 is arranged to communicate wirelessly with remote devices, such as aremote server1212 orGPS satellite1214.Remote server1212 relates to one or more of any electrical device suitable for communicating with antenna1210 (e.g., a network device, a cell phone, a computer, etc.)Antenna1210 may represent multiple as opposed to just one physical antenna. For example, some embodiments include separate antennae for GPS and remote server access. Data may be transmitted using any suitable telecommunications or wireless protocol, including an Internet Protocol such as TCP. Since the need to use the defibrillator and to contact medical personnel may occur anywhere and possibly in very remote areas,antenna1210 may be configured to exchange data with a variety of cellular networks, communications satellites and/or transmitters. That is,antenna1210 is preferably capable of communicating with distant devices that are not near, physically connected to or within line-of-sight of thedefibrillator1201.
• Referring next toFIG. 12B andFIG. 12C, exemplary electrical designs for a defibrillator according to a particular embodiment of the present invention will be described. As will be appreciated by a person of ordinary skill in the art,FIG. 12B illustrates an exemplary circuit diagram that electrically couples abattery1200, acapacitor1202 anddefibrillator electrodes1204.FIG. 12C illustrates an exemplary charging circuit for charging thestorage capacitor1202 using thebattery1200. It should be noted that the component values and circuit arrangements depicted inFIGS. 12B and 12C relate only to particular embodiments and may be modified to suit the needs of particular applications.
• Referring now toFIG. 13 andFIGS. 14-15, a method for using one of the aforementioned defibrillators according to an embodiment of the present invention will be described. Initially, thepaddle module204 ofFIG. 14A is opened (step1302). Preferably, the opening of thepaddle module204 involves the opening or breaking of a frangible seal, which can be detected by a sensor in the defibrillator and be used to trigger a wide variety of appropriate actions, as discussed earlier. Some designs involve the breaking of a pin or magnetic lock, the unfastening of a latch, the release of a locking mechanism, etc.
• The opening of thepaddle module204 can be performed in a wide variety of ways. Preferably, thepaddle module204 is arranged in such a way such that the action required to open thepaddle module204 is clearly purposeful rather than accidental. In the illustrated embodiment, for example, a twisting motion is utilized to break the frangible seal. That is, the paddles are twisted in a direction substantially parallel to electricallyconductive contact surfaces1402 on the paddles. Various designs contemplate a wide variety of opening operations, including permanently deforming or physically tearing the seal, releasing a latch, breaking a magnetic lock, etc.
• At some point after the opening of the seal, the one or more capacitors in the defibrillator will be charged by one or more batteries (step1304.) As described earlier, the opening of the seal may trigger the charging of the capacitor. By way of example, a sensor may detect when the seal has been opened. Afterward, an opening confirmation signal may be transmitted by the sensor to a processor in the defibrillator. When the opening confirmation signal is received by the processor, the processor will respond by issuing a command to charge the capacitor. Accordingly, no additional manual intervention (e.g., the pressing of a button, the activation of a switch, the issuing of a command, etc.) by the user may be required to charge the capacitor once the seal has been broken or opened. Although some designs contemplate manual charging of the capacitor by the operator pressing a button, in some embodiments the capacitor is charged automatically upon the opening of the seal, so that the user has one less task to distract him or her.
• A host of other actions may be triggered by the opening of the seal. By way of example, the sending of a wireless communication may be triggered based on the opening of the seal. That is, the processor in the defibrillator, after receiving an opening confirmation signal from a sensor that monitors whether the seal has been broken, automatically arranges for the transmission of a text message, phone call, email, etc. This automatic feature allows a user of the defibrillator to focus less on contacting third parties and more on monitoring the condition of the cardiac arrest victim.
• After the opening of thepaddle module204, the defibrillator paddles202 are pulled apart from one another and placed on thechest1402 of the victim. (step1306 andFIG. 14B). In a preferred embodiment, as discussed earlier, when the defibrillator paddles202 are pulled apart, a connectingstructure206 is exposed from within thepaddle module204 and expands between the defibrillator paddles202. The connectingstructure206 includes one or more sheet-like sections with a first and an opposing second surface. The first surface includes instructions for operating the defibrillator. When the defibrillator paddles202 are positioned properly on thechest1402 of the victim (i.e., such that exposed portions of the connectingstructure206 are flat and not twisted and electrically conductive contact surfaces of the defibrillator paddles202 are positioned apart and face in a downward direction towards the chest1402), the first surface of the connectingstructure206 faces upward towards the user. Accordingly, a user holding the paddles can easily review the instructions on the first surface of the connectingstructure206 simply by looking downward.
• Once the defibrillator paddles202 are placed appropriately, defibrillator electrodes within each paddle begin receiving electrical signals from the heart of the victim (step1308). The electrical signals are received by a processor in the defibrillator. The processor determines whether the electrical signals correspond to a cardiac arrhythmia (step1310).
• When a cardiac arrhythmia is found, one or more charged capacitors within the defibrillator may release their charge through the defibrillator electrodes in the paddles. The release of electrical charge results in the delivery of an electrical shock (step1312). The electrical shock may take any form suitable for arresting a cardiac arrhythmia. In a preferred implementation, if no cardiac arrhythmia is detected that would be conducive to a defibrillation (step1310), the defibrillator would remain in a monitoring mode, charged and ready to deliver a shock (step1312) should the victim's rhythm deteriorate. By way of example, the shock may involve a monophasic or biphasic discharge between approximately 150 and 250 joules, a voltage of approximately 1400 to 2000 volts at the defibrillator electrodes and/or last between 4 and 20 milliseconds. In some embodiments, the shock is only delivered manually (e.g., after the user activates a button, lever or switch to trigger the shock.) Some designs involve automatic delivery of the shock. That is, the shock is automatically delivered after a predetermined period of time as long as the defibrillator electrodes are still receiving electrical signals that correspond with a cardiac arrhythmia. In some designs, the user therefore need not depress a switch or perform additional actions to initiate the shock.
• Some implementations restrict the number of shocks that may be delivered, in part to minimize the size of the electrical system of the defibrillator. To the best knowledge of the inventors, conventional automated external defibrillators are arranged to deliver numerous electrical shocks sufficient to arrest cardiac arrhythmia in multiple people without replacement of the defibrillator capacitors. Although such approaches have obvious advantages, it is believed that trading off longevity for portability may be advantageous in some applications. Also, users will be forced to return and refurbish used defibrillators, which encourages regular maintenance and may enhance their reliability and safety. Therefore, in some implementations, the memory in the defibrillator includes computer code for limiting the total number of electrical shocks given to the maximum number that may be expected to deliver an effective voltage for defibrillation. By way of example, the total number of electrical shocks may be limited to a designated number of shocks that is no more than approximately 4 to 10 shocks, even when electrical signals corresponding to a cardiac arrhythmia are still being received at the defibrillator electrodes. In still other implementations, all of the batteries in the defibrillator are collectively sized and rated to generate no more than the designated number of shocks at the electrodes without any recharging.
• For a person without medical or professional training, carrying out the above operations can be stressful, particularly in a life-or-death situation involving the defibrillation of a cardiac arrest victim. Accordingly, it is helpful to provide easy-to-use instructions with the defibrillator to assist the user in performing the above tasks. As discussed earlier, various designs involve a connectingstructure206, which includes multiple sheet-like sections with information for operating the defibrillator. Referring now toFIG. 15, a method for instructing a user in the operation of a defibrillator using the connectingstructure206 will be described.FIG. 15 includes defibrillator paddles202 and a connectingstructure206 that physically and electrically couples them together. The connectingstructure206 includes a segmented series of sheet-like portions1502. Each sheet-like portion1502 includes an instructional surface1504a-1504fthat is coupled to an electronic display device. Each electronic display device includes one or more lighting components of any suitable type (e.g., a light emitting device, a light reflecting device, an LED, a liquid crystal display, an electronic ink display, a computer display, a light source, etc)
• The electronic display devices may change their flashing speeds, colors, sequencing, etc. to help guide a user through various operations involving the defibrillator. By way of example, each instructional surface1504a-1504fmay represent a particular operation in a sequence of operations for using the defibrillator. In the illustrated embodiment,instructional surface1504ccorresponds to the placing of the defibrillator paddles202 on the chest of a person and the receiving of electrical signals therefrom. Therefore, when no electrical signals are being received at the defibrillator paddles202, the electronic display device at theinstructional surface1504cmay flash using a first sequence and/or a first color. In addition or alternatively, the device may display an image, symbol and/or message. When electrical signals are being received and are being processed, the electronic display device at theinstructional surface1504cmay flash using a second sequence and/or a second color. When the electrical signals are being received and correspond with a cardiac arrhythmia, theinstructional surface1504cmay flash using a third sequence and/or a third color. The first, second and third sequences and colors are different and thus can be used to distinguish between different modes of operation and/or results. To use a simple example, the first sequence (i.e., the one relating to not getting any electrical signals at the paddles at all) may be a slow flashing sequence and involve the color yellow. The second sequence (i.e., the one relating to getting and processing electrical signals at the paddles) may be a somewhat faster flashing sequence and involve the color green. The third sequence (i.e., the one relating to detecting a cardiac arrhythmia) may be a non-flashing, steady light held for a predetermined period and involve the color red. After the third sequence and color have been presented,paddle button1508 and/or another instructional surface may light up, to indicate that an electrical shock will be delivered automatically and imminently, or to encourage the user to initiate an electrical shock manually (e.g., by pressing paddle button1508). The aforementioned approach is but one technique among many for using flashing sequences, lighting, colors and other visual effects with the connectingstructure206 to guide a defibrillator user.
• Referring now toFIGS. 16A and 16B, amethod1600 for operating a defibrillator according to one embodiment of the present invention is described. The steps of themethod1600 may be applied to any of the previously described defibrillator embodiments e.g.,defibrillator200 ofFIG. 2A. Initially, instep1602 ofFIG. 16A, signals are received indicating whether a seal on the defibrillator has been broken. To conserve power, some embodiments involve a processor that is initially deactivated or in a low-power mode prior to the opening of the seal. The processor is then activated or powered in response to the opening of the seal without executing any computer code. In some implementations, the signals referenced instep1602 refer to signals received by a defibrillator processor from a sensor that is coupled with the seal. As indicated instep1604, the signals may be repeatedly checked to determine if the seal has been broken. If the seal has not been broken, time is allowed to pass and additional signals are received and analyzed. If the seal has been broken, one or more actions may be triggered. For example, a battery in the defibrillator may automatically charge a capacitor so that an electrical shock may be delivered at the defibrillator electrodes. Additionally or alternatively, data may be wirelessly transmitted. This has a wide variety of applications. By way of example, the transmitted data may take the form of an email sent to an email server, a text message sent to a cell phone, or data packets sent via an Internet protocol to a remote server. The data may include any relevant information e.g., the identity of the owner of the defibrillator, the current, GPS-derived location of the defibrillator, the cell phone number of the owner, etc. It should be appreciated that the operations ofstep1606 are performed automatically upon a determination that the seal has been broken (step1604) and do not require additional intervention by the user of the defibrillator (e.g., such actions do not require the pressing of a button, the manual activation of a switch, additional human interaction with the defibrillator, etc.)
• Afterward, the method may optionally proceed to step1608 ofFIG. 16B.FIG. 16B describes amethod1607 for analyzing signals received from the defibrillator electrodes and limiting the number of electrical shocks that are applied at the defibrillator electrodes. Atstep1608, signals are received from the defibrillator electrodes. The signals are analyzed to determine if they correspond to heart activity of any kind. For example, if the defibrillator paddles have not been placed on the chest or have been placed at the wrong locations, then the signals received through the defibrillator electrodes may be faint, erroneous or non-existent. Excessive moisture or inadequate pressure may also contribute to poor or distorted signals. In such cases, steps may be taken to improve the reception of the heart signals. For example, sensor data may be received from one or more sensors coupled with the defibrillator electrodes (step1618). As discussed earlier in connection withFIG. 12A, a wide variety of sensors may be used, including pressure sensors, humidity/moisture sensors, etc. The sensors may help identify a reason for the erroneous, faint or non-existent signals e.g., inadequate pressure being applied to the defibrillator paddles, too much moisture on the chest of the person, improper positioning of the paddles, etc.) If such problems are detected, a suitable warning or message is displayed to help a user rectify the problem (steps1620 and1622). This warning or message may be conveyed to a user using a wide variety of mediums, including digital images, audio messages, electronic text on a display, lighting sequences, etc. Afterward, signals are again received at the defibrillator electrodes (step1608) and the process of analyzing the signals begins again. Ideally, the warning message and sensor data will have helped the user to take corrective action and improve the signals received through the defibrillator electrodes.
• If it is determined that the signals have adequate strength and clarity and correspond to some form of heart activity, whether abnormal or normal, the signals are then analyzed to see if they correspond to a cardiac arrhythmia (step1611). If the signals reflect the normal functioning of the heart, an electrical shock is not delivered at that time. In a preferred embodiment, the defibrillator then remains in a monitoring or standby mode (i.e., the defibrillator electrodes again receives electrical signals atblock1608 and proceeds to block1610.) In some implementations, when signals correspond with the normal functioning of the heart and/or the received heart signals match a particular predetermined pattern, further shocks may be prevented (step1616). If the received signals correspond to a cardiac arrhythmia, then an electrical shock is delivered (step1612). The total number of electrical shocks delivered using the method ofFIG. 16B is counted (e.g., COUNT_SHOCKS=COUNT_SHOCKS+1, where COUNT_SHOCKS initially equals 0). Atstep1614, the total number of delivered shocks is evaluated and compared against a designated, predetermined limit. For example, as described earlier in the application, the total number of allowable shocks may be limited to 4 to 10 shocks (e.g., LIMIT=5). If the limit has been reached (e.g., if COUNT_SHOCKS=LIMIT), then the delivery of any additional shocks may be prevented (step1616). If the limit has not been reached, then the method returns to step1611, where signals from the defibrillator electrodes are again assessed to determine if the shock managed to arrest the cardiac arrhythmia.
• Although only a few embodiments of the invention have been described in detail, it should be appreciated that the invention may be implemented in many other forms without departing from the spirit or scope of the invention. For example, the present application refers to the term “shock” or “electrical shock.” Generally, any reference in the present application to an “electrical shock” or “shock” may be understood as an electrical shock that is generated at the defibrillator electrodes, where each electrical shock lasts between 4 and 20 milliseconds, involves discharges of approximately 150 to 250 joules and/or involves applying a voltage at the defibrillator electrodes of between 1400 and 2000 volts. The electrical shock may involve any appropriate waveform known to a person of ordinary skill in the art e.g., biphasic, monophasic, etc. It should be appreciated, however, that for various applications electrical shocks with different electrical characteristics may be used (e.g., the voltage differential may be as high as 5000 volts, the discharges may be smaller than 150 joules or larger than 250 joules, etc.) Additionally, the features described in one of the described embodiments may be combined with or used to modify the features of almost any other described embodiment in the present application. For example,FIGS. 1-6 illustrate various defibrillators, most of which involve both a sealedpaddle module204 and connectingstructure206 with one or more sheet-like portions. Also contemplated by the present invention, however, is a sealedpaddle module204 without the connectingstructure206 and an unsealed defibrillator with the connectingstructure206. Similarly, the paddle guards902 ofFIG. 9B and theconductive protrusions804 ofFIG. 8C may be used on paddles or pads in almost any type of defibrillator arrangement, including but not limited to the sealedpaddle module204 and the connectingstructure206 ofFIGS. 1-6. In another example, any of the steps of the methods depicted inFIGS. 16A and 16B may be combined with, modified based on or supplemented with features described in connection withFIG. 12A. Although the illustrated embodiments primarily depict defibrillator paddles with housings, in some applications pads rather paddles may be used. Generally, pads are understood as being thinner and more flexible than paddles. It should be appreciated, however, that any of the features attributed to the defibrillator paddles in the present application may instead be applied to defibrillator pads. Therefore, the present embodiments should be considered as illustrative and not restrictive and the invention is not limited to the details given herein, but may be modified within the scope and equivalents of the appended claims.

Claims (23)

1. A portable defibrillator comprising:

two pads electrically connected to each other, each pad including a defibrillator electrode, the defibrillator electrode including a plurality of electrically conductive protrusions; and

an electrical system coupled with the two pads, the electrical system including at least a battery and a capacitor, the battery arranged to charge the capacitor, the capacitor arranged to apply a voltage at the defibrillator electrodes, thereby delivering an electrical shock suitable for arresting a cardiac arrhythmia.

2. The portable defibrillator as recited inclaim 1, wherein:

each pad is a paddle with a protective housing that covers the corresponding defibrillator electrode, the two paddles sealed together using a releasable seal to form a paddle module, the housings of the paddles cooperating to form the exterior of the paddle module; and

the pluralities of electrically conductive protrusions are unexposed and disposed within the paddle module.

3. The portable defibrillator as recited inclaim 1, wherein the plurality of electrically conductive protrusions includes at least 100 sharp protrusions arranged to penetrate skin of a person, thereby facilitating current flow through the person.

4. The portable defibrillator as recited inclaim 1, wherein each of the plurality of electrically conductive protrusions has a diameter of less than 33 gauge on the Stubs scale.

5. The portable defibrillator as recited inclaim 2 wherein the plurality of protrusions have a sterilization assurance level (SAL) of approximately 10-3 or less.

6. The portable defibrillator as recited inclaim 2, wherein the plurality of protrusions extend out of an electrically conductive base plate and have a bristle-like arrangement.

7. The portable defibrillator as recited inclaim 2, wherein:

a total volume of the capacitor is less than 400 cubic centimeters; and

the electrical system is arranged to apply a maximum voltage of no more than 1400 volts at the defibrillator electrodes.

8. A portable defibrillator comprising:

two pads electrically connected directly to each other, each pad including a defibrillator electrode, the defibrillator electrode including a plurality of electrically conductive protrusions; and

an electrical system coupled with the two pads, the electrical system including at least a battery and a capacitor, the battery arranged to charge the capacitor, the capacitor arranged to apply a voltage at the defibrillator electrodes, thereby delivering an electrical shock suitable for arresting a cardiac arrhythmia.

9. The portable defibrillator as recited inclaim 8, wherein:

each pad is a paddle with a protective housing that covers the corresponding defibrillator electrode, the two paddles sealed together using a releasable seal to form a paddle module, the housings of the paddles cooperating to form the exterior of the paddle module; and

the pluralities of electrically conductive protrusions are unexposed and disposed within the paddle module.

10. The portable defibrillator as recited inclaim 8, wherein the plurality of electrically conductive protrusions includes at least 100 sharp protrusions arranged to penetrate skin of a person, thereby facilitating current flow through the person.

11. The portable defibrillator as recited inclaim 8, wherein each of the plurality of electrically conductive protrusions has a diameter of less than 33 gauge on the Stubs scale.

12. The portable defibrillator as recited inclaim 9 wherein the plurality of protrusions have a sterilization assurance level (SAL) of approximately 10-3 or less.

13. The portable defibrillator as recited inclaim 9, wherein the plurality of protrusions extend out of an electrically conductive base plate and have a bristle-like arrangement.

14. The portable defibrillator as recited inclaim 9, wherein:

a total volume of the capacitor is less than 400 cubic centimeters; and

the electrical system is arranged to apply a maximum voltage of no more than 1400 volts at the defibrillator electrodes.

15. A portable defibrillator comprising:

two pads electrically connected to each other, each pad including a defibrillator electrode, the defibrillator electrode including a plurality of electrically conductive protrusions; and

an electrical system partially incorporated within each pad, the electrical system including at least a battery and a capacitor, the battery arranged to charge the capacitor, the capacitor arranged to apply a voltage at the defibrillator electrodes, thereby delivering an electrical shock suitable for arresting a cardiac arrhythmia.

16. The portable defibrillator as recited inclaim 15, wherein:

each pad is a paddle with a protective housing that covers the corresponding defibrillator electrode, the two paddles sealed together using a releasable seal to form a paddle module, the housings of the paddles cooperating to form the exterior of the paddle module; and

the pluralities of electrically conductive protrusions are unexposed and disposed within the paddle module.

17. The portable defibrillator as recited inclaim 15, wherein the plurality of electrically conductive protrusions includes at least 100 sharp protrusions arranged to penetrate skin of a person, thereby facilitating current flow through the person.

18. The portable defibrillator as recited inclaim 15, wherein each of the plurality of electrically conductive protrusions has a diameter of less than 33 gauge on the Stubs scale.

19. The portable defibrillator as recited inclaim 16 wherein the plurality of protrusions have a sterilization assurance level (SAL) of approximately 10-3 or less.

20. The portable defibrillator as recited inclaim 16, wherein the plurality of protrusions extend out of an electrically conductive base plate and have a bristle-like arrangement.

21. The portable defibrillator as recited inclaim 16, wherein:

a total volume of the capacitor is less than 400 cubic centimeters; and

the electrical system is arranged to apply a maximum voltage of no more than 1400 volts at the defibrillator electrodes.

22. The portable defibrillator ofclaim 1 further comprising an external power module that is coupled to the two pads, the external power module having a portion of the electrical system in the external power module, wherein the combination of the two pads and the external power module deliver the electrical shock suitable for arresting a cardiac arrhythmia.

23. A portable defibrillator comprising:

two or more pads electrically connected to each other, each pad including a defibrillator electrode, the defibrillator electrode including a plurality of electrically conductive protrusions; and

an electrical system partially incorporated within each pad, the electrical system including at least a battery and a capacitor, the battery arranged to charge the capacitor, the capacitor arranged to apply a voltage at the defibrillator electrodes, thereby delivering an electrical shock suitable for arresting a cardiac arrhythmia.

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