Automated External Defibrillator (AED) Electrode

Abstract

Aspects of the present invention provide AED electrodes that use an acrylic adhesive to physically secure and electrically couple the electrodes to a victim, for example, for the purpose of delivering a high-energy discharge of 10 to 360 joules at a current of 100 A to 2500 A. The use of such an acrylic adhesive for securing the electrodes to a victim in AED electrodes according to these aspects of the present invention has the advantage of, among other things, extending their shelf life and thereby reducing the cost and associated burden of deployed AEDs. Further aspects of the present invention provide AEDs incorporating electrodes of the type described above. Still other aspects of the present invention provide methods for manufacturing such AEDs and / or electrodes. Still other aspects of the present invention provide methods for defibrillating a victim using such AEDs and / or electrodes, including delivering from 10 joules, and in some cases up to 360 joules, at a high current of 100 A to 2500 A.

Description

[Technical Field]

[0001] The present invention relates to automated external defibrillators (AEDs), and more particularly to electrodes that are part of the electrical circuit that conducts shock energy from the AED into the victim's body.

[0002] This application claims the benefit of priority to U.S. Patent Application Serial No. 63 / 387,280, filed December 13, 2022, entitled "Automated External Defibrillation (AED) Electrodes," the teachings of which are incorporated herein by reference. [Background technology]

[0003] An external defibrillator is an emergency medical device designed to deliver a controlled electric shock to a victim's heart in the event of cardiac arrest, restoring a functional cardiac rhythm. The shock is delivered by electrodes electrically connected to the external defibrillator and placed in contact with the victim's body.

[0004] These portable external defibrillators, commonly known as automated external defibrillators (AEDs), which include automatic and semi-automatic varieties, have been embraced by non-healthcare professionals and are being deployed in countless locations outside of traditional healthcare settings.

[0005] Due to the life-saving effectiveness of AEDs, an increasing number of non-medical personnel are purchasing and deploying AEDs in their individual settings, allowing them to attempt rescue without the delays associated with transporting the victim to a medical facility or transporting a medical facility to the victim (e.g., a life-saving ambulance).

[0006] Individuals as well as businesses purchase and deploy AEDs. Because time is of the essence in any rescue operation, a particular individual or user may purchase multiple AEDs for installation in multiple locations. This installation may be on multiple floors of a home for an individual, or throughout an entire facility (e.g., a factory, office building, or large retail center) for a business. Thus, no matter where in the home / facility a victim is, access to an AED takes only a few seconds, if not minutes.

[0007] AEDs are designed to be stored in a location for long periods of time with minimal supervision and maintenance, providing easy access. AED maintenance primarily focuses on replacing AED consumables (e.g., batteries and electrodes) that deteriorate or wear out over time. Among such consumables, electrodes have traditionally been the most susceptible to deterioration.

[0008] In operation, an AED (i) ensures proper electrode placement on the victim by measuring impedance using very low current signals of less than 100 microamperes and at 8 kHz and 16 kHz, (ii) determines whether the victim's heart is in a shockable rhythm by obtaining ECG measurements from low current / low voltage signals of around 500 microvolt amplitude, and (iii) defibrillates the victim's heart by delivering high currents of 100 A to 2500 A, with energy ranging from 10 joules and in some cases up to 360 joules depending on the victim (e.g., infant, child, or adult).

[0009] The acquisition and transmission of signals and energy to and from the heart is accomplished by electrically connecting the AED to the victim by means of a pair of electrodes, facilitated by some form of temporary adhesive that both secures the electrodes to the victim and allows for the electrical connection.

[0010] Currently, the temporary adhesives used on AED electrodes are hydrogel-based, and while these temporary adhesives are acceptable for obtaining the necessary impedance and ECG data and for transmitting defibrillation energy, hydrogel-based adhesives present significant practical problems.

[0011] Electrodes with hydrogel adhesive must be packaged for storage to prevent the hydrogel from drying out and becoming ineffective as an adhesive. Even with the most advanced packaging, packaged hydrogel electrodes have a shelf life of only a few years. AED batteries, which are also consumables, can be designed to have a shelf life of many years or longer.

[0012] Additionally, the short shelf life of hydrogel electrodes complicates AED manufacturing. This short shelf life makes electrodes a just-in-time supply inventory item. Just-in-time manufacturing inventory items increase inventory costs and waste in AED manufacturing.

[0013] There is a need in the art for AED electrodes with longer shelf lives that would reduce the maintenance costs and burden of deployed AEDs and result in a lower cost manufacturing process for AEDs. Summary of the Invention [Means for solving the problem]

[0014] The above-mentioned objects are achieved within the scope of the present invention, an embodiment of which provides an AED electrode that uses an acrylic adhesive to physically secure and electrically connect the electrode to a victim, for example, for the purpose of delivering a high-energy discharge of 10 to 360 joules at a current of 100 A to 2500 A. The use of such an acrylic adhesive to secure the electrode to a victim in accordance with this embodiment of the present invention has the benefit, among other things, of extending the shelf life of the electrode, thereby reducing the costs and associated burden of deployed AEDs.

[0015] Related aspects of the present invention provide AED electrodes, for example, of the type described above, sized and / or otherwise configured to effectively transmit such high-energy discharges to the victim. Yet another related aspect of the present invention provides AED electrodes in which the acrylic adhesive is the skin-contacting adhesive. Yet another related aspect of the present invention provides AED electrodes, for example, of the type described above, in which the acrylic adhesive is provided on a transfer tape. Yet another aspect of the present invention provides AED electrodes, for example, of the type described above, in which the acrylic adhesive is the Omin-Wave adhesive product (Product ID: FLX068983) from FLEXcon Company, Inc. of Massachusetts. Yet another aspect of the present invention provides AED electrodes, for example, of the type described above, in which the acrylic adhesive couples low-energy signals from the victim to the electrode.

[0016] A further aspect of the present invention provides an AED incorporating electrodes of the type described above. Yet other aspects of the present invention provide methods for manufacturing such AEDs and / or electrodes. A further aspect of the present invention provides methods for defibrillating a victim using such AEDs and / or electrodes (including delivering energy from 10 Joules, and in some cases up to 360 Joules, at high currents from 100 A to 2500 A). These and other aspects and advantages of the present invention will become apparent from the following detailed description and accompanying drawings, which illustrate, by way of example, features of the invention. [Brief explanation of the drawings]

[0017] A more complete understanding of the present invention can be obtained by reference to the drawings.

[0018] [Figure 1] FIG. 1 is a front view of an exemplary AED system according to the present invention.

[0019] [Figure 2] FIG. 2 is a diagram of relevant structural areas of the exemplary AED shown in FIG.

[0020] [Figure 3] FIG. 3 is a side view of an AED electrode according to the present invention.

[0021] [Figure 4] FIG. 4 is an exploded view of the AED electrodes shown in FIG.

[0022] [Figure 5] FIG. 5 is a top view of an AED electrode according to the present invention, showing the general dimensions of the various elements of the electrode.

[0023] [Figure 6] FIG. 6 is a perspective view of an AED electrode according to the present invention with the protective layer removed. DETAILED DESCRIPTION OF THE INVENTION

[0024] Referring to the drawings, Figure 1 shows an AED system 100. As shown in Figure 1, the AED system includes an AED 110 and electrodes 120 electrically connected thereto. More specifically, the AED includes at least a pair of electrodes that are configured to be placed on the victim's chest or back (if the victim is a child). Depending on the type of AED, whether automatic or automated, if automated, a shock button 124 is provided.

[0025] An AED 110 of the type known in the art and adapted in accordance with the teachings herein may include additional features such as a speaker, an audio output jack, a defined user interface, an ON / OFF switch, a status indicator, a card port for data storage, a Universal Serial Bus (more commonly known as a USB port), a standardized interface socket, and other features. Some of these features may directly assist in the use of the AED, such as a speaker for communication with the user of the AED, while others are optional. Many of the features that assist the user are based on the rescue protocol implemented by the AED.

[0026] 2, the AED 110 includes three main functional units: a power supply 130; a control circuit 140; and a high voltage circuit 150.

[0027] Power source 130 is typically a portable power source such as a battery or multiple batteries, although other types of power sources known in the art for use with AEDs may additionally or alternatively be used and adapted in accordance with the teachings herein.

[0028] Control circuitry 140, powered by power source 130, is of a conventional type known in the art and adapted in accordance with the teachings herein, including, by way of non-limiting example, a main processor for executing an AED program, including control programming, stored in memory. Consistent with practice in the art (adapted in accordance with the teachings herein), the control circuitry acquires ECG signals from the electrodes, performs impedance measurements across the deployed electrodes, analyzes the acquired ECG signals, determines whether the AED should shock the victim, and, if so, initiates a shock sequence to deliver the shock. Shock delivery may be controlled by the control circuitry or may require the user to deliver the shock using a button or similar activation mechanism, all in accordance with practice in the art in accordance with the teachings herein.

[0029] A conventional high voltage circuit 150 known in the art and adapted in accordance with the teachings herein generates the energy necessary to administer a shock when commanded to do so by a control circuit or otherwise. When a shock is delivered, the shock energy is transferred from the high voltage circuit to the electrodes 120 and then to the victim.

[0030] The AED 110, and more generally the AED system 100, operates in a conventional manner known in the art adapted in accordance with the teachings herein.

[0031] Continuing with FIG. 3, at least one (and preferably all) electrodes 120 include a base 200 adhered to a conductive layer 210, which in turn has an adhesive 220 adhered to the conductive layer. As shown, the conductive layer is ideally encapsulated between the base and the adhesive layer. The encapsulation of the conductive layer is further illustrated in FIG. 5, which shows, by way of non-limiting example, the dimensions in inches of the base (here labeled "Foam" by way of non-limiting example), the conductive layer (here labeled "Tin"), and the adhesive (here labeled "Adhesive"). The base can be adhered to the conductive layer by any method known in the art adapted in accordance with the teachings herein.

[0032] Continuing with Figure 3, the conductive layer 210 is electrically connected to the AED 110, such as by a rivet 230 and a wire 232. Such a wire may have a connector (not shown) for temporarily connecting the electrode to the AED to facilitate pad replacement.

[0033] The adhesive layer 220 has a first side 220A that can be adhered to the victim's skin and a second side 220B that is adhered to the conductive layer 210, and if necessary or desired, is adhered to secure the conductive layer to the base 200, which is accomplished by encapsulation of the conductive layer (see FIG. 5 for example relevant dimensions). The adhesive layer has a bonding adhesive on the side that is adhered to the conductive layer and possibly the base, forming at least a semi-permanent bond with the conductive layer and, if applicable, the base. Preferably, the semi-permanent bond is at least stronger than the bond formed between the adhesive layer and the victim's skin, such that when the electrode is removed from the victim's skin, only a small amount of adhesive remains attached to the electrode, all in accordance with practice in the art adapted in accordance with the teachings herein.

[0034] The adhesive 220 is suitable for conducting ECG signals from the victim to the conductive layer 210, for conducting impedance signals generated by the control system 140 to and from the conductive layer, and for conducting multiple shocks generated by the high voltage circuit 150 from the conductive layer through the adhesive layer to the victim. The electrode area complies with ANSI / AAMI DF39;199, section 201.108.7. The dimensions of a typical AED pad used by applicant Defibtech, LLC are shown in FIG. 5 as a non-limiting example.

[0035] Conductive layer 210 is also sized in accordance with ANSI / AAMI DF39;1993, Section 201.108.7 and may be formed of any suitable conductive material, although tin is commonly used. Base layer 200 is sized as described above and is made of foam or other materials (or combinations thereof) conventional in the art adapted in accordance with the teachings herein.

[0036] Continuing with FIG. 5, a typical area of ​​the conductive layer 210 is approximately 77 cm 2 is 4.6 Joules / cm 2Given a discharge density of 300 joules (potential adult condition), this tends to set an upper limit on the energy density of AED pads with a surface area of ​​approximately 2 cm. 2 A typical electrode for measuring an ECG signal, when used as an AED pad, generates 4.6 joules / cm 2 , which is harmful to the victim and therefore ineffective.

[0037] 6, the electrode may further include a temporary protective layer 222 on a first surface 220A of the adhesive layer 220 (i.e., the surface of the adhesive layer that adheres to the victim's skin) to prevent unintentional adhesion of the adhesive. The electrode 120 may further be packaged in a container or pouch (not shown).

[0038] In use, the electrode 120 is deployed by removing it from any packaging, removing any protective layer 222 over the adhesive, and placing the first surface 220A on the victim's skin in the appropriate location. AEDs typically use two electrodes, positioned so that both receive ECG signals and deliver shock energy. For a typical adult, one electrode is placed in the upper left quadrant of the victim's chest, and the other in the lower right quadrant. For children, one electrode may be placed on the back and the other on the chest.

[0039] As previously described, the electrodes conduct low-energy signals from the victim to the AED 110 and high-energy signals from the AED to the victim. Thus, in operation, the AED first conducts a low-energy signal through the adhesive 220 to the conductive layer 210, which conducts it to the AED for analysis. If analysis of the received signal recommends a shock, the AED discharges a high-energy burst into the signal receiver, through the adhesive, and into the victim.

[0040] The inventors have discovered that an acrylic adhesive can conduct the necessary low-energy signals from the heart and between the electrodes, as well as conduct high-energy discharges, e.g., shocks, from the medical device (i.e., AED 110) to the victim without harming the victim. An acrylic adhesive for electrodes suitable for practicing the present invention is one that includes a pressure-sensitive organic polar salt with a conductive matrix. While the electrodes are considered consumables, the adhesive must remain effective to support multiple shocks during a particular rescue. Ideally, the adhesive should be biocompatible, conforming to biocompatibility standards such as ISO-10993. One acrylic adhesive that finds use in the practice of the present invention is OMNI-WAVE adhesive (Product ID: FLX068983), a commercially available product from FLEXcon Company, Inc. of Massachusetts, and is described, for example, in the product data sheet entitled "Skin Contact Applications - Electrodes & Wearables - Hydrogel-Free Bio-Signal Sensing Transfer Tape," dated November 10, 2022, available from the company, the teachings of which are incorporated herein by reference, and further described at https: / / www.flexcon.com / product-finder / product / 68983 / omniwave-tt-200-black-h502-150-poly-h9-44pp8, the teachings of which are also incorporated herein by reference.

[0041] Other properties of electrode 120 and the adhesive used therein are described in the Summary of the Invention above.

[0042] While specific or exemplary embodiments have been described, it should be understood that these embodiments are presented by way of example only and are not intended to limit the scope of the invention(s) disclosed herein. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms.

Claims

1. 1. A method of manufacturing an AED electrode for use in an AED system for delivering a defibrillation shock to a victim at a predetermined shock energy in joules, comprising: obtaining a conductive base having a surface area such that said shock energy per square centimeter does not exceed 5 joules per square centimeter; obtaining a dry adhesive, the dry adhesive being signal and electrical conductive with respect to at least impedance signals, ECG signals, and defibrillation energy, and suitable for adhering to the victim's skin; adhering the dry adhesive to the base.

2. 10. The method of claim 1, wherein the dry adhesive adheres to the victim's skin and remains effective after four defibrillation discharges.

3. 3. The method of claim 2, wherein each of the defibrillation discharges exceeds 50 joules.

4. obtaining a protective cover, the protective cover being only temporarily adhered to the dry adhesive; The method of claim 1 further comprising adhering the protective cover to the dry adhesive.

5. The method of claim 1 , wherein the dry adhesive is an acrylic containing an organic polar salt and a conductive matrix.

6. The method of claim 5 wherein the dry adhesive is pressure sensitive.

7. 1. An AED system for delivering a defibrillation shock to a victim, comprising: an AED system capable of delivering a defibrillation shock; a pair of electrodes electrically connected to the AED system, the electrodes employing a dry adhesive having a first side and a second side, the dry adhesive capable of conducting at least an impedance signal, an ECG signal, and defibrillation energy; It has a conductive base, The dry adhesive is adhered to the conductive base on the first side and the second side is releasably adhereable to the victim's skin.

8. 1. A method of delivering a defibrillation shock to a victim, comprising: identifying a victim who may be experiencing cardiac arrest; obtaining an AED having a pair of electrodes, the electrodes including a dry adhesive capable of conducting at least an impedance signal, an ECG signal, and defibrillation energy; adhering the pair of electrodes to a victim; If determined by the AED, delivering a defibrillation shock to the victim.

9. An AED electrode, the electrode using an acrylic adhesive to physically secure and electrically couple the electrode to a victim, and delivering a high energy discharge of 10 to 360 joules at a current of 100 A to 2500 A to the victim.

10. 10. The AED electrode of claim 9, wherein the electrode is sized and / or otherwise configured to effectively transmit such a high energy discharge to the victim.

11. 10. The AED electrode of claim 9, wherein the acrylic adhesive is a skin-contacting adhesive.

12. 10. The AED electrode of claim 9, wherein the acrylic adhesive is provided on a transfer tape.

13. 10. The AED electrode of claim 9, wherein the acrylic adhesive is Omin-Wave adhesive product from FLEXcon Company, Inc. of Massachusetts (Product ID: FLX068983).

14. 10. The AED electrode of claim 9, wherein the acrylic adhesive is adapted for low energy signals from the victim to the electrode.

15. AED comprising one or more electrodes of the kind according to claims 9 to 14.

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