Abstract:
According to an aspect of the present disclosure, an automatic external defibrillator configured to deliver electrical pulses and/or shocks to a heart of a patient during a cardiac emergency is provided and includes a housing supporting an electrical connector; a defibrillator electrode delivery system supported on the housing; and a pair of defibrillation electrode pads supported by the defibrillator electrode delivery system. Each of the pair of defibrillation electrode pads is pre-connected to the electrical connector of the housing. A hydrogel layer of each defibrillation electrode pad is retained by the defibrillator electrode delivery system in such a manner so as to reduce a moisture vapor transmission rate thereof.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/315,159, filed on Mar. 18, 2010, entitled “Electrode Delivery System,” the entire content of which is being incorporated herein by reference. 
    
    
     BACKGROUND 
     1. Technical Description 
     The present disclosure relates to defibrillator and defibrillation electrodes and, more particularly, to systems, methods and packages to facilitate the use and connection of defibrillation electrodes to a defibrillator prior to the electrodes being used on a patient, while allowing the electrodes to maintain a sufficient amount of moisture to be able to properly function. 
     2. Background of Related Art 
     Electrodes which are typically used in medical applications generally include a conductor and a connector. The connector is attached at one end to the conductor and includes a plug at the other end to be plugged into a defibrillator or other device. The conductor is often covered or coated in a conductive gel, which enhances its ability to adhere to a patient&#39;s skin. When the conductive gel becomes too dry, it may lose its ability to adhere to a patient or demonstrate excessively high contact impedance. To prevent the conductive gel from drying out, the electrode may be stored in a package prior to use. 
     In a medical setting, there are often a variety of different defibrillators and electrodes at a clinician&#39;s disposal and it is not uncommon for several of the defibrillators and electrodes to have different manufacturers. Compatibility among defibrillators (or other medical devices) and electrodes of different brands is often lacking, which can cause confusion as to which particular electrode to use with a given defibrillator. Thus, clinicians open electrode packages to determine if the electrode (or electrode plug) is compatible with the defibrillator. If the electrode (or electrode plug) is not compatible with the defibrillator, the opened electrode is set aside and the clinician would open a different packaged electrode. As can be appreciated, testing electrodes in this fashion leads to waste, as the electrodes that are not compatible are likely to become too thy if not used in a timely fashion. 
     Further, in preparation for an emergency situation, clinicians may perform as many steps as possible before such an emergency situation arises. For example, a clinician may prepare a defibrillator by “pre-connecting” a compatible electrode to the defibrillator. Pre-connecting a compatible electrode to a defibrillator prevents rapid diffusion of moisture from the conductive gel, and reduces the number of steps that are needed to take place during an actual emergency. 
     In many instances, when an emergency situation arises at a public location remote from a medical facility, Automatic External Defibrillators (AED&#39;s) may generally be available for use on the individual experiencing the medical emergency. An AED is a portable electronic device that automatically diagnoses the potentially life threatening cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia in a patient, and is able to treat them through defibrillation, the application of electrical therapy which stops the arrhythmia, allowing the heart to reestablish an effective rhythm. 
     A need exists for a system of delivering electrodes to a patient that is easier to use and more simple to use, and that reduces the time required for a user of the AED to set-up the AED. 
     SUMMARY 
     The present disclosure relates to systems, methods and packages to facilitate the use and connection of defibrillation electrodes to a defibrillator prior to the electrodes being used on a patient, while allowing the electrodes to maintain a sufficient amount of moisture to be able to properly function. 
     According to an aspect of the present disclosure, an automatic external defibrillator configured to deliver electrical pulses and/or shocks to a heart of a patient during a cardiac emergency is provided and includes a housing supporting an electrical connector; a defibrillator electrode delivery system supported on the housing; and a pair of defibrillation electrode pads supported by the defibrillator electrode delivery system. Each of the pair of defibrillation electrode pads is pre-connected to the electrical connector of the housing. A hydrogel layer of each defibrillation electrode pad is retained by the defibrillator electrode delivery system in such a manner so as to reduce a moisture vapor transmission rate thereof. 
     The defibrillator electrode delivery system may include an electrode receiving surface defined on an outer surface of the housing, and wherein each defibrillation electrode pad is adhered to the electrode receiving surface of the housing. 
     The electrode receiving surface of the housing may be coated with a release material. 
     The defibrillator electrode delivery system may include a pair of spaced apart brackets extending from the housing; and a release liner sized to extend across the space defined by the pair of brackets, wherein the brackets are configured to retain the release liner in close proximity to the housing, and wherein each defibrillation electrode pad is adhered to a surface of the release liner. 
     The defibrillator electrode delivery system may include a carrier flap having a side edge connected to the housing, wherein an electrode pad of the pair of defibrillation electrode pads is adhered to a surface of a respective side of the carrier flap. 
     The defibrillator electrode delivery system may include a hinge connecting the side edge of the carrier flap to the housing. The defibrillator electrode delivery system may include a clamp connecting the side edge of the carrier flap to the housing. 
     For each of the pair of defibrillation electrode pads, the defibrillator electrode delivery system may include a two-part fastener member selectively securing each of the pair of defibrillation electrode pads to the housing, wherein a first part of the two-part fastener is secured to the housing and a second part of the two-part fastener is secured to a backing layer of each electrode pad. 
     Each defibrillation electrode pad may include a backing layer, a substrate overlying the backing layer, a hydrogel overlying the substrate and a liner overlying the hydrogel. 
     The defibrillator may further include a pair of contact pads supported in a surface of the housing, wherein each contact pad is electrically connected to the connector of the housing by a respective electrical connector, and wherein each electrode pad of the pair of defibrillation electrode pads is adhered to a surface of the housing so as to be in contact with a respective contact pad. 
     The defibrillator may be configured to perform checks of an impedance of the electrode pads when the electrode pads are in contact with the contact pads. 
     The defibrillator may be configured to automatically power-up upon a separation of the pair of defibrillation electrode pads from the contact pads. 
     The defibrillator may be configured to automatically power-up upon a separation of at least one of the pair of defibrillation electrode pads from the contact pads. 
     An impedance reading by the contact pads may be changed upon the separation of at least one of the pair of defibrillation electrode pads from the contact pad resulting in the automatic power-up of the defibrillator. 
     The defibrillator electrode delivery system may include a release liner supported on a surface of housing, and wherein the pair of defibrillation electrode pads may include an apex electrode and a sternum electrode adhered to a surface of the release liner, wherein the apex electrode includes a tab that projects from a perimeter of the release liner. 
     The sternum electrode may include a tab, and wherein the tab of the sternum electrode is exposed following a separation of the apex electrode from the release liner. 
     The release liner may be slidably supported on the surface of the housing, wherein as the tab of the apex electrode is pulled in a direction substantially parallel to a plane of the release liner, the release liner is slid in the direction of the pull and separated from the apex electrode. 
     In use, when the apex electrode is separate from the release liner, the tab of the sternum electrode may be exposed. 
     According to another aspect of the present disclosure, an automatic external defibrillator configured to deliver electrical pulses and/or shocks to a heart of a patient during a cardiac emergency is provided and includes a housing supporting an electrical connector, a battery and high voltage circuitry; and a pair of defibrillation electrode pads supported on the housing, wherein each of the pair of defibrillation electrode pads is pre-connected to the electrical connector of the housing, and wherein each defibrillation electrode pad is in electrical communication with the battery and the high voltage circuitry. The defibrillator is automatically activated by a separation of at least one of the pair of defibrillation electrode pads from the housing. A hydrogel layer of each defibrillation electrode pad is retained by the housing in such a manner so as to reduce a moisture vapor transmission rate thereof. 
     The defibrillator may further include a pair of contact pads supported in a surface of the housing, wherein each contact pad is electrically connected to the connector of the housing by a respective electrical connector, and wherein each electrode pad of the pair of defibrillation electrode pads is disposed on a surface of the housing so as to be in contact with a respective contact pad. 
     The defibrillator may be configured to perform checks of an impedance of the electrode pads when the electrode pads are in contact with the contact pads. 
     The defibrillator may be configured to automatically power-up upon a separation of the pair of defibrillation electrode pads from the contact pads. 
     The defibrillator may be configured to automatically power-up upon a separation of at least one of the pair of defibrillation electrode pads from the contact pads. 
     An impedance reading by the contact pads may be changed upon the separation of at least one of the pair of defibrillation electrode pads from the contact pad resulting in the automatic power-up of the defibrillator. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of electrode delivery systems are described herein with reference to the drawings wherein: 
         FIG. 1  is a top, plan view of a defibrillator electrode delivery system according to an embodiment of the present disclosure; 
         FIG. 2  is a side, elevational view of a defibrillator electrode delivery system according to another embodiment of the present disclosure; 
         FIG. 3A  is a side, elevational view of a defibrillator electrode delivery system according to a further embodiment of the present disclosure; 
         FIG. 3B  is an enlarged view of the indicated area of detail of  FIG. 3A ; 
         FIG. 4  is a side, elevational view, with parts separated, of a defibrillator electrode delivery system according to yet another embodiment of the present disclosure; 
         FIG. 5  is a side, elevational view of a defibrillator electrode delivery system according to still another embodiment of the present disclosure; 
         FIG. 6  is a side, elevational view of a defibrillator electrode delivery system according to another embodiment of the present disclosure; and 
         FIG. 7  is a top, plan view of a defibrillator electrode delivery system according to another embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the presently disclosed defibrillator electrode delivery system will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. 
     As illustrated in  FIG. 1 , a defibrillator electrode delivery system, according to an embodiment of the present disclosure, is generally designated as  100 . Defibrillator electrode delivery system  100  includes an automatic external defibrillator (AED)  102  defining a surface  140  configured to store or retain a pair of electrode pads  10 ,  20 . Electrode pads  10 ,  20  are electrically connectable to or pre-connected to AED  102  via respective lead wires  12 ,  22  joined at a connector  30 . 
     Surface  140  is coated with a release material to selectively adhere electrode pads  10 ,  20  thereto and to facilitate the removal of electrode pads  10 ,  20  therefrom when needed. For example, the release material may be Teflon, silicone, and combinations thereof. 
     In this configuration, a gel layer of each electrode pad  10 ,  20  has a reduced tendency to dry-out. Due to the adherence of the electrode pads  10 ,  20  to surface  140  of AED  102 , no special packaging is required that reduces a moisture vapor transmission rate (MVTR) of the electrode pads  10 ,  20 . 
     As illustrated in  FIG. 2 , a defibrillator electrode delivery system, according to another embodiment of the present disclosure, is generally designated as  200 . Defibrillator electrode delivery system  200  includes an automatic external defibrillator (AED)  202  having a pair of spaced apart brackets  212 ,  214  supported on a surface thereof. Defibrillator electrode delivery system  200  is configured to store or retain a pair of electrode pads  10 ,  20  that are supported on a release liner  250 . Brackets  212 ,  214  are spaced apart an amount sufficient to engage, capture and/or lock down on release liner  250  to thereby maintain electrode pads  10 ,  20  secured to AED  202 . Electrode pads  10 ,  20  are electrically connected to AED  202  via respective lead wires (not shown) joined at a connector (not shown). 
     In this configuration, a gel layer of each electrode pad  10 ,  20  has a reduced tendency to dry-out. Due to the adherence of the electrode pads  10 ,  20  to release liner  250 , no special packaging is required that reduces a moisture vapor transmission rate (MVTR) of the electrode pads  10 ,  20 . 
     As illustrated in  FIGS. 3A and 3B , a defibrillator electrode delivery system, according to a further embodiment of the present disclosure, is generally designated as  300 . Defibrillator electrode delivery system  300  includes an automatic external defibrillator (AED)  302  having a carrier flap or page  360  hingedly connected thereto via a hinge member  362 . Defibrillator electrode delivery system  300  is configured to store or retain a pair of electrode pads  10 ,  20  that are supported on a front side, a back side and/or on opposed sides  360   a ,  360   b  of flap  360  (as shown in  FIGS. 3A and 3B ). As shown in  FIG. 3B , each electrode pad  10 ,  20  may include a respective pull tab  11 ,  21  to facilitate the removal of electrode pads  10 ,  20  from flap  360 . Electrode pads  10 ,  20  are electrically connectable to or pre-connected to AED  302  via respective lead wires  12 ,  22  joined at a connector  30 . 
     In this configuration, a gel layer of each electrode pad  10 ,  20  has a reduced tendency to dry-out. Due to the adherence of the electrode pads  10 ,  20  to flap  360 , no special packaging is required that reduces a moisture vapor transmission rate (MVTR) of the electrode pads  10 ,  20 . 
     As illustrated in  FIG. 4 , a defibrillator electrode delivery system, according to still another embodiment of the present disclosure, is generally designated as  400 . Defibrillator electrode delivery system  400  includes an automatic external defibrillator (AED)  402  having a two-part fastener member  470  associated therewith for selectively securing a pair of electrode pads thereto (only one electrode pad  10  being shown). Two-part fastener member  470  includes a first part  470   a  secured to AED  402  and a second part  470   b  secured to a backing layer  10   a  of electrode pad  10 . Electrode  10  includes a conductive and/or non-conductive substrate  10   b  overlying backing layer  10   a , on a side opposite the second part  470   b  of the two-part fastener member  470 . Electrode  10  further includes a gel or hydrogel layer  10   c  overlying substrate  10   b , and a liner  10   d  overlying gel or hydrogel layer  10   c.    
     Two-part fastener member  470  may be in the form of a hook and loop type fastener where one of the first part  470   a  and the second part  470   b  is the hook portion and the other of the first part  470   a  and the second part  470   b  is the loop portion. It is contemplated that the two-part fastener member  470  may include double-sided tape or the like. 
     In this configuration, a gel or hydrogel layer  10   e  of electrode pad  10  has a reduced tendency to dry-out. Due to the securement of the electrode pad  10  to AED  402  and to the provision of a liner  10   d  overlying gel or hydrogel layer  10   c , no special packaging is required that reduces a moisture vapor transmission rate (MVTR) of the electrode pads. 
     As illustrated in  FIG. 5 , a defibrillator electrode delivery system, according to another embodiment of the present disclosure, is generally designated as  500 . Defibrillator electrode delivery system  500  includes an automatic external defibrillator (AED)  502  having a release liner  580  secured to a surface thereof via a clamp  582 . Defibrillator electrode delivery system  500  is configured to store or retain at least one electrode pad  10  on a front side  580   a  of release liner  580 . As shown in  FIG. 5 , electrode pad  10  may include a pull tab  11  to facilitate the removal of electrode pad  10  from release liner  580 . 
     In this configuration, a gel layer of electrode pad  10  has a reduced tendency to dry-out. Due to the adherence of the electrode pad  10  to release liner  580 , no special packaging is required that reduces a moisture vapor transmission rate (MVTR) of the electrode pads  10 ,  20 . 
     As illustrated in  FIG. 6 , a defibrillator electrode delivery system, according to yet another embodiment of the present disclosure, is generally designated as  600 . Defibrillator electrode delivery system  600  includes an automatic external defibrillator (AED)  602  including a pair of electrical contact points or pads  690 ,  692  disposed in a surface thereof. Defibrillator electrode delivery system  600  includes a pair of electrode pads  10 ,  20  electrically connectable to or pre-connected to AED  602  via respective lead wires  12 ,  22  joined at a connector  30 . Electrode pads  10 ,  20  are also in contact with respective contact pads  690 ,  692 . Each electrical contact pad  690 ,  692  is electrically connected to a respective electrical connector  690   a ,  692   a  which electrically interconnected to respective lead wires  12 ,  22  by way of connector  30 . 
     In this manner, a first electrical circuit is defined which includes contact pad  690 , a respective electrical connector  690   a , connector  30 , lead wire  12  and electrode pad  10 . Also, a second electrical circuit is defined which includes contact pad  692 , a respective electrical connector  692   a , connector  30 , lead wire  22  and electrode pad  20 . 
     AED  602 , as schematically shown in  FIG. 6 , includes a battery “B” and high voltage circuitry “C” disposed in a housing  602   a  thereof. The battery and the high voltage circuitry are electrically connected to connector  30  and/or electrical connectors  690   a ,  690   b.    
     It is contemplated that as electrode pads  10 ,  20  are lifted or separated from AED  602 , that electrode pads  10 ,  20  separate from contact pads  690 ,  692 , altering an impedance or breaking a respective circuit therebetween, and thereby causing AED  602  to automatically begin to power-up or initialize (i.e., run an automated set-up process with readies AED  602  prior to use in a cardiac emergency). It is further contemplated that AED  602  is automatically powered-up upon a separation of any one of electrode pads  10 ,  20  from contact pads  690 ,  692  of AED  602 . 
     Alternatively, or in addition to the automated set-up process, as so configured, an impedance check may be performed across each electrode pad  10 ,  20  to check an impedance of each electrode pad  10 ,  20  and determine if a moisture content of a gel layer of each electrode pad  10 ,  20  is acceptable for use thereof. 
     As illustrated in  FIG. 7 , a defibrillator electrode delivery system, according to still another embodiment of the present disclosure, is generally designated as  700 . Defibrillator electrode delivery system  700  includes an automatic external defibrillator (AED)  702  including a pair of electrode pads, an apex electrode pad  10  and a sternum electrode pad  20 . Electrode pads  10 ,  20  are electrically connectable to or pre-connected to AED  702  via respective lead wires  12 ,  22 . Apex electrode pad  10  includes a pull tab  13  that projects from or extends from a perimeter of a box or liner  704  disposed on AED  702 , which retains electrode pads  10 ,  20 . Electrode pads  10 ,  20  are arranged on box or liner  704  such that, as apex electrode pad  10  is peeled off of box or liner  704 , liner  704  rolls forward and exposes a pull tab  23  of sternum electrode pad  20  so that the sternum electrode pad  20  is ready to be removed from liner  704  after placement of apex electrode pad  10  is placed against the patient. 
     In accordance with any of the embodiments of the present disclosure described above, it is contemplated that as electrode pads  10 ,  20  are removed from or separated from the surface of the AED, that the AED may automatically begin to power-up. 
     Electrode pads configured for use with any of the electrode delivery systems disclosed herein are shown and described in International Patent Application Serial No. PCT/US2007/010060, filed Apr. 27, 2007, in U.S. patent application Ser. No. 12/237,803, filed on Sep. 25, 2008, and U.S. Patent Application Publication No. 2009/0227857, filed on Mar. 6, 2008, the entire content of each of which being incorporated herein by reference. 
     An example of a suitable polymer which may be utilized in the electrode pads disclosed herein includes RG-63B hydrogel, commercially available from Tyco Healthcare Group d/b/a/Covidien. Other suitable hydrogels include those disclosed in U.S. Patent Application Publication No. 2009/0270709, filed on Oct. 30, 2009, and U.S. Patent Application Publication No. 2009/0270710, filed on Oct. 30, 2009, the entire disclosures of each of which are incorporated by reference herein for all purposed. 
     It is to be understood that the foregoing description is merely a disclosure of particular embodiments and is in no way intended to limit the scope of the disclosure. Other possible modifications will be apparent to those skilled in the art and are intended to be within the scope of the present disclosure.