Abstract:
A package stores at least one electrode pad having a lead. The package includes an interior for storing the pad, and includes a portion that is openable to allow removal of the package from the leads. For example, the openable portion of the package may include a sealed seam through which the lead extends. The operator can peel apart the seam to both open the package and free the package from the lead. Where the pad is a defibrillator electrode pad, the ability to quickly and easily free the package from the lead may save precious seconds during the rescue of a patient in cardiac arrest. For example, freeing the package from the lead typically allows the operator a fuller view of and easier access to the defibrillator and the patient, and eliminates a potential distraction.

Description:
BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The invention relates generally to packages for storing an electrode pad of a medical device such as an automatic or semi-automatic external defibrillator (AED), and more particularly to a package that comes free of the electrode-pad lead while or after one opens the package. In one embodiment of the invention, one peels apart the portion of the package seam through which the lead extends to free the package from the lead. 
   2. Description of the Prior Art 
   AEDs have saved many lives in non-hospital settings, and, as a result of advances in AED technology, the number of lives saved per year is rising. Typically, an AED analyzes a patient&#39;s heart rhythm and instructs an operator to administer an electrical shock to the patient if appropriate. For example, a shock can often revive a patient who is experiencing ventricular fibrillation (VF). Because older models of AEDs include only basic diagnostic and safety features, they are often difficult to operate. Therefore, only specially trained persons such as emergency medical technicians (EMTs) can use these older models to administer shocks to patients. Newer models, however, often include advanced diagnostic and safety features that allow minimally trained persons to administer shocks to patients. Consequently, more people are using AEDs to save lives. 
   Because a heart rhythm that responds to an electrical shock can cause permanent damage or death within a short time if left untreated, an AED operator should be able to set up and use an AED to shock a patient within seconds after the operator arrives at the scene. Statistically, for each minute that a person is in cardiac arrest and is not receiving cardiopulmonary resuscitation (CPR), his/her chance of survival decreases by 10%. And in most cases, there is no chance for resuscitation after 10 minutes. Unfortunately, many people do not know how to administer CPR. And, even in the best of circumstances, it can take a few minutes to retrieve the AED and a few additional minutes for the AED to diagnose and shock the patient. Therefore, even if the patient is discovered immediately, the operator often has little time to remove the defibrillator electrode pads from their package, attach the pads to the patient, connect the pads to the AED, and activate the AED without further decreasing the patient&#39;s chances of survival. Clearly, the faster the operator can set up and activate the AED, the more likely it is that the patient will survive. 
   One way to facilitate faster set up of an AED is to connect the pads to the AED before it is needed to revive a patient. Such pad pre-connection typically shortens the AED setup time by eliminating the operator steps of determining how to connect, and then connecting the pads to the AED. For example, one can store the AED with the pads pre-connected so that the AED will be ready when needed. 
     FIG. 1  is a view of a conventional defibrillator-electrode-pad storage system  10 , which allows pre-connection of defibrillator electrode pads to an AED (FIG.  7 ). The system  10  includes a package  12  and two defibrillator electrode pads  14   a  and  14   b  (shown in phantom line) stored within an interior  16  of the package  12 . Electrode-pad leads  18   a  and  18   b  extend from a sealed opening  20  in the package  12 , and a connector  22  electrically connects the electrode pads  14   a  and  14   b  to the AED via the leads  18   a  and  18   b . The package  12  may also include a tear line  24  to facilitate opening of the package. The rears of the pads  14   a  and  14   b  each include a conductive layer (not shown), which is typically coated with a contact gel (not shown). The gel provides electrical conduction between a patient (not shown) and the conductive layer and also helps adhere the pads  14   a  and  14   b  to the patient. Typically, a release liner is placed over the gel surface of each electrode to prevent the gel from adhering to the package or other electrodes. However, the electrode gel surfaces could also be adhered to the inside surfaces of the package or to a common release liner, shared by both electrodes. Typically, the pads  14   a  and  14   b  are viable only while the respective contact gels each maintain a respective moisture level that is at or above a predetermined threshold. Therefore, the package  12  typically limits moisture loss from the package interior  16  to a rate sufficient for maintaining adequate moisture in the contact gels for a predetermined period such as one year. The package  12  also protects the pads  14   a  and  14   b  from shipping and storage damage, and thus is often ruggedly constructed and reinforced around the opening  20 . 
   During set up of the pre-connected AED, the operator (not shown) tears the top of the package  12  off at the tear line  24 , removes the pads  14   a  and  14   b  from the package interior  16  via the torn-open top of the package  12 , and attaches the pads  14   a  and  14   b  to a patient (not shown). 
   Referring to  FIG. 2 , one problem with the defibrillator-electrode-pad storage system  10  is that after the operator (not shown) opens the package  12 , it remains attached to the leads  18   a  and  18   b , and thus may hinder the operator (not shown) as he/she attempts to revive the patient (not shown). For example, the package  12  may distract the operator, who may waste valuable seconds trying to remove the package from the leads  18   a  and  18   b . Moreover, the package  12  may obscure the operator&#39;s view of the AED ( FIG. 7 ) or the patient, or may get in the operator&#39;s way as he/she attempts to access the AED or the patient. 
   Unfortunately, it is often difficult and time consuming to remove the package  12  from the leads  18   a  and  18   b . The package  12  is often ruggedly constructed and reinforced around the opening  20 , it is typically difficult for an operator (not shown) to free the package  12  from the leads  18   a  and  18   b . And although an operator may have the strength or a cutting tool (e.g., scissors) to free the package  12  from the leads  18   a  and  18   b , this would typically waste valuable seconds of rescue time and possibly damage the leads. Furthermore, although an operator may have the strength or a tool to widen the opening  20  enough to slip the package  12  over the connector  22 , he/she would have to disconnect the connector from the AED ( FIG. 7 ) and thus lose the time saved by pre-connection. 
   Consequently, there is a need for a package that can be quickly and easily removed from the leads of electrode pads and that also protects and maintains the viability of the pads. 
   SUMMARY OF THE INVENTION 
   A package is provided for storing at least one electrode pad having a lead. The package includes an interior for storing the electrode pad, and includes a portion that is openable to allow removal of the package from the lead. For example, the openable portion of the package may include a sealed seam through which the lead extends. The operator can peel apart the seam to both open the package and free the package from the lead. 
   Because it has an openable portion that allows removal of the package from a lead, the package often reduces the time it takes for an operator to set up a medical device such as an AED and attach an electrode pad to a patient. For example, the ability to quickly and easily free the package from the lead may save precious seconds by allowing the operator a fuller view and easier access to the medical device and the patient, and by eliminating a potential operator distraction. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a view of a conventional electrode-pad storage system. 
       FIG. 2  is a view of the storage system of  FIG. 1  with the pad package open but stuck to the pad leads. 
       FIG. 3  is a view of an electrode-pad storage system according to an embodiment of the invention. 
       FIG. 4  is a view of the storage system of  FIG. 3  with the pad package open. 
       FIG. 5  is a view of an electrode-pad storage system according to another embodiment of the invention. 
       FIG. 6  is a view of the storage system of  FIG. 5  with the pad package open. 
       FIG. 7  is a view of an AED system that incorporates the electrode-pad storage system of  FIGS. 3-4  or the system of  FIGS. 5-6  according to an embodiment of the invention. 
       FIG. 8  is a block diagram of an AED circuit that the AED of  FIG. 7  incorporates according to an embodiment of the invention. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   The following discussion is presented to enable a person skilled in the art to make and use the invention. Various modifications to the preferred embodiments will be readily apparent to those skilled in the art, and the generic principles herein may be applied to other embodiments and applications without departing from the spirit and scope of the present invention as defined by the appended claims. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein. 
     FIG. 3  is a view of an electrode-pad storage system  30 , which includes a package  32  that an operator (not shown) can quickly and easily free from the pad leads  18   a  and  18   b  according to an embodiment of the invention. The system  30  also includes two defibrillator electrode pads  14   a  and  14   b  (shown in phantom line), electrode-pad leads  18   a  and  18   b , and a connector  22 , which are respectively similar to the pads  14   a  and  14   b , leads  18   a  and  18   b , and connector  22  of  FIGS. 1 and 2 . 
   The package  32  includes an interior  34  for holding the pads  14   a  and  14   b , front and back sides  36   a  and  36   b  (FIG.  4 ), sealed seams  38   a  and  38   b , a sealed opening  40  through which the leads  18   a  and  18   b  extend, a folded top edge  42 , side edges  44   a  and  44   b  (FIG.  4 ), and pull tabs  46   a  and  46   b.    
   The sides  36   a  and  36   b  of the package  32  are formed from a single piece of material that is folded together along the top edge  42  and that inhibits moisture loss from the interior  34  in the manner described above in conjunction with FIG.  1 . Materials suitable for the sides  36   a  and  36   b  are known, and some are described in U.S. patent application Ser. No. 09/746,117, entitled “HALF CLEAR PACKAGE FOR USE WITH DEFIBRILLATION ELECTRODES”, filed Dec. 22, 2000, which is incorporated by reference. 
   The sides  36   a  and  36   b  are sealed together along the seams  38   a  and  38   b  with a conventional adhesive that causes the sealed seams to inhibit moisture loss from the package interior  34  and yet allows an operator to quickly and easily peel the package  32  open. This is known as a peelable seal. The seams  38   a  and  38   b  follow the respective contours of the edges  44   a  and  44   b , and thus taper toward and meet at the opening  40 , which is also sealed with the adhesive to inhibit moisture loss from the interior  34 . As discussed below in conjunction with  FIG. 4 , the taper of the seams  38   a  and  38   b  reduces the peeling force needed to open the package  32  as compared to the peeling force needed to open a package where portions of the seams  38   a  and  38   b  are parallel to the top edge  42 . 
   The tabs  46   a  and  46   b  ( FIG. 4 ) are respective integral extensions of the sides  36   a  and  36   b . The tabs  46   a  and  46   b  are not sealed to one another; this allows an operator to grasp and pull apart the tabs to open the package  32  and to simultaneously free the package from the leads  18   a  and  18   b.    
   Alternative embodiments of the electrode-pad storage system  30  are contemplated. For example, the sides  36   a  and  36   b  ( FIG. 4 ) may be two separate pieces that are sealed together along a seam (not shown) that is adjacent to or aligned with the top edge  42 . Furthermore, the opening  40  may be along this top-edge seam, along one of the seams  38   a  and  38   b , or along a fourth seam (not shown) formed between the bottom (tab) ends of the seams  38   a  and  38   b . Moreover, the seams  38   a  and  38   b  may be aligned with, and thus not overlapped by, the edges  44   a  and  44   b . In addition, the edges  44   a  and  44   b  may have different contours—such as a non-tapered contour—than the seams  38   a  and  38   b , respectively. Furthermore, the tabs  46   a  and  46   b  may be pieces of material (not shown) that are respectively attached to the sides  36   a  and  36   b , and thus not integral extensions of the sides. Moreover, the sides  36   a  and  36   b  may be opaque or have see-through portions. In addition, there may be more or fewer than two defibrillator electrode pads  14   a  and  14   b , or the electrode pads may be monitor (e.g., electrocardiogram, brainwave) pads or other types of pads. Furthermore, the entire lengths of the leads  18   a  and  18   b , may be sealed inside of the package  32 —the connector  22  may be inside or outside of the package—before the package is opened. 
     FIG. 4  is a perspective view of the electrode-pad storage system  30  of  FIG. 3  after an operator (hands  48   a  and  48   b  shown) has opened the package  32 . 
   Referring to  FIGS. 3 and 4 , a procedure for opening the package  32  is described according to an embodiment of the invention. The operator first grasps the tabs  46   a  and  46   b  with, for example, the fingers of his respective right and left hands  48   a  and  48   b . The operator may position his fingers as shown or in any other grasping position. Next, the operator pulls the tabs  46   a  and  46   b  apart (as indicated by the arrows) to open the package  32 . Because the seams  38   a  and  38   b  are pulled apart along the region, i.e., the opening  40 , through which the leads  18   a  and  18   b  extend, the leads are free of the package  32 , particularly after the operator removes the pads  14   a  and  14   b  from the package. 
   The taper of the seams  38   a  and  38   b  makes it easier for the operator to open the package  32 . Theoretically, there are two boundary points—one along the seam  38   a , the other along the seam  38   b —that the operator is peeling apart. i.e., separating, at any one time. A boundary point is the adhered point of a seam that is at the boundary between the separated and adhered portions of the seam. A unit of force—which is dependent, e.g., on the amount and strength of the adhesive, the width of the seam, and the taper angle of the seam—is needed to separate each boundary point. Although this unit of force may change from boundary point to boundary point, one can approximate by assuming that the same unit of force—a calculated mean unit for example—is needed to separate each boundary point. Therefore, the fewer boundary points that are being separated at any one time, the less force required to peel apart the package  32 . By comparison, if the seams  38   a  or  38   b  have a portion that is parallel to the top edge  42 , then the operator must separate more than two boundary points at a time, and thus pull apart the tabs  46   a  and  46   b  more forcefully, while peeling apart this parallel-seam portion. Consequently, although the package  32  can include such a parallel seam portion, opening such a package may be more difficult for the operator than opening a package with tapered seams. 
     FIG. 5  is a view of an electrode-pad storage system  54 , which includes a package  56  that an operator (not shown) can quickly and easily free from the pad leads  18   a  and  18   b  according to another embodiment of the invention. The system  54  also includes two defibrillator electrode pads  14   a  and  14   b  (shown in phantom line), electrode-pad leads  18   a  and  18   b , and a connector  22 , which are respectively similar to the pads  14   a  and  14   b , leads  18   a  and  18   b , and connector  22  of  FIGS. 1-4 . The package  56  includes an interior  34 , front and back sides  36   a  and  36   b , seams  38   a  and  38   b , an opening  40 , edges  44   a  and  44   b , and tabs  46   a  and  46   b , which are respectively similar to the like components of the package  32  of  FIGS. 3 and 4 . 
   A significant difference between the package  32  of  FIGS. 3 and 4  and the package  56  is that the sides  36   a  and  36   b  are formed from two pieces of material—not from a single, folded piece of material like the sides  36   a  and  36   b  of the package  32 . Together, the seams  38   a  and  38   b  extend all the way around the package interior  34 , and are tapered toward the opening  40  in the bottom half of the package  56  and toward a top region  58  in the top half of the package. 
   The alternative embodiments discussed above in conjunction with  FIGS. 3 and 4  for the electrode-pad storage system  30 , as well as other alternative embodiments, are contemplated for the electrode-pad storage system  54 . 
     FIG. 6  is a perspective view of the electrode-pad storage system  54  of  FIG. 5  after an operator (hands  48   a  and  48   b  shown) has opened the package  56 . 
   Referring to  FIGS. 5 and 6 , the procedure for opening the package  56  is similar to the procedure for opening the package  32  as described above in conjunction with  FIGS. 3 and 4 . Furthermore, the taper of the seams  38   a  and  38   b  makes it easier for the operator to open the package  56  as discussed above in conjunction with  FIGS. 3 and 4 . 
     FIG. 7  illustrates a general AED system  60 , which includes an AED  62  for generating a shock and which includes the defibrillator-electrode-pad storage system  30  of  FIGS. 3-4  or the system  54  of  FIGS. 5-6  according to an embodiment of the invention. For clarity, the system  60  is discussed as including the electrode-pad storage system  30  of  FIGS. 3-4 , and the electrode pads  14   a  and  14   b  are shown removed from the opened package  32 . The connector  22  couples the electrode pads  14   a  and  14   b  to a connector  66  of the AED  62 . As discussed above in conjunction with  FIGS. 1 and 2 , the connector  22  may be pre-connected to the AED connector  66  to save time for the operator in an emergency. Otherwise, the operator can couple the connector  22  to the connector  66  before or after opening the package  32 . 
   The AED  62  may include a battery  70  for supplying power, a main on/off key switch  72 , a display  74  for displaying operator instructions, cardiac waveforms, or other information, a speaker  76  for providing audible operator instructions, an AED status indicator  78 , and a shock button  80 , which the operator presses to deliver a shock to the patient. The AED  62  may also include a microphone  82  for recording the operator&#39;s voice and other audible sounds that occur during the rescue, and a data card  84  for storing these sounds along with the patient&#39;s ECG and a record of AED events for later study. 
   Still referring to  FIG. 7 , during an emergency where it is determined that a patient (not shown) may need a shock, the operator retrieves the AED  62  and installs the battery  70  if it is not already installed. Next, the operator removes the defibrillator electrode pads  14   a  and  14   b  from the package  32  as discussed above in conjunction with  FIGS. 3-4 . Because it is free of the leads  18   a  and  18   b , the package  32  can be discarded such that it does not distract the operator or obscure his view of or access to the AED  62  or the patient. If the connector  22  is not pre-connected, the operator inserts it into the connector  66 . Then, the operator turns the on/off switch  72  to the “on” position to activate the AED  62 . Following the instructions displayed on the display  74  or “spoken” via the speaker  76 , the operator attaches the electrode pads  14   a  and  14   b  to the patient. After the operator attaches the electrode pads  14   a  and  14   b  to the patient, the AED  62  analyzes the patient&#39;s ECG to determine whether the patient is suffering from a shockable heart rhythm. If the AED  62  determines that the patient is suffering from a shockable heart rhythm, then the display  74  or the speaker  76  instructs the operator to depress the shock button  80  to deliver a shock to the patient. Conversely, if the AED  62  determines that the patient is not suffering from a shockable heart rhythm, the display  74  or the speaker  76  informs the operator not to shock the patient, and may inform the operator to seek appropriate non-shock treatment for the patient. Furthermore, when it informs the operator not to shock the patient, the AED  62  may disable the shock button  80 . 
     FIG. 8  is a block diagram of an AED circuit  90 , which the AED  62  of  FIG. 7  can incorporate according to an embodiment of the invention. The defibrillator electrode pads  14   a  and  14   b  are coupled to the circuit  90  via the connectors  22  and  66  and are operable to sense a patient&#39;s ECG (not shown) and to apply an electrical shock to the patient (not shown). A shock-delivery-and-ECG front-end circuit  92  samples the patient&#39;s ECG during an analysis mode of operation and provides a shock to the patient via the connectors  22  and  66  and the electrode pads  14   a  and  14   b  during a shock-delivery mode of operation. A gate array  94  receives the ECG samples from the circuit  92  and provides them to a processor unit (PU)  96 , which stores and analyzes the samples. If analysis of the patient&#39;s ECG indicates that the patient is suffering from a shockable heart rhythm, then the processor unit  96  instructs the circuit  92  via the gate array  94  to enable delivery of a shock when an operator (not shown in  FIG. 8 ) presses the shock button  80 . Conversely, if analysis of the patient&#39;s ECG indicates that the patient is not suffering from a shockable heart rhythm, then the processor unit  96  may disable the circuit  92  from delivering a shock to the patient. 
   Still referring to  FIG. 8 , the circuit  90  includes a power-management circuit  98  for distributing power from the battery  70  to the subcircuits of the circuit  90 . The on/off switch  72  turns the circuit  90  “on” and “off”, a status circuit  102  indicates the status of the circuit  90 , and a gate array  104  interfaces the power-management circuit  98 , the on/off circuit  72 , and the status circuit  102  to the circuit  92 , the processor unit  96 , and the gate array  94 . As discussed above in conjunction with  FIG. 7 , the display  74  displays information to an operator, the speaker  76  provides audio instructions to the operator, and the microphone  82  records the operator&#39;s voice and other audible sounds. The data card  84  is connected to the gate array  94  via a port  108 . The card  84  stores the operator&#39;s voice and other sounds along with the patient&#39;s ECG and a record of AED events for later study. A status-measurement circuit  110  provides the status of the circuit  90  subcircuits to the processor unit  96 , and LEDs  112  provide information to the operator such as whether the processor unit  96  has enabled the circuit  92  to deliver a shock to the patient. A contrast button  114  allows the operator to control the contrast of the display screen  74 , and a memory such as a read only memory (ROM)  116  stores programming information for the processor unit  96  and the gate arrays  94  and  104 . 
   The AED circuit  90  and other AED circuits are further discussed in the following references, which are incorporated by reference: U.S. Pat. No. 5,836,993, U.S. Pat. No. 5,735,879 entitled ELECTROTHERAPY METHOD AND APPARATUS, U.S. Pat. No. 5,607,454 entitled ELECTROTHERAPY METHOD AND APPARATUS, and U.S. Pat. No. 5,879,374 entitled DEFIBRILLATOR WITH SELF-TEST FEATURES.