Abstract:
A disposable internal defibrillator paddle providing for a more economical and easier defibrillation procedure than non disposable paddles. The disposable paddle contains: (a) a handle attached to a shaft attached to a spoon, the spoon having a receiving unit, and the handle, the shaft, and the spoon are all made of non conducting material; and (b) an electrode plate attaching onto the receiving unit of the spoon.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    During open-heart surgery, a pair of internal defibrillation paddles is used to restart the patient&#39;s heart. Each internal defibrillation paddle comprises a handle attached to a shaft attached to a spoon electrode. The paddle handles are held by a surgeon while the spoon electrodes are inserted into the patient&#39;s chest and placed in direct contact with the myocardium (heart muscle). An electric discharge is passed from one spoon electrode through the patient&#39;s heart to a second spoon electrode.  
           [0002]    Prior to use, paddle electrodes must be sterilized to eliminate patient infection. Modern sterilization methods use heat or chemical agents, such as ethylene oxide. The methods and materials used degrade the paddle materials limiting their useful life. Most manufacturers specify a maximum service life for paddles, usually in the range of 50-100 sterilization cycles. However, there is no convenient mechanism for users to measure and track the number of sterilization cycles a paddle experiences. Therefore, there is no easy way to determine if the service life of the paddles has been exceeded.  
           [0003]    Sterilization can cause two problems. First, the process is expensive and often uses environmentally unfriendly materials. Second, it is destructive and the expensive reusable paddles must be replaces periodically. Furthermore, it is difficult to pass the cost of the paddle electrodes to the patient because the actual service life is indeterminate.  
           [0004]    Paddle cleaning is required after use because dried blood and other dried body fluids must be removed prior to sterilization. Cleaning is time consuming, expensive, and hazardous due to possible contamination with AIDS, Hepatitis, or other infectious materials.  
           [0005]    Further, paddles are now made as durable as possible. This means that a paddle electrode contact area is made of thick rigid metal in the shape of a large flat “spoon.” This one-size fits all shape of the spoon is fixed and may not conform equally well to the curvature of all hearts.  
           [0006]    Therefore, what is needed is a paddle not subject to the problems indicated above, such as a disposable paddle. What is also needed is a way to test the disposable paddle without comprising the sterility of the paddle.  
         SUMMARY OF THE INVENTION  
         [0007]    In an exemplary embodiment, the present invention provides for disposable paddles that are economical to manufacture and require no cleaning or maintenance as non-disposable paddles do.  
           [0008]    Furthermore, the present invention provides for disposable paddles in a sterile package capable of being tested without comprising the sterility of the paddles or the package.  
           [0009]    Moreover, the present invention provides for a spoon electrode and shaft that are flexible allowing for custom shaping and better electrical contact potentially allowing reduced energy shocks.  
           [0010]    Thus, objects of the present invention are to realize an improved internal defibrillation system. Objects of the present invention can be achieved, in one embodiment, by a self testing internal defibrillator package apparatus, which includes (a) a first spoon electrode inside the package, the first spoon electrode electrically connected to a first wire inside the package; (b) a second spoon electrode inside the package, the second spoon electrode electrically connected to a second wire inside the package; (c) a testing unit inside the package electrically connecting the first spoon electrode and the second spoon electrode; (d) a first conductor located outside the package, the first conductor electrically connected to the first wire; and (e)a second conductor located outside the package, the second conductor electrically connected to the second wire.  
           [0011]    Objects of the invention can also be achieved, in one embodiment, by an apparatus which includes (a) a disposable paddle apparatus which includes a shaft; and (b) a malleable spoon electrode connected to the shaft, allowing an operator to contour the spoon electrode to a particular shape.  
           [0012]    Objects of the invention can also be achieved, in one embodiment, by a method which includes (a) molding two malleable spoon electrodes to conform to a patient&#39;s heart; and (b) applying an electric charge between the spoon electrodes to attempt to resuscitate the heart-.  
           [0013]    Objects of the invention can also be achieved, in one embodiment, by an apparatus which includes (a) a first internal defibrillator paddle and a second internal defibrillator paddle both electrically connected to a testing unit, the paddles and the testing unit located inside a package; and (b) a first connector connected to the first internal defibrillator paddle and a second connector connected to the second internal defibrillator paddle, both connectors located outside of the package, wherein an electrical charge placed between the first connector and the second connector activates the testing unit.  
           [0014]    Objects of the invention can also be achieved, in one embodiment, by an apparatus which includes (a) a handle attached to a shaft attached to a spoon, the spoon having a receiving unit, and the handle, the shaft, and the spoon are all made of non conducting material; and (b) an electrode plate attaching onto the receiving unit of the spoon.  
           [0015]    Objects of the invention can also be achieved, in one embodiment, by an apparatus which includes (a) a nonconductive handle integrally attached to a nonconductive shaft integrally attached to a conductive spoon electrode, wherein the spoon electrode is made of a malleable material. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    [0016]FIG. 1 is a drawing illustrating prior art paddles;  
         [0017]    [0017]FIG. 2 is a drawing illustrating disposable paddles, according to one embodiment of the present invention;  
         [0018]    [0018]FIG. 3 is a drawing illustrating a package comprising disposable paddles, according to one embodiment of the present invention;  
         [0019]    [0019]FIG. 4 is a an exploded view of the circled portion of FIG. 3, illustrating bacteria proof seal around cables, according to one embodiment of the present invention;  
         [0020]    [0020]FIG. 5 is a drawing illustrating a self testing package, one embodiment of the present invention;  
         [0021]    [0021]FIGS. 6A, 6B,  6 C are circuit diagrams illustrating a testing unit, according to numerous embodiments of the present invention; and  
         [0022]    [0022]FIG. 7 is a drawing illustrating a disposable paddle, according to one embodiment of the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0023]    Reference will be now made in detail to the present preferred embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout.  
         [0024]    The present invention provides for disposable internal defibrillator paddles (“paddles”). Disposable paddles are preferable to standard reusable paddles in that no cleaning or re-sterilization is needed. Further, the present invention provides for sterile testing paddles, which do not compromise the sterility of the package. An electric charge can be placed on connectors located outside of the package, yet if the paddles operate properly, a visual indication will result.  
         [0025]    [0025]FIG. 1 is a drawing illustrating prior art internal paddles. The paddles pictured are not disposable, nor are they specially packaged. The paddle comprises a handle  100  attached to a shaft  101  attached to a spoon electrode  102 . Since theses paddle are not disposable, the spoon  102  must be rigid, and not capable of being shaped. A wire  104  should be connected to a power source. Paddles like this are used in pairs, with an electric current generated between them to help start a patient&#39;s heart.  
         [0026]    [0026]FIG. 2 is a drawing illustrating disposable paddles, according to one embodiment of the present invention. A first handle  200  is connected to a first shaft  201  which is connected to a first spoon electrode  203 . Note that the first shaft  201  has an optional first bend  202 , to facilitate placement of the first spoon electrode  203  on the heart  208 . The first spoon electrode  203  is pressed against the heart  208 , to make electrical contact. A second handle  204  is connected to a second shaft  205  which is connected to a second spoon electrode  207 . Note that the second shaft  205  also has an optional second bend  206 . The second spoon electrode  207  is pressed against the heart  208  to make electrical contact. When an electric charge is placed between the first spoon electrode  203  and the second spoon electrode  207 , a stopped heart may hopefully start beating again.  
         [0027]    The spoon electrodes  203 ,  207  and/or shafts  201 ,  205  can be made of a malleable material. This is advantageous, in that each patient&#39;s heart is shaped differently, the spoon and/or shaft can be molded by the physician to match the contour of a particular patient&#39;s heart. This results in improved electrical contact with the heart.  
         [0028]    [0028]FIG. 3 is a drawing illustrating a package comprising disposable paddles, according to one embodiment of the present invention. A package  300  can be a shallow tray and is typically packaged to maintain the sterility of the contents inside, and is sealed with a lid  301 . The lid  301  can be airtight to maintain the sterility of the package  300 .  
         [0029]    A first connector  302  is located outside of the package  300 . The first connector  302  is electrically connected through the package  300  to a first wire  304  located inside the package  300 . The first wire  304  is electrically connected to a first spoon electrode  306 . The first spoon electrode  306  is electrically connected to a testing unit  308  (to be described in more detail below). The testing unit  308  is electrically connected to a second spoon electrode  310 . The second spoon electrode  310  is electrically connected to a second wire  312 . The second wire  312  is electrically connected through the package  300  to a second connector  314  located outside of the package  300 . Note that the first wire  304  and the second wire  312  can be joined into twin wires  316  in certain places, however the first wire  304  and the second wire  312  are still insulated from each other.  
         [0030]    A first handle  318  is attached to the first spoon electrode  306 , and a second handle  320  is attached to the second spoon electrode  310 . The handles  318 ,  320 , are used by a physician to place the electrode spoons on the patient&#39;s heart. In one embodiment of the present invention, the first wire  304  runs through the first handle  318  to the first spoon electrode  306 , the first handle  318  being made of a non-conducting material so a physician touching the first handle  318  will not affect the flow of current. The second handle  320  is configured similarly. The handles  318 , 320  are typically integrally attached to the spoon electrodes  306 ,  310 , respectively.  
         [0031]    As a result of the above described configuration, when an electric current is placed between the first connector  302  and the second connector  314 , which are both located outside of the package (or on an outside surface of the package), the current can flow inside the package through the testing unit  308 .  
         [0032]    The testing unit  308  is an electrical device which gives a visual or audible indication that the current applied to the first connector  302  and the second connector  314  flows properly between the spoons.  
         [0033]    The testing unit  308  can be, for example, a type of lamp such as a neon lamp, a light emitting diode. The package  300  can contain a clear portion  316  allowing a person to see that the lamp actually lights. In another embodiment, the lid  301  itself can be transparent, so the separate clear portion  316  is not necessary. The testing unit  308  can also be an audible alarm, such as a bell or a buzzer. In this case, the clear portion  316  will typically not be necessary.  
         [0034]    [0034]FIG. 4 is a an exploded view of the circled portion of FIG. 3, illustrating bacteria proof seal (or microbial barrier) around cables, according to one embodiment of the present invention. The twin wires  400  pass through a donut  402  around the twin wires that fuses when the lid of the package (not pictured) is sealed, providing a bacteria proof seal.  
         [0035]    [0035]FIG. 5 is a drawing illustrating a self testing package, one embodiment of the present invention. The package  500  comprises a transparent portion  502  (or visual indicator), so someone can see the contents inside without opening the package. A first clip  504  (or contact) and a second clip  506  are outside the package and can receive an electric charge from a power source (not pictured) by attaching wires from the power source onto the clips.  
         [0036]    [0036]FIGS. 6A, 6B,  6 C are circuit diagrams illustrating a testing unit, according to numerous embodiments of the present invention.  
         [0037]    Referring now to FIG. 6A, a first electrode  600  is connected to a load resistor  602 , which is connected to a neon lamp  604 , which is connected to a second electrode  606 . When an electric current passes between the first electrode and the second electrode, the neon lamp lights up, indicating a positive test result.  
         [0038]    Referring now to FIG. 6B, a first electrode  608  is connected to a load resistor  610  which is connected to a first light emitting diode  612  and a second light emitting diode  614 , connected in parallel, which is then connected to a second electrode  616 . When an electric current passes between the first electrode  600  and the second electrode  606 , the light emitting diodes  612 ,  614  light up, indicating a positive test result.  
         [0039]    Referring now to FIG. 6C, a first electrode  618  is connected to a resistor  620  (or current limiting device), which is connected to a current indicator  622 , which is connected to a second electrode  624 . When an electric current passes between the first electrode  618  and the second electrode  624 , the current indicator  622  activates, indicating a positive test result.  
         [0040]    Further, the testing unit can optionally contain a convention voltage checking device, checking for a predetermined voltage before the indicator activates. In this way, if corrosion or other defect results in a smaller voltage than applied, this will identify the problem. An optional switch can also be connected to testing unit to allow a user to operate the unit by pressing a switch assuming everything is connected properly.  
         [0041]    It can be appreciated that one of ordinary skill in the art can modify the above circuits illustrated in FIGS. 6A, 6B, and  6 C, resulting in various configurations designed to give an indication (visual, audible, or otherwise) that the current is flowing properly through the two electrodes.  
         [0042]    Spoon electrodes can be made of a malleable conductive material, so that a physician can mold the spoon electrode to a particular shape matching the patient&#39;s heart. Because prior art non-disposable spoons were designed to last over a large number of uses, they were typically made of a rigid thick material, which could not be shaped. The present invention spoon electrodes can be made of, for example, a thin aluminum alloy or stainless steel. Since these spoon electrodes are disposable, there is no concern over bending the material too much that the spoon may not last for the next use. Further, the shaft can also be made of a malleable nonconductive material, so that a physician can mold the shaft to better accommodate the heart. The shaft can be made of a malleable nonconductive material, such as molded rubber or plastic.  
         [0043]    The package containing the disposable paddles will typically be sterile, so that a surgeon need not worry about sterilizing the paddles once he needs them. The sterilization of the contents of the package can be typically performed by any one of a number of known sterilization methods, such as, for example, using gamma radiation or ethylene oxide.  
         [0044]    [0044]FIG. 7 is a drawing illustrating a disposable paddle, according to an embodiment of the present invention.  
         [0045]    As stated above, the present invention can provide a disposable one-use paddle assembly, providing a cost efficient and easy system. FIG. 7 illustrates an embodiment of such an assembly.  
         [0046]    A wire  700  carrying electric current used to shock a patient&#39;s heart is connected to a handle  702 . The handle connects to a shaft  704 , which connects to a spoon  706 . The handle  702 , shaft  704 , and spoon  706  are typically integrally molded into one piece. The handle  702 , shaft  704 , and spoon  706 , can also be made of any variety of molded plastic. In this embodiment, the handle, shaft, and spoon are made of nonconductive material.  
         [0047]    The wire  700  passes directly through the handle  702  and shaft  704  so that the wire  700  is not conductively exposed at any point up to the spoon  706 . Alternatively, the wire  700  can be an insulated wire, which passes under the handle  702  and shaft  704 . The shaft  704  may also comprise a groove (not illustrated) through an underside of the shaft  704  to receive the wire  700 .  
         [0048]    An electrode plate  708  (or conductive plate) snaps onto the spoon  706 , the electrode plate  708  providing an electrical contact to the patient&#39;s heart. The electrode pate  708  comprises a head  710 , which snaps into a receiving unit  709  (in this case, a hole) in the spoon  706 . An optional washer  712  snaps onto the head  710  to lock the electrode plate  708  into place on the spoon  706 .  
         [0049]    A conductive washer  714  is connected to the wire  700  and snaps onto the head  710 , electrically connecting the conductive washer  714  to the electrode plate  708 . A portion of the head  710  that snaps onto the conductive washer  714  should be made of conductive material so that current can pass to the electrode plate  708 .  
         [0050]    A cap  716  can be placed over the conductive washer  714  to ensure that the current passing through the conductive washer  714  is not exposed. The cap  716  can be attached over the conductive washer  714  to the spoon  706  by a number of conventional methods, for example an adhesive can be used, or a circular groove (not pictured) can be molded into the spoon  706  so that the cap  716  can snap onto the groove.  
         [0051]    Note that in another embodiment, the wire  700  can pass directly through the handle  702  and shaft  704 , and connect directly with a conductive middle part of the head  710 . In this embodiment, the washers  712   714  and cap  716  are not needed, as the wire  700  is not conductively exposed to any outside surface other than the electrode plate  708 . Note that in this embodiment, the middle part of the head  710  will be made of conducting material, while a tip of the head  710  will not be made of conducting material.  
         [0052]    In another embodiment of the present invention, the handle  702  can comprise an opening (not pictured) to receive the shaft  704 . In this way, the effective length of the shaft  704  can be adjusted by sliding the shaft  704  through the handle  702 . The shaft can be locked in to the into the handle so it does not slide once it is set to a desired length by any conventional locking mechanism, such as a locking collar.  
         [0053]    In another embodiment of the present invention, a paddle can comprise a handle which is integrally attached to a non conducting shaft which is integrally attached to a conductive spoon electrode. Unlike the above embodiment, this paddle is manufactured with a conductive spoon electrode integrally attached to the shaft. In this embodiment, a separate electrode plate (as described above) is not needed. Other than the separate electrode plate, all of the above described embodiments can be applied to this variation of the invention.  
         [0054]    Although a few preferred embodiments of the present invention have been shown and described, it would be appreciated by those skilled in the art that changes may be made in this embodiment without departing from the principles and spirit f the invention, the scope of which is defined in the claims and their equivalents.