Patent Document

BACKGROUND OF THE INVENTION 
     The present invention relates to an electrode and connector assembly and method for using same. 
     More particularly the present invention relates to electrodes used for external pacing, defibrillation, and monitoring of the heart. Often these electrodes have multiple functions. Some are used for defibrillation, pacing, and monitoring. Others are used for pacing only. Still others are used for defibrillation and monitoring. These electrodes are usually substantially larger than other types of electrodes, such as electrodes used solely for monitoring. The larger size is necessary because of the need to spread large electrical charges used for defibrillating or pacing over a larger surface than would be needed for an electrode used solely for monitoring. 
     In the defibrillation process a charge of electricity is introduced to the patient through the external electrode for stimulating the heart and for correcting heart fibrillation. For pacing a charge is introduced to the patient through the electrode for pacing the heartbeat. 
     Electrodes used only for monitoring receive small quantities of electrical energy generated when the patient&#39;s heart beats. These small quantities of electricity are transmitted through the electrode to a console which is capable of analyzing and charting the patient&#39;s heartbeat. 
     Electrodes used for the above purposes are often disposable. They are placed on the patient&#39;s skin during use and then discarded. These disposable electrodes usually include electrical connectors or wires which are connected permanently to the electrode and which lead to a console or machine for performing the various functions intended. Disposal of these electrodes also results in the disposal of the connectors or the wires because the connectors or wires are usually permanently connected to the electrode. 
     The connectors and the wires are the most expensive components of prior art defibrillation and pacing electrodes. Disposal of the connectors and/or the wires with the electrodes results in wasted cost. 
     One solution to this waste problem is to provide a defibrillation or pacing electrode that can be detached from the connector and wire before disposal. There are several problems however in providing a detachable connector to an electrode used for defibrillation or pacing. The connector must provide positive and reliable contact with the electrode so as to minimize arcing, failure, or any form of open circuit to the electrode during the defibrillation or pacing process. 
     The detachable connector must also be fail-safe. Paramedics or other medical personnel applying the electrodes to a patient are often doing so under conditions of emergency. Because of this, the connector must be one which can be attached quickly and easily with a minimum of confusion. The structure of the connector should be such that even under these confusing circumstances the medical personnel can attach the connector to the electrode in a reliable manner. 
     The connector must provide a strong connection to the electrode because often the conditions under which the electrode is being used are conducive to jostling, moving, and other forms of physical movement between the connector and the electrode. The strength of the connection is therefore important to maintaining proper electrical continuity. 
     Therefore, a primary object of the present invention is the provision of an improved electrode and connector assembly and method for using same. 
     A further object of the present invention is the provision of an electrode that can be used for defibrillation or pacing but which does not have a connector or wire permanently attached to the electrode. 
     A further object of the present invention is the provision of an electrode and connector assembly for use in defibrillation or pacing and which permits the electrode to be disposable without having to dispose of the connector or the wire. 
     A further object of the present invention is the provision of an improved electrode and connector assembly for use in defibrillation or pacing and which provides detachable connection between the connector and the electrode. 
     A further object of the present invention is the provision of an electrode and connector assembly which provides detachable, but also very strong and reliable connection between the connector and the electrode. 
     A further object of the present invention is the provision of an improved electrode and connector assembly which will function even if the medical personnel attach the connector in a reverse position from its intended connection. 
     A further object of the present invention is the provision of an electrode and connector assembly which includes a connector that can be quickly and easily attached during confusing circumstances often encountered in a medical emergency. 
     A further object of the present invention is the provision of an improved electrode and connector assembly which is economical to manufacture, durable in use, and efficient in operation. 
     SUMMARY OF THE INVENTION 
     The foregoing objects may be achieved by a combination of an electrode for defibrillation or pacing and a detachable connector. The electrode includes a dielectric backing layer, a conductive sheet layer, and a conductive gel layer. The conductive sheet layer includes a tab portion. An electrically conductive wire includes first and second opposite ends and a connector connected to the first end of the wire. The connector is detachably connected to the tab portion of the conductive sheet layer on the electrode. The connector has a first electrical contact providing electrical continuity between the tab portion of the conductive layer of the electrode and the conductor wire. 
     The tab portion of the conductive layer includes a hole extending therethrough and the connector includes a post protruding through the hole in the tab portion. 
     The electrode itself contains no connector or wire. This substantially reduces the cost of the electrode and consequently makes disposal of the electrode less expensive. The connector and wire may be used over and over again with different electrodes. 
     The connector includes first and second jaw members embracing the tab portion of the conductive sheet layer therebetween, and a post extends from the first of these members. The second member includes a hole extending therethrough and the post protrudes at least partially through the hole in the second member. 
     In use, the jaw members of the connector are positioned over the tab portion of the electrode. The jaws are clamped together over the tab potion of the electrode, with the post of one of the jaw members protruding through the hole in the tab portion and also through the hole in the other jaw member. A latch latches the two jaw members together in a clamped position over the tab portion of the electrode. In this position the connector is tightly secured to the tab portion and cannot be removed due to the post extending through the hole in the tab portion. 
     Each of the jaw members includes its own respective electrical contact leading to the wire, so that the connector can be attached over the tab portion of the electrode in a reverse position from its usual intended position, and still function as a proper connector to the wire. The connector and electrode assembly are very reliable and provide strong structural and electrical connection between the wire and the electrode. After use, the connector can be detached from the tab portion of the electrode and the electrode may be thrown away. 
     The present invention is preferred for use in defibrillating or pacing, but may have application for use in other types of electrode functions. 
    
    
     BRIEF DESCRIPTION OF THE FIGURES OF THE DRAWINGS 
     FIG. 1 is a perspective view of the electrode and connector assembly of the present invention. 
     FIG. 2 is a view similar to FIG. 1, but showing the release liner removed from the electrode and showing the connector in its clamped position attached to the electrode. 
     FIG. 3 is a sectional view taken along line  3 — 3  of FIG.  2 . 
     FIG. 4 is a sectional view taken along line  4 — 4  of FIG.  3 . 
     FIG. 5 is a sectional view taken along line  5 — 5  of FIG.  3 . 
     FIG. 6 is a bottom perspective view of the electrode of the present invention. 
     FIG. 6A is a schematic view of the various layers within the electrode. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to FIGS. 1 and 2 an electrode  10  includes a tab  12  having a hole  14  extending therethrough. The electrode  10  includes a backing layer  16  which is made of a dielectric material and a release liner  18  which is removed from the electrode during use. 
     The specific structure of the electrode  10  is shown in FIGS. 6 and 6A. Closest to the patient is a hydrogel or conductive adhesive layer  40  which is commonly used for electrodes of this type. The hydrogel  40  is tacky and is adapted to attach to the patient&#39;s skin. The hydrogel  40  is also electrically conductive. Examples of hydrogels which may be used for this purpose are a gel manufactured by LecTec Corporation under the product designation LT3300. Another example is a gel manufactured by Ludlow Corporation under the product designation RG63T. 
     Immediately below the hydrogel  40  is a conductive sheet  42 . Conductive sheet  42  may be tin, carbon, or a carbonized polymer material commonly used for electrodes of this type. It is a highly conductive material so that it will provide electrical continuity from the patient&#39;s chest through the hydrogel layer  40  and through the conductive sheet  42 . Below the conductive sheet  42  is a reinforcing or strengthening layer  52 . A preferred material for the strengthening layer  52  is a material manufactured by DuPont under the trademark Tyvec®. It is a dielectric spunbonded olefin material which imparts strength to the conductive sheet  42 . The electrode may be manufactured without the strengthening layer  52 , but it is preferred that the strengthening layer  52  be utilized. Below the strengthening layer  42  is the backing sheet  16 . 
     The conductive sheet  42  includes a tab portion  44  having a hole  46  extending therethrough. Hole  46  is registered with hole  14  in the backing layer  16 . The backing sheet layer  16  is a dielectric material and includes a backing sheet tab  48  (FIG. 1) which is registered with the tab portion  44  of the conductive sheet  42 . The upper surface of sheet  16  as viewed in FIG. 6A includes an adhesive coating  50  thereon for attaching to the strengthening layer  52  and the conductive sheet  42 . Adhesive  50  also facilitates attachment of electrode  10  to a patient&#39;s skin. The sheets  40 ,  42 ,  52 , and  16  are all assembled in a laminated fashion. 
     As can be seen in FIG. 6, the upper surface of tab portion  44  of conductive sheet  42  is exposed. A front pad  54  which is dielectric covers the neck portion  55  of the conductive layer  42 , but leaves the tab portion  44  exposed. 
     FIG. 1 shows the proper orientation of electrode  10  for placement on a patient&#39;s chest. The exposed portion of tab  44  is presented downwardly, and the tab  12  of the backing layer  16  is presented upwardly. 
     A connector  20  is permanently connected to a lead wire  22  and includes an upper jaw member  24 , having a shank portion  56  and a rounded portion  58 . A hole  26  extends through the rounded portion  58  of the upper jaw member  24 . Connector  20  also includes a lower jaw member  28  having an upwardly protruding post  30 , which when clamped in the position shown in FIG. 2 protrudes through hole  14  in backing sheet  16 , hole  46  in conductive sheet  42 , and at least partially through hole  26  in the upper jaw member  24 . 
     Referring to FIG. 3, the upper jaw member  24  includes a circular sealing ring  60  which surrounds an upper contact  62 . Upper contact  62  is flat much in the shape of a washer and surrounds hole  26  in upper jaw member  24 . The hole  26  includes tapered margins  66  which permit the post or nose  30  to cam upwardly during the closing of the upper and lower jaw members  24 ,  28  with respect to one another. 
     Embedded within the upper jaw member  24  is an embedded contact  68  which is in electrical connection with upper contact  62  and which extends rearwardly within upper jaw member  24  until it protrudes outwardly from jaw member  24  to form a spring contact  70 . Spring contact  70  engages the lower jaw member  28  and provides a spring action yieldably holding the jaw members  24 ,  28  spread apart from one another in the position shown in FIG.  1 . 
     Upper jaw member  24  includes two elongated shield side ribs  72 ,  74  (FIG. 4) which shield the spring  70  and prevent sparks from exiting the connector  20  during use. A shield cross rib  76  provides the same function. At the rear of the upper jaw  24  are a pair of hinge bosses  78 . 
     Bottom jaw member  28  includes a sealing ring  80  positioned to register with the sealing ring  60  of the upper jaw member  24 . The sealing rings  60 ,  80  are sufficiently flexible to provide sealing contact with the electrode  10  when the jaw members  24 ,  28  are in their closed position. 
     Surrounding the nose or post  30  is a lower contact  82  which is in the shape of a washer and which corresponds generally to the size and shape of the upper contact  62 . An embedded contact  84  is in electrical connection with the lower contact  82  and extends rearwardly to an exposed portion  86  which is in contact with spring  70 . The embedded contact  84  then extends rearwardly and is in electrical contact with the wire  22 . The rear of bottom jaw member  28  includes a pair of spaced apart hinge pins  88  which are adapted to fit within the hinge bosses  78  so as to provide a hinged connection between upper and lower jaw members  24 ,  28 . 
     The upper surface of the lower jaw member  28  also includes shield side ribs  90 ,  92 . 
     A latch mechanism is provided for latching the upper and lower jaw members  24 ,  28  in their closed positions and includes a latch member  32  having a latch pawl  94  thereon. latch member  32  is adapted to fit through a latch hole  34  extending through the upper jaw member  24 . 
     In operation, the jaw members  24 ,  28  are normally held in their open position by the engagement between spring  70  and contact  86 . In order to attach the connector  20  to the electrode  10 , the nose or post  30  is inserted through the opening  14  and the jaw members  24 ,  28  are closed or clamped together, pivoting about the hinge  36  formed by hinge pins  38  and hinge bosses  78 . The latch  32  extends through the opening  34  and the pawl  94  springs into engagement with the upper surface of the upper jaw member  24  so as to latch the two jaw members  24 ,  28  together in the position shown in FIGS. 2 and 3. 
     In this clamped position the lower contact  82  is in direct contact with the tab portion  44  of conductive sheet  42 . This provides electrical continuity from the patient&#39;s skin, through the hydrogel  40 , then through the conductive sheet member  42 , then through the lower contact  82  and the embedded contact  84  to provide electrical continuity to the wire  22 . 
     The various shield ribs  72 ,  74 ,  76 ,  90  and  92  prevent any inadvertent sparking from being emitted from the electrical connector  20 . 
     The connector  20  is intended to be connected with the bottom contact  82  in contact with the electrical conductive sheet  42 . However, in the confusion of an emergency situation it is possible that the operator may connect the connector  20  in a reverse position from its intended use so that the upper jaw member  24  is facing downwardly and the lower jaw member  28  is facing upwardly. In this situation the upper contact  62  will engage the conductive sheet member  42  and the embedded contact  68  will provide electrical connection through the spring  70  to the exposed portion  86  of the embedded conductor  84 , and thence to the wire  22 . 
     Thus the connector  20  provides a fail-safe function in the event that it is connected in an inverted or reversed manner. In such a situation it will still provide good electrical conductivity and continuity from the patient&#39;s skin to the wire  20 . 
     The tapered surface  66  provides a camming action between the nose  30  and the upper jaw member  24  so that in the confusion and haste of an emergency situation the upper and lower jaw members will cam together and self-align to the proper position. The fact that the post  30  protrudes through the holes  14 ,  46  of the electrode  10  provides solid mechanical and electrical connection between the connector  20  and the electrode  10 . 
     In the drawings and specification there has been set forth a preferred embodiment of the invention, and although specific terms are employed, these are used in a generic and descriptive sense only and not for purposes of limitation. Changes in the form and the proportion of parts as well as in the substitution of equivalents are contemplated as circumstances may suggest or render expedient without departing from the spirit or scope of the invention as further defined in the following claims.

Technology Category: 4