Large surface area electrode - Patent Review 5295482

What is claimed is:

1. A large surface area electrode, for use with a power supply having a more uniform current density distribution for contacting an exposed surface of skin of a living body having a contour, comprising a layer of flexible conductive material of a predetermined geometrical shape and having first and second surfaces, said layer of flexible conductive material being normally relatively flat but being capable of assuming the contour of the skin of the body when the electrode is placed in contact with the body with the first surface of the layer engaging the exposed surface of the skin of the body, said layer of flexible conductive material having a central portion and a surrounding ring portion, said central portion and said surrounding ring portion having outer edges, means forming a flexible carrier layer having a first surface secured to the second surface of the layer of flexible conductive material and serving to support said central portion and said surrounding ring portion so that the surrounding ring portion is spaced from and insulated from the central portion and coupling means adapted to couple said central portion and said surrounding ring portion to said power supply for controlling the current densities at said edges so that the current densities at said edges do not exceed predetermined values, said coupling means forming a direct connection to the central portion and including a resistor connected to said surrounding ring portion.

2. An electrode as in claim 1, wherein said layer of flexible conductive material has an additional surrounding ring portion which surrounds said first named surrounding ring portion and wherein said means forming a flexible carrier layer also serves to support the additional surrounding ring portion so that the additional surrounding ring portion is spaced from and insulated from the central portion and the first named surrounding ring portion and wherein said coupling means includes a resistor connected to said additional surrounding ring portion and adapted to be coupled to the power supply.

3. An electrode as in claim 2, wherein said first named surrounding portion has a width and said additional surrounding ring portion has a width which is less than the width of the first named surrounding portion.

4. An electrode as in claim 2, wherein said coupling means includes a conductive flexible foil having portion in contact with said second surface of the layer of flexible conductive material.

5. An electrode as in claim 4, wherein said flexible carrier layer has a second surface together with a flexible backing layer secured to the second surface of the flexible carrier layer, said flexible backing layer being comprises of a resilient flexible material having first and second surfaces, an adhesive adherent to said first surface of the backing layer and also being adherent to the second surface of the carrier layer.

6. An electrode as in claim 5, wherein and backing layer has a size so that it has an outer margin that extends beyond the layer of flexible conductive material.

7. An electrode as in claim 1 together with a release liner removable secured to said first surface of the layer of flexible conductive material and being adherent to the adhesive carried by the outer margin of the flexible carrier layer.

8. An electrode as in claim 7, wherein said resistor is carried by the backing layer.

9. An electrode as in claim 1 together with a non-conductive insulating material disposed in the space between the surrounding ring portion and the central portion.

10. An electrode as in claim 9, wherein said flexible conductive material is formed on a conductive elastomer and wherein the non-conductive insulating material in the space between the surrounding ring portion and the central portion is a non-conductive elastomer.

11. An electrode as in claim 10, wherein said central portion is substantially circular and wherein said surrounding ring portion is in the form of a concentric ring portion.

12. An electrode in claim 1, wherein said flexible conductive material is comprised of a material which is substantially transparent to x-rays.

13. An electrode as in claim 1 having an oval geometric configuration with a longitudinal axis, wherein said means forming a flexible carrier layer includes a tail and further including conductors carried by said tail, said conductors being connected to the central portion and the surrounding portion of the flexible conductive material.

14. An electrode as in claim 13 wherein said tail has a length of at least approximately 6".

15. A large surface area electrode for use with a power supply for contacting an exposed surface of a patient comprising a first conductive element, a second conductive element substantially surrounding the first conductive element and being spaced form the first conductive element, means adapted to connect the first conductive element directly to the power supply and resistor means connected to the second conductive element and being adapted to be connected to the power supply, said resistor means providing a substantially uniform current density in the first and second conductive elements.

16. An electrode as in claim 15 wherein said first and second conductive elements include a flexible conductive metal foil.

17. An electrode as in claim 16 wherein said first and second conductive elements include a flexible conductive material.

18. An electrode as in claim 17 wherein said flexible conductive metal foil has a central portion with radially extending slits therein.

19. An electrode as in claim 18 wherein said flexible metal foil has a central portion having an outer margin, said central portion corresponding in geometry to the first conductive element together with first and second sets of radially extending slits formed in the central portions with one set of slits extending radially outwardly from the center and the other set of slits extending radially inwardly from the outer margin.

20. An electrode as in claim 19 wherein said first and second slits are offset circumferentially with respect to each other.

21. An electrode as in claim 17 wherein said conductive material is a gel.

22. An electrode as in claim 21 wherein said gel has a resistivity of less than 500 ohm-cm.

23. An electrode as in claim 21 wherein said gel is a hydrogel.

24. An electrode as in claim 21 wherein said gel is a conductive elastomer.

25. An electrode as in claim 15 together with a flexible backing material mounting said first and second conductive elements.

26. An electrode as in claim 25 together with a third conductive element having an outer margin, said third conductive element substantially surrounding the second conductive element.

27. An electrode as in claim 26 wherein said first, second and third conductive elements have surface areas which are unequal.

28. An electrode as in claim 27 wherein the surface area of the second conductive element is less than the surface area of the first conductive element and wherein the surface area of the third conductive element is less than the surface area of the second conductive element.

29. An electrode as in claim 26 wherein said conductive elements have surface areas which are approximately equal.

30. An electrode as in claim 26 wherein said backing material has a portion thereof having a perimeter extending beyond the outer margin of the third conductive element, said backing material having circumferentially spaced apart cutouts formed therein which do not intersect the perimeter of the backing material.

31. A large surface area electrode for use with a power supply and adapted to contact the skin of a patent having an impedance, comprising a plurality of separate conductive elements adapted to engage the skin of the patient, and circuitry coupled to the conductive elements and adapted to connect the conductive elements to the power supply for supplying predetermined currents to the conductive elements, said circuitry including viewing resistors for carrying the current supplied to the separate conductive elements, said viewing resistors developing voltages across the same in accordance with the current flowing through the resistors and means coupled to the viewing resistors for ascertaining the voltages developed across the viewing resistors and means responsive to these developed voltages to ascertain whether or not additional current should be supplied to the conductive elements in accordance with the impedance of the skin of the patient.

Description Submit all comments and votes

This invention relates to large surface area electrodes.

Large area electrodes have heretofore been provided and have been utilized for applying defibrillation pulses to patients with hearts that are in defibrillation. Large area electrodes have also been used in connection with electrosurgery. In the past, in connection with such large area electrodes, it has been found that there is a concentration of current around the edges of the electrodes which creates an increased current density passing through the skin close to the edge of the electrode which causes non-uniform heating of the skin leading to increased redness of the skin in that area and possibly actual burning to the extent of causing second or third degree burns and blisters around the edges of the electrode. In addition, in some applications of large area electrodes in which the large area electrodes must be placed on the patient's skin for relatively long periods of time, there is a tendency for the electrodes to dry out and therefore substantially decrease their effectiveness. There is therefore a need for a new and improved large area electrode which will overcome these disadvantages.

In general, it is an object of the present invention to provide a large surface area electrode which has a more uniform current distribution.

Another object of the invention is to provide an electrode of the above character which will perform reliably for long periods of time.

Another object of the invention is to provide an electrode of the above character in which the current is distributed over at least one additional edge.

Another object of the invention is to provide an electrode of the above character in which the current is distributed over a plurality of edges.

Another object of the invention is to provide an electrode of the above character comprised of a plurality of separate conductive elements.

Another object of the invention is to provide an electrode of the above character which has a central conductive element and outer conductive elements.

Another object of the invention is to provide an electrode of the above character in which the conductive elements are separately connected to a power supply.

Another object of the invention is to provide an electrode of the above character in which resistors are provided for connecting the outer conductive elements to the power supply and the central conductive element is directly connected to the power supply without the use of a resistor.

Another object of the invention is to provide an electrode of the above character in which the resistors have been selected to provide a more uniform current density distribution.

Another object of the invention is to provide an electrode of the above character in which a conductive material is provided over each of the conductive elements.

Another object of the invention is to provide an electrode of the above character in which the conductive material on the conductive elements is to provide a conductive material which has a low resistivity.

Another object of the invention is to provide an electrode of the above character in which the conductive material in each conductive element is insulated from another conductive element.

Another object of the invention is to provide an electrode of the above character in which resistances are provided and adjusted so that the current distribution at the edges is generally uniform.

Another object of the invention is to provide an electrode of the above character which is conformable to the skin of a patient.

Another object of the invention is to provide an electrode of the above character in which radially extending slits are provided in the electrode to achieve improved conformability.

Another object of the invention is to provide an electrode of the above character in which the slits are provided in two sets of circumferentially spaced apart, radially extending slits with one set being offset with respect to the other to maintain good conductivity in the electrode.

Another object of the invention is to provide an electrode of the above character in which a backing material is provided for the conductive electrode and wherein the backing material is provided with circumferentially spaced apart cutouts to provide improved conformability.

Another object of the invention is to provide an electrode of the above character in which the cutouts extend through the backing material and are triangularly-shaped with their apexes facing inwardly toward the center of the electrode.

Another object of the invention is to provide an electrode of the above character in which the resistors for the electrodes are carried by connectors connected to the electrodes.

Another object of the invention is to provide an electrode of the above character in which the conductive elements have substantially equal areas.

Another object of the invention is to provide an electrode of the above character in which the conductive elements can have non-equal areas.

Another object of the invention is to provide an electrode of the above character which can be readily and economically fabricated.

Another object of the invention is to provide an electrode of the above character which can be readily applied to the patient.

Additional objects and features of the invention will appear from the following description in which the preferred embodiments are set forth in detail in conjunction with the accompanying drawings.

FIG. 1 is a top plan view of a large surface area electrode incorporating the present invention with certain portions thereof being removed.

FIG. 2 is a cross-sectional view taken along the line 2--2 of FIG. 1.

FIGS. 3 and 4 are schematic illustrations showing the manner in which resistors are connected in the electrode shown in FIG. 1.

FIG. 5 is a graph showing the current distribution in the electrode shown in FIG. 1.

FIG. 6 is a top plan view of another embodiment of an electrode incorporating the present invention.

FIG. 7 is a top plan view of another embodiment of a large surface area electrode incorporating the present invention and having electrode elements of substantially equal area.

FIG. 8 is a graph showing the current density versus radial distance for the electrode shown in FIG. 7.

FIG. 9 is a drawing showing the manner in which a pair of electrodes incorporating the present invention is interconnected to cable adapters of an existing defibrillator or cardioverter.

FIG. 10 is a cross-sectional view taken along the line 10--10 of FIG. 9 showing the type of cable utilized.

FIG. 11 is circuit diagram in block form showing the manner in which electrodes of the present invention are utilized with a patient for causing defibrillation.

FIG. 12 is a detailed circuit diagram of a portion of the circuitry shown in block form in FIG. 11.

In general, the large surface area electrode with a more uniform current distribution is utilized for contacting the smooth surface of the skin of a living body having a contour. The electrode is comprised of a layer of flexible conductive material of a predetermined geometrical shape and having first and second surface areas. The layer is normally relatively flat but is capable of assuming the contour of the portion of the body when the electrode is placed in contact with the body with the first surface engaging the exposed surface of the skin on that body. The layer of conductive material has a central portion and a surrounding ring portion. The central portion and the surrounding ring portion have outer margins with edges. Means forming a flexible carrier layer is secured to the second surface of the layer of flexible conductive material and serves to support the central portion and the surrounding ring portion so that the surrounding ring portion is spaced from and insulated from the central portion. Coupling means is provided which is adapted to couple the central portion and the surrounding ring portion to the power supply for controlling the current density at the edges so that the current density at the edges does not exceed a predetermined value. The coupling means forms a direct connection to the central portion and includes a resistor connected to said surrounding ring portion.

More particularly, as shown in the drawings, the large surface area electrode 11, shown in FIGS. 1 and 2 of the drawings, consists of a backing or support layer 12 formed of a suitable insulating flexible material such as an adhesive closed cell soft foam having a thickness ranging approximately 0.020 inches to 0.050 inches and, preferably, a thickness of approximately 0.030 inches. The backing or support layer 12 is provided with first and second surfaces 13 and 14 upon which a suitable sticky-type adhesive 16 is present on the surface 13. The backing or support layer 12 with its adhesive 16 applied thereto can be purchased as a manufactured item and is available from a number of commercial sources. The backing or support layer 12 can have any desired geometrical configuration. For example, it can be substantially circular as shown with a tail portion 12a utilized for a purpose hereinafter described.

A carrier layer 18 is provided which can be formed of a suitable relatively strong flexible stretchable material such as a thin plastic film formed of Nylon. Alternatively, a woven plastic fabric can be provided such as one woven of Nylon. A woven carrier layer 18 may be preferable in certain applications where it is desirable to conform to a curved surface in two dimensions. In other words, it is desirable that the layer be able to stretch.

This carrier layer 18 is provided with first and second surfaces 19 and 21 with surface 19 being adherent to the adhesive layer 16 provided on the backing or support layer 12. The other or second surface 21 is provided with an adhesive 22 on the surface thereof. A conducting foil 23 having first and second surfaces 24 and 26 is provided with the surface 24 being adherent to adhesive layer 22 on the carrier layer 16. The foil 23 is in the form of a metallic conducting foil of a suitable material such as aluminum and is formed into the desired pattern in a suitable manner such as die-cutting. For example, as shown in FIG. 2 a central circular conductive foil portion or element 23a and spaced apart concentric conductive foil ring portions or elements 23b and 23c can be provided.

In accordance with the enlarged surface area desired for the electrode 11, the portions 23a, 23b and 23c can have relatively large dimensions. For example, the inner circular portion 23a can have a radius of 1.3 inches. The first ring portion 23b can have an inner radius of 1.4 inches, an outer radius of 1.7 inches. The second ring portion 23b can have an inner radius of 1.8 inches and an outer radius of 2 inches to provide a foil 23 which has an outer diameter of 4 inches. With such a construction, it can be seen that the first ring portion 23b has a width of 0.3 inches and the second ring portion 23c has a width of 0.2 inches. The adhesive backing or support layer 12 can extend a suitable distance as, for example, one additional inch beyond the outer margin of the foil 23.

A conductive elastomer layer 31 is adherent to the surface 26 of the foil 23 and is generally patterned in the same way as the foil 23 to provide a central conductive elastomer portion or member 31a and two conductive elastomer ring-like portions or members 31b and 31c. The conductive elastomer 31 is preferably of the type described in U.S. Pat. No. 5,211,714. It should be understood, however, that any elastomer such as an ionically conductive hydrogel or an electrically conductive composite can be used. The conductive elastomer 31 is characterized by its dryness and its retention tackiness over extended periods of time. As described therein, it can be comprised of a conductive silicone. The constituents of this conductive elastomer layer, as disclosed in said co-pending application, are incorporated herein by reference. This conductive elastomer will not be described in detail because of the detailed disclosure in said co-pending application.

The portions 31a, 31b and 31c of the conductive elastomer layer 31 are electrically separated from each other and are spaced apart as shown in the drawings by a suitable distance as, for example, 1/16" and are supported by the carrier layer 18 which serves as an insulator. As pointed out previously with respect to the foil layer 23, the conductive elastomer layer 31 also can have various geometric shapes as desired. The annular or circular spaces 32 and 33 provided between the portions 31a and 31b and between portions 31b and 31c can be filled with a suitable non-conducting elastomer 34 as shown in the drawings to provide a flush surface extending across the top of the conductive elastomer layer 31. The non-conductive elastomer 34 serves two functions. It serves to provide a continuous sticky surface on the top surface of the electrode 11. It also serves to prevent any migration of the relatively soft conductive elastomer layer 31 and thereby serves to maintain the spacing and concentricity of the conductive ring portions 31b and 31c.

Means is provided for making contact to the portions 31a, 31b and 31c of the conductive elastomer layer 31 and consists of leads 36, 37 and 38. The leads can be separate or can be formed integral with the foil portions 23a, 23b and 23c, as for example by die-cutting or etching the same from a single sheet of foil. The integral lead 36 extends through a hole 39 in the support layer 12 (see FIG. 2) and is electrically coupled to the portion 23a. The leads 37 and 38 also extend through the hole 39 and are electrically connected to the ring-like portions 31b and 31c in a similar manner. As can be seen, particularly in FIG. 1, the leads 36, 37 and 38 are electrically isolated from each other and extend outwardly in a generally radial direction over the tab or tail portion 12a of the support layer 12. In order to make it possible to make the conductive elastomer ring members 31b and 31c in continuous circles and bridge over the leads 36, 37 and 38, it is necessary to insulate the leads 36 and 37 from the ring members 31b and 31c. This can be accomplished by individually insulating the portions of the leads underlying the ring members 31b and 31c. Alternatively, as shown in FIGS. 1 and 2, this can be accomplished by inserting a rectangular piece in the form of an adhesive patch 40 of a suitable flexible insulating material such as a polyimide with an adhesive thereon between the three leads 36, 37 and 38 and the ring members 31b and 31c.

Resistance means is provided for connecting the leads 36, 37 and 38 to an appropriate power supply (not shown), as for example a defibrillator power supply, and for dividing the voltage applied to the conductive elastomer members 31a, 31b and 31c to achieve the desired current densities. It has been found that it is unnecessary to have a resistor for the center portion or members 31a to achieve the desired current distribution. Such resistance means thus consists of resistor 41 which is in a suitable form as, for example, a thin film resistor such as shown in FIG. 1. One end of the resistor 41 is connected to the lead 37 at 42 and the other end of the resistor 41 is connected to the lead 36 at 43. Another similar thin film resistor 46 is provided which has one end connected to the lead 38 at 47 and has the other end connected to the lead 36 at 43. The lead 36 at the connection 43 is connected to another lead 51 which extends to the outside world. This connection 43 is shown in FIG. 2 in which it can be seen that the lead 51 is covered by an insulator 52 and is connected to a connector 53. The connector 53 extends through holes 57 and 58 provided in the fold-over portion of the carrier layer 18 and the foil lead 36 so that the connector 53 is engaged on two sides by the foil lead 36 and is clamped together by a fastener 59. The resistors 41 and 46 are connected to the foil 23 by suitable means as solder 61 (see FIG. 2). Another layer 68 of the same adhesive foam utilized for the backing or support layer 12 is secured to the surface 14 of the backing or support layer 12 and overlies the electrical connection formed by the fastener 59 with the lead 51. This layer 68 serves to permit the electrodes from shorting out to each other and for preventing personnel utilizing the same from being shocked by an electrical current.

In connection with the present invention, the resistors 41 and 46 hereinbefore disclosed have been formed in a foil which has been etched into the appropriate shape to provide the appropriate resistances desired. It should, however, be appreciated that standard resistors as, for example, carbon film resistors or Nichrome wire can be utilized if desired. The use of the thin foil makes it possible to provide a low profile for the electrode 11 while still providing good power handling capabilities economically.

Although, in the present invention, the resistors 41 and 46 which have been utilized have been disclosed as being part of the electrode itself it should be appreciated that separate conductors or wires can be brought out from the ring portions or elements 21b and 21c and the resistors applied externally to achieve the same results.

A release liner 69 serving as a protective layer is provided which overlies the conductive elastomer layer 31 and has its outer margins adherent to the adhesive layer 16 of the backing or support layer 12. The release liner can also be formed of a material which is substantially moisture impervious to increase the life of the large area electrode when it is out of its packaging.

In FIG. 2, the vertical dimensions have been exaggerated to illustrate the various layers forming a part of the electrode 11. The electrode assembly shown in FIGS. 1 and 2 is in reality in the form of a relatively thin flexible sandwich. The release liner 68 remains in place until the electrode 11 is ready to be used.

Generally, the electrodes 11 are utilized in pairs and for that reason an additional lead 71 has been provided as shown in FIG. 1 which is connected to another electrode of the same type as shown in FIG. 1 with both electrodes being connected to a male connector 72 of a conventional type by the leads 51 and 71. The male connector 72 is adapted to mate with a female connector 76 which is connected by a lead 77 to a conventional power supply (not shown) hereinbefore described.

FIGS. 3 and 4 show two different arrangements showing how the resistors 41 and 46 can be utilized for interconnecting the portions 23a, 23b and 23c underlying the portions 31a, 31b and 31c of the conductive elastomer layer 31. In the arrangement shown in FIG. 3, the current carrying lead 51 is connected to the center conductor 36 connected to the circular portion 31a and with one end of each of the resistors 41 and 46 being connected to the lead 51 and the other ends of the resistors 41 and 46 being connected to the leads 37 and 38. Typically, the resistors 41 and 46 have different values with the resistor 41 connected to the inner ring portion 31b being of a smaller resistive value than the resistor 46 connected to the outer ring portion 31c.

In the arrangement shown in FIG. 4, the conductor 51 is again directly connected to the central lead 36 connected without a resistor to the portion 31a with the resistor 41 being connected from the lead 36 to the lead 37 and with the resistor 46 being connected from the lead 38 to the lead 37. In such an arrangement, the resistor 41 would be the smaller resistor whereas the resistor 46 would be the larger resistor.

It should appreciated that in accordance with the present invention it is desirable to provide at least one ring which surrounds the central portion; however, it is preferable to provide at least one additional ring. Other rings can be provided if desired. By way of example, the resistors 41 and 46 in the arrangement shown in FIG. 3 have values of approximately 10 and 25 ohms, respectively, whereas in the arrangement shown in FIG. 4, the resistors 41 and 46 would have values of 5 and 14 ohms, respectively.

Both of the arrangements shown in FIGS. 3 and 4 can be utilized. In certain applications, the arrangement shown in FIG. 4 may be desirable because it ensures that the outer electrode is always at a lower voltage than an inner electrode. It cannot possibly be higher since its driving voltage is received from the preceding inner ring.

In utilizing the electrodes incorporating the present invention in applications, for example, in applying defibrillation pulses to patients with hearts that are in fibrillation from a conventional defibrillator power supply, it has been found that the use of the concentric ring portions of a conductive elastomer greatly reduces the current concentration at the outer edges of the electrode. This greatly reduces current crowding at the surface of the skin of the patient to thereby avoid burning and substantially reduce any redness induced in the skin by the application of the defibrillation pulses. By utilizing the concentric ring portions of the present invention, it is possible to step down the voltage which is applied to the patient from the center of the electrode outwardly so that there is no more than an appropriate proportion of the voltage at each margin of the electrode to thereby control the amount of current at each edge in the electrode.

In accordance with the present invention, the voltage is adjusted so that the peak current at the outer margin or edge of each of the portions 31a, 31b and 31c is no more than a predetermined amount and, preferably, approximately equal. Typically, this is ascertained by determining the resistance values in conjunction with normal skin impedance levels. The resistors are then selected so that on an average the current flow is shared between the electrode portions 31a, 31b and 31c. In addition, it has been found desirable to tailor the area of the concentric ring portions 31b and 31c so their areas decrease the farther they are from the center of the electrode. It has been found that the same current density can be obtained on the outer margin of a smaller area outer electrode as on the outer margin from a larger area electrode disposed inwardly toward the center from the outer electrode. In fact, it has been found that the same difference in current density occurs between the outer and inner edges of two concentric ring portions as occurs between the outer edge of a circle and the center of a circle. As the area of a ring portion increases, the ratio of current density from the outer edge to the inner edge of that ring portion decreases. Thus, as the area of the ring portion increases, the current flow at the edge increases. To optimize the size of the ring portions, an area is chosen for the ring portions so that at the outer edge of the ring portions, the current density drops down to approximately the same level as it does in the center of the center electrode portion. In the next ring portion from the center its area is chosen in a similar manner until current density at the outer edges is of the same value. The farther a ring portion is from the center of the electrode, the area is decreased to obtain the same current density at the outer edge.

In this way, it is possible to keep the minimum-to-maximum current density variation which appears at any place in the large surface area of the electrode 11 in a small range to prevent current concentration at the edges which might cause burning. This is shown in graph in FIG. 5 in which the relative current density for one embodiment of the present invention having three non-equal area portions is plotted with respect to radius. The dotted line 81 shown in FIG. 5 shows a typical curve for an electrode made in accordance with the present invention but without the use of separate ring portions in which the conductive elastomer is continuous from the center to its outer margin. As can be seen from curve 81, the relative current density increases from 0.20 at the center of the electrode in a substantially straight line horizontal up to about 1.2" and thereafter progressively increases rapidly as the radial distance nears the outer margin of the electrode. The three curves 82, 83 and 84 represent the current density on each of the three portions of a three-area electrode. Curve 82 is for the center portion 31 a, curve 83 is for the ring portion 31b and curve 84 is for the outer ring portion 31c.

The total current that is being delivered by the electrode is given by the integral of the product of the value represented by the curve 81 at a given radial distance and the area element of that radial distance. By going to multiple electrodes as shown in FIG. 1, it is still desirable to conserve current. By lowering current densities at the outer edges of the portions 31a, 31b and 31c, it is necessary to raise the current density elsewhere in the electrode. By examining curve 84, it can be seen that the current density has been greatly reduced in the area of the electrode exceeding 1.8 radial inches. Thus, the relative current density for curve 84 goes from approximately 0.20 to approximately 0.65, which is substantially below that of curve 81. However, the curve 83 for the portion 31c shows that while the current density starts at approximately 0.20, it goes above the curve 81 for the radial distance 1.4 to approximately 1.7 to approximately 0.65 to provide an increased relative current density with the maximum current density being approximately the same as that of the outer segment 31c as represented by curve 84. For curve 82, the relative current density starts at 0.20 at the center and then remains relatively straight or flat, the same as curve 81, but at approximately 1.1 radial inches the current density increases substantially above that of curve 81 and, again, ends up at a maximum current density of approximately 0.65, the same as for curves 83 and 84. From the three curves 82, 83 and 84, it can be seen that the maximum current density at the outer edges of the three portions 31a, 31b and 31c are substantially the same and that the minimum-to-maximum current density in each portion is also substantially the same, to thereby greatly reduce the possibility of any burning occurring at the edges during use of the electrode in defibrillation.

In utilizing the large surface electrode of the present invention, it has been found that the defibrillation threshold is equal to or better than which can be obtained with threshold defibrillator electrodes which are presently available on the market. Large single burn rings normally associated with the commercially-available electrodes have been greatly minimized or eliminated. In the present invention, a large portion of the energy which has been previously concentrated at one edge of the electrode is now distributed across the entire electrode with the concentrations at the additional edges being greatly diminished so that no burning of the skin of the patient occurs but only a slight redness appears at three concentric ring-like locations at the outer margins of the inner portion 31a, the outer margin of the concentric ring portion 31b and the outer margin of the concentric ring portion 31c. Thus, with a large surface area electrode of the present invention, the current distribution through the skin has been distributed over a larger area of the skin to greatly reduce the possibility of burning of the skin of the patient even after an exposure to a significant number of high energy pulses to the extent that only a reddening of the skin of the patient occurs with no severe burning being present. As pointed out previously, this is achieved by the use of a plurality of concentric rings in which resistors are utilized to provide voltage drops between the rings to thereby distribute the current flow to the rings.

In addition, it has been found that the large area electrodes of the present invention using the material disclosed in copending application Ser. No. 07/745,863, filed Aug. 16, 1991, are relatively transparent to x-rays and thus cast a minimum shadow when used in medical procedures. This shadow is almost invisible.

Typically, the electrodes of the present invention are sold in pairs and are used in that manner. When used, they are typically disposed of after use.

Another embodiment of a large surface electrode that incorporates the present invention is shown in FIG. 6 and has an oval geometrical configuration rather than the circular configuration shown in FIG. 1. This oval configuration can be envisioned as splitting the circle shown in FIG. 1 in half and moving them apart and inserting a straight portion therebetween. The oval-shaped electrode 89 is constructed in a manner similar to that shown in FIGS. 1 and 2 and includes a conductive elastomer layer 91 having a central portion 91a and surrounding portions 91b and 91c. The conductive elastomer 91 is carried by a backing or support layer 92 which is the same type as backing or support layer 12. The backing layer 92 is provided with a tail 92a which extends at approximately a 45.degree. angle from the longitudinal axis of the oval-shaped electrode 89. Leads of the type heretofore described in connection with the previous embodiment are provided on the tail 92a and consist of a lead 93 which is connected to the central portion 91a, lead 94 connected to the portion 91b and lead 96 connected to the portion 91c. Resistors 98 and 99 are provided on the tail 92a. As shown schematically in FIG. 6, resistor 98 is connected between the conductor 93 and the conductor 94 whereas resistor 99 is connected between the conductor 93 and the conductor 96. The conductor 93 is connected by an insulated conductor 101 to a suitable connector of the type hereinbefore described such as connector 72 shown in FIG. 1.

The current distribution in the large surface area electrode 89 shown in FIG. 6 and is very similar to the current distribution for the electrode in FIG. 1. The current distribution will still be relatively uniform throughout the surface area of the electrode with a sharp decline at the edges as hereinbefore described in conjunction with the previous embodiment. The current on the curved portion of the electrode 88 will be slightly higher than the current along the straight portions of the electrode. However, the salient feature of current sharing between the electrode portions is present to the same extent in FIG. 6 as it is in FIG. 1.

In accordance with the present invention, the tail 92a should have a length of approximately 6" or longer. This makes it possible to make connections through connectors and the like to the electrode 89 outside the normal x-ray field so that the visibility of the subject matter within the body human being examined will not be occluded by shadows from the connectors and the like making connections to the electrode 89.

By use of the oval-shaped electrode, it is possible to achieve a reasonably large surface area equivalent to that which can be obtained with a circular electrode to thereby provide an equivalent defibrillation efficacy. Using such an oval-shaped electrode or pad 89 which typically would be placed over the apex of the heart of the patient with the tail extending downwardly over the side of the patient. The use of the oval-shaped electrode leaves sufficient space on the chest of the patient above the electrode 89 so that the precordial electrodes (not shown) can be appropriately placed. The large surface area circular electrodes such as that shown in FIG. 1 would make it difficult to properly place the precordial electrodes particularly on smaller patients.

Another embodiment of a large area electrode incorporating the present invention is shown in FIG. 7. The electrode 101 is provided with a backing or support layer 102 similar to the backing or support layer 12, and is also provided with a carrier layer (not shown