DE2305220A1 - INACTIVE ELECTRODE FOR ELECTROSURGICAL PROCEDURES - Google Patents

Description

Inactive electrode for electrosurgical procedures

The invention relates to an inactive electrode for electrosurgical Interventions using high-frequency radio waves and relates in particular to an electrode-electrolyte unit, which can be easily adapted to the course of body surfaces and with which in the surgical diathermy allows the electrical current used to sever the G-webs to be conducted safely to ground.

Today's knowledge of surgical diathermy goes mainly to the work of Iredell and Turner in 1919 back. For deriving the thereby for tissue severing The electrical current used to ground is an indifferent or inactive electrode, which is also called a plate electrode and by placing it on the patient's body establishes the connection to the ground. For the sake of simplification, let it be one Electrode hereinafter generally referred to as body electrode. Although since the time when Iredell and Turner demonstrated the effectiveness of a body electrode about 463 cm tall or about 15.2 by 30.5 cm Many innovations have been introduced into electrosurgical methods, it is surprising to find that

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one doggedly in the field of surgical diathermy believes and promotes this, according to which a relatively large part of the body surface to avoid burns should be covered by an equally large plate electrode or body electrode that dissipates to earth.

Today's literature is full of references to the need to choose the dimensions of body electrodes with about 15 »2 χ 12.7 cm, about 15.2 χ 20.3 cm, etc., with a rule of thumb a ratio of about 58, 1 cm electrode area per 100 W output power of the electrical surgical device applies. It is well known that such a device used in surgical diathermy generates a high-frequency electrical current which is applied to an active or surgical electrode used for cutting tissue and scarring blood vessels, with a large body electrode providing a current path with a low current density is created in order to close the circuit to the electrical surgical device and to limit tissue heating at the point of contact between the electrode and the skin to a minimum. ^- In order to reduce the skin resistance at the point of contact, electrolytes are usually used, for example electrically conductive pastes, gels or saline solutions. In general, however, a warning is given that the electrolytes dry out during long-term electrosurgical interventions and that it is therefore very important that there is a large contact area between the skin and the body electrode in order to avoid burns and other complications.

It is evident that the commonly used large body electrodes Have disadvantages. They do not nestle easily against the body and of course there are relatively few places on the body surface where the body electrodes can be attached. Do you bring them Body electrode under a sick person, for example

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it is difficult to determine whether substantial or sufficient contact is maintained between the electrode and the body, especially when the patient is moving or being moved. Depending on the point of contact and how the If the body electrode is applied, the blood circulation can easily be impaired and thus the risk of burns increase. The general stiffness of the body electrodes and their unyielding and occasionally sharp ones Edges can significantly disrupt the patient's well-being, especially during long-term interventions. Of course A large body electrode increases the possibility of accidental contact with surgical instruments or other metallic objects so that the patient may be burned. This list is not Completely.

With regard to the state of the art, reference is made to the following publications:
U.S. Patents 3,6Q1,126, 3,590,322, 3,568,662,

3,543,760 and 3,518,984.
Canadian Patent 675,494.

French patents 1 255 797 and -915 335. J.P. Mitchell and G.IT. Lumb, "The Principles of Surgical

Diathermy and Its Limitations ", British Journal of Surgery,. No. 50, November 1962, pp. 314-320. J.P. Mitchell and G.N. Lumb, "A Handbook of Surgical Diathermy,"

Bristol, John Wright and Sons Ltd., 1966, pp. 34-38. Morris J. Nicholson, "Anesthesia and Analgesia - Current

Researches ", Vol. 49, No. 8, May / June 1970. A.K. Dobbie," The Electrical Aspects of Surgical Diathermy ",

Bio-Medical Engineering, 1969, pp. 206-216. Charles G. Battig, "Electrosurgical Burn Injuries and Their Prevention ", JAMA June 17, 1968, Volume 204, No. 12,

Pp. 91 - 95.
Alvin S. WaId, Valentino DB Mazzia, Prank C. Spencer, "Accidental Burns", JAMA August 16, 1971, Volume 217, No. 7, pp. 916-921.

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The later publication by Mitchell and Lumb from the 1966 it can be seen that the body electrode of conventional size and usually made of lead is about

2 15j2 χ 12.7 cm, which means that it has an area of about 194 cm Has. There it goes on to say: "It has been proven in practice, however

2 found that the total size was about 77.4 cm can reduce, and that the maximum power can still be achieved without heating, provided that over the there is sufficient contact across the entire surface, "

The aforementioned publication by A.K. Dobbie disagrees of the opinion that monitoring with an EKG machine causes diathermic burns and continues (p.214, Column 3) ϊ

"This is basically impossible if the body electrode (s) is or is properly applied to the patient and if the surgeon does not use strong diathermy currents within a few centimeters of a monitoring electrode connected to ground, there due to the presence of the much lower impedance that is found on the body electrode with its short return path results, only a small current via the alternative EKG current path to the ground connection of the diathermy device flows back. An EKG electrode measuring 5 x 3 cm has a touch impedance of approx 15 ohms and is able to without excessive heat generation Continuous stream for 120 seconds of 600 mA when the electrode is placed directly over a muscle. When applied over adipose tissue the maximum current is around 500 mA. "

The author continues:

"A properly applied EKG electrode is able to absorb the currents used in pediatric surgery at a Setting of the power regulator to 2 or 3 to lead. "

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In US Pat. No. 3,601,126, Pig. 2 to 6 proposed an inactive electrode, which has a metallized film as an electrode on which a sponge-like, viscous electrolyte containing foil is applied.

Canadian patent 675 494 describes an electrode in which a metal foil is sandwiched between a plastic film, which has a pressure-sensitive adhesive coating on its inner surface, and an absorbent felt or Tissue piece is arranged, "which can be wetted with an electrically conductive agent." The peripheral edge of the The existing layer of plastic film extends considerably beyond the circumferential edges of the other two layers. In the Plastic film and in the metal film opposing recesses are formed in which a push button executed connector is added.

As can be seen from the following description, the mentioned publications and the excerpts made therefrom, easily distinguishable.

For the rest, reference is made to a domestic application of the applicant in the electrolyte masses of the type dealt with here and a body soaked in advance for sensing the bioelectric potentials of a living animal body with details to be discribed.

The invention is based on the object of creating an inactive electrode which has the disadvantages of conventional ones plate-like body electrodes do not adhere and which has a relatively small size, easily can cling to different body surfaces, so that there is a large number of contact points that continue is intended for single use, can be easily and securely attached to the body without obstructing blood circulation, which is still capable for long periods of time

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good and permanent contact between the electrode-electrolyte unit and maintain the skin with minimal electrolyte dehydration and minimal impedance rise, and which can be moistened, sterilized and / or tightly packed or layered in advance, among other things.

Advantages of the invention emerge from the following description and from the claims.

The object of the invention is with an electrode-electrolyte unit solved, in which the electrode according to the invention is an electrically conductive element, of which a predetermined Part of its electrically conductive surface is essentially complete and conductive the skin of a patient can be brought over an intermediate mass of electrolyte, which in turn is sufficiently thick to keep the conductive element at a sufficient distance from the skin in all areas. Preferably belongs to the invention Electrode-electrolyte unit an electrically conductive electrode element, for example a disk or a wire, which are usually made of metal or other similar electrically conductive material from the

ρ
at least about 0.245 cm of its conductive surface are essentially completely in contact with an electrolyte mass,

2
of which at least about 13 cm of its conductive surface can be brought into substantially complete and conductive contact with the skin of a patient, and whose thickness is at least about 0.254 mm, around said conductive element in all areas at a distance of at least about 0.254 to keep miu off the skin of a sick person. The thickness of the intervening electrolyte mass should be greater than about 0.254 mm, generally at least about 4-1.19 mm when the size

Contact connection

the / surface area of the conductive / element is less than about

2 2

0.645 cm ', i.e. if they are between about 0.245 cm and about

ρ
0.645 cm in order to keep said conductive element in all areas at a distance of at least about 4.19 mm from the skin surface of a patient.

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If, for example, a wire is used that is embedded in an electrolyte mass, for example, the surface of the Wire preferably at a distance of at least about 4.826 mm from a patient's skin, with the electrolyte mass is generally interposed and in this way an effective current transfer from the skin to the creates wire-shaped electrode.

Surprisingly, it has been found that a wide variety of electrode shapes and configurations are used if at least the minimum sizes given above for the conductive surfaces are observed. For example the wire-shaped electrode can take the form of a loop, a straight line, a screw turn, a rectangle, of an ellipse, etc. provided that it goes without saying the minimum size and the minimum thickness of the electrolyte are observed for the surface of the conductive element will. The scope of the invention also includes other forms of electrodes, such as snap fasteners, metal foils, Discs, wire mesh, etc. Preferably, the intervening electrolyte covers substantially all of it skin-side surface of the electrode, with a sufficient distance between the conductive surface of the electrode and the skin must be maintained.

As an example of an electrode-electrolyte unit in which the electrolyte mass is the surface of the electrode on the skin side such a unit is not completely covered. called, which is composed of a disc of non-conductive Plastic, which is penetrated by a plurality of recesses, for example the hexagonal cells resemble a honeycomb, and consist of an electrode disk that is layered on a surface of the honeycomb-shaped Disc is applied and by closing the recesses in this way forms individual honeycomb-shaped cavities.

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Although all of these cavities are filled with an electrolyte mass, "for example with a gel or a paste can, it is only necessary according to the invention to fill so many of these cavities that, as described above, - one

2 Conductive contact with at least about 0.245 cm of the terminal electrode disk area comes about and that self-

2
understandably bring at least about 13 cm of the conductive surface of the electrolyte mass into substantially complete and conductive contact with a patient's skin. The honeycomb-shaped disk must of course be sufficiently thick and, in the case of a thin disk, sufficiently rigid to produce a distance of at least about 0.254 mm between the patient's skin and the side of the electrode disk facing it. to be observed.

It goes without saying that there are many other shapes for the Electrode element and the electrolyte mass are possible, which fall within the scope of the invention and are easily result from the general and specific description.

In one of the preferred embodiments, the electrode of an electrode-electrolyte unit is a proportionate one small, thin and flexible sheet of electrically conductive metal, which on one side is essentially completely covered by is covered with a viscous electrolyte mass of substantially uniform thickness and with this in substantially all areas has contact, the area size of said covered side of the electrode between approximately

2 2

3.23 cm and about 64.5 cm, generally between about

2 2

13 cm and about 32.3 cm, and the thickness of the electrolyte mass is between about 1.574 mm and about 12.7 mm.

In this embodiment, the thin, resilient sheet or film of electrically conductive metal is preferred made of stainless or corrosion-resistant steel, and the electrolyte is an alleal sulfate, for example

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Sodium sulfate, in an aqueous, highly viscous, semi-solid preparation with an alkali sulfate content between about 0.5 and about 20 wt .- ^.

Although the alkali sulfates, such as sodium sulfate, potassium sulfate and lithium sulfate, work very well as electrolytes. In this context, electrolytes from other water-soluble, ionizable inorganic and electrolytes are also suitable organic salts, including alkali halides and alkali nitrates, such as sodium chloride, potassium bromide, Potassium nitrate and the like, also include ammonium halides, nitrate and sulfate, magnesium halides, nitrate and sulfate, as well as other ionizable alkali salts, ionizable organic salts or organic salts of lemon, wine, salicylic, Benzoic, lactic or other similar acids with metals, such as alkali and alkaline earth metals with sodium, potassium, Magnesium et al.

In the electrolyte preparation or mass, e.g. in the aqueous alkali metal sulfate solution, there is preferably a small, but contain an effective amount of a water-soluble and swellable mucus to form a viscous electrolyte mixture achieve that, according to a further form of training, in the interstices of a sponge-like, cellular Matrix, for example a polyurethane foam or other similar absorbent material, absorbed or in this is evenly distributed in order to obtain a highly viscous, semi-solid electrolyte mass.

The water-soluble and swellable slimes which can be used according to the invention and which are also used as gel-forming acids and water-soluble resins are known to include carboxymethyl cellulose, polyvinyl alcohols, cellulosic gums, Polymethylene oxide, sodium alginate, gum tragacanth, polyacrylic acids, such as those hydrophilic high viscosity polyacrylic acids having a molecular weight between about 1,000,000 and about 6 000 000 covering cosmetic and pharmaceutical

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Preparations are suitable, for example the water-soluble Carbopol resins of Β.Έ ¹ . Goodrich Chemical Co.

The best results are obtained with the polyacrylic acids by treating them with any neutralizing agent neutralized, e.g. with fairly strong organic and inorganic bases, including NaOH, KOH, IELOH, Mono-, di- and trialkylamines, mono-, di- and trialkanolamines, such as iriethanolamine, triamylamine, dodecylamine, di (2-ethylhexyl) amine and the like, belong.

The neutralized mucilage obtained is usually in a concentration of between about 0.2 and about 8.0 wt .- ^, preferably between about 0.85 and about 5.0 wt ^c / 0, based on the total weight of the electrolyte composition, available .

If necessary, common additives, e.g. inhibitors that prevent mold formation or solidification (mold inhibitors), can be used. added in small amounts usually less than about $ 1 be. For example, very beneficial results can be obtained with chlorinated aromatic hydrocarbons, e.g. 2-chloro-meta-5-xylenol, and with salts of organic acids, e.g. with sodium benzoate, etc. achieve.

Although the mixing of the constituents of the electrolyte mentioned in these preferred embodiments can be made in a variety of modifiable order, it is preferable for reasons of expediency, the aqueous Prepare the alkali metal sulfate solution separately and add the slime component to this while stirring appropriately, which can then be neutralized in situ. As far as an inhibitor of the above type or the like. is used, this becomes to achieve better distribution, preferably added together with the neutralizing agent.

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Generally, the ElektinLyt components are used at room temperature and atmospheric pressure mixed. If necessary, you can however, for example, elevated temperatures and pressures can be used to great advantage.

If appropriate, the electrolyte can be used as an electrolyte paste, gel or the like. be arranged in one or more columns, such as in the honeycomb-shaped disc mentioned above. The electrolyte can also be a paste or gel in which usually inert, fine-grain additives are finely distributed, such as talc powder, regenerated cellulose, sand, large-volume SiOp precipitated in the smoke, silica gel or other similar fillers. In general, the proportion of filler of the total weight of the mass of electrolyte in, for example, paste or gel form, and the Püllsto'ff between about 5 and 60 wt ^c / 0, preferably between about 20 and 50 wt .- ^.

Although stainless or corrosion-resistant steel is one of the preferred materials for the manufacture of the electrode element is, the invention is not limited to this. The electrode can be made of any conductive material be made such as aluminum, copper, silver, silver / silver chloride, brass, platinum, gold, and the like. The conductive Metal, for example, can only be used as a plating on a substrate, for example made of another metal, made of plastic or the like. be upset. A flexible sheet of conductive metal can be made from metal powder, for example produce that fritted together to the desired shape will. Its foil can be made from metal powder by embedding the metal grains in a binder, such as e.g. in a polymer binder or a polymer matrix. "Conductive metal" also includes other conductive materials, such as. a slice of coal, understood.

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The invention is described below with reference to schematic drawings several implementation examples with further details explained. In the drawing shows:

1 shows a perspective view of a protective cover for an electrode,

FIG. 2 shows a section along the line 2-2 in FIG. 1 the electrode and the protective cover,

Figure 3 is a perspective view, partially exploded Illustration of the electrode with the protective cover removed,

Fig. 4 is a perspective view, partially exploded Illustration of the electrode with the protective cover removed and the removable one removed Protective film,

5 shows a perspective view, in an exploded view, of part of the electrode after it has been removed the protective cover, the protective film, the non-conductive shell, the push button and the pliable and elastic film, the cellular matrix soaked with electrolyte shown in FIG. 4 being replaced by a Single disc made of cotton-fiber fleece fabric, which has also been soaked with electrolyte, has been replaced,

6 shows a view similar to FIG. 5, but with a plurality of stacked and electrolyte-impregnated ones Discs made of cotton fiber fleece fabric,

7 is a perspective view of a disk-shaped, sponge-like cellular electrolyte matrix with embedded wire electrode,

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Pig. 8 is an exploded perspective view of a portion of the electrode after it has been removed the protective cover, the protective film, the non-conductive shell, the push button and the pliable and elastic foil, wherein the conductive metal foil is coated with a polymer film, which is used for visualization the metal foil is cut out in places,

FIG. 9 shows a section along the line 9-9 in FIG. 8 the conductive metal foil covered with the polymer film,

Fig. 10 is a view similar to Figs. 5 and 8 of part of the electrode, the disc-shaped, sponge-like cellular electrolyte matrix is coated with a polymer film, which is used to make the electrolyte matrix visible is cut out in places,

FIG. 11 shows a section through that shown in FIG Matrix made visible by partially omitting the polymer film,

Fig. 12 is a view similar to Fig. 10 of a portion of the electrode showing the conductive metal foil and the disk-shaped, sponge-like cellular electrolyte matrix each coated with a polymer film and rotating in places cutting out of the polymer film are made visible,

Fig. 13 is a view similar to Fig. 10 of part of the electrode, the one containing the electrolyte Element is a disk made of non-conductive polymer, which is penetrated by honeycomb-shaped recesses some of which are filled with electrolyte gel and others are unfilled, and

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14 shows a section taken near the center point through part of the electrode with the protective cover removed and cellular electrolyte matrix, wherein the non-conductive shell is filled with an electrolyte gel is shown.

The drawing shows an electrode designated in its entirety by 10, which is essentially rectangular so-pliable and elastic film 12, which in the example shown has a substantially centrally arranged non-conductive shell 14, the surface of the foil 12 and the outer surface of the flat base 16 of the shell 14 in the are arranged on the same level. The shell 14 takes in its cavity facing a (not shown) body surface a resilient electrode 17 made of a conductive metal foil which is attached to the inner surface of the cup base 16 rests and is arranged in a plane with this. Of the The diameter of the shell 14 is substantially greater than its height, so that there is a low profile.

The resilient or pliable and resilient foil 12, the shell 14 and the resilient conductive metal foil or Electrode 17 are held together with a metallic conductor, which consists of a penetrating snap fastener part 18, which is a has lower circular plate 20 and a hollow rivet 22 protruding from the center thereof, and an upper plate 24 is composed, which has an upwardly projecting sleeve 26 for receiving the hollow rivet 22.

In order to assemble and connect the parts together, the shell 14, in which the metal foil or electrode is centered and aligned, and the upper plate 24 with its upwardly projecting sleeve 26 on both sides of the Foil 12 held in the middle and in alignment with one another. The hollow rivet 22 is then pushed through the recesses that are aligned with one another in the central areas of the metal foil 17, the

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Base 16 and the film 12 inserted through into the sleeve 26. By pressing together the push button parts, the upper part of the tubular rivet 22 is bent inward and its side walls spread outwards so that the snap fastener parts are tight are connected to each other.

On its underside, the film or plate 12 has a layer 28 made of a commercially available one for medical purposes suitable acrylic adhesive that is pressure sensitive or is liable for print orders. Until the electrode 10 is used, the adhesive layer 28 is covered with a paper protective strip 30 covered, on whose surface resting against the adhesive layer 28, a release agent is applied. The outside surface the base 16 of the shell 14 is not only attached to the plate 12 with the push button described above, but adheres via the pressure sensitive adhesive layer 28 on the plate 12 on the underside thereof. To this end, the Paper protection strip 30 has a recess through which the shell 14 penetrates.

The plate 12 is preferably made of a foamed plastic, for example polyurethane, PVC, or the like., that allows sufficient air access to the skin. Such a plate is pliable and can easily be contoured to adapt to the skin and allows free movement of the skin at the contact point. The shell 14 can be made of a non-conductive vacuum in a vacuum be molded thermoplastic film material that is not only pliable, but also sufficiently rigid or is stiff in order to maintain the shape given to it. A variety of are suitable for making the shell 14 Plastic materials such as linear polyethylene, polyvinyl chloride, gelulose acetate butyrate or the like.

In order to obtain a preassembled unit from the electrolyte and the electrode 10, a disc-shaped, sponge-like cellular matrix 32 made of non-conductive,

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open-cell material with an electrolyte gel. Preferably the diameter of the sponge-like matrix 32 is substantially equal to the diameter of the base 16 of the shell 14 and its thickness "greater than the depth of the shell 14. It is sufficiently soaked with the electrolyte gel that this when the electrode 10 is pressed against the skin, the entire volume of the cavity between the skin, the conductive metal foil and the plate 20 fills so that through the gel between the skin formed by the conductive metal foil Electrode 17 and the conductive plate 20 a good electrical contact is made.

The sponge-like matrix 32 can be made from open cell polyurethane foam, although other cellular ones Materials are also suitable. Soaking the sponge-like matrix 32 with the gel, for example with sodium sulfate, can be done in such a way that the matrix is immersed in a quantity of the gel, squeezed and before Remove it from the gel gradually releasing it, in the same way you would soak a sponge with water. Of course the impregnation of the matrix with the electrolyte can also be carried out in other ways.

As a result of the wetting or impregnation with the viscous electrolyte, the soaked sponge-like matrix 32 tends to on the electrode 17 formed by the conductive metal foil, on the conductive plate 20 and on the inner surfaces of the Shell 14 to adhere. In the example shown, the sponge-like cellular matrix 32 is attached on the conductive plate 20 of the electrode unit with one made of plastic, for example made of nylon or polyacetate manufactured non-conductive rivet 34, which with an upwardly protruding shaft 35 through a recess in the aqueous, highly viscous, semi-solid electrolyte mass 32 through into the Neck part of the hollow rivet 22 penetrates and is clamped in this.

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Furthermore, in Pig. 1, 2 and 3 illustrated embodiment according to the invention a the shell 14 and the one with gel fully soaked sponge-like matrix 32 covering protective cover so that the electrode 10 can be stored ready for use can. The protective sheath 38 is a substantially flat one Strips of non-conductive plastic film with flat edge portions 40 and a cylindrical raised central portion 42, whose inner diameter is essentially the same as the outer diameter of the shell 14. The height of the cylindrical Middle part 42 is at least equal to the total height of the shell and the sponge-like matrix 32. The protective cover 38 adheres slightly on the protective film 30, 'so that when you pull off the Protective film 30, the protective cover 38 is taken. the Protective cover 38 can, however, easily be peeled off from protective film 30 without it being peeled off.

The protective cover 38 is on the non-adhesive surface of the Protective film 30 attached, the cylindrical central part 42 being slipped over the shell 14. The protective cover 38 prevents Soiling and evaporation or drying out of the aqueous semi-solid matrix 32. As already indicated, needs the protective film 30 to be peeled off the plate 12 before using the electrode 10, wherein it is the protective cover 38 takes away.

In a further embodiment according to the invention that shown in FIG. 3 is sponge-like, disc-shaped and cellular electrolyte matrix 32 replaced by a disc 50 made of cotton fiber fleece fabric (FIG. 5) »This disc is at least about 0.254 mm thick and saturated with an electrolyte gel and completely covers the lower or skin-side surface of the electrode film 17, i.e. the diameter of the disk 50 is preferably larger than that of the disc-shaped conductive metal foil 17.

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The embodiment according to FIG. 6 is similar to the structure shown in FIG. In the essential points, except that the electrolyte mass is composed of several layer-like disks 60 made of cotton fiber fleece fabric, which also are soaked or soaked with electrolyte gel.

The embodiment shown in Fig. 7 is a disk-shaped, sponge-like, designed without a central opening. cellular electrolyte matrix 70 in which a thin wire electrode 72 is embedded along its diameter plane in the transverse direction one end of which is within the cellular electrolyte matrix disc ends while the other end of the wire to ground and away from the skin-facing surface of the cellular matrix disc is led. Does the electrolyte contacting conductive surface of the wire have a size in the range between

2 2

about 0.245 cm and about 0.645 cm, then the thickness of the electrolyte mass should be at least about 4.19 mm, ie. the wire should be kept a distance of at least about 4.19 mm from the skin.

FIG. 8 shows a further embodiment in which the sponge-like cellular electrolyte matrix shown in FIG 32, but without a central opening, separated from the conductive metal foil disk 17 by a polymer film 80 is, with both the edge parts and the side walls of the conductive metal foil 17 »as drawn, all around from Polymer film 80 are covered. Neither matrix 32 nor film 80 have a central opening. Fig. 9 illustrates one Section through the conductive metal foil 17 from FIG. 8 connected to the polymer film 80.

In the embodiment shown in FIG. 10, the one shown in FIG. 3 is executed without a central opening cellular matrix 32 on the skin-side surface and on the side walls of a continuous polymer film 80 of the in Figures 8 and 9 covered. Fig. 11 only shows a section through the covered cellular matrix from Fig.

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In the embodiment shown in FIG. 12, the sponge-like, disc-shaped cellular matrix 32 and the conductive metal foil 17 on their skin-side and Side surfaces covered with a continuous polymer film 80.

The embodiment shown in Fig. 13 has the Pig. 3 shown electrode-electrolyte unit, at the element 32 containing the electrolyte by a Disc 90 made of a non-conductive material, for example from a polymer material, and made of honeycomb-shaped, hexagonal recesses 92 is penetrated, in the place of which similar recesses can be provided and some of which in the example shown are filled with electrolyte gel, while others do not have such a filling exhibit.

FIG. 14 shows a further embodiment in which, instead of the sponge-like matrix 32 shown in FIG with an ElektraLyt gel or an electrolyte paste 100 filled non-conductive shell 14 is provided.

The polymer disk 90 containing the electiolyte (Fig. 13) can be made of any polymeric, preferably non-conductive, plastic that is usually rigid enough is to remain dimensionally stable under the pressures usually applied in use. Mostly come as polymers Polyamides, polyethylene, polyvinyl chloride, polyurethane, oxymethylene polymers and others are possible. As already mentioned, Instead of hexagonal, the recesses can also be round, rectangular, elliptical or similar in shape.

The polymer sheet or film 80 (FIGS. 8 to 12) can also be non-conductive and made of a polymer such as e.g. polyvinylidene chloride (saran), nylon, polyethylene, polyester, polyacrylic, etc.

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Further advantages result from the use of a polymer film as in Pig. 8 to 12 shown that the skin surface a sick person not in direct contact with an electrolyte such as sodium chloride, must be, whereby the well-being of the patient is increased. Can also be used in terms of storage and avoidance Corrosion means direct contact between a caustic electrolyte, such as sodium chloride, and the metallic electrode discs are avoided.

From the above description it can be seen that there are many other designs for the electrode-electrolyte unit are possible without the unity losing its superior effect, which consists in dealing with it when deriving of current to ground during surgical interventions with electrical operating instruments burns at the same time and avoid the complications associated with the use of large body electrode plates. From the ! following it will be seen that current through the inventive Unity is derived very, effectively and results from the use of large body electrode plates resulting risks are eliminated.

It may be useful in certain circumstances in conjunction with one or the other of the embodiments described or proposed for the electrode above Use rectangular or strip-shaped electrolyte bodies to connect the ground to extremities or Carry out hard-to-reach places on the human body. Because the invention has such a uniform distribution the current density creates on the surfaces and through the electrolyte and electrode elements result for the person skilled in a variety of options for shaping and using the proposed unit.

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The invention is illustrated in more detail in the following EXAMPLES in which percentages and parts are given as wt .- $. or. Understand parts by weight.

EXAMPLE · I

The following ingredients are mixed into an electrolyte preparation;

93f3 parts of water
2.0 parts carboxypolymethylene (polyacrylic acid, mt 4 ooo ooo - 6 ooo ooo) ^Ä

1.6 parts of triethanolamine

0.1 part of 2-chloro-m-xylenol

3.0 parts sodium sulfate (anhydrous)

³⁵ Garbopol 940, trade name of the Β.Ί ?. Goordieh Chemical Co.

The anhydrous sodium sulphate is dissolved in water with vigorous stirring, and the polyacrylic acid is then dissolved with vigorous stirring Stirring, sieved into the aqueous salt solution until the polyacrylic acid is homogeneously dispersed and / or dissolved. One through gentle heating and stirring of the triethanolamine and des 2-Ohlor-m-xylenols prepared solution is under vigorous Stir as the polyacrylic acid is quickly added to the mixture. The vigorous stirring takes place for a further 10 to 60 minutes, until the desired viscosity is reached.

EXAMPLE II

The following ingredients are mixed into an electrolyte preparation:

79.1 parts of water

2.4 parts of Oarbopol 940

3.0 parts of triethanolamine

0.5 part of 2-chloro-m-xylenol
15.0 parts sodium sulfate (anhydrous)

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Mixing takes place essentially as described in Example I, with the exception that the 2-chloro-m-xylenol and the triethanolamine following the polyacrylic acid separately and one after the other with each subsequent violent Stirring can be added.

EXAMPLE III

The following components are essentially used after the in the method described in Example I mixed to form an electrolyte preparation:

7413 parts of water 2.4 parts of Carbopol 940 3.1 parts of triethanolamine

0.2 part of 2-chloro-m-xylenol 20.0 parts of sodium sulfate (anhydrous).

EXAMPLE IV

With each of the electkirolyte preparations produced in the aforementioned examples, a sponge-like, cellular and pliable polyurethane matrix impregnated and the resulting semi-solid mass by incorporation into an electrode des in Pig. 1 to 4 shown type tested. The single ones Components are designed with the following dimensions:

Black-like matrix 32 made of polyurethane foam: Diameter about 57.15 mm thickness about 7.874 mm density about 32 kg / nr

Conductive foil 17 of the electrode made of stainless or corrosion-resistant Stole:

Diameter about 45 % 72 mm thickness about 0.076 mm diameter of the recess about 4.19 mm

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Shell 14 made of polyvinyl chloride:

Outside diameter about 63 mm shoulder or wall radius about 1.6 mm Thickness of the base 16 about 1.016 mm, diameter of the recess about 1.778 mm

Soft, elastic and resilient plate 12 made of polyurethane: Length about 190.5 mm, width about 76.2 mm, thickness about 4.8 mm End radius (both sides) about 39.624 mm

Protective cover 38 made of PVC film:

Thickness of the semi-rigid PVC film about 0.254 mm Inner diameter of the cylindrical central part about 65.28 mm

Penetrating snap fastener part 18:

The material of the components 20, 22, 24 and 26 is

stainless or corrosion-resistant steel circular plate 20 of hollow rivet 22, Diameter about 10.668 mm

Height about 5.207 mm hollow rivet

Outside diameter about 3 »2 mm. Circular plate 24 diameter about 10.668 mm

Height about 3.429 mm sleeve 26

Outside diameter about 3 »937 mm Inside diameter about 3 »175 mm

Hiet 34, expandable, made of polyacetal: Tapered shaft 35 length approximately 9.652 mm

Largest diameter about 2.692 mm

The above-described inactive or body electrode is attached to the push button 18 via a connector and cable to the ground connection of a conventional electrical high-frequency radio wave surgical device, model OSY Bovie, with changeable Output power connected.

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- 24 - 42 556

! Plague procedure (continuation of example IV)

The above-described electrode is used for experimental purposes on the upper arm (biceps) of an adult male (age between 30 and 40 years, weight about 82 kg, height about 183 cm) attached by gluing. The sodium sulfate electrolyte has the composition given in Example II described above and focus on. The push button 18 of the electrode is connected to the Ground connection of an electrical surgical device, type CSV Bovie, connected. The test subject stops in the Hand a piece of fresh beef liver measuring about 20 χ 76 χ 2 cm, which has been coated with electrolyte gel from Example II, the impedance between the skin (hand) of the test subject uiö. to belittle the liver it holds.

After switching on the CSV device, a conventional spherical surgical electrode is used with a sphere diameter of about 3> 2 mm on the liver piece during surgery worked. The current pulse settings used and specified below have been selected to be significantly higher than usual in actual operations:

1. After setting the CSV device to cutting capacity 60 when setting the cutting current selector on 1, choose an uninterrupted working time of 2 minutes.

2. Pause for 1 minute.

3. Repeat process (1), but with the cutting power regulator set to 70.

4. Pause again for 1 minute.

5. Repeat process (1), but with the cutting power regulator set to 80.

At the contact surface between the electrolyte sponge 32 and the skin of the subject a temperature increase of less than about 0.55 ⁰ C is observed. The test person has no sensation of warmth and of course does not suffer any burns.

/ 25 309832 / 054S

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EXAMPLE V

This example is a repeat of Example IV in all material respects, except that the power control not for a G-ewebsdurchtrennung or cutting is carried out, but for a tissue destruction or coagulation, which constitute cutting power selector is set to the fourth The results obtained are the same.

EXAMPLE VI

The disposable body electrodes described in Example III have been used in over six hundred normal surgical procedures,

performed in more than a dozen hospitals across the United States during 1971. From the reports on this it can be seen that the electrodes not only have no burns or other Caused harm, but that they did an excellent job.

EXAMPLE VII

This example is a replication of the liver test in Example IV using those described in Example III Electrode. However, the area facing the electrolyte is that formed by the conductive metal foil 17

2
Electrode only about 3 »23 cm, the diameter of the sponge-like electrolyte matrix 32 is only about 20.3 mm and the rivet 34 is not used. The current pulse settings are as follows:

1. Cutting power regulator set to 30, cutting current selector set to 1, uninterrupted working time 0.5 minutes.

2. Break of 0.5 minutes.

3. Cutting power regulator set to 40, cutting current selector set to 1, uninterrupted working time 1.0 minutes.

4. Break of 0.5 minutes.

5. Cutting power regulator set to 50, cutting current selector set to 1, uninterrupted working time 0.5 minutes.

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- 26 - 42 556

6. Break of 0.25 minutes.

7. Cutting power regulator set to 50, cutting current selector set to 1, Working time 0.5 minutes.

8. Break of 0.5 minutes.

9.Cutting power regulator set to 60, 'Cutting current selector set to 1, continuous working time 2.0 minutes.

10. Break of 0.5 minutes.

11.Cutting power regulator set to 70, Cutting current selector set to 1, uninterrupted working time 2.0 minutes.

There will be a temperature rise of less than about -1.7 ° C established. The test subject does not experience any harmful effects.

From the above it follows that the inactive electrode according to the invention, quite surprisingly, is the one described at the outset Overcomes disadvantages and corresponds to the requirements mentioned in a particularly advantageous manner.

EXAMPLE VIII

The following are the results of the electrical insulation of the metallic conductor in the electrode-electrolyte unit under consideration over the skin resulting advantages explained.

1. Experimental set-up

An active or surgical electrode described below is attached to the underside of a subject's forearm attached. This active electrode becomes electrical with the associated connection of a commercially available electrical Surgical equipment described in Example IV above Type (type OSV Bovie from the manufacturer Liebel-Plorsheim Company) connected. A thermoelectric ammeter is interposed in this electrical connection. The too

309832 / OS AB / 27

- 27 -. 42 556

A testing body electrode that dissipates to earth is attached to the Outside of the upper arm attached to the same side of the body as the active electrode. The body electrode is over a thermoelectric radio frequency ammeter with the Ground connection of the electrical surgical device connected.

The electrical surgical device is then switched on. The current flow (in Amperes) through the active and the inactive The loop and the power settings of the device are recorded. The duration of the uninterrupted switch-on (duty cycle), during which there is either the inactive or the active Electrode heat develops to a degree that is perceived as very uncomfortable (sensation of warmth).

2. Trial data

a) The active one described in example IY is used Electrode, i.e. a disk made of stainless or corrosion-resistant steel 316; with a radius of about 22.86 mm and a thickness of about 0.076 mm, the center of which is a cranked retaining clip made of stainless or corrosion-resistant Steel 316 bears. The active electrode also has on its upper side an approximately 7 »874 mm thick and about 57.15 mm in diameter measuring polyurethane foam matrix of medium size Density impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate.

b) Experimental body electrodes

(1) Body electrode A has the same structure as the above-described active electrode.

(2) Body electrode B is a disk made of the aforementioned 316 steel, with a radius of about 22.86 mm and a thickness of about 0.076 mm, and has a cranked retaining clip made of steel 316 in its center. This disc is placed directly on the skin.

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0.72 1 35.0 0.70 7.5 0.72 9.5 0.76 10.0 0.73 12.5 0.74 19.0

- 28 - 42 556

(3) body electrode C is a 316 steel disk, with a radius of about 22.86 mm and a thickness of about 0.076 mm, and has a at its center cranked retaining clip made of steel 316. The surface of this disc is thin with that described in Example II The gel was coated with 15 parts by weight of sodium sulfate. ■

Setting act. inact. Switch-on

Body experimental OSV Bovie- Elektr.Elektr. duration electrode person device A. A sec.

A male I cutting 1/33 0.73 B male I cutting 1/33 -

C male. I cutting 1/33 0.72

A male II cutting 1/33 0.74

B male II cutting 1/33 0.72

G male * II cutting 1/33 0.72

EXAMPLE IX

Attempts to determine the distance between the metallic conductor and the skin are as follows carried out:

1. Distance about 0.254 mm.

a) The active electrode from Example VIII, 2a is used.

b) Body electrode A is a disk made of steel 316, with a radius of approximately 22.86 mm and a thickness of approximately 0.076 mm, and has a cranked holding clamp made of steel 316 in its center. The disc is with a a piece of porous paper measuring about 51 x 51 mm (about 0.254 mm thick paper for laboratory use) covered, which is impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate.

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c) Body electrode B (lengthy. 5) is designed similar to Body electrode A, with the exception that the disc with a diameter of about 57.15 mm and about 0.254 mm thick piece of cotton nonwoven fabric is covered, which is impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate.

^Ä Laboratory wipe, registered trademark "Shur-Wipe", sold by Port Howard Paper, Greenbay, Wise.

Setting act. inact. Switch-on

Experimental CSV Bovie electr. Electr. Duration

person device A A sec.

male III cutting 1/33 0.73 0.76 58.0

male IV cutting 1/34 0.74 0.79> 120.0

EXAMPLE X

The experiments described below show that the performance of the electrode-electrolyte unit can be improved (Glow or caustic plate) according to the invention can use a variety of inert carriers or fillers in the gel,

1. The structure of the active electrode is the same as in the above-described example VIII, 2a.

2. Experimental body electrodes

(a) Body electrode A is a 316 steel disk, approximately 22.86 mm in radius and thickness of about 0.076 mm, and has a cranked retaining clip made of steel 316 in its center. The disc is thinly coated with the electrolyte gel described in Example II.

(b) Body electrode B is a 316 steel disk. with a radius of about 22.86 mm and a thickness of about 0.076 mm, and has a in its center

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Cranked retaining clip made of 316 steel. The electrode has an approximately 3 »175 mm high column of electrolyte with a diameter of about 57.15 mm. The electrolyte is a mixture of 50 parts by volume each from the solution described in Example II described gel with 15 parts by weight of sodium sulfate and washed sand with a grain size between about 0.18 and about 0.42 mm (40-80 mesh, US Standard. Sieve accepted). The cylindrical shape of the * Electrolyte is through a shell made of vinyl plastisol ", which has an inside height of about 3.175 mm and an inside diameter of about 57.15 mm.

(c) body electrode G "is a disc made of steel 316, with a radius of about 22.86 mm and a thickness of about 0.076 mm, which is at the top of the disc has a column of electrolyte about 3.175 mm high and about 57.15 mm in diameter. The electrolyte is a mixture of 50 parts by volume of the gel described in Example II with 15 parts by weight sodium sulfate and regenerated cellulose (chemical cotton). The cylindrical The shape of the electrolyte is secured by a shell made of vinyl plastisol (Fig. 14) which has an interior height of about 3.175 mm and an inner diameter of about 57.15 mm. Of course, the disc is wearing in the middle a cranked holding clamp made of steel 316,

(d) Body electrode D is a 316 steel disk, approximately 22.86 mm in radius and thickness of about 0.076 mm, which has a cranked retaining clip made of steel 316 in its center. The electrode has an approximately 3.175 mm high column of electrolyte with a diameter of about 57.15 mm. The electrolyte is a mixture of that described in Example II and 15 parts by weight Gel containing sodium sulfate, the $ 24.3 wt

/ 31 309832/0545

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powdered talc are added. The cylindrical shape of the electrolyte is made up of a shell Vinyl plastisol (Pig. 14) secured an interior height of about 3> 175 mm and an inner diameter of about 57.15 mm.

(e) body electrode E is a disc made of steel 316, with a radius of about 22.86 mm and a thickness of about 0.076 mm, and has a at its center cranked retaining clip made of steel 316. The electrode points at the top of the disk 40 in diameter Layers of cotton-fiber fleece fabric measuring about 57.15 mm and each about 0.254 mm thick (Pig. 6), which are impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate.

(f) Body electrode P is a disk made of steel 316, with a radius of about 22.86 mm urrl of a thickness of about 0.076 mm, and has a cranked retaining clip made of steel 316 in its center. The electrode has a polyurethane foam on the top of the pane produced matrix - density about 24 kg / m, thickness about 5.334 mm, diameter about 57.15 mm - with the gel described in Example II with 15 parts by weight of sodium sulfate is soaked.

(g) Body electrode G is the same as body electrode P except for the polyether urethane foam matrix with a diameter of about 57.15 mm, a thickness of about 4.521 mm and a density of about 76.9 kg / nr having.

309832 / Q5A5

- 32 - IV Cut 1/30 act,
Electr.
A. 42 556 . 18.5 I? Cut 1/33 0.59 2305220 55.0 Body-
electr. IV Cut 1/33 0.68 inact. Switch-on
Electrical duration
A - sec. 40.0 A. IV Cut 1/33 0.69 0.65 59.0 B. setting
Trial ES? Bovie
person device IV Cut 1/33 0.72 0.70 90.0 C. male IV Cut 1/33 0.68 0.71 69.0 S. male V Cut 1/33 0.69 0.76 51.0 male 0.73 0.70 G- male 0.71 D. male , 0.77 male male EXAMPLE XI

The experiments described below were carried out with various Area sizes both for the electrolyte mass as also carried out for the metallic electrode conductors.

1 * The design of the active electrode corresponds exactly to that in Example VIII, 2a.

2. Versuehs body electrodes

(a) Body electrode A is a conductor made of steel 316, with a radius of about 20.32 mm, an area

ρ
of about 13 cm and a thickness of about 0.076 mm, and has a cranked holding clamp made of steel 316 in the middle. Before placing the electrode on the skin, the conductor is thin with the gel described in Example II with 15 parts by weight of sodium sulfate coated.

Body electrode B has a metallic contact piece, a silver wire, diameter about 0.304 mm, Length about 25 »4 mm, area about 0.245 cm (Fig. 7). This wire is in a polyether urethane foam matrix, Hadius about 20.32 mm, area

about 13 cm, thickness about 4.755 mm, embedded that is impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate. The wire

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/ 33

- 33 - 42 556

is embedded in the top of the Sckaumisatrix and has a minimum distance to their skin-facing surface of more than about 4.44-5 rom.

Setting act. inact. Switch-on

Body Vsrsachs ÖS? Bovie electr, electr. Duration electr _e person device AA sec.

A raännl. III cutting 1/33 0.64 0.74 11.0 B mti-nnl. I'll cut 1/33 0 _? 64 .0.72 22.0

(υ) body electrode G ± q'c a conductor made of stainless or more corrosion-resistant steel, with a radius of about 47.244 m% of a die.tee of about. 0.076 mm and

an area of about 69.66 cm, the one in its center a cranked retaining clip made of stainless or corrosion-resistant steel had ¥ before being put on Applying the electrode to the skin, thin the conductor using the gel described in Example II 15 parts by weight of sodium sulphate coated.

(d) Body electrode D is a 316 steel disk with a hadius of approximately 47.244 mm and an area

about 69.66 cm, '' • Hid has one in the middle cranked retaining clip made of steel 316. On the top of the metallic conductor is a polyether urethane foam MatriXi with a radius of about 47.244 mm, an area of about 69.66 cm, and with a thickness of about 4.755 mm, attached using the gel described in Example II with 15 parts by weight of sodium sulfate is impregnated.

Setting act. inact. Switch-on

Ibody- experimental- CS? Bovie- electr. Electr. Permanent electr. person device A A sec »

C male III cutting 1/50 - 1.30 17.0 D male III cutting 1/50 ', 30 30.0

/ 34 309832 / 054S

- 34 - 42

EXAMPLE XII /

The following data demonstrates that the geometric shape of both the electrolyte mass and the metallic conductor can be modified in many ways.

1. Elliptical shape

a) The design of the active electrode is similar to that of the im Example VIII, 2a.

b) The test body electrode is an elliptical conductor made of steel 316, the major axis of which is about 98.4 mm and the minor axis about 55 _? 5 mm long, and which has a cranked holding clamp made of steel 316 in the middle. An elliptical polyether urethane foam matrix, main axis about 111 mm long, Hefbenaehse about 63.5 mm long, thickness about 4.755 mm, is attached to the metallic conductor and is impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate.

Setting active 'inactive switch-on test CSV Bovie electrode electrode duration person device A A sec.

male IV blades 1/45 0.86 0.97 75.0 male V blades 1/45 0.86 0.98 7 90.0 male VI cutting edges 1/45 0.84 0.95 7 90.0

c) The test body electrode is a square conductor made of steel 316, edge length approx. 2% 4 mm, thickness approx 0.076 mm, which has a cranked holding clamp made of steel 316 in its center. At the top of the metallic conductor is a square polyether urethane tree matrix, Edge length about 76.2 mm, thickness about 4.755 now, attached that with the example shown in II

. described gel with 15 parts by weight of sodium sulfate is soaked.

/ 35 309832/0545

556

Test subject

setting
CSV Bovie series

active inactive switch-on Slektroae Slektrode duration A A sec.

male III cutting 1/43

male IV cutting 1/43

male V cutting 1/43

male II cutting 1/43

1.18
1.20
1.20
1.20

34.0 26.0 47.0 24.0

3E

3E

5E

In all cases the active electrode became much hotter than the body electrode.

d) The test body electrode is a rectangular conductor made of steel 316, about 25.4 mm long, about 12.7 mm wide, about 0.076 mm thick, and has a cranked retaining clip made of steel 316 in the middle. On the top of the metallic conductor is a polyether urethane foam matrix, approximately 101 mm long, approximately 25.4 mm wide, approximately 4.755 mm thick attached, which is the same as in Example II described gel is soaked with 15 sewing ropes of sodium sulfate.

Test subject

setting
CSV Bovie device

active

electrode

inactive
electrode

Duty cycle sec.

male IV cutting 1/42 O ₉ 80 male V cutting 1/42

0.92
0.86

73.0 94.0

EXAMPLE ZIII

The following data show that one is either between conductor and electrolyte, or between skin and electrolyte or a non-conductive material (insulating material) between the conductor and the electrolyte as well as between the skin and the electrolyte can arrange.

a) The active electrode used in Example VIII, 2a used.

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b) Experimental body electrode A is a disk made of steel 316, with a diameter of about 57.15 mm and a thickness of about 0.076 mm, and has a at its center cranked retaining clip made of steel 316. The disc is completely covered with a piece of polyvinylidene chloride or Saran pilm about 0.076 mm thick covered (Pig. 8 and 9) On the top of the polyvinylidene chloride film is a ' Polyether urethane foam matrix, with a diameter of about 57.15 mm and a thickness of about 7.874 mm, attached, which is impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate.

c) Experimental body electrode B is a disk made of steel 316, with a diameter of about 57.150 mm and a thickness of about 0.076 mm, and has a cranked retaining clip made of steel 316. At the top of the disc is a polyether urethane matrix, with a diameter of about 57-15 mm and a thickness of approximately 7.874 mm, attached, which is impregnated with the gel described in Example II with 15 parts by weight of sodium sulfate. The foam matrix is completely covered from above with an approximately 0.076 mm thick saran or polyvinylidene chloride pilm Pig. 10 and 11).

d) Experimental body electrode Q is a disc made of steel 316, with a diameter of about 57.15 now and a thickness of about 0.076 mm, and has a cranked retaining clip made of steel 316 in its center. The disc is completely covered with an approximately 0.076 mm thick saran or polyvinylidene chloride pilm. Above this is a polyethylene urethane matrix, with a diameter of about 57.15 mm, arranged with that in Example II "described gel is soaked with 15 parts by weight of sodium sulfate. The foam matrix is complete from above covered with another approximately 0.076 mm thick saran or polyvinylidene chloride pilm (Pig. 12).

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e) Experimental body electrode D is a disk made of steel 316, with a diameter of about 57 »15 mm and a thickness of about 0.076 mm, and has a cranked holding clamp made of steel 316 in its center. Above the disc is a piece of cotton-iFiber fleece fabric, diameter about 57.15 mm, thickness about 0.254 mm, arranged with the gel described in Example II with 15 parts by weight Sodium sulfate is soaked. This piece of tissue is completely from above with a thickness of about 0.076 mm Polyvinylidene chloride pilm covered.

body
electrode Trial-
person Setting
CSV Bovie-
device xnaktxve
electrode
A. Switch
duration
Sec. A. male III Cutting 1/27 . 0.75 ? 120.0 B. male, III Cutting 1/25 0.74 61.0 C. male III Cutting 1/25 0.74 93.0 D. male III Cutting 1/22 0.74 41.0

It should be noted that any material that can be used as the insulating material can be used as the insulating material usually found in electrical capacitors. However, it must be such that the skin and the Electrolyte and also the electrolyte and the metallic conductor with the changing current frequencies, as they are when working occur, capacitively, be coupled with electrical surgical devices.

Of course, the experimental arrangement described in Example VIII also applies to each of Examples IX to XIII.

In the table below are for each of the above Male subjects I to VI involved in the experiments, age and weight indicated:

/ 38 309832/0545

38 38 - weight 42 556 35 about 88.5 kg 2305220 Bäännl. 28 about 77.1 kg Test subject 40 age about 82.8 kg I. 33 years ewta 77.1 kg II 36 years about 81.6 kg III years about 60.2 kg IV years V years VI years

From the above test descriptions it is clear that the electrodes designed with small dimensions after the. Invention and the novel electrolytes with which they are associated make a very powerful biomedical one Represent a single-use instrument. This realization contradicts the known doctrines of the state in all points of technology in the field of indifferent or body electrodes, not to mention the myriad advantages that ensure their immediate success.

The invention is not restricted to the above exemplary embodiments, but rather within the scope of this basic concept can be modified in many ways.

30 9 8 32/0545

Claims (36)

EXPECTATIONS IJ Inactive electrode for use in electrosurgical Interventions that can easily be snuggled up against body surfaces, characterized in that the electrode of an electrode-electrolyte unit (10) is an electrically conductive element which has a partial surface at least about 0.245 cm is essentially completely in contact with an electrolyte mass (32; 5O; 6O; 7Oj9O; 100), ρ which, with a proportion of at least about 13 cm of its conductive surface, is essentially complete and Can bring conductive contact on the skin of a patient and has a thickness of at least about 0.254 mm to the to keep the conductive element at a distance from the patient's skin in all areas, at least this thickness Konit & kt— is about 4.192, ram when the / surface area of the conductive 2 2 Element between about 0.245 cm and about 0.645 cm is great. 2. Electrode according to claim 1, characterized in that g e k e η η, that the electrically conductive element is a disk. 3 »electrode according to claim 1, characterized GEK e η η - characterized in that the electrically conductive element is a wire (72). 4 »Electrode according to claim 1, characterized in that that the electrically conductive element is a flexible foil (17) made of stainless or corrosion-resistant steel and that the electrolyte is an alkali metal sulfate. 309832/0545 -Jt- 42 556 5. Electrode according to claim 4, characterized in that the electrolyte is an aqueous preparation in which the proportion of alkali metal sulfate is between about 0.5 wt. -Fo and an amount with which an approximately saturated aqueous solution can be produced leaves. 6. Electrode according to claim 5 »characterized in that the electrolyte is an aqueous preparation which contains between about 5 wt. - ^c ß> and about 20 wt .- ^ alkali metal sulfate. 7. Electrode according to claim 6, characterized in that the alkali metal sulfate is sodium sulfate. 8. Electrode according to claim 4, characterized in that g e k e η η - records, that a low profile, non-conductive shell (14) one facing the body surface Has cavity that the flexible conductive metal foil (17) forming the electrode is attached to a base (16) the cavity is arranged in the plane of this base (16), and that the electrolyte mass (32) is received in this cavity is, the surface of the electrode facing away from the base (16) completely covers and rests against it. 9. Electrode according to claim 8, characterized in that g e k e η η, that the electrolyte is an aqueous, highly viscous semi-solid preparation, the alkali metal sulfate in one Amount that is between about 3 wt .- ^ and an amount with which can be made into an approximately saturated aqueous solution, and a small but effective amount of one in water contains soluble and swellable mucus, and that the sulphate-mucus mixture in a sponge-like, cellular Matrix (32) is embedded evenly distributed. / 3 309832/0545 '42556 10 »Electrode according to claim 9 j characterized by g e k e η η, that the mucus is a neutralized, water-soluble and swellable Garboxypolymethylene and at a concentration of about $ 0.2 to about $ 5.0 on the G-E including the weight of the electrolyte preparation, available is. 11 «electrode according to claim 8. characterized geke η η is characterized in that the electrode is a resilient 'J ¹ O lie (17) made of stainless or corrosion-resistant steel, which has electrical contact with a conductive part (20,22) which is the base (16) penetrates the shell (14) and leads to a ground connection outside the shell (14). 12. Electrode according to claim 11, characterized in that g e k e η η, that the aqueous, highly viscous, semi-solid electrolyte mass essentially forms the cavity of the shell (14). fills and has a thickness which is at least as great as the depth of the shell (14). 13 · Electrode according to claim 12, characterized in that the thickness of the aqueous, highly viscous semi-solid electrolyte mass is greater than the depth of the shell (14). 14. Electrode according to claim 13 »characterized in that the open side of the shell (14) of a removable protective cover (38) is covered, which is made of an insulating material and a protruding Has part (42) which covers the semi-solid electrolyte mass emerging from the shell (14). 15. Electrode according to claim 14, characterized in that g e k e η η - · draws that the shell (14) to one with a Recessed flexible and elastic plate (12) rests, and that with the outer surface of the base (16) of the / 4 309832/0545 - JC - 42 556 Shell (14) in the same plane arranged surface of the plate (12) is significantly larger than the outer surface of the base (16) and comprises a pressure sensitive or pressure sensitive adhesive layer for adhering to a surface of the body. 16. Electrode according to claim 15 »characterized by g e k e η η, that an electrically conductive fastening part (20,22) through the recess in the flexible and elastic plate (12) and through the base (16) of the shell (14) penetrates and is securely attached to the flexible conductive metal foil (17), and that the Electrode can be electrically connected to earth via a part (24,26). 17. Electrode according to claim 16, characterized in that: e η η - ζ ei chne t that the electrically conductive fastening part (20, 22) to achieve a durable connection with the flexible conductive metal foil (17) through a recess formed in this thin, flexible poly (17). penetrates through, and that the fastening part (20,22) is designed as a push button made of conductive metal. 18. Electrode according to claim 17? thereby g e k e η η - ζ e i without t that the penetrating part (22) of the push button penetrates three aligned recesses, which in the resilient conductive metal foil (1-7) »in the shell (14) and in the resilient and elastic, with a Adhesive layer provided plate (12) are formed, and in a complementary sleeve (26), which from the non-adhesive Plane of the plate (12) protrudes, penetrates and is locked in this. 19. Electrode according to claim 18, characterized in that g e k e η η, that through a recess formed in the aqueous, highly viscous, semi-solid electrolyte mass / 5 309832 / 0S4S -J5 - 42 556 Shank (35) of a non-conductive rivet (34) penetrates and into the cavity of the penetrating part (22) of the push button penetrates and is locked in this, around the semi-solid slektrolyte mass with the resilient conductive Metal foil (17) to connect and to this in immediate To bring plant. 20. Electrode according to claim 15 »characterized geke η η - ζ ei without t that a protective film (30) is removably attached to the adhesive layer (28), and that the protective cover (38) is connected to this. 21 α electrode according to claim 1, characterized in that the electrolyte mass on its skin-side surface with a capacitor electrical insulating material / D84elli ^trikum ^ with which a capacitive coupling can be established under conditions such as occur when performing electrosurgical interventions. 22β Electrode according to claim 21, characterized in that the insulating material on the contact surface is arranged between the electrically conductive element and the slektrolyte mass. 23 ο electrode according to claim 21, characterized in that g e k e η η g s i c h η e t that a similar insulating material is also used on the contact surface between the electrolyte mass and the electrically conductive element is arranged. 24 = electrode according to claim 23, characterized geke η η - η% si ο h et that the insulating material is a thin polymer 'IPiIm (80). 25 ο electrode according to claim 24, characterized GEK e η η - characterized in that the insulating material is a Saran-l ilm is?. / 6 309832 / QEiS 42 556 26. Electrode according to claim 1 _f thereby gek e η η - ζ e i ch η et that the electrolyte mass is an electrolyte containing tissue. 27. An electrode according to claim 26, characterized GEK e η η - characterized in that the fabric is a cotton fiber non-woven tissue. 28. Electrode according to claim 1, characterized in that the electrolyte preparation is an inert one Contains filler. 29. Electrode according to claim 28, characterized in that g e k e η η, that the inert filler is powdered talc. 30. Procedure used in surgical diathermy. Let high-frequency radio waves be diverted electrically to ground, marked by the fact that on the Body surface and in the same plane with this a flexible sheet of conductive metal forming an electrode is placed on, the body surface facing 2 Area of the film between about 3 »23 cm and about 64.5 cm is dimensioned large, and that between the opposing surfaces of the electrode and the body and with immediate and a mass of electrolyte is placed thereon in substantially complete abutment, the substantially uniform thickness is between about 1.574 mm and about 12.7 mm. 31. The method according to claim 30, characterized in that: e η η - draws that the one facing the body surface 2 Area of the electrode foil between about 13 cm and about 2
32.3 cm tall. / 7 309832/0545 -% - 42 32. The method according to claim 30, characterized in that g e k e η η, that the conductive metal of the resilient polie is stainless or corrosion-resistant steel, and that the electrolyte is an alkali metal sulfate. 33 «The method according to claim 32, characterized in that it is ώ. η - indicates that the alkali sulfate is sodium sulfate. 34 «Method according to claim 33, characterized in that geke η _; n 55eich.net that the electrolyte used is an aqueous preparation in which the proportion of alkali metal sulfate is between about 0.5% by weight and an amount with which an approximately saturated aqueous solution can be produced. 35. The method according to claim 34, characterized in that g e k e n.n that an aqueous preparation is used as the electrolyte, which is between about 5 wt .- ^ and about Contains 20 wt .- # alkali metal sulfate. 36. The method according to claim 35, characterized in that the alkali metal sulfate is sodium sulfate. 30983 2 '/ 0545