CA1138532A - Electrosurgical grounding pad - Google Patents

Electrosurgical grounding pad

Info

Publication number
CA1138532A
CA1138532A CA000343132A CA343132A CA1138532A CA 1138532 A CA1138532 A CA 1138532A CA 000343132 A CA000343132 A CA 000343132A CA 343132 A CA343132 A CA 343132A CA 1138532 A CA1138532 A CA 1138532A
Authority
CA
Canada
Prior art keywords
metal sheet
electrode
foam
film
secured
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000343132A
Other languages
French (fr)
Inventor
Lawrence S. Lazar
Robert F. Wittemann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johnson and Johnson Hospital Services Inc
Original Assignee
Johnson and Johnson Products Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johnson and Johnson Products Inc filed Critical Johnson and Johnson Products Inc
Application granted granted Critical
Publication of CA1138532A publication Critical patent/CA1138532A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/16Indifferent or passive electrodes for grounding

Abstract

ABSTRACT OF THE INVENTION

ELECTROSURGICAL GROUNDING PAD

A grounding electrode useful in electrosurgery and easily contoured to body surfaces which comprises a flexible, perforated metal sheet, the lower side of which is coated with a conductive adhesive and the upper side of which is adhesively secured to a fenestrated film, said fenestrated film being adhesively secured to an open cell polymeric foam, and a conductive snap or button for conducting an electrical current secured to said metal sheet and extending through said fenestrated film and said polymeric foam. Preferably, the metal sheet is aluminum foil, the conductive adhesive is a quaternary polymer and said open cell foam is polyurethane.

Description

113~532 The instant invention relates to electrosurgical grounding pads, i.e. grounding electrodes useful in electro-surgical procedures.
In electrosurgical procedures, e.g , cauterization, fulguration and electrocoagulation, a ground electrode is contacted with the patient to prevent burning, etc.
Metal plates or foil may be used as grounding elec-trodes, preferably the plate or foil is coated with an elec-trically conductive gel to insure grounding of the patient.
This procedure is described in U S. Patent ~os. 3,960,141, 3,972,329 and 3,848,600.
The latter patent teaches the importance of insuring that the conductive area of the grounding electrode, which is in contact with the patient undergoing the electrosurgical procedure, is at least 9 square inches. Metal plates are, of course, nonconformable to the contours of the human body, therefore, problems in patient burns have occurred with such grounding electrodes. Foils are more conformable however, in the prior art electrodes, an adhesive area is also re-quired to insure that the foil will be maintained in proper body contacting relationship. An adhesive area is added which increases the overall area of the grounding pad elec-trode in contact with the patient without concomitant in-crease in conductive area.
Medical electrodes useful in monitoring and stimu-lating procedures are known wherein conductive adhesives have been utilized. However, these electrodes have much smaller areas of conductivity and are therefore, not sugges-ted for use as electrosurgical grounding electrodes. See for example, U.S. Patents3,607,788, 3,565,049, 3,426,746, 3,845,757, 4,016,869, 4,008,721, 3,993,049 and 3,911,906.

li3~53Z

In U.S Patent No 4,066,078, an electrode is des-cribed which utilizes a quaternary polymer or a sulfated polymer as a conductive adhesive. While this patent dis-closes an electrode suitable for any medical use, it does not teach that the amount of absorbed moisture must be main-tained between 6 and 20 weight percent of the quaternary polymer throughout the electrosurgical procedure, e.g , up to 8 hours, to insure adhesion of the electrode to the human body.
The instant invention relates to an electrosurgical grounding pad comprising an open cell foam, laminated to a fenestrated film, e.g., polyethylene, said film being adhered to a perforated metal foil, e.g., aluminum, which is in turn coated over substantially the entire surface away from said film with an electroconductive polymer, e.g~, a quaternary polymer, and an electrically conductive snap or button mech-anically and electrically connected with said metal foil extending through the open cell foam, said snap or button being adapted for connection to an electrosurgical device.
Preferably, said foam is laminated at the surface away from said fenestrated polyethylene film to a woven fabric such as nylon tricot.
The foam is necessary to impart proper feel to the electrosurgical grounding pad of the instant invention by contributing to the loft of the construction. The foam use-ful in preparing the instant novel electrosurgical grounding pad must be open celled to provide moisture transmission away from the conductive adhesive.
The foam may be a polyethylene, polyurethane, etc., examples of which are ~nown in the art~ The foam density may vary from 0.5 to 5 lb/ft3 preferably from 1 to 3 lbs per ft3.

The foam is preferably hydrophobic so as not to retain the moisture which passes from the patient through the conductive adhesive.
It is critical that the electrosurgical grounding pad of the instant invention be conformable to parts of the human body where it is used, such as the leg or arm. There-fore, the foam must be flexible. A flexibility of from 0.2 to lO psi as measured by the compressive stress at l~h def-lection is desirable in the instant foams.
The fenestrated film contributes to the strength of the electrosurgical grounding pad of the instant in~ention, especially the strength of the connection between the snap and the metal foil, functions to support the foil during per-foration, and bonds the foil to the foam. The fenestrated film may be polyethylene of thickness .00025l~ to ,0031~ or another polymer having similar strength at said thickness.
A paper or other nonwoven also may be utilized as the fenes-trated film However, additional adhesive must be used in bonding the paper to the foil and the foam. In the preferred embodiment, the fenestrated film is perforated with said perforations being registered through the perforations of the metal foil.
The metal foil provides conductivity between the conductive adhesive and the snap. Most any metal foil which is suitable to conduct the current required during electro-surgical procedure may be used. However, very high modulus of elasticity foils (e.g stainless steel) would detract from conformability and therefore are not preferred. Gener-ally, aluminum foil is the material of choice. The aluminum foil will have a thickness of from .00025~l to .003~l, pre-ferably from .00025ll to .OOlll.

113~532 The conductive adhesive is any conductive material which will bond to the metal foil and to the human body and is compatible with the patient's skin These adhesives are known in the art as described in U.S. Patent Nos 3,845,757, 4,016,869, 4,008,721, 3,565,049 and 3,911,906. These materials can be loaded with salts such as NaCl, Na2S04, K2S04, etc. or con-ductive particles such as carbon, alumina, etc The most preferred em~odiment for use in the electrosurgical grounding pad of the instant invention is described in U.S. Patent No.
4,066,078. The adhesives of U.S. Patent 4,066,078 may be present in thicknesses of from .001ll to .030ll and at such thicknesses will meet the criteria of providing less th~n 700 ohms at electrosurgical grounding frequencies (primary frequency) of 25 kilohertz to 5 megahertz. The conductive adhesives of U.S. Patent No. 4,066,078 are preferred over the aforementioned conductive adhesives because they are unfilled and unsalted materials It has been found that materials containing fillers and salts in general have a lower degree of adhesion to the human body and, therefore, tend to lower the adhesion function during the long electrosurgical pro-cedures in which the grounding pad is used Furthermore, the conductive adhesives of U S Patent No. 4,066,078 are hydrophilic in nature and transport water away from the human body The layers of hydrophobic conductive adhesives disclosed in the above-referenced patents, must be perforated to provide pathways for the removal of water This cuts down the effective conductive area. It has been found that the especially preferred quaternary homopolymer adhesive e.g., the homopolymer of an ester of an ~,~-olefinically unsatur-ated carboxylic acid and a monohydric alcohol having a ter-minal quaternary ammonium group, when plasticized with from ~13~53Z

15% to 25% by weight of a polyhydric alcohol such as glycerol, gives the best balance of adhesive and conductive properties.
These materials are especially suitable for use in the electro-surgical grounding pad of the instant invention when the moisture content thereof is maintained between 6 and 20 weight percent based on the conductive adhesive. Therefore, it is important that the preferred construction include sufficient perforations per square inch in metal foil and film when this adhesive is utilized as the conductive adhesive so that mois-ture may be transmitted away from the adhesive. Generally,110 to 120 perforations of .0451l diameter, per inch2 will be suitable to provide from about 18 to 2~/o open area in the foil and film laminate. This degree of openness is suitable to maintain the above moisture content in the adhesive.
The snap functions to mechanically and electrically connect the aluminum foil to the electrosurgical apparatus as show~l. For example, in ~iguro L~ the snap may comprise an eyelet and post construction. The eyelet is located under the aluminum foil and the post is attached thereto by punch-ing through the construction into the eyelet and crimpingsaid eyelet to the post to form an electrically integral con-nection. The material of choice for said post is nickel coated brass which is harder than aluminum and is easily fabricated. Because of its conductivity and compatability properties, the eyelet is preferably aluminum. Copper is also suitable except for use in conjunction with the preferred quaternary adhesive homopolymer, since it has been found to discolor said polymer and thereby detract from the appearance of the electrosurgical grounding pad of the invention The post is an open cylinder having sharp edges. This form of construction provides a self piercing feature and is pre-ferred since it minimizes the insulation of the post from the 1~38532 eyelet by the electrosurgical grounding pad materials during the connection of the post and the eyelet.
The woven fabric contributes to the conformability of the electrosurgical grounding pad of the instant invention while providing strength to the construction and minimizing the extensibility of the foam. The fabric also contributes to the esthetic quality of the construction. It is preferred that a fabric having a biaxial stretch be used although a uni-laterally stretchable fabric can be used when such stretch is in the long dimension of the fabric. It is important that the fabric be conformable since, when wrapping a limb, the outer layer must not buckle and thereby reduce the contact of the conductive adhesive below. Preferably, the fabric is a nylon tricot.
According to the above description of the invention, from a broad aspect, there is provided a grounding electrode useful in electrosurgery and easily contoured to body sur-faces. The grounding electrode comprises an open cell poly-meric foam. The electrode also comprises a flexible, per-forated metal sheet having an upper side and a lower side~Further provided is a fenestrated film having first and second sides. Electrically conductive means is adapted to be connected to an electrosurgical device for conducting an electric current therefrom. The lower side of the metal sheet is coated with a conductive adhesive and the upper side of the metal sheet is adhesively secured to the first side of the fenestrated film. The polymeric foam is adhesively se-cured to the second side of the fenestrated film. The conduc-tive means is secured ~o the metal sheet and extends through the fenestrated film and the polymeric foam.
Figure 1 describes a preferred embodiment of the instant invention.
~ 6 --, ., , 113~S32 Figure 2 describes a method of making said pre-ferred embodiment.
Starting with the lower surface of the instant electrosurgical grounding pad construction 7 represents a release paper which is used to protect adhesive layer 6 prior to affixing said electrosurgical grounding pad to the body of a patient. Preferably, adhesive layer 6 comprises a homopolymer of a quaternary monomer such as described in U.S. Patent No. 4,066,078. The adhesive is in turn secured at the surface away from the release paper to a perforated aluminum foil 2. The aluminum foil is secured by means of an extrusion bonded, low density, polyethylene adhesive to a fenestrated polyethylene film 1. The perforations (c) extend through both said polyethylene film and said aluminum foil in registered relationship An open cell polyurethane foam 3 is laminated to said polyethylene film. A tricot nylon fabric 4 is laminated to said polyurethane foam and comprises the upper surface of the instant electrosurgical grounding pad. Extending through said fabric 4, ~oam 3, film 1 and foil 2 layers is a snap 5 which is suitable for electrically and mechanically connecting the instant electro-surgical grounding pad to an electrosurgical apparatus via a cable or wire. Snap 5 comprises post (a) having a ball portion (al) extending above said tricot nylon layer and a self piercing end (a2) located distally therefrom. The piercing end is useful for puncturing the above noted layers and may be crimped onto eyelet (b) which abuts the lower surface of said aluminum foil thereby providing electrical contact bet-ween the said aluminum foil and said ball (al). The post is made from nickel-coated brass and the eyelet is aluminum.
Aluminum foil 2 and polyethylene film 1 are ex-trusion honded in zone 11 to form a laminate. The film and : ~ , li3~S32 the foil may be laminated by means of a polyethylene adhesive e.g., low density polyethylene. The laminate may be corona treated at the polyethylene surface to increase the polarity and yield a stronger bond from the subsequent flame lamina-tion process. The corona treated laminate is perforated in zone 12 by means of a perforating machine A urethane foam 3 is laminated to a tricct nylon fabric 4 in zone 13 and said laminate is bonded to the perforated laminate from zone 12 in zone 14. As shown, the foam is laminated to the perforated polyethylene film by a flame lamination process. To the laminate from zone 1~ is affixed a conductive metal snap 5, said snap, as described above, being a two piece construction having a self piercing post for piercing said laminate and an eyelet which engages said post and the lower surface of said aluminum foil. The eyelet is set toward the edge of said laminate and the post is driven through the laminate and crimped into the eyelet. The laminate is coated at the alu-minum foil surface in zone 15 with a conductive adhesive film 6 such as the homopolymer of a quaternary polymer. The conductive adhesive film 6 is carried to said zone 15 supported on re-lease paper 7. Electrosur~ical grounding pads measuring approximately 20 square inches are punched out of the above laminate by die cutting to the release paper in zone 16.
Finally, individual grounding pads ready for packagin~ are cut by means of a guillotin~ knife in zone 17.

Claims (6)

The embodiments of the invention in which an exclu-sive property or privilege is claimed are defined as follows:-
1. A grounding electrode useful in electrosurgery and easily contoured to body surfaces which comprises:
an open cell polymeric foam;
a flexible, perforated metal sheet having an upper side and a lower side;
a fenestrated film having first and second sides, and electrically conductive means adapted to be connected to an electrosurgical device for conducting an electrical current therefrom; said lower side of said metal sheet being coated with a conductive adhesive, said upper side of said metal sheet being adhesively secured to said first side of said fenestrated film, said polymeric foam being adhesively secured to said second side of said fenestrated film, and said conductive means being secured to said metal sheet and extending through said fenestrated film and said polymeric foam.
2. The electrode of claim 1 wherein said metal sheet is aluminum.
3. The electrode of claim 1 wherein said means for conducting an electrical current comprises a snap composed of an aluminum eyelet secured to said metal sheet and a nickel coated brass post that extends beyond said polymeric foam and passes therethrough and through said film and is mechanically secured to said aluminum eyelet in electrical conducting re-lationship to said metal sheet.
4. The electrode of claim 1 wherein said conductive adhesive comprises a quaternary polymer.
5. The electrode of claim 1 wherein said foam is poly-urethane.
6. The electrode of claim 1 additionally including a nylon fabric adhesively secured to said open cell foam at the surface away from said metal sheet.
CA000343132A 1979-01-08 1980-01-07 Electrosurgical grounding pad Expired CA1138532A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US1503 1979-01-08
US06/001,503 US4267840A (en) 1979-01-08 1979-01-08 Electrosurgical grounding pad

Publications (1)

Publication Number Publication Date
CA1138532A true CA1138532A (en) 1982-12-28

Family

ID=21696360

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000343132A Expired CA1138532A (en) 1979-01-08 1980-01-07 Electrosurgical grounding pad

Country Status (10)

Country Link
US (1) US4267840A (en)
EP (1) EP0013613B1 (en)
JP (1) JPS55101257A (en)
AT (1) ATE1879T1 (en)
AU (1) AU529037B2 (en)
CA (1) CA1138532A (en)
DE (1) DE3061166D1 (en)
IN (1) IN150864B (en)
PH (1) PH16549A (en)
ZA (1) ZA8083B (en)

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Also Published As

Publication number Publication date
IN150864B (en) 1983-01-01
DE3061166D1 (en) 1983-01-05
ATE1879T1 (en) 1982-12-15
JPS55101257A (en) 1980-08-01
EP0013613B1 (en) 1982-12-01
PH16549A (en) 1983-11-10
JPS639865B2 (en) 1988-03-02
AU529037B2 (en) 1983-05-26
ZA8083B (en) 1981-08-26
EP0013613A1 (en) 1980-07-23
US4267840A (en) 1981-05-19
AU5437480A (en) 1980-07-17

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