US3805769A - Disposable electrode - Google Patents

Abstract

A disposable electrode structure for operatively connecting electrical equipment to the surface of live skin of a patient, employing a self-contained electrical conductive material for affecting the connection, and cover means for protectively sealing said conductive material, readily removable from the electrode structure at time of use.

Description

United States Patent 1191 Sessions Apr. 23, 1974 DISPOSABLE ELECTRODE [76] Inventor: Robert Sessions, German Church Rd., Hinsdale, ll].

[22] Filed: May 24, 1973 [21] Appl. No; 363,717

Related US. Application Data [63] Continuation of Ser. No. 175,443, Aug. 27, 1971,

abandoned.

[52] US. Cl. l28/2.06 E, 29/629, 29/630 R, l28/2.1 E, 128/417, l28/DIG. 4 [51] Int.Cl A6lb 5/04 [58] Field of Search l28/2.06 E, 2.1 E, 404, 128/411, 417, 418, DIG. 4; 136/175; 29/629,

[5 6] References Cited UNITED STATES PATENTS 2,887,112 5/1959 Smith 128/417 3,085,577 4/1963 Berman et al. 128/418 3,170,459 2/1965 Phipps et al....

3,487,827 1 1970 Edmark 3,518,984 7 1970 Mason 3,581,736 6/1971 Zenkich l28/2.06 E

Primary Examiner-William E. Kamm Attorney, Agent, or Firm-l-lill, Sherman, Meroni,

, Gross & Simpson 57 ABSTRACT A disposable electrode structure for operatively connecting electrical equipment to the surface of live skin of a patient, employing a self-contained electrical conductive material for affecting the connection, and cover means for protectively sealing said conductive material, readily removable from the electrode structure at time of use.

24 Claims, 4 Drawing Figures DISPOSABLE ELECTRODE BACKGROUND OF THE INVENTION With the development and common usage of various types of electrical and electronic equipment for measuring and/or monitoring human body functions and the like, the demand for a suitable, highly 'efficient electrode structure has progressively increased.

While it has been demonstrated in the past that an electrode structure employing a suitable conductive material such as a conductive gel, would appear to be the most effective from an operational standpoint, the use of such conductive gels has resulted in additional problems, particularly in connection with preserving the usefulness of the gel over prolonged periods whereby the electrode structure will have a relatively long shelf life, i.e., from manufacture to actual usage.

It has proved to be desirable to clean and slightly roughen skin surface at the point of connection of the electrode thereto.

Likewise, as reuse of a medical or surgical structure will normally require cleaning, sterilization, etc., the utilization of a disposable type structure requires not only a highly efficient structure but one that is very inexpensive to manufacture and generally quite simple in construction.

SUMMARY OF THE INVENTION The present invention therefore has as its principal object the production of a highly efficient electrode structure of the type involved, utilizing a conductive gel or other suitable material as the connecting medium and yet which is relatively simple and relatively inexpensive to manufacture whereby the same may be economically employed as a single use structure which is disposable following use.

This is accomplished in this invention by employing a structure comprising a plurality of sheets of suitable material, certain of which are each provided with a layer or coating of adhesive which form the means for securing respective elements to one another permanently, or detachably, and for connection of the structure to the skin of the patient. The metallic electrical terminal is disposed for connection to such skin surface by means of a conduit in gel, carried on a pad disposed at such terminal.

The conductive gel is protected, prior to use by a cover assembly which includes an annular spacing member encircling the pad and gel, a protective sheet for the skin-engageable adhesive, and a cover sheet, the assembly being cooperable with a portion of the electrode structure to form a sealed protective enclosure for the pad and gel, operative to prevent undesired deterioration thereof over relatively long periods of storage, etc., prior to usage.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, wherein like reference characters indicate like or corresponding parts:

FIG. 1 is a transverse sectional view of a disposable electrode structure and its protective cover assembly, taken approximately on the line II of FIG 2;

FIG. 2 is a bottom view of the structure as illustrated in FIG. 1;

FIG. 3 is a sectional view similar to FIG. 1 of the electrode structure following removal of the protective cover assembly therefor; and

FIG. 4 is a plan diagrammatic view illustrating respective steps of a method of making the electrode structure and its cover assembly.

DETAILED DESCRIPTION OF THE INVENTION Referring to FIG. 1, 2 and 3, the reference numeral 1 indicates generally the electrode structure in accordance with the present invention while reference numeral 2 indicates generally the protective cover assembly adapted to be engaged therewith and subsequently stripped off at time of use. While other configurations may be suitable in specific applications, I have found that in general a circular configuration is preferable and the various components making up the electrode structure and the basic cover assembly structure are illustrated as being circular in configuration with the various components generally arranged on a common axis.

THE ELECTRODE STRUCTURE Referring to FIGS. 2 and 3, the electrode structure 1 comprises a first sheet 3 of suitable material and generally circular in configuration. I have found that'a thin fibrous porous material is preferable. A very satisfactory material is that known as Micropore, a brand manufactured by Minnesota Mining & Mfg. Co. The sheet 3 is provided with an opening 4 therein, likewise illustrated as being of circular configuration, across which extends a second relativelyimpermeable sheet 5, likewise of circular configuration, of a size to completely cover the opening 4 and overlie the sheet 3 ad-' jacent the periphery of the opening 4, thesheet 5 having a layer 6 thereon of suitable adhesive by means of which thesheet 5 is firmly attached to the sheet 3. Thesheet 5 preferably is fabricated from suitable plastics, a polyethylene-vinyl laminate being particularly suitable. The sheet 3 likewise provided with an adhesive coating 7 on the lower or outer face as viewed in FIG. 3 by means of which the structure may be secured to the skin of a patient, theadhesive being of the nontoxic type commercially procurable.

Secured to thesecond sheet 5 is an electrical terminal, indicated generally by thenumeral 8 which is illustratedas comprising an outer connector-member 9 and an innerconact member 10. The connector member 9 comprises a circular base portion 11 from which extends a hollowbulbous portion 12 while theinner member 10 comprises a similarcircular base portion 13 from which extends a hollow shank or stem 14. The latter is inserted in thebulbous portion 12 and the free end crimped over during the mounting operation to rigidly clamp the two members in operative position with the stem 14 extending through thesheet 5 and the latter firmly secured between thebase portions 11 and 13 of the respective members. Disposed in the opening 4 and overlying thebase portion 13 of themember 10 is a circularporous pad 15, secured in operative position by means of the exposed adhesive on thesheet 5. Thepad 15 may be constructed, for example, of a porous or foam-type plastic such as that used in plastic sponges and the like, thepad 15 having or containing a supply of a conductive gel 16.

As illustrated in FIG. 3, thebulbous portion 8 of the member 9 forms one half of a connector structure, to which another cooperable connector member 17 may be engaged, whereby an electrical conductor or the like 18 may be connected to theterminal 8.

In use, the electrode structure illustrated in FIG. 3 is applied after suitable cleaning or preparation, if any, of the skin surface, by pressing th structure down the the skin surface to bring thepad 15 in firm engagement with the skin surface, following which the peripheral portions of the structure are pressed firmly into engagement with the skin surface, whereby the adhesive layer 7 will firmly adhere to such surface and thereby effectively secure the electrode structure'thereto, with thepad 15 thus providing a good physical connection between the contact member of theterminal 8 and the skin surface while the gel 16 forms an efficient electrically conductive connection between such skin surface and thebase portion 13 of themember 10. Following such mounting of the electrode structure, the connec-.

tor member 17 may be engaged with theterminal 8 to operatively connect the conductor or line 18 to the electrode structure.

PROTECTIVE COVER ASSEMBLY The protective cover assembly 2 is constructed to not only seal the pad and the gel 16 carried thereby, as well as protect the adhesive layer 7, but to prevent undesired contacting of the pad and thus possible squeezing forces on the pad, which might force the material 16 therefrom and thus possibly impair the operation of the structure at the time of use. In the embodiment of the invention illustrated, the cover assembly 2 cornprises a relatively impermeable sheet of material 19, preferably heavier and stiffer than the first sheet 3 of the electrode structure, for example, a suitable paper, the sheet 19 having substantially the same external diameter as the sheet 3 and provided with an opening 20 therein which, in the embodiment illustrated, is slightly smaller than the opening 4 in the sheet 3.

Disposed at the exterior face of the sheet 19 is aspacing ring 21 of suitable material, for example, polyethylene, the ring, as illustrated, having an inner diameter which is less than the diameters of both openings 20 and 4 in the respective sheets 19 and 3, whereby the inner face of thering 21 may be engaged with the adhesive layer 6 on thesheet 5 to provide an effective seal between the latter and the ring. At the same time, the inner diameter of thering 21 is greater than the diameter of thepad 5, whereby the ring will not engage and compress the pad. Overlying thering 21 is acover sheet 22, illustrated as having a diameter intermediate the outer diameter of thering 21 and the outer peripheral edge of the sheet 19, thesheet 22 having anadhesive layer 23 thereon by means of which the sheet is firmly secured to the adjacent face of thering 21 and to the adjacent outer face of the sheet 19. Thesheet 22 preferably is adapted to provide an effective seal for the gel 16 and conveniently may be fabricated from the same material as thesheet 5. Likewise, thesheet 22 preferably has a diameter sufficient to permit the effective engagement of thesheet 22 to the sheet 19 to form a unitary cover assembly. To provide further protection of this gel 16, a second pad 15', may be provided which is disposed in opposition to thepad 15 and secured to the cover assembly by theadhesive layer 23 as thesheet 22. This construction eliminates any possibility of thepad 15 and gel thereon coming in contact with theadhesive layer 23.

It will be particularly noted that thepads 15, 15' and the material 16 contained thereon are, by this construction, effectively sealed against external contamination with thering 21 andsheets 5 and 22 forming a substantially air-tight chamber in which the conductive material may be stored for relatively long periods of time without material deterioration.

When it is desired to use the electrode structure, the protective sheet 19 is merely stripped from the sheet 3 carrying with it thespacing ring 21 as well as thecover sheet 23 andpad 15. In this connection, it will be noted that in the construction illustrated thering 21 partially overlies the sheet 19 so that the adhesive layer 6 on thesheet 5 is not in contact with the entire area of the adjacent face of thering 21, whereas the opposite face of the ring is in contact throughout its area with the adhesive of thecover sheet 22. In view thereof, as well as the fact that the ring is, in effect, partially gripped between thesheets 19 and 22, thering 21 will readily separate from thesheet 5 instead of from the remainder of the cover assembly.

To facilitate such stripping, the sheet 19 preferably has a radially extending cut 24 therein extending from the opening 20 to the periphery of the sheet to enable the sheet 19 to be readily grasped thereat for stripping.

Likewise, if the sheet 19 does not have a smooth surface readily strippable from the adhesive 7, the sheet may be provided with suitable surface coating, for example, a suitable silicone of known type. A cleaning strip 25, having a rough outer surface may be mounted on the face of the core assembly for use as an abrading type cleaning member and may, for example, be formed from a synthetic rubber material.

MANUFACTURE OF THE STRUCTURE A preferred method of manufacture of the structure above-described is illustrated in FIG. 4 which depicts successive steps in such manufacture with alternate steps II being illustrated.

The first step, as illustrated at I, may be the forming of an opening 4 in an adhesive coated strip of stock S from which the sheet 3 is to be eventually produced. Thecircular sheet 5, following cutting from suitable adhesive coated sheet stock is then disposed over the opening 4, as illustrated at II, and pressed into firm contact therewith whereby the adhesive coating on thesheet 5 will firmly secure the latter to the strip S. Theterminal 8 may then be applied to thesheet 5 in any suitable manner in accordance with the techniques commonly employed in connection with such type of structure.

If desired theterminal 8 may be first mounted on the sheet I and then the latter secured to the stock S'as illustrated at IIIT. IIIB illustrates the assembly at IIIT but from the reverse side of the strip S and at IV the previously formed sheet 19 with thecut 24 therein is disposed in operative position and firmly mounted by means of the adhesive layer 7 to the strip S. At V thisring 21 is applied, engaging the adhesive 6 of thesheet 5. At VI, thepad 15 is disposed in operative position and firmly engaged with the adhesive layer 6. Thepad 5 is then impregnated with the conductive material 16 at VII, followed by the placement of thepad 15. If desired this gel may be disposed with thepad 15.

Thecover sheet 22, following previous formation from adhesive coated stock is applied in operative position, as illustrated at Vlll, and firmly adhesively connected with the adjacent face of thering 21 and outer surface of the sheet 19, following which the cleaning strip is adhesively secured to the assembly, as illustrated at IX. The strip S is then suitably cut to provide a circular configuration to the sheet 3, as illustrated at X, completing the manufacture.

In some cases it may be desirable to initially secure the pad with or without the gel 16 to thecover sheet 22 and then secure the cover sheet to the assembly.

It will be noted that the various production steps are each simple in themselves and as the adhesive coatings enable fast and effective connection between the respective parts, assembly may be performed at a very rapid rate.

It will be particularly noted that the enclosure of thepad 15 and its contents of conductive material by the pad 15',polyethylene ring 21, and sealed by the respective polyethylene-vinyllaminated sheets 5 and 22, insure an air-tight sealing of the conductive material whereby the same may be stored over relatively long periods without material deterioration.

The inclusion of the cleaning strip 25, while not directly required with an electrode structure, enables the operator to quickly and effectively prepare the skin surface prior to the mounting of the electrode without other apparatus and at the same time provides an individual cleaning member for each electrode.

Having thus described my invention it will be obvious that various immaterial modifications may be madein the same without departing from the spirit of my invention.

I claim as my invention:

1. A disposable type electrode for operatively connecting electrical equipment to the surface of live skin of a patient, comprising a sheet of relatively porous material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, said sheet having an opening therein, a second sheet of relatively impermeable material completely spanning the area of said opening, said second sheet having an adhesive coating on the adjacent face thereof contacting said first sheet for retaining the same in assembled relation an electrical terminal extending-through and secured to said second sheet on a portion thereof extending across the opening in said first sheet, said terminal hav-' ing means at the outer side of said second sheet for effecting connection with an electrical conductor, and having a contact portion disposed in the opening said first sheet, the area of said opening being greater than the area of said contact portion to provide an annular area therearound at which the adhesive coating of said second sheet is exposed, a pad of porous material disposed at the opening in said first sheet and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce 'a conductive connection between said connector and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet. on a portion thereof extending across the opening in said first sheet, said terminal having means at the outer side of said second sheet for effecting connection with an electrical conductor, and having a contact portion disposed in the opening said first sheet, the area of said opening being greater than the area of said contact portion to provide an annular area therearound at: which the adhesive coating of said second sheet is exposed, a pad of porous material disposed at the opening in said first sheet and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce a conductive connection between said connector and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet.

2. An electrode according to claim 1, wherein the dimensions of the opening in said first sheet of the electrode structure are greater than the corresponding outer dimensions of said pad to provide an annular space between said pad and first sheet at which the adhesive coating on said second sheet is exposed, and clo sure means in sealing engagement with said second sheet.

3. An electrode according to claim 1 wherein said pad, respective sheets and 'the opening in said first sheet are respectively circular in configuration, with the respective components and said terminal being disposed on a common axis.

4. An electrode according to claim 1, wherein said electrical terminal comprises an outer connector member and an inner contact member engaged therewith, each of which is provided with a base portion in contact with the adjacent face of said second sheet, that of the inner member being in engagement with the adhesive coating on said second sheet, said inner member extendingthrough said second sheet and engaging said outer member with said second sheet clamped between said base portions.

5. As an article of manufacture, a disposable type electrode for operatively connecting electrical equipment to the surface of live skin of a patient, comprising a sheet of material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, said sheet having an opening therein, a second sheet of material completely spanning the area of said opening with its peripheral portions adhesively secured to said first sheet to retain the same in assembled relation, an electrical terminal extending through and secured to said second sheet on a portion thereof extending across the opening in said first sheet, said terminal having means at the outer side of second sheet for effecting connection with an electrical conductor, and having a contact portion, disposed in the opening in said first sheet, a pad of porous material disposed at the opening in said first sheet and engaged with the adjacent contact portion, said pad being retained in position by adhesive surrounding said adjacent contact portion, a quantity of electrically conductive material contained on said pad operative to produce a conductive connection between said connector and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of said sheet, and a protective cover structure for said pad and exposed adhesive of said first sheet, of a size to extend across and engage said adhesive of the first sheet, the adhesive-engaged surface of said cover structure being such that the latter may be easily stripped from such adhesive, said cover structure having means for spacing the portion of said cover structure covering said pad, outwardly from peripheral portions of said cover structure, forming a recess at the inner side thereof, into which said pad extends.

6. An article of manufacture according toclaim 5, wherein said cover structure comprises a protective sheet engaged with the adhesive of the said first sheet, and having an opening therein greater in size than said pad, an annular spacing member encircling the opening in such sheet and having an internal size greater than that of said pad and an external size greater than the opening in such protective sheet, and a cover sheet greater in size than said spacing member overlying the latter and having a coating of adhesive on the adjacent face in engagement with said spacing member, the peripheral edges of said cover sheet extending laterally outward from said spacing member and in adhesive engagement with the outer face of the adjacent sheet of said cover member.

7. An article of manufacture according to claim 6, wherein said sheet of the cover assembly contacting the adhesive of said first sheet is provided with a cut therein extending from the opening therein to the periphery thereof for facilitating stripping of such sheet from said first sheet and thereby the cover assembly from the electrode structure.

8. An article of manufacture according to claim 7, wherein the surface of said sheet of the cover assembly contacting the adhesive of said first sheet is provided with a coating of a material which will permit relatively easy stripping of said sheet from the first sheet.

9. An article of manufacture according. to claim 8, wherein said surface coating comprises a silicone composition.

10. An article of manufacture according to claim 7, wherein said pad, spacing member, respective sheets and the openings therein are respectively circular in configuration, with the respective components and said terminal being disposed on a common axis.

11. An article of manufacture according to claim 6, wherein the dimensions of the respective openings in said first sheet of the electrode structure and said protective sheet are greater than the corresponding inner dimensions of said spacing ring, whereby said pad and its contents are sealed by said ring, the second sheet of the electrode structure and said cover sheet of the cover assembly, said sheets being secured to said ring by the respective adhesive coatings.

12. An article of manufacture according to claim 6, wherein said electrical terminal comprises an outer connector member and an inner contact member engaged therewith, each of which is provided with a base portion in contact with the adjacent face of said second sheet, that of the inner member being in engagement with the adhesive coating on said second sheet, said inner member extending through said second sheet and engaging said outer member with said second sheet clamped between said base portions.

13. An article of manufacture according toclaim 5, comprising a path of material secured to said cover assembly and having a relatively rough exterior surface which may be employed to roughen the skin surface of the patient at the point of application of the electrode thereto.

14. An article of manufacture according toclaim 13, wherein said patch comprises a strip of adhesive backed synthetic rubber or the like adhesively secured to said cover assembly.

15. An article of manufacture according toclaim 5, wherein said cover assembly is provided with a porous pad disposed within said annular spacing member and secured to the assembly by the adhesive coating on said protective sheet, with said last-mentioned pad disposed in opposition to the gel-supporting pad of the electrode structure.

16. A method of fabricating a disposable electrode and protective cover assembly therefor, comprising the steps of forming an opening, in an elongated strip of adhesively coated sheet material, defining the central portion of the electrode, mounting an adhesively coated second sheet of relatively impermeable material across said opening utilizing therefor, the adhesive on said second sheet, mounting and electrical terminal on said second sheet, which terminal includes a contact disposed at the adhesively coated face thereof and substantially centered in said opening, applying a protective sheet, having an opening formed therein, of a size approximately that of-said first opening, to the adhesive surface of said strip with such opening in aligned relation with the opening in'said strip, mounting a pad, greater in size than said contact portion, to said second sheet by means of the adhesive thereon with said pad in superimposed relation on said portion, said pad being less in size than the opening in said strip whereby an annularly shaped area of the adhesive on said second sheet remains exposed, applying to such assembled structure a ring-like member having an inner peripheral size greater than that of said pad and less than that of the opening in said strip with said spacing member encircling said pad and engaged with the adhesive of the second sheet, applying a conductive material to said pad, covering said spacing member with an adhesively coated sheet of relatively impermeable material having a peripheral size greater than the outer periphery of spacing member and less than that of the outer periphery of said protective sheet, securing said cover sheet by means of the adhesive thereon to said spacing member and the protective sheet, thereby sealing the pad and conductive material thereon in the chamber defined by said spacing member and said second and cover sheets, and severing the assembled electrode and protected cover assembled from said elongated strip.

17. A method according to claim 16 comprising the additional step of cutting said protective sheet, prior to its engagement with said first sheet, along a generally radial line extending from the opening therein to the peripheral edge of such sheet.

18. A method according to claim 16, comprising the additional step of applying to the outer face of said cover sheet, prior to the severance of the structure from said elongated strip, a piece of abrading-type cleaning material having an adhesive coating on the face thereof applied to said cover sheet by means of which said cleaning material is secured thereto.

19. A method according to claim 16 wherein the step of mounting said electrical terminal to said second sheet is effected prior to the mounting of the latter on said strip.

20. A method according to claim 16 wherein the step of mounting said electrical terminal to said second sheet is effected following mounting of the latter on said strip.

21. A disposable type electrode for operatively connecting electrical equipment to the surface of live skin of a patient, comprising a relatively large sheet of relatively porous material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, a second relatively small sheet of relatively impermeable material centrally disposed with respect to said first sheet and secured thereto with the peripheral edges of the second sheet spaced inwardly from the peripheral edges of the first sheet, said second sheet having an adhesive coating on the face thereof corresponding to the adhesively coated face of said first sheet, said sheets being retained in assembled relation by the adhesive of one of said sheets engaged with the adjacent face of the other of said sheets, and with the central portion of the adhesively coated face of said second sheet being exposed, an electrical terminal extending through the exposed central portion of said second sheet, said terminal having a contact portion disposed at the adhesively coated face thereof and means, ex tending outwardly from the other face thereof, arranged for effecting connection with an electrical conductor, the area of said adhesive coated face of said second sheet being greater than the area of said contact portion to provide an exposed area therearound, a pad of porous material disposed at and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce a conductive connection between said contact portion and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet.

22. As an article of manufacture, a disposable type electrode for operatively connecting electrical equipment to the surface of live skin of a patient, comprising a relatively large sheet of relatively porous material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, a second relatively small sheet of relatively impermeable material centrally disposed with respect to said first sheet and secured thereto with the peripheral edges of the second sheet spaced inwardly from the peripheral edges of the first sheet, said second sheet having an adhesive coating on the face thereof corresponding to the adhesively coated face of said first sheet, said sheets being retained in assembled relation by the adhesive of one of said sheets engaged with the adjacent face of the other of said sheets, and with the central portion of the adhesively coated face of said second sheet being exposed, an electrical terminal extending through the exposed central portion of said second sheet, said terminal having a contact portion disposed at the adhesively coated face thereof and means, extending outwardly from the other face thereof, arranged for effecting connection with an electrical conductor, the area of said adhesive coated face of said second sheet being greater than the area of said contact to provide an exposed area therearound, a pad of porous material disposed at and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce a conductive connection between said contact portion and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet, and a protective cover structure for said pad and exposed adhesive of said first sheet, of a size to extend across and engage said adhesive of the first sheet, the adhesive engaged surface of said cover structure being such that the latter may be easily stripped from such adhesive, said cover structure, covering said pad, outwardly from peripheral portions of said cover structure, forming a recess at the inner side thereof, into which said pad ex tends.

23. An article of manufacture according toclaim 22, wherein the outer periphery of the exposed area of the adhesively coated face of said second sheet is of a size to overlie and adhesively engage the adjacent portion of said cover structure and form a seal therebetween whereby the pad and preapplied conductive gel are thereby sealed between said second sheet and said cover structure.

24. A method of fabricating a disposable electrode and protective cover assembly therefor, comprising the steps of disposing on an elongated strip of adhesively coated sheet material, a relatively small adhesively coated second sheet of relatively impermeable material with the adhesively coated faces of said first and second sheets being correspondingly oriented and with second sheet being secured to said first sheet by the adhesive on one of said sheets, and with the central portion of the adhesively coated face of said relatively smaller second sheet being exposed, mounting an electrical terminal on said second sheet, which terminal includes a contact portion disposed atand less in size than the exposed adhesively coated face of said second sheet substantially centered thereon whereby said exposed face forms an annularly shaped adhesive coated area therearound, applying a protective sheet, having an opening formed therein of a size approximately that of the exposed adhesively coated face of said second sheet, to the adhesive surface of said strip with such opening in aligned relation with said exposed adhesively coated face of said second sheet, mounting a pad, greater in size that said contact portion, to said second sheet by means of the adhesive thereon, with said pad in superimposed relation on said portion, said pad being less in size than the exposed adhesively coated face of said second sheet whereby an annularly shaped area of adhesive on said second sheet remains exposed, applying a conductive material to said pad, covering said pad with a cover structure of relatively impermeable material having a peripheral size greater than the outer periphery of the exposed adhesively coated face of said second sheet and having an outwardly extending cen tral portion of a size to enclose said pad securing the adjacent peripheral portions of said outwardly extending portion to said second sheet by means of the exposed adhesive thereon, thereby sealing the pad and conductive material thereon in the chamber defined by the outwardly extending portion of said cover structure and said second sheet, and severing the assembled electrode and protective cover structure from said elongated strip.

Disclaimer and Dedication 3,805,769.R0bert W. Sessions, Hinsdale, Ill. DISPOSABLE ELECTRODE. Pa-

tent dated Apr. 23, 1974. Disclaimer and Dedication filed Feb. 4, 1981, by the assignee, Minnesota Mining & Manufacturing Co. Hereby disclaims and dedicates to the Public the remaining term of said patent.

[Oflicial Gazette October 25, 1983.]

Claims (24)

1. A disposable type electrode for operatively connecting electrical equipment to the surface of live skin of a patient, comprising a sheet of relatively porous material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, said sheet having an opening therein, a second sheet of relatively impermeable material completely spanning the area of said opening, said second sheet having an adhesive coating on the adjacent face thereof contacting said first sheet for retaining the same in assembled relation an electrical terminal extending-through and secured to said second sheet on a portion thereof extending across the opening in said first sheet, said terminal having means at the outer side of said second sheet for effecting connection with an electrical conductor, and having a contact portion disposed in the opening said first sheet, the area of said opening being greater than the area of said contact portion to provide an annular area therearound at which the adhesive coating of said second sheet is exposed, a pad of porous material disposed at the opening in said first sheet and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce a conductive connection between said connector and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet. on a portion thereof extending across the opening in said first sheet, said terminal having means at the outer side of said second sheet for effecting connection with an electrical conductor, and having a contact portion disposed in the opening said first sheet, the area of said opening being greater than the area of said contact portion to provide an annular area therearound at which the adhesive coating of said second sheet is exposed, a pad of porous material disposed at the opening in said first sheet and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce a conductive connection between said connector and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet.

2. An electrode according to claim 1, wherein the dimensions of the opening in said first sheet of the electrode structure are greater than the corresponding outer dimensions of said pad to provide an annular space between said pad and first sheet at which the adhesive coating on said second sheet is exposed, and closure means in sealing engagement with said second sheet.

3. An electrode according to claim 1 wherein said pad, respective sheets and the opening in said first sheet are respectively circular in configuration, with the respective components and said terminal being disposed on a common axis.

4. An electrode according to claim 1, wherein said electrical terminal comprises an outer connector member and an inner contact member engaged therewith, each of which is provided with a base portion in contact with the adjacent face of said second sheet, that of the inner member being in engagement with the adhesive coating on said second sheet, said inner member extending through said second sheet and engaging said outer member with said second sheet clamped between said base portions.

5. As an article of manufacture, a disposable type electrode for operatively connecting electrical equipment to tHe surface of live skin of a patient, comprising a sheet of material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, said sheet having an opening therein, a second sheet of material completely spanning the area of said opening with its peripheral portions adhesively secured to said first sheet to retain the same in assembled relation, an electrical terminal extending through and secured to said second sheet on a portion thereof extending across the opening in said first sheet, said terminal having means at the outer side of second sheet for effecting connection with an electrical conductor, and having a contact portion, disposed in the opening in said first sheet, a pad of porous material disposed at the opening in said first sheet and engaged with the adjacent contact portion, said pad being retained in position by adhesive surrounding said adjacent contact portion, a quantity of electrically conductive material contained on said pad operative to produce a conductive connection between said connector and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of said sheet, and a protective cover structure for said pad and exposed adhesive of said first sheet, of a size to extend across and engage said adhesive of the first sheet, the adhesive-engaged surface of said cover structure being such that the latter may be easily stripped from such adhesive, said cover structure having means for spacing the portion of said cover structure covering said pad, outwardly from peripheral portions of said cover structure, forming a recess at the inner side thereof, into which said pad extends.

6. An article of manufacture according to claim 5, wherein said cover structure comprises a protective sheet engaged with the adhesive of the said first sheet, and having an opening therein greater in size than said pad, an annular spacing member encircling the opening in such sheet and having an internal size greater than that of said pad and an external size greater than the opening in such protective sheet, and a cover sheet greater in size than said spacing member overlying the latter and having a coating of adhesive on the adjacent face in engagement with said spacing member, the peripheral edges of said cover sheet extending laterally outward from said spacing member and in adhesive engagement with the outer face of the adjacent sheet of said cover member.

7. An article of manufacture according to claim 6, wherein said sheet of the cover assembly contacting the adhesive of said first sheet is provided with a cut therein extending from the opening therein to the periphery thereof for facilitating stripping of such sheet from said first sheet and thereby the cover assembly from the electrode structure.

8. An article of manufacture according to claim 7, wherein the surface of said sheet of the cover assembly contacting the adhesive of said first sheet is provided with a coating of a material which will permit relatively easy stripping of said sheet from the first sheet.

9. An article of manufacture according to claim 8, wherein said surface coating comprises a silicone composition.

10. An article of manufacture according to claim 7, wherein said pad, spacing member, respective sheets and the openings therein are respectively circular in configuration, with the respective components and said terminal being disposed on a common axis.

11. An article of manufacture according to claim 6, wherein the dimensions of the respective openings in said first sheet of the electrode structure and said protective sheet are greater than the corresponding inner dimensions of said spacing ring, whereby said pad and its contents are sealed by said ring, the second sheet of the electrode structure and said cover sheet of the cover assembly, said sheets being secured to said ring by the respective adhesive coatings.

12. An article of manufacture according to claim 6, wherein saId electrical terminal comprises an outer connector member and an inner contact member engaged therewith, each of which is provided with a base portion in contact with the adjacent face of said second sheet, that of the inner member being in engagement with the adhesive coating on said second sheet, said inner member extending through said second sheet and engaging said outer member with said second sheet clamped between said base portions.

13. An article of manufacture according to claim 5, comprising a path of material secured to said cover assembly and having a relatively rough exterior surface which may be employed to roughen the skin surface of the patient at the point of application of the electrode thereto.

14. An article of manufacture according to claim 13, wherein said patch comprises a strip of adhesive backed synthetic rubber or the like adhesively secured to said cover assembly.

15. An article of manufacture according to claim 5, wherein said cover assembly is provided with a porous pad disposed within said annular spacing member and secured to the assembly by the adhesive coating on said protective sheet, with said last-mentioned pad disposed in opposition to the gel-supporting pad of the electrode structure.

16. A method of fabricating a disposable electrode and protective cover assembly therefor, comprising the steps of forming an opening, in an elongated strip of adhesively coated sheet material, defining the central portion of the electrode, mounting an adhesively coated second sheet of relatively impermeable material across said opening utilizing therefor, the adhesive on said second sheet, mounting and electrical terminal on said second sheet, which terminal includes a contact disposed at the adhesively coated face thereof and substantially centered in said opening, applying a protective sheet, having an opening formed therein, of a size approximately that of said first opening, to the adhesive surface of said strip with such opening in aligned relation with the opening in said strip, mounting a pad, greater in size than said contact portion, to said second sheet by means of the adhesive thereon with said pad in superimposed relation on said portion, said pad being less in size than the opening in said strip whereby an annularly shaped area of the adhesive on said second sheet remains exposed, applying to such assembled structure a ring-like member having an inner peripheral size greater than that of said pad and less than that of the opening in said strip with said spacing member encircling said pad and engaged with the adhesive of the second sheet, applying a conductive material to said pad, covering said spacing member with an adhesively coated sheet of relatively impermeable material having a peripheral size greater than the outer periphery of spacing member and less than that of the outer periphery of said protective sheet, securing said cover sheet by means of the adhesive thereon to said spacing member and the protective sheet, thereby sealing the pad and conductive material thereon in the chamber defined by said spacing member and said second and cover sheets, and severing the assembled electrode and protected cover assembled from said elongated strip.

17. A method according to claim 16 comprising the additional step of cutting said protective sheet, prior to its engagement with said first sheet, along a generally radial line extending from the opening therein to the peripheral edge of such sheet.

18. A method according to claim 16, comprising the additional step of applying to the outer face of said cover sheet, prior to the severance of the structure from said elongated strip, a piece of abrading-type cleaning material having an adhesive coating on the face thereof applied to said cover sheet by means of which said cleaning material is secured thereto.

19. A method according to claim 16 wherein the step of mounting said electrical terminal to said second sheet is effected prior to the mounting of the latter on said strip.

20. A Method according to claim 16 wherein the step of mounting said electrical terminal to said second sheet is effected following mounting of the latter on said strip.

21. A disposable type electrode for operatively connecting electrical equipment to the surface of live skin of a patient, comprising a relatively large sheet of relatively porous material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, a second relatively small sheet of relatively impermeable material centrally disposed with respect to said first sheet and secured thereto with the peripheral edges of the second sheet spaced inwardly from the peripheral edges of the first sheet, said second sheet having an adhesive coating on the face thereof corresponding to the adhesively coated face of said first sheet, said sheets being retained in assembled relation by the adhesive of one of said sheets engaged with the adjacent face of the other of said sheets, and with the central portion of the adhesively coated face of said second sheet being exposed, an electrical terminal extending through the exposed central portion of said second sheet, said terminal having a contact portion disposed at the adhesively coated face thereof and means, extending outwardly from the other face thereof, arranged for effecting connection with an electrical conductor, the area of said adhesive coated face of said second sheet being greater than the area of said contact portion to provide an exposed area therearound, a pad of porous material disposed at and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce a conductive connection between said contact portion and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet.

22. As an article of manufacture, a disposable type electrode for operatively connecting electrical equipment to the surface of live skin of a patient, comprising a relatively large sheet of relatively porous material having an adhesive coating on one face thereof adapted to adhere to such a skin surface, a second relatively small sheet of relatively impermeable material centrally disposed with respect to said first sheet and secured thereto with the peripheral edges of the second sheet spaced inwardly from the peripheral edges of the first sheet, said second sheet having an adhesive coating on the face thereof corresponding to the adhesively coated face of said first sheet, said sheets being retained in assembled relation by the adhesive of one of said sheets engaged with the adjacent face of the other of said sheets, and with the central portion of the adhesively coated face of said second sheet being exposed, an electrical terminal extending through the exposed central portion of said second sheet, said terminal having a contact portion disposed at the adhesively coated face thereof and means, extending outwardly from the other face thereof, arranged for effecting connection with an electrical conductor, the area of said adhesive coated face of said second sheet being greater than the area of said contact to provide an exposed area therearound, a pad of porous material disposed at and engaged with said contact portion, said pad having an area greater than that of said contact portion and retained in operative position in engagement therewith by the exposed adhesive coating of said second sheet, and a quantity of electrically conductive material contained on said pad, preapplied thereto and forming therewith a unitary part of the electrode, operative to produce a conductive connection between said contact portion and live skin in contact with said pad when said first sheet is applied to such live skin and retained in position by the adhesive coating of such sheet, and a protective cover structure for said pad and exposed adhesive of said first sheet, of a size to extend across and engage said adhesive of the first sheet, the adhesive engaged surface of said cover structure being such that the latter may be easily stripped from such adhesive, said cover structure, covering said pad, outwardly from peripheral portions of said cover structure, forming a recess at the inner side thereof, into which said pad extends.

23. An article of manufacture according to claim 22, wherein the outer periphery of the exposed area of the adhesively coated face of said second sheet is of a size to overlie and adhesively engage the adjacent portion of said cover structure and form a seal therebetween whereby the pad and preapplied conductive gel are thereby sealed between said second sheet and said cover structure.

24. A method of fabricating a disposable electrode and protective cover assembly therefor, comprising the steps of disposing on an elongated strip of adhesively coated sheet material, a relatively small adhesively coated second sheet of relatively impermeable material with the adhesively coated faces of said first and second sheets being correspondingly oriented and with second sheet being secured to said first sheet by the adhesive on one of said sheets, and with the central portion of the adhesively coated face of said relatively smaller second sheet being exposed, mounting an electrical terminal on said second sheet, which terminal includes a contact portion disposed at and less in size than the exposed adhesively coated face of said second sheet substantially centered thereon whereby said exposed face forms an annularly shaped adhesive coated area therearound, applying a protective sheet, having an opening formed therein of a size approximately that of the exposed adhesively coated face of said second sheet, to the adhesive surface of said strip with such opening in aligned relation with said exposed adhesively coated face of said second sheet, mounting a pad, greater in size that said contact portion, to said second sheet by means of the adhesive thereon, with said pad in superimposed relation on said portion, said pad being less in size than the exposed adhesively coated face of said second sheet whereby an annularly shaped area of adhesive on said second sheet remains exposed, applying a conductive material to said pad, covering said pad with a cover structure of relatively impermeable material having a peripheral size greater than the outer periphery of the exposed adhesively coated face of said second sheet and having an outwardly extending central portion of a size to enclose said pad securing the adjacent peripheral portions of said outwardly extending portion to said second sheet by means of the exposed adhesive thereon, thereby sealing the pad and conductive material thereon in the chamber defined by the outwardly extending portion of said cover structure and said second sheet, and severing the assembled electrode and protective cover structure from said elongated strip.

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