US3911906A - Dry applied and operably dry electrode device - Google Patents
Dry applied and operably dry electrode device Download PDFInfo
- Publication number
- US3911906A US3911906A US463784A US46378474A US3911906A US 3911906 A US3911906 A US 3911906A US 463784 A US463784 A US 463784A US 46378474 A US46378474 A US 46378474A US 3911906 A US3911906 A US 3911906A
- Authority
- US
- United States
- Prior art keywords
- skin
- layer
- electrode device
- electrical connection
- tacky
- 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 - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
- A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/251—Means for maintaining electrode contact with the body
- A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
- A61B5/259—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/325—Preparing electrode sites, e.g. by abrasion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0492—Patch electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/048—Electrodes characterised by a specific connection between lead and electrode
Definitions
- An electrode device for establishing an electrical connection between electromedical apparatus and the skin of the human anatomy comprising a composite electrode body for self-adhering engagement with a substantial surface area of the skin to establish the electrical connection throughout substantially the entire engaged area of the skin without the use of conductive pastes, gels or other liquids, such as solvents or the like, the composite electrode body being porous and hypoallergenic and including a carrier layer and a thin flexible layer of pressure sensitive adhesive mate rial having fine electrically conductive particles dispersed throughout providing a tacky skin-engaging surface the particles being provided in an amount sufficient to effect the electrical connection with the engaged area of the skin through the layer by particle to particle contact while permitting the skin-engaging surface of the layer to remain tacky prior to skin en gagement.
- a removable sheet having a release surface engaging the tacky skin-engaging surface of the layer is operable to be separated therefrom prior to application without substantially reducing the tackiness thereof.
- Electrodes of the type adapted to establish an electrical connection between electromedical apparatus, such as an electrocardiograph or the like, and the skin of the human anatomy and more-particularly to an electrode of this type which is especially suitable for long term monitoring.
- Typical electrodes now available for use in long term monitoring usually rely upon the utilization of a conductive paste or gel to establish the actual electrical connection with the patients skin.
- a typical example of an electrode of this type is disclosed in US. Pat. No. 3,713,435.
- the disclosed arrangement is one in which a central electrolyte paste receiving structure providing an exterior terminal, such a male snap fastener element, is fixedly secured to a surrounding sheet-like member having a pressure sensitive adhesive thereon which serves to adhere the central structure to the skin.
- Electrodes of this type have proven quite reliable in effecting the required electrical connection, however, there are disadvantages and inconveniences presented.
- the primary disadvantage resides in the utilization of the electrolyte gel which requires that such gel be extraneously supplied during application or that the electrode be packaged individually with the gel in a liquid tight container.
- the necessity to provide extraneous gel during application is an obvious inconvenience. Where this inconvenience is obviated by packaging the gel with the electrode structure, overall costs are increased by the cost of packaging. Moreover, any premature exposure of the packaged electrode to atmospheric conditions will result in the drying out of the gel.
- an electrolyte gel in contact with the skin can cause skin irritation and sores to develop.
- Another possible source of skin irritation during use is the adhesive which contacts the larger area of the skin surrounding the area of electrolyte contact.
- the total skin contact area subject to irritation is substantially greater than the area through which the electrical connection is made since the area of electrical contact is separate and distinct from the area of securement.
- the area of electrical contact is capable of surface to surface shifting which may produce artifact.
- the electrode is referred to as dry but cannot be applied without utilizing an extraneous supply of acetone solvent or the like.
- the solvent is wiped or dabbed on the patients skin and the electrode is also wetted with solvent, then immediately pressed upon the wet area and held for a second or two until the electrode has started to adhere.
- the small layer of solvent is then rapidly absorbed into the skin and dry electrode.
- This electrode obviates many of the abovementioned disadvantages of the first-mentioned type of electrode.
- the electrode is dry, in the sense of not utilizing an electrolyte paste or gel to effect the electrical connection during use, and hence the disadvantages inherent in the use of such electrolytes is obviated.
- the disadvantages previously discussed in relation to the provision of separate electrical contact and skin securement areas are obviated, since skin adherence is obtained coextensively in the area where electrical contact is made.
- the second-mentioned type of electrode presents other disadvantages which are related to the necessity of utilizing a solvent to apply the electrode.
- This necessity essentially raises the same type of problems which are presented with the use of electrolyte gels.
- application cannot be effectively accomplished unless a supply of solvent is available.
- a substantial inconvenience is presented where the solvent supply is separate from the electrode supply.
- the packaging problems presented to integrate the two are even more daunting than those presented by electrolyte gels because of the inherent volatile nature of the solvent.
- An object of the present invention is to provide an electrode which will fill such need by securing all of the advantages of the prior art electrodes without any of the attendant disadvantages.
- this objective is obtained by providing a composite electrode body having a tacky skin-engaging surface formed by a thin flexible layer of pressure sensitive adhesive material having fine electrically conductive particles dispersed throughout including the skin-engaging surface in an amount sufficient to provide an effective electrical connection with the engaged area of the skin through the layer by particle to particle contact while permitting the skinengaging surface of the layer to remain tacky prior to skin engagement.
- the tacky surface is protected prior to use by a removable sheet having a release surface engaging the tacky surface which, when the sheet is removed, does not substantially reduce the tackiness of the surface.
- the composite electrode body also includes a thin flexible carrier layer or layers coextensively connected with the tacky surface layer and with an appropriate terminal structure capable of detachable connection to the electromedical apparatus.
- the carrier layer or layers may be either non-conductive, in which case the terminal structure directly contacts the conductive particles of the pressure sensitive adhesive layer, or conductive, in which case the conductive layer may be interposed in series between the conductive particles of the pressure sensitive adhesive layer and the terminal structure.
- Another object of the present invention is the provision of an electrode of the type described which is simple in construction, easy and convenient to apply, efficient in operation and economical to manufacture.
- FIG. 1 is a perspective view of an electrode construction embodying the principles of the present invention.
- F IG. 2 is an enlarged, sectional view taken along the line 22 of FIG. 1.
- an electrode device for establishing an electrical connection between electromedical apparatus, such as an electrocardiograph or the like, and the skin of the human anatomy.
- the electrode device consists essentially of a composite electrode body, generally indicated at 12, for self-adhering engagement with a substantial surface area of the skin, to establish the electri cal connection therewith throughout substantially the entire engaged area of the skin without the use of conductive pastes, gels or other liquids, such as solvents or the like, and a terminal structure, generally indicated at 14, for enabling the electrode device to be detachably electrically connected with the electromedical apparatus.
- the composite body 12 provide a tacky skin-engaging surface 16 which is formed by a thin flexible layer 18 of pressure-sensitive adhesive material having fine electrically conductive particles dispersed throughout, including the tacky surface 16 in an amount sufficient to provide an electrical connection from the surface 16 through the layer 18 by particle to particle contact while permitting the surface 16 to remain tacky prior to skin engagement.
- a further critical characteristic of the composite structure is that the adhesive layer is coextensively secured with a carrier structure of thin flexible sheet-like form which in the preferred embodiment shown is a carrier layer 20 laminated to the pressure sensitive adhesive layer 18 by the adhesive qualities of the latter.
- the carrier layer 20 provides a non-tacky exterior surface 22 opposed to the tacky surface 16.
- composite contemplates constructions other than the aforesaid clearly defined laminar one and specifically one in which there are layers of different material characteristics with merging interfaces which are not well-defined, as distinguished from interfaces which are sufficiently well-defined as to be capable of delamination.
- the composite body is thin and flexible to the extent of readily following the skin movements of the patient to which it is applied without any portion of the surface 16 losing adherence with the skin.
- the composite body is preferably hypoallergenic and porous so as to substantially eliminate any allergic reaction due to the application of the electrode device to the skin of the patient and virtually eliminate skin maceration caused by moisture build-up. These characteristics are greatly preferred where the electrode device 10 of the present invention is to be used for long term monitoring.
- a further highly desirable characteristic is that the composite body is capable of removal after use without leaving residue from the layer 18 on the skin.
- the composite body may be formed of any desired materials capable of providing the abovementioned essential characteristics
- the preferred construction shown which admirably meets the essential characteristics as well as the preferred characteristics noted above, utilizes the backing layer and pressure sensitive adhesive material embodied in the surgical tape marketed by 3M Company under the trademark MICROPORE with fine powder carbon being utilized as the electrically conductive particles.
- the carrier layer 20 is a thin flexible highly porous non-woven fabric and the adhesive material is a synthetic acrylic copolymer.
- a preferred amount of fine carbon powder to be included in the adhesive is 25%, although it will be understood that more or less can be used in accordance with the principles enunciated above.
- the composite body is constructed in accordance with known procedures including specifically those commercially utilized in the formation of MICROPORE surgical tape with the fine carbon particles in the above amount being initially mixed uniformly in the syntehtic acrylic copolymer while in liquid form.
- Layer thicknesses are preferably the same as those provided in the aforesaid MICROPORE tape although either or both may be increased or decreased if desired.
- the preferred shape of the composite body 12 is the circular configuration shown in the drawings since the terminal construction can be centered therein. A preferred diameter size is 2 inches. However, it will be understood that the composite body 12 may assume other shapes and sizes. With respect to size, the contact area provided by the above-preferred diameter dimension should not be greatly reduced in order to insure a low resistance connection, while size increase is limited only by practical considerations. Square and rectangular shape variations are specifically contemplated as well as elliptical and any others considered desirable.
- the invention is not limited to the above-preferred specific construction.
- any of the known per se constructions in the aforementioned patents may be utilized and the disclosure of each is hereby incorporated by reference into the present specification for that specific purpose per se.
- Other specific constructions which clearly meet the essential and preferred characteristics include a carrier layer and adhesive material such as embodied in the TRAN- SPORE and DURAPORE surgical tapes marketed by 3M Company.
- the carrier layer 20 may be a porous Polyethylene/Ethylene Vinyl Acetate film or a porous woven cloth or fabric.
- porosity in the layer 16 and 20 is not essential where the electrode device is not contemplated for use in long term monitoring, indeed a carrier layer of thicker polyethylene may be desirable for short term disposable use since it is easier to handle. For long term monitoring use, the porous and hypoallergenic characteristics are practically necessary.
- the terminal structure 14 may assume a variety of forms including the simple wire construction of the aforesaid US. Pat. No. 3,547,105.
- a male snap fastener construction such as that shown in the aforesaid US. Pat. No. 3,713,435 is preferred.
- the male snap fastener terminal structure 14 shown in the drawings consists essentially of two similarly shaped metallic elements 24 and 26 crimped together. Each element includes a generally flange-shaped mounting portion and a projecting generally knob-shaped terminal portion.
- the terminal structure is fixedly connected to the carrier layer 20 prior to lamination with the layer 16, the connection being effected by suitably perforating the layer, extending the knob portion of the smaller element upwardly through the perforation while the larger element is held thereover and effecting the crimping action.
- the mounting flange portions of the two elements thus grip the marginal portions of the layer 20 defining the perforation.
- the terminal also suggests the utilization of carbon loaded plastic as the carrier layer in which case a single unitary terminal could be secured to the exterior surface of the carrier layer or even made integral therewith.
- the carrier layer 20 are constructed of nonconductive material, it is within the contemplation of the present invention to form the carrier layer of conductive material such as carbon loaded plastic, metallic foil, etc.
- the tacky surface 18 of the carbon loaded pressure sensitive adhesive layer 20 is protected prior to the application of the electrode device 10 with removable sheet means, a preferred form of which is tacky surface 18.
- the exterior surface of 'the paper sheet 28 is preferably provided with abrasive granules 32 or simila'rjsubstances which will perform 'the usual known function of such granules.
- the removable sheet 28 is formed essentially of very fine sand paper with the non-abrasive surface thereof coated with silicone.
- abrasive pretreatment of the skin is not at all essential to the pretreatment.
- the removable sheet 28 is separated and then the composite body 12 is simply pressed onto the abraded skin area so that the tacky surface 18 is firmly adhered thereto.
- Connection with the electromedical apparatus is effected simply by detachably connecting the lead thereof to the terminal structure 14 in conventional fashion. While the application has been described above in a sequence in which the rubbing of the skin with the abrasive surface 32 is performed prior to the removal of the sheet, the sequence of these procedures may be reversed.
- the removable sheet means may be formed of two sheets, rather than one as shown, with each sheet having removal tabs, as is well known.
- An electrode device for establishing an electrical connection between electromedical apparatus and the skin of the human anatomy, said electrode device comprising composite electrode body means for selfadhering engagement with a substantial surface area of the skin to establish the aforesaid electrical connection throughout substantially the entire engaged area of the skin without the use of conductive pastes, gels or other liquids, such as solvents or the like, said composite electrode body means including a tacky skin-engaging surface formed by a thin flexible layer of pressure sensitive adhesive material having fine non metallic electrically conductive particles dispersed throughout including said tacky skin-engaging surface in an amount sufficient to provide the aforesaid electrical connection with the engaged area of the skin through said layer by particle to particle contact while permitting the skinengaging surface of said layer to remain tacky prior to skin engagement, removable sheet means having a release surface engaging the tacky skin-engaging surface of said layer operable to be separated therefrom without substantially reducing the tackiness thereof in response to the removal of said removable sheet means, said composite electrode body means further including carrier layer means disposed in substantially coexten
Abstract
Description
Claims (8)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US463784A US3911906A (en) | 1974-04-24 | 1974-04-24 | Dry applied and operably dry electrode device |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US463784A US3911906A (en) | 1974-04-24 | 1974-04-24 | Dry applied and operably dry electrode device |
Publications (1)
Publication Number | Publication Date |
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US3911906A true US3911906A (en) | 1975-10-14 |
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Application Number | Title | Priority Date | Filing Date |
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US463784A Expired - Lifetime US3911906A (en) | 1974-04-24 | 1974-04-24 | Dry applied and operably dry electrode device |
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Cited By (91)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2307553A1 (en) * | 1975-04-14 | 1976-11-12 | Medtronic Inc | SKIN ELECTRODE |
US3993049A (en) * | 1974-12-26 | 1976-11-23 | Kater John A R | Electrodes and materials therefor |
US4016869A (en) * | 1974-11-18 | 1977-04-12 | Siemens Aktiengesellschaft | Signal collector system |
US4027664A (en) * | 1975-11-17 | 1977-06-07 | Baxter Travenol Laboratories, Inc. | Diagnostic electrode assembly with a skin preparation surface |
US4066078A (en) * | 1976-02-05 | 1978-01-03 | Johnson & Johnson | Disposable electrode |
US4067342A (en) * | 1976-04-06 | 1978-01-10 | Medtronic, Inc. | Tape electrode |
US4088133A (en) * | 1976-09-13 | 1978-05-09 | Products International Company | Electrode for electrosurgical procedure |
US4125110A (en) * | 1975-11-25 | 1978-11-14 | Hymes Alan C | Monitoring and stimulation electrode |
WO1979000042A1 (en) * | 1977-07-13 | 1979-02-08 | A Mercuri | Biomedical electrode assembly |
DE2740270A1 (en) * | 1977-09-07 | 1979-03-15 | Alan C Hymes | Electrode for forming electrical contact to the skin - comprises a support element, a connection device and an adhesive polysaccharide substrate |
FR2416018A1 (en) * | 1977-04-02 | 1979-08-31 | Sony Corp | ELECTRODE INTENDED TO BE APPLIED TO A LIVING BODY |
US4166465A (en) * | 1977-10-17 | 1979-09-04 | Neomed Incorporated | Electrosurgical dispersive electrode |
EP0013613A1 (en) * | 1979-01-08 | 1980-07-23 | Johnson & Johnson Products Inc. | Electrosurgical grounding pad |
DE3010754A1 (en) * | 1979-03-21 | 1980-10-02 | Minnesota Mining & Mfg | BIOMEDICAL ELECTRODE |
EP0029297A1 (en) * | 1979-11-16 | 1981-05-27 | LecTec Corporation | Electrode with disposable interface member |
US4273135A (en) * | 1977-08-19 | 1981-06-16 | Minnesota Mining And Manufacturing Company | Biomedical electrode |
US4274419A (en) * | 1979-10-19 | 1981-06-23 | Quinton Instrument Co. | Skin preparation device and method used in the application of medical electrodes |
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WO1981002097A1 (en) * | 1980-01-23 | 1981-08-06 | Minnesota Mining & Mfg | Conductive adhesive and biomedical electrode |
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FR2483674A1 (en) * | 1980-05-27 | 1981-12-04 | Mitsubishi Electric Corp | CONFORMABLE CONDUCTIVE COMPOSITIONS OF ELECTRICITY AND ELECTRODES COMPRISING SUCH A COMPOSITION |
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US4458696A (en) * | 1979-08-07 | 1984-07-10 | Minnesota Mining And Manufacturing Company | T.E.N.S. Electrode |
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