CA1067963A - Tape electrode for transmitting electrical signals through the skin - Google Patents

Tape electrode for transmitting electrical signals through the skin

Info

Publication number
CA1067963A
CA1067963A CA247,279A CA247279A CA1067963A CA 1067963 A CA1067963 A CA 1067963A CA 247279 A CA247279 A CA 247279A CA 1067963 A CA1067963 A CA 1067963A
Authority
CA
Canada
Prior art keywords
skin
tape
electrode
coating
layer
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
CA247,279A
Other languages
French (fr)
Inventor
Charles V. Burton
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.)
Medtronic Inc
Original Assignee
Medtronic 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 Medtronic Inc filed Critical Medtronic Inc
Application granted granted Critical
Publication of CA1067963A publication Critical patent/CA1067963A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/41Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/251Means for maintaining electrode contact with the body
    • A61B5/257Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A61B5/259Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • A61N1/0492Patch electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • A61N1/048Electrodes characterised by a specific connection between lead and electrode

Abstract

TAPE ELECTRODE FOR TRANSMITTING
ELECTRICAL SIGNALS THROUGH THE SKIN

ABSTRACT
A tape form electrode is provided which is usable for transmission of electrical signals into the human body through the skin. The electrode is of a construction so that it can be applied to the skin to secure good electrical contact therewith and remain in place for many days despite normal movement and the normal activities of the subject such as perspiring, and washing. The construction utilizes a porous backing material which has an adhesive layer on one side thereof and over the adhesive layer a second layer which has incorporate therein a quantity of finely divided silver metal. The composition construction is of a thickness and selection of materials such that it readily "breaths" thereby permitting escape of normal amounts of perspiration from the skin of the subject. The adhesive is normal-ly "dry" and is activated at the time of application by a suitable solvent.

Description

1~i7~3 The present invention is directed to electrodes for application to the outer layer o~ skin of the human body, and is more specifically directed to such electrodes which are intended to be used as transmission electrodes for injecting significant electrical energy into the human body rather than as mere monitoring electrodes. The current levels in monitoring electrodes is low enough that conductive jellies and the like have been widely used in monitoring electrodes that are on the market. Such jelly ~ype electrodes are less desirable for a number of reasons than the electrodes of the present invention.
An electrode for use on the human skin that is intended to be used for the introduction of electrical energy into the human body desirably would meet a number of goals. Among these would be that the electrode would be one readlly handleable by a lay person so that no special skills are in-volved in its application and use. Not only must it be readily handleable by a lay person, but it is desirably one which has a minimum of care required `~ in its handling and does not produce any mess such as is encountered with the use of conductive jellies. The desirable~skin electrode also is one which can be applied to the skin to provide good electrical contact for rela-` tively high powered transmission compared to monitoring electrodes and which can be left in place for many days while the subject wearing theelectrode goes about normal activities. In order to be relatively semi-permanently . , affixed to the skin of the subject, the electro~e should be one which has characteristics which strongly discourage the growth of any bacterial or other micro-organisms between the region between the electrode and the skin. Be-cause of the intended relatively high power transm~sion into the skin of the :, :
`~ sub~ect, lt is impQrtant that the conductivity across the electrode be high ,, enoug~ so as to distribute such a current load over a relatively broad area of the skin. This also necessitates a mèans of electrode leacl contact that 1~i7~3 does not provide local "hot" spots that burn the skin of the subject. Of courseJ when prolonged application of an electrode is intended~ the materials involved in the total electrode usage mus~ be ones which are non-allergenic to the skln of a great majority of patients. A further important requirement of a desirable electrode is that it be low in cost.
- In accordance with the present invention, each of the above desir-a~le criteria is accomplished. The electrode of the invention is of simpli-c~ty in its construction and its use on the human body. It can be affixed to the skin of a subject readily. Also in accordance with the invention a means of making external lead contact thereto is provided that eliminates the problem of hot spot areas. The electrode is capable of long duration contact with the skin of the subject without causing any allergenic or other adverse reactions on most skins. It can be left on the skin of the subject - for long periodsof time without loosening and in the event a slight loosening occursl the electrode can be readily reaffixed to the skin without complete removal therefrom.
According to the broadest aspect of the invention there is provided a tape electrode for prolonged adhesion to the epidermal layer of skin of a human, and re-adhereable without removal by application of a non-aqueous `~ 20 solvent comprislng: a highly porous tape substrate, a conductive coating oneone surface of said substrate, said conductive coating including a mixture of a skin compatible metal particles blended into a water insoluble, low-i tack adhesive matrix in an amount sufficient to provide electrical continuity between the metal particles, said adhesive matrix being a non-toxic, non-irritating and non-allergenic polymer that is at least partially soluble in a volatile organic solvent, the thickness of said adhesive matrix coating being such that water vapor generated at the surface of the skin readily per-meates through said coating ~`layer and tape substrate.

'': .

1~67~36~

The inventlon will now be described in greater detail with refer-ence to the accompanying drawings wherein:
~igure 1 is a side cross sectional view of a tape form electrode in accordance with the present lnvention;
Pigure 2 is a perspective view of an electrode lead and tape in accordance w~th the invention in exploded view;
Figure 3 is a cross sectional and schematic illustration of an electrode in accordance with the invention affixed to the skin; and, Figure 4 is an alternative form of applying a lead to the tape electrode~
Referring first to Figure 1, there is illustrated in cross section-al and enlarged view for purposes of illustration a tape electrode in accord-ance with the present invention. The tape electrode consists of a backing material 10 onto which the active materials forming the electrode are applied.
The backing material 10 is desirably of a thin, 1exible porous cloth like material through which water in either gas or liquid form can pass. The pas--sage of water through this material is the essential requirement in order that moisture that is generated by the skin can have a path for exit so as to avoid any lifting of the tape electrode from the skin under the prolonged usage. Naturally, the backing material 10 must be of a type tha~ is not water soluble. It has been found that a non-woven rayon fiber material is satis-factory for the~purpose.
:i Joined to the tape member 10 on one side thereof is a layer 11 of an adhesive material. While several choices of adhesive material are suit-s ableJ lt has~been found that an acrylic copolymer adhesive such as is used in medical tapes is good for this purpose. Layer 11 should be as thin as possible while still providing a total coverage of the one surface of mater-ial 10. The function of this adhesive layer is to provide a substrate for ~ : -~ -3 .` !
' ~6796~3 application ~or the active electrode materlal thereto. Acryllc copolymers when ln thln layers have proven to be relatively permeable to molsture and permlt the exit of any perspiration materials that are generated by the sk.in under normal usage. By thin ls meant that layer 11 would be just thick enough to provlde a sealing functlon for the surface of backing 10. The actual thlckness of the adhesive extending beyond the fabric of backing 10 may be as little a 1 mil.
Layer ll may be eliminated and layer 12 applied directly to backing 10. However, this is a less desirable construction as it utilizes more of the expensive silver containing material of layer 12, to be described, than is the case when layer 11 is present.
Coated over the surface of layer 11 is a layer 12 which has ~he electrically actlve portions of the invention. Layer 12 is a mixture of an ad~esive material that is blended with a quantity of silver metal to make the adhesive layer 12 conductive. The quantity of silver metal that must be incorporatedwlthln the adhesive of layer 12 may be varied over relatively broad limlts. For the sake of economy it is desirable to keep the amount o~ silver belng utilized to as low a level as is possible. This can be .
accomplished by making the particles of silver metal very small and blending them into the adhesive. A suitable adhesive for the purpose is an acrylic ., ~ copolymer of the same type as that described in layer 11. One suitable such ;
acrylic polymer is a material available from National Starch Company under ~`~ their designation resin 30-1289. This material is a vinyl acrylic copolymer : ~ iD an organlc solvent.
; The copolymer is blended with a~quantity of finely divided silver metal. Silver metal isppreferred for its bacterial activity although other skin compatable metal powders like gold or the platinum metals can be used.

~ : ~
The sil~er metal can be conveniently obtained from Handy and Harmon under ., = .. ~ . ... . ~ . .: .... . . . .

their designation Silflake 135. The sllver from this source is in a flake form so that it retains its metallic appearance. Such a metallic appearance is helpful to the user thereof to ldentify that it is a metallic material. A
suitable blend includes approximately 1,000 grams of the silver which is blend-ed with 300 grams of the copolymer material to ~ake the material which is applied as a coating 12. Higher amount of silver relative to copolymer may be utilized in forming layer 12. The higher quantity of silver is desirable in reducing the volume resistivity of the finished coating 12, but results in a commensurately higher cost per unit area of electrode. Somewhat lower.

quantities of silver can be utilized with commensurately increased volume resistivity. In the quantities indicated, the volume resistivity will be less than one ohm-centimeters. With the quantity of silver that is given above, the composite material forming layer 12 will be in a ~ssentially non-tacking condition~ This is desirable for ready rolling and storage of the material. ln applying layer 12 over layer 11, it is desirable to Eluidize the silver-acrylic copolymer by incorp~ration therein of a quantity of a suitable solvent such as ~oluene and acetone. Following the coating operation the solvent readily evaporates to leave the finished material. The thickness of layer 12 should be as low as is possible while retaining electrical con-2Q tinuity ae~oss the tape surface. By so doing not only is cost reduced, butmore importantly the layer 12 is more readily permeable to moisture with declining thlckness. For long term applica~ion to the skin this is a criti-- cal factor. Desirably~ layer 12 is less than 5 mils in thickness and pre-ferably 2 - 3 mils.
,~ :
A completed tape can be made in the lengths desired for ultimate distribution to the users. When a tape is made, one may conveniently place a liner of a silicone or polyethylene coated paper as a protection to the coated surface until it is, deslred to actually use a section of the tape as :~675~:i3 an electrode. ~lternatively~ the outer face o~ backing 10 may be treated so as to make it non-adhereable to layer 12 when the finish tape is coiled on itself. In this latter case, the treatement must be such that moisture permeability is not lost by such treatment.
Referring now to Figure 2 there is illustrated in a perspective view a tape member as described in Figure 1 and a means for applying an elec-trode thereto prior to the application to the skin of the subject. The electrode contact means comprises a small piece of tape of the same type as that previously described. The electrode connection is generally designated as 13.
The connector-ll3 of Figure 2 comprises a small rectangular piece of tape which may be of a construction as shown in ~igure 1 which has been slit part way through on opposite sides thereof adjacent one end as illu-strated to provide tabs 14 and 15. An insulated lead wire 16 having a bare ;
- metal exposed end thereon 17 is inserted so that the metallic end 17 is in direct physical contact with layer 12' between the tab ends 14 and 15.
` These tab ends are then wrapped around the metallic end as shown and bonded thereto by ordinary pressure or with the aid of a quantity of solvent. This makes a direct electrical contact not only with the tabs 14 and 15 but also with the balance of the layer 12'. Layer 12' which includesaLcontact ad-, hesive readily can be joined to layer 12 of the tape electrode member by placing the two layers 12 and 12' in physical contact with one another.
Thus, complete electrical contact is achieved throughout the surface of the ~ tape to be applied to the subject skin and there are no localized hot spots - that will arise due to a contact point of a narrow wire electrode.
Figure 4 illustrates an alternate means of making elect;rical connection to a tape electrode in accordance with the invention. In this ~n~tanceJ aL strip of tape electrode is described in ~igure 1 has the lead ,;", ,., " ., ~ ., " ,. . .,,, ",.,,, ~ ., ,, ,.~ " ", , ~ , "

~67~63 member 16 bare end 17 pressed to an intermediate portion between the ends thereof. Portions of the layer 12 are pressed together to envelope end 17 as shown with the free ends of the tape electrode available for contact to the skin. An ups~anding loop of tape isolates lead 17 from direct contact to the skin.
In actual use, the tape and electrode assembly of the invention are applied as follows: the subject determines the area of skin to which he wishes to apply an electrode and cleans it in the ordinary manner, wash-lng excess body oils from the surface of the skin. A tape of suitable size is cut from a spool and an electrode assembly either previously made or fab-rlcated at the time of usage in accordance with the description given with Figures 2 or 4 is joined in the manner previously described to the tape to be applled to the subject's skin. The skin of the subject is then either coated with a layer of a skin compatable solvent for the adhesive of layer 12 such as acetone or a low molecular weight alcohol and facing 12 of the tape is placed against this liquid layer. The function of the solvent is to partially dissolve ;layer 12 to give it a high tack and wetting capability to the human skin. In this condition, the electrode material 12 readily penetrates into the intricacies of the human skin as is generally illustrated ; 20 in Figure 3 to provide the intimacy of physical contact not available with mere contact adheslves of some of the prior art.
As a referred method of applying an electrode, the electrode with face 12 towa~d the skin is pressed on to the skin of the subject. Little~
if any, adhesion results in this step. Then the solvent, such as acetone or a lo~ molecular weight alcohol is applied through the back 10 of the tape, penetrates do~n through the layers 10, and 11 and partially solubilizes la~er 12 br~nging about the same type o~ intimate skin contact as illustrated in pigure 3. The solvent having a low boiling point readily evaporates from ~ ' ' ., ':
.~

~L~67~3 the tape electrode resulting in a semi-permanent bond of the electrode to the skin. Should the applied tape show undesired signs of loosening, use of a drop of solvent through backing 10 readily re-adheres the tape to the skln.
An electrode so constructed and applled to the skin provides all of the advantages which were initially set forth in the specification above.
The combination of a water insoluble material that is of very low thickness permits the transmission of water vapor thereacross so that it does not have an~ significant tendency to loosen or flake of under prolonged exposure.
The fact that the adhesive is water insoluble permits its use under condi-ti~ns where the subject is bathing and is otherwise exposing the exterior parts of the electrode to normal daily donditions.
-~ Once the purpose for which the electrode has been attached is no longer required, the electrode may be readily removed. Asuser merely grips and peels the èlectrode off from the skin. If desired, any residual amount of adhesive and silver which is retained on the skin due to intricacies of the skin surface can be loosened and washed free by use of the same solvent that is utilized in softening and solubilizing in the instance of applying the electr-de ' .

Claims (7)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A tape electrode for prolonged adhesion to the epidermal layer of skin of a human, and re-adhereable without removal by application of a non-aqueous solvent comprising:
a) a highly porous tape substrate, b) a conductive coating on one surface of said substrate, said conduc-tive coating including a mixture of a skin compatible metal particles blended into a water insoluble, low-tack adhesive matrix in an amount sufficient to provide electrical continuity between the metal particles, said adhesive matrix being a non-toxic, non-irritating and non-allergenic polymer that is at least partially soluble in a volatile organic solvent, the thickness of said adhesive matrix coating being such that water vapor generated at the surface of the skin readily permeates through said coating layer and tape substrate.
2. A tape electrode in accordance with Claim 1 wherein said metal particles are silver.
3. A tape electrode in accordance with Claim 2 wherein said conductive coating has a volume resistivity of less than one ohm-cm.
4. A tape electrode in accordance with Claim 1 wherein the adhesive matrix is an acrylic copolymer and said coating is less than 5 mils in thickness.
5. A tape electrode in accordance with Claim 1 wherein said substrate has a non-conducting moisture permeable adhesive layer intermediate said substrate and said conductive coating.
6. A tape electrode in accordance with Claim 1 including a lead wire electrically joined thereto and in isolation from the surface of said conduc-tive surface adapted to be placed into contact with the skin, said lead wire being enveloped between two layers of tape with the conductive faces thereof against each other and said lead wire.
7. A tape electrode in accordance with Claim 4 wherein said coating has a volume resistivity of less than one ohm-cm.
CA247,279A 1975-04-14 1976-03-08 Tape electrode for transmitting electrical signals through the skin Expired CA1067963A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US05/567,612 US4008721A (en) 1975-04-14 1975-04-14 Tape electrode for transmitting electrical signals through the skin

Publications (1)

Publication Number Publication Date
CA1067963A true CA1067963A (en) 1979-12-11

Family

ID=24267906

Family Applications (1)

Application Number Title Priority Date Filing Date
CA247,279A Expired CA1067963A (en) 1975-04-14 1976-03-08 Tape electrode for transmitting electrical signals through the skin

Country Status (16)

Country Link
US (1) US4008721A (en)
JP (1) JPS51124082A (en)
BE (1) BE840524A (en)
BR (1) BR7602148A (en)
CA (1) CA1067963A (en)
CH (1) CH597872A5 (en)
DD (1) DD124709A5 (en)
DE (3) DE7626334U1 (en)
DK (1) DK135976A (en)
ES (1) ES445991A1 (en)
FR (1) FR2307553A1 (en)
GB (1) GB1520351A (en)
IT (1) IT1059969B (en)
NL (1) NL7602970A (en)
SE (1) SE7604323L (en)
ZA (1) ZA761454B (en)

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Also Published As

Publication number Publication date
NL7602970A (en) 1976-10-18
AU1259376A (en) 1977-10-06
ZA761454B (en) 1977-03-30
BR7602148A (en) 1976-10-05
BE840524A (en) 1976-08-02
DE2612130A1 (en) 1976-10-28
DE7608817U1 (en) 1977-05-26
SE7604323L (en) 1976-10-15
JPS51124082A (en) 1976-10-29
IT1059969B (en) 1982-06-21
DD124709A5 (en) 1977-03-09
DE7626334U1 (en) 1977-06-02
ES445991A1 (en) 1977-06-16
DK135976A (en) 1976-10-15
GB1520351A (en) 1978-08-09
CH597872A5 (en) 1978-04-14
US4008721A (en) 1977-02-22
FR2307553A1 (en) 1976-11-12

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