WO1988003820A1 - Dispositif electroconducteur pour applications medicales, et materiau utilise dans ce dernier - Google Patents

Dispositif electroconducteur pour applications medicales, et materiau utilise dans ce dernier Download PDF

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Publication number
WO1988003820A1
WO1988003820A1 PCT/GB1987/000835 GB8700835W WO8803820A1 WO 1988003820 A1 WO1988003820 A1 WO 1988003820A1 GB 8700835 W GB8700835 W GB 8700835W WO 8803820 A1 WO8803820 A1 WO 8803820A1
Authority
WO
WIPO (PCT)
Prior art keywords
conductive
network
silver
medium
electrically
Prior art date
Application number
PCT/GB1987/000835
Other languages
English (en)
Inventor
Bernard Weller
John Anderson
Original Assignee
Goldhon Limited
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 Goldhon Limited filed Critical Goldhon Limited
Publication of WO1988003820A1 publication Critical patent/WO1988003820A1/fr

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Classifications

    • 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
    • A61N1/0408—Use-related aspects
    • A61N1/046—Specially adapted for shock therapy, e.g. defibrillation
    • 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
    • A61N1/0496—Patch electrodes characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives

Definitions

  • the present invention relates to an electrically- conductive device for medical purposes, in particular to tho s e s u ch m ed i ca l devi ce s co m m o n ly known a s "electrodes ". Also provided i s an electrical ly conductive material for use in the same.
  • a formable polymer composition having electrically-conductive properties is broadly defined as one which comprises a formable polymeric material having dispersed therein an electrically-conductive material -in particulate form compri s ing meta l or metal coated particles , the conductive material being present in an amount to provide an overall - specif ic conductivity in the composition of at least about 2 mho cm" .
  • the earlier composition includes one or more components to provide a composition having contact adhesive properties which can be used to produce a transducer or so- called "electrode”.
  • Such a transducer is said to comprise a backing member through which is mounted an electrically-conductive contact so that an electrical lead can be connected to one part of the contact at the rear of the backing member.
  • the contact then provides an unbroken electrical path through the backing member to a portion of the said electrically-conductive adhesive composition forming at least part of an adhesive layer disposed on the front of the backing member through which the front of the transducer may be adhered to the skin.
  • the earlier transducer device is disclosed as useful in e.c.g. measurement applications and as a cardiac stimulator.
  • An essentia-1 electrode component comprises a_mixture of a polymerized form of 2-acrylamido-J2_- ⁇ methylpropanesulphonic acid or one of its salts with water and/or an alcohol.
  • the mixture possesses electrically conductive properties, flexible properties and adhesive properties particularly lending itself to skin contact and adhesion.
  • the earlier electrode includes an electrical current distribution member which also electrically contacts an electrical conductor lead as well as a substrate member of said mixture.
  • the current distribution member is preferably formed of a metallic foil, such as stainless steel foil, which is said to be readily available in very thin configuration or form such as 0.001 inches (0.025 mm). Such a foil may be included in the electrode without having any substantial effect on its flexibility. Due to the adhesive nature of the substrate the foil readily adheres thereto. Other forms of distribution member may also be used, such as wire mesh, conductive cloth or the like.
  • the earlier invention is predicated on the provision of a skin contacting component which is homogeneous and creep resistant and thus (according to the generalities of that disclosure) is able to avoid the development of "hot spots". Nevertheless, we have found that electrode arrangements, such as the disclosed arrangement which depend on pure metal (or metal alloy) in the form of say a sheet or wire mesh to distribute the charge over the electrode, suffer from the disadvantage that the charge distribution is uneven.
  • ⁇ can be overcome by providing a three-dimensironal conductive polymeric network coated with a conductive material (preferably silver or silver/silver chloride) as a carrier matrix for a conductive medium. In that manner, good interface characteristics can be obtained
  • conductive media both in an e.c.g. measurement and in a defibrillation use situation
  • a much wider variety of conductive media can be employed, and an "electrode" which has a good storage life can be produced at a lower cost.
  • the conductive polymeric network and conductive medium construction can provide low and constant polarisation potentials and good current distribution, whereas known electrodes are deficient in one or both of these.
  • the present invention provides an electrically-conductive device for medical purposes, and especially a defibrillation or defibrillation/e.c.g. electrode, which device comprises a three-dimensional conductive polymeric network supported on one face of a backing member, the backing member including an electrically-conductive contact passing through the member from said one face of the member, and the network having a conductive medium interspersed therethrough to provide an electrical path through the device (via the medium, the network and the contact) when placed on the skin.
  • a defibrillation or defibrillation/e.c.g. electrode which device comprises a three-dimensional conductive polymeric network supported on one face of a backing member, the backing member including an electrically-conductive contact passing through the member from said one face of the member, and the network having a conductive medium interspersed therethrough to provide an electrical path through the device (via the medium, the network and the contact) when placed on the skin.
  • the three- dimensional conductive network may be any polymeric network which is conductive per se or has been treated to render it conductive.
  • it may be based on a polymeric material which is conductive such as a polyacetylene or a carbon fibre f illed polymer.
  • the network may be any polymeric network capable of providing either surface or inherent electronic conductivity .
  • the network may be any random or regular co l l ect ion or co l locat ion of s trands or filaments or the like of conductive coated or conducting polymeric material, which are linked together to provide a three-dimensional network structure comprising said s trand s etc. and a multipl ici ty of inters tices .
  • the network is a woven or unwoven mesh comprising strands of polymer, typically which form a regular network, and more preferably an open weave mesh, or a network based on an expanded reticular structure such as a sponge defining interstices in the case of a mesh or capillaries in the case of a sponge.
  • the various s trands etc. which f orm the network may be woven together, fused together, or in any other way linked, such as by adhesion, into a three-dimensional polymeric network structure.
  • the network may be formed by selective cutting of a polymeric sheet material followed by stretching. So that any chosen three-dimensional polymeric network based on a non-conductive polymer may function as an electrically-conductive material, the network is provided with a conductive coating.
  • a coating may comprise any material which can provide the necessary conducting properties, but generally speaking the network will be coated with a thin coating or a film of a metal or of a metal and a metal salt.
  • the metal or metal and metal salt should be non-corroding, non-corrosive, non-toxic and neither exhibit nor afford any adverse side effects when placed in close contact with the human skin for extended periods of time.
  • metallic silver or an equilibrium mixture of silver/silver chloride/chloride ions are preferred as materials to provide the coating for the polymeric network, the latter being the most preferred— * ⁇
  • the non-conductive polymer on which a network may be based may comprise a thermoplastics material or a thermo- or cold-setting material.
  • the polymeric material preferably should be one which neither exhibits nor affords any adverse side effects when placed in close contact with the human skin for extended periods of time.
  • a variety of polymeric materials may be employed, for example, polyvinyl compounds; polyalkenes, e.g. polyethylenes, polypropylenes and polyisobutenes; polyacrylates; polymethacrylates; .pa polyamides, e.g. nylon; and polyurethanes.
  • One especially preferred polymeric network is based on nylon and comprises an open weave nylon mesh coated with silver or silver/silver chloride.
  • Another especially preferred polymeric network comprises a sponge (e.g. polyurethane sponge) coated with silver or silver/silver chloride.
  • the network may be employed as a single layer or as a plurality of superimposed layers.
  • each such layer may comprise either the same or a different network material.
  • the interstices of the network may be regular or irregular and of any suitable -shape such as square, hexagonal, circular, or the like, and of any suitable size.
  • the largest dimensions of the interstices will be of the order of below about 5 mm, more preferably of from about 0.5 mm to about 3 mm, for example, about 1.5 to about 2 mm.
  • variations in size of the interstices across the device may be employed to vary electronic characteristics in the final device.
  • the size of the interstices preferably may be increased towards the edge(s), and /or to decrease the resistance towards the centre of the device the size of the -interstices preferably may be .pa decreased towards the centre.
  • strands may be cropped from those areas of the mesh adjacent the outer edge(s) to increase mesh size and/or a finer mesh network may be superimposed e.g. as a disc of mesh, at the centre of the device.
  • the backing member of the device of the invention will comprise a sheet material, which most usefully (in some instances) may be a conductive sheet material, although typically it will comprise non-conductive sheet material.
  • a wide variety of sheet materials may be employed, preferably polymeric sheet materials which exhibit at least a degree of flexibility.
  • sheet materials there may be cited polyvinylchloride, polyethylene, polypropylene and like materials.
  • the electrically-conductive contact is a stud or ball pillar or the like compatible with existing e.c.g. or def ibrillation leads or the like. which provides a means of connecting the leads to the device of the invention.
  • a stud or pillar may be formed of metal e.g. silver, or of a coated metal e.g. silver coated with silver chloride, the latter being preferred.
  • the contact is mounted at or about the centre of the backing member and, in order to avoid uncomfortable corners, the backing member may be a disc or, more preferably to keep waste to a minimum, a square with rounded corners.
  • the conductive medium may be selected from a number of media as more fully described below.
  • Such media in themselves may be adhesive and, by virtue of that property, may provide in the device overall the necessary adhesive- roperties to enable the device to be adhered to the skin in a satisfactory manner.
  • ⁇ t may be preferred (whatever the conductive medium employed) to include an annulus of non-conducting contact adhesive material surrounding a central portion or plug comprising said polymeric network and conductive medium disposed on the backing member. More preferably, such an annulus may be formed of a hypoallergenic pressure-sensitive skin adhesive material. Most preferred is an annulus comprising a hypoallergenic composition based on polyisobutene.
  • the conductive medium may be any medium which can be interspersed through the interstices of the three-dimensional polymeric network so as to provide the necessary electrical path through the device via the medium etc. when the device is placed on the skin, and any required or desired degree of skin adhesion.
  • an electronically conducting network interfaced with an ionically conducting medium, which in turn is compatible with the conducting medium naturally provided at the skin surface.
  • the medium used in the invention will be a relatively viscous material so that it does not readily flow out of the polymeric network.
  • the conductive medium may be a gel or the like, typically one based on an aqueous conducting system; or a formable conductive polymer composition as described and claimed in International Publication No.
  • the conductive medium may be as follows:
  • An aqueous- and/or alcohol-based conductive gel for example, one having a gel structure based on a sulphonic acid or one of its salts.
  • a gel may be one barsed on a polymer of 2-acrylamido-2- methylpropanesulphoni ⁇ acid or a salt thereof and water and/or an alcohol e.g. glycerol, such as that sold as "Hydrogel" by Promean.
  • a formable polymer composition comprising a formable polymeric material having randomly dispersed there in an el ectrical ly conductive ma teria l in particulate form.
  • the particulate material is one comprising metal or metal-coated particles having a narrow spectrum of particle size and being present in an amount to provide an overall specific conductivity of at least about 2 mho cm " , and in a proportion which at least exceeds that of the critical percolation volume.
  • such a material will be based on silver- coated glass spheres , e.g. ballotini , as described in the above-mentioned Int e rn at i o na l Pub l i cat i on.
  • such a composition will be based on polyisobutene, which may be mixed with one or more phase structure, flow and/or moisture permeability modifiers, for example, low molecular weight polyalkenes, e.g. polyethylene, or hydroxyalkyl celluloses, e.g. hydroxymethyl cellulose.
  • polyisobutene typically may have a viscosity average molecular weight in the range of from about 40,000 to about 100,000.
  • such a composition in accordance with the preferred aspects of the earlier invention more preferably includes an additive to reduce contact resistance with the skin when applied to unprepared skin.
  • an additive is one which provides an aqueous medium within the composition to
  • the composition preferably includes an additive comprising a mixture of: *
  • a hygroscopic agent such as glycerine or glycerol or polyvinyl alcohol
  • a thickening agent for example, carboxymethyl-cellulose , which mixture may be used in an amount of, for example, from about 1% to about 5% by weight of the total composition.
  • a first mixture comprising additive and electrically-conductive material, and a second mixture comprising polymer and electrically-conductive material, those mixtures then being blended to form the final composition.
  • preferred ranges of the various components for the first mixture are: (i) A ratio of hygroscopic agent e.g. glycerol, to water of from about 20:80 to about 80:20 by weight,
  • a percentage of electrically-conductive material e.g. silver-coated glass spheres, in the overall mixture of from about 70% to about 80% by weight.
  • the overall composition will include no more than about 20% by weight of such a first mixture including said additive since the use of more than about 20% by weight could result in a composition that is both too soft and which could leave a heavy residual deposit on the skin when the transducer is removed after use.
  • the upper limit for the first mixture is about 15% by weight based on the total weight of the composition.
  • the additive may be modified so that it comprises: *
  • a water-soluble salt for example, sodium chloride.
  • a composition comprising: 1.
  • a formable polymer for example, polyisobutene,
  • a hygroscopic agent for example, as described above, and
  • a water-soluble salt for example, sodium chloride.
  • glycerol saturated with a saturated solution of sodium chloride in water e.g. distilled water.
  • the device of the present invention can be constructed and arranged as an "electrode" or transducer intended for use in a wide variety of medical applications.
  • the device of the invention may be constructed and arranged as an e. ⁇ .g. monitoring and/or diagnosis electrode, as a neo-natal electrode, as a defibrillation electrode or the like.
  • the device of the invention provides electrical conductivity both in terms of taking a signal from a patient and in terms of directing a signal into a patient.
  • the device of the invention has significant advantages over the usual metal paddles used as defibrillation devices which must be used 'in a somewhat harsh manner, and with great skill, otherwise the patient can be burnt. Since the device of the present invention provides good electrical contact with the skin, it can be used in a more gentle manner without burning.
  • the invention provides a device as defined or described herein which is a defibrillation or a defibrillation/e.c.g. electrode.
  • a defibrillation or a defibrillation/e.c.g. electrode Such an electrode affords a more uniform charge distribution than with known electrode arrangements such as that of U.S. Specification No. 4,581,821.
  • FIG. 1 is a diagrammatic cross section through one form of device in accordance with the invention.
  • FIG 2 is a diagrammatic cross section through another form of device in accordance with the invention.
  • the device shown comprises a backing member 11 which on one face 12 carries a layer of a viscous conducting medium 13.
  • conducting medium 13 is embedded a polymeric network material comprising a mesh T4.
  • a stud and eyelet contact 15 provides electrical contact through the backing member 11 to the medium 13 and mesh 14, and secures together the mesh and backing member.
  • Example 1 An electrode was prepared using the following materials and formulations, namely:
  • Backing member 11 - a pvc sheet material.
  • Conductive medium (and adhesive) 1 4 - a gel medium sold by Promean under the name "Hydrogel RG 63A" - typically a layer of about 1 mm in thickness.
  • an electrode device having a backing member of 4 x 4 cm overall dimensions and a mesh of the same dimensions was produced.
  • the device also has high quality reproducible e.c.g. signal characteristics.
  • Example 2 A device is produced in accordance with the details of Example except that the nylon mesh is replaced by a silver-coated polyurethane sponge, i.e. to provide a sponge 17 as shown in Figure 2, the interstices of which are filled with the Promean "Hydrogel".
  • the sponge can be attached to the backing sheet either via the "Hydrogel” or by using a suitable adhesive such as the acrylic adhesive Fasson S277 made by John Cleland.
  • Example 1 A device i s produced in accordance wi th the details of Example 1 except that the Promean "Hydrogel" is replaced by a polyisobutene composition in accordance with International Publication No. WO 84/ 02423 , for example, a composition as described in Example 1 of that publication, namely one formulated as follows:
  • Silver-coated glass spheres prepared as described in the International Publication 72 Polyisobutene (viscosity average molecular weight of about 50,000) 28
  • Example 3 is repeated except that there is used a conductive medium as follows:
  • Silver-coated glass spheres prepared as described in the International Publication mentioned above 70 Polyisobutene (viscosity average molecular weight of about 50,000) 25 Glycerol (BP grade) saturated with a saturated solution of sodium chloride in distilled water
  • Example 4 is repeated except that the silver- coated glass spheres are omitted and the composition is thus formulated as follows:
  • Example 2 is repeated except that the conductive medium is glycerol (BP grade) saturated with a saturated solution of sodium chloride in distilled water.
  • the conductive medium is glycerol (BP grade) saturated with a saturated solution of sodium chloride in distilled water.
  • Example 6 is repeated except that the conductive medium is based on polyvinyl alcohol rather than glycerol and has the following composition:
  • composition Percent by weight of . the total composition
  • a defibrillation electrode was prepared using the materials and formulations of Example 1 except that the stud and eyelet 15 was replaced by a Newey-Goodman ball pillar, and the backing member was 4 inches x 4 inches (about 10 cm x about 10 cm).
  • the invention provides a device through which electrical signals can be received from or transmitted to living tissue by means of an electrode comprising a three-dimensional conductive polymeric network functioning as an interface membrane embedded in and/or carrying a conductive medium.
  • the specific details mentioned above may be varied to a wide degree within the spirit and scope of the following claims provided only that the device is based on the said network as defined and the said conductive medium.
  • the device of the invention in some embodiments can use a novel material insofar as it employs a conductive polymeric network, and especially a sponge, having a conductive medium interspersed throughout the interstices thereof.
  • an electrically-conductive material which material comprises a three-dimensional conductive polymeric network, especially in the form of a sponge, having a conductive medium interspersed throughout tHe interstices thereof.
  • such- a material may comprise a polymeric sponge comprising a material such as polyurethane in which the capillaries of the sponge have an electrically-conductive coating such as one provided by silver or silver/silver chloride/chloride, with a conductive medium as described above interspersed therethrough.

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  • Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Le dispositif décrit comporte un réseau (14) polymère conducteur tridimensionnel supporté sur une face d'un élément support (11). Ce dernier comprend un contact (15) électroconducteur passant à travers ledit élément (11) à partir d'une face de ce dernier, et le réseau possède un milieu conducteur entremêlé à travers (13). Le milieu (13) constitue un chemin électrique à travers le dispositif (via le milieu (13), le réseau (14) et le contact (15)) lorsque celui-ci est placé sur la peau. Est également décrit un matériau électro-conducteur, lequel matériau comprend un réseau (14) polymère conducteur tridimensionnel possédant un milieu conducteur (13) entremêlé à travers les interstices dudit réseau.
PCT/GB1987/000835 1986-11-21 1987-11-23 Dispositif electroconducteur pour applications medicales, et materiau utilise dans ce dernier WO1988003820A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8627937 1986-11-21
GB08627937A GB2197791A (en) 1986-11-21 1986-11-21 Electrically-conductive electrode for medical purposes

Publications (1)

Publication Number Publication Date
WO1988003820A1 true WO1988003820A1 (fr) 1988-06-02

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Application Number Title Priority Date Filing Date
PCT/GB1987/000835 WO1988003820A1 (fr) 1986-11-21 1987-11-23 Dispositif electroconducteur pour applications medicales, et materiau utilise dans ce dernier

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EP (1) EP0290542A1 (fr)
GB (1) GB2197791A (fr)
WO (1) WO1988003820A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH676326A5 (fr) * 1987-12-14 1991-01-15 Intrinsic Ag
US5670557A (en) * 1994-01-28 1997-09-23 Minnesota Mining And Manufacturing Company Polymerized microemulsion pressure sensitive adhesive compositions and methods of preparing and using same
JP3640996B2 (ja) * 1994-01-28 2005-04-20 ミネソタ マイニング アンド マニュファクチャリング カンパニー 高分子複合材料
TW369558B (en) * 1994-01-28 1999-09-11 Minnesota Mining & Mfg Polymerized microemulsion pressure sensitive adhesive compositions and methods of preparing and using same

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2291732A1 (fr) * 1974-11-25 1976-06-18 Kaufman John Electrode applicable sur le corps et utilisee en liaison avec un equipement electromedical
US4066078A (en) * 1976-02-05 1978-01-03 Johnson & Johnson Disposable electrode
WO1984002423A1 (fr) * 1982-12-11 1984-06-21 Kennedy John W Composition polymere façonnable
EP0085327B1 (fr) * 1982-01-18 1986-04-30 Medtronic, Inc. Compositions conductrices de l'électricité et électrodes pour l'utilisation de celles-ci

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3602216A (en) * 1969-09-16 1971-08-31 United Aircraft Corp Paste dispensing body electrode
GB1556364A (en) * 1975-07-03 1979-11-21 Cardiolink Electrodes Ltd Electromedical electrode
GB1594214A (en) * 1977-01-21 1981-07-30 Cardio Tech Body electrodes
US4516581A (en) * 1983-06-20 1985-05-14 Ferris Manufacturing Corp. EKG electrode
US4748983A (en) * 1985-08-27 1988-06-07 Kureha Kagaku Kogyo Kabushiki Kaisha X-ray transmissive electrode for a living body

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2291732A1 (fr) * 1974-11-25 1976-06-18 Kaufman John Electrode applicable sur le corps et utilisee en liaison avec un equipement electromedical
US4066078A (en) * 1976-02-05 1978-01-03 Johnson & Johnson Disposable electrode
EP0085327B1 (fr) * 1982-01-18 1986-04-30 Medtronic, Inc. Compositions conductrices de l'électricité et électrodes pour l'utilisation de celles-ci
WO1984002423A1 (fr) * 1982-12-11 1984-06-21 Kennedy John W Composition polymere façonnable

Also Published As

Publication number Publication date
GB8627937D0 (en) 1986-12-31
EP0290542A1 (fr) 1988-11-17
GB2197791A (en) 1988-06-02

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