Classifications

• • 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
  • A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
  • A61B5/266—Bioelectric electrodes therefor characterised by the electrode materials containing electrolytes, conductive gels or pastes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
  • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
  • A61B5/0006—ECG or EEG signals
• • 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
  • A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
  • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
  • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053

Definitions

• the invention relates generally to an activatable power cell and applications for activatable power cells, including applications for such cells in electrocardiographic monitoring and transdermal drug delivery.
• the invention relates to patient monitoring devices powered by an activated power cell and having a wireless connection between a patient and a remote location.
• Biomedical electrodes have long been used for diagnostic and therapeutic purposes including electrocardiographic monitoring and diagnosis, electrosurgery, iontophoretic (electrically enhanced) transdermal delivery of drugs, and defibrillation.
• these electrodes In their most basic form these electrodes have a conductive medium contacting mammalian skin and a means for electrical communication that interacts between the conductive medium and electrical diagnostic, therapeutic, or electrosurgical equipment.
• a cable connecting the electrode to the equipment is the most commonly used means to accomplish the electrical communication.
• the cable may be hardwired to the electrode or may releasably attach to it with, for example, a head-and-socket connection or a clasp and tab connection.
• remote (or wireless) monitoring systems have been suggested. These systems typically include a disposable self-contained, wireless electrode-transmitter unit that is applied to the patient and an adapter for receiving a transmitted signal from the transmitter unit and feeding it to a display device. Other enhancements such as digital transmission, error correction methodologies and reverse communication to the electrode (e.g., via a transceiver) have also been suggested to enhance the utility of wireless connection in the field the medical diagnostics. In spite of active research in this area, however, such systems have not been widely made commercially available. One reason inhibiting the practical utility of these systems is the unavailability of a suitable energy supply for the electrode.
• a self-contained electronic device can theoretically be supplied with power either passively or actively. Passively, a device can receive energy radiated toward it from a remote source energy and accumulate it, using for example an inductor and a capacitor. There are, however, limits to the power that can be transmitted in this way and the range over which it can be transmitted, especially in a controlled environment such as a health care facility where problems of electromagnetic interference are particularly acute.
• An active energy source is normally supplied by a battery.
• the present invention provides a power source that comprises a galvanic cell in a partial state of construction. More specifically, in one aspect, the invention provides a galvanic cell that is activatable on demand.
• the cell comprises an anode conductor, a cathode conductor and an electrolyte-containing substance, where the electrolyte- containing substance is separated from at least one of the anode conductor or cathode conductor by an electrically insulative separator material until the cell is activated by removing the separator and allowing the electrolyte-containing substance to contact both the anode and cathode conductors.
• the invention provides a biomedical electrode capable of communicating information between a patient and a remote location and having within it a galvanic cell in a state of partial construction.
• the biomedical electrode generally comprises:
• a galvanic cell connected to the signal processing circuit, the galvanic cell comprising an anode conductor, a cathode conductor, and electrolyte-containing substance, where the electrolyte-containing substance is separated from at least one of the anode conductor and the cathode conductor until the biomedical electrode is used on the patient.
• the invention provides a method for obtaining and communicating electrical signals of electrophysiological or electrobiological origin from a patient, the method comprising: providing a biomedical electrode comprising a first quantity of conductive medium in electrical contact with a signal processing circuit and a galvanic cell connected to signal processing circuit, the galvanic cell comprising an anode construction, a cathode construction, and electrolyte containing substance, where the electrolyte containing substance is separated from at least one of the anode and cathode constructions; providing a second quantity of conductive medium in electrical contact with the signal processing circuit; causing the electrolyte containing substance to contact the anode and cathode constructions; applying the first quantity of conductive medium and the second quantity of conductive medium to the patient; transducing electrical signals from the patient's body to obtain diagnostic or therapeutic information; and transmitting the information via the signal processing circuit.
• the invention emphasizes the utility of the galvanic cell as substantially described above for therapeutic devices.
• the invention provides a device for delivering a pharmaceutically active agent, the device comprising: a first quantity of electrically conductive medium and a second quantity of electrically conductive medium; a galvanic cell comprising an anode conductor, a cathode conductor, and electrolyte-containing substance, where the anode conductor is in electrical contact with the first quantity of electrically conductive medium and the cathode conductor is in electrical contact with the second quantity of electrically conductive medium, and where the electrolyte-containing substance is separated from at least one of the anode and cathode conductors until the device is to be used on a patient; and at least one quantity of pharmaceutically active agent capable of existing in an ionized state incorporated within one or both of the first quantity of electrically conductive medium or the second quantity of electrically conductive medium.
• the invention provides a device for delivering a pharmaceutically active agent, where the device comprises a galvanic cell that includes an anode conductor, a cathode conductor, and two fields of electrolyte-containing substance where prior to activation at least one field of electrolyte-containing substance is separated from at least one of the anode and cathode conductors and following activation the anode conductor is in electrical contact with one field of electrolyte-containing substance and the cathode conductor is electrical contact the second field of electrolyte-containing substance.
• At least one quantity of pharmaceutically active agent capable of existing in an ionized state is incorporated within at least one of the fields of electrolyte-containing substance.
• FIG. 1 is a perspective view of a biomedical electrode according to the present invention
• FIG. 2 is a perspective view of the biomedical electrode of FIG. 1 , illustrated with the backing removed and the separator disengaged
• FIG. 3 is a side view of the biomedical electrode of FIG. 1 ;
• FIG. 4 is a partial perspective view of an alternative embodiment of the biomedical electrode having two cells arranged in series;
• FIG. 5 is a perspective view of a drug delivery device, illustrated with the backing removed and the separator disengaged in a manner similar to the illustration of FIG. 2;
• FIG. 6 is a perspective view of an alternate drug delivery device where at least one of the electrolyte containing substances further comprises a pharmaceutically active substance.
• the invention provides a galvanic cell that is capable of providing power as a low cost, shelf stable battery for an electronic device.
• the galvanic cell includes an anode construction, a cathode construction, and an electrolyte-containing substance, examples of which are described more fully herein.
• the electrolyte-containing substance is separated from at least one of the anode and cathode constructions by an electrically insulative separator which can be removed to bring the electrolyte-containing substance in contact with the anode and cathode constructions and activate the battery.
• the separator is generally made in the form of a solid, removable barrier or membrane between at least one of the cathode and anode conductor constructions and the electrolyte substance.
• the separator can be in the form of, for example, a frangible container that when broken removes the barrier and activates the battery, or it can take the form of a hand-removable polymeric or nonwoven liner.
• batteries of various output voltages may be constructed within the scope of this invention by serial connection of two or more galvanic cells.
• the galvanic cell is incorporated into a biomedical sensor and connected to a signal processing circuit. In such an assembly the galvanic cell can be conveniently made from some of the same or similar materials from which the rest of the sensor is manufactured, using some of the same web-based manufacturing techniques.
• the invention includes a biomedical sensor that is capable of communicating biological information, including electrical signals of electrophysiological or electrobiological origin (e.g., EKG, etc.) and measurements of other biological parameters (e.g., temperature, respiration, etc.), between a patient to a remote location.
• biological information including electrical signals of electrophysiological or electrobiological origin (e.g., EKG, etc.) and measurements of other biological parameters (e.g., temperature, respiration, etc.), between a patient to a remote location.
• the information may be used for either or both diagnostic or therapeutic purposes.
• a suitable biomedical electrode includes a first quantity of conductive medium in electrical contact with a signal processing circuit.
• the signal processing circuit is adapted to communicate information to the remote location.
• the biomedical electrode In order to transduce electrical signals from the patient, the biomedical electrode requires a reference potential from a patient's body. It is contemplated that preferred embodiments of the invention will include a structure capable of providing this reference internally. Conveniently, such a structure will include a second conductive medium in electrical contact with the signal processing circuit. In preferred embodiments, the electrode will have a backing to provide support, and in particularly preferred embodiments this backing will extend so that it is adjacent to both the first conductive medium and the second conductive medium. For a biomedical electrode construction, it may prove convenient to make the first conductive medium and the second conductive medium from an electrolyte-containing gel or an electrolyte-containing conductive adhesive.
• the first and second conductive media can also be possible to make the first and second conductive media from the same material, for example where the conductivity of the material in a given set of dimensions is different in the x-y and z planar directions. Preferred materials will be discussed more particularly below.
• the electrolyte containing substance in the galvanic cell is made from the same material as the first conductive medium.
• the invention provides a device capable of delivering a pharmaceutically active agent across a tissue surface (e.g., transdermally or transmucosally).
• a tissue surface e.g., transdermally or transmucosally.
• Such devices generally employ at least two electrodes, both of which are positioned in intimate electrical contact with some portion of the skin.
• One electrode called the active or donor electrode, is the electrode from which the therapeutic agent is delivered into the body.
• the other electrode called the counter or return electrode, serves to close the electrical circuit through the body.
• the circuit is completed by connection of the electrodes to a source of electrical energy, e.g. a battery, and usually to circuitry capable of controlling current passing through the device.
• the present invention can be thought of as a drug delivery device having a first quantity of electrically conductive medium and a second quantity of electrically conductive medium. Both of these media may be conveniently formed from a conductive adhesive.
• the drug delivery device also has a galvanic cell comprising an anode construction, a cathode construction and electrolyte-containing substance. The anode is in electrical contact with the first quantity of electrically conductive medium and the cathode is in electrical contact with the second quantity of electrically conductive medium.
• the electrolyte-containing substance is electrically separated from the anode and the cathode until the drug delivery device is to be used on the patient.
• At least one quantity of pharmaceutically active agent, or drug, capable of existing in an ionized state is present and incorporated within one of the first quantity of electrically conductive medium or the second quantity of electrically conductive medium.
• the agent or agents desired for delivery it may also be possible to incorporate multiple agents in one or both of the first and second quantities of electrically conductive media.
• a circuit between the anode and the cathode is completed through the patient, with a result that the pharmaceutically active drug achieves enhanced penetration of the skin through iontophoresis.
• at least one of the quantities of electrically conductive media not only completes the circuit to the body but also acts as the electrolyte containing substance.
• the drug delivery device may further comprise an electronic circuit to control the current delivery and thus, indirectly, the timing and rate of the drug delivery.
• a circuit may also include a subcircuit for outside control of the drug delivery parameters, either patient mediated or physician mediated by means of wireless interactive control with a remote device.
• biomedical electrodes for the exchange of electromagnetic energy between matter of biological origin and an external electronic device are constructed comprising an electrical conductor preferably in sheet form; an electrolyte containing substance coplanar with the said conductor; means of electromagnetic communication between the conductor and a remote electronic device; means of separating the conductor from the electrolyte- containing substance; and activation of the electrode upon demand by removing the separating means.
• This application may be incorporated into a multifunction electrode used for defibrillation and external cardiac pacing such as that described by Ferrari in U.S. Pat. 5,571,165.
• the conductor may have wireless or wired connection to an external remote electronic device, typically known as an automatic external defibrillator (AED), which in turn may itself be controlled via wireless communication means.
• AED automatic external defibrillator
• FIG. 1 a perspective view of a biomedical electrode 20 according to the present invention is illustrated. While the description of FIG. 1 and the subsequent related figures will refer primarily to a biomedical electrode construction, it will be understood for ease of explanation that the galvanic cell construction illustrated for the biomedical electrode could also be used and/or adapted for any application as a power source for an electronic device.
• the biomedical electrode 20 (or, alternatively, a battery construction incorporating the galvanic cell of the invention) can be made in the form of a multilayered structure, with the topmost layer, a backing 22, hiding most of the other layers in this view. However, a portion of the separator 24 can be seen projecting from one end of the biomedical electrode 20. Referring now to FIG.
• a substrate 26 is present for conveniently mounting some of the electronic components and conductive pathways.
• the substrate 26 is preferably a flexible polymeric film, and in this view has beeu rendered transparent so that objects attached to its underside, and objects positioned below it, can be visualized.
• a first conductive medium 28 under the substrate 26 is kept in electrical contact with a signal processing circuit 30 by first contact pad 32 and pathway 34.
• a second conductive medium 36 under the substrate 26 is kept in electrical contact with the signal processing circuit 30 by second contact pad 38 and pathway 40.
• the undersides of pads 32 and 38 are conveniently coated with a layer containing silver/silver chloride.
• the biomedical electrode 20 includes a galvanic cell 50 connected to the signal processing circuit 30 by means of positive power conduit 52 and negative power conduit 54.
• the galvanic cell 50 includes an anode construction 56 connected to the positive power conduit 52, and a cathode construction 58 connected to the negative power conduit 54.
• the separator 24 is illustrated as having been removed from the biomedical electrode 20 allowing the anode 56 and the cathode 58 to contact an electrolyte-containing substance 60.
• the electrolyte- containing substance 60 is separated from the anode 56 and the cathode 58. It will be recognized that it is only required to separate one of the anode 56 or the cathode 58 from the electrolyte-containing substance 60 to prevent completion of the galvanic cell 50 prior to use, although many preferred embodiments will separate both the anode and the cathode. It is considered within the scope of the invention for either separator 24, or a similar but distinct separator, to separate the silver/silver chloride elements 32 and 38 from the respective conductive media 28 and 36. Such a separator is also removed before use and can serve to preserve the silver/silver chloride elements 32 and 38 from corrosion during the shelf life of the electrode 20.
• FIG. 3 a side view of the biomedical electrode 20 is illustrated.
• backing 22 has a layer of skin compatible adhesive 62 adhered to its lower surface.
• the layer of skin compatible adhesive 62 serves to adhere the substrate 26 to the backing 22, and also at its periphery to eventually secure the biomedical electrode 20 to a patient's body.
• Additional quantity of skin compatible adhesive 64 may also be applied to the region of the substrate 26 immediately below the signal processing circuit 30 to provide additional adhesion to the patient.
• FIG. 4 a partial perspective view of an alternative embodiment of the biomedical electrode 20a is illustrated. Only the end portion of biomedical electrode 20a is presented, showing two cells arranged in series to provide twice the output voltage of one cell. Two fields of electrolyte-containing substance 60a and 60b are present and are electrically separated, as seen on the underside of transparent substrate 26. An anode construction 56a and a cathode construction 58a can be seen in contact with field of electrolyte-containing substance 60a in this view, where the separator 24 has been removed. Another anode construction 56b and another cathode construction 58b can be seen in contact with field of electrolyte-containing substance 60b.
• FIG. 5 a perspective view of a drug delivery device 120 is illustrated. In a manner analogous to FIG. 2, in this illustration the drug delivery device 120 is drawn with a backing that would be present in most preferred embodiments removed, and with separator 124 disengaged.
• a substrate 126 is present for mounting some of the electronic components and conductive pathways. The substrate 126 is preferably a flexible polymeric film, and in this view, as in FIG.
• a first conductive medium 128 under the substrate 126 is in intimate electrical contact with first contact pad 132, which is in turn in electrical contact with pathway 134.
• a second conductive medium 136 under the substrate 126 is in intimate electrical contact with second contact pad 138, which is in turn in electrical contact with pathway 140.
• the drug delivery device 120 includes a galvanic cell including an anode construction 156 connected to pathway 134, and a cathode construction 158 connected to pathway 140.
• the separator 124 is illustrated as having been removed from the drug delivery device 120, allowing the anode 156 and the cathode 158 to contact an electrolyte-containing substance 160.
• the electrolyte- containing substance 160 is separated from the anode 156 and the cathode 158. It will again be recognized that it is only required to separate one of the anode 156 or the cathode 158 from the electrolyte-containing substance 160 to prevent completion of the galvanic cell 150 prior to use.
• An additional quantity of skin-compatible pressure sensitive adhesive 162 may also be present to secure the device 120 to a patient.
• At least one of first conductive medium 128 or second conductive medium 136 will have incorporated within it at least one quantity of pharmaceutically active drug.
• the drug In order to be suitable for iontophoresis, the drug should be capable of existing in an ionized state when so incorporated.
• Some pharmaceutically active drugs that have been successfully used with iontophoresis in the past, and are believed to be suitable with the present invention include lidocaine and epinephrine as described in U.S. Patent 6,295,469 to Linkwitz et al., the entire contents of which are hereby incorporated by reference.
• FIG. 6 a perspective view of an alternate drug delivery device 220 is illustrated.
• the drug delivery device 220 is drawn with a backing that would be present in most preferred embodiments removed, and with the separator disengaged.
• a substrate 226 is present for conveniently mounting some of the electronic components and conductive pathways.
• the substrate 226 is preferably a flexible polymeric film, and in this view, as in FIG. 2 above, has been rendered transparent so that objects attached to its underside, and objects positioned below it, can be visualized.
• Substrate 226 has a layer of pressure sensitive adhesive on its surface opposing that upon which the electronic components and conductive pathways are mounted, and in the illustrated embodiment the a release liner 268 is shown extending beyond substrate 226 to provide for easy removal.
• a first field of electrolyte-containing substance 228 under the substrate 226 is in intimate electrical contact with anode 256, which is in turn in electrical contact with pathway 234. It will be noted that in this embodiment the first field of electrolyte- containing substance 228 also acts as a conductive medium and therefore performs both roles accomplished separately by the first conductive medium 128 and electrolyte containing substance 160 in the embodiment of FIG. 5. Similarly a second field of electrolyte-containing substance 236 under the substrate 226 is in intimate electrical contact with cathode 258, which is in turn in electrical contact with pathway 240.
• the second field of electrolyte-containing substance 236 is also a conductive medium and thus performs both roles accomplished separately by the second conductive medium 136 and electrolyte-containing substance 160 in the embodiment of FIG. 5. Additional quantities of skin-compatible pressure sensitive adhesive may be used to secure the device 220 to a patient.
• the drug delivery device 220 includes a galvanic cell, but that cell is divided into two half-cells, the two half-cells having the circuit between them completed partially through the body of the patient. The rest of the circuit between the two half-cells is completed via pathways 234 and 240 and optionally current controlling and/or wireless communicating electronics 231.
• the drug delivery device 220 includes a separator 224, which in this Figure is illustrated as having been removed from drug delivery device 220. Until the separator 224 is removed, at least one of the first field of electrolyte-containing substance 228 or second field of electrolyte-containing substance 236 is separated from the conductor of either the anode 256 or the cathode 258, respectively.
• At least one of the first field of electrolyte-containing substance 228 or the second field of electrolyte-containing substance 236 has incorporated within it at least one quantity of pharmaceutically active drug.
• the electrolyte-containing substance 60 may either be made from the same material as the conductive adhesive 28, or be another substance better optimized to the purpose of facilitating current production from the galvanic cell 50. If the electrolyte- containing substance 60 is not compatible with skin contact a protective scrim 66 is provided. A release liner 68 is provided to protect the adhesive areas until the biomedical electrode 20 is to be used. In this view, it will be appreciated that the separator 24 is provided as a J-folded separation liner to facilitate its removal to activate the galvanic cell 50 when the electrode is to be used. A variety of materials may be used for separator 24 and/or release liner 68. Liners prepared from paper or a polymer such as a polyester or polypropylene material, coated with a silicone release type coating that is readily separable from both the skin-compatible adhesive 62 and the first and second conductive mediums 28 and 36, are considered particularly suitable.
• a variety of materials may be used for the backing 22.
• a flexible material is preferred which will be comfortable to the user, and is relatively strong and thin.
• Preferred materials are polymer foams, especially polyethylene foams, non-woven pads, especially polyester non-wovens, various types of paper, and polymer films.
• the electrolyte-containing substance can be made from the same or from a different material as that used to make the electrically conductive medium, if one is present. Depending upon the intended or desired application, optimizing each material to its role might be relatively more important, or the advantages of simplifying the production process by using one material in both roles might be more important. Regardless, most of the contemplated embodiments of a biomedical sensor or a drug delivery device will employ some formulation of a pressure-sensitive conductive adhesive in each role.
• Suitable skin-compatible pressure sensitive adhesives 62 include acrylate ester adhesives, acrylate ester copolymer adhesives being particularly preferred. Such materials are generally described in U.S. Pat. Nos. 2,973,826; Re 24,906; Re 33,353; 3,389,827; 4,112,213; 4,310,509; 4,323,557; 4,732,808; 4,917,928; 4,917,929; and European Patent Publication 0 051 935, all of which are incorporated herein by reference.
• one such suitable adhesive may be formed from a copolymer having from about 95 to about 97 weight percent isooctyl acrylate and from about 5 to about 3 percent acrylamide and having an inherent viscosity of 1.1 - 1.25 dl/g.
• two different classes of pressure-sensitive conductive adhesives may be considered most suitable: those adhesives that have a single homogeneous phase, and those adhesives that have two different, but bicontinuous phases. In the latter case, one phase is conveniently hydrophobic, while the other is conveniently hydrophilic. It is believed that single-phase adhesives may have the advantage of presenting more reactive surface area to the anode and the cathode, and two-phase adhesives may have the advantage providing good adhesion between the anode and the electrolyte-containing substance in the face of the evolution of gas at the anode.
• TEGBM triethylene glycol 0.09 bis (methacrylate)
• Suitable two-phase bicontinuous pressure-sensitive conductive adhesives are disclosed in U.S. Patent 5,338,490, to Dietz et al. Certain improvements to the process of making this bicontinuous adhesive are discussed in copending and coassigned U.S. Application Serial No. 09/844,031, titled "Microemulsion Compositions and Methods of Making and Using Same.” Both of these references are incorporated herein by reference.
• a suitable backing material may be fabricated from polymeric sheets, and these can be solid, foamed, or nonwoven sheets as is well known to those skilled in the art.
• a polyethylene foam having closed cells, and commercially available from Voltek, Inc. of Lawrence, NH, is useful as a backing material.
• polyester film having a thickness of about 0.05-0.2 millimeters is considered particularly suitable.
• One such film is a polyester film commercially available as "Mellinex" 505-300, 329, or 339 film from ICI Americas of Hopewell, NA. It may, however, be desirable that the substrate also exhibit some permeability to gas to facilitate the escape of gas evolved during power generation.
• the pads, conductive pathways, and cathode conductors are conveniently placed on a substrate by the screenprinting or ink jet printing of a conductive ink.
• a silver/silver chloride ink commercially available as "R-301" ink from Ercon, Inc. of Wareham, MA, may be preferred.
• This material can be applied to the substrate at a thickness of about 25.4 micrometers, and preferably about 200 micrometers. The thickness of the coating will depend in part on the relative AgCl content in the ink. The higher this content, the thinner the coating will need to be to get the same relative weight of AgCl.
• Embodiments of the invention can be made using magnesium ribbon and zinc ribbon as the anode; however, it is contemplated that a magnesium or zinc loaded ink can be compounded that will prove suitable and allow the anode conductor to be printed onto the substrate.
• a multilayer conductor can be made generally as follows.
• a polyester substrate can be made with a first coating of a silver containing ink approximately 2.5 micrometers thick. Over this layer a conductive carbon ink can be coated to a thickness of approximately 20 micrometers, and a third, top layer of a silver/silver chloride ink can be coated to a thickness of about 80 micrometers.
• cathode constructions such as those made from a magnesium or zinc containing ink, can be similarly coated on carbon, which may itself be coated on a metal ink layer. The function of the carbon layer is to provide a continuous conductive pathway to the surface of the anode/cathode.
• the carbon which does not corrode, allows a convenient non corrosive contact between the cell conductors and external circuits.
• the first silver (or metal) layer under the carbon layer may not be absolutely necessary.
• the function of the first silver layer is to spread the current out in the x-y plane of the coating. It is also protected by the overlying carbon ink layer.

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