WO2016205881A1 - Matériau anisotropiquement conducteur destiné à être utilisé avec une surface biologique - Google Patents

Matériau anisotropiquement conducteur destiné à être utilisé avec une surface biologique Download PDF

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Publication number
WO2016205881A1
WO2016205881A1 PCT/AU2016/050530 AU2016050530W WO2016205881A1 WO 2016205881 A1 WO2016205881 A1 WO 2016205881A1 AU 2016050530 W AU2016050530 W AU 2016050530W WO 2016205881 A1 WO2016205881 A1 WO 2016205881A1
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WIPO (PCT)
Prior art keywords
conductive
substrate
electrode
conductive material
conductive elements
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Application number
PCT/AU2016/050530
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English (en)
Inventor
Dusan Milojevic
Warren Smith
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Ti2 Medical Pty Ltd
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
Priority claimed from AU2015902423A external-priority patent/AU2015902423A0/en
Application filed by Ti2 Medical Pty Ltd filed Critical Ti2 Medical Pty Ltd
Publication of WO2016205881A1 publication Critical patent/WO2016205881A1/fr

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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
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/68335—Means for maintaining contact with the body using adhesives including release sheets or liners
    • 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
    • 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
    • A61B2562/0215—Silver or silver chloride containing
    • 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
    • A61B2562/0217—Electrolyte containing
    • 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
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • 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
    • A61B2562/14—Coupling media or elements to improve sensor contact with skin or tissue
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes
    • 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
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • 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
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296—Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]

Definitions

  • the present disclosure relates to the interfacing of an electrode with a biological surface of a subject for therapeutic, diagnostic and/or general body characterisation purposes.
  • Electrodes typically, electrical signals are applied to a subject and/or detected from a subject transcutaneously, using electrodes placed on or in close proximity to a biological surface of the subject, such as a skin surface.
  • Transcutaneous electrical stimulation and bioelectrical impedance monitoring are two technologies, therapeutic and diagnostic, respectively, that use electrodes in this manner and which are becoming increasingly popular among medical practitioners.
  • Other established techniques in this area include electrocardiography (ECG), electroencephalography (EEG), electromyography (EMG), electrocorticography,
  • electrooculography electroretinography
  • electroantennography electroantennography
  • audiology electrooculography, electroretinography, electroantennography, audiology and
  • the quality and reproducibility of measurement and/or stimulation between an electrode and tissue is highly dependent on the nature of the interface between the electrode and the skin surface (electrode/skin interface).
  • the measured signal is generally proportional in size to the effective electrode area.
  • the size of the effective electrode area can differ from the size of the actual physical electrode area, the physical electrode area being defined by a surface of the electrode that is to contact the skin.
  • the degree of size difference between the physical electrode area and the effective electrode area will depend on the degree and quality of electrical contact between the contact surface and the skin surface. While it is not always necessary that the effective electrode area is the same as the physical electrode area, it can be highly desirable for the size of the effective electrode area to be easily reproducible to ensure measurement consistency.
  • an electrically conductive gel or solution is typically used as a compliant interfacing layer, primarily to minimise contact impedance and achieve a reproducible effective electrode area.
  • Conductive gel is typically applied to the skin surface and/or electrode as free-running gel. Where a conductive solution (e.g. sodium chloride) is used, it can be soaked in an absorbent medium such as gauze that is placed on the skin prior to placement of an electrode thereon. The electrode is typically held in place relative to the skin surface by medical tape or elastic bands etc. Often, however, the area of contact of the gel or solution, which is an important determinant of contact impedance, will be undefined and inconsistent, and therefore tend to degrade any measurement or stimulation reproducibility.
  • a conductive solution e.g. sodium chloride
  • the use of conductive gel or solution when applying electrodes to skin includes a number of shortcomings, most notably through the high dependence on the skill of the user that must precisely apply the electrodes to the subject, and the lack of measurement or stimulation reproducibility.
  • the use of conductive gel or solution can also be messy and awkward, requiring extensive cleaning of the subject's skin or electrode after completion, potentially decreasing use or compliance.
  • a newer generation of electrode contains a self-adhesive conductive layer, typically in the form of a semi-rigid conductive gel/polymer layer that is situated on the electrode surface.
  • the layer has adhesive properties to ensure that the electrode, once placed on the skin, can stay in contact with the skin surface. Electrodes configured in the manner are typically disposable.
  • electrodes with self-adhesive conductive layers also have shortcomings. For example, where the electrode is to be kept in contact with the skin surface for an extended period of time, e.g., for hours or even days, changes in composition of the conductive layer may occur, potentially affecting measurement or stimulation reproducibility. Moreover, the application of such electrodes to a skin surface for extended periods of time can cause discomfort to the subject, decreasing patient compliance. Additionally, some users can have allergic sensitization to the self-adhesive conductive layers. Another problem that has emerged is the difficulty and cost of manufacturing of these types of electrodes, as the self- adhesive conductive layers have to be deposited in a highly precise and accurate manner onto an electrode surface, requiring complex and expensive equipment.
  • Electrodes are designed, predominantly, to conform to relatively flat skin surfaces, featuring small or substantially no curvature.
  • electrotherapeutic and electrodiagnostic techniques increases, however, demand has increased for electrodes that can interface with highly curved anatomical features, such as fingers, toes, joints, and various facial locations.
  • the provision of a conductive gel/polymer layer on an electrode can add significantly to the rigidity of the electrode, reducing the ability for the electrode to flex and conform to curved skin surfaces.
  • Electrodes that employ gel or conductive solution are generally not suitable when used at or adjacent to compromised skin surfaces.
  • Compromised skin surfaces can include wounds ranging from acute cuts and bruises, to more chronic conditions, such as diabetic ulcers, for example.
  • the electrodes have limited benefits in most diagnostic and therapeutic systems.
  • conductive gels and solutions are not formulated to promote healing and any adhesiveness can cause further damage to fragile skin and cause pain to the subject upon removal.
  • the present disclosure provides an anisotropically electrically conductive material to electrically interface an electrode with a portion of a biological surface, the conductive material comprising:
  • a flexible substrate having first and second surfaces on opposite sides, respectively, of the substrate
  • the first surface of the substrate may be located in close proximity to a biological surface such that the first ends of the discrete conductive elements electrically contact the biological surface.
  • the biological surface may be a tissue surface such as a skin surface, including the epidermis, dermis or hypodermis, for example, although the conductive material may be used in conjunction with any biological surface of a subject, including surfaces of other organs such as the heart, liver, kidneys, lungs, stomach, eyes, brain, bladder, prostate, pancreas, or thyroid.
  • the biological surface may be a surface of tissue that has been excised from a body, e.g., for transplant, research purposes or otherwise.
  • the first surface of the substrate may contact, or at least face, the biological surface.
  • the second surface of the substrate may be located in close proximity to an electrode such that the second ends of conductive elements of a subset of the plurality of discrete conductive elements electrically contact simultaneously a contact surface of the electrode.
  • the second surface of the substrate may contact, or at least face, the surface of the electrode.
  • the present disclosure provides a method of electrically interfacing an electrode with a portion of a biological surface, the method comprising:
  • the conductive material comprising:
  • a flexible substrate having first and second surfaces on opposite sides, respectively, of the substrate
  • each conductive element is exposed at the first surface of the substrate and a second end of each conductive element is exposed at the second surface of the substrate, the conductive elements being distributed across the substrate and physically and electrically separated from each other by non-conductive portions of the substrate;
  • the method further comprising:
  • the conductive material may provide an anisotropic conductive medium having good electrical conductance through the thickness of the material, i.e. in a direction substantially perpendicular to the first and second surfaces, but little or no electrical conductance laterally, i.e. in a direction parallel to the first and second surfaces.
  • An electrode may be positioned anywhere on or over the second surface of the flexible substrate such that its contact surface electrically contacts the second ends of conductive elements of different subsets of the plurality of discrete conductive elements.
  • the electrode may contact the first subset of the plurality of discrete conductive elements and then may be moved to contact a second subset of the plurality of discrete conductive elements.
  • Each subset of the discrete conductive elements may be defined, generally, by the area across which the contact surface of the electrode extends and will generally include multiple discrete conductive elements.
  • each subset may comprise 2 or more conductive elements, 3 or more conductive elements, 5 or more conductive elements or otherwise.
  • the electrode By contacting the second ends of any subset of conductive elements, the electrode electrically interfaces with the portion of the biological surface that is in electrical contact with the first ends of that subset of conductive elements. Due to the anisotropicity of the conductive material, there may be substantially no electrical interfacing between the electrode and the rest of the biological surface.
  • the area of the substrate over which the electrode makes contact will generally include multiple discrete conductive elements. So that multiple discrete conductive elements are available for contact with an electrode contact surface having a variety of different sizes, a relatively large number of conductive elements may be provided, the conductive elements may be relatively small in comparison to the electrode contact surface and the conductive elements having a relatively high density distribution across the substrate.
  • the total number of conductive elements distributed across the substrate may be greater than 10, greater than 20, greater than 50, greater than 100, greater than 500, or greater than 1000.
  • the density of conductive elements across the substrate may be at least 1 per cm 2 , at least 2 per cm 2 , at least 5 per cm 2 , or at least 10 per cm 2 .
  • the area of each conductive element at its first or second end, in a plane substantially parallel to the first and second surfaces of the substrate may be less than 0.5 cm 2 , less than 0.25 cm 2 , less than 0.1 cm 2 or less than 0.05 cm 2 .
  • the maximum distances between neighbouring conductive elements may be less than 1.0 cm, less than 0.75 cm, less than 0.5 cm, less than 0.25 cm, less than 0.1 cm, or less than 0.05cm. It is conceived that conductive elements may also be distributed in a microscopic scale. For example, the area of each conductive element at its first or second end, in a plane substantially parallel to the first and second surfaces of the substrate, may be less than 0.01cm 2 . Moreover, the maximum distances between the ends of neighbouring conductive elements may be less than 0.01cm.
  • Different subsets of the conductive elements may be selected as desired by varying the position of the electrode at the second surface and/or by varying the shape or size of the electrode contact surface. Different subsets of the conductive elements may be selected in order to electrically 'probe' different parts of the biological surface, e.g. to enable
  • the conductive material may be used with multiple electrodes simultaneously, each electrode being connected to a different, discrete subset of the conductive elements.
  • each electrode being connected to a different, discrete subset of the conductive elements.
  • the conductive material may be used with multiple electrodes simultaneously, each electrode being connected to a different, discrete subset of the conductive elements.
  • the electrode may be desirable that, wherever the electrode is located with respect to the second surface of the substrate, its contact surface will electrically contact a subset of the plurality of conductive elements that contains substantially the same number of conductive elements. This may be desirable particularly where the conductive elements have substantially uniform sizes and shapes and therefore substantially the same electrical properties.
  • the conductivity of the conductive material may be substantially constant over any area comprising multiple conductive elements.
  • different subsets of conductive elements may also be selected by provision of a non-conductive, insulating layer, providing a mask element between the electrode and the conductive material.
  • the mask element may locate between a portion of the electrode contact surface and the second surface of the conductive material, preventing electrical contact between the electrode and some of the conductive elements over which the electrode is located.
  • the mask element may comprise a sheet of non-conductive material that includes, for example, a hole or recess that defines the desired area of electrical contact between the electrode contact surface and the second surface of the conductive material.
  • the mask element may comprise adhesive to attach the mask element to the second surface of the conductive material or to the electrode contact surface, or may be a mobile mask element that is designed to rest against rather than be attached to the electrode or conductive material.
  • the conductive material may be used in addition to, or more preferably as replacement for, a conductive gel or conductive solution as an interface between an electrode and a biological surface.
  • the conductive material may maintain low contact impedances and introduce high reproducibility in the quality of electrical contact and therefore measurement or stimulation values.
  • the conductive material may provide a hygienic barrier between the biological surface and the electrode and associated electrical componentry.
  • the conductive material including the substrate thereof, may be substantially non-porous to prevent propagation of biological material such as body surface exudates and bacteria between the electrode and the biological surface.
  • the conductive elements may be sealingly engaged with the substrate as they extend through the substrate.
  • the conductive material may provide a non-diffusive barrier.
  • the conductive material may be movable relative to the biological surface, reducing the possibility of irritation to the subject occurring in comparison to an approach where the conductive material is adhered directly to the biological surface, for example. Despite this, in some embodiments, the conductive material may be adapted to adhere to the biological surface.
  • each conductive element carries an individual signal component and an individual noise component.
  • the overall signal transferred is a sum of the individual signals components, which are generally in phase with each other such that constructive interference between the individual signal components can occur.
  • the overall noise transferred is a sum of the individual noise components.
  • the individual noise components are random in nature, destructive interference between the individual noise components can occur. Therefore, the overall signal amplitude can be increased in comparison to the overall noise signal, improving the signal-to-noise ratio.
  • the substrate may comprise a single layer of material or multiple layers of material, e.g. multiple layers of material stacked on top of each other.
  • the substrate may comprise a non-conductive (i.e. insulating) material such as a polymeric foam, polymeric film or a combination of foam and film.
  • the substrate may be formed entirely of the non-conductive material. Polymers such as silicone, polyurethane or polyethylene may be used, for example.
  • the substrate may be hydrophobic or hydrophilic.
  • the substrate may be formed of medical grade material, for example a medical grade elastomer. In some embodiments, the substrate may be transparent so that target sites on the biological surface for electrical interfacing can be identified through the substrate.
  • the substrate may comprise textile, e.g., woven or knitted material.
  • the conductive material and/or substrate may be a cloth.
  • the substrate may be substantially flat or it can be have a three-dimensional shape, e.g. a curved or otherwise structured shape. The three-dimensional shape may be pre-formed in the substrate.
  • the conductive material may provide, or may be comprised in, a medical interface such as a medical dressing.
  • the medical dressing may be a pad, a compress, bandage or tape (including kinesiology tape) configured for application to tissue to promote healing of tissue, to protect the tissue from harm, to restrict or control movement of the tissue, and/or to generally allow monitoring of the tissue.
  • the conductive material may be held in place by, or may be comprised in, a bandage, plaster, belt or band (e.g. a headband or wristband), for example. Additionally or alternatively, the conductive material may be held in place using adhesive tape, and/or through use of an adhesive layer that may form part of the dressing.
  • the conductive material may provide an electrically conductive path to tissue for the purpose of monitoring the tissue, electrostimulation of the tissue or otherwise.
  • the electrically conductive path may extend through a thickness of the conductive material.
  • the conductive material may provide for, or enable contact with, an electrode.
  • the tissue at which the conductive material, e.g. in the form of a medical dressing, may be applied may include a wound or other types of tissue damage and/or imperfections.
  • the conductive material may be applied at tissue including a cut, burn, abscess, carbuncle, blister, wart, rash, scar, infection, bedsore, disease, muscle tear, ligament tear or otherwise.
  • the conductive material may be flexible and pliable.
  • the conductive material may bend to follow the curvature of a biological surface.
  • the conductive material may be configured so that, upon bending during normal use, electrical independence of the discrete conductive elements may still be maintained (i.e. the discrete conductive elements may not come into electrical contact with each other).
  • the conductive elements may comprise a conductive medium such as silver, gold, brass, platinum, titanium, graphene, carbon nanotubes and/or conducting polymer or composites of such conductive media with polymer and/or ceramics.
  • the conductive elements may comprise non-conductive materials metallised with gold, brass, platinum, titanium or other biocompatible metals, or may comprise non-conductive materials made conductive by suitable treatment with conductive polymer inks, for example.
  • the conductive elements may comprise conductive gel or conductive solution. Where conductive gel is used, the gel may be located in discrete conduits, e.g., in tubes that have open ends at both the first and second surfaces.
  • the plurality of conductive elements may be provided across the substrate in an array, e.g. in a substantially uniform array.
  • the conductive elements may be provided in a regular array.
  • the array may include equidistant rows and columns across the substrate. Nevertheless, alternative distributions of conductive elements are possible such as rectilinear arrays, curvilinear arrays, hexagonal arrays or otherwise.
  • the conductive elements may be in a line, or arranged in different shapes and patterns. At the surface of the substrate, the distance between adjacent conductive elements (e.g.
  • a higher density array of conductive elements may be provided.
  • conductivity of the conductive material may be substantially constant over any area comprising a plurality of the conductive elements. Nevertheless, substantially constant conductivity may still be achieved, particularly over larger areas, even where an irregular array and/or non-identical conductive elements are employed. Moreover, in some embodiments it may be desirable to vary the conductive properties of the conductive material over different areas of the conductive material, depending on its desired use.
  • the conductive elements may comprise pillars of a conductive medium, which pillars extend substantially in a straight line between the first and second surfaces of the substrate.
  • the pillars may be solid or hollow.
  • the conductive elements may comprise curved or looped conductive medium that takes an indirect route and/or multiple routes between the first and second surfaces of the substrate.
  • the conductive elements may comprise conductive yarn.
  • the yarn may be formed of a single conductive fibre or lengths of interlocked conductive fibres.
  • the conductive yarn may comprise a single conductive medium only, e.g. silver only, or a combination of two or more materials, e.g. silver-coated yarn or a combination of a conductive medium and absorbent material, the use of absorbent material being discussed in more detail below.
  • coaxial yarn may be provided that comprises a central conductive core coated with an outer layer of absorbent, e.g., superabsorbent polymer.
  • the loops may comprise one or more full turns and/or partial (e.g. half-) turns.
  • Each loop of conductive medium may have a region that extends out of the first surface of the substrate to provide at least part of the first end of the conductive element.
  • Each loop of conductive medium may also have a region that extends out of the second surface of the substrate to provide at least part of the second end of the conductive element. So that the loop of conductive medium can extend out of and protrude from both the first and second surfaces, the loop may have a dimension in the thickness direction of the substrate (i.e. in a direction directly between the first and second surfaces of the substrate) that is larger than the thickness of the substrate.
  • conductive yarn to form at least a portion of the conductive elements, e.g. to form one or more conductive loops, may ensure that the material retains flexibility.
  • the conductive yarn may be flexible such that the flexibility of the substrate material is substantially retained when the conductive elements are located therein.
  • the conductive yarn may also be relatively soft and compliant, ensuring that any contact between the conductive yarn and the biological surface does not cause significant discomfort to the subject.
  • the conductive elements comprise pillars of conductive medium, which pillars may be relatively inflexible or rigid in some embodiments, sufficient flexibility in the conductive material comprising the conductive elements may still be achievable if the substrate is suitably flexible and the pillars are suitably spaced from each other.
  • loops of conductive medium in the conductive elements may ensure that the conductive elements are held firmly in position in the substrate.
  • the use of loops of conductive medium may ensure that a relatively large area of the conductive elements can be exposed at the first and second surface of the substrate to provide at least a portion of the first and/or second ends of the conductive element.
  • the area may be relatively large in comparison to a cross-section of the conductive medium
  • an intermediate portion of a length of the conductive medium may contact the biological surface, rather than an end of the conductive medium.
  • An intermediate portion may provide a relatively smooth, compliant surface in comparison to an end of the conductive medium. This may again reduce the likelihood that any significant discomfort is caused to the subject.
  • Loops of conductive medium may be introduced into the substrate using methods known in the textile arts such as sewing, crocheting, knitting, embroidering or weaving, for example.
  • a variety of different techniques may be employed to provide or position the conductive elements in the substrate. For example, where loops of conductive yarn are used, the loops may be sewn into position in the substrate, e.g. by hand or using mechanical, automated techniques. Where pillars of conductive medium are used as conductive elements or otherwise, wires or other conductive features may be inserted in the substrate using a variety of different insertion techniques including at a microscopic or macroscopic scale.
  • the conductive material may comprise moisture holding features.
  • the moisture holding features may be provided at least at or adjacent the first surface of the substrate. Prior to bringing the first ends of the conductive elements in to contact with the biological surface, the first surface of the substrate and/or the biological surface may be wetted with a liquid such as water. Sweat from the subject may also be used.
  • the moisture holding features may comprise absorbent material. A portion of the liquid may be absorbed into the absorbent material.
  • the conductive material, at least at the first surface of the substrate may be maintained in a damp state, improving electrical contact between the conductive elements and the biological surface over a substantial period of time.
  • absorbent material when used as a moisture holding feature, it may be provided in the form of yarn, e.g., superabsorbent yarn.
  • the yarn may be formed of lengths of interlocked superabsorbent fibres.
  • Each conductive element may comprise absorbent material adjacent or intertwined with the conductive medium.
  • Each conductive element may comprise one or more loops of absorbent material in addition to loops of conductive medium.
  • Each loop of absorbent material may have a region that extends out of the first surface of the substrate to provide a portion of the first end of the conductive element that contacts the biological surface.
  • Each loop of absorbent material may also have a region that extends out of the second surface of the substrate to provide a portion of the second end of the conductive element that contacts the electrode. So that each loop of superabsorbent material can extend out of and protrude from the first and second surfaces, the loop may have a dimension in the thickness direction of the substrate (i.e. in a direction directly between the first and second surfaces of the substrate) that is larger than the thickness of the substrate.
  • one or more of the conductive elements comprises a loop of the conductive medium and a loop of the absorbent material.
  • the loop of the conductive medium may be provided in a first plane and the loop of the absorbent material may be provided in a second plane, different from the first plane.
  • the first and second planes may be substantially perpendicular to each other and substantially perpendicular to a plane of the first and/or second surfaces. In this arrangement or otherwise, regions of the loop of conductive medium and the loop of absorbent material that are exposed at the first surface of the substrate may cross each other. Similarly, regions of the loop of conductive medium and the loop of absorbent material that are exposed at the second surface of the substrate may cross each other.
  • first end and/or second end of the conductive element may have a cross-shape.
  • the first end and/or second end may comprise, or appear as, a single cross-stich, for example.
  • the cross-stich may be formed in part from conductive medium and in part from absorbent material.
  • two perpendicular loops of conductive medium are provided, with the loop of the absorbent material being parallel to one of the two loops of conductive medium.
  • two loops of absorbent material may be provided, each loop of absorbent material being parallel to a respective one of the two perpendicular loops of conductive medium.
  • multiple loops of conductive and/or absorbent material may be provided, configured in cross (+), star/asterisk (*) shapes or otherwise.
  • the loop of conductive medium may be located outwardly of the loop of the absorbent material.
  • the conductive material may be positioned outside of the absorbent material and thus further away from the adjacent first or second surface of the substrate.
  • the approach may ensure that the conductive medium is closer than the absorbent material to the biological surface and/or electrode surface. Good electrical contact may therefore be achieved between the conductive medium and the biological surface and/or electrode surface, e.g. as a result of the conductive medium being first to contact the biological surface and/or electrode surface.
  • each conductive element may be substantially flush with the first surface of the substrate or may protrude from the first surface of the substrate.
  • the second end of each conductive element may be substantially flush with the second surface of the substrate or may protrude from the second surface of the substrate. It may be desirable for the first and/or second ends to protrude from the respective substrate surface to ensure better/easier contact with the biological surface or electrode, respectively.
  • a degree of protrusion of the first or second end of the conductive element from the surface of the substrate may be controlled by varying a number of loops of material that may form the conductive element, for example.
  • the greater the number of loops the more that the conductive element may protrude from the surface, particularly where loops cross over each other at the surface.
  • a diameter of yarn that may be comprised in the conductive elements may be adjusted to control the degree of protrusion. In general, the greater the diameter of the yarn, the more that the conductive element may protrude from the surface.
  • the degree of protrusion of the first or second end of the conductive element may be increased by providing small protrusions or "bumps" on the first or second surfaces of the substrate such that the ends of the conductive elements extend over the surface protrusions or "bumps".
  • a reduction may be achieved by ensuring that the height of the protruding ends of the conductive elements, relative to the adjacent surfaces of the substrate, is less than half of the spacing between neighbouring conductive elements.
  • the conductive material may be adhered to the biological surface.
  • one or more adhesive elements e.g. adhesive layers, may be comprised in the conductive material.
  • the adhesive elements may be located on the first and/or second surface of the substrate such as to surround each conductive element individually, or to surround a periphery of the plurality of the conductive elements, for example.
  • the adhesive elements may be used to adhere the material to an electrode and/or to the biological surface.
  • the substrate may have one or more disposable protective layers that are removably adhered to the adhesive layers such as to cover the adhesive layers when the adhesive layers are not in use, making manufacture, packaging and subsequent handling more straightforward.
  • a protective layer covering adhesive at the first surface comprises a plurality of holes, each hole aligning with the first end of a respective conductive element in the substrate.
  • the protective layer may be used as a template for introducing the conductive elements into the substrate during manufacture of the conductive material. Additionally or alternatively, the protective layer may be used as a mask to enable selective dampening of substantially only the absorbent portions of conductive elements and not the entire substrate, limiting any liquid spread laterally through the substrate when the material is wetted, reducing the possibility for lateral conduction to occur across the substrate. Wetting may be used to dampen absorbent material to improve electrical contact, as described above.
  • Adhesive elements or layers may comprise medically approved adhesive suitable for short or long term contact with biological surface.
  • the strength of the adhesive may be selected based on the particular intended application, the target biological surface site, or the intended length of use, for example.
  • Advanced medically-approved adhesive layers which become adhesive (or non-adhesive) upon application of a selected "trigger" such as moisture or biological surface temperature may also be used.
  • an anisotropically conductive material is described relative to which an electrode can be moved in order to electrically interface with different portions of a biological surface over which the conductive material is placed.
  • the conductive material may be adapted to be used in a fixed relationship relative to an electrode.
  • the conductive material may form part of an electrode device.
  • a conductive member e.g. a conductive layer, may be introduced in a fixed relationship with the substrate, and which electrically contacts second ends of a plurality of the conductive elements.
  • an electrode device comprising:
  • a flexible non-conductive substrate having first and second surfaces on substantially opposite sides, respectively, of the substrate;
  • each conductive element is exposed at the first surface of the substrate and a second end of each conductive element is exposed at the second surface of the substrate, the conductive elements being physically and electrically separated from each other by portions of the non-conductive substrate;
  • each conductive member being fixed relative to the substrate and being connected to the second ends of all or a subset of the plurality of conductive elements.
  • a single conductive member may be provided.
  • the single conductive member may be connected to second ends of all of the plurality of conductive elements, for example.
  • each conductive member may be in the form of a conductive layer on the second surface of the substrate.
  • Each conductive member may provide an electrode, which is fixed to the substrate, and which is wired (e.g. hard-wired) to external electrical componentry such as monitoring or electrostimulation apparatus.
  • each conductive member may include a contact portion that can be releasably electrically connected to external electrical componentry as desired.
  • the contact portion may be in the form of a tab. The tab may extend beyond an edge of the substrate, for example.
  • the electrode device may include absorbent material configured as described above.
  • the absorbent material may form part of the conductive elements or may be provided as a layer at the first surface of the substrate that extends over and/or between the first ends of the conductive elements.
  • the electrode device may include an adhesive portion.
  • the adhesive portion may be used to secure the electrode device to the biological surface.
  • the adhesive portion may be in the form of an adhesive layer provided at the first surface of the substrate, for example.
  • the present disclosure provides a garment comprising an anisotropically conductive material according to the first aspect of the present disclosure.
  • the garment may be any type of garment suitable to extend over a portion of a subject's body in a close-fit manner.
  • the conductive material of the garment may rest on a biological surface, particularly a skin surface, enabling good electrical contact to be achieved with the skin surface.
  • Suitable garments may include, for example, gloves, socks (including compression socks), hats, wrist bands, head bands, arm bands, ankle straps, shoulder straps or otherwise.
  • the garment may be formed entirely of the conductive material or the conductive material may form one of multiple portions, e.g. layers, of the garment.
  • the conductive material may provide a liner of the garment, acting as a hygienic barrier between a main body of the garment and the skin surface.
  • the main body e.g. an outer layer of the garment
  • the electrodes being adapted to electrically interface with the skin surface through the liner comprising the conductive material.
  • the present disclosure provides a liner for a garment, the liner comprising conductive material according to the first aspect of the present disclosure.
  • the liner may be disposed after single use, ensuring that liner is clean when used with a garment.
  • the conductive material can provide a biological interface, e.g. a medical interface, and in some embodiments may provide, or may be comprised in, a medical dressing, e.g., a wound dressing, to provide protection and promote healing of tissue or otherwise, while also providing an electrically conductive path to the tissue.
  • a medical dressing e.g., a wound dressing
  • the dressing may comprise adhesive to attach to a biological surface surrounding the tissue, e.g., surrounding a wound.
  • the present disclosure provides a medical interface, e.g. a medical dressing such as a wound dressing, comprising an anisotropically conductive material according to the first aspect of the present disclosure.
  • the present disclosure provides a garment comprising an electrode device according to the third aspect of the present disclosure.
  • the garment may be any type of garment suitable to extend over a portion of a subject's body in a close-fit manner.
  • the electrode device of the garment may rest on a skin surface, enabling good electrical contact to be achieved with the skin.
  • Suitable garments may include, for example, gloves, socks (including compression socks), hats, wrist bands, head bands, arm bands, ankle straps, shoulder straps, belts or otherwise.
  • the garment may comprise a plurality of the electrode devices integrated therein.
  • the conductive material, electrode device, garment, medical interface and/or liner according to the present disclosure may have a wide variety of applications where electrical signals are to be applied to and/or detected from a subject transcutaneously.
  • applications may include bioimpedance monitoring, electrostimulation, electrocardiography (ECG), electroencephalography (EEG), electromyography (EMG), electrocorticography, electrooculography, electroretinography, electroantennography, audiology and
  • the construction of the conductive material, electrode device, garment, medical interface and/or liner may reduce a dependence on the skill of the person applying electrodes to a biological surface to achieve high quality electrode contact and measurement reproducibility. The construction may also reduce any mess or awkwardness associated with the application of electrodes to a biological surface.
  • the conductive material, electrode device, garment, medical interface and/or liner may be suitable for use in a wide variety of conditions, including where an electrode is to be interfaced with a biological surface for extended periods of time, e.g., for longer than a few minutes, such as hours or even one or more days.
  • the conductive material, electrode device, garment, medical interface and/or liner may be sufficiently flexible to conform to both flat anatomical features and curved anatomical features, such as fingers, toes, joints, and various facial locations, for example.
  • the conductive material, electrode device, garment, medical interface and/or liner may be used in contact or close proximity with compromised skin or other biological surfaces, since it may provide a relatively soft, supple, dry and inert contact surface.
  • the conductive material, electrode device, garment, medical interface and/or liner may be used in contact with or in close proximity to wounds, ranging from acute cuts and bruises, to more chronic conditions, such as diabetic ulcers.
  • the conductive material, electrode device, garment, medical interface and/or liner may be easy to position on the biological surface.
  • the quality of the electrical contact may be high, contact impedances may be low, and measurement and stimulation values may be consistent and reproducible.
  • the conductive material, electrode device, garment, medical interface and/or liner may have simple, reliable constructions, providing for ease of manufacture at reduced costs. Reduced costs may allow the conductive material, electrode device, garment, medical interface and/or liner to be used as a disposable item.
  • the conductive material, electrode device, garment, medical interface and/or liner may also be suitable for washing, enabling reuse while maintaining sterility.
  • the present disclosure provides an electrode for use with the anisotropically conductive material according to the first aspect, particularly where at least the second end of each conductive element protrudes from the second surface of the substrate.
  • an electrode comprising:
  • an insulating layer extending over a first surface of the conductive layer, wherein the insulation layer has a hole therethrough, the shape and size of the hole defining an electrical contact surface of the electrode.
  • the present disclosure provides a kit comprising the anisotropically conductive material according to the first aspect, wherein the second end of each conductive element protrudes from the second surface of the substrate;
  • an electrode comprising:
  • an insulating layer extending over a first surface of the conductive layer, wherein the insulating layer has a hole therethrough, the shape and size of the hole defining an electrical contact surface of the electrode to electrically contact simultaneously the protruding second ends of conductive elements of a subset of the plurality of discrete conductive elements.
  • the depth of at least the insulating layer may be smaller than the height of the second end of each conductive element (i.e. smaller than the maximum distance to which the second end of each conductive element protrudes from the second surface of the substrate).
  • the ability to define a contact surface of an electrode by forming a hole in an insulating layer can also provide a number of other advantages.
  • an end user of the electrode may be able to form the hole and/or adapt the shape and/or size of the hole as appropriate for the desired use.
  • the user may use a knife, scissors or other type of cutting device to form the hole.
  • a kit may be provided including at least one conductive layer and a plurality of insulating layers, each insulating layer having a hole of a different size and/or shape. Accordingly, a user may select an insulating layer for use with the conductive layer that has a hole with a shape and/or size appropriate for the desired use. This may prevent a user having to pre -order an electrode of a specific size and shape.
  • the insulating layer may have an adhesive layer on a surface thereof to connect the insulating layer to the conductive layer.
  • the insulating layer may be configured as a sticker.
  • the electrode may further comprise an insulating backing layer extending over a second surface of the conductive layer, the second surface being on an opposite side of the conductive layer to the first surface.
  • the hole in the insulating layer may have a variety of different shapes and sizes.
  • the hole may be round, oval, square, rectangular, triangular, or otherwise.
  • the area covered by the hole may be considerably smaller than the area of the first surface of the conductive layer.
  • the hole may cover an area that is less than 50%, less than 25% or less than 10% of the area of the first surface of the conductive layer.
  • the insulating layer may not extend over the entire first surface of the conductive layer.
  • the insulating layer may leave a contact portion of the first surface of the conductive layer exposed for electrically connecting, through hard wiring or a releasable wired connection, to other electrical componentry.
  • a releasable wired connection may utilise a conductive clip such as a spring or crocodile clip, which releasably attaches to contact portion.
  • the contact portion may be located at substantially an opposite of the conductive layer from the electrical contact surface of the electrode defined by the hole in the insulating layer.
  • an insulating layer is described, which insulating layer may be adhered to the conductive layer of the electrode.
  • the insulating layer may be adhered to the conductive material or provided as a mobile element between the conductive material and the conductive layer of the electrode.
  • the insulating layer may be considered an insulating mask element that prevents electrical contact between the electrode and some of the conductive elements over which the electrode is located.
  • Fig. 1 shows an oblique view of a portion of conductive material according to an embodiment of the present disclosure
  • Fig. 2a shows a schematic cross-sectional view of the conductive material of Fig. 1 along line A—A of Fig. 1 ;
  • Fig. 2b shows a schematic cross-sectional view of conductive material according to variation of the conductive material of Fig. 2a;
  • Fig. 3a shows a schematic cross-sectional view of the conductive material of Fig. 1 adjacent a skin surface;
  • Fig. 3b shows a schematic cross-sectional view of the conductive material of Fig. 3a having an electrode located thereon;
  • Fig. 3c shows a schematic cross-sectional view of the conductive material of Fig. 3a having an electrode repositioned thereon;
  • Fig. 3d shows a schematic cross-sectional view of the conductive material of Fig. 3a having two electrodes located thereon;
  • FIG. 4a shows an oblique view of a glove comprising conductive material according to an embodiment of the present disclosure
  • Fig. 4b shows an oblique view of a medical dressing comprising conductive material according to an embodiment of the present disclosure
  • Fig. 5 shows a schematic cross-sectional view of conductive material according to another embodiment of the present disclosure
  • Fig. 6 shows an oblique view of a portion of conductive material according to another embodiment of the present disclosure
  • Fig. 7a shows a plan view of an electrode according to an embodiment of the present disclosure .
  • Fig. 7b shows a cross-sectional view of the electrode of Fig. 7a, along line A—A of Fig. 7a;
  • FIG. 8 shows a cross-section view of the electrode of Figs. 7a and 7b in electrical contact with conductive material according to an embodiment of the present disclosure
  • FIG. 9 shows a plan view of an electrode according to another embodiment of the present disclosure.
  • Fig. 10 shows a schematic cross-sectional view of an electrode device comprising conductive material according to an embodiment of the present disclosure
  • Fig. 11 shows an oblique view of a portion of conductive material according to an embodiment of the present disclosure having an insulating mask element.
  • FIG. 1 A portion of conductive material 1 according to an embodiment of the present disclosure is illustrated in Figs. 1 and 2a.
  • the material 1 includes a flexible substrate 10 having first and second surfaces 11, 12, the first and second surfaces being located on substantially opposite sides of the substrate 10.
  • the material 1 also includes a plurality of discrete conductive elements 13 distributed in an array across the substrate 10. As seen in Fig. 2a, each conductive element 13 extends through the flexible substrate 10 such that a first end 131 of each conductive element 13 is exposed at and protrudes from the first surface 11 of the substrate 10 and a second end 132 of each conductive element 13 is exposed at and protrudes from the second surface 12 of the substrate 10.
  • the substrate 10 is formed substantially of non-conductive material such as a polymeric film, and therefore the discrete conductive elements 13 are electrically isolated from each other through the substrate 10.
  • the conductive material 1 provides an anisotropic conductive medium having good electrical conductivity through the thickness of the textile 1 (the thickness direction being indicated by arrow T in Fig. 2a), but little or no electrical conductivity laterally through the material 1 (the lateral direction being indicated by arrow L in Fig. 2).
  • the first surface 11 of the substrate 10 is located in close proximity to a skin surface 14 of a subject such that first surface 11 faces the skin surface 14 and the first ends 131 of the conductive elements 13 each electrically contact the skin surface 14.
  • the first surface 11 may at least partly contact the skin surface 14 or may be spaced slightly from the skin surface 14 by virtue of a protrusion of the first ends 131 of the conductive elements 13.
  • an electrode 15 is located in close proximity to the second surface 12 of the substrate 10 such that a contact surface 151 of the electrode 15 faces the second surface 12 and the second ends 132 of a subset of the conductive elements 13 each electrically contact the contact surface 151 of the electrode 15.
  • the second surface 12 may at least partly contact the contact surface 151 of the electrode 15 or may be spaced slightly from the contact surface 151 by virtue of a protrusion of the second ends 132 of the conductive elements 13.
  • the subset of conductive elements that is contacted by the electrode 15 is indicated by reference numeral 13a in Fig. 3b.
  • the subset of conductive elements 13a is defined, generally, by the area across which the contact surface 151 of the electrode 15 extends.
  • the electrode 15 By contacting the second ends 132 of the conductive elements 13 of the subset 13a, the electrode 15 will electrically interface with a portion of the skin surface 14 that is in contact with the first ends 131 of the conductive elements 13 of the subset 13a. Since the conductivity of the material 1 is anisotropic, there may be substantially no electrical interfacing between the electrode and the rest of the skin surface 14.
  • Different subsets of the conductive elements 13 may be selected as desired by varying the position of the electrode 15 on the second surface 12 of the substrate 10 and/or by varying the shape or size of the electrode 15. Different subsets of the conductive elements 13 may be selected in order to electrically 'probe' different parts of the skin surface 14 of the subject, e.g. to enable bioimpedance monitoring and/or to apply electro-stimulation across different regions of tissue of the subject. As an example, after using the electrode 15 to electrically probe the area of the skin surface 14 that is in contact with the first subset 13a of conductive elements, as illustrated in Fig. 3b, the electrode 15 may be shifted, as illustrated in Fig.
  • Electrodes 15a, 15b may be used to electrically probe different areas of the skin surface 14 at the same time by simultaneously contacting discrete, electrically isolated subsets 13c, 13d of the conductive elements 13.
  • the electrodes 15 can contact multiple discrete conductive elements 13 that form each subset 13a, 13b, 13c, 13d of the conductive elements 13, the conductive elements are relatively small in comparison to the electrode contact surface 151 and the conductive elements have a relatively high distribution density across the substrate 10. In general, it is not intended that the electrode contacts only one conductive element. Rather, it is intended that the electrode contacts multiple conductive elements that form a subset of the plurality of conductive elements.
  • conductive elements In the portion of conductive material illustrated in Fig. 1, thirty-six conductive elements are shown distributed across the substrate. However, depending on the size of the substrate, the size of the conductive elements, and the distribution density of the conductive elements, the total number of conductive elements is essentially limitless. The total number of conductive elements distributed across the substrate can be greater than 50, greater than 100, greater than 500, or greater than 1000, for example. [0108] The density of conductive elements across the substrate can be at least 1 per cm2, at least 2 per cm 2 , at least 5 per cm 2 , or at least 10 per cm 2 , for example.
  • each conductive element at its first or second end, in a plane substantially parallel to the first and second surfaces of the substrate may be less than 0.5 cm 2 , less than 0.25 cm 2 , less than 0.1 cm 2 or less than 0.05 cm 2 , for example.
  • the maximum distances between the ends of neighbouring conductive elements may be less than 1.0 cm, less than 0.75 cm, less than 0.5 cm, less than 0.25 cm, less than 0.1 cm, or less than 0.05cm, for example.
  • the conductive elements may be distributed in a microscopic scale.
  • the area of each conductive element at its first or second end, in a plane substantially parallel to the first and second surfaces of the substrate may be less than 0.01cm 2 .
  • the maximum distances between the ends of neighbouring conductive elements may be less than 0.01cm.
  • the higher the density of conductive elements the closer the effective electrode area of the electrode 15 may be in size and shape to the physical electrode area of the electrode 15.
  • the size and shape of the physical electrode area corresponds to the size and shape of the electrode contact surface 151.
  • the size and shape of the effective electrode area is dependent on the number of conductive elements 13 in the subset, and the shape and size of each conductive element 13 in the subset, particularly where they contact the skin surface 14.
  • each conductive element 13 each include loops of yarn.
  • each conductive element includes a loop of conductive yarn 133 and a loop of superabsorbent yarn 134.
  • the conductive yarn is formed from lengths of interlocked conductive fibres and the superabsorbent yarn is formed from lengths of interlocked superabsorbent fibres.
  • each loop 133, 134 includes almost 2 full turns of yarn although more or fewer full or partial turns may be used.
  • Each loop 133, 134 has a region that extends out of the first surface 11 of the substrate 10 and a region that extends out of the second surface 12 of the substrate, the remainder of each loop 133, 134 being substantially surrounded by/embedded in the substrate 10.
  • the regions of the loops 133, 134 that extend out of the first surface 11 of the substrate 10 form the first ends 131 of the conductive elements 13.
  • the regions of the loops 133, 134 that extend out of the second surface 12 of the substrate 10 form the second ends 132 of the conductive elements 13.
  • each loop 133, 134 of conductive material 13 can extend out of the first and second surfaces 11, 12, each loop has a dimension in the thickness direction T of the substrate 10 that is larger than the thickness of the substrate 10.
  • the loops of yarn 133, 134 are sewn into place.
  • the sewing substantially locks the loops into the substrate 10.
  • the regions of the loops of yarn 133,134 that form the first and second ends 131, 132 of the conductive elements 13 provide relatively large, smooth and compliant surfaces for electrical contact with the skin surface 14 and electrode 15.
  • the loops of conductive yarn 133 provide the main conductive path for electricity to flow through the substrate 10 between the electrode 15 and the skin surface 14.
  • the loops of superabsorbent yarn 134 provide the substrate 10 with a moisture holding feature, adjacent the conductive yarn 13, that can improve the quality of electrical contact between the conductive yarn of the conductive element 13 and the skin surface 14.
  • a liquid such as water. A portion of the liquid is absorbed into the loops of superabsorbent yarn 134 .
  • the conductive material 1, at least at the first surface 11 of the substrate 10, can be maintained in a damp state for an extended period of time, improving electrical contact between the conductive elements 13 and the skin surface 14.
  • the improved electrical contact results in lower contact impedances between the conductive elements 13 and the skin surface 14.
  • Other types of absorbent or superabsorbent material may be used as moisture holding features in place of superabsorbent yarn.
  • the loop of the conductive yarn 133 is provided in a first plane, the first plane being substantially parallel to the page on which Fig. 2 is presented, and the loop of the superabsorbent yarn 134 is provided in a second plane, the second plane being substantially perpendicular to the first plane/the page and perpendicular to the first and second surfaces 11, 12 of the substrate.
  • the arrangement is such that the loop of conductive yarn 133 crosses the loop of superabsorbent yarn 134 at the first end 131 of the conductive element 13, and the loop of conductive yarn 133 also crosses the loop of superabsorbent yarn 134 at the second end 132 of the conductive element 13.
  • first and second ends 131, 132 of the conductive elements 13 are each provided in the form of single cross-stiches at the first and second surfaces 11, 12 of the substrate 10, respectively.
  • the cross-stitches are most easily identifiable in Fig. 1.
  • One part of each cross-stich is provided by conductive yarn 133 and the other part of each cross-stitch is provided by superabsorbent yarn 134.
  • two loops of conductive yarn 133 are provided, the loops being perpendicular to each other.
  • the loop of superabsorbent yarn 134 lies adjacent to, and runs parallel to, one of the two loops of conductive yarn 133.
  • the conductive yarn may be intertwined with the superabsorbent yarn.
  • the loop of conductive yarn 133 encircles a larger area than, and is located outwardly of, the loop of superabsorbent yarn 134. Accordingly, where the conductive yarn crosses the superabsorbent yarn, the conductive yarn is positioned to the outside of the superabsorbent yarn, further away from the substrate.
  • the approach ensures that the loop of the conductive yarn 133 is better disposed to contacting the skin surface 14 and the electrode 15 than the loop of superabsorbent yarn 134. This may ensure a higher quality of electrical contact than if the positions of the two types of yarn were reversed.
  • the conductive material 1 can provide a biological interface for achieving electrical contact between an electrode and a biological surface such as a skin surface on which the conductive material 1 is located.
  • the conductive material 1 may be provided in the form of a patch or cloth that is freely locatable over any skin surface prior to electrode contact.
  • the conductive material 1 may form all or part of a garment.
  • the conductive material 1 forms part of a glove 2 that is configured to fit over a hand in a tight-fit manner.
  • the conductive material 1 provides a panel of the glove 2 adapted to locate over the back of the hand, although it may be provided in other parts of the glove, e.g. the fingers or thumb of the glove, or the entire glove may be formed of the conductive material 1.
  • Other garments into which the conductive material 1 can be integrated include, for example, socks (including compression socks), hats, wrist bands, head bands, arm bands, ankle straps, and shoulder straps, belts etc.
  • an electrode 15 can be electrically interfaced with a portion of the skin surface 14 of the hand by electrically contacting any subset of the conductive elements 13 across which the contact surface of electrode 15 can reach.
  • a subset of electrodes that may be contacted by the electrode 15 is indicated in Fig. 4a by circle 21.
  • the conductive material 1 forms part of a main body of the garment.
  • the conductive material 1 can provide a liner of a garment, acting as a hygienic barrier between a main body of the garment and the skin surface.
  • the main body may include electrodes integrated therein, the electrodes being adapted to electrically interface with the skin surface through the conductive material of the liner.
  • the conductive material 1 is provided in a medical interface and specifically in this embodiment a medical dressing such as a wound dressing 20.
  • the wound dressing 20 is comprised in a bandage 22 (located over a leg 23 in this example).
  • An electrode can be brought into contact with the dressing to electrically contact the wound and/or tissue surrounding the wound.
  • the wound dressing 20 including the conductive material can therefore provide protection and promote healing of a wound while also providing an electrically conductive path to the wound or tissue surrounding the wound, for the purpose of monitoring of the wound, electrostimulation or the wound, or otherwise.
  • the tissue at which medical dressings according to the present disclosure may be applied may include a wound or other types of tissue damage and/or imperfections.
  • the dressing may be applied at tissue including a cut, burn, sore, abscess, carbuncle, blister, wart, rash, scar, infection, disease, muscle tear, ligament tear or otherwise.
  • a conductive material 3 according to an alternative embodiment of the present disclosure is represented in Fig. 5.
  • the conductive material 3 is configured in a similar manner to the conductive material 1 described above with reference to Figs. 1 to 3d.
  • a layer of adhesive material 34 is located over the first surface 31 of the substrate 30 of the conductive material 3 to adhere the conductive material to a skin surface.
  • conductive material 4 is provided that is configured in a similar manner to the conductive material 1 described above with reference to Figs. 1 to 3d.
  • the conductive material 4 includes a first layer of adhesive material
  • a first protective layer 411 is removably adhered to the first adhesive layer 401 such as to cover the first adhesive layer 401
  • a second protective layer 412 is removably adhered to the second adhesive layer 402 such as to cover the second adhesive layer 402.
  • the protective layers 411, 412 can cover the adhesive layers 401, 402 when they are not in use, making manufacture, packaging and subsequent handling by users more straightforward.
  • the protective layers 411, 412 can be removed, e.g. by peeling, to expose the adhesive layers 401,
  • the first protective later 411 includes an array of holes 413 therein, each hole 413 aligning with a first end 431 of a respective conductive 43 element in the substrate 40.
  • the first protective layer 411 may be used as a template for introducing the conductive elements 43 into the substrate 40 during manufacture of the conductive material 4. Additionally or alternatively, the protective layer can be used as a mask to enable selective dampening of material of the conductive elements 43, and not the entire substrate 40, limiting any liquid spread laterally through the substrate 40 when the material is wetted, reducing the possibility for lateral conduction to occur across the substrate 40. Wetting may be used to dampen the absorbent material in the conductive elements 43 to improve electrical contact, in accordance with discussions above.
  • the first end 131, 331, 431 of each conductive element 13, 33, 43 protrudes from the first surface 1 1, 31, 41 of the substrate 10, 30, 40.
  • each conductive element 13, 33 protrudes from the second surface 12, 32, 42 of the substrate 10, 30, 40.
  • the degree of protrusion of the first and second ends of the conductive elements can be controlled during manufacture of the conductive material by varying the number of turns in each loop of material that form the conductive elements, for example. In general, the greater the number of turns in each loop, the more that the conductive element may protrude from the surface, particularly where loops cross over each other at the surface. Additionally or alternatively, the diameter of the yarn may be adjusted to control the degree of protrusion.
  • anisotropically conductive material according to the present disclosure includes conductive elements that may protrude from a surface of a substrate of the conductive material, the conductive material is particularly suited for use with an electrode according to an embodiment of the present disclosure as now illustrated in Fig. 7a and 7b.
  • an electrode 5 is provided including a conductive layer 51 and an insulating layer 52.
  • the insulating layer 52 extends over a first surface 511 of the conductive layer 51.
  • a first surface 521 of the insulating layer 52 has an adhesive layer 53 thereon, the adhesive layer 53 adhering the insulating layer 52 to the conductive layer.
  • the insulating layer 52 (and the adhesive layer 53) has a hole 521 therethrough, exposing a region of the first surface 511 of the conductive layer 51, which region provides an electrical contact surface 512 of the electrode 5.
  • each conductive element 63 extends through the flexible substrate 60 such that a first end 631 of each conductive element 63 is exposed at and protrudes from the first surface 61 of the substrate 60 and a second end 632 of each conductive element 63 is exposed at and protrudes from the second surface 62 of the substrate 60.
  • each conductive element 63 is provided in the form of a pillar, rather than a loop of yarn.
  • each conductive element 63 protrudes from the second surface 62 of the substrate, when the electrode 5 is brought into contact with the conductive material 6, the second ends 632 of a subset 63a of the plurality of conductive elements can extend through the hole 521 in the insulating layer 52.
  • the subset 63a of the conductive elements 63 can therefore make electrical contact with the electrode contact surface 512. This is also made possible by the flexible and compressible nature of the substrate 60, which enables the subset 63a of the plurality of conductive elements 63, and the adjacent portion of the substrate 60, to move relative to the remainder of the conductive material 6.
  • the subset 63a of the plurality of conductive elements 63 can move and contact the electrode contact surface 512.
  • the first ends 631 of the subset 63 a of the plurality of conductive elements 63 are shown raised relative to the first ends 631 of other conductive elements 63. In practice, however, the first ends 631 may remain substantially aligned with each other, conforming to a biological surface that they may contact. Due to the flexibility and compressibility of the substrate 60, the subset 63a of the plurality of conductive elements 63 can still be positioned to contact the electrode contact surface 512 independently of the other conductive elements 63.
  • conductive elements 63 are provided in the form of pillars in this embodiment, they may take a number of different shapes as long as they protrude at the second surface 62 of the substrate 60.
  • the pillars may be replaced by loops of yarn as described with respect to preceding embodiments.
  • the insulating layer 52 does not extend over the entire first surface 511 of the conductive layer 51, leaving a contact portion 513 exposed for electrically connection, through hard wiring or a releasable wired connection, to other electrical componentry.
  • a releasable wired connection may utilise a conductive clip such as a spring or crocodile clip, which releasably attaches to contact portion 513.
  • the contact portion 513 is located at substantially an opposite of the conductive layer 51 from the electrical contact surface 512. However, the contact portion 513 is in electrical contact with the electrode contact surface 512 through the bulk of the conductive layer 51.
  • the ability to define a contact surface 512 of an electrode 5 by forming a hole 521 in an insulating layer 52 can also provide a number of other advantages.
  • an end user of the electrode 5 may be able to form the hole 521 and/or adapt the shape and/or size of the hole 521 as appropriate for the desired use.
  • the user may use a knife, scissors or other type of cutting device to form or adapt the hole 521.
  • a kit may be provided including at least one conductive layer and a plurality of insulating layers, each insulating layer having a hole of a different size and/or shape.
  • the hole 521 ' in the insulating layer 52 may be larger than the hole 521 of Fig. 7a, and take a square shape.
  • a user may select an insulating layer for use with the conductive layer that has a hole with a shape and/or size appropriate for the desired use. This may prevent a user having to pre -order an electrode of a specific size and shape, for example.
  • conductive materials 1, 3, 4, 6 are described relative to which one or more electrodes can be moved in order to electrically interface with different portions, selectively, of a skin surface of a subject over which the conductive material is placed.
  • the conductive material may be adapted to be used in a fixed relationship with an electrode.
  • the conductive material may form part of an electrode device.
  • the insulating layer 52 provides in essence a form of insulating mask element that locates between a portion of the contact surface of the electrode and the conductive material, preventing electrical contact between the electrode and some of the conductive elements over which the electrode is located. While the mask element is adhered to the electrode, the same result can be replicated by adhering a mask element to the conductive material, or by providing a mobile mask element between the conductive material and the electrode.
  • conductive material 1 configured generally as shown in Fig. 1, has an insulating mask element 80 located on its second surface 12, the mask element 80 having a hole 81 therethrough that defines the area of electrical contact for an electrode.
  • the technique may rely on protrusion of each conductive element from the substrate to allow the conductive elements to extend through the hole 81 in the mask element 80.
  • the mask element 80 can extend across an area that is substantially the same as or larger than the area of the electrical contact surface of the electrode, while the hole 81 in the mask element 80 extends across an area that is smaller than the area of the electrical contact surface of the electrode.
  • An end user of the conductive material 1 may form the hole 81 and/or adapt the shape and/or size of the hole 81 as appropriate for the desired use.
  • the user may use a knife, scissors or other type of cutting device to form or adapt the hole 81.
  • a kit may be provided including the conductive material 1 and a plurality of mask elements 80, each mask element 80 having a hole 81 of a different size and/or shape.
  • a user may select a mask element for use with the conductive material 1 that has a hole 81 with a shape and/or size appropriate for the desired use.
  • An electrode device 7 according to an embodiment of the present disclosure is illustrated in Fig. 10.
  • the electrode device 7 can be integrated into a garment or used independently of any garment.
  • the electrode device 7 includes components that are also present in the conductive material 3 described above with reference to Fig. 5.
  • the electrode device includes a flexible non-conductive substrate 70 in which a plurality of conductive elements 73 are distributed, and a layer of adhesive 76 provided over a first surface 71 of the substrate 70.
  • a second surface 72 of the substrate 70 is not configured to be selectively contacted by one or more electrodes. Rather, an electrically conductive member, in particular an electrically conductive layer 75, is fixed to the second surface 72 of the substrate 70.
  • the conductive layer 75 electrically contacts second ends 732 of each one of the conductive elements 73.
  • the conductive layer 75 includes a conductive tab 751 at one side, which tab 751 extends beyond an edge of the substrate 70.
  • the tab 751 can be electrically connected, through hard wiring or a releasable wired connection, to external componentry.
  • a releasable wired connection may utilise a conductive clip such as a spring or "crocodile" clip, which releasably attaches to the tab 751.
  • the electrode device 7, with or without the adhesive layer 76 may provide a medical interface, e.g. a medical dressing such as a wound dressing, or any other type of biological interface.
  • the dressing may function in a similar manner to the dressing 20 discussed above with reference to Fig. 4b, for example.
  • the integrated conductive layer 75 is in permanent contact with the conductive elements, such as to define an effective electrode contact area in a predetermined manner. In each case, the effective electrode contact area extends to the outer perimeter of the conductive elements that are electrically contacted.
  • the electrode device 7 may provide a general form of electrode.
  • Example #1 and sample #2 were separately used as conductive interfaces between one of the electrodes (a current injection electrode) and the subject's skin.
  • a current injection electrode a current injection electrode
  • lateral resistance between neighbouring "cross-shaped pillars" was determined to be suitably large when dampened Samples #1 and #2 were pre -tested on a conductive metal surface using a multimeter.
  • the current injection site was at the middle of the palmar aspect of the wrist 60 mm proximal to the wrist crease. Current was applied at a frequency of 50kHz.
  • the 'conductive gel on sputtered gold' electrode used without any conductive material interface, can be considered the most ideal current- injection electrode arrangement. It can be seen in Table 1 that each combination of current electrode used with conductive material interface gave acceptable average whole body resistance and reactance values, within 4% of the 'conductive gel on sputtered gold' electrode.
  • Example #3 A sample of conductive material (sample #3), configured generally in accordance with the conductive material discussed above with reference to Figs. 1, 2a and 2b, was used as a conductive interface between one of the electrodes (a current injection electrode) and the subject's skin on the left arm. Prior to in vivo testing, lateral resistance between neighbouring "cross-shaped pillars" was determined to be suitably large when dampened Sample #3 was pre -tested on a conductive metal surface using a multimeter. Current was applied at a frequency of 50kHz.

Abstract

La présente invention concerne un matériau anisotropiquement électroconducteur destiné à servir d'interface électrique entre une électrode et une partie d'une surface biologique. Le matériau conducteur comprend un substrat flexible ayant des première et seconde surfaces sur des côtés opposés, respectivement, du substrat. Une pluralité d'éléments électroconducteurs distincts s'étendent à travers le substrat de telle sorte qu'une première extrémité de chaque élément conducteur est exposée au niveau de la première surface du substrat et qu'une seconde extrémité de chaque élément conducteur est exposée au niveau de la seconde surface du substrat, les éléments conducteurs étant répartis sur l'ensemble du substrat, et physiquement et électriquement séparés les uns des autres par des parties non conductrices du substrat. Les premières extrémités des éléments conducteurs distincts peuvent entrer électriquement en contact avec la surface biologique. Une électrode peut entrer en contact avec les secondes extrémités des éléments conducteurs d'un premier sous-ensemble de la pluralité d'éléments conducteurs distincts.
PCT/AU2016/050530 2015-06-23 2016-06-23 Matériau anisotropiquement conducteur destiné à être utilisé avec une surface biologique WO2016205881A1 (fr)

Applications Claiming Priority (2)

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AU2015902423 2015-06-23
AU2015902423A AU2015902423A0 (en) 2015-06-23 Anisotropically conductive material for use with a biological surface

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EP3494875A1 (fr) * 2017-12-11 2019-06-12 ETH Zurich Dispositif détecteur pour détecter un signal électrique
WO2019119045A1 (fr) * 2017-12-22 2019-06-27 Ti2 Medical Pty Ltd Matériau anisotropiquement conducteur destiné à être utilisé avec une surface biologique
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US11324424B2 (en) 2017-03-09 2022-05-10 Smith & Nephew Plc Apparatus and method for imaging blood in a target region of tissue
US11559438B2 (en) 2017-11-15 2023-01-24 Smith & Nephew Plc Integrated sensor enabled wound monitoring and/or therapy dressings and systems
US11596553B2 (en) 2017-09-27 2023-03-07 Smith & Nephew Plc Ph sensing for sensor enabled negative pressure wound monitoring and therapy apparatuses
US11633153B2 (en) 2017-06-23 2023-04-25 Smith & Nephew Plc Positioning of sensors for sensor enabled wound monitoring or therapy
US11633147B2 (en) 2017-09-10 2023-04-25 Smith & Nephew Plc Sensor enabled wound therapy dressings and systems implementing cybersecurity
US11638664B2 (en) 2017-07-25 2023-05-02 Smith & Nephew Plc Biocompatible encapsulation and component stress relief for sensor enabled negative pressure wound therapy dressings
US11690570B2 (en) 2017-03-09 2023-07-04 Smith & Nephew Plc Wound dressing, patch member and method of sensing one or more wound parameters
US11717447B2 (en) 2016-05-13 2023-08-08 Smith & Nephew Plc Sensor enabled wound monitoring and therapy apparatus
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US11791030B2 (en) 2017-05-15 2023-10-17 Smith & Nephew Plc Wound analysis device and method
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US11925735B2 (en) 2017-08-10 2024-03-12 Smith & Nephew Plc Positioning of sensors for sensor enabled wound monitoring or therapy
US11931165B2 (en) 2017-09-10 2024-03-19 Smith & Nephew Plc Electrostatic discharge protection for sensors in wound therapy
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US11969538B2 (en) 2018-12-21 2024-04-30 T.J.Smith And Nephew, Limited Wound therapy systems and methods with multiple power sources

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US11717447B2 (en) 2016-05-13 2023-08-08 Smith & Nephew Plc Sensor enabled wound monitoring and therapy apparatus
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US11633153B2 (en) 2017-06-23 2023-04-25 Smith & Nephew Plc Positioning of sensors for sensor enabled wound monitoring or therapy
US11638664B2 (en) 2017-07-25 2023-05-02 Smith & Nephew Plc Biocompatible encapsulation and component stress relief for sensor enabled negative pressure wound therapy dressings
US11076997B2 (en) 2017-07-25 2021-08-03 Smith & Nephew Plc Restriction of sensor-monitored region for sensor-enabled wound dressings
US11925735B2 (en) 2017-08-10 2024-03-12 Smith & Nephew Plc Positioning of sensors for sensor enabled wound monitoring or therapy
US11633147B2 (en) 2017-09-10 2023-04-25 Smith & Nephew Plc Sensor enabled wound therapy dressings and systems implementing cybersecurity
US11759144B2 (en) 2017-09-10 2023-09-19 Smith & Nephew Plc Systems and methods for inspection of encapsulation and components in sensor equipped wound dressings
US11931165B2 (en) 2017-09-10 2024-03-19 Smith & Nephew Plc Electrostatic discharge protection for sensors in wound therapy
US11957545B2 (en) 2017-09-26 2024-04-16 Smith & Nephew Plc Sensor positioning and optical sensing for sensor enabled wound therapy dressings and systems
US11596553B2 (en) 2017-09-27 2023-03-07 Smith & Nephew Plc Ph sensing for sensor enabled negative pressure wound monitoring and therapy apparatuses
US11839464B2 (en) 2017-09-28 2023-12-12 Smith & Nephew, Plc Neurostimulation and monitoring using sensor enabled wound monitoring and therapy apparatus
US11559438B2 (en) 2017-11-15 2023-01-24 Smith & Nephew Plc Integrated sensor enabled wound monitoring and/or therapy dressings and systems
WO2019115373A1 (fr) * 2017-12-11 2019-06-20 Eth Zurich Dispositif capteur pour détecter un signal électrique
EP3494875A1 (fr) * 2017-12-11 2019-06-12 ETH Zurich Dispositif détecteur pour détecter un signal électrique
WO2019119045A1 (fr) * 2017-12-22 2019-06-27 Ti2 Medical Pty Ltd Matériau anisotropiquement conducteur destiné à être utilisé avec une surface biologique
US11944418B2 (en) 2018-09-12 2024-04-02 Smith & Nephew Plc Device, apparatus and method of determining skin perfusion pressure
US11969538B2 (en) 2018-12-21 2024-04-30 T.J.Smith And Nephew, Limited Wound therapy systems and methods with multiple power sources

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