WO2018132298A1 - Systèmes et dispositifs d'application de pansements - Google Patents

Systèmes et dispositifs d'application de pansements Download PDF

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Publication number
WO2018132298A1
WO2018132298A1 PCT/US2018/012391 US2018012391W WO2018132298A1 WO 2018132298 A1 WO2018132298 A1 WO 2018132298A1 US 2018012391 W US2018012391 W US 2018012391W WO 2018132298 A1 WO2018132298 A1 WO 2018132298A1
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WO
WIPO (PCT)
Prior art keywords
less
micro
amperes
llec
array
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PCT/US2018/012391
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English (en)
Inventor
Joseph Del Rossi
Troy PALUSZCYK
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Vomaris Innovations, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Vomaris Innovations, Inc. filed Critical Vomaris Innovations, Inc.
Publication of WO2018132298A1 publication Critical patent/WO2018132298A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • 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
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/328—Applying electric currents by contact electrodes alternating or intermittent currents for improving the appearance of the skin, e.g. facial toning or wrinkle treatment

Definitions

  • Embodiments disclosed herein include systems, devices, and methods for storing and applying dressings, for example, dressings for treating tissues. These tissues may have sustained injury and/or wounds (including surgical incisions), or could benefit from treatment for skin-related conditions (for example, acne, rosacea, rash, or the like), or could benefit from treatment or pre-treatment to minimize risk of injury (for example, muscle damage).
  • Disclosed systems, devices, and methods can comprise a multi-array matrix of biocompatible microcells and provide a treatment site with a localized voltage and/or microcurrent.
  • Disclosed systems and devices can comprise a multi-array matrix on a substrate or base layer that is reversibly attached to, for example, a backing layer or card, for example a cardboard backing layer.
  • the substrate can comprise an adhesive to reversibly attach the substrate to the backing layer and then to the treatment site.
  • the substrate can comprise a "tab" to allow the user to remove the dressing from the backing layer or card.
  • the tab can be reversibly attached to both the substrate as well as the backing layer, and used to remove the substrate from the backing layer. During application of the dressing to a treatment area, the tab can be removed.
  • the backing layer covers the adhesive to maintain the adhesive's effectiveness prior to use and provide for more efficient storage.
  • an irregularly- shaped bandage can be associated via adhesive with a square or rectangular backing layer to provide a more efficiently-stored system.
  • the backing layer comprises a port or void exposing the multi-array matrix.
  • the port or void can provide access to the multi-array matrix, for example to hydrate the matrix or apply a hydrogel or active agent or the like.
  • Disclosed systems and devices can retain the ability to produce voltage and/or microcurrent at a treatment site for a longer period of time than conventional devices, for example through the use of a hydrogel.
  • the system or device comprises a dehydrated hydrogel, which can provide a conductive environment upon rehydration or reconstitution. Further, in certain embodiments the hydrogel helps to maintain a moist, conductive environment.
  • Embodiments disclosed herein include treatment of a muscle or muscle group (for example a muscle group surrounding a joint), either before, during, or after athletic activity or exercise.
  • a method of treatment disclosed herein can comprise applying an embodiment disclosed herein to the area where treatment is desired.
  • Embodiments disclosed herein can be used to treat irregular surfaces of the body, including the face, the shoulder, the elbow, the wrist, the finger joints, the hip, the knee, the ankle, the toe joints, etc. Additional embodiments disclosed herein can be used in areas where tissue is prone to movement, for example the eyelid, the ear, the lips, the nose, the shoulders, the back, etc.
  • Still other embodiments provide methods for manufacturing application and storage systems comprising systems and devices capable of providing a low level micro-current to a treatment area.
  • Disclosed methods can comprise applying a hydrogel to an array of microcells associated with or attached or dried to or bonded to a substrate and dehydrating the hydrogel.
  • Disclosed embodiments can activate enzymes, increase glucose uptake, drive redox signaling, increase H 2 0 2 production, increase cellular protein sulfhydryl levels, and increase (IGF)-1 R phosphorylation.
  • Embodiments can also up-regulate integrin production and accumulation in treatment areas.
  • FIG. 1 is a detailed plan view of a substrate comprising a multi-array matrix of an embodiment disclosed herein.
  • FIG. 2 is a detailed plan view of a substrate comprising a pattern of applied electrical conductors in accordance with an embodiment disclosed herein.
  • FIG. 3 is an embodiment using the applied pattern of FIG. 2.
  • FIG. 4 is a cross-section of FIG. 3 through line 3-3.
  • FIG. 5 is a detailed plan view of an alternate embodiment disclosed herein which includes fine lines of conductive metal solution connecting electrodes upon the base layer.
  • FIG. 6 is a detailed plan view of another alternate embodiment having a line pattern and dot pattern.
  • FIG. 7 is a detailed plan view of yet another alternate embodiment having two line patterns.
  • FIGs. 8A-8E depict alternate embodiments showing the location of discontinuous regions as well as anchor regions of the system.
  • FIG. 9 depicts a detailed plan view of a substrate layer electrode pattern disclosed herein.
  • FIG. 10 depicts a detailed plan view of a substrate layer electrode pattern disclosed herein.
  • FIG. 1 1 depicts a detailed plan view of a substrate layer electrode pattern disclosed herein.
  • FIG. 12 depicts an exploded view of a disclosed embodiment.
  • FIG. 13 depicts an embodiment in use, with the user removing the substrate from the backing layer.
  • FIG. 14 depicts void regions in a backing layer with a multi-array matrix visible.
  • Described herein are systems, devices, and methods for storing and applying dressings for treating tissues, for example, organs such as skin or muscles, including skin conditions, wounds, and the like.
  • a dressing system comprising a substrate comprising a multi-array matrix, and a backing layer or card with which the substrate is associated reversibly.
  • the backing layer or card can comprise a void or "cut-out.”
  • Embodiments disclosed herein comprise methods, systems and devices that can provide a low level electric field (LLEF) to a tissue or organism (thus a "LLEF system") or, when brought into contact with an electrically conducting material, can provide a low level electric micro-current (LLEC) to a tissue or organism (thus a "LLEC system”).
  • LLEF low level electric field
  • a LLEC system is a LLEF system that is in contact with an electrically conducting material, for example a liquid material.
  • the microcurrent or electric field can be modulated, for example, to alter the duration, size, shape, field depth, duration, current, polarity, or voltage of the system.
  • the watt-density of the system can be modulated.
  • Embodiments can comprise a gel, for example a hydrogel.
  • Activation agent as used herein means a composition useful for maintaining a moist environment within and about the skin.
  • Activation agents can be in the form of gels (for example a hydrogel) or liquids.
  • Activation agents can be conductive.
  • Activation gels can also be antibacterial.
  • an activation agent can be a liquid such as sweat or topical substance such as petroleum jelly (for example with a conductive component added).
  • Adfixing as used herein can mean contacting a patient or tissue with a device or system disclosed herein.
  • affixing can comprise the use of straps, elastic, etc.
  • Antimicrobial agent refers to an agent that kills or inhibits the growth of microorganisms.
  • One type of antimicrobial agent can be an antibacterial agent.
  • Antibacterial agent or “antibacterial” as used herein refers to an agent that interferes with the growth and reproduction of bacteria. Antibacterial agents are used to disinfect surfaces and eliminate potentially harmful bacteria. Unlike antibiotics, they are not used as medicines for humans or animals, but are found in products such as soaps, detergents, health and skincare products and household cleaners.
  • Antibacterial agents may be divided into two groups according to their speed of action and residue production:
  • the first group contains those that act rapidly to destroy bacteria, but quickly disappear (by evaporation or breakdown) and leave no active residue behind (referred to as non-residue-producing). Examples of this type are the alcohols, chlorine, peroxides, and aldehydes.
  • the second group consists mostly of compounds that leave long-acting residues on the surface to be disinfected and thus have a prolonged action (referred to as residue-producing). Common examples of this group are triclosan, triclocarban, and benzalkonium chloride.
  • Another type of antimicrobial agent can be an anti-fungal agent that can be used with the devices described herein.
  • Applied or “apply” as used herein refers to contacting a substrate or surface with a conductive material, for example printing, painting, or spraying a conductive ink on a surface.
  • applying can mean contacting a patient or tissue or organism with a device or system disclosed herein.
  • Backing layer or "card” as used herein refers to a layer with which the substrate comprising the multi-array matrix is associated, for example reversibly associated using an adhesive.
  • a backing layer can include a port or void area of an appropriate shape, for example, a square, a circle, a slit, etc.
  • Conductive material refers to an object or type of material which permits the flow of electric charges.
  • Conductive materials can comprise solids such as metals or carbon, or liquids such as conductive metal solutions and conductive gels. Conductive materials can be applied to form at least one matrix. Conductive liquids can dry, cure, or harden after application to form a solid material.
  • Discontinuous region refers to a "void" in a substrate material such as a hole, slot, or the like.
  • the term can mean any void in the material though typically the void is of a regular shape.
  • a void in the material can be entirely within the perimeter of a material or it can extend to the perimeter of a material.
  • Dots refers to discrete deposits of dissimilar reservoirs that can function as at least one battery cell.
  • the term can refer to a deposit of any suitable size or shape, such as squares, circles, triangles, lines, etc.
  • the term can be used synonymously with “electrodes,” “microcells,” “microspheres,” etc.
  • Microspheres refers to small spherical particles, with diameters in the micrometer range (typically 1 ⁇ to 3000 ⁇ (3 mm)). Microspheres are sometimes referred to as microparticles. Microspheres can be manufactured from various natural and synthetic materials. The term can be used synonymously with "micro-balloons,” “beads,” “particles,” etc.
  • Electrode refers to similar or dissimilar conductive materials. In embodiments utilizing an external power source the electrodes can comprise similar conductive materials. In embodiments that do not use an external power source, the electrodes can comprise dissimilar conductive materials that can define an anode and a cathode.
  • Expandable refers to the ability to stretch while retaining structural integrity and not tearing.
  • the term can refer to solid regions as well as discontinuous or void regions; solid regions as well as void regions can stretch or expand.
  • Matrices refer to a pattern or patterns, such as those formed by electrodes on a surface, such as a fabric or a fiber, or the like. Matrices can also comprise a pattern or patterns within a solid or liquid material or a three dimensional object. Matrices can be designed to vary the electric field or electric current or microcurrent generated. For example, the strength and shape of the field or current or microcurrent can be altered, or the matrices can be designed to produce an electric field(s) or current or microcurrent of a desired strength or shape. “Matrices” can also refer to the random distribution of electrodes in a gel, such as a hydrogel.
  • Sheets as used herein refer to substrate, typically in bulk quantities. As such, “sheets” can refer to a continuous roll or unit of substrate.
  • “Stretchable” as used herein refers to the ability of embodiments that stretch without losing their structural integrity. That is, embodiments can stretch to accommodate irregular skin surfaces or surfaces wherein one portion of the surface can move relative to another portion.
  • Tab refers to an area of the dressing or backing layer or substrate that provides the user means to remove the substrate from the backing layer.
  • the tab can comprise a "tear-away” such that it is removable.
  • Treatment can include the use of disclosed embodiments on tissue to prevent, reduce, or repair damage. Treatment can include use on an injury, for example a wound.
  • “Viscosity” as used herein refers to a measurement of a fluid's resistance to gradual deformation by shear stress or tensile stress.
  • disclosed methods, systems, and devices can comprise a backing layer or card with which the substrate comprising the multi-array matrix is associated.
  • the substrate can be reversibly associated with the backing layer via, for example, an adhesive layer.
  • the backing layer or card can comprise a void region or port.
  • the port can expose the multi-array matrix. This port can provide access to the multi-array matrix, for example to hydrate the matrix, to apply an active agent to the matrix, to apply a hydrogel to the matrix, or the like.
  • the backing layer or card can be shaped to follow the outline of the dressing or substrate.
  • the backing layer or card can be circular when used with round dressings.
  • the backing layer or card can comprise a shape contrasting with that of the dressing or substrate.
  • the backing layer or card can be square or rectangular when used with round dressings.
  • the system is provided as a single card associated with a single substrate or dressing. In further embodiments, the system is provided as a single card associated with multiple substrates or dressings.
  • the adhesive layer can, in embodiments, allow the substrate to be reversibly associated with an area where treatment is desired, for example a tissue, or the like.
  • the adhesive layer can maintain the association between the substrate and the backing layer prior to application of the substrate to a treatment area, for example during storage periods.
  • the backing layer or substrate can comprise at least one "tab" to allow the user to remove the dressing comprising the substrate from the backing layer or card.
  • disclosed methods, systems, and devices can retain their ability to provide localized voltage and/or amperage at a treatment site for a sustained period of time.
  • this sustained period of time can be achieved by including a hydrogel in or with the multi-array matrix of biocompatible microcells and dehydrating the hydrogel. Once dehydrated, the device can be stored without losing its ability to later deliver a localized voltage and/or amperage. The localized voltage and/or amperage can be triggered or activated by rehydrating the hydrogel as described herein.
  • the herein-described methods, systems, and devices provide a multi-array matrix of biocompatible microcells coated or otherwise impregnated with a hydrogel, which can then be dried to remove the water in the hydrogel.
  • the methods, systems, and devices described herein can comprise a multi-array matrix of biocompatible microcells that can produce a localized treatment voltage or microcurrent or both at a treatment site.
  • the voltage can be a low level electric field (LLEF).
  • LLEF low level electric field
  • This electric filed can be delivered to a tissue or organism (thus a "LLEF system") or, when brought into contact with an electrically conducting material, can provide a low level electric micro-current (LLEC) to a tissue or organism (thus a "LLEC system”).
  • LLEC low level electric micro-current
  • a LLEC system is a LLEF system that is in contact with an electrically conducting material, for example a liquid material.
  • the micro-current or electric field can be modulated, for example, to alter the duration, size, shape, field depth, duration, current, polarity, or voltage of the system.
  • the field is very short, for example in the range of physiologic electric fields.
  • the direction of the electric field produced by devices disclosed herein is omnidirectional over the surface of the wound and more in line with the physiologic electric fields.
  • the multi-array matrix of biocompatible microcells can comprise a first array comprising a pattern of microcells formed of a conductive material and a second array comprising a pattern of microcells formed from a second conductive material.
  • the first conductive material can be formed from, for example, a first conductive solution and the second conductive material can be formed from, for example, a second conductive solution.
  • the first and/or second conductive solutions can include a metal species such as a metal species capable of defining at least one voltaic cell for spontaneously generating at least one electrical current with the metal species of the first array when said first and second arrays are introduced to an electrolytic solution and said first and second arrays are not in physical contact with each other.
  • Certain embodiments utilize an external power source such as AC or DC power, or pulsed RF, or pulsed current, such as high voltage pulsed current.
  • the electrical energy is derived from the dissimilar metals creating a battery at each electrode/electrode interface, whereas those embodiments with an external power source can employ conductive electrodes in a spaced configuration to predetermine the electric field shape and strength.
  • embodiments disclosed herein can employ phased array, pulsed, square wave, sinusoidal, or other wave forms, combinations, or the like. Certain embodiments utilize a controller to produce and control power production and/or distribution to the device.
  • Electrodes or microcells can comprise discrete deposits of dissimilar reservoirs that can function as at least one battery cell.
  • the deposits can be of any suitable size or shape, such as squares, circles, triangles, lines, etc.
  • dots can be used synonymously with, "microcells," and the like.
  • Each electrode or microcell can be or comprise a conductive material, for example, a metal.
  • the electrodes or microcells can comprise any electrically-conductive material, for example, an electrically conductive hydrogel, metals, electrolytes, superconductors, semiconductors, plasmas, and nonmetallic conductors such as graphite and conductive polymers.
  • Electrically conductive metals can include, for example, silver, copper, gold, aluminum, molybdenum, zinc, lithium, tungsten, brass, carbon, nickel, iron, palladium, platinum, tin, bronze, carbon steel, lead, titanium, stainless steel, mercury, Fe/Cr alloys, and the like.
  • the electrode can be coated or plated with a different metal such as aluminum, gold, platinum or silver.
  • a primary surface is a surface of a LLEC or LLEF system that comes into direct contact with an area to be treated, for example a skin surface.
  • the difference of the standard potentials of the electrodes or dots or reservoirs can be in a range from about 0.05 V to approximately about 5.0 V.
  • the standard potential can be about 0.05 V, about 0.06 V, about 0.07 V, about 0.08 V, about 0.09 V, about 0.1 V, about 0.2 V, about 0.3 V, about 0.4 V, about 0.5 V, about 0.6 V, about 0.7 V, about 0.8 V, about 0.9 V, about 1 .0 V, about 1 .1 V, about 1 .2 V, about 1 .3 V, about 1 .4 V, about 1 .5 V, about 1 .6 V, about 1 .7 V, about 1 .8 V, about 1 .9 V, about 2.0 V, about 2.1 V, about 2.2 V, about 2.3 V, about 2.4 V, about 2.5 V, about 2.6 V, about 2.7 V, about 2.8 V, about 2.9 V, about 3.0 V, about 3.1 V, about 3.2 V, about
  • the difference of the standard potentials of electrodes or dots or reservoirs can be at least 0.05 V, at least 0.06 V, at least 0.07 V, at least 0.08 V, at least 0.09 V, at least 0.1 V, at least 0.2 V, at least 0.3 V, at least 0.4 V, at least 0.5 V, at least 0.6 V, at least 0.7 V, at least 0.8 V, at least 0.9 V, at least 1 .0 V, at least 1 .1 V, at least 1 .2 V, at least 1 .3 V, at least 1 .4 V, at least 1 .5 V, at least 1 .6 V, at least 1 .7 V, at least 1 .8 V, at least 1.9 V, at least 2.0 V, at least 2.1 V, at least 2.2 V, at least 2.3 V, at least 2.4 V, at least 2.5 V, at least 2.6 V, at least 2.7 V, at least 2.8 V, at least 2.9 V, at least 3.0 V, at least 3.1
  • the difference of the standard potentials of electrodes or dots or reservoirs can be less than 0.05 V, less than 0.06 V, less than 0.07 V, less than 0.08 V, less than 0.09 V, less than 0.1 V, less than 0.2 V, less than 0.3 V, less than 0.4 V, less than 0.5 V, less than 0.6 V, less than 0.7 V, less than 0.8 V, less than 0.9 V, less than 1 .0 V, less than 1 .1 V, less than 1.2 V, less than 1 .3 V, less than 1 .4 V, less than 1 .5 V, less than
  • systems and devices disclosed herein can produce a LLEC of between for example about 1 and about 200 micro-amperes, between about 10 and about 190 micro-amperes, between about 20 and about 180 micro-amperes, between about 30 and about 170 micro-amperes, between about 40 and about 160 micro-amperes, between about 50 and about 150 micro-amperes, between about 60 and about 140 micro-amperes, between about 70 and about 130 micro-amperes, between about 80 and about 120 microamperes, between about 90 and about 100 micro-amperes, between about 100 and about 150 micro-amperes, between about 150 and about 200 micro-amperes, between about 200 and about 250 micro-amperes, between about 250 and about 300 micro-amperes, between about 300 and about 350 micro-amperes, between about 350 and about 400 micro-amperes, between about 400 and about 450 micro-amperes, between about 450 and about 500 micro
  • systems and devices disclosed herein can produce a LLEC of between for example about 1 and about 400 micro-amperes, between about 20 and about 380 micro-amperes, between about 40 and about 360 micro-amperes, between about 60 and about 340 micro-amperes, between about 80 and about 320 micro-amperes, between about 100 and about 300 micro-amperes, between about 120 and about 280 micro-amperes, between about 140 and about 260 micro-amperes, between about 160 and about 240 microamperes, between about 180 and about 220 micro-amperes, or the like.
  • systems and devices disclosed herein can produce a LLEC of between for example about 1 micro-ampere and about 1 milli-ampere, between about 50 and about 800 micro-amperes, between about 200 and about 600 micro-amperes, between about 400 and about 500 micro-amperes, or the like.
  • systems and devices disclosed herein can produce a LLEC of about 10 micro-amperes, about 20 micro-amperes, about 30 micro-amperes, about 40 microamperes, about 50 micro-amperes, about 60 micro-amperes, about 70 micro-amperes, about 80 micro-amperes, about 90 micro-amperes, about 100 micro-amperes, about 1 10 micro-amperes, about 120 micro-amperes, about 130 micro-amperes, about 140 microamperes, about 150 micro-amperes, about 160 micro-amperes, about 170 micro-amperes, about 180 micro-amperes, about 190 micro-amperes, about 200 micro-amperes, about 210 micro-amperes, about 220 micro-amperes, about 240 micro-amperes, about 260 microamperes, about 280 micro-amperes, about 300 micro
  • the disclosed systems and devices can produce a LLEC of not more than about 10 micro-amperes, or not more than about 20 micro-amperes, not more than about 30 micro-amperes, not more than about 40 micro-amperes, not more than about 50 micro-amperes, not more than about 60 micro-amperes, not more than about 70 microamperes, not more than about 80 micro-amperes, not more than about 90 micro-amperes, not more than about 100 micro-amperes, not more than about 1 10 micro-amperes, not more than about 120 micro-amperes, not more than about 130 micro-amperes, not more than about 140 micro-amperes, not more than about 150 micro-amperes, not more than about 160 micro-amperes, not more than about 170 micro-amperes, not more than about 180 micro-amperes, not more than about 190 micro-amperes, not more than
  • systems and devices disclosed herein can produce a LLEC of not less than 10 micro-amperes, not less than 20 micro-amperes, not less than 30 microamperes, not less than 40 micro-amperes, not less than 50 micro-amperes, not less than 60 micro-amperes, not less than 70 micro-amperes, not less than 80 micro-amperes, not less than 90 micro-amperes, not less than 100 micro-amperes, not less than 1 10 micro-amperes, not less than 120 micro-amperes, not less than 130 micro-amperes, not less than 140 microamperes, not less than 150 micro-amperes, not less than 160 micro-amperes, not less than 170 micro-amperes, not less than 180 micro-amperes, not less than 190 micro-amperes, not less than 200 micro-amperes, not less than 210 micro-amperes,
  • 14.3mA not less than about 14.4mA, not less than about 14.5mA, not less than about 14.6mA, not less than about 14.7mA, not less than about 14.8mA, not less than about 14.9mA, not less than about 15.0mA, not less than about 15.1 mA, not less than about 15.2mA, not less than about 15.3mA, not less than about 15.4mA, not less than about 15.5mA, not less than about 15.6mA, not less than about 15.7mA, not less than about 15.8mA, and the like.
  • the electrodes or microcells can comprise a clear conductive material.
  • a clear conductive material for example, in certain embodiments indium tin oxide (ITO) can be used.
  • ITO indium tin oxide
  • TCOs transparent conductive oxides
  • conductive polymers metal grids, carbon nanotubes, graphene, and nanowire thin films can be employed.
  • array, reservoir or electrode geometry can comprise shapes including circles, polygons, lines, zigzags, ovals, stars, or any suitable variety. This provides the ability to design/customize surface electric field shapes as well as depth of penetration. For example, in embodiments it can be desirable to employ an electric field of greater strength or depth to achieve optimal treatment.
  • Reservoir or electrode or dot sizes and concentrations can vary, as these variations can allow for changes in the properties of the electric field created by embodiments of the invention.
  • Certain embodiments provide an electric field at about, for example, 0.5-5.0 V at the device surface under normal tissue loads with resistance of 100 to 100K ohms.
  • disclosed devices can provide an electric field of greater than physiological strength, for example to a depth of, for example, at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, at least 10 mm, at least 1 1 mm, at least 12 mm, at least 13 mm, at least 14 mm, at least 15 mm, at least 16 mm, at least 17 mm, at least 18 mm, at least 19 mm, at least 20 mm, at least 21 mm, at least 22 mm, at least 23 mm, at least 24 mm, at least 25 mm, at least 26 mm, at least 27 mm, at least 28 mm, at least 29 mm, at least 30 mm, at least 31 mm, at least 32 mm, at least 33 mm, at least 34 mm, at least 35 mm, at least 36 mm, at least 37 mm,
  • dissimilar metals can be used to create a customized electric field with a desired voltage or microcurrent.
  • the pattern of reservoirs can control the watt density and shape of the electric field. For example.
  • the electric field or current or both applied to a tissue can be designed or produced or adjusted based upon feedback from the tissue or upon an algorithm within sensors operably connected to the embodiment and a control module.
  • the electric field, electric current, or both can be stronger in one zone and weaker in another.
  • the electric field, electric current, or both can change with time and be modulated based on treatment goals or feedback from the tissue or patient.
  • the control module can monitor and adjust the size, strength, density, shape, or duration of electric field or electric current based on tissue parameters.
  • embodiments disclosed herein can produce and maintain localized electrical events.
  • embodiments disclosed herein can produce specific values for the electric field duration, electric field size, electric field shape, field depth, current, polarity, and/or voltage of the device or system.
  • the disclosed systems and devices can include a base layer.
  • the base layer can be useful in reducing the amount of motion between tissue and device and/or can be a substrate for the multi-array matrix of biocompatible microcells.
  • the base layer can be elastic.
  • the base layer or the substrate can include components such as straps to maintain or help maintain its position.
  • the base layer or substrate can comprise a strap on either end of the long axis, or a strap linking on end of the long axis to the other.
  • the straps can comprise velcro, snaps, or a similar fastening system.
  • the strap can comprise a conductive material, for example a wire to electrically link the device with other components, such as monitoring equipment or a power source.
  • the strap can comprise a conductive material, for example a wire, to electrically link the device with other components, such as monitoring equipment or a power source.
  • the device can be wirelessly linked to monitoring or data collection equipment, for example linked via Bluetooth to a cell phone or computer that collects data from the device.
  • the device can comprise data collection means, such as temperature, pH, pressure, or conductivity data collection means.
  • disclosed devices and systems can comprise data collection means, such as temperature, pH, pressure, or conductivity data collection means.
  • Embodiments can comprise a display, for example to visually present, for example, the temperature, pH, pressure, or conductivity data to a user.
  • Embodiments can include, for example, tracking equipment so as to track and/or quantify a user's movements or performance.
  • Embodiments can include, for example, an accelerometer, so as to measure acceleration or impact forces on a user.
  • an elastic material can comprise an elastic film with elasticity, for example, similar to that of skin, or greater than that of skin, or less than that of skin.
  • the LLEC or LLEF system can comprise a laminate where layers of the laminate can be of varying elasticities.
  • an outer layer may be highly elastic and an inner layer in-elastic or less elastic.
  • a layer can be made to stretch by placing stress relieving discontinuous regions or slits through the thickness of the material so there is a mechanical displacement rather than stress that would break the fabric weave before stretching would occur.
  • the slits can extend completely through a layer or the system or can be placed where expansion is required.
  • the slits do not extend all the way through the system or a portion of the system such as the substrate.
  • the discontinuous regions can pass halfway through the long axis of the substrate.
  • the substrate can be shaped to fit an area of desired use or treatment.
  • the device can be shaped to fit the area around the eye or the eye itself, to treat, for example, a corneal injury.
  • the device can be shaped to fit the area around the eye to be used prior to or following surgery, for example blepharoplasty.
  • the substrate can be a bandage.
  • the bandage can include any or all of the features described herein.
  • the substrate can comprise a fabric, a fiber, or the like.
  • the substrate can be pliable, for example to better follow the contours of an area to be treated, such as the face or back.
  • the substrate can comprise a gauze or mesh or plastic.
  • Suitable types of pliable substrates for use in embodiments disclosed herein can be absorbent or non-absorbent textiles, low-adhesives, vapor permeable films, hydrocolloids, alginates, foams, foam-based materials, cellulose-based materials including Kettenbach fibers, hollow tubes, fibrous materials, such as those impregnated with anhydrous/hygroscopic materials, beads and the like, or any suitable material as known in the art.
  • the substrate can comprise "anchor" regions or "arms” or straps to affix the system securely.
  • anchor regions of the substrate can extend to areas of minimal stress or movement to securely affix the system in place.
  • the backing layer can be designed to accommodate substrates of a particular shape or size.
  • the backing layer or card can comprise, for example, cardboard, a fabric, a fiber, or the like.
  • the backing layer or card can be pliable. Suitable types of pliable backing layers or cards for use in embodiments disclosed herein can be absorbent or non-absorbent textiles, low-adhesives, vapor permeable films, hydrocolloids, alginates, foams, foam-based materials, cellulose-based materials including Kettenbach fibers, hollow tubes, fibrous materials, such as those impregnated with anhydrous/hygroscopic materials, beads and the like, or any suitable material as known in the art.
  • the devices described herein can comprise at least one hydrogel that coats or otherwise impregnates the multi-array matrix of biocompatible microcells of the device.
  • a hydrogel as described herein can include any hydrogel known in the art that can provide rehydration characteristics that allow bioelectric devices as described herein to function as if the hydrogel were not present or substantially as if the hydrogel were not present, yet keep the microcell batteries activated for an extended time as if an amorphous hydrogel were applied at time of use.
  • the hydrogel can coat the matrix present on the base layer or substrate.
  • the hydrogel can comprise the matrix.
  • the hydrogel can function to retain or "lock” the eventual rehydration voltages and/or amperages that provide localized treatment.
  • Suitable hydrogels can include, but are not limited to polyvinyl alcohol, sodium polyacrylate, acrylate based polymers, glycolated polymers, cellulose, glycerol, sugars, agarose, methylcellulose, hyaluronan, other naturally derived polymers, and combinations thereof.
  • a hydrogel can be configured in a variety of viscosities. Viscosity is a measurement of a fluid or material's resistance to gradual deformation by shear stress or tensile stress.
  • the electrical field can be extended through a semi-liquid hydrogel with a low viscosity. In other embodiments the electrical field can be extended through a solid hydrogel with a high viscosity.
  • the hydrogel(s) described herein may be configured to have a viscosity of between about 0.5 Pa s and greater than about 10 12 Pa s.
  • the viscosity of a hydrogel can be, for example, between 0.5 and 10 12 Pa s, between 1 Pa s and 10 6 Pa s, between 5 and 10 3 Pa s, between 10 and 100 Pa s, between 15 and 90 Pa s, between 20 and 80 Pa s, between 25 and 70 Pa s, between 30 and 60 Pa s, or the like when applied to a device.
  • the hydrogel can be supplied in a device as described herein as an amount of hydrogel per square foot of system or device.
  • Embodiments disclosed herein can comprise active agents or cosmetic agents or drugs, for example applied prior to applying the dressing to the treatment area, or applied to the substrate.
  • Suitable active agents con comprise, for example, hypoallergenic agents, drugs, biologies, stem cells, growth factors, skin substitutes, cosmetic products, combinations, or combinations thereof, or the like.
  • Stem cells can include, for example, embryonic stem cells, bone-marrow stem cells, adipose stem cells, and the like.
  • a growth factor is a naturally-occurring substance capable of stimulating cellular growth, proliferation, healing, and cellular differentiation, often a protein or a steroid hormone. Growth factors are important for regulating a variety of cellular processes. Growth factors typically act as signaling molecules between cells. Examples are cytokines and hormones that bind to specific receptors on the surface of their target cells. They often promote cell differentiation and maturation, which varies between growth factors. For example, bone morphogenetic proteins stimulate bone cell differentiation, while fibroblast growth factors and vascular endothelial growth factors stimulate blood vessel differentiation.
  • Growth factors can include, for example, Adrenomedullin (AM), Angiopoietin (Ang), Autocrine motility factor, Bone morphogenetic proteins (BMPs), Brain-derived neurotrophic factor (BDNF), Epidermal growth factor (EGF), Erythropoietin (EPO), Fibroblast growth factor 1 or 2(FGF-1 or -2), Fetal Bovine Somatotrophin (FBS), Glial cell line-derived neurotrophic factor (GDNF), Granulocyte colony-stimulating factor (G-CSF), Granulocyte macrophage colony-stimulating factor (GM-CSF), Growth differentiation factor-9 (GDF9), Hepatocyte growth factor (HGF), Hepatoma-derived growth factor (HDGF), Insulin-like growth factor (IGF), Keratinocyte growth factor (KGF), Migration-stimulating factor (MSF), Myostatin (GDF-8), Nerve growth factor (NGF) and other neurotrophins, Platelet-derived growth factor (PD), Platelet
  • Cosmetic products can include, for example, moisturizers, exfoliants, antioxidants, sunscreens, and the like.
  • Drugs can include but are not limited to, for example, anti-inflammatories, painkillers, antibiotics, antivirals, and wound treatment compositions.
  • active agents or cosmetic agents or drugs can be mixed with a hydrogel prior to application to a multi-array matrix of biocompatible microcells, or can be otherwise attached to the hydrogel when the hydrogel is already part of a device, such as by chemical substitution or through the use of intermolecular forces.
  • the active agent can be applied to an area of treatment prior to contacting the area with a system or device disclosed herein.
  • dissimilar conductive metals used to make a LLEC or LLEF system disclosed herein can be silver and zinc, and the electrolytic solution can include sodium chloride in water.
  • the electrodes are applied onto a non-conductive surface to create a pattern, most preferably an array or multi-array of voltaic cells that do not spontaneously react until they contact an electrolytic solution. Sections of this description use the terms "printing” with "ink,” but it is to be understood that the patterns may also be “painted” with “paints.” The use of any suitable means for applying a conductive material is contemplated.
  • ink can comprise any material such as a solution suitable for forming an electrode on a surface such as a conductive material including a conductive metal solution.
  • printing or “painted” can comprise any method of applying a solution to a material upon which a matrix is desired, for example a transparent or translucent material.
  • the applied electrodes or reservoirs or dots can adhere or bond to the primary surface or substrate because a biocompatible binder is mixed, in embodiments into separate mixtures, with each of the dissimilar metals that will create the pattern of voltaic cells, in embodiments. Most inks are simply a carrier, and a binder mixed with pigment.
  • conductive metal solutions can be a binder mixed with a conductive element. The resulting conductive metal solutions can be used with an application method such as screen printing to apply the electrodes to the primary surface in predetermined patterns. Once the conductive metal solutions dry and/or cure, the patterns of spaced electrodes can substantially maintain their relative position, even on a flexible material such as that used for a LLEC or LLEF system.
  • the conductive metal solution can be allowed to dry before being applied to a surface so that the conductive materials do not mix, which could interrupt the array and cause direct reactions that will release the elements.
  • the binder itself can have a beneficial effect such as reducing the local concentration of matrix metallo-proteases through an iontophoretic process that drives the cellulose into the surrounding tissue.
  • This process can be used to electronically drive other components such as drugs, active agents, or cosmetic agents, into the surrounding tissue.
  • the binder can comprise any biocompatible liquid material that can be mixed with a conductive element (for example, metallic crystals of silver or zinc) to create a conductive solution.
  • a conductive element for example, metallic crystals of silver or zinc
  • a solvent reducible polymer such as the polyacrylic nontoxic silk-screen ink manufactured by COLORCON ® Inc., a division of Berwind Pharmaceutical Services, Inc. (see COLORCON ® NO-TOX ® product line, part number NT28).
  • the binder is mixed with high purity (at least 99.99%, in an embodiment) metallic silver crystals to make the silver conductive solution.
  • the silver crystals which can be made by grinding silver into a powder, are preferably smaller than 100 microns in size or about as fine as flour.
  • the size of the crystals is about 325 mesh, which is typically about 40 microns in size or a little smaller.
  • the binder is separately mixed with high purity (at least 99.99%, in an embodiment) metallic zinc powder which has also preferably been sifted through standard 325 mesh screen, to make the zinc conductive solution.
  • the size of the metal crystals, the availability of the surface to the conductive fluid and the ratio of metal to binder can affect the release rate of the metal from the mixture. For example, when COLORCON ® polyacrylic ink is used as the binder, about 10 to 40 percent of the mixture should be metal for a long term bandage (for example, one that stays on for about 10 days). If the same binder is used, but the percentage of the mixture that is metal is increased to 60 percent or higher, a typical system or device will be effective for longer.
  • the percent of the mixture that should be metal can be 40 percent, or 42 percent, 44 percent, 46 percent, 48 percent, 50 percent, 52 percent, 54 percent, 56 percent, 58 percent, 60 percent, 62 percent, 64 percent, 66 percent, 68 percent, 70 percent, 72 percent, 74 percent, 76 percent, 78 percent, 80 percent, 82 percent, 84 percent, 86 percent, 88 percent, 90 percent, or the like.
  • LLEC or LLEF systems comprising a pliable substrate it can be desired to decrease the percentage of metal down to, for example, 20 percent, 18 percent, 16 percent, 14 percent, 12 percent, 10 percent, 5 percent, or less, or to use a binder that causes the crystals to be more deeply embedded, so that the primary surface will be antimicrobial for a very long period of time and will not wear prematurely.
  • Other binders can dissolve or otherwise break down faster or slower than a polyacrylic ink, so adjustments can be made to achieve the desired rate of spontaneous reactions from the voltaic cells.
  • a pattern of alternating silver masses or electrodes or reservoirs and zinc masses or electrodes or reservoirs can create an array of electrical currents across the primary surface or base layer.
  • a basic pattern, shown in FIG. 1 has each mass of silver equally spaced from four masses of zinc, and has each mass of zinc equally spaced from four masses of silver, according to an embodiment.
  • the first electrode 6 is separated from the second electrode 10 by a spacing 8.
  • the designs of first electrode 6 and second electrode 10 are simply round dots, and in an embodiment, are repeated. Numerous repetitions 12 of the designs result in a pattern.
  • each silver design preferably has about twice as much mass as each zinc design, in an embodiment.
  • the silver designs are most preferably about a millimeter from each of the closest four zinc designs, and vice-versa.
  • the resulting pattern of dissimilar metal masses defines an array of voltaic cells when introduced to an electrolytic solution.
  • a dot pattern of masses like the alternating round dots of FIG. 1 can be preferred when applying conductive material onto a flexible base layer, as the dots won't significantly affect the flexibility of the material.
  • the pattern of FIG. 2 can be used.
  • the first electrode 6 in FIG. 2 is a large hexagonally shaped dot
  • the second electrode 10 is a pair of smaller hexagonally shaped dots that are spaced from each other.
  • the spacing 8 that is between the first electrode 6 and the second electrode 10 maintains a relatively consistent distance between adjacent sides of the designs.
  • Numerous repetitions 12 of the designs result in a pattern 14 that can be described as at least one of the first design being surrounded by six hexagonally shaped dots of the second design.
  • FIGS. 3 and 4 show how the pattern of FIG . 2 can be used to make an embodiment disclosed herein.
  • the pattern shown in detail in FIG. 2 is applied to the primary surface 2 of an embodiment.
  • the back 20 of the printed material is fixed to a substrate layer 22. This layer is adhesively fixed to a pliable layer 16.
  • FIG. 5 shows an additional feature, which can be added between designs, that can initiate the flow of current in a poor electrolytic environment.
  • a fine line 24 is printed using one of the conductive metal solutions along a current path of each voltaic cell.
  • the fine line will initially have a direct reaction but will be depleted until the distance between the electrodes increases to where maximum voltage is realized.
  • the initial current produced is intended to help control edema so that the LLEC system will be effective. If the electrolytic solution is highly conductive when the system is initially applied the fine line can be quickly depleted and the device will function as though the fine line had never existed.
  • FIGS. 6 and 7 show alternative patterns that use at least one line design.
  • the first electrode 6 of FIG. 6 is a round dot similar to the first design used in FIG. 1 .
  • the second electrode 10 of FIG . 6 is a line. When the designs are repeated, they define a pattern of parallel lines that are separated by numerous spaced dots.
  • FIG . 7 uses only line designs.
  • the first electrode 6 can be thicker or wider than the second electrode 10 if the oxidation- reduction reaction requires more metal from the first conductive element (mixed into the first design's conductive metal solution) than the second conductive element (mixed into the second design's conductive metal solution).
  • the lines can be dashed.
  • Another pattern can be silver grid lines that have zinc masses in the center of each of the cells of the grid.
  • the pattern can be letters printed from alternating conductive materials so that a message can be printed onto the primary surface-perhaps a brand name or identifying information such as patient blood type.
  • the silver design can contain about twice as much mass as the zinc design in an embodiment.
  • each voltaic cell that contacts a conductive fluid such as a cosmetic cream can create approximately 1 volt of potential that will penetrate substantially through its surrounding surfaces. Closer spacing of the dots can decrease the resistance, providing less potential, and the current will not penetrate as deeply.
  • spacing between the closest conductive materials on the base layer or substrate can be, for example, about 1 ⁇ , about 2 ⁇ , about 3 ⁇ , about 4 ⁇ , about 5 ⁇ , about 6 ⁇ , about 7 ⁇ , about 8 ⁇ , about 9 ⁇ , about 10 ⁇ , about 11 ⁇ , about 12 ⁇ , about 13 ⁇ , about 14 ⁇ , about 15 ⁇ , about 16 ⁇ , about 17 ⁇ , about 18 ⁇ , about 19 ⁇ , about 20 ⁇ , about 21 ⁇ , about 22 ⁇ , about 23 ⁇ , about 24 ⁇ m, about 25 ⁇ , about 26 ⁇ m, about 27 ⁇ , about 28 ⁇ , about 29 ⁇ m, about 30 ⁇ , about 31 ⁇ m, about 32 ⁇ , about 33 ⁇ , about 34 ⁇ m, about 35 ⁇ , about 36 ⁇ m, about 37 ⁇ , about 38 ⁇ , about 39 ⁇ m, about 40 ⁇ , about 41 ⁇ m, about 42 ⁇ , about 43 ⁇ , about 44 ⁇ m, about 45 ⁇ ,
  • the closest spacing between conductive materials on the base layer or substrate can be not more than 0.1 mm, not more than 0.2 mm, not more than 0.3 mm, not more than 0.4 mm, not more than 0.5 mm, not more than 0.6 mm, not more than 0.7 mm, not more than 0.8 mm, not more than 0.9 mm, not more than 1 mm, not more than 1.1 mm, not more than 1.2 mm, not more than 1.3 mm, not more than 1.4 mm, not more than 1.5 mm, not more than 1.6 mm, not more than 1.7 mm, not more than 1.8 mm, not more than 1.9 mm, not more than 2 mm, not more than 2.1 mm, not more than 2.2 mm, not more than 2.3 mm, not more than 2.4 mm, not more than 2.5 mm, not more than 2.6 mm, not more than 2.7 mm, not more than 2.8 mm, not more than 2.9 mm, not more than 3
  • closest spacing between the conductive materials on the base layer or substrate can be not less than 0.1 mm, or not less than 0.2 mm, not less than 0.3 mm, not less than 0.4 mm, not less than 0.5 mm, not less than 0.6 mm, not less than 0.7 mm, not less than 0.8 mm, not less than 0.9 mm, not less than 1 mm, not less than 1 .1 mm, not less than 1 .2 mm, not less than 1 .3 mm, not less than 1 .4 mm, not less than 1 .5 mm, not less than 1 .6 mm, not less than 1 .7 mm, not less than 1 .8 mm, not less than 1 .9 mm, not less than 2 mm, not less than 2.1 mm, not less than 2.2 mm, not less than 2.3 mm, not less than 2.4 mm, not less than 2.5 mm, not less than 2.6 mm, not less than 2.7 mm,
  • Disclosures of the present specification include LLEC or LLEF systems comprising a primary surface of a material wherein the material is adapted to be applied to an area of tissue such as a muscle; a first electrode design formed from a first conductive liquid that includes a mixture of a polymer and a first element, the first conductive liquid being applied into a position of contact with the primary surface, the first element including a metal species, and the first electrode design including at least one dot or reservoir, wherein at least one of the at least one dot or reservoir has approximately a 1 .5 mm +/- 1 mm mean diameter; a second electrode design formed from a second conductive liquid that includes a mixture of a polymer and a second element, the second element including a different metal species than the first element, the second conductive liquid being printed into a position of contact with the primary surface, and the second electrode design including at least one other dot or reservoir, wherein at least one of the at least one other dot or reservoir has approximately a 2.5 mm +/- 2
  • electrodes, dots or reservoirs can have a mean diameter of, for example, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 .0 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8 mm, about 1 .9 mm, about 2.0 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about
  • electrodes, dots or reservoirs can have a mean diameter of not less than 0.2 mm, not less than 0.3 mm, not less than 0.4 mm, not less than 0.5 mm, not less than 0.6 mm, not less than 0.7 mm, not less than 0.8 mm, not less than 0.9 mm, not less than 1 .0 mm, not less than 1 .1 mm, not less than 1 .2 mm, not less than 1 .3 mm, not less than 1 .4 mm, not less than 1 .5 mm, not less than 1 .6 mm, not less than 1 .7 mm, not less than 1 .8 mm, not less than 1 .9 mm, not less than 2.0 mm, not less than 2.1 mm, not less than 2.2 mm, not less than 2.3 mm, not less than 2.4 mm, not less than 2.5 mm, not less than 2.6 mm, not less than 2.7 mm, not less than 2.8
  • electrodes, dots or reservoirs can have a mean diameter of not more than 0.2 mm, not more than 0.3 mm, not more than 0.4 mm, not more than 0.5 mm, not more than 0.6 mm, not more than 0.7 mm, not more than 0.8 mm, not more than 0.9 mm, not more than 1 .0 mm, not more than 1 .1 mm, not more than 1 .2 mm, not more than 1 .3 mm, not more than 1 .4 mm, not more than 1 .5 mm, not more than 1 .6 mm, not more than 1 .7 mm, not more than 1 .8 mm, not more than 1 .9 mm, not more than 2.0 mm, not more than 2.1 mm, not more than 2.2 mm, not more than 2.3 mm, not more than 2.4 mm, not more than 2.5 mm, not more than 2.6 mm, not more than 2.7 mm, not more than 2.8
  • FIG. 9 shows an embodiment utilizing two electrodes (one positive and one negative) .
  • Upper arms 140 and 145 can be, for example, about 1 , 2, 3, or 4 mm in width.
  • Lower arm 147 and serpentine 149 can be, for example, about 1 , 2, 3, or 4 mm in width.
  • the electrodes can be, for example, 1 , 2, or 3 mm in depth.
  • FIG. 10 shows an embodiment utilizing two electrodes (one positive and one negative) .
  • Upper arms 150 and 155 can be, for example, about 1 , 2, 3, or 4 mm in width.
  • the extensions protruding from the lower arm 156 can be, for example, about 1 , 1 .5, 2, 2.5, 3, 3.5, or 4 mm in width .
  • the extensions protruding from the comb 158 can be, for example, about 1 , 2, 3, 4, 5, 6, or 7 mm in width.
  • the electrodes can be, for example, about 1 , 2, or 3 mm in depth .
  • FIG. 1 1 shows an embodiment utilizing two electrodes (one positive and one negative) .
  • Upper arms 160 and 165 can be, for example, about 1 , 2, 3, or 4 mm in width.
  • Lower block 167 can be, for example, about 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, or 54 mm along its shorter axis.
  • Lower block 167 can be, for example, about 60, 65, 70, 75, 80, 85, 90, 95, or 100 mm along its longer axis.
  • the electrodes can be, for example, about 1 , 2, or 3 mm in depth.
  • the width and depth of the various areas of the electrode can be designed to produce a particular electric field, or, when both electrodes are in contact with a conductive material, a particular electric current.
  • the width of the various areas of the electrode can be, for example, about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1 .1 mm, about 1 .2 mm, about 1 .3 mm, about 1 .4 mm, about 1 .5 mm, about 1 .6 mm, about 1 .7 mm, about 1 .8 mm, about 1 .9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7
  • the depth or thickness of the various areas of the electrode can be, for example, about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, v3.7 mm, about
  • the shortest distance between the two electrodes in an embodiment can be, for example, about 0.1 mm, or about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm,
  • the length of the long axis of the electrode can be, for example, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, about 5 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.6 mm, about
  • the length of the short axis of the electrode can be, for example, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, about 5 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.6 mm, about
  • FIG. 12 depicts a backing layer 123, substrate 124, tear tab 125, and void region 120.
  • FIG. 13 depicts an embodiment in use, with a user removing the substrate layer 130 from the backing layer 135.
  • FIG. 14 depicts void regions 140 in a backing layer with visible multi-array matrix 145.
  • the material concentrations or quantities within and/or the relative sizes (e.g., dimensions or surface area) of the first and second reservoirs can be selected deliberately to achieve various characteristics of the systems' behavior.
  • the quantities of material within a first and second reservoir can be selected to provide an apparatus having an operational behavior that depletes at approximately a desired rate and/or that "dies" after an approximate period of time after activation.
  • the one or more first reservoirs and the one or more second reservoirs are configured to sustain one or more currents for an approximate pre-determined period of time, after activation.
  • a coating of a hydrogel can be manually spread on the multi- array matrix of biocompatible microcells. This process can be accomplished using a coating system similar to one used in silkscreening.
  • the hydrogel can be thinned by adding additional water to the hydrogel before application. When the viscosity of the hydrogel has been reduced sufficiently, the thinned hydrogel can be applied. A reduced viscosity hydrogel can be used for dip coating.
  • a hydrogel can be sprayed onto a multi-array matrix of biocompatible microcells in a manner similar to spray painting.
  • a thinned hydrogel can be used for spraying.
  • Disclosed methods can comprise hydrating the multi-array matrix, removing the dressing from the backing layer using the "tab" (as seen in FIG. 13), then applying the dressing to an area where treatment is desired.
  • Disclosed methods of use comprise application of a system or device described herein to a tissue, for example skin (such as around the eyes), a joint, a muscle, or a muscle group.
  • the application can be performed prior to, during, or after use of the muscle or muscle group to be treated.
  • a shoulder can be treated prior to engaging in an athletic activity, for example pitching a baseball.
  • Disclosed embodiments can increase glucose uptake, drive redox signaling, increase H 2 0 2 production, increase cellular protein sulfhydryl levels, and increase (IGF)-1 R phosphorylation.
  • Disclosed embodiments include devices and methods for increasing capillary density.
  • Further aspects include a method of directing cell migration using a device disclosed herein. These aspects include methods of improving re-epithelialization.
  • Further aspects include methods of increasing cellular thiol levels. Additional aspects include a method of energizing mitochondria.
  • Further aspects include a method of stimulating cellular protein expression.
  • Further aspects include a method of stimulating cellular DNA synthesis.
  • Further aspects include a method of stimulating cellular Ca 2+ uptake.
  • Embodiments include devices and methods for increasing transcutaneous partial pressure of oxygen. Further embodiments include methods and devices for treating or preventing pressure ulcers.
  • these systems, devices, and methods can increase ATP production, and angiogenesis, thus accelerating the healing process.
  • Disclosed systems, devices, and methods can also reduce bacterial population and/or proliferation, for example, in and around injuries or wounds.
  • Additional aspects include methods of preventing bacterial biofilm formation. Aspects also include a method of reducing microbial or bacterial proliferation, killing microbes or bacteria, killing bacteria through a biofilm layer, or preventing the formation of a biofilm. Embodiments include methods using devices disclosed herein in combination with antibiotics for reducing microbial or bacterial proliferation, killing microbes or bacteria, killing bacteria through a biofilm layer, or preventing the formation of a biofilm.
  • Further aspects include methods of treating diseases related to metabolic deficiencies, such as diabetes, or other diseases wherein the patient exhibits a compromised metabolic status.
  • Embodiments disclosed herein include LLEC and LLEF systems that can promote and/or accelerate the muscle recovery process and optimize muscle performance.
  • embodiments disclosed herein can increase or decrease cell migration.
  • Further embodiments can increase cellular protein sulfhydryl levels and cellular glucose uptake. Increased glucose uptake can result in greater mitochondrial activity and thus increased glucose utilization.
  • Disclosed embodiments can produce an electrical stimulus and/or can electro- motivate, electro-conduct, electro-induct, electro-transport, and/or electrophorese one or more therapeutic materials in areas of target tissue (e.g., iontophoresis), and/or can cause one or more biologic or other materials in proximity to, on or within target tissue to be rejuvenated.
  • target tissue e.g., iontophoresis
  • Further disclosure relating to materials that can produce an electrical stimulus can be found in U.S. Patent No. 7,662, 176 entitled FOOTWEAR APPARATUS AND METHODS OF MANUFACTURE AND USE issued February 16, 2010, which is incorporated herein by reference in its entirety.
  • Methods disclosed herein can include applying a disclosed embodiment to an area to be treated.
  • Embodiments can include selecting or identifying a patient in need of treatment.
  • methods disclosed herein can include application of a device disclosed herein to an area to be treated.
  • a user can remove a substrate comprising a multi-array matrix from the backing layer using the "tear" tab.
  • the tear tab can be detachable from the backing layer.
  • disclosed methods include application to the treatment area or the device of an antibacterial.
  • the antibacterial can be, for example, alcohols, aldehydes, halogen-releasing compounds, peroxides, anilides, biguanides, bisphenols, halophenols, heavy metals, phenols and cresols, quaternary ammonium compounds, and the like.
  • the antibacterial agent can comprise, for example, ethanol, isopropanol, glutaraldehyde, formaldehyde, chlorine compounds, iodine compounds, hydrogen peroxide, ozone, peracetic acid, formaldehyde, ethylene oxide, triclocarban, chlorhexidine, alexidine, polymeric biguanides, triclosan, hexachlorophene, PCMX (p-chloro- m-xylenol), silver compounds, mercury compounds, phenol, cresol, cetrimide, benzalkonium chloride, cetylpyridinium chloride, ceftolozane/tazobactam, ceftazidime/avibactam, ceftaroline/avibactam, imipenem/MK-7655, plazomicin, eravacycline, brilacidin, and the like.
  • compounds that modify resistance to common antibacterials can be employed.
  • some resistance-modifying agents may inhibit multidrug resistance mechanisms, such as drug efflux from the cell, thus increasing the susceptibility of bacteria to an antibacterial.
  • these compounds can include Phe-Arg- ⁇ - naphthylamide, or ⁇ -lactamase inhibitors such as clavulanic acid and sulbactam.
  • the system can also be used for preventative treatment of tissue injuries.
  • Preventative treatment can include preventing the reoccurrence of previous muscle injuries.
  • an embodiment can be shaped to fit a patient's shoulder to prevent recurrence of a deltoid injury.
  • the in vitro scratch assay is a well-developed method to measure cell migration in vitro.
  • the basic steps involve creating a "scratch" in a cell monolayer, capturing images at the beginning and at regular intervals during cell migration to close the scratch, and comparing the images to quantify the migration rate of the cells.
  • the in vitro scratch assay is particularly suitable for studies on the effects of cell- matrix and cell-cell interactions on cell migration, mimic cell migration during wound healing in vivo and are compatible with imaging of live cells during migration to monitor intracellular events if desired.
  • this method has also been adopted to measure migration of individual cells in the leading edge of the scratch.
  • IGF-1 R phosphorylation was demonstrated by the cells plated under the PROCELLERA ® device as compared to cells plated under insulin growth factor alone.
  • Integrin accumulation also affects cell migration. An increase in integrin accumulation was achieved with the LLEC system. Integrin is necessary for cell migration, and is found on the leading edge of migrating cell.
  • the tested LLEC system enhanced cellular migration and IGF-1 R / integrin involvement. This involvement demonstrates the effect that the LLEC system had upon cell receptors involved with the wound healing process.
  • Wounds were assessed until closed or healed. The number of days to wound closure and the rate of wound volume reduction were compared. Patients treated with LLEC received one application of the device each week, or more frequently in the presence of excessive wound exudate, in conjunction with appropriate wound care management. The LLEC was kept moist by saturating with normal saline or conductive hydrogel. Adjunctive therapies (such as negative pressure wound therapy [NPWT], etc.) were administered with SOC or with the use of LLEC unless contraindicated.
  • NGWT negative pressure wound therapy
  • the SOC group received the standard of care appropriate to the wound, for example antimicrobial dressings, barrier creams, alginates, silver dressings, absorptive foam dressings, hydrogel, enzymatic debridement ointment, NPWT, etc.
  • Etiology-specific care was administered on a case-by-case basis. Dressings were applied at weekly intervals or more.
  • the SOC and LLEC groups did not differ significantly in gender, age, wound types or the length, width, and area of their wounds.
  • Wound dimensions were recorded at the beginning of the treatment, as well as interim and final patient visits. Wound dimensions, including length (L), width (W) and depth (D) were measured, with depth measured at the deepest point. Wound closure progression was also documented through digital photography. Determining the area of the wound was performed using the length and width measurements of the wound surface area.
  • Closure was defined as 100% epithelialization with visible effacement of the wound. Wounds were assessed 1 week post-closure to ensure continued progress toward healing during its maturation and remodeling phase.
  • the LLEC wound treatment group demonstrated on average a 45.4% faster closure rate as compared to the SOC group. Wounds receiving SOC were more likely to follow a "waxing-and-waning" progression in wound closure compared to wounds in the LLEC treatment group. [0158] Compared to localized SOC treatments for wounds, the LLEC (1) reduces wound closure time, (2) has a steeper wound closure trajectory, and (3) has a more robust wound healing trend with fewer incidence of increased wound dimensions during the course of healing.
  • the LLEC was made of polyester printed with dissimilar elemental metals as described herein. It comprises alternating circular regions of silver and zinc dots, along with a proprietary, biocompatible binder added to lock the electrodes to the surface of a flexible substrate in a pattern of discrete reservoirs.
  • the silver positive electrode cathode
  • the zinc negative electrode anode
  • the LLEC used herein consisted of metals placed in proximity of about 1 mm to each other thus forming a redox couple and generating an ideal potential on the order of 1 Volt.
  • the calculated values of the electric field from the LLEC were consistent with the magnitudes that are typically applied (1 -10 V/cm) in classical electrotaxis experiments, suggesting that cell migration observed with the bioelectric dressing is likely due to electrotaxis.
  • External electrical stimulus can up-regulate the TCA (tricarboxylic acid) cycle.
  • the stimulated TCA cycle is then expected to generate more NADH and FADH 2 to enter into the electron transport chain and elevate the mitochondrial membrane potential (Am).
  • Fluorescent dyes JC-1 and TMRM were used to measure mitochondrial membrane potential.
  • JC- 1 is a lipophilic dye which produces a red fluorescence with high Am and green fluorescence when Am is low.
  • TMRM produces a red fluorescence proportional to Am.
  • Treatment of keratinocytes with LLEC for 24h demonstrated significantly high red fluorescence with both JC-1 and TMRM , indicating an increase in mitochondrial membrane potential and energized mitochondria under the effect of the LLEC.
  • Keratinocyte migration is known to involve phosphorylation of a number of receptor tyrosine kinases (RTKs) .
  • RTKs receptor tyrosine kinases
  • scratch assay was performed on keratinocytes treated with LLEC or placebo for 24h. Samples were collected after 3h and an antibody array that allows simultaneous assessment of the phosphorylation status of 42 RTKs was used to quantify RTK phosphorylation. It was determined that LLEC significantly induces IGF-1 R phosphorylation.
  • Sandwich ELISA using an antibody against phospho-IGF- 1 R and total IGF-1 R verified this determination. As observed with the RTK array screening, potent induction in phosphorylation of IGF-1 R was observed 3h post scratch under the influence of LLEC. IGF- 1 R inhibitor attenuated the increased keratinocyte migration observed with LLEC treatment.
  • MCB diochlorobimane reacts with only low molecular weight thiols such as glutathione. Fluorescence emission from UV laser- excited keratinocytes loaded with either MBB or MCB was determined for 30 min. Mean fluorescence collected from 10,000 cells showed a significant shift of MBB fluorescence emission from cells. No significant change in MCB fluorescence was observed, indicating a change in total protein thiol but not glutathione.
  • HaCaT cells were treated with LLEC for 24 h followed by a scratch assay. Integrin expression was observed by immuno-cytochemistry at different time points. Higher integrin expression was observed 6h post scratch at the migrating edge.
  • integrin subunit alpha-v Another phenomenon observed during re-epithelialization is increased expression of the integrin subunit alpha-v.
  • integrin a major extracellular matrix receptor
  • integrin subunits there are a number of integrin subunits, however we chose integrin aV because of evidence of association of alpha-v integrin with IGF-1 R, modulation of IGF-1 receptor signaling, and of driving keratinocyte locomotion.
  • integrin alpha v has been reported to contain vicinal thiols that provide site for redox activation of function of these integrins and therefore the increase in protein thiols that we observe under the effect of ES may be the driving force behind increased integrin mediated cell migration.
  • Other possible integrins which may be playing a role in LLEC -induced IGF-1 R mediated keratinocyte migration are a5 integrin and a6 integrin.
  • Cell culture Immortalized HaCaT human keratinocytes were grown in Dulbecco's low-glucose modified Eagle's medium (Life Technologies, Gaithersburg, MD, U.S.A.) supplemented with 10% fetal bovine serum, 100 U/ml penicillin, and 100 ⁇ g/ml streptomycin. The cells were maintained in a standard culture incubator with humidified air containing 5% C02 at 37°C.
  • Scratch assay A cell migration assay was performed using culture inserts (IBIDI®, Verona, Wl) according to the manufacturer's instructions. Cell migration was measured using time-lapse phase-contrast microscopy following withdrawal of the insert. Images were analyzed using the AxioVision Rel 4.8 software.
  • N-Acetyl Cysteine Treatment Cells were pretreated with 5mM of the thiol antioxidant N-acetylcysteine (Sigma) for 1 h before start of the scratch assay.
  • IGF-1 R inhibition When applicable, cells were preincubated with 50nM IGF-1 R inhibitor, picropodophyllin (Calbiochem, MA) just prior to the Scratch Assay.
  • Cellular H 2 0 2 Analysis To determine intracellular H 2 0 2 levels, HaCaT cells were incubated with 5 pM PF6-AM in PBS for 20 min at room temperature. After loading, cells were washed twice to remove excess dye and visualized using a Zeiss Axiovert 200M microscope.
  • Catalase gene delivery HaCaT cells were transfected with 2.3 x 107 pfu
  • AdCatalase or with the empty vector as control in 750 ⁇ of media was added 4 h later and the cells were incubated for 72 h.
  • RTK Phosphorylation Assay Human Phospho-Receptor Tyrosine Kinase phosphorylation was measured using Phospho-RTK Array kit (R & D Systems).
  • ELISA Phosphorylated and total IGF-1 R were measured using a DuoSet IC ELISA kit from R&D Systems.
  • Mitochondrial membrane potential was measured in HaCaT cells exposed to the LLEC or placebo using TMRM or JC- 1 (MitoProbe JC-1 Assay Kit for Flow Cytometry, Life Technologies), per manufacturer's instructions for flow cytometry.
  • Integrin alpha V Expression Human HaCaT cells were grown under the MCD or placebo and harvested 6h after removing the IBIDI® insert. Staining was done using antibody against integrin aV (Abeam, Cambridge, MA).
  • PROCELLERA ® LLEC system increased cellular protein sulfhydryl levels. Further, the PROCELLERA ® system increased cellular glucose uptake in human keratinocytes. Increased glucose uptake can result in greater mitochondrial activity and thus increased glucose utilization, providing more energy for cellular migration and proliferation. This can "prime" the wound healing process before a surgical incision is made and thus speed incision healing.
  • the main bacterial strain used in this study is Propionibacterium acnes and multiple antibiotics-resistant P. acnes isolates are to be evaluated.
  • ATCC medium (7 Actinomyces broth) (BD) and/or ATCC medium (593 chopped meat medium) is used for culturing P. acnes under an anaerobic condition at 37°C. All experiments are performed under anaerobic conditions.
  • Culture medium (7 Actinomyces broth) (BD) and/or ATCC medium (593 chopped meat medium) is used for culturing P. acnes under an anaerobic condition at 37°C. All experiments are performed under anaerobic conditions.
  • LNA Leeming-Notman agar
  • P. acnes is a relatively slow-growing, typically aero-tolerant anaerobic, Gram-positive bacterium (rod) .
  • P. acnes is cultured under anaerobic condition to determine for efficacy of an embodiment disclosed herein (PROCELLERA®).
  • Overnight bacterial cultures are diluted with fresh culture medium supplemented with 0.1 % sodium thioglycolate in PBS to10 5 colony forming units (CFUs).
  • CFUs colony forming units
  • the bacterial suspensions 0.5 mL of about 105) are applied directly on PROCELLERA® (2" x 2") and control fabrics in Petri-dishes under anaerobic conditions.
  • portions of the sample fabrics are placed into anaerobic diluents and vigorously shaken by vortexing for 2 min.
  • the suspensions are diluted serially and plated onto anaerobic plates under an anaerobic condition. After 24 h incubation, the surviving colonies are counted.
  • the LLEC limits bacterial proliferation.
  • the lactate threshold also known as lactate inflection point or anaerobic threshold, is the exercise intensity at which lactate (more specifically, lactic acid) starts to accumulate in the blood stream.
  • lactate more specifically, lactic acid
  • the reason for the acidification of the blood at high exercise intensities is two-fold: the high rates of ATP hydrolysis in the muscle release hydrogen ions, as they are co-transported out of the muscle into the blood via the monocarboxylate transporter, and also bicarbonate stores in the blood begin to be used up. This happens when lactate is produced faster than it can be removed (metabolized) in the muscle.
  • lactate produced by the muscles is removed by the body without it building up (e.g. , aerobic respiration) .
  • lactate threshold e.g. anaerobic respiration
  • excess lactate can build up in tissue causing a lower pH and soreness, called acidosis.
  • This excess lactate build-up decreases athletic ability during exercise as well tissue recovery after exercise and can be a primary source of post-exercise muscle stiffness/pain.
  • the embodiment increases cellular glucose uptake. Increased glucose uptake can result in greater mitochondrial activity and thus increased glucose utilization, providing more energy for cellular activity to remove lactic acid from muscle tissue. It has been shown that increased cellular glucose utilization can also sustain anaerobic respiration for a longer period of time during exercise, thus increasing a person's lactate threshold. An increased lactate threshold prevents lactate from building-up in muscle tissue, thus reducing or preventing muscle damage and/or pain.
  • a 29 year-old tennis player reports pain on the outside of her elbow.
  • Her doctor performs arthroscopic surgery to correct the damaged tissue.
  • an embodiment as disclosed herein is applied to the patient's elbow to stimulate healing and prevent post-surgical infection.
  • the doctor hydrates the matrix through the void in the backing layer, removes the substrate/matrix from the backing layer, and applies the substrate/matrix to the treatment area.
  • a 42 year-old golfer reports pain on the inside of his elbow. His doctor performs arthroscopic surgery to correct the damaged tissue. Following surgery, an embodiment as disclosed herein is applied to the patient's elbow to stimulate healing and prevent postsurgical infection. The doctor hydrates the matrix, removes the substrate/matrix from the backing layer and applies the substrate/matrix to the treatment area.

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Abstract

L'invention concerne des systèmes de traitement bioélectriques qui comprennent une couche de support, par exemple une couche comprenant un orifice à travers lequel la matrice à réseaux multiples du dispositif peut être hydratée.
PCT/US2018/012391 2017-01-11 2018-01-04 Systèmes et dispositifs d'application de pansements WO2018132298A1 (fr)

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CN110772378A (zh) * 2019-10-31 2020-02-11 京东方科技集团股份有限公司 敷料
WO2020205862A1 (fr) * 2019-04-03 2020-10-08 Vomaris Innovations, Inc. Utilisations systémiques de champs électriques
WO2021006928A1 (fr) * 2019-07-11 2021-01-14 Vomaris Innovations, Inc. Procédés et dispositifs de traitement de sites de fixation externes

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WO2020205862A1 (fr) * 2019-04-03 2020-10-08 Vomaris Innovations, Inc. Utilisations systémiques de champs électriques
WO2021006928A1 (fr) * 2019-07-11 2021-01-14 Vomaris Innovations, Inc. Procédés et dispositifs de traitement de sites de fixation externes
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