Electrode assembly with filling structure between electrode elements - Patent Application 20070122997

Abstract

The device for providing a tumor treatment field includes an electrode layer having a plurality of electrode elements. The first and second electrode elements are spaced apart within the electrode layer along a first axis. The electrode layer has at least one filling structure having a first filling portion located in a space between the first and second electrode elements. The at least one filling structure is configured to provide the electrode layer with a substantially constant height along the first axis. The device can further include an upper adhesive layer, a lower adhesive layer, and an anisotropic material layer therebetween. The plurality of electrode elements can be in electrical contact with an outward-facing surface of the anisotropic material layer.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and benefit of the filing date of U.S. Provisional Application No. 63 / 408,918, filed September 22, 2022, which is incorporated by reference herein in its entirety. [Background technology]

[0002] Tumor Treating Field (TT Field) therapy is a proven approach to treating tumors using alternating current (AC) electric fields at frequencies between 50 kHz and 1 MHz, more commonly between 100 and 500 kHz. In current commercially available systems, the AC electric field is induced by electrode assemblies (e.g., arrays of capacitively coupled electrodes, also known as transducer arrays) placed on opposite sides of the subject's body. When an AC voltage is applied between the opposing electrode assemblies, an AC current flows through the electrode assemblies into the subject's body. The higher the current, the greater the therapeutic effect. Summary of the Invention [Means for solving the problem]

[0003] In one embodiment, the present disclosure provides a device having an electrode layer. The electrode layer includes a plurality of electrode elements, each of which has a skin-facing surface. At least first and second electrode elements are spaced apart within the electrode layer along a first axis. The electrode layer further includes at least one filling structure. The at least one filling structure includes a first filling portion located in a space between the first and second electrode elements. The at least one filling structure is configured to provide the electrode layer with a substantially constant height along the first axis. The anisotropic material layer has a skin-facing surface and an opposite outward-facing surface. The upper adhesive layer includes a conductive adhesive composite. The upper adhesive layer is disposed outside the anisotropic material layer. The skin-contacting structure includes an adhesive layer including the conductive adhesive composite. At least one electrode element of the plurality of electrode elements is in electrical contact with the outward-facing surface of the anisotropic material layer. The skin-contacting structure is disposed inside the anisotropic material layer and configured to contact the skin of a subject.

[0004] A method of using the device includes positioning at least first and second electrode assemblies on a subject's body, each of the first and second electrode assemblies including an electrode layer. The electrode layer includes a plurality of electrode elements, each of the plurality of electrode elements having a skin-facing surface. The at least first and second electrode elements are spaced apart within the electrode layer along a first axis. The electrode layer further includes at least one filling structure. The at least one filling structure includes a first filling portion located in a space between the first electrode element and the second electrode element. The at least one filling structure is configured to provide the electrode layer with a substantially constant height along the first axis. The anisotropic material layer has a skin-facing surface and an opposite outward-facing surface. The upper adhesive layer includes a conductive adhesive composite. The upper adhesive layer is disposed outside the anisotropic material layer. The skin-contacting structure includes an adhesive layer including the conductive adhesive composite. At least one electrode element of the plurality of electrode elements is in electrical contact with the outward-facing surface of the anisotropic material layer. The skin contact structure is disposed inside the anisotropic material layer and configured to contact the skin of the subject. The skin contact structure is in contact with the skin of the subject. An AC voltage is applied between the first electrode assembly and the second electrode assembly to generate an electric field. [Brief explanation of the drawings]

[0005] [Figure 1] FIG. 1 is a top view of an electrode assembly according to the present disclosure, with some layers shown transparent to reveal the underlying layers. [Figure 2] 2 is a cross-sectional view of the electrode assembly of FIG. 1 taken along plane 2-2', dimensions not shown to scale. [Figure 3] 3 is a close-up detail view of an exemplary electrode element of the cross section shown in FIG. 2. [Figure 4] 2 is a partial cross-sectional view along plane 2-2' of an exemplary electrode assembly according to embodiments disclosed herein, dimensions not shown to scale. [Figure 5] 1 is a schematic diagram of a system for providing a tumor treatment field as disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0006] Various embodiments will now be described in detail with reference to the accompanying drawings, in which like reference numerals represent like elements, and the description of like elements will not be repeated for each embodiment, but will be considered the same if previously described herein.

[0007] This application describes exemplary electrode assemblies that can be used, for example, to deliver a TT field to the body of a subject to treat one or more cancers or tumors in the body of a subject.

[0008] The present invention may be more readily understood by reference to the following detailed description, examples, drawings, claims, and accompanying text, although it is to be understood that the invention is not limited to the particular apparatus, devices, systems, and / or methods disclosed, unless otherwise specified, as such may, of course, vary.

[0009] Headings are provided for convenience only and should not be construed as limiting the invention in any way. Embodiments described under any heading or in any portion of this disclosure may be combined with embodiments described under the same heading or other headings or in other portions of this disclosure.

[0010] Unless otherwise indicated herein or otherwise clearly contradicted by context, any combination of the elements described herein in all possible variations thereof is encompassed by the invention.

[0011] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, unless the context dictates otherwise, it is understood that disclosure of an element in the singular can support embodiments in which only one of such element is provided as well as embodiments in which more than one of such element is provided.

[0012] In the foregoing and following descriptions, the terms "front," "inner," and "skin-facing," when used as disclosed herein, are used interchangeably to refer to a face or surface of the disclosed electrode assembly (or a component thereof) that faces or is oriented toward a subject's skin (or generally toward a subject's body). Similarly, the terms "rear," "upper," "outer," and "outward-facing," when used as disclosed herein, are used interchangeably to refer to a face or surface of the disclosed electrode assembly (or a component thereof) that faces or is oriented away from a subject's skin (or generally toward a subject's body). For example, an "inner face" can face toward a subject's skin, and an "outer face" can face away from a subject's skin. Device structure and configuration

[0013] 1-3 , the device 10 (also referred to herein as an “electrode assembly”) may include an electrode layer 20 having a plurality of electrode elements 22 (e.g., 22 a-c). Each electrode element 22 of the plurality of electrode elements may have a skin-facing surface 24. The first and second electrode elements 22 a, b may be spaced apart within the electrode layer 20 along the first axis 12. The electrode layer 20 may further include at least one filling structure 30. The at least one filling structure 30 may include a first filling structure 30 a having a first filling portion 32 a located within a space 34 a between the first electrode element 22 a and the second electrode element 22 b. The at least one filling structure 30 may be configured to provide the electrode layer 20 with a substantially constant height along the first axis 12.

[0014] In some optional aspects, the device 10 can further include an anisotropic material layer 40 having an outward-facing surface 44 opposite the skin-facing surface 42 ( FIG. 2 ). The upper adhesive layer 50 can include a conductive adhesive composite. The upper adhesive layer 50 can be disposed on the outer side 46 of the anisotropic material layer. In some embodiments, the upper adhesive layer 50 is disposed on the outer side 44 of the anisotropic material layer. The device 10 can further include a skin-contacting structure 60 including at least one adhesive layer comprising a conductive adhesive composite. The skin-contacting structure can have an inner (skin-facing) surface 61 and an outer side 63. The skin-contacting structure 60 can be disposed on the inner (skin-facing) surface 48 of the anisotropic material layer 40 and configured to contact the subject's skin 100. In some embodiments, the skin-contacting structure 60 is disposed on the inner (skin-facing) surface 42 of the anisotropic material layer 40 and configured to contact the subject's skin 100. In some aspects, the electrode layer 20 can be present on the outer side 46 of the anisotropic material layer.

[0015] In other embodiments, the device 10 may not have an anisotropic material layer (i.e., the device 10 does not include an anisotropic material layer). In these embodiments, the upper adhesive layer 50 may be disposed on the outside of the skin-contacting structure 60, or the upper adhesive layer 50 may not be present, in which case the skin-contacting structure may be disposed inside the electrode layer. This allows the skin-contacting structure to be disposed inside the upper adhesive layer.

[0016] At least one electrode element 22 of the plurality of electrode elements can be in electrical contact with the outward facing surface 44 of the anisotropic material layer 40 .

[0017] In some embodiments, each electrode element 22 of the plurality of electrode elements can be in electrical contact with the outwardly facing surface 44 of the anisotropic material layer 40. Thus, the anisotropic material layer 40 can extend continuously across the area in which each electrode element is located.

[0018] In some optional embodiments, each electrode element 22 of the plurality of electrode elements can include a layer of dielectric material 70 having a skin-facing inner surface 72 and an opposing outer surface 74 ( FIG. 3 ). In these embodiments, the skin-facing inner surface 72 of the dielectric material 70 can define the inner surface 24 of the electrode element 22. Each electrode element 22 can further include a metal layer 76 having an inner surface 77 and an opposing outer surface 78. The metal layer 76 can be disposed on the outer surface 74 of the dielectric layer 70.

[0019] In some optional aspects, the dielectric material 70 can include a ceramic material. In other aspects, the dielectric material 70 can include a high dielectric polymer. In exemplary aspects, the dielectric material 70 can have a dielectric constant ranging from 10 to 50,000. In some embodiments, the dielectric layer 70 includes a high dielectric polymer material such as poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and / or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene). These two polymers are abbreviated herein as "poly(VDF-TrFE-CTFE)" and "poly(VDF-TrFE-CFE)," respectively. These embodiments are particularly advantageous because these materials have a dielectric constant of approximately 40. In some embodiments, the polymer layer can be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or "poly(VDF-TrFE-CTFE-CFE)." In some embodiments, dielectric material layer 70 comprises a terpolymer including polymerized units of monomers such as VDF, TrFE, CFE, and / or CTFE in any suitable molar ratio. Suitable terpolymers include, for example, those having 30-80 mol % VDF, 5-60 mol % TrFE, with CFE and / or CTFE making up the remainder of the terpolymer's molar percentages.

[0020] In another embodiment, the electrode element 22 does not include a dielectric material.

[0021] The plurality of electrode elements 22 may optionally include a third electrode element 22c. The second electrode element 22b may be located between the first electrode element 22a and the third electrode element 22c and spaced apart from the first electrode element 22a and the third electrode element 22c along the first axis 12. The at least one filling structure 30 may further include a second filling portion 32b located between the second electrode element 22b and the third electrode element 22c along the first axis 12. For example, the first filling structure 30a may have the second filling portion 32b located in the space 34b between the second electrode element 22b and the third electrode element 22c. In other embodiments, a second filling structure (not shown) not integrally formed with the first filling structure 30a may be positioned in the space 34b.

[0022] In some optional embodiments, the plurality of electrode elements 22 can include at least two rows of electrode elements 26 extending along a second axis 14 perpendicular to or parallel to the first axis 12. The at least two rows of electrode elements can include a first row of electrode elements 26a including first electrode elements 22a and a second row of electrode elements 26b including second electrode elements 22b. A first filler portion 32a can be located between the first row 26a and the second row 26b of the electrode elements 22, e.g., between the electrode elements 22a and 22b along the first axis 12. If desired, the plurality of electrode elements 22 can be arranged in exactly two rows 26, e.g., as shown with rows 26a and 26b separately.

[0023] Further, in any embodiment, the plurality of electrode elements 22 can include at least three rows 26 (optionally, exactly three rows) of electrode elements 22 extending along a second axis 14 perpendicular to the first axis 12 or parallel to the second axis 14. The at least three rows of electrode elements 22 can include a first row 26a of electrode elements 22a including first electrode elements 22a, a second row 26b of electrode elements 22b including second electrode elements 22b, and a third row 26c of electrode elements 22c including third electrode elements 22c. A first filler portion 32a can be located between the first row 26a and the second row 26b of electrode elements 22, e.g., between electrode elements 22a and 22b along the first axis 12. A second filler portion 32b can be located between the second row 26b and the third row 26c of electrode elements 22, e.g., between electrode elements 22b and 22c along the first axis 12.

[0024] In various exemplary embodiments, each row 26 of electrode elements 22 can include three electrode elements 22. In other embodiments, each row 26 of electrode elements 22 can include two electrode elements 22, four electrode elements 22, five electrode elements 22, or more electrode elements 22.

[0025] In some embodiments, at least one filling structure 30 can comprise a foam. In some embodiments, at least one filling structure 30 can comprise any polymeric material, including rubber polymers, elastomers, thermoplastic polymers, and thermoset polymers. In some embodiments, at least one filling structure 30 can comprise a hydrocolloid. In some embodiments, at least one filling structure 30 can comprise a gel. Optionally, in these embodiments, at least one filling structure 30 can comprise a hydrocolloid gel. In various optional embodiments, the filling structure can be or can comprise a drug.

[0026] The filling structure 30 can function as a drug substrate, which can receive, absorb, or retain an applied topical agent. Thus, the filling structure 30 can contain a topical agent integrated within or on the filling structure. The topical agent can include oil, water, petrolatum, wax, cellulose, or a combination thereof as a base ingredient. The topical agent can be a cream, ointment, lotion, gel, wax, paste, or mineral oil jelly. The topical agent can include at least one of an antibiotic, a steroid, an antiseptic, an emollient, an anesthetic, a terpene, a botanical extract, a silicone-based organic polymer, an antifungal, a burn reliever, a skin repair agent, an astringent, or an antihistamine. For example, the topical agent can be a steroid or corticosteroid, such as a topical agent such as hydrocortisone or betamethasone. The topical agent can be or include a skin repair agent, which can include a hydrocolloid material. The topical agent can be any compound capable of soothing, healing, and / or alleviating inflammation, wounds, or other irritations that may occur on the skin of a subject's body. The topical agent can be dispersed substantially uniformly throughout the thickness of the drug substrate, or the topical agent can be disposed substantially on the surface of the drug substrate.

[0027] When the filler structure is or includes a hydrocolloid layer, the hydrocolloid layer can function as a topical agent. The hydrocolloid layer can be a gel or include any suitable material that can thicken upon contact with a wound (e.g., to absorb fluids or secretions from damaged or broken skin). The hydrocolloid layer can include any suitable material (e.g., a hydrocolloid gel) that can transform into a gel or gel-like substance upon absorbing moisture from the skin. In at least some exemplary embodiments, the hydrocolloid layer can include pectin, a material with collagen-like properties (e.g., gelatin), carboxymethylcellulose (e.g., sodium carboxymethylcellulose), and / or any other suitable material.

[0028] The hydrocolloid layer may or may not include an adhesive and may or may not have adhesive properties. The hydrocolloid layer may include, for example, an adhesive layer similar to the adhesive layers disclosed herein. The hydrocolloid layer may function as an adhesive (e.g., have adhesive properties). Also, for example, the hydrocolloid layer may not include an adhesive or exhibit adhesive properties.

[0029] The drug can provide a soothing effect to the patient's skin in response to irritation caused by device 10. For example, in embodiments in which the filler material is or includes a hydrocolloid, or in embodiments in which the filler material is or includes a drug, the electrode assembly can be moved (translated) after a treatment period so that the filler material is positioned to cover areas of the skin previously covered by the electrodes. Such translation of the electrode assembly can provide pain relief and some healing to areas of skin that may have become inflamed due to the presence of the electrodes on the skin.

[0030] In some embodiments, the at least one filling structure 30 and the plurality of electrode elements 22 have a combined surface area that is at least 20%, or at least 30%, or at least 40%, or at least 50%, or at least 60%, or at least 70% of the surface area of ​​the anisotropic material layer 40. In some embodiments, the combined surface area of ​​the at least one filling structure 30 and the plurality of electrode elements 22 is no more than 80%, or no more than 70%, or no more than 60%, or no more than 50%, or no more than 40%, or no more than 30% of the surface area of ​​the anisotropic material layer 40.

[0031] In various embodiments, the at least one filling structure 30, or portions thereof, can be complementary to the shape of the electrode elements. In some optional embodiments, the first and second filling portions are part of a shaped layer of filling structure material that fills the gaps between all of the electrode elements and has notches 35 as void spaces to accommodate each of the plurality of electrode elements. For example, in some optional embodiments, the at least one filling structure 30 can be a single filling structure that is a single continuous structure defining multiple notches for accommodating each of the plurality of electrode elements. The notches 35 can be complementary to the shape of the electrode elements. Furthermore, it is contemplated that the at least one filling structure 30, either as a single filling structure or as a combination of multiple conforming filling portions, can be shaped to occupy all gaps between electrode elements arranged in any pattern, not just a row and column arrangement.

[0032] In other embodiments, at least one filling structure 30 can include multiple separate elements. For example, a first filling structure can define a first filling portion 32 and a second filling structure can define a second filling portion 32 (e.g., 32a and 32b).

[0033] In some embodiments, the first filler portion 32a can have a shape complementary to the shape of the space 34a between the first electrode element 22a and the second electrode element 22b.

[0034] In some optional embodiments, the first filler portion 32 a and / or the second filler portion 32 b can be part of a strip of filler structural material that fills the gap between one or more rows 26 of electrode elements or one or more columns 28 of electrode elements 22. For example, the first strip of filler material 36 a can extend between the first column 26 a and the second column 26 b of electrode elements 22, and the second strip of filler material 36 b can extend between the second column 26 b and the third column 26 c of electrode elements 22.

[0035] Further optionally, filling structure 30 can include notches 38 (shown in dashed lines in FIG. 1 ) to enhance flexibility and breathability of device 10. For example, notch 38 can include a single continuous notch or multiple notches located along an axis extending between electrode elements 22 to enhance flexibility between the electrode elements. In some embodiments, notch 38 can include multiple spaced notches extending along an axis located between columns 28 of electrode elements 22 or between rows 26 of electrode elements 22. In some embodiments, notch 38 can include a continuous notch extending continuously through multiple electrodes (e.g., along an entire row 26 of electrode elements or along an entire column 28 of electrode elements). Optionally, notch 38 can include multiple notches between consecutive columns 26 of electrodes.

[0036] As described above, the upper adhesive layer 50 can be disposed on the outer side 46 or outer surface 44 of the anisotropic material layer. In some embodiments, the upper adhesive layer 50 does not include a hydrogel. For example, the upper adhesive layer 50 can include a conductive adhesive composite, as further disclosed herein. The conductive adhesive composite of the upper adhesive layer 50 can include a dielectric material and conductive particles dispersed within the dielectric material. Suitable dielectric materials include acrylic polymers and silicone polymers, and suitable conductive particles include carbon flakes, carbon granules, carbon fibers, carbon black powder, graphite powder, carbon nanotubes, carbon nanowires, and the like. For example, the upper adhesive layer 50 can include carbon black. In an exemplary embodiment, the upper adhesive layer 50 can include an adhesive provided by ADHESIVE RESEARCH, such as ARcare® 8006 conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). In any other embodiment, the upper adhesive layer 50 can include carbon fibers or nanowires. For example, in exemplary embodiments, upper adhesive layer 50 can include a dry carbon / salt adhesive, such as FLX068983-FLEXcon® OMNI-WAVE™ TT 200 BLACK H-502 150 POLY H-9 44PP-8, a product developed by FLEXcon, Inc., Spencer, Massachusetts, USA, or other similar OMNI-WAVE products from FLEXcon. In various embodiments, the thickness of upper adhesive layer 50 can range from about 25 μm to about 150 μm.

[0037] In some optional embodiments, the skin-contacting structure 60 can be a single layer including a conductive adhesive composite. In some embodiments, the conductive adhesive composite includes a dielectric material and conductive particles dispersed within the dielectric material; suitable dielectric materials and suitable conductive particles are described above. In some embodiments, the skin-contacting structure 60 can include an adhesive (e.g., an acrylic adhesive) including carbon fibers or carbon nanowires. The skin-contacting structure 60 can include an adhesive (e.g., an acrylic adhesive) including carbon black powder. In exemplary embodiments, the thickness of the skin-contacting structure 60 can range from about 25 μm to about 150 μm. For example, optionally, the thickness of the skin-contacting structure 60 can be about 50 μm. The conductive adhesive composite for the skin-contact adhesive can include similar or identical components to the conductive adhesive composite for the upper adhesive layer, although they may or may not be the same in a particular electrode assembly.

[0038] As shown in FIG. 4 , in some optional embodiments, the skin-contacting structure 60 can have an outer adhesive layer 62, an inner adhesive layer 64, and a substrate 66 positioned between the outer adhesive layer 62 and the inner adhesive layer 64. While shown as a single component in FIG. 2 , it is contemplated that the skin-contacting structure 60 shown in FIG. 2 can include inner and outer adhesive layers and a substrate, as shown in FIG. 4 . The outer adhesive layer 62 can be disposed on the skin-facing side 48 of the anisotropic material layer 40. Optionally, the outer adhesive layer 62 of the skin-contacting structure 60 can be disposed on the skin-facing surface 42 of the anisotropic material layer. The inner adhesive layer 64 can be configured to contact the subject's skin. In further embodiments, the inner adhesive layer 64 can contact the subject's skin.

[0039] In some embodiments, the outer adhesive layer 62 and the inner adhesive layer 64 of the skin-contacting structure 60 do not include a hydrogel. For example, the outer adhesive layer 62 and the inner adhesive layer 64 of the skin-contacting structure 60 can include a conductive adhesive composite, as further disclosed herein. The conductive adhesive composite of the inner adhesive layer 64 and the outer adhesive layer 62 of the skin-contacting structure 60 can include a dielectric material and conductive particles dispersed within the dielectric material, as described above.

[0040] Alternatively, it is contemplated that the outer and / or inner adhesive layers 62, 64 may comprise a hydrogel.

[0041] In some optional embodiments, the outer adhesive layer 62 and / or the inner adhesive layer 64 can include carbon black. For example, in an exemplary embodiment, the outer adhesive layer 62 and / or the inner adhesive layer 64 can include an adhesive provided by ADHESIVE RESEARCH, such as ARcare® 8006 conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). In other optional embodiments, the outer adhesive layer 62 and / or the inner adhesive layer 64 can include carbon fibers or nanowires. For example, in an exemplary embodiment, the outer adhesive layer 62 and / or the inner adhesive layer 64 can include a dry carbon / salt adhesive, such as OMNI-WAVE™ TT 200 BLACK H-502 150 POLY H-9 44PP-8, a product developed by FLEXcon, Inc. of Spencer, Massachusetts, USA, or other similar OMNI-WAVE products from FLEXcon.

[0042] In some optional embodiments, the thickness of outer adhesive layer 62 can be at least 40 μm (optionally, at least 45 μm or at least 50 μm). For example, the thickness of outer adhesive layer 62 can be in the range of about 40 μm to about 75 μm (e.g., optionally, about 40 μm to about 70 μm, or about 40 μm to about 65 μm, or about 45 μm to about 75 μm, or about 45 μm to about 70 μm, or about 45 μm to about 65 μm, or about 50 μm to about 75 μm, or about 50 μm to about 70 μm, or about 50 μm to about 65 μm). Further, in optional embodiments, inner adhesive layer 64 can have a thickness of at least 40 μm (optionally, at least 45 μm or at least 50 μm). For example, the thickness of the inner adhesive layer 64 can be in the range of about 40 μm to about 75 μm (e.g., optionally about 40 μm to about 70 μm, or about 40 μm to about 65 μm, or about 45 μm to about 75 μm, or about 45 μm to about 70 μm, or about 45 μm to about 65 μm, or about 50 μm to about 75 μm, or about 50 μm to about 70 μm, or about 50 μm to about 65 μm). It has been found that excessive thickness (e.g., greater than 75 μm, or in certain embodiments greater than 65 μm) can leave residue after removal from the subject or patient. Furthermore, it has been found that an insufficient thickness (e.g., less than 25 μm in certain embodiments) can cause the layer to easily break.

[0043] In some embodiments, the substrate 66 of the skin-contacting structure 60 (FIG. 4) can be electrically conductive. In various optional aspects, the substrate 66 of the skin-contacting structure 60 can have a continuous, uninterrupted structure. In these aspects, it is believed that the substrate can be electrically conductive and conduct electricity between the outer adhesive layer 62 and the inner adhesive layer 64, similar to scanning electron microscope (SEM) tape.

[0044] In another embodiment, the substrate 66 of the skin-contacting structure 60 can have an at least partially open structure configured to allow adhesive to flow between or between the inner adhesive layer 64 and the outer adhesive layer 62 of the skin-contacting structure. In this manner, the adhesive can conduct electricity through the substrate 66. For example, in some embodiments, the substrate 66 can include a mesh. Optionally, the mesh can have a density of about 6 grams per square meter to about 8 grams per square meter. In other embodiments, the substrate 66 can include a scrim.

[0045] In various optional embodiments, the substrate 66 of the skin-contacting structure 60 can include paper, any suitable polymer (eg, polyester, polyolefin, etc.), or fabric.

[0046] Optionally, the skin-contacting structure 60 is reusable.

[0047] In some optional embodiments, the upper adhesive layer 50 does not include a hydrogel. In further or alternative embodiments, the skin-contacting structure 60 does not include a hydrogel. Thus, in some optional embodiments, both the upper adhesive layer 50 and the skin-contacting structure 60 do not include a hydrogel. In other embodiments, either the upper adhesive layer 50 or the skin-contacting structure 60, or both, may be comprised of a hydrogel.

[0048] In exemplary aspects, the conductive adhesive composite of any layer of the device can include a dielectric material and conductive particles dispersed within the dielectric material. In some embodiments, at least a portion of the conductive particles define a conductive path through the thickness of the conductive adhesive composite. It is believed that the conductive particles can align in response to the application of an electric field, causing the conductive particles to undergo electrophoresis. In some aspects, the dielectric material of the conductive adhesive composite of each of the first and second electrode assemblies is a polymer adhesive. Optionally, in these aspects, the polymer adhesive can be an acrylic adhesive. In some aspects, the conductive particles can include carbon. Optionally, in these aspects, the conductive particles can include graphite powder. Additionally or alternatively, the conductive particles can include carbon flakes. Additionally or alternatively, the conductive particles can include carbon particles. Additionally or alternatively, the conductive particles can include carbon fibers. Additionally or alternatively, the conductive particles can include carbon nanotubes or carbon nanowires. Additionally or alternatively, the conductive particles can include carbon black powder. In further aspects, the conductive adhesive composite further includes a polar substance (e.g., a polar salt). The polar salt can be a quaternary ammonium salt, such as a tetraalkylammonium salt. Exemplary conductive adhesive composites and methods for making such conductive adhesive composites are disclosed in U.S. Patent Nos. 8,673,184 and 9,947,432, which are incorporated herein by reference for all purposes. In an exemplary embodiment, the conductive adhesive composite can be a dry carbon / salt adhesive, such as the aforementioned OMNI-WAVE adhesive composition manufactured and sold by FLEXCON (Spencer, Massachusetts, USA).

[0049] In some embodiments, the anisotropic material layer 40 has a first thermal conductivity in a direction perpendicular to the plane of the layer. The thermal conductivity of the anisotropic material layer 40 can be at least two times the first thermal conductivity in a direction parallel to the plane of the anisotropic material layer. For example, in some embodiments, the thermal conductivity of the anisotropic material layer 40 can be at least three times, at least four times, or at least five times higher than the first thermal conductivity in a direction parallel to the plane of the anisotropic material layer. In some embodiments, the thermal conductivity in the parallel direction is at least ten times higher than the first thermal conductivity. In various embodiments, for example, the thermal conductivity of the anisotropic material layer 40 in a direction parallel to the plane of the anisotropic material layer can be at least 1.5 times, 2 times, 3 times, 5 times, 10 times, 20 times, 100 times, 200 times, or 1,000 times higher than the first thermal conductivity.

[0050] The anisotropic material layer 40 can have a first resistance in a direction perpendicular to the plane of the layer. In some optional embodiments, the resistance of the layer in a direction parallel to the plane of the layer is less than half of the first resistance. In exemplary embodiments, the resistance of the anisotropic material layer 40 in a direction parallel to the plane of the layer can be less than 10% of the first resistance. In exemplary embodiments, the resistance of the anisotropic material layer 40 in a direction parallel to the plane of the layer can be less than 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5%, or less than 0.1% of the first resistance.

[0051] In some optional embodiments, the anisotropic material can include graphite. In some optional embodiments, the graphite can include synthetic graphite. The anisotropic material layer can be or include a layer of pyrolytic graphite made from compressed, high-purity exfoliated mineral graphite, a graphitized polymer film, or a graphite foil. Examples of suitable forms of graphite include synthetic graphite such as pyrolytic graphite (including, but not limited to, pyrolytic graphite sheet (PGS) available from Panasonic Industries, Ltd., Kadoma City, Osaka Prefecture, Japan), other forms of synthetic graphite such as graphite foil made from compressed, high-purity exfoliated mineral graphite (including, but not limited to, MinGraph® 2010A flexible graphite available from Mineral Seal, Inc., Tucson, Arizona, USA), or graphitized polymer films, such as graphitized polyimide films (including, but not limited to, graphite available from Kaneka Corporation, Moka City, Ibaraki Prefecture, Japan). In alternative embodiments, an electrically conductive anisotropic material other than graphite may be used in place of graphite.

[0052] The multiple electrode elements 22 can be wired (e.g., using wires, traces on a flex circuit, etc.) to leads 90 (FIG. 4) that can supply AC voltage from an AC voltage generator 820 (FIG. 5) to the electrode elements to generate a TT field when the device 10 (e.g., 10a and 10b in FIG. 5) is attached to the subject's body for treatment.

[0053] The device 10 can include a flexible, self-adhesive backing 80 (FIGS. 1, 2, and 4) covering the exterior of at least a portion (optionally all) of the anisotropic material layer 40. The flexible, self-adhesive backing 80 can facilitate adhesion of the device to the patient's skin and provide stability and support to the device 10. In conventional electrode assemblies, individual electrode elements are positioned on and contact the patient's skin via a layer of conductive hydrogel. An alternating current can be applied to the patient's body through the individual electrode elements and the patient's skin, inducing an electric field within the body. Traditionally, electrode elements include ceramic disks as dielectric layers, which result in a raised profile for each electrode (and an uneven depth profile across the area of ​​the electrode assembly). As disclosed herein, a continuous conductive structure provided by a conductive anisotropic material layer (e.g., a sheet of pyrolytic graphite) can extend across multiple electrode elements (optionally, all of the electrode elements). Furthermore, the filler structure can flatten the surface of the continuous conductive structure rather than forming ridges or valleys between rows / columns of electrode elements. The combination of the continuous conductive structure and the filling structure provides superior conductivity over the “perimeter insulation” associated with conventional electrode assemblies, which provide conductivity only along the Z axis and not in the XY plane along which the array extends. Additionally, the filling structure 30 provides support to the device 10, potentially improving device performance. Omitting the filling structure could leave large gaps between the electrode elements, significantly weakening the device’s structural support and potentially resulting in imperfect contact between the electrodes and the skin, resulting in poor overall device conduction, and potentially hot spots. Furthermore, as discussed above, in embodiments in which the filling material is or includes a hydrocolloid, or in embodiments in which the filling material is or includes a drug, the electrode assembly can be moved (translated) after a treatment period so that the filling material is positioned to cover areas of the skin previously covered by the electrodes. This translation of the electrode assembly can provide pain relief and some healing to areas of skin that may have become inflamed due to the presence of the electrodes on the skin.Omission of the hydrocolloid or drug-containing filling structure eliminates the relief effect of the drug, but even when drug is used without a filling material, the uneven depth profile across the area of ​​the electrode assembly results in large gaps in the areas between the electrode elements, resulting in minimal or at least incomplete contact with the skin. How to use the device

[0054] 5, the method can include positioning at least first and second electrode assemblies 10a,b on a body of a subject. Each of the first and second electrode assemblies 10a,b can be a device 10 described herein. For example, each of the first and second electrode assemblies 10a,b can include an electrode layer 20 (FIGS. 1-2) having a plurality of electrode elements 22.

[0055] As described above and with reference to FIGS. 1-4 , each electrode element 22 of the plurality of electrode elements can have a skin-facing surface 24. The first and second electrode elements 22 a,b can be spaced apart within the electrode layer 20 along the first axis 12. The electrode layer 20 can further include at least one filling structure 30. The at least one filling structure 30 can include a first filling structure 30 a having a first filling portion 32 a located in a space 34 a between the first and second electrode elements. The at least one filling structure 30 can be configured to provide the electrode layer 20 with a substantially constant height along the first axis 12.

[0056] Each of the first and second electrode assemblies 10a,b may further include an anisotropic material layer 40 having an outward-facing surface 44 opposite a skin-facing surface 42. The upper adhesive layer 50 may include a conductive adhesive composite. The upper adhesive layer 50 may be disposed on the outer side 46 of the anisotropic material layer. The device 10 may include a skin-contacting structure 60 having an adhesive layer including the conductive adhesive composite. The skin-contacting structure 60 may be disposed on the inner (skin-facing side) 48 of the anisotropic material layer 40 or directly on the inner (skin-facing side) 42 of the anisotropic material layer 40. The skin-contacting structure 60 may be a single-layer adhesive (conductive adhesive composite), or the skin-contacting structure 60 may include multiple layers. For example, the skin-contacting structure 60 may include an outer adhesive layer 62, an inner adhesive layer 64, and a substrate 66 positioned between the outer adhesive layer 62 and the inner adhesive layer 64, as described above.

[0057] At least one electrode element 22 of the plurality of electrode elements can be in electrical contact with the outward facing surface 44 of the anisotropic material layer 40 .

[0058] The skin contact structure 60 of each of the first and second electrode assemblies 10a,b can contact the subject's skin 100. An alternating voltage can be applied between the first electrode assembly 10a and the second electrode assembly 10b, thereby generating an electric field.

[0059] The AC voltage between the first and second electrode assemblies 10a,b can be applied by an AC voltage generator 820. In some embodiments, the frequency of the AC voltage is between 50 kHz and 1 MHz, or between 100 kHz and 500 kHz. In the illustrated example, the AC voltage generator is controlled by a controller 822. The controller 822 can use the temperature measurements to control the amplitude of the current supplied through the first and second electrode assemblies 10a, 10b to maintain the temperature below a safety threshold (e.g., 41°C). This can be accomplished, for example, by measuring a first temperature of the first electrode element and a second temperature of the second electrode element, and controlling the application of the AC voltage based on the first and second temperatures, as described below.

[0060] FIG. 5 shows an example of hardware suitable for this purpose. More specifically, a temperature sensor 800 (e.g., a thermistor) is positioned in thermal contact with each electrode element (e.g., the dielectric 70 / metal layer 76) in each electrode assembly 10a, b. The temperature sensors 800 shown in FIG. 5 measure first and second temperatures (e.g., the temperature of the first electrode element in each of the first and second electrode assemblies), respectively. Typically, multiple temperature sensors 800 measure the temperature of each of the multiple electrode elements in each of the first and second electrode assemblies, and a controller 822 controls the output of an AC voltage generator 820 based on these temperatures. Exemplary Embodiments

[0061] In view of the described products, systems, methods, and variations thereof, more specific aspects of the present invention are described below. However, these specifically described aspects should not be construed as having any limiting effect on different claims containing different or more general teachings set forth herein, or as the "particular" aspects being limited in any way other than in the inherent meaning of the language literally used.

[0062] Aspect 1: An apparatus, comprising: a plurality of electrode elements, each of the plurality of electrode elements having a skin-facing surface; an electrode element, wherein at least first and second electrode elements are spaced apart within the electrode layer along a first axis; and an electrode layer including at least one filling structure, the at least one filling structure including a first filling structure having a first filling portion located in a space between the first electrode element and the second electrode element, the at least one filling structure configured to provide the electrode layer with a substantially constant height along a first axis; an upper adhesive layer comprising a conductive adhesive composite; a skin-contacting structure having an adhesive layer comprising a conductive adhesive composite; The skin-contacting structure is disposed inside the top adhesive and is configured to contact the subject's skin.

[0063] Embodiment 2: The device of embodiment 1, further comprising an anisotropic material layer having a skin-facing surface and an opposite outward-facing surface; an upper adhesive layer disposed on an outer side of the anisotropic material layer; the electrode layer is disposed on the outer side of the anisotropic material layer; At least one electrode element of the plurality of electrode elements is in electrical contact with an outwardly facing surface of the anisotropic material layer; The skin-contacting structure is disposed inside the anisotropic material layer and is configured to contact the skin of the subject.

[0064] Embodiment 3: The device of embodiment 2, wherein each electrode element of the plurality of electrode elements is in electrical contact with an outwardly facing surface of the anisotropic material layer.

[0065] Aspect 4: The device of any one of the preceding aspects, wherein each electrode element of the plurality of electrode elements: a dielectric layer having a skin-facing inner surface and an opposing outer surface; a metal layer having an inner surface and an opposite outer surface, the metal layer being disposed on the outer surface of the dielectric layer.

[0066] Embodiment 5: The device of embodiment 4, wherein the dielectric material is a ceramic material.

[0067] Embodiment 6: A device described in any one of the preceding embodiments, wherein the plurality of electrode elements further includes a third electrode element, the second electrode element being positioned between and spaced apart from the first electrode element and the third electrode element along the first axis, and the at least one filling structure further including a second filling portion positioned between the second electrode element and the third electrode element along the first axis.

[0068] Embodiment 7: A device described in any of the preceding embodiments, wherein the plurality of electrode elements includes at least two rows of electrode elements extending along a second axis perpendicular to the first axis or parallel to the second axis, the at least two rows of electrode elements including a first row of electrode elements including the first electrode elements and a second row of electrode elements including the second electrode elements, and the first filling portion is located between the first row of electrode elements and the second row of electrode elements along the first axis.

[0069] Embodiment 8: An apparatus as described in embodiment 6, wherein the plurality of electrode elements includes at least three rows of electrode elements extending along a second axis perpendicular to the first axis or parallel to the second axis, the at least three rows of electrode elements including a first row of electrode elements including the first electrode elements, a second row of electrode elements including the second electrode elements, and a third row of electrode elements including the third electrode elements, wherein the first filling portion is located between the electrode elements of the first row and the electrode elements of the second row, and the second filling portion is located between the electrode elements of the second row and the electrode elements of the third row.

[0070] Embodiment 9: The device of embodiment 7 or embodiment 8, wherein each row of electrode elements comprises three electrode elements.

[0071] Embodiment 10: The device of any of the preceding embodiments, wherein the upper adhesive layer and the skin-contacting structure do not comprise a hydrogel.

[0072] Embodiment 11: A device described in any one of embodiments 2 to 10, wherein the anisotropic material layer has a first thermal conductivity in a direction perpendicular to the plane of the layer, and the thermal conductivity of the layer in a direction parallel to the plane of the layer is at least twice the first thermal conductivity.

[0073] Embodiment 12: A device described in any one of embodiments 2 to 11, wherein the anisotropic material layer has a first resistance in a direction perpendicular to the plane of the layer, and the resistance of the layer in a direction parallel to the plane of the layer is less than half of the first resistance.

[0074] Embodiment 13: The device of any one of Embodiments 2-12, wherein the anisotropic material comprises synthetic graphite.

[0075] Embodiment 14: The device of any one of embodiments 2-13, wherein the anisotropic material layer is or includes a layer of pyrolytic graphite made from compressed high-purity exfoliated mineral graphite, a graphitized polymer film, or a graphite foil.

[0076] Embodiment 15: The device of any one of the preceding embodiments, wherein the skin-contacting structure comprises: an outer adhesive layer comprising a conductive adhesive composite; an inner skin-facing adhesive layer comprising a conductive adhesive composite; and a substrate positioned between the inner adhesive layer and the outer adhesive layer.

[0077] Embodiment 16: The device of embodiment 15, wherein the inner and outer adhesive layers of the skin-contacting structure do not comprise a hydrogel.

[0078] Embodiment 17: The device of embodiment 15 or embodiment 16, wherein the conductive adhesive composites of the inner adhesive layer and the outer adhesive layer of the skin-contacting structure each independently comprise: Dielectric material and and conductive particles dispersed within a dielectric material.

[0079] Embodiment 18: The device of any one of embodiments 15-17, wherein the substrate of the skin-contacting structure has a continuous, uninterrupted structure.

[0080] Embodiment 19: The device of embodiment 18, wherein the substrate of the skin-contacting structure is electrically conductive.

[0081] Embodiment 20: The device of any one of embodiments 15-19, wherein the substrate of the skin-contacting structure is a mesh or scrim layer.

[0082] Embodiment 21: The device of any one of the preceding embodiments, wherein the at least one filling structure is or comprises a foam, gel, or hydrocolloid.

[0083] Embodiment 22: The device of any one of the preceding embodiments, wherein the first filler portion has a shape complementary to the shape of the space between the first electrode element and the second electrode element.

[0084] Embodiment 23: A device described in any one of embodiments 6 to 22, wherein the first filling portion and / or the second filling portion is part of a strip of filling structural material that fills a gap between one or more rows of electrode elements or one or more columns of electrode elements.

[0085] Embodiment 24: An apparatus described in any one of embodiments 6 to 22, wherein the first filling portion and the second filling portion are part of a molded layer of a filling structural material that fills the gaps between all of the electrode elements, and have notches as void spaces to accommodate each electrode element among the multiple electrode elements.

[0086] Embodiment 25: The device of any one of the preceding embodiments, wherein the filler structure comprises a hydrocolloid.

[0087] Embodiment 26: The device of any one of the preceding embodiments, wherein the filling structure is or comprises a hydrocolloid or a hydrocolloid gel.

[0088] Embodiment 27: A device of any one of the preceding embodiments, wherein the filling structure comprises an agent.

[0089] Aspect 28: An apparatus, comprising: a plurality of electrode elements, each of the plurality of electrode elements having a skin-facing side and a skin-facing surface; At least first and second electrode elements are spaced apart within the electrode layer along a first axis; and an electrode layer including at least one filling structure, the at least one filling structure including a first filling structure having a first filling portion located in a space between the first electrode element and the second electrode element, the at least one filling structure being configured to provide the electrode layer with a substantially constant height along a first axis; a skin-contacting structure having an adhesive layer comprising a conductive adhesive composite or hydrogel; a skin-contacting structure disposed on a skin-facing side of the electrode element and configured to contact the subject's skin; The filling structure includes a foam, a gel, a hydrocolloid, or a hydrocolloid gel.

[0090] Embodiment 29: The device of any one of the preceding embodiments, wherein the filling structure comprises a hydrocolloid or a hydrocolloid gel.

[0091] Embodiment 30: A device according to any one of the preceding embodiments, wherein the loading structure is or comprises a drug.

[0092] Aspect 31: A method comprising: positioning at least the first and second devices of any one of the previous aspects on a body of a subject such that the skin-contacting structures contact the skin of the subject; applying an AC voltage between the first device and the second device to generate an electric field.

[0093] Although the present invention has been disclosed with reference to particular embodiments, numerous modifications, variations, and variations can be made to the described embodiments without departing from the scope and spirit of the invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described embodiments, but rather have the full scope defined by the following claims and equivalents thereof. [Explanation of symbols]

[0094] 10 equipment 10a First electrode assembly 10b Second electrode assembly 12 1st axis 20 electrode layer 22 Electrode Elements 22a 1st electrode element 22b Second electrode element 22c 3rd electrode element 24 Skin-facing surface and inner surface of electrode element 26a First row electrode element 26b Second row electrode element 26c Third row electrode element 30 Filling structure 30a 1st filling structure 32a 1st filling part 32b 2nd filling part 34a Space 34b space 36a 1st Strip 36b 2nd Strip 40 Anisotropic Material Layer 42 Skin-facing surface of anisotropic material layer 44 Outward facing surface of anisotropic material layer 46 Outside of anisotropic material layer 48 Skin-facing side of anisotropic material layer 50 Upper adhesive layer 60 Skin contact structure 62 Outer adhesive layer 64 Inner adhesive layer 66 Base material 70 dielectric material layer 72 Skin-facing inner surface of dielectric material 74 Outer surface of dielectric material 76 Metal layer 77 Inner surface of metal layer 78 Outer surface of metal layer 80 Self-adhesive backing 90 leads 100 skin 800 Temperature Sensor 820 AC voltage generator 822 Controller

Claims

1. 1. An apparatus comprising: a plurality of electrode elements, each of the plurality of electrode elements having a skin-facing surface; a plurality of electrode elements, at least first and second electrode elements being spaced apart within the electrode layer along a first axis; and an electrode layer including at least one filling structure having a first filling portion located in a space between the first electrode element and the second electrode element, the at least one filling structure configured to provide an electrode layer of a substantially constant height along a first axis; and an anisotropic material layer having a skin-facing surface and an opposite outward-facing surface; an upper adhesive layer including a conductive adhesive composite, the upper adhesive layer being disposed outside the anisotropic material layer; a skin-contacting structure having an adhesive layer comprising a conductive adhesive composite; the electrode layer is located outside the anisotropic material layer, and at least one electrode element of the plurality of electrode elements is in electrical contact with an outward surface of the anisotropic material layer; The skin-contacting structure is disposed inside the anisotropic material layer and configured to contact the skin of the subject.

2. The apparatus of claim 1 , wherein each electrode element of the plurality of electrode elements is in electrical contact with an outwardly facing surface of the anisotropic material layer.

3. Each electrode element of the plurality of electrode elements is a dielectric layer having a skin-facing inner surface and an opposing outer surface; 10. The apparatus of claim 1, further comprising: a metal layer having an inner surface and an opposite outer surface, said metal layer disposed on the outer surface of said dielectric layer.

4. The device of claim 3 , wherein the dielectric material is a ceramic material.

5. 2. The device of claim 1, wherein the plurality of electrode elements further includes a third electrode element, the second electrode element being located between the first and third electrode elements along the first axis and spaced apart from the first and third electrode elements along the first axis, and the at least one filling structure further includes a second filling portion located between the second and third electrode elements along the first axis.

6. 2. The device of claim 1, wherein the plurality of electrode elements includes at least two rows of electrode elements extending along a second axis perpendicular to or parallel to the first axis, the at least two rows of electrode elements including a first row of electrode elements including the first electrode elements and a second row of electrode elements including the second electrode elements, and the first filling portion is located between the first row of electrode elements and the second row of electrode elements along the first axis.

7. 6. The device of claim 5, wherein the plurality of electrode elements includes at least three rows of electrode elements extending along or parallel to a second axis perpendicular to the first axis, the at least three rows of electrode elements including a first row of electrode elements including the first electrode elements, a second row of electrode elements including the second electrode elements, and a third row of electrode elements including the third electrode elements, the first filler portion being located between the first row of electrode elements and the second row of electrode elements, and the second filler portion being located between the second row of electrode elements and the third row of electrode elements.

8. The device of claim 6 , wherein each row of electrode elements includes three electrode elements.

9. 2. The apparatus of claim 1, wherein the anisotropic material layer has a first thermal conductivity in a direction perpendicular to the plane of the layer, and the thermal conductivity of the layer in a direction parallel to the plane of the layer is at least twice the first thermal conductivity.

10. 10. The device of claim 1, wherein the anisotropic material layer has a first resistance in a direction perpendicular to the plane of the layer, and a resistance of the layer in a direction parallel to the plane of the layer is less than half of the first resistance.

11. The device of claim 1 , wherein the anisotropic material comprises synthetic graphite.

12. 10. The device of claim 1, wherein the anisotropic material layer is or includes a layer of pyrolytic graphite made from compressed high-purity exfoliated mineral graphite, a graphitized polymer film, or a graphite foil.

13. The skin-contacting structure comprises: an outer adhesive layer comprising a conductive adhesive composite; an inner skin-facing adhesive layer comprising a conductive adhesive composite; The device of claim 1 , comprising a substrate positioned between the inner adhesive layer and the outer adhesive layer.

14. The conductive adhesive composites of the inner adhesive layer and the outer adhesive layer of the skin-contacting structure each individually comprise: Dielectric material and and conductive particles dispersed within the dielectric material.

15. The device of claim 1 , wherein the at least one filling structure is or includes a foam, a gel, or a hydrocolloid.

16. The device of claim 1 , wherein the at least one filling structure comprises a drug.

17. The device of claim 1 , wherein the first filler portion has a shape complementary to a shape of a space between the first electrode element and the second electrode element.

18. 6. The device of claim 5, wherein the first filler portion and / or the second filler portion is part of a strip of filler structural material that fills the gap between one or more rows of electrode elements or between one or more columns of electrode elements.

19. 6. The device of claim 5, wherein the first and second filling portions are part of a molded layer of a filling structural material that fills gaps between all of the electrode elements and has cutouts as void spaces to accommodate each electrode element of the plurality of electrode elements.

20. 1. A method comprising: Positioning at least first and second electrode assemblies on the subject's body, each of the first and second electrode assemblies comprising: a plurality of electrode elements, each of the plurality of electrode elements having a skin-facing surface; an electrode element, wherein the at least first and second electrode elements are spaced apart within the electrode layer along a first axis; an electrode layer including at least one filling structure, the at least one filling structure including a first filling structure having a first filling portion located in a space between a first electrode element and a second electrode element, the at least one filling structure being configured to provide an electrode layer of a substantially constant height along the first axis; an anisotropic material layer having a skin-facing surface and an opposite outward-facing surface; an upper adhesive layer including a conductive adhesive composite, the upper adhesive layer being disposed outside the anisotropic material layer; a skin-contacting structure having an adhesive layer comprising a conductive adhesive composite; the electrode layer is located outside the anisotropic material layer, and at least one electrode element of the plurality of electrode elements is in electrical contact with an outward surface of the anisotropic material layer; the skin-contacting structure is disposed inside the anisotropic material layer; the skin-contacting structure contacting the skin of a subject; applying an alternating voltage between the first electrode assembly and the second electrode assembly, thereby generating an electric field.

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