Electrode assembly with filling structure between electrode elements

Abstract

An apparatus for providing a tumor treatment field includes an electrode layer having a plurality of electrode elements. The first electrode element and the second electrode element are spaced along a first axis within the electrode layer. The electrode layer has at least one filling structure having a first filling portion positioned within a space between the first electrode element and the second electrode element. The at least one fill structure is configured to provide a substantially uniform height for the electrode layer along the first axis. The device may also have an upper adhesive layer, a lower adhesive layer, and a layer of anisotropic material between the upper adhesive layer and the lower adhesive layer. The plurality of electrode elements may be in electrical contact with the outwardly facing surface of the anisotropic material layer.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority and filing date of U.S. Provisional Application No. 63 / 408,918, filed on September 22, 2022, the entire contents of which are incorporated herein by reference. Background Art

[0003] Tumor Treatment Field (TTField) therapy is a proven approach for treating tumors using alternating electric fields with frequencies between 50kHz and 1MHz (more commonly between 100KHz and 500KHz). In current commercial systems, the alternating electric fields are induced by electrode assemblies (e.g., arrays of capacitively coupled electrodes, also called 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 couples through the electrode assemblies and enters the subject's body. And higher currents are closely associated with higher therapeutic efficacy. Summary of the invention

[0004] In one aspect, a device having an electrode layer is disclosed herein. The electrode layer has a plurality of electrode elements, each of the plurality of electrode elements having a surface facing the skin. At least a first electrode element and a second electrode element are spaced apart along a first axis within the electrode layer. The electrode layer also has at least one filling structure. The at least one filling structure includes a first filling structure having a first filling portion positioned within 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 uniform height along the first axis. An anisotropic material layer has a surface facing the skin and an opposite outwardly facing surface. An upper adhesive layer includes a conductive adhesive composite. The upper adhesive layer is disposed on an outer side of the anisotropic material layer. A skin contact structure has an adhesive layer including a conductive adhesive composite. At least one electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the anisotropic material layer. The skin contact structure is disposed on an inner side of the anisotropic material layer and is configured to contact the skin of a subject.

[0005] A method of using the device may include positioning at least a first electrode assembly and a second electrode assembly on a subject's body, each of the first electrode assembly and the second electrode assembly comprising an electrode layer. The electrode layer has a plurality of electrode elements, each of the plurality of electrode elements having a surface facing the skin. At least the first electrode element and the second electrode element are spaced apart along a first axis within the electrode layer. The electrode layer also has at least one filling structure. The at least one filling structure includes a first filling structure having a first filling portion positioned within 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 uniform height along the first axis. The anisotropic material layer has a surface facing the skin and an opposite outwardly facing surface. The upper adhesive layer includes a conductive adhesive composite. The upper adhesive layer is disposed on an outer side of the anisotropic material layer. A skin contact structure has an adhesive layer including a conductive adhesive composite. At least one electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the anisotropic material layer. The skin contact structure is disposed on an inner side of the anisotropic material layer and is configured to contact the subject's skin. The skin contact structure contacts the subject's skin. An alternating voltage is applied between the first electrode assembly and the second electrode assembly to generate an electric field. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 is a top plan view of an electrode assembly according to the present disclosure, with some layers shown as transparent to reveal underlying layers.

[0007] Figure 2 yes Figure 1 A cross-sectional view of an electrode assembly of FIG. 2 taken in plane 2-2'. Dimensions are not shown to scale.

[0008] Figure 3 yes Figure 2 Close-up detail of an exemplary electrode element shown in cross-section.

[0009] Figure 4 2 is a partial cross-sectional view of an exemplary electrode assembly according to embodiments disclosed herein, taken in plane 2 - 2 ′. Dimensions are not shown to scale.

[0010] Figure 5 is a schematic diagram of a system for providing a tumor treating field as disclosed herein.

[0011] Various embodiments are described in detail below with reference to the drawings, wherein like reference numerals denote like elements, and wherein description of like elements may not be repeated for each embodiment but may be considered the same if previously described herein. DETAILED DESCRIPTION

[0012] The present application describes exemplary electrode assemblies that can be used, for example, to deliver TTFields to a subject's body and treat one or more cancers or tumors located within the subject's body.

[0013] The present invention may be more readily understood by reference to the following detailed description, examples, drawings and claims and the descriptions preceding and following them. However, it should be understood that the present invention is not limited to the particular apparatus, devices, systems and / or methods disclosed unless otherwise indicated, and thus may of course vary.

[0014] The headings are provided for convenience only and should not be construed as limiting the invention in any way. Embodiments illustrated under any heading or in any section of the disclosure may be combined with embodiments illustrated under the same or any other heading or other section of the disclosure.

[0015] Any combination of the elements described herein in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[0016] As used in the 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 should be understood that disclosure of an element in a singular form can support embodiments providing only a single one of such elements as well as embodiments providing a plurality of such elements.

[0017] In the above and below descriptions, the terms "front", "inner", and "skin-facing" are used interchangeably, and all refer to the face or surface of the disclosed electrode assembly (or its components) that faces or is toward the subject's skin (or generally toward the subject's body) when used as disclosed herein. Similarly, the terms "rear", "upper", "outer", and "outwardly facing" are used interchangeably, and all refer to the face or surface of the disclosed electrode assembly (or its components) that faces or is toward the subject's skin (or generally toward the subject's body) when used as disclosed herein. For example, the "inner face" may face the subject's skin, and the "outer face" may face away from the subject's skin.

[0018] Equipment structure and construction

[0019] refer to Figures 1 to 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., 22a to 22c). Each electrode element 22 of the plurality of electrode elements may have a skin-facing surface 24. The first electrode element 22a and the second electrode element 22b may be spaced apart along the first axis 12 within the electrode layer 20. The electrode layer 20 may also include at least one filling structure 30. The at least one filling structure 30 may include a first filling structure 30a having a first filling portion 32a positioned within a space 34a between the first electrode element 22a and the second electrode element 22b. The at least one filling structure 30 may be configured to provide the electrode layer 20 with a substantially uniform height along the first axis 12.

[0020] In some optional aspects, the device 10 may further include an anisotropic material layer 40 having a skin-facing surface 42 and an opposite, outwardly facing surface 44 ( Figure 2 ). 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. In some embodiments, the upper adhesive layer 50 is disposed on the outer side surface 44 of the anisotropic material layer. The device 10 may also include a skin contact structure 60 having at least one adhesive layer including a conductive adhesive composite. The skin contact structure may have an inner (skin-facing) surface 61 and an outer side surface 63. The skin contact structure 60 may be disposed on the inner (skin-facing) side 48 of the anisotropic material layer 40 and may be configured to contact the subject's skin 100. In some embodiments, the skin contact structure 60 may be disposed on the inner (skin-facing) surface 42 of the anisotropic material layer 40 and is configured to contact the subject's skin 100. In some aspects, the electrode layer 20 may be located on the outer side 46 of the anisotropic material layer.

[0021] In other embodiments, device 10 may be free of an anisotropic material layer (i.e., device 10 does not include an anisotropic material layer). In these aspects, upper adhesive layer 50 may be disposed on the outside of skin contact structure 60, or may not be present in the case where the skin contact structure may be disposed on the inside of the electrode layer. Thus, the skin contact structure may be disposed on the inside of the upper adhesive.

[0022] At least one electrode element 22 of the plurality of electrode elements is in electrical contact with the outwardly facing surface 44 of the anisotropic material layer 40 .

[0023] In some aspects, at least one electrode element 22 of the plurality of electrode elements is in electrical contact with an outwardly facing surface 44 of anisotropic material layer 40. Thus, anisotropic material layer 40 can extend continuously across the region where each of the plurality of electrode elements is positioned.

[0024] In some optional aspects, each electrode element 22 of the plurality of electrode elements may include a layer of dielectric material 70 having an inner side 72 facing the skin and an opposite outer side 74 ( Figure 3 ). In these aspects, the inner face 72 of the dielectric material 70 facing the skin can define the inner surface 24 of the electrode element 22. Each electrode element 22 can also include a metal layer 76 having an inner face 77 and an opposite outer face 78. The metal layer 76 can be disposed on the outer face 74 of the layer of dielectric material 70.

[0025] In some optional aspects, the dielectric material 70 may include a ceramic material. In other aspects, the dielectric material 70 may include a high dielectric polymer. In exemplary aspects, the dielectric material 70 may have a dielectric constant in the range of 10 to 50,000. In some embodiments, the layer of dielectric material 70 includes a high dielectric polymer material, such as poly(difluoroethylene-trifluoroethylene-chlorotrifluoroethylene) and / or poly(difluoroethylene-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 the dielectric constants of these materials are about 40. In some embodiments, the polymer layer may be poly(difluoroethylene-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or "poly(VDF-TrFE-CTFE-CFE)". In some embodiments, the layer of dielectric material 70 includes a terpolymer comprising 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 mol % to 80 mol % VDF, 5 mol % to 60 mol % TrFE, with CFE and / or CTFE making up the balance of the mol % of the terpolymer.

[0026] In an alternative aspect, electrode element 22 does not include a dielectric material.

[0027] The plurality of electrode elements 22 may optionally include a third electrode element 22c. The second electrode element 22b may be positioned between the first electrode element 22a and the third electrode element 22c along the first axis 12 and spaced apart from the first electrode element and the third electrode element. At least one filling structure 30 may also include a second filling portion 32b positioned 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 a second filling portion 32b positioned within a space 34b between the second electrode element 22b and the third electrode element 22c. In other aspects, a second filling structure (not shown) that is not integrally formed with the first filling structure 30a may be positioned within the space 34b.

[0028] In some optional aspects, the plurality of electrode elements 22 may include at least two rows 26 of electrode elements extending along or parallel to a second axis 14 perpendicular to the first axis 12. The at least two rows of electrode elements may include: a first row 26a of electrode elements 22 including first electrode elements 22a and a second row 26b of electrode elements including second electrode elements 22b. The first filling portion 32a may be positioned between the first row 26a of electrode elements 22 and the second row 26b of electrode elements 22, for example, positioned between electrode elements 22a and electrode elements 22b along the first axis 12. Optionally, the plurality of electrode elements 22 may be arranged in exactly two rows 26, for example, as shown by isolated rows 26a and 26b.

[0029] In further optional aspects, the plurality of electrode elements 22 may include at least three rows 26 (optionally, exactly three rows) of electrode elements 22 extending along or parallel to a second axis 14 perpendicular to the first axis 12. The at least three rows 26 of electrode elements 22 may include: a first row 26a of electrode elements including first electrode elements 22a, a second row 26b of electrode elements including second electrode elements 22b, and a third row 26c of electrode elements including third electrode elements 22c. The first filling portion 32a may be positioned between the first row 26a of electrode elements 22 and the second row 26b of electrode elements 22, for example, between the electrode elements 22a and the electrode elements 22b along the first axis 12. The second filling portion 32b may be positioned between the second row 26b of electrode elements 22 and the third row 26c of electrode elements 22, for example, between the electrode elements 22b and the electrode elements 22c along the first axis 12.

[0030] In various exemplary aspects, each row 26 of electrode elements 22 can include three electrode elements 22. In other aspects, 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.

[0031] In some aspects, at least one filling structure 30 may include foam. In some aspects, at least one filling structure 30 may include any polymeric material, including rubber polymers, elastomers, thermoplastic polymers, and thermosetting polymers. In some aspects, at least one filling structure 30 may include a hydrocolloid. In some aspects, at least one filling structure 30 may include a gel. Optionally, in these aspects, at least one filling structure 30 may include a hydrocolloid gel. In various optional aspects, the filling structure may be or may include a drug.

[0032] The filling structure 30 can serve as a drug substrate, and the drug substrate may be able to receive, absorb or maintain at least one of the topical drugs applied thereto. Therefore, the filling structure 30 may include a topical drug integrated in or on the filling structure. The topical drug may include a base component of oil, water, vaseline, wax, cellulose or a combination thereof. The topical drug may be a cream, an ointment, an emulsion, a gel, a wax, a paste or a mineral oil jelly. The topical drug may include at least one of an antibiotic, a steroid, an antiseptic, an emollient, an anesthetic, a terpene, a plant extract, a silicon-based organic polymer, an antifungal agent, a burn relief agent, a skin repair agent, a astringent or an antihistamine. For example, the topical drug may be a steroid or a corticosteroid, or may be a topical drug such as hydrocortisone or betamethasone. The topical drug may be or may include a skin repair agent, which may include a hydrocolloid material. The topical drug may be any desired compound that can soothe, heal and / or relieve inflammation, ulcers or other irritations that may occur on the body skin of the subject. The external drug may be substantially uniformly distributed throughout the thickness of the drug substrate, or alternatively, the external drug may be substantially disposed on the surface of the drug substrate.

[0033] When the filling structure is or includes a hydrocolloid layer, the hydrocolloid layer can be used as an external medicament. The hydrocolloid layer can be a gel, or it can include any suitable material or material that thickens when contacting a wound (e.g., based on absorbing liquids or secretions from damaged or injured skin). The hydrocolloid layer can include any suitable material that can become a gel or gel-like material (e.g., a hydrocolloid gel) when 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), carboxymethyl cellulose (e.g., sodium carboxymethyl cellulose), and / or any other suitable material.

[0034] The hydrocolloid layer may or may not include adhesive and / or may or may not have adhesive properties. The hydrocolloid layer may include an adhesive layer similar to, for example, an adhesive layer disclosed herein. The hydrocolloid layer may serve as an adhesive (e.g., having adhesive properties). For example, the hydrocolloid layer neither includes adhesive nor exhibits adhesive properties.

[0035] The medication may provide relief to the patient's skin to counteract the irritation caused by the device 10. For example, for embodiments where the filler material is or includes a hydrocolloid or embodiments where the filler material is or includes a medication, the electrode assembly may be moved (translationally moved) after a period of treatment such that the filler material now occupies a position where it covers the skin area that was previously covered by the electrode. Such translational movement of the electrode assembly is performed with the goal of providing relief and some degree of healing to the skin area that may have been subjected to skin irritation due to the presence of the electrodes on the skin.

[0036] In some aspects, the combined surface area of ​​at least one filling structure 30 and the plurality of electrode elements 22 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 aspects, the combined surface area of ​​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.

[0037] In various aspects, at least one filling structure 30 or a portion thereof may be complementary to the shape of the electrode element. In some optional aspects, the first filling portion and the second filling portion are part of a filling structure material forming layer that fills the gaps between all electrode elements in the electrode element, having openings 35 as void spaces to accommodate corresponding electrode elements in a plurality of electrode elements. For example, in some optional aspects, at least one filling structure 30 may be a single filling structure that is a single continuous structure that defines a plurality of openings to accommodate each electrode element in a plurality of electrode elements, respectively. The openings 35 may be complementary to the shape of the electrode element. It is also conceivable that at least one filling structure 30 may be shaped to occupy all gaps between electrode elements arranged in any manner (not just in rows and columns), whether as a single filling structure or as a combination of multiple accessory filling portions.

[0038] In other aspects, 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 (eg, 32a and 32b).

[0039] In some aspects, the first filling 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.

[0040] In some optional aspects, the first filler portion 32a and / or the second filler portion 32b can be part of a strip of filler structural material that fills the gaps between one or more rows 26 of electrode elements or one or more columns 28 of electrode elements 22. For example, the first filler material strip 36a can extend between the first row 26a of electrode elements 22 and the second row 26b of electrode elements 22, and the second filler material strip 36b can extend between the second row 26b of electrode elements 22 and the third row 26c of electrode elements 22.

[0041] In further optional aspects, the filling structure 30 may include openings 38 (e.g. Figure 1), to improve the flexibility and air permeability of the device 10. For example, the openings 38 may include a single continuous opening or multiple openings positioned along an axis extending between the electrode elements 22 to improve the flexibility between the electrode elements. In some aspects, the openings 38 may include a plurality of spaced openings extending along an axis positioned between each column 28 of electrode elements 22 or between each row 26 of electrode elements 22. In some aspects, the openings 38 may include continuous openings that extend continuously through multiple electrodes (e.g., along an entire row 26 of electrode elements or along an entire column 28 of electrode elements). Optionally, the openings 38 may include multiple openings between consecutive rows 26 of electrodes.

[0042] As discussed above, the upper adhesive layer 50 may be disposed on the outer side 46 or the outer side surface 44 of the anisotropic material layer. In some aspects, the upper adhesive layer 50 does not include a hydrogel. For example, the upper adhesive layer 50 may include a conductive adhesive composite as further disclosed herein. The conductive adhesive composite of the upper adhesive layer 50 may include a dielectric material and conductive particles dispersed in the dielectric material. Suitable dielectric materials include acrylic polymers and silicone polymers; and suitable conductive particles include carbon flakes, carbon particles, carbon fibers, carbon black powder, graphite powder, carbon nanotubes or carbon nanowires, etc. For example, the upper adhesive layer 50 may include carbon black. In an exemplary aspect, the upper adhesive layer 50 may be an adhesive provided by ADHESIVE RESEARCH, such as manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). 8006 conductive adhesive composite. In other optional aspects, the upper adhesive layer 50 may include carbon fibers or carbon nanowires. For example, in an exemplary aspect, the upper adhesive layer 50 may include a dry carbon / salt adhesive, such as a product developed by FLEXcon (Spencer, MA, USA). OMNI-WAVE™ TT200BLACK H-502150POLY H-944PP-8 or other such OMNI-WAWE products from FLEXcon. In various aspects, the thickness of the upper adhesive layer 50 can be from about 25 μm to about 150 μm.

[0043] In some optional aspects, the skin contact structure 60 can be a single layer including a conductive adhesive composite. In some aspects, the conductive adhesive composite includes a dielectric material and conductive particles dispersed in the dielectric material, wherein suitable dielectric materials and suitable conductive particles are discussed above. In some aspects, the skin contact structure 60 may include an adhesive (e.g., an acrylic adhesive) containing carbon fibers or carbon nanowires. The skin contact structure 60 may include an adhesive (e.g., an acrylic adhesive) containing carbon black powder. In exemplary aspects, the thickness of the skin contact structure 60 may be about 25 μm to about 150 μm. For example, optionally, the thickness of the skin contact structure 60 may be about 50 μm. Although the conductive adhesive composite for the skin contact adhesive may have a composition similar to that of the conductive adhesive composite for the upper adhesive layer, or even the same composition, in any particular electrode assembly, they may be the same or different.

[0044] like Figure 4 As illustrated, in some optional aspects, the skin contact 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. Figure 2 Shown as a single component, but conceivable Figure 2 The skin contact structure 60 depicted in FIG. 1 may include a Figure 4 The inner adhesive layer and outer adhesive layer and substrate shown. The outer adhesive layer 62 can be arranged on the skin-facing side 48 of the anisotropic material layer 40. Optionally, the outer adhesive layer 62 of the skin contact structure 60 can be arranged on the skin-facing surface 42 of the anisotropic material layer. The inner adhesive layer 64 can be configured to contact the skin of the experimenter. In other aspects, the inner adhesive layer 64 can contact the skin of the experimenter.

[0045] In some aspects, the outer adhesive layer 62 and the inner adhesive layer 64 of the skin contact structure 60 do not include a hydrogel. For example, the outer adhesive layer 62 and the inner adhesive layer 64 of the skin contact structure 60 can include a conductive adhesive composite as further disclosed herein. The conductive adhesive composite of the outer adhesive layer 62 and the inner adhesive layer 64 of the skin contact structure 60 can include a dielectric material and conductive particles dispersed within the dielectric material, as discussed above.

[0046] Alternatively, it is contemplated that outer adhesive layer 62 and / or inner adhesive layer 64 may include a hydrogel.

[0047] In some optional aspects, the outer adhesive layer 62 and / or the inner adhesive layer 64 can include carbon black. For example, in an exemplary aspect, the outer adhesive layer 62 and the inner adhesive layer 64 can include an adhesive provided by ADHESIVE RESEARCH, such as manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). 8006 conductive adhesive composite. In other optional aspects, the outer adhesive layer 62 and / or the inner adhesive layer 64 may include carbon fibers or nanowires. For example, in an exemplary aspect, the outer adhesive layer 62 and / or the inner adhesive layer 64 may include a dry carbon / salt adhesive, such as a product developed by FLEXcon (Spencer, MA, USA). OMNI-WAVETM TT 200BLACK H-502150POLYH-944PP-8 or other such OMNI-WAWE products from FLEXcon.

[0048] In some optional aspects, the thickness of the outer adhesive layer 62 can be at least 40 μm (optionally, at least 45 μm or at least 50 μm). For example, the thickness range of the outer adhesive layer 62 can be about 40 μm to about 75 μm (for example, 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). In other optional aspects, the thickness of the inner adhesive layer 64 can be 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 range from about 40 μm to about 75 μm (e.g., optionally, from about 40 μm to about 70 μm, or from about 40 μm to about 65 μm, or from about 45 μm to about 75 μm, or from about 45 μm to about 70 μm, or from about 45 μm to about 65 μm, or from about 50 μm to about 75 μm, or from about 50 μm to about 70 μm, or from about 50 μm to about 65 μm). It has been found that excessive thickness (e.g., greater than 75 μm, or even greater than 65 μm in some embodiments) may leave residue after removal from a subject or patient. It has further been found that insufficient thickness (e.g., less than 25 μm in some embodiments) can cause these layers to break very easily.

[0049] In some embodiments, the substrate 66 ( Figure 4) can be conductive. In various optional aspects, the substrate 66 of the skin contact structure 60 can have a continuous, uninterrupted structure. In these aspects, it is contemplated that the substrate can be conductive, conducting electricity between the outer adhesive layer 62 and the inner adhesive layer 64 in a manner similar to a scanning electron microscope (SEM) tape.

[0050] In alternative aspects, the substrate 66 of the skin contact structure 60 can have an at least partially open structure that is configured to allow adhesive to flow between or among the inner adhesive layer 64 and the outer adhesive layer 62 of the skin contact structure. In this way, the adhesive can be conductive through the substrate 66. For example, in some aspects, the substrate 66 can include a mesh. Optionally, the density of the mesh can be from about 6 grams per square meter to about 8 grams per square meter. In other aspects, the substrate 66 can include a scrim.

[0051] In various optional aspects, the substrate 66 of the skin contacting structure 60 can include paper, any suitable polymer (eg, polyester, polyolefin, etc.), or fabric.

[0052] Optionally, the skin contacting structure 60 may be reusable.

[0053] In some optional aspects, the upper adhesive layer 50 does not include a hydrogel. In additional or alternative aspects, the skin contact structure 60 does not include a hydrogel. Thus, in some optional aspects, neither the upper adhesive layer 50 nor the skin contact structure 60 includes a hydrogel. In other aspects, the upper adhesive layer 50 or the skin contact structure 60, or both, may include a hydrogel.

[0054] In exemplary aspects, the conductive adhesive composite of any of these layers of the device may include a dielectric material and conductive particles dispersed in 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 contemplated that the conductive particles may be aligned in response to the application of an electric field so that the conductive particles undergo electrophoresis. In some aspects, the dielectric material of the conductive adhesive composite of each of the first electrode assembly and the second electrode assembly is a polymer adhesive. Optionally, in these aspects, the polymer adhesive may be an acrylic adhesive. In some aspects, the conductive particles may include carbon. Optionally, in these aspects, the conductive particles may include graphite powder. Additionally or alternatively, the conductive particles may include carbon flakes. Additionally or alternatively, the conductive particles may include carbon particles. Additionally or alternatively, the conductive particles may include carbon fibers. Additionally or alternatively, the conductive particles may include carbon nanotubes or carbon nanowires. Additionally or alternatively, the conductive particles may include carbon black powder. In further aspects, the conductive adhesive composite further includes a polar material (e.g., a polar salt). The polar salt may 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. Pat. No. 8,673,184 and U.S. Pat. No. 9,947,432, both of which are incorporated herein by reference for all purposes. In exemplary aspects, the conductive adhesive composite can be a dry carbon / salt adhesive, such as the OMNI-WAVE adhesive composite manufactured and sold by FLEXCON (Spencer, MA, USA).

[0055] In some aspects, 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 in a direction parallel to the plane of the anisotropic material layer 40 may be more than twice higher than the first thermal conductivity. For example, in some aspects, the thermal conductivity of the anisotropic material layer 40 in a direction parallel to the plane of the anisotropic material layer may be more than three times, more than four times, or more than five times higher than the first thermal conductivity. In some aspects, the thermal conductivity in the parallel direction is more than ten times higher than the first thermal conductivity. In various aspects, for example, the thermal conductivity of the anisotropic material layer 40 in a direction parallel to the plane of the anisotropic material layer may be 1.5 times, 2 times, 3 times, 5 times, 10 times, 20 times, 100 times, 200 times, or even more than 1,000 times the first thermal conductivity.

[0056] The anisotropic material layer 40 may have a first resistance in a direction perpendicular to the plane of the layer. In some optional aspects, 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 aspects, the resistance of the anisotropic material layer 40 in a direction parallel to the plane of the layer may be less than 10% of the first resistance. In exemplary aspects, the resistance of the anisotropic material layer 40 in a direction parallel to the plane of the layer may be less than 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5%, or even less than 0.1% of the first resistance.

[0057] In some optional aspects, the anisotropic material layer may include graphite. In some optional aspects, the graphite may include synthetic graphite. The anisotropic material layer may be or may include a pyrolytic graphite layer, a graphitized polymer film, or a graphite foil made from compressed high-purity exfoliated mineral graphite. Examples of suitable forms of graphite include synthetic graphite, such as pyrolytic graphite (including but not limited to pyrolytic graphite flakes (PGS), available from Panasonic Industry, Kadoma, Osaka, Japan); other forms of synthetic graphite, including but not limited to graphite foil made from compressed high-purity exfoliated mineral graphite (including but not limited to 2010A flexible graphite, which can be supplied by Mineral Seal Corp. in Tucson, Arizona, USA) or a graphitized polymer film, for example, a graphitized polyimide film (including but not limited to products supplied by Kaneka Corp. in Moka, Tochigi, Japan). In alternative embodiments, a conductive anisotropic material other than graphite can be used instead of graphite.

[0058] Multiple electrode elements 22 may be routed together (eg, using wires, traces on a flexible circuit, etc.) to a lead 90 ( Figure 4 ). Lead 90 can be connected from AC voltage generator 820 ( Figure 5 ) supplies AC voltage to the electrode elements to generate an AC voltage in the device 10 (e.g. Figure 5 10a and 10b) in the figure generates a TTField when fixed to the subject's body for treatment.

[0059] The device 10 may include a flexible self-adhesive backing 80 ( Figure 1 , Figure 2 and Figure 4), the flexible self-adhesive backing covers the outside of at least a portion (optionally all) of the anisotropic material layer 40. The flexible self-adhesive backing 80 can improve the adhesion between the device and the patient's skin and provide stability and support for the device 10. In a conventional electrode assembly, a single electrode element is closely attached to and contacts the patient's skin via a layer of conductive hydrogel. Alternating current can be applied to the patient's body through the patient's skin via the individual electrode elements, thereby inducing an electric field in the body. Traditionally, electrode elements include ceramic disks as dielectric layers, and these ceramic disks result in a raised profile at each of these electrodes (and an uneven depth profile across the entire area of ​​the electrode assembly). As disclosed herein, a continuous conductive structure provided by a conductive anisotropic material layer (such as a pyrolytic graphite sheet) can extend across multiple electrode elements (optionally, all of these electrode elements). In addition, the filling structure can make the surface of the continuous conductive structure flat, rather than forming ridges and valleys between rows / columns of electrode elements. The combination of the continuous conductive structure and the filling structure provides better conductivity than the "peripheral isolation" associated with conventional electrode assemblies, in which conductivity is only provided along the z-axis and not along the xy plane along which the array extends. In addition, the filling structure 30 can provide support for the device 10 to improve the performance of the device. Omitting the filling structure, thereby leaving larger gaps between the electrode elements, can significantly weaken the structural support of the device, which in turn can lead to poor contact between the electrodes and the skin, thereby reducing conductivity across the device and can cause hot spots. In addition, as discussed above, for embodiments in which the filling material is or includes a hydrocolloid or embodiments in which the filling material is or includes a drug, the electrode assembly can be moved (translationally moved) after a period of treatment so that the filling material now occupies a position so that it covers the skin area that was previously covered by the electrode. The purpose of performing such translational movement of the electrode assembly is to provide relief and a degree of healing to the skin area that may have suffered skin irritation due to the presence of the electrode on the skin. Omitting a fill structure including a hydrocolloid or drug will fail to provide drug relief, but even if a drug is utilized without a fill material, due to the uneven depth distribution across the area of ​​the electrode assembly, large gaps will exist in the areas between the electrode elements and contact with the skin will be minimal or at least incomplete.

[0060] How to use the device

[0061] Also refer to Figure 5 , a method may include positioning at least a first electrode assembly 10a and a second electrode assembly 10b on a subject's body. Each of the first electrode assembly 10a and the second electrode assembly 10b may be a device 10 as described herein. For example, each of the first electrode assembly 10a and the second electrode assembly 10b may include an electrode layer 20 ( Figure 1 to Figure 2).

[0062] As discussed above and with reference to Figures 1 to 4 , each electrode element 22 of the plurality of electrode elements may have a skin-facing surface 24. The first electrode element 22a and the second electrode element 22b may be spaced apart along the first axis 12 within the electrode layer 20. The electrode layer 20 may also include at least one filling structure 30. The at least one filling structure 30 may include a first filling structure 30a having a first filling portion 32a positioned within a space 34a between the first electrode element and the second electrode element. The at least one filling structure 30 may be configured to provide a substantially uniform height for the electrode layer 20 along the first axis 12.

[0063] The first electrode assembly 10a and the second electrode assembly 10b may also each include an anisotropic material layer 40 having a skin-facing surface 42 and an opposite outward-facing surface 44. An 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 contact structure 60 having an adhesive layer including a conductive adhesive composite. The skin contact structure 60 may be disposed on the inner (skin-facing) side 48 of the anisotropic material layer 40, or it may be disposed directly on the inner (skin-facing) surface 42 in the anisotropic material layer 40. The skin contact structure 60 may be a single layer of adhesive (conductive adhesive composite), or alternatively, the skin contact structure 60 may include multiple layers. For example, the skin contact 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 discussed above.

[0064] At least one electrode element 22 of the plurality of electrode elements is in electrical contact with the outwardly facing surface 44 of the anisotropic material layer 40 .

[0065] The skin contact structure 60 of each of the first electrode assembly 10a and the second electrode assembly 10b may contact the subject's skin 100. An alternating voltage may be applied between the first electrode assembly 10a and the second electrode assembly 10b, thereby generating an electric field.

[0066] The alternating voltage between the first electrode assembly 10a and the second electrode assembly 10b can be applied by an AC voltage generator 820. In some embodiments, the frequency of the alternating voltage is between 50kHz and 1MHz or between 100kHz and 500kHz. In the illustrated example, the AC voltage generator is controlled by a controller 822. The controller 822 can use temperature measurement to control the amplitude of the current delivered via the first electrode assembly 10a and the second electrode assembly 10b so as to maintain the temperature below a safe threshold (e.g., 41°C). This can be achieved, for example, by measuring a first temperature of the first electrode element, measuring a second temperature of the second electrode element, and controlling the application of the alternating voltage based on the first temperature and the second temperature, as described below.

[0067] Figure 5 An example of hardware suitable for this purpose is depicted in . More specifically, a temperature sensor 800 (e.g., a thermistor) is positioned in thermal contact with a corresponding electrode element (e.g., dielectric material 70 / metal layer 76) within each of the electrode assemblies 10a, 10b. Figure 5 The temperature sensor 800 shown measures a respective first temperature and a second temperature (e.g., at a first electrode element in each of the first electrode assembly and the second electrode assembly, respectively). Typically, a plurality of such temperature sensors 800 measure respective temperatures at a plurality of electrode elements in each of the first electrode assembly and the second electrode assembly, and the controller 822 controls the output of the AC voltage generator 820 based on these temperatures.

[0068] Exemplary Aspects

[0069] In view of the described products, systems and methods and variations thereof, certain more specifically described aspects of the invention are described below. However, these specifically described aspects should not be construed as having any limiting effect on any different claims containing different or more general teachings described herein, or that the "particular" aspects are limited in some manner other than by the inherent meaning of the language literally used therein.

[0070] Aspect 1: A device, comprising:

[0071] An electrode layer, the electrode layer comprising:

[0072] a plurality of electrode elements, each electrode element of the plurality of electrode elements having a skin-facing surface, wherein at least a first electrode element and a second electrode element are spaced apart within the electrode layer along a first axis; and

[0073] at least one filling structure, wherein the at least one filling structure includes a first filling structure having a first filling portion positioned within a space between the first electrode element and the second electrode element, wherein the at least one filling structure is configured to provide a substantially uniform height for the electrode layer along the first axis;

[0074] an upper adhesive layer comprising a conductive adhesive composite; and

[0075] a skin contact structure having an adhesive layer comprising a conductive adhesive composite,

[0076] Wherein the skin contact structure is disposed on an inner side of the upper adhesive and is configured to contact the skin of a subject.

[0077] Aspect 2: The device according to aspect 1, further comprising an anisotropic material layer, the anisotropic material layer having a skin-facing surface and an opposite outward-facing surface,

[0078] wherein the upper adhesive layer is disposed on the outer side of the anisotropic material layer,

[0079] wherein the electrode layer is located on the outer side of the anisotropic material layer,

[0080] wherein at least one electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the anisotropic material layer, and

[0081] The skin contact structure is disposed on an inner side of the anisotropic material layer and is configured to contact the skin of a subject.

[0082] Aspect 3: The apparatus of aspect 2, wherein each electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the anisotropic material layer.

[0083] Aspect 4: The apparatus according to any one of the preceding aspects, wherein each electrode element of the plurality of electrode elements comprises:

[0084] a layer of dielectric material having an inner side facing the skin and an opposing outer side; and

[0085] A metal layer has an inner face and an opposite outer face, wherein the metal layer is disposed on the outer face of the layer of dielectric material.

[0086] Aspect 5: The apparatus of aspect 4, wherein the dielectric material is a ceramic material.

[0087] Aspect 6: An apparatus according to any one of the preceding aspects, wherein the plurality of electrode elements further comprises a third electrode element, wherein the second electrode element is positioned along the first axis between the first electrode element and the third electrode element and separated from the first electrode element and the third electrode element, and wherein the at least one filling structure further comprises a second filling portion, the second filling portion being positioned along the first axis between the second electrode element and the third electrode element.

[0088] Aspect 7: An apparatus according to any one of the preceding aspects, wherein the plurality of electrode elements include at least two rows of electrode elements extending along or parallel to a second axis perpendicular to the first axis, wherein the at least two rows of electrode elements include: a first row of electrode elements including the first electrode elements and a second row of electrode elements including the second electrode elements, wherein the first filling portion is positioned along the first axis between the first row of electrode elements and the second row of electrode elements.

[0089] Aspect 8: An apparatus according to Aspect 6, wherein the plurality of electrode elements include at least three rows of electrode elements extending along or parallel to a second axis perpendicular to the first axis, wherein the at least three rows of electrode elements include: 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 positioned between the first row of electrode elements and the second row of electrode elements, and wherein the second filling portion is positioned between the second row of electrode elements and the third row of electrode elements.

[0090] Aspect 9: The apparatus according to aspect 7 or aspect 8, wherein each row of electrode elements comprises three electrode elements.

[0091] Aspect 10: The device of any of the preceding aspects, wherein neither the upper adhesive layer nor the skin contact structure comprises a hydrogel.

[0092] Aspect 11: A device according to any one of Aspects 2 to 10, wherein the anisotropic material layer has a first thermal conductivity in a direction perpendicular to the plane of the layer, and wherein the thermal conductivity of the layer in a direction parallel to the plane of the layer is more than twice higher than the first thermal conductivity.

[0093] Aspect 12: A device according to any one of Aspects 2 to 11, wherein the anisotropic material layer has a first resistance in a direction perpendicular to the plane of the layer, and wherein the resistance of the layer in a direction parallel to the plane of the layer is less than half of the first resistance.

[0094] Aspect 13: The apparatus of any one of Aspects 2 to 12, wherein the anisotropic material comprises synthetic graphite.

[0095] Aspect 14: The apparatus according to aspects 2 to 13, wherein the anisotropic material layer is or includes a pyrolytic graphite layer, a graphitized polymer film, or a graphite foil made of compressed high-purity exfoliated mineral graphite.

[0096] Aspect 15: The device according to any one of the preceding aspects, wherein the skin contact structure comprises:

[0097] an outer adhesive layer, the outer adhesive layer comprising a conductive adhesive composite;

[0098] an inner skin-facing adhesive layer, the inner skin-facing adhesive layer comprising a conductive adhesive composite; and

[0099] A substrate is positioned between the inner and outer adhesive layers.

[0100] Aspect 16: The device of aspect 15, wherein the inner and outer adhesive layers of the skin contact structure do not include a hydrogel.

[0101] Aspect 17: The device according to aspect 15 or aspect 16, wherein the conductive adhesive composite of the inner adhesive layer and the outer adhesive layer of the skin contact structure each independently comprises:

[0102] Dielectric materials; and

[0103] Conductive particles are dispersed within the dielectric material.

[0104] Aspect 18: The device of any one of aspects 15 to 17, wherein the substrate of the skin contact structure has a continuous, uninterrupted structure.

[0105] Aspect 19: The device of aspect 18, wherein the substrate of the skin contact structure is electrically conductive.

[0106] Aspect 20: The device according to any one of aspects 15 to 19, wherein the substrate of the skin contact structure is a mesh layer or a scrim layer.

[0107] Aspect 21: The device according to any of the preceding aspects, wherein the at least one filling structure is or includes a foam, a gel or a hydrocolloid.

[0108] Aspect 22: The apparatus according to any one of the preceding aspects, wherein the first filling portion has a shape complementary to a shape of the space between the first electrode element and the second electrode element.

[0109] Aspect 23: The apparatus according to any one of aspects 6 to 22, wherein the first filling portion and / or the second filling portion is a portion of a filling structure material band that fills gaps between one or more rows of electrode elements or one or more columns of electrode elements.

[0110] Aspect 24: An apparatus according to any one of Aspects 6 to 22, wherein the first filling portion and the second filling portion are part of a filling structural material forming layer that fills the gaps between all electrode elements in the electrode elements, and have openings that serve as void spaces for accommodating corresponding electrode elements in the multiple electrode elements.

[0111] Aspect 25: The device of any of the preceding aspects, wherein the filling structure comprises a hydrocolloid.

[0112] Aspect 26: The device according to any of the preceding aspects, wherein the filling structure is or includes a hydrocolloid or a hydrocolloid gel.

[0113] Aspect 27: The device according to any of the preceding aspects, wherein the filling structure includes a drug.

[0114] Aspect 28: A device, comprising:

[0115] An electrode layer, the electrode layer comprising:

[0116] a plurality of electrode elements, each electrode element of the plurality of electrode elements having a skin-facing side and a skin-facing surface, wherein at least a first electrode element and a second electrode element are spaced apart within the electrode layer along a first axis; and

[0117] at least one filling structure, wherein the at least one filling structure includes a first filling structure having a first filling portion positioned within a space between the first electrode element and the second electrode element, wherein the at least one filling structure is configured to provide a substantially uniform height for the electrode layer along the first axis;

[0118] a skin contact structure having an adhesive layer comprising a conductive adhesive composite or a hydrogel,

[0119] wherein the skin contact structure is disposed on the skin-facing side of the electrode element and is configured to contact the skin of a subject; and

[0120] The filling structure comprises foam, gel, hydrocolloid or hydrocolloid gel.

[0121] Aspect 29: The device according to any of the preceding aspects, wherein the filling structure comprises a hydrocolloid or a hydrocolloid gel.

[0122] Aspect 30: The device according to any of the preceding aspects, wherein the filling structure is or includes a drug.

[0123] Aspect 31: A method, comprising:

[0124] positioning at least a first device and a second device according to any one of the preceding aspects on a body of a subject such that the skin contact structure contacts the skin of the subject; and

[0125] An alternating voltage is applied between the first device and the second device, thereby generating an electric field.

[0126] Although the present invention has been disclosed with reference to certain embodiments, various modifications, changes and variations may be made to the described embodiments without departing from the field and scope of the invention as defined in the appended claims. Therefore, it is intended that the present invention not be limited to the described embodiments, but rather has the full scope defined by the language of the appended claims and their equivalents.

Claims

1. A device, comprising: An electrode layer, the electrode layer comprising: a plurality of electrode elements, each electrode element of the plurality of electrode elements having a skin-facing surface, wherein at least a first electrode element and a second electrode element are spaced apart within the electrode layer along a first axis; and at least one filling structure, wherein the at least one filling structure includes a first filling structure having a first filling portion positioned within a space between the first electrode element and the second electrode element, wherein the at least one filling structure is configured to provide a substantially uniform height for the electrode layer along the first axis; a layer of anisotropic material having a skin-facing surface and an opposite, outward-facing surface; an upper adhesive layer, the upper adhesive layer comprising a conductive adhesive composite, wherein the upper adhesive layer is disposed on an outer side of the anisotropic material layer; and a skin contact structure having an adhesive layer comprising a conductive adhesive composite, wherein the electrode layer is located on the outer side of the anisotropic material layer, and wherein at least one electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the anisotropic material layer, and The skin contact structure is disposed on an inner side of the anisotropic material layer and is configured to contact the skin of a subject. 2 . The apparatus of claim 1 , wherein each electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the anisotropic material layer.

3. The apparatus of claim 1 , wherein each of the plurality of electrode elements comprises: a layer of dielectric material having an inner side facing the skin and an opposing outer side; and A metal layer has an inner face and an opposite outer face, wherein the metal layer is disposed on the outer face of the layer of dielectric material. The apparatus of claim 3 , wherein the dielectric material is a ceramic material.

5. The apparatus of claim 1 , wherein the plurality of electrode elements further comprises a third electrode element, wherein the second electrode element is positioned between the first electrode element and the third electrode element along the first axis and is separated from the first electrode element and the third electrode element, and wherein the at least one filling structure further comprises a second filling portion, the second filling portion being positioned between the second electrode element and the third electrode element along the first axis.

6. The apparatus of claim 1 , wherein the plurality of electrode elements comprises at least two rows of electrode elements extending along or parallel to a second axis perpendicular to the first axis, wherein the at least two rows of electrode elements comprise: A first row of electrode elements includes the first electrode elements and a second row of electrode elements includes the second electrode elements, wherein the first filling portion is positioned along the first axis between the first row of electrode elements and the second row of electrode elements.

7. The apparatus of claim 5, wherein the plurality of electrode elements comprises at least three rows of electrode elements extending along or parallel to a second axis perpendicular to the first axis, wherein the at least three rows of electrode elements comprise: 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 positioned between the first row of electrode elements and the second row of electrode elements, and wherein the second filling portion is positioned between the second row of electrode elements and the third row of electrode elements.

8. The apparatus of claim 6, wherein each row of electrode elements comprises three electrode elements.

9. The apparatus of claim 1, wherein the layer of anisotropic material has a first thermal conductivity in a direction perpendicular to a plane of the layer, and wherein the thermal conductivity of the layer in a direction parallel to the plane of the layer is more than two times higher than the first thermal conductivity.

10. The device of claim 1, wherein the layer of anisotropic material has a first resistance in a direction perpendicular to a plane of the layer, and wherein 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 apparatus of claim 1 , wherein the anisotropic material comprises synthetic graphite.

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

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

14. The device of claim 13, wherein the conductive adhesive composite of the inner adhesive layer and the outer adhesive layer of the skin contact structure each independently comprises: Dielectric materials; and Conductive particles are 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 apparatus according to claim 1 , wherein the first filling portion has a shape complementary to a shape of the space between the first electrode element and the second electrode element.

18. The device according to claim 5, wherein the first filling portion and / or the second filling portion is a portion of a strip of filling structural material filling a gap between one or more rows of electrode elements or one or more columns of electrode elements.

19. The apparatus according to claim 5, wherein the first filling portion and the second filling portion are part of a filling structure material forming layer that fills the gaps between all of the electrode elements, and has openings that serve as void spaces for accommodating corresponding electrode elements of the plurality of electrode elements.

20. A method comprising: Positioning at least a first electrode assembly and a second electrode assembly on a body of a subject, each of the first electrode assembly and the second electrode assembly comprising: An electrode layer, the electrode layer comprising: a plurality of electrode elements, each electrode element of the plurality of electrode elements having a skin-facing surface, wherein at least a first electrode element and a second electrode element are spaced apart within the electrode layer along a first axis; and at least one filling structure, wherein the at least one filling structure includes a first filling structure having a first filling portion positioned within a space between the first electrode element and the second electrode element, wherein the at least one filling structure is configured to provide a substantially uniform height for the electrode layer along the first axis; a layer of anisotropic material having a skin-facing surface and an opposite, outward-facing surface; an upper adhesive layer, the upper adhesive layer comprising a conductive adhesive composite, wherein the upper adhesive layer is disposed on an outer side of the anisotropic material layer; and a skin contact structure having an adhesive layer including a conductive adhesive composite; wherein the electrode layer is located on the outer side of the anisotropic material layer, and at least one electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the anisotropic material layer, wherein the skin contact structure is disposed on the inner side of the anisotropic material layer, and wherein the skin-contact structure contacts the subject's skin; and An alternating voltage is applied between the first electrode assembly and the second electrode assembly to generate an electric field.

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