Device comprising dielectric layer coupled with anisotropic layer

Abstract

A device having an outer adhesive layer comprising a conductive gel or conductive adhesive, at least one layer of anisotropic material, a layer of dielectric material, and a skin contact layer comprising a conductive gel or conductive adhesive. The at least one layer of anisotropic material and the layer of dielectric material are located between the outer adhesive layer and the skin-contacting layer. The dielectric material layer is in contact with at least a first layer of the at least one anisotropic material layer to form a capacitive structure.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority and filing date of U.S. Provisional Patent Application No. 63 / 356,228, filed on June 28, 2022, the entire contents of which are hereby incorporated by reference. Technical Field

[0003] The present application relates to a device for providing a tumor treatment field, the device having at least one layer of anisotropic material and a layer of dielectric material in contact with the anisotropic material. Background Art

[0004] Tumor treating field (TT field) therapy is a proven method of treating tumors using alternating electric fields with frequencies between 50kHz and 1MHz (more commonly 100-500KHz). The alternating electric fields are induced by electrode assemblies (e.g., capacitively coupled electrode arrays, also called transducer arrays) placed on opposite sides of a target location in the subject's body. When an AC voltage is applied between the opposing electrode assemblies, an AC current is coupled through the electrode assemblies and into the subject's body. Summary of the invention

[0005] In one aspect, a device is disclosed herein having an outer adhesive layer comprising a conductive gel or conductive adhesive, at least one anisotropic material layer, a dielectric material layer, and a skin contact layer comprising a conductive gel or conductive adhesive. The at least one anisotropic material layer and the dielectric material layer are located between the outer adhesive layer and the skin contact layer. The dielectric material layer contacts at least a first layer of the at least one anisotropic material layer to form a capacitive structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 is a cross-sectional view of a known electrode assembly for providing a TT field.

[0007] Figure 2 is a schematic top view of an exemplary apparatus as disclosed herein.

[0008] Figure 3 It is taken along line A-A' Figure 2 An exemplary cross-sectional view of a device.

[0009] Figure 4 It is taken along line A-A' Figure 2 Another exemplary cross-sectional view of a device.

[0010] Figure 5 It is taken along line A-A' Figure 2 Another exemplary cross-sectional view of a device.

[0011] Figure 6 is a schematic top view of an exemplary apparatus as disclosed herein.

[0012] Figure 7 is a cross-sectional view of an exemplary device as disclosed herein.

[0013] Figure 8 is a block diagram of a system using an apparatus as disclosed herein.

[0014] Various embodiments are described in detail below with reference to the drawings, wherein like reference numerals refer to like elements. DETAILED DESCRIPTION

[0015] The present application describes apparatus (eg, exemplary treatment assemblies) that can be used, for example, to deliver TT fields to a subject's body and treat one or more cancers or tumors located in the subject's body.

[0016] 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.

[0017] The headings are provided for convenience only and should not be construed as limiting the invention in any way. The embodiments shown under any heading or in any section of the disclosure may be combined with embodiments shown under the same or any other heading or other section of the disclosure.

[0018] 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.

[0019] Introduction

[0020] Figure 1 A conventional device for applying a TT field is depicted. As shown, the device may include a circuit board, a metal pad coupled to the circuit board, a ceramic disk located below the metal pad to serve as a dielectric material, and a skin contact layer including a hydrogel.

[0021] In the disclosed apparatus, system and method, the use of polymer film as the dielectric material layer ensures greater flexibility than traditional ceramic discs, so it fits the subject's skin better, but the high dielectric constant polymer film is fragile and is often pierced when adjacent to the metal pad and during the cutting process during array manufacturing. In addition, high dielectric polymers are expensive and require more cost-effective materials. The apparatus, system and method disclosed herein provide a certain degree of protection for the dielectric material layer. In addition, when providing a dielectric material coupled to the anisotropic material layer for the disclosed apparatus, system and method, the contact area with the capacitor layer can be the entire area of ​​the anisotropic material layer. The increase in the capacitor area means that the dielectric material does not need to have such a high dielectric constant, so a more cost-effective material can be used (for example, a cheaper polymer or metal oxide (such as Al2O3), which can be applied to the substrate by chemical vapor deposition (CVD) and has sufficient flexibility as a film).

[0022] equipment

[0023] References Figures 2 to 5 A device 10 is disclosed that includes an outer adhesive layer 20. The outer adhesive layer 20 may include a conductive gel or conductive adhesive 22. The device 10 may also include at least one anisotropic material layer 30, a dielectric material layer 40, and a skin contact layer 50. The skin contact layer 50 may include a conductive gel or conductive adhesive 52. In some aspects, the anisotropic material layer is a non-metallic anisotropic material layer.

[0024] At least one anisotropic material layer 30 and a dielectric material layer 40 may be located between the outer adhesive layer 20 and the skin contact layer 50. The dielectric material layer 40 may contact at least the first layer 30a of the at least one anisotropic material layer 30 to form a capacitive structure 12.

[0025] In some aspects, device 10 can include circuit board 60 (e.g., a printed circuit board (PCB) or a flexible circuit). Circuit board 60 can be electrically coupled to external adhesive layer 20. In some optional aspects, circuit board 60 can be electrically coupled to external adhesive layer 20 via one or more conductive elements (e.g., metal pads 70) that are in electrical contact with circuit board 60. Figure 2 , two metal pads 70 are shown, but additional electrode elements may be included in device 10. In alternative embodiments, device 10 includes only a single electrode element (eg, a single metal pad 70).

[0026] In some optional aspects, the surface area of ​​each of the dielectric material layer 40 and the first anisotropic material layer 30a can be greater than the total surface area of ​​the at least one metal pad 70. For example, the surface area of ​​the dielectric material layer 40 and the first anisotropic material layer 30a can be at least twice (e.g., about 3-5 times) the total surface area of ​​the at least one metal pad.

[0027] In some aspects, the anisotropic material layer 30 may include an anisotropic material sheet 32 ​​having a back side 34 and a front side 36 (the front side facing the skin of the subject). The anisotropic material sheet 32 ​​may have a first thermal conductivity in a direction perpendicular to the front side 36. In some aspects, the thermal conductivity of the sheet in a direction parallel to the front side may be more than two times higher than the first thermal conductivity. In further aspects, the anisotropic material sheet 32 ​​may have a first resistance in a direction perpendicular to the front side, and the resistance of the sheet in a direction parallel to the front side may be less than half of the first resistance.

[0028] In some optional aspects, the first anisotropic material layer 30a can include graphite.

[0029] Optionally, the first anisotropic material layer 30a may include synthetic graphite.

[0030] In further optional aspects, the first anisotropic material layer 30a may include a pyrolytic graphite sheet or a graphitized polymer film.

[0031] In a further optional aspect, the first anisotropic material layer 30a may include a graphite foil. For example, optionally, the first anisotropic material layer may include a graphite foil made of compressed high-purity exfoliated mineral graphite.

[0032] The dielectric material layer 40 may have a skin-facing surface 42 and an opposite outwardly facing surface 44. The first anisotropic material layer 30a may have a skin-facing surface 38a and an opposite outwardly facing surface 39a.

[0033] In some aspects, such as Figure 3 As shown, the outwardly facing surface 44 of the dielectric material 40 can be in contact with the skin-facing surface 38a of the first anisotropic material layer 30a. Figure 3 As shown, the outwardly facing surface 39a of the first anisotropic material layer 30a can be in contact with the outer adhesive layer 20. In a further aspect, as shown in FIG. Figure 3 As shown, the skin-facing surface 42 of the dielectric material layer 40 may be in contact with the skin-contacting layer 50 .

[0034] In some aspects, such as Figure 4As shown, the skin-facing surface 42 of the dielectric material 40 can be in contact with the outward-facing surface 39a of the first anisotropic material layer 30a to form the capacitive structure 12. In some optional aspects, the outward-facing surface 44 of the dielectric material 40 can be in contact with the external adhesive layer 20 (e.g., conductive gel or conductive adhesive 22). In some embodiments, the skin-facing surface 38a of the first anisotropic material layer 30a can be in contact with the skin contact layer 50. Figure 4 The embodiment shows that Figure 3 Compared to the embodiments of the present invention, the relative positioning of the anisotropic material layer 30a and the dielectric material layer 40 between the external adhesive layer 20 and the skin contact layer 50 is reversed. Figure 4 In an embodiment, the relative positions of other components in the device 10 (eg, the circuit board 60 and the metal pad 70 ) may remain unchanged.

[0035] refer to Figure 5 In some optional aspects, at least one anisotropic material layer 30 may include a second anisotropic material layer 30b. A dielectric material layer 40 is located between the first anisotropic material layer 30a and the second anisotropic material layer 30b to form a capacitive structure 12. The second anisotropic material layer 30b may have a skin-facing surface 38b and an opposite outward-facing surface 39b. In some aspects, the outward-facing surface 39a of the first anisotropic material layer 30a may be in contact with the external adhesive layer 20. In further aspects, the skin-facing surface 42 of the dielectric material layer 40 may be in contact with the outward-facing surface 39b of the second anisotropic material layer 30b. In further aspects, the skin-facing surface 38b of the second anisotropic material layer 38b may be in contact with the skin contact layer 50.

[0036] In some optional aspects, the dielectric material layer 40 can be located between the first anisotropic material layer 30a and the second anisotropic material layer 30b and in contact with the two layers ( Figure 5 In these aspects, except for the three-layer sandwich structure (first anisotropic material layer 30a - dielectric material layer 40 - second anisotropic material layer 30b), the relative positions of other components in the device 10 (such as the circuit board 60 and the metal pad 70) can remain unchanged.

[0037] refer to Figure 6 (and previous Figures 3 to 5), in some optional aspects, the device can include a wire 80 electrically coupled to the external adhesive layer 20. Optionally, in these aspects, the device 10 does not include a circuit board 60 or a flexible circuit. Optionally, the wire 80 can be coupled to the external adhesive layer 20 via one or more metal pads 70 or via a metal layer. Optionally, in the alternative, the device 10 does not include a metal pad 70 or a metal layer. Optionally, the wire 80 can be coupled to the external adhesive layer 20 via a circuit board 60 or a flexible circuit. Such embodiments can exist for each of the embodiments described herein.

[0038] refer to Figure 7 , the device 10 may include at least one anisotropic material layer 30 and a dielectric material layer 40. The dielectric material layer 40 may contact at least the first layer 30a of the at least one anisotropic material layer 30 to form a capacitive structure 12.

[0039] At least one anisotropic material layer 30 and dielectric material layer 40 may be located between opposing conductive material layers 90 (eg, Figure 3 to Figure 4 1 and 1 ). In various aspects, the conductive material 90 can optionally include a conductive gel or a conductive adhesive. In further aspects, the conductive material 90 can include a conductive grease. In these aspects, a covering 92 (e.g., a bandage, plaster, or other covering structure) can hold the assembly 10 in a stacked arrangement and against the patient's skin. Optionally, a bandage or other covering 92 can be used in any of the embodiments described herein. In addition to replacing the conductive gel or conductive adhesive of the outer adhesive layer with a conductive grease, and optionally adding a bandage or covering 92, Figure 7 Example and Figure 4 The embodiments are similar, and the relative positions of other components in the device 10 (e.g., the circuit board 60 and the metal pads 70) can remain unchanged. In fact, replacing the conductive gel or conductive adhesive of the outer adhesive layer with conductive grease, and optionally adding a bandage or cover 92, can also be used as an additional embodiment of any and all other embodiments described herein. In addition, replacing the conductive gel or conductive adhesive of the skin contact layer with conductive grease, and optionally adding a bandage or cover 92, can also be used as an additional embodiment of any and all other embodiments described herein.

[0040] Exemplary embodiments disclosed herein incorporate into the device a sheet of material (also referred to herein as anisotropic material layer 30) having anisotropic thermal and / or anisotropic electrical properties. If the sheet of material has anisotropic thermal properties (e.g., thermal conductivity in a plane is greater than thermal conductivity perpendicular to the plane), the sheet spreads heat more evenly over a larger surface area. If the sheet of material has anisotropic electrical properties (e.g., electrical conductivity in a plane is greater than electrical conductivity perpendicular to the plane; or conversely, electrical resistance in a plane is less than electrical resistance perpendicular to the plane), the sheet spreads electrical current more evenly over a larger surface area. In each case, when a given AC voltage is applied to the device, this lowers the temperature of the hot spot and raises the temperature of the cooler area. Thus, the current can be increased (and thus the therapeutic effect) without exceeding a safe temperature threshold at any point on the subject's skin.

[0041] In some embodiments, the anisotropic material is anisotropic with respect to electrical conductivity properties. In some embodiments, the anisotropic material is anisotropic with respect to thermal conductivity properties. In some embodiments, the anisotropic material is anisotropic with respect to both electrical conductivity properties and thermal conductivity properties.

[0042] Anisotropic thermal properties include directional thermal properties. Specifically, the sheet has a first thermal conductivity in a direction perpendicular to its front face. And the thermal conductivity of the sheet in a direction parallel to the front face is more than twice higher than the first thermal conductivity. In some preferred embodiments, the thermal conductivity in the parallel direction is more than ten times higher than the first thermal conductivity. For example, the thermal conductivity of the sheet in a direction parallel to the front face can 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 higher than the first resistance.

[0043] Anisotropic electrical properties include directional electrical properties. Specifically, the sheet has a first resistance in a direction perpendicular to its front face. And the resistance of the sheet in a direction parallel to the front face is less than the first resistance. In some preferred embodiments, the resistance in the parallel direction is less than half of the first resistance or less than 10% of the first resistance. For example, the resistance of the sheet 70 in a direction parallel to the front face may be less than 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5% or even less than 0.1% of the first resistance.

[0044] In some embodiments (eg, when the anisotropic material sheet is a pyrolytic graphite sheet), the anisotropic material sheet has both anisotropic electrical properties and anisotropic thermal properties.

[0045] In some optional aspects, the anisotropic material layer is a non-metallic anisotropic material layer. The use of non-metallic anisotropic materials is particularly advantageous in cases where it is desired to prevent ion transfer into the subject. More specifically, the use of metal sheets may result in ion transfer into the subject.

[0046] In some optional aspects, the dielectric material layer 40 can include a high dielectric constant polymer. In alternative aspects, the dielectric material 40 can be a ceramic material. In alternative aspects, the dielectric material 40 can be a metal oxide (e.g., Al2O3), which can be applied to the substrate by chemical vapor deposition (CVD) and has sufficient flexibility as a thin film.

[0047] In various optional aspects, dielectric material layer 40 can have a dielectric constant in a range of 10 to 50,000.

[0048] In some preferred embodiments, the high dielectric polymer material 40 includes 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. The dielectric constant of these materials is about 40. In some embodiments, the polymer layer can be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or "poly(VDF-TrFE-CTFE-CFE)".

[0049] In some embodiments, the terpolymer used in the insulating polymer layer may include any suitable molar ratio of VDF, TrFE, CFE and / or CTFE. Suitable terpolymers include, for example, those having 30 to 80 mol% VDF, 5 to 60 mol% TrFE, with CFE and / or CTFE constituting the remainder of the mol% of the terpolymer.

[0050] In all embodiments disclosed herein, preferably, the dielectric material layer should completely cover the area of ​​the anisotropic material layer (or when the dielectric material layer is combined with one or more other insulating materials, it should completely cover or substantially completely cover the area of ​​the anisotropic material layer) so that the double layer functions as a capacitive structure. Therefore, in exemplary aspects, it is expected that the surface area of ​​the dielectric material layer (or the surface area of ​​the dielectric material combined with other insulating materials) can be greater than or equal to the surface area of ​​the anisotropic material layer, wherein the size of the anisotropic material layer is less than or equal to the corresponding size of the dielectric material layer, so that the periphery of the anisotropic material does not exceed the periphery of the dielectric material.

[0051] While complete coverage of the anisotropic material is preferred, it is contemplated that other embodiments may include structures in which the dielectric material substantially covers areas of the anisotropic material. As used herein, the term "substantially covers" refers to structures in which the dielectric material (or the dielectric material in combination with other insulating materials) covers at least 90%, or at least 95%, or at least 99% of the surface area of ​​the anisotropic material.

[0052] How to use the device

[0053] Methods of using the device 10 as disclosed herein may include using the device 10 to generate an electric field. Figure 8 An exemplary system 200 for applying an electric field using a device 10 as disclosed herein is shown. Multiple devices 10 (e.g., two devices as shown) can be positioned with a target area therebetween. An AC voltage or AC current generator 210 can be in communication with each device 10. The AC voltage or AC current generator 210 can be configured to generate an alternating electric field across the target area.

[0054] The method may include positioning a first device in devices 10 at a first location on or in a subject's body. For example, device 10 may be positioned on the subject's skin on the right side of the subject's head facing a target area (eg, a brain tumor).

[0055] The second device in the device 10 can be positioned at a second position on or in the patient's body. For example, the second device 10 can be positioned on the subject's skin on the left side of the patient's head facing the target area.

[0056] An alternating voltage may be applied between devices 10. The application may be achieved by applying an alternating voltage between (i) a first electrode element (e.g., metal pad 70) arranged to electrically contact anisotropic material layer 30 of first device 10 and (ii) a second electrode element arranged to electrically contact anisotropic material layer 30 of second device 10.

[0057] In some embodiments, the frequency of the alternating voltage is between 50kHz and 1MHz, or between 100kHz and 500kHz. In some aspects, the AC voltage generator can be controlled by a controller. The controller can use temperature measurements to control the amplitude of the current to be delivered via the device 10 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 a first electrode element, measuring a second temperature of a second electrode element, and controlling the application of the alternating voltage based on the first temperature and the second temperature, as described below.

[0058] More specifically, a temperature sensor (e.g., a thermistor) can be positioned in thermal contact with a corresponding electrode element within each of the devices 10. The temperature sensor can measure a corresponding first temperature and a second temperature (e.g., at the first electrode element and the second electrode element in the first device and the second device 10, respectively), and the controller can control the output of the AC voltage generator based on these temperatures. Other temperature sensors located at additional electrode elements can be used to measure the temperature at multiple electrode elements in the transducer array, and the controller can control the current applied to each electrode element based on the temperature difference compared to a threshold temperature (e.g., 41° C.), thereby balancing any temperature hot spots on the array.

[0059] Advantages of the disclosed device

[0060] The disclosed device 10 can be easier and less expensive to manufacture than other structures. The use of a polymer film as the dielectric material 40 provides greater flexibility than conventional ceramic discs and therefore conforms better to the subject's skin, but polymer films are fragile and are often punctured when adjacent to the metal pads 70 and during cutting during array manufacturing. The dielectric material 40 can be protected by the anisotropic material layer 30, thereby increasing the durability of the dielectric material 40. In addition, when the device is provided with a dielectric material 40 coupled to the anisotropic material 30, the contact area with the capacitor layer can be the entire area of ​​the anisotropic material layer 30. The increase in capacitor area means that the dielectric polymer does not need to have such a high dielectric constant (polymers with high dielectric constants are generally more expensive than materials with low dielectric constants), so less expensive materials can be used (e.g., polymers or metal oxides (e.g., Al2O3), which can be applied to the substrate by chemical vapor deposition (CVD) and are sufficiently flexible as a thin film).

[0061] Device having a layer comprising a conductive adhesive composite

[0062] Optionally, the outer adhesive layer 20 and / or the skin contact layer 50 may include a hydrogel. It is also contemplated that the outer adhesive layer 20 and / or the skin contact layer 50 may include a conductive adhesive composite (described further below) rather than a hydrogel.

[0063] In exemplary aspects, the conductive adhesive composite 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. In some embodiments, it is expected that the conductive particles can be aligned in response to the application of an electric field so that the conductive particles undergo electrophoresis. In some aspects, the dielectric material is a polymer adhesive. Optionally, in these aspects, the polymer adhesive can be an acrylic adhesive. In some aspects, the conductive particles may contain 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 nanotubes. Additionally or alternatively, the conductive particles may include carbon black powder. In further aspects, the conductive adhesive composite also 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, 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 composition manufactured and sold by FLEXCON (Spencer, MA, USA). In other exemplary aspects, the conductive adhesive composite can be a conductive adhesive, such as the OMNI-WAVE adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). 8006 conductive adhesive composition.

[0064] In exemplary aspects, outer adhesive layer 20 and / or skin contact layer 50 do not include a hydrogel.

[0065] In a further exemplary aspect, skin contact layer 50 does not include latex rubber polymers.

[0066] In a further exemplary aspect, skin contact layer 50 does not include silver or silver chloride.

[0067] In a further aspect, the thickness of the conductive adhesive composite layer ranges from about 30 μm to about 2000 μm, for example, 30 μm to about 200 μm. Optionally, the thickness of the conductive adhesive composite in the outer adhesive layer can range from about 30 μm to about 2000 μm, or from about 50 μm to about 1000 μm, or from about 50 μm to about 200 μm, or from about 70 μm to about 150 μm. Optionally, the thickness of the conductive adhesive composite in the skin contact layer can range from about 30 μm to about 100 μm, or from about 30 μm to about 70 μm, or from about 40 μm to about 60 μm, or from about 45 μm to about 55 μm.

[0068] In a further aspect, the conductive adhesive composition excludes water.

[0069] In exemplary aspects, the conductive particles of the conductive adhesive composite include a plurality of groups of conductive particles. In these aspects, the conductive particles of the combined groups of conductive particles can be aligned to define respective conductive paths through the thickness of the conductive film in the adhesive composite electrode assembly.

[0070] Optionally, in exemplary aspects, the device may also include a release liner covering the skin contact layer. In these aspects, it is contemplated that prior to use, the device may be provided with a release liner to ensure that the skin contact layer does not adhere to undesirable surfaces or locations. Immediately prior to use, the release liner may be removed and the skin contact layer may be positioned in contact with the patient's skin.

[0071] In exemplary aspects, by using a conductive adhesive composite as disclosed herein as a skin contact layer, it is contemplated that additional backing and / or cover layers (e.g., self-adhesive backings) may be omitted. In these aspects, it is contemplated that the conductive adhesive composite may provide sufficient adhesion to the skin such that additional layers do not need to be provided to maintain the desired position of the device on the subject's body, thereby improving ease of use and reducing overall cost of manufacture and use.

[0072] In a further aspect, by avoiding the use of hydrogels within the devices disclosed herein, it is expected that an electrode assembly comprising a conductive adhesive composite as disclosed herein does not require moisture-proof packaging, thereby making the cost of packaging more affordable. Additionally, it is expected that the conductive adhesive composite of the disclosed electrode assembly can avoid the signal variation issues of hydrogels, thereby providing consistent material properties (e.g., viscosity) and reliable performance during the delivery of the TT field. In addition, it is expected that the disclosed conductive adhesive composite can have a longer shelf life than hydrogels, thereby reducing the frequency with which the electrode assembly (or the skin contact layer of the electrode assembly) must be replaced.

[0073] It is also contemplated that embodiments including sheets of anisotropic material may additionally help avoid or reduce overheating of the electrode and associated skin discomfort by dissipating current and heat in a lateral (in-plane) direction rather than directly through the layer in a concentrated manner (in a direction perpendicular to the plane of the skin contact layer).

[0074] Exemplary Aspects

[0075] 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 enumerated 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.

[0076] Aspect 1: A device, comprising:

[0077] an outer adhesive layer, the outer adhesive layer comprising a conductive gel or a conductive adhesive;

[0078] at least one layer of anisotropic material;

[0079] a dielectric material layer; and

[0080] a skin contact layer, the skin contact layer comprising a conductive gel or a conductive adhesive,

[0081] wherein the at least one anisotropic material layer and the dielectric material layer are located between the outer adhesive layer and the skin contact layer, and

[0082] The dielectric material layer contacts at least a first layer of the at least one anisotropic material layer to form a capacitor structure.

[0083] Aspect 2: The device of aspect 1, further comprising a circuit board or a flexible circuit, wherein the circuit board or the flexible circuit is electrically coupled to the outer adhesive layer.

[0084] Aspect 3: The apparatus of aspect 2, wherein the circuit board or flexible circuit is electrically coupled to the outer adhesive layer through at least one metal pad in electrical contact with the circuit board or flexible circuit.

[0085] Aspect 4: The apparatus of aspect 3, wherein the dielectric material layer and the first anisotropic material layer each have a surface area greater than a total surface area of ​​the at least one metal pad.

[0086] Aspect 5: A device according to any one of the preceding aspects, wherein the first anisotropic material layer comprises an anisotropic material sheet having a front side and a back side, the sheet having a first thermal conductivity in a direction perpendicular to the front side, wherein the thermal conductivity of the sheet in a direction parallel to the front side is more than twice as high as the first thermal conductivity, or the sheet having a first resistance in a direction perpendicular to the front side, wherein the resistance of the sheet in a direction parallel to the front side is less than half of the first resistance.

[0087] Aspect 6: The apparatus of any preceding aspect, wherein the first anisotropic material layer comprises graphite.

[0088] Aspect 7: The apparatus of any of the preceding aspects, wherein the first anisotropic material layer comprises synthetic graphite.

[0089] Aspect 8: The apparatus according to any of the preceding aspects, wherein the first anisotropic material layer comprises a pyrolytic graphite sheet or a graphitized polymer film.

[0090] Aspect 9: The apparatus of aspect 6, wherein the first anisotropic material layer comprises graphite foil.

[0091] Aspect 10: The apparatus of aspect 9, wherein the first anisotropic material layer comprises a graphite foil made of compressed high-purity exfoliated mineral graphite.

[0092] Aspect 11: A device according to any of the preceding aspects, wherein the dielectric material layer has a skin-facing surface and an opposite outward-facing surface, wherein the first anisotropic material layer has a skin-facing surface and an opposite outward-facing surface, and wherein the outward-facing surface of the dielectric material is in contact with the skin-facing surface of the first anisotropic material layer.

[0093] Aspect 12: The apparatus of aspect 11, wherein the outwardly facing surface of the first anisotropic material layer is in contact with the external adhesive layer.

[0094] Aspect 13: The device according to aspect 11 or aspect 12, wherein the skin-facing surface of the dielectric material layer is in contact with the skin contact layer.

[0095] Aspect 14: A device according to any one of Aspects 1 to 10, wherein the dielectric material layer has a skin-facing surface and a relative outward-facing surface, wherein the first anisotropic material layer has a skin-facing surface and a relative outward-facing surface, and wherein the skin-facing surface of the dielectric material layer is in contact with the outward-facing surface of the first anisotropic material layer.

[0096] Aspect 15: The apparatus of aspect 14, wherein the outwardly facing surface of the dielectric material layer is in contact with the outer adhesive layer.

[0097] Aspect 16: The device according to aspect 14 or aspect 15, wherein the skin-facing surface of the first anisotropic material layer is in contact with the skin contact layer.

[0098] Aspect 17: The apparatus according to any one of aspects 1 to 10, wherein the at least one anisotropic material layer further comprises a second anisotropic material layer, and wherein the dielectric material layer is located between the first anisotropic material layer and the second anisotropic material layer.

[0099] Aspect 18: A device according to Aspect 17, wherein the dielectric material layer has a skin-facing surface and a relative outward-facing surface, wherein the first anisotropic material layer has a skin-facing surface and a relative outward-facing surface, wherein the second anisotropic material layer has a skin-facing surface and a relative outward-facing surface, and wherein the outward-facing surface of the first anisotropic material layer is in contact with the external adhesive layer.

[0100] Aspect 19: The device of aspect 18, wherein the skin-facing surface of the dielectric material layer is in contact with the outward-facing surface of the second anisotropic material layer.

[0101] Aspect 20: The device according to aspect 18 or aspect 19, wherein the skin-facing surface of the second anisotropic material layer is in contact with the skin contact layer.

[0102] Aspect 21: The apparatus of any one of aspects 17 to 20, wherein the dielectric material layer is located between and in contact with the first anisotropic material layer and the second anisotropic material layer.

[0103] Aspect 22: The device according to any of the preceding aspects, wherein the dielectric material layer comprises a dielectric polymer. The dielectric constant of the dielectric polymer may be greater than 10, for example, 10 to 50,000.

[0104] Aspect 23: The apparatus of any one of Aspects 1 to 21, wherein the dielectric material is a ceramic material.

[0105] Aspect 24: The apparatus of any one of aspects 1 to 21, wherein the dielectric material is a metal oxide.

[0106] Aspect 25: The apparatus of any preceding aspect, wherein the dielectric material has a dielectric constant in the range of 10 to 50,000.

[0107] Aspect 26: The device of aspect 1, further comprising a wire electrically coupled to the outer adhesive layer.

[0108] Aspect 27: The device of aspect 26, wherein the device does not include a circuit board or a flexible circuit.

[0109] Aspect 28: A device, comprising:

[0110] at least one layer of anisotropic material;

[0111] a dielectric material layer, wherein the dielectric material layer contacts at least a first layer of the at least one anisotropic material layer to form a capacitor structure; and

[0112] Opposing conductive material layers, wherein the at least one anisotropic material layer and the dielectric material layer are located between the opposing conductive material layers.

[0113] Aspect 29: The apparatus of aspect 28, wherein the conductive material of at least one of the opposing conductive material layers is a conductive adhesive.

[0114] Aspect 30: The apparatus of aspect 28, wherein the conductive material of at least one of the opposing conductive material layers is a conductive gel.

[0115] Aspect 31: The apparatus according to any one of aspects 28 to 30, wherein the conductive material of at least one of the opposing conductive material layers is conductive grease.

[0116] Aspect 32: The apparatus of aspect 28, wherein the conductive material of at least one of the opposing conductive material layers is a conductive gel or a conductive adhesive.

[0117] Aspect 33: The device according to any one of Aspects 28 to 32, further comprising a cover configured to hold the capacitive structure in close contact with the patient's skin.

[0118] Aspect 34: A method comprising: generating an electric field using the apparatus according to any one of the preceding aspects.

[0119] Aspect 35: The method according to aspect 34, wherein the electric field is an alternating electric field with a frequency of 50 kHz to 1 MHz or 100 kHz to 500 kHz.

[0120] Although the present invention has been disclosed with reference to certain embodiments, many modifications, variations and changes 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 is not limited to the described embodiments, but has the full scope defined by the language of the appended claims and their equivalents.

Claims

1. A device, comprising: an outer adhesive layer, the outer adhesive layer comprising a conductive gel or a conductive adhesive; at least one layer of anisotropic material; a dielectric material layer; as well as a skin contact layer, the skin contact layer comprising a conductive gel or a conductive adhesive, wherein the at least one anisotropic material layer and the dielectric material layer are located between the outer adhesive layer and the skin contact layer, and The dielectric material layer contacts at least a first layer of the at least one anisotropic material layer to form a capacitor structure. 2 . The device of claim 1 , further comprising a circuit board or a flexible circuit, wherein the circuit board or the flexible circuit is electrically coupled to the outer adhesive layer.

3. The apparatus of claim 2 , wherein the circuit board or flexible circuit is electrically coupled to the external adhesive layer via at least one metal pad in electrical contact with the circuit board or flexible circuit, wherein the dielectric material layer and the first anisotropic material layer each have a respective surface area greater than the total surface area of ​​the at least one metal pad.

4. The apparatus of claim 1, wherein the first anisotropic material layer comprises graphite.

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

6. The device of claim 1 , wherein the dielectric material layer has a skin-facing surface and an opposite outward-facing surface, wherein the first anisotropic material layer has a skin-facing surface and an opposite outward-facing surface, and wherein the outward-facing surface of the dielectric material is in contact with the skin-facing surface of the first anisotropic material layer.

7. The apparatus of claim 6, wherein the outwardly facing surface of the first anisotropic material layer is in contact with the outer adhesive layer.

8. The device of claim 6, wherein the skin-facing surface of the dielectric material layer is in contact with the skin-contact layer.

9. The device of claim 1 , wherein the dielectric material layer has a skin-facing surface and an opposite outward-facing surface, wherein the first anisotropic material layer has a skin-facing surface and an opposite outward-facing surface, and wherein the skin-facing surface of the dielectric material layer is in contact with the outward-facing surface of the first anisotropic material layer.

10. The apparatus of claim 9, wherein the outwardly facing surface of the layer of dielectric material is in contact with the outer adhesive layer.

11. The device of claim 9, wherein the skin-facing surface of the first anisotropic material layer is in contact with the skin contact layer.

12. The apparatus of claim 1, wherein the at least one anisotropic material layer further comprises a second anisotropic material layer, and wherein the dielectric material layer is located between the first anisotropic material layer and the second anisotropic material layer.

13. The apparatus of claim 1, wherein the layer of dielectric material comprises a dielectric polymer.

14. A device, comprising: at least one layer of anisotropic material; a dielectric material layer, wherein the dielectric material layer contacts at least a first layer of the at least one anisotropic material layer to form a capacitor structure; as well as Opposing conductive material layers, wherein the at least one anisotropic material layer and the dielectric material layer are located between the opposing conductive material layers.

15. The device of claim 14, wherein the conductive material of at least one of the opposing conductive material layers is a conductive gel, a conductive adhesive or a conductive grease.

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