Patent Application
20240100321
Tumor Treating Fields (TTFields) therapy is a proven approach for treating tumors using alternating electric fields at frequencies between 50 kHz-1 MHz, more commonly, 100-500 kHz. 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 opposing electrode assemblies, an AC current is coupled through the electrode assemblies and into the subject's body. And higher currents are strongly correlated with higher efficacy of treatment.
Disclosed herein, in one aspect, is an apparatus having an electrode layer. The electrode layer has a plurality of electrode elements, each electrode element of the plurality of electrode elements having a skin-facing surface. At least first and second electrode elements are spaced apart within the electrode layer along a first axis. The electrode layer further has at least one filler structure. The at least one filler structure comprises a first filler structure having a first filler portion positioned within a space between the first and second electrode elements. The at least one filler structure is configured to provide the electrode layer with a substantially consistent height along the first axis. A layer of anisotropic material has a skin-facing surface and an opposing outwardly facing surface. An upper adhesive layer comprises a conductive adhesive composite. The upper adhesive layer is disposed on an outer side of the layer of anisotropic material. A skin contact structure has an adhesive layer comprising 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 layer of anisotropic material. The skin contact structure is disposed on an inner side of the layer of anisotropic material and is configured to contact skin of a subject.
A method of using the apparatus can comprise positioning at least first and second electrode assemblies on a body of a subject, each of the first and second electrode assemblies comprises an electrode layer. The electrode layer has a plurality of electrode elements, each electrode element of the plurality of electrode elements having a skin-facing surface. At least first and second electrode elements are spaced apart within the electrode layer along a first axis. The electrode layer further has at least one filler structure. The at least one filler structure comprises a first filler structure having a first filler portion positioned within a space between the first and second electrode elements. The at least one filler structure is configured to provide the electrode layer with a substantially consistent height along the first axis. A layer of anisotropic material has a skin-facing surface and an opposing outwardly facing surface. An upper adhesive layer comprises a conductive adhesive composite. The upper adhesive layer is disposed on an outer side of the layer of anisotropic material. A skin contact structure has an adhesive layer comprising 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 layer of anisotropic material. The skin contact structure is disposed on an inner side of the layer of anisotropic material and is configured to contact skin of a subject. The skin contact structure contacts skin of the subject. An alternating voltage is applied between the first electrode assembly and the second electrode assembly, thereby generating an electric field.
Various embodiments are described in detail below with reference to the accompanying drawings, wherein like reference numerals represent like elements, and wherein descriptions of like elements may not be repeated for every embodiment, but may be considered to be the same if previously described herein.
This application describes exemplary electrode assemblies that may be used, e.g., for delivering TTFields to a subject's body and treating one or more cancers or tumors located in the subject's body.
The present invention can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, it is to be understood that this invention is not limited to the specific apparatuses, devices, systems, and/or methods disclosed unless otherwise specified, and as such, of course, can vary.
Headings are provided for convenience only and are not to be construed to limit the invention in any manner. Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure.
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.
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 is understood that disclosure of a singular form of an element can provide support for embodiments in which only a single one of such elements is provided, as well as for embodiments in which a plurality of such elements are provided.
In the preceding and following description, the terms “front,” “inner,” and “skin-facing” are used interchangeably to refer to a face or surface of the disclosed electrode assemblies (or components thereof) that faces or is oriented toward the skin of a subject (or generally toward the body of a subject) when used as disclosed herein. Similarly, the terms “rear,” “upper,” “outer,” and “outwardly facing” are used interchangeably to refer to a face or surface of the disclosed electrode assemblies (or components thereof) that faces away from or is oriented away from the skin of a subject (or generally away from the body of the subject) when used as disclosed herein. For example, an “inner face” can face the skin of the subject, and an “outer face” can face away from the skin of the subject.
Referring to
In some optional aspects, the apparatus 10 can further comprise a layer of anisotropic material 40 having a skin-facing surface 42 and an opposing outwardly facing surface 44 (
In other embodiments, the apparatus 10 can be free of a layer of anisotropic material (i.e., the apparatus 10 does not comprise a layer of anisotropic material). In these aspects, the upper adhesive layer 50 can be disposed on an outer side of the skin contact structure 60, or the upper adhesive layer 50 may also be absent in which case the skin contact structure can be disposed on an inner side of the electrode layer. Thus, the skin contact structure can be disposed on an inner side of the upper adhesive.
At least one electrode element 22 of the plurality of electrode elements can be in electrical contact with the outwardly facing surface 44 of the layer of anisotropic material 40.
In some aspects, each electrode element 22 of the plurality of electrode elements can be in electrical contact with the outwardly facing surface 44 of the layer of anisotropic material 40. Accordingly, the layer of anisotropic material 40 can extend continuously across an area within which each of the electrode elements is positioned.
In some optional aspects, each electrode element 22 of the plurality of electrode elements can comprise a layer of dielectric material 70 having a skin-facing inner face 72 and an opposing outer face 74 (
In some optional aspects, the dielectric material 70 can comprise a ceramic material. In other aspects, the dielectric material 70 can comprise a high dielectric polymer. In exemplary aspects, the dielectric material 70 can have a dielectric constant ranging from 10 to 50,000. In some embodiments, the layer of dielectric material 70 comprises a high dielectric polymer material such as poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and/or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene). Those two polymers are abbreviated herein as “Poly(VDF-TrFE-CTFE)” and “Poly(VDF-TrFE-CFE),” respectively. These embodiments are particularly advantageous because the dielectric constant of these materials is on the order of 40. In some embodiments, the polymer layer can be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or “Poly(VDF-TrFE-CTFE-CFE).” In some embodiments, the layer of dielectric material 70 comprises a terpolymer comprising polymerized units of monomers such as VDF, TrFE, CFE and/or CTFE in any suitable molar ratio. Suitable terpolymers include those, for example, having 30 to 80 mol % VDF, 5 to 60 mol % TrFE, with CFE and/or CTFE constituting the balance of the mol % of the terpolymer.
In alternative aspects, the electrode elements 22 do not comprise a dielectric material.
The plurality of electrode elements 22 can optionally comprise a third electrode element 22c. The second electrode element 22b can be positioned between, and spaced from, the first and third electrode elements 22a,c along, the first axis 12. The at least one filler structure 30 can further comprise a second filler portion 32b positioned between the second and third electrode elements 22b,c along the first axis 12. For example, the first filler structure 30a can have a second filler portion 32b positioned within a space 34b between the second and third electrode elements 22b,c. In other aspects, a second filler structure (not shown) that is not integrally formed with the first filler structure 30a can be positioned within the space 34b
In some optional aspects, the plurality of electrode elements 22 can comprise at least two rows 26 of electrode elements that extend along or parallel to a second axis 14 that is perpendicular to the first axis 12. The at least two rows of electrode elements can comprise a first row 26a of electrode elements 22 that includes the first electrode element 22a and a second row 26b of electrode elements that includes the second electrode element 22b. The first filler portion 32a can be positioned between the first and second rows 26a,b of electrode elements 22, for example, between electrode elements 22a and 22b along the first axis 12. Optionally, the plurality of electrode elements 22 can be arranged in exactly two rows 26, for example, as shown by row 26a and row 26b in isolation.
In further optional aspects, the plurality of electrode elements 22 can comprise at least three rows 26 (optionally, exactly three rows) of electrode elements 22 that extend along or parallel to a second axis 14 that is perpendicular to the first axis 12. The at least three rows 26 of electrode elements 22 can comprise a first row 26a of electrode elements that includes the first electrode element 22a, a second row of electrode elements 26b that includes the second electrode element 22b, and a third row of electrode elements 26c that includes the third electrode element 22c. The first filler portion 32a can be positioned between the first and second rows 26a,b of electrode elements 22, for example, between electrode elements 22a and 22b along the first axis 12. The second filler portion 32b can be positioned between the second and third rows 26b,c of electrode elements 22, for example, between electrode elements 22b and 22c along the first axis 12.
In various exemplary aspects, each row 26 of electrode elements 22 can comprise three electrode elements 22. In other aspects, each row 26 of electrode elements 22 can comprise two electrode elements 22, four electrode elements 22, five electrode elements 22, or more.
In some aspects, the at least one filler structure 30 can comprise foam. In some aspects, the at least one filler structure 30 can comprise any polymeric material, including rubber polymers, elastomers, thermoplastic polymers and thermosetting polymers. In some aspects, the at least one filler structure 30 can comprise a hydrocolloid. In some aspects, the at least one filler structure 30 can comprise a gel. Optionally, in these aspects, the at least one filler structure 30 can comprise a hydrocolloid gel. In various optional aspects, the filler structure can be or can comprise a medication.
The filler structure 30 can act as a medication substrate and the medication substrate may be capable of at least one of receiving, absorbing, or holding a topical medication applied thereto. Accordingly, the filler structure 30 can comprise a topical medication integrated in or on the filler structure. The topical medication can comprise a base component of oil, water, petrolatum, wax, cellulose, or a combination thereof. The topical medication can be a cream, an ointment, a lotion, a gel, a wax, a paste, or a mineral oil jelly. The topical medication can comprise 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, an astringent, or an antihistamine. For example, the topical medication can be a steroid or corticosteroid, and can be a topical medication such as hydrocortisone or betamethasone. The topical medication can be or can comprise a skin repair agent that can include a hydrocolloid material. The topical medication can be any desired compound capable of soothing, healing, and/or providing relief for inflammation, sores, or other irritation that may develop on the skin of the subject's body. The topical medication can be substantially evenly distributed through a thickness of the medication substrate or, alternatively, the topical medication can be substantially disposed on the surface of the medication substrate.
When the filler structure is or comprises a hydrocolloid layer, the hydrocolloid layer can serve as a topical medication. The hydrocolloid layer can be a gel or it can include any suitable material or materials that can thicken when contacting a wound (e.g., based on absorbing liquid or secretions from damaged or wounded skin). The hydrocolloid layer can include any suitable material that can change into a gel or gel-like material when absorbing moisture from skin (e.g., hydrocolloid gel). In at least some exemplary embodiments, the hydrocolloid layer can include pectin, a material having collagen-like properties (e.g., gelatin), carboxymethyl cellulose (e.g., sodium carboxymethyl cellulose), and/or any other suitable material.
The hydrocolloid layer may or may not include adhesive and/or may or may not have adhesive properties. The hydrocolloid layer can include an adhesive layer similar to for example the adhesive layers disclosed herein. The hydrocolloid layer may act as an adhesive (e.g., have adhesive properties). Also for example, the hydrocolloid layer may neither include adhesive nor exhibit adhesive properties.
The medication can provide relief to the skin of the patient to counteract irritation caused by the apparatus 10. For example, for embodiments for which the filler material is or comprises a hydrocolloid, or for which the filler material is or comprises a medication, the electrode assembly may be moved (a translational movement) after a period of treatment so that the filler material now occupies a location such that it covers areas of the skin formerly covered by the electrodes. Performing such a translational movement of the electrode assembly serves the purpose of providing relief and some degree of healing to areas of the skin that may have suffered skin irritation due to the presence of the electrodes on the skin.
In some aspects, the at least one filler structure 30 and the plurality of electrode elements 22 have a combined surface area that is at least 20%, or at least 30%, or at least 40%, or at least 50%, or at least 60%, or at least 70% of a surface area of the layer of anisotropic material 40. In some aspects, the at least one filler structure 30 and the plurality of electrode elements 22 have a combined surface area that 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 a surface area of the layer of anisotropic material 40.
In various aspects, the at least one filler structure 30, or portions thereof, can be complementary to the shapes of the electrode elements. In some optional aspects, the first filler portion and the second filler portion are part of a shaped layer of filler structure material that fills the gaps between all of the electrode elements, having cut-outs 35 as void spaces that receive respective electrode elements of the plurality of electrode elements. For example, in some optional aspects, the at least one filler structure 30 can be a single filler structure being a single contiguous structure that defines a plurality of cut-outs to respectively receive each electrode element of the plurality of electrode elements. The cut-outs 35 can be complementary to the shape of the electrode elements. It is further contemplated that the at least one filler structure 30 can be shaped to occupy all gaps between electrode elements arranged in any pattern, and not just in a rows-and-columns arrangement, whether as a single filler structure, or as a combination of multiple fitting filler portions.
In other aspects, the at least one filler structure 30 can comprise a plurality of separate elements. For example, a first filler structure can define the first filler portion 32, and a second filler structure can define the second filler portion 32 (for example, 32a and 32b).
In some aspects, the first filler portion 32a can have a shape that is complementary to a shape of the space 34a between the first and second electrode elements 22a,b.
In some optional aspects, the first filler portion 32a and/or the second filler portion 32b can be part of a strip of filler structure material that fills the gap between either one or more rows 26 of electrode elements or one or more columns 28 of electrode elements 22. For example, a first strip of filler material 36a can extend between the first and second rows 26a,b of electrode elements 22, and a second strip of filler material 36b can extend between the second and third rows 26b,c of electrode elements 22.
In further optional aspects, the filler structure 30 can comprise cut-outs 38 (shown in broken lines in
As discussed above, the upper adhesive layer 50 can be disposed on an outer side 46, or on the outer side surface 44, of the layer of anisotropic material. In some aspects, the upper adhesive layer 50 does not comprise hydrogel. For example, the upper adhesive layer 50 can comprise a conductive adhesive composite, as further disclosed herein. The conductive adhesive composite of the upper adhesive layer 50 can comprise a dielectric material and conductive particles dispersed within the dielectric material. Suitable dielectric materials include acrylic polymers and silicone polymers; and suitable conductive particles include carbon flakes, carbon granules, carbon fibers, carbon black powder, graphite powder, carbon nanotubes, carbon nanowires, and the like. For example, the upper adhesive layer 50 can comprise carbon black. In exemplary aspects, the upper adhesive layer 50 can comprise adhesive provided by ADHESIVE RESEARCH, such as ARcare® 8006 electrically conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). In other optional aspects, the upper adhesive layer 50 can comprise carbon fibers or nanowires. For example, in exemplary aspects, the upper adhesive layer 50 can comprise a dry carbon/salt adhesive, such as the developmental product FLX068983—FLEXcon® OMNI-WAVE™ TT 200 BLACK H-502 150 POLY H-9 44PP-8 from FLEXcon, Spencer, MA, USA, or other such OMNI-WAVE products from FLEXcon. In various aspects, the upper adhesive layer 50 can have a thickness from about 25 μm to about 150 μm.
In some optional aspects, the skin contact structure 60 can be a single layer comprising a conductive adhesive composite. In some aspects, the conductive adhesive composite comprises a dielectric material and conductive particles dispersed within the dielectric material, where suitable dielectric materials and suitable conductive particles are discussed above. In some aspects, the skin contact structure 60 can comprise an adhesive (e.g., acrylic adhesive) comprising carbon fiber or carbon nanowires. The skin contact structure 60 can comprise an adhesive (e.g., acrylic adhesive) comprising carbon black powder. In exemplary aspects, the skin contact structure 60 can have a thickness from about 25 μm to about 150 μm. For example, optionally, the skin contact structure 60 can have a thickness of about 50 μm. Although the conductive adhesive composite for the skin contact adhesive can have similar components, or even the same components, as the conductive adhesive composite for the upper adhesive layer, in any particular electrode assembly they may or may not be the same.
As illustrated in
In some aspects, the outer and inner adhesive layers 62, 64 of the skin contact structure 60 do not comprise hydrogel. For example, the outer and inner adhesive layers 62, 64 of the skin contact structure 60 can comprise a conductive adhesive composite, as further disclosed herein. The conductive adhesive composite of the inner and outer adhesive layers 64, 62 of the skin contact structure 60 can comprise a dielectric material and conductive particles dispersed within the dielectric material, as discussed above.
Alternatively, it is contemplated that the outer and/or inner adhesive layers 62, 64 can comprise hydrogel.
In some optional aspects, the outer adhesive layer 62 and/or the inner adhesive layer 64 can comprise carbon black. For example, in exemplary aspects, the outer adhesive layer 62 and/or the inner adhesive layer 64 can comprise adhesive provided by ADHESIVE RESEARCH, such as ARcare® 8006 electrically conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). In other optional aspects, the outer adhesive layer 62 and/or the inner adhesive layer 64 can comprise carbon fibers or nanowires. For example, in exemplary aspects, the outer adhesive layer 62 and/or the inner adhesive layer 64 can comprise a dry carbon/salt adhesive, such as the developmental product FLX068983—FLEXcon® OMNI-WAVE™ TT 200 BLACK H-502 150 POLY H-9 44PP-8 from FLEXcon, Spencer, MA, USA, or other such OMNI-WAVE products from FLEXcon.
In some optional aspects, the outer adhesive layer 62 can have a thickness of at least 40 μm (optionally, at least 45 μm or at least 50 μm). For example, the thickness of the outer adhesive layer 62 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). In further optional aspects, the inner adhesive layer 64 can have a thickness of at least 40 μm (optionally, at least 45 μm or at least 50 μm). For example, the thickness of the inner adhesive layer 64 can 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 was discovered that an excessive thickness (e.g., greater than 75 μm or, even, greater than 65 μm in certain embodiments) can leave a residue following removal from a subject or patient. It was further discovered that an insufficient thickness (e.g., less than 25 μm in certain embodiments) can result in the layers breaking too easily.
In some embodiments, the substrate 66 of the skin contact structure 60 (
In alternative aspects, the substrate 66 of the skin contact structure 60 can have an at least partially open structure that is configured to permit flow of adhesive between or among the inner and outer adhesive layers 64, 62 of the skin contact structure. In this way, the adhesive can conduct electricity through the substrate 66. For example, in some aspects, the substrate 66 can comprise a mesh. Optionally, the mesh can have a density from about 6 grams per square meter to about 8 grams per square meter. In other aspects, the substrate 66 can comprise a scrim.
In various optional aspects, the substrate 66 of the skin contact structure 60 can comprise paper, any suitable polymer (e.g., polyester, polyolefin, etc.), or fabric.
Optionally, the skin contact structure 60 can be reusable.
In some optional aspects, the upper adhesive layer 50 does not comprise hydrogel. In further or alternative aspects, the skin contact structure 60 does not comprise hydrogel. Accordingly, in some optional aspects, both the upper adhesive layer 50 and the skin contact structure 60 do not comprise hydrogel. In other aspects, either the upper adhesive layer 50 or the skin contact structure 60, or both, may comprise hydrogel.
In exemplary aspects, the conductive adhesive composite of any of the layers of the apparatus can comprise a dielectric material and conductive particles dispersed within the dielectric material. In some embodiments, at least a portion of the conductive particles define a conductive pathway through a thickness of the conductive adhesive composite. It is contemplated that the conductive particles can be aligned in response to application of an electric field such that the conductive particles undergo electrophoresis. In some aspects, the dielectric material of the conductive adhesive composite of each of the first and second electrode assemblies is a polymeric adhesive. Optionally, in these aspects, the polymeric adhesive can be an acrylic adhesive. In some aspects, the conductive particles can comprise carbon. Optionally, in these aspects, the conductive particles can comprise graphite powder. Additionally, or alternatively, the conductive particles can comprise carbon flakes. Additionally, or alternatively, the conductive particles can comprise carbon granules. Additionally, or alternatively, the conductive particles can comprise carbon fibers. Additionally, or alternatively, the conductive particles can comprise carbon nanotubes or carbon nanowires. Additionally, or alternatively, the conductive particles can comprise carbon black powder. In further aspects, the conductive adhesive composite further comprises a polar material (e.g., a polar salt). The polar salt may be a quaternary ammonium salt, such as a tetra alkyl ammonium salt. Exemplary conductive adhesive composites, as well as methods for making such conductive adhesive composites, are disclosed in U.S. Pat. Nos. 8,673,184 and 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 compositions, described above, manufactured and sold by FLEXCON (Spencer, MA, USA).
In some aspects, the layer of anisotropic material 40 has a first thermal conductivity in a direction that is perpendicular to a plane of the layer. The thermal conductivity of the layer of anisotropic material 40 in directions that are parallel to the plane of the layer of anisotropic material can be more than two times higher than the first thermal conductivity. For example, in some aspects, the thermal conductivity of the layer of anisotropic material 40 in directions that are parallel to the plane of the layer of anisotropic material can be more than three times higher, more than four times higher, or more five times higher than the first thermal conductivity. In some aspects, the thermal conductivity in the parallel directions is more than ten times higher than the first thermal conductivity. In various aspects, for example, the thermal conductivity of the layer of isotropic material 40 in directions that are parallel to the plane of the layer of anisotropic material can be more than: 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 thermal conductivity.
The layer of anisotropic material 40 can have a first resistance in a direction that is perpendicular to a plane of the layer. In some optional aspects, resistance of the layer in directions that are parallel to the plane of the layer is less than half the first resistance. In exemplary aspects, the resistance of the layer of anisotropic material 40 in directions that are parallel to the plane of the layer can be less than 10% of the first resistance. In exemplary aspects, the resistance of the layer of anisotropic material 40 in directions that are parallel to the plane of the layer can be less than 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5%, or even less than 0.1% of the first.
In some optional aspects, the anisotropic material can comprise graphite. In some optional aspects, the graphite can comprise synthetic graphite. The layer of anisotropic material can be, or can comprise, a layer of pyrolytic graphite, graphitized polymer film, or 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 Sheet (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, that supplied by MinGraph® 2010A Flexible Graphite, available from Mineral Seal Corp., Tucson, Arizona, USA), or graphitized polymer film, e.g., graphitized polyimide film, (including, but not limited to, that supplied by Kaneka Corp., Moka, Tochigi, Japan. In alternative embodiments, conductive anisotropic materials other than graphite may be used instead of graphite.
The plurality of electrode elements 22, can be wired together (e.g., using wires, traces on a flex circuit, etc.) to a lead 90 (
The apparatus 10 can comprise a flexible self-adhesive backing 80 (
Referring also to
As discussed above and with reference to
The first and second electrode assemblies 10a,b can each further comprise a layer of anisotropic material 40 having a skin-facing surface 42 and an opposing outwardly facing surface 44. An upper adhesive layer 50 can comprise a conductive adhesive composite. The upper adhesive layer 50 can be disposed on an outer side 46 of the layer of anisotropic material. The apparatus 10 can comprise a skin contact structure 60 having an adhesive layer comprising a conductive adhesive composite. The skin contact structure 60 can be disposed on an inner (skin-facing) side 48 of the layer of anisotropic material 40, or it can be disposed directly on the inner (skin-facing) surface 42 of the layer of anisotropic material 40. The skin contact structure 60 can be a single layer adhesive (a conductive adhesive composite), or, alternatively, the skin contact structure 60 may comprise multiple layers. For example, the skin contact structure 60 may comprise an outer adhesive layer 62, an inner adhesive layer 64, and a substrate 66 positioned between the outer and inner adhesive layers 62, 64, as discussed above.
At least one electrode element 22 of the plurality of electrode elements can be in electrical contact with the outwardly facing surface 44 of the layer of anisotropic material 40.
The skin contact structure 60 of each of the first and second electrode assemblies 10a,b can contact skin 100 of the subject. An alternating voltage can be applied between the first electrode assembly 10a and the second electrode assembly 10b, thereby generating an electric field.
The alternating voltage between the first electrode assembly and the second electrode assembly 10a,b can be applied by an AC voltage generator 820. In some embodiments, the frequency of the alternating voltage is between 50 kHz and 1 MHz, or between 100 kHz and 500 kHz. In the illustrated example, the AC voltage generator is controlled by a controller 822. The controller 822 may use temperature measurements to control the amplitude of the current to be delivered via the first and second electrode assemblies 10a and 10b in order to maintain temperatures below a safety threshold (e.g., 41° C.). This may be accomplished, for example, by measuring a first temperature of the first electrode element, measuring a second temperature of the second electrode element, and controlling the applying of the alternating voltage based on the first temperature and the second temperature, as described below.
In view of the described products, systems, and methods and variations thereof, herein below are described certain more particularly described aspects of the invention. These particularly recited aspects should not however be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language literally used therein.
Aspect 1: An apparatus comprising:
Aspect 2: The apparatus of aspect 1, further comprising a layer of anisotropic material having a skin-facing surface and an opposing outwardly facing surface,
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 layer of anisotropic material.
Aspect 4: The apparatus of any one of the preceding aspects, wherein each electrode element of the plurality of electrode elements comprises:
Aspect 5: The apparatus of aspect 4, wherein the dielectric material is a ceramic material.
Aspect 6: The apparatus of 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 between, and spaced from, the first and third electrode elements along the first axis, and wherein the at least one filler structure further comprises a second filler portion positioned between the second and third electrode elements along the first axis.
Aspect 7: The apparatus of any one of the preceding aspects, wherein the plurality of electrode elements comprises at least two rows of electrode elements that extend along or parallel to a second axis that is perpendicular to the first axis, wherein the at least two rows of electrode elements comprises a first row of electrode elements that includes the first electrode element and a second row of electrode elements that includes the second electrode element, wherein the first filler portion is positioned between the first and second rows of electrode elements along the first axis.
Aspect 8: The apparatus of aspect 6, wherein the plurality of electrode elements comprises at least three rows of electrode elements that extend along or parallel to a second axis that is perpendicular to the first axis, wherein the at least three rows of electrode elements comprises a first row of electrode elements that includes the first electrode element, a second row of electrode elements that includes the second electrode element, and a third row of electrode elements that includes the third electrode element, wherein the first filler portion is positioned between the first and second rows of electrode elements, and wherein the second filler portion is positioned between the second and third rows of electrode elements.
Aspect 9: The apparatus of aspect 7 or aspect 8, wherein each row of electrode elements comprises three electrode elements.
Aspect 10: The apparatus of any one of the preceding aspects, wherein the upper adhesive layer and the skin contact structure do not comprise hydrogel.
Aspect 11: The apparatus of any one of aspects 2-10, wherein the layer of anisotropic material has a first thermal conductivity in a direction that is perpendicular to a plane of the layer, and wherein thermal conductivity of the layer in directions that are parallel to the plane of the layer is more than two times higher than the first thermal conductivity.
Aspect 12: The apparatus of any one of aspects 2-11, wherein the layer of anisotropic material has a first resistance in a direction that is perpendicular to a plane of the layer, and wherein resistance of the layer in directions that are parallel to the plane of the layer is less than half the first resistance.
Aspect 13: The apparatus of any one of aspects 2-12, wherein the anisotropic material comprises a synthetic graphite.
Aspect 14: The apparatus of any one of aspects 2-13, wherein the layer of anisotropic material is or comprises a layer of pyrolytic graphite, graphitized polymer film, or graphite foil made from compressed high purity exfoliated mineral graphite.
Aspect 15: The apparatus of any one of the preceding aspects, wherein the skin contact structure comprises:
Aspect 16: The apparatus of aspect 15, wherein the inner and outer adhesive layers of the skin contact structure do not comprise hydrogel.
Aspect 17: The apparatus of aspect 15 or aspect 16, wherein the conductive adhesive composite of the inner and outer adhesive layers of the skin contact structure, each, individually, comprises:
Aspect 18: The apparatus of any one of aspects 15-17, wherein the substrate of the skin contact structure has a continuous, uninterrupted structure.
Aspect 19: The apparatus of aspect 18, wherein the substrate of the skin contact structure is electrically conductive.
Aspect 20: The apparatus of any one of aspects 15-19, wherein the substrate of the skin contact structure is a mesh or scrim layer.
Aspect 21: The apparatus of any one of the preceding aspects, wherein the at least one filler structure is or comprises a foam, a gel, or a hydrocolloid.
Aspect 22: The apparatus of any one of the preceding aspects, wherein the first filler portion has a shape that is complementary to a shape of the space between the first and second electrode elements.
Aspect 23: The apparatus of any one of aspects 6-22, wherein the first filler portion and/or the second filler portion is part of a strip of filler structure material that fills the gap between either one or more rows of electrode elements or one or more columns of electrode elements.
Aspect 24: The apparatus of any one of aspects 6-22, wherein the first filler portion and the second filler portion are part of a shaped layer of filler structure material that fills the gaps between all of the electrode elements, having cut-outs as void spaces that receive respective electrode elements of the plurality of electrode elements.
Aspect 25: The apparatus of any one of the preceding aspects, wherein the filler structure comprises a hydrocolloid.
Aspect 26: The apparatus of any one of the preceding aspects, wherein the filler structure is or comprises a hydrocolloid or a hydrocolloid gel.
Aspect 27: The apparatus of any one of the preceding aspects, wherein the filler structure comprises a medication.
Aspect 28: An apparatus comprising:
Aspect 29: The apparatus of any one of the preceding aspects, wherein the filler structure comprises a hydrocolloid or a hydrocolloid gel.
Aspect 30: The apparatus of any one of the preceding aspects, wherein the filler structure is or comprises a medication.
Aspect 31: A method comprising:
While the present invention has been disclosed with reference to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.
This application claims priority to and the benefit of the filing date of U.S. Provisional Application No. 63/408,918, filed Sep. 22, 2022, the entirety of which is hereby incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63408918 | Sep 2022 | US |
